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TOPLINE: 

The Breast Cancer Index (BCI) can predict which premenopausal women with hormone receptor–positive breast cancer benefit from ovarian function suppression (OFS) therapy. Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.

METHODOLOGY:

• Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
• Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
• BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
• The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
• Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.

TAKEAWAY:

• According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
• Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
• In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
• BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.

IN PRACTICE:

“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.

SOURCE:

The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.

LIMITATIONS: 

The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.

DISCLOSURES:

Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

The Breast Cancer Index (BCI) can predict which premenopausal women with hormone receptor–positive breast cancer benefit from ovarian function suppression (OFS) therapy. Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.

METHODOLOGY:

• Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
• Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
• BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
• The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
• Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.

TAKEAWAY:

• According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
• Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
• In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
• BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.

IN PRACTICE:

“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.

SOURCE:

The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.

LIMITATIONS: 

The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.

DISCLOSURES:

Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

The Breast Cancer Index (BCI) can predict which premenopausal women with hormone receptor–positive breast cancer benefit from ovarian function suppression (OFS) therapy. Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.

METHODOLOGY:

• Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
• Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
• BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
• The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
• Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.

TAKEAWAY:

• According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
• Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
• In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
• BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.

IN PRACTICE:

“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.

SOURCE:

The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.

LIMITATIONS: 

The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.

DISCLOSURES:

Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Despite experiencing higher rates of positive margins and pathologic node involvement, patients with early-stage breast cancer who undergo nipple-sparing mastectomy are less likely to receive adjuvant radiation therapy than are those who have breast-conserving surgery. 

METHODOLOGY:

• Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
• Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
• The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
• The team also compared overall survival outcomes in patients with positive margins and node involvement.

TAKEAWAY: 

• Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
• Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
• Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
• In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).

IN PRACTICE:

The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.

SOURCE:

The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology. 

LIMITATIONS: 

Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes. 

DISCLOSURES:

The study did not receive any funding support. The authors disclosed no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Despite experiencing higher rates of positive margins and pathologic node involvement, patients with early-stage breast cancer who undergo nipple-sparing mastectomy are less likely to receive adjuvant radiation therapy than are those who have breast-conserving surgery. 

METHODOLOGY:

• Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
• Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
• The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
• The team also compared overall survival outcomes in patients with positive margins and node involvement.

TAKEAWAY: 

• Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
• Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
• Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
• In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).

IN PRACTICE:

The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.

SOURCE:

The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology. 

LIMITATIONS: 

Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes. 

DISCLOSURES:

The study did not receive any funding support. The authors disclosed no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Despite experiencing higher rates of positive margins and pathologic node involvement, patients with early-stage breast cancer who undergo nipple-sparing mastectomy are less likely to receive adjuvant radiation therapy than are those who have breast-conserving surgery. 

METHODOLOGY:

• Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
• Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
• The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
• The team also compared overall survival outcomes in patients with positive margins and node involvement.

TAKEAWAY: 

• Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
• Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
• Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
• In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).

IN PRACTICE:

The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.

SOURCE:

The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology. 

LIMITATIONS: 

Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes. 

DISCLOSURES:

The study did not receive any funding support. The authors disclosed no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies. 

Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast. 

However, men often fly under the radar. 

Although males represent half of BRCA1/2 pathogenic variant carriers, men are much less likely to receive genetic testing for BRCA mutations. “Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers. 

The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.

A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai. 

Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said. 
 

BRCA Mutations in Men: What’s the Risk? 

Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers. 

BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.

For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.

Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%. 
 

When to Test, When to Screen?

Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.

BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization. 

For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.

Even for confirmed BRCA carriers, cancer screening guidelines for men vary.

For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family. 

Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening. 

The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.

The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review. 

For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.

And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.

A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”

To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.

Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.

Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies. 

Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast. 

However, men often fly under the radar. 

Although males represent half of BRCA1/2 pathogenic variant carriers, men are much less likely to receive genetic testing for BRCA mutations. “Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers. 

The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.

A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai. 

Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said. 
 

BRCA Mutations in Men: What’s the Risk? 

Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers. 

BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.

For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.

Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%. 
 

When to Test, When to Screen?

Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.

BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization. 

For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.

Even for confirmed BRCA carriers, cancer screening guidelines for men vary.

For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family. 

Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening. 

The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.

The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review. 

For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.

And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.

A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”

To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.

Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.

Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies. 

Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast. 

However, men often fly under the radar. 

Although males represent half of BRCA1/2 pathogenic variant carriers, men are much less likely to receive genetic testing for BRCA mutations. “Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers. 

The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.

A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai. 

Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said. 
 

BRCA Mutations in Men: What’s the Risk? 

Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers. 

BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.

For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.

Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%. 
 

When to Test, When to Screen?

Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.

BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization. 

For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.

Even for confirmed BRCA carriers, cancer screening guidelines for men vary.

For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family. 

Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening. 

The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.

The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review. 

For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.

And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.

A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”

To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.

Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.

Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

People over age 60 who drink alcohol regularly are at an increased risk of early death, particularly from cancer or issues related to the heart and blood vessels.

That’s according to the findings of a new, large study that was published in JAMA Network Openand build upon numerous other recent studies concluding that any amount of alcohol consumption is linked to significant health risks. That’s a change from decades of public health messaging suggesting that moderate alcohol intake (one or two drinks per day) wasn’t dangerous. Recently, experts have uncovered flaws in how researchers came to those earlier conclusions.

In this latest study, researchers in Spain analyzed health data for more than 135,000 people, all of whom were at least 60 years old, lived in the United Kingdom, and provided their health information to the UK Biobank database. The average age of people at the start of the analysis period was 64.

The researchers compared 12 years of health outcomes for occasional drinkers with those who averaged drinking at least some alcohol on a daily basis. The greatest health risks were seen between occasional drinkers and those whom the researchers labeled “high risk.” Occasional drinkers had less than about two drinks per week. The high-risk group included men who averaged nearly three drinks per day or more, and women who averaged about a drink and a half per day or more. The analysis showed that, compared with occasional drinking, high-risk drinking was linked to a 33% increased risk of early death, a 39% increased risk of dying from cancer, and a 21% increased risk of dying from problems with the heart and blood vessels.

More moderate drinking habits were also linked to an increased risk of early death and dying from cancer, and even just averaging about one drink or less daily was associated with an 11% higher risk of dying from cancer. Low and moderate drinkers were most at risk if they also had health problems or experienced socioeconomic factors like living in less affluent neighborhoods.

The findings also suggested the potential that mostly drinking wine, or drinking mostly with meals, may be lower risk, but the researchers called for further study on those topics since “it may mostly reflect the effect of healthier lifestyles, slower alcohol absorption, or nonalcoholic components of beverages.”

A recent Gallup poll showed that overall, Americans’ attitudes toward the health impacts of alcohol are changing, with 65% of young adults (ages 18-34) saying that drinking can have negative health effects. But just 39% of adults age 55 or older agreed that drinking is bad for a person’s health. The gap in perspectives between younger and older adults about drinking is the largest on record, Gallup reported.

The study investigators reported no conflicts of interest.

A version of this article first appeared on WebMD.com.

People over age 60 who drink alcohol regularly are at an increased risk of early death, particularly from cancer or issues related to the heart and blood vessels.

That’s according to the findings of a new, large study that was published in JAMA Network Openand build upon numerous other recent studies concluding that any amount of alcohol consumption is linked to significant health risks. That’s a change from decades of public health messaging suggesting that moderate alcohol intake (one or two drinks per day) wasn’t dangerous. Recently, experts have uncovered flaws in how researchers came to those earlier conclusions.

In this latest study, researchers in Spain analyzed health data for more than 135,000 people, all of whom were at least 60 years old, lived in the United Kingdom, and provided their health information to the UK Biobank database. The average age of people at the start of the analysis period was 64.

The researchers compared 12 years of health outcomes for occasional drinkers with those who averaged drinking at least some alcohol on a daily basis. The greatest health risks were seen between occasional drinkers and those whom the researchers labeled “high risk.” Occasional drinkers had less than about two drinks per week. The high-risk group included men who averaged nearly three drinks per day or more, and women who averaged about a drink and a half per day or more. The analysis showed that, compared with occasional drinking, high-risk drinking was linked to a 33% increased risk of early death, a 39% increased risk of dying from cancer, and a 21% increased risk of dying from problems with the heart and blood vessels.

More moderate drinking habits were also linked to an increased risk of early death and dying from cancer, and even just averaging about one drink or less daily was associated with an 11% higher risk of dying from cancer. Low and moderate drinkers were most at risk if they also had health problems or experienced socioeconomic factors like living in less affluent neighborhoods.

The findings also suggested the potential that mostly drinking wine, or drinking mostly with meals, may be lower risk, but the researchers called for further study on those topics since “it may mostly reflect the effect of healthier lifestyles, slower alcohol absorption, or nonalcoholic components of beverages.”

A recent Gallup poll showed that overall, Americans’ attitudes toward the health impacts of alcohol are changing, with 65% of young adults (ages 18-34) saying that drinking can have negative health effects. But just 39% of adults age 55 or older agreed that drinking is bad for a person’s health. The gap in perspectives between younger and older adults about drinking is the largest on record, Gallup reported.

The study investigators reported no conflicts of interest.

A version of this article first appeared on WebMD.com.

People over age 60 who drink alcohol regularly are at an increased risk of early death, particularly from cancer or issues related to the heart and blood vessels.

That’s according to the findings of a new, large study that was published in JAMA Network Openand build upon numerous other recent studies concluding that any amount of alcohol consumption is linked to significant health risks. That’s a change from decades of public health messaging suggesting that moderate alcohol intake (one or two drinks per day) wasn’t dangerous. Recently, experts have uncovered flaws in how researchers came to those earlier conclusions.

In this latest study, researchers in Spain analyzed health data for more than 135,000 people, all of whom were at least 60 years old, lived in the United Kingdom, and provided their health information to the UK Biobank database. The average age of people at the start of the analysis period was 64.

The researchers compared 12 years of health outcomes for occasional drinkers with those who averaged drinking at least some alcohol on a daily basis. The greatest health risks were seen between occasional drinkers and those whom the researchers labeled “high risk.” Occasional drinkers had less than about two drinks per week. The high-risk group included men who averaged nearly three drinks per day or more, and women who averaged about a drink and a half per day or more. The analysis showed that, compared with occasional drinking, high-risk drinking was linked to a 33% increased risk of early death, a 39% increased risk of dying from cancer, and a 21% increased risk of dying from problems with the heart and blood vessels.

More moderate drinking habits were also linked to an increased risk of early death and dying from cancer, and even just averaging about one drink or less daily was associated with an 11% higher risk of dying from cancer. Low and moderate drinkers were most at risk if they also had health problems or experienced socioeconomic factors like living in less affluent neighborhoods.

The findings also suggested the potential that mostly drinking wine, or drinking mostly with meals, may be lower risk, but the researchers called for further study on those topics since “it may mostly reflect the effect of healthier lifestyles, slower alcohol absorption, or nonalcoholic components of beverages.”

A recent Gallup poll showed that overall, Americans’ attitudes toward the health impacts of alcohol are changing, with 65% of young adults (ages 18-34) saying that drinking can have negative health effects. But just 39% of adults age 55 or older agreed that drinking is bad for a person’s health. The gap in perspectives between younger and older adults about drinking is the largest on record, Gallup reported.

The study investigators reported no conflicts of interest.

A version of this article first appeared on WebMD.com.

Given the clinical presentation and the absence of other systemic or dermatological findings, the diagnosis of chevron nails was made.

Discussion

Chevron nails, also known as V-shaped nails or herringbone nails, are an uncommon but benign nail condition typically observed in infancy and early childhood. The condition is characterized by transverse ridges on the nails that converge towards the center, forming a V or chevron shape. This condition was first described by Perry et al. and later by Shuster et al., who explained that the condition might result from axial growth of the nail with synchronous growth occurring from a chevron-shaped growing edge of the nail root. Alternatively, Shuster suggested that sequential growth, with localized variation in the nail production rate, could propagate a wave from the center of the nail to the edge.

The etiology of chevron nails is not well understood, but it is believed to result from temporary disruptions in the nail matrix, possibly related to minor illness or physiological stress during infancy.

In the case of our 7-month-old patient, the history of mild upper respiratory infections might have contributed to the development of chevron nails. However, the lack of other significant illness, skin involvement, or systemic findings supports the benign and self-limiting nature of this condition. Parents were reassured that chevron nails typically resolve on their own as the child grows and that no specific treatment is necessary.
 

Differential Diagnosis

The differential diagnosis of transverse nail changes in children includes other conditions such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita.

Trachyonychia, also known as “sandpaper nails,” trachyonychia is characterized by the roughening of the nail surface, giving it a dull and ridged appearance. The condition may affect all 20 nails and is often associated with underlying dermatological conditions such as lichen planus or alopecia areata. Unlike chevron nails, trachyonychia presents with more diffuse nail changes and does not typically feature the distinct V-shaped ridging seen in this patient.

Lichen planus is an inflammatory condition that can affect the skin, mucous membranes, and nails. Nail involvement in lichen planus can lead to longitudinal ridging, thinning, and sometimes even complete nail loss. The absence of other characteristic features of lichen planus, such as violaceous papules on the skin or white lacy patterns on mucous membranes (Wickham striae), makes this diagnosis less likely in our patient.

Darier disease, also known as keratosis follicularis, is a genetic disorder characterized by greasy, warty papules primarily on seborrheic areas of the skin, nail abnormalities, and sometimes mucosal involvement. Nail changes in Darier disease include longitudinal red and white streaks, V-shaped notching at the free edge of the nails, and subungual hyperkeratosis. These nail changes are more severe and distinct than the simple transverse ridging seen in chevron nails. The absence of other clinical signs of Darier disease, such as skin papules or characteristic nail notching, makes this diagnosis unlikely in our patient.

Pachyonychia congenita is a rare genetic disorder characterized by thickened nails (pachyonychia), painful plantar keratoderma, and sometimes oral leukokeratosis. The condition typically presents with significant nail thickening and other systemic findings, which were absent in our patient. The distinct pattern of V-shaped ridging observed in chevron nails does not align with the typical presentation of pachyonychia congenita.
 

Next Steps

No specific treatment is required for chevron nails. The condition is typically self-resolving, and the nails usually return to a normal appearance as the child continues to grow. Parents were advised to monitor the nails for any changes or new symptoms and were reassured about the benign nature of the findings. Follow-up was scheduled to ensure the resolution of the condition as the child develops.

Conclusion

Chevron nails are an important consideration in the differential diagnosis of transverse nail ridging in infants and young children. While the condition is benign and self-limiting, it is crucial to differentiate it from other nail dystrophies, such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita, which may require further investigation or intervention. Awareness of chevron nails can help prevent unnecessary worry and provide reassurance to parents and caregivers.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Delano S, Belazarian L. Chevron nails: A normal variant in the pediatric population. Pediatr Dermatol. 2014 Jan-Feb;31(1):e24-5. doi: 10.1111/pde.12193.

John JM et al. Chevron nail — An under-recognised normal variant of nail development. Arch Dis Child. 2024 Jul 18;109(8):648. doi: 10.1136/archdischild-2024-326975.

Shuster S. The significance of chevron nails. Br J Dermatol. 1996;135:151–152. doi: 10.1046/j.1365-2133.1996.d01-961.x.

Starace M et al. Nail disorders in children. Skin Appendage Disord. 2018 Oct;4(4):217-229. doi: 10.1159/000486020.

Given the clinical presentation and the absence of other systemic or dermatological findings, the diagnosis of chevron nails was made.

Discussion

Chevron nails, also known as V-shaped nails or herringbone nails, are an uncommon but benign nail condition typically observed in infancy and early childhood. The condition is characterized by transverse ridges on the nails that converge towards the center, forming a V or chevron shape. This condition was first described by Perry et al. and later by Shuster et al., who explained that the condition might result from axial growth of the nail with synchronous growth occurring from a chevron-shaped growing edge of the nail root. Alternatively, Shuster suggested that sequential growth, with localized variation in the nail production rate, could propagate a wave from the center of the nail to the edge.

The etiology of chevron nails is not well understood, but it is believed to result from temporary disruptions in the nail matrix, possibly related to minor illness or physiological stress during infancy.

In the case of our 7-month-old patient, the history of mild upper respiratory infections might have contributed to the development of chevron nails. However, the lack of other significant illness, skin involvement, or systemic findings supports the benign and self-limiting nature of this condition. Parents were reassured that chevron nails typically resolve on their own as the child grows and that no specific treatment is necessary.
 

Differential Diagnosis

The differential diagnosis of transverse nail changes in children includes other conditions such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita.

Trachyonychia, also known as “sandpaper nails,” trachyonychia is characterized by the roughening of the nail surface, giving it a dull and ridged appearance. The condition may affect all 20 nails and is often associated with underlying dermatological conditions such as lichen planus or alopecia areata. Unlike chevron nails, trachyonychia presents with more diffuse nail changes and does not typically feature the distinct V-shaped ridging seen in this patient.

Lichen planus is an inflammatory condition that can affect the skin, mucous membranes, and nails. Nail involvement in lichen planus can lead to longitudinal ridging, thinning, and sometimes even complete nail loss. The absence of other characteristic features of lichen planus, such as violaceous papules on the skin or white lacy patterns on mucous membranes (Wickham striae), makes this diagnosis less likely in our patient.

Darier disease, also known as keratosis follicularis, is a genetic disorder characterized by greasy, warty papules primarily on seborrheic areas of the skin, nail abnormalities, and sometimes mucosal involvement. Nail changes in Darier disease include longitudinal red and white streaks, V-shaped notching at the free edge of the nails, and subungual hyperkeratosis. These nail changes are more severe and distinct than the simple transverse ridging seen in chevron nails. The absence of other clinical signs of Darier disease, such as skin papules or characteristic nail notching, makes this diagnosis unlikely in our patient.

Pachyonychia congenita is a rare genetic disorder characterized by thickened nails (pachyonychia), painful plantar keratoderma, and sometimes oral leukokeratosis. The condition typically presents with significant nail thickening and other systemic findings, which were absent in our patient. The distinct pattern of V-shaped ridging observed in chevron nails does not align with the typical presentation of pachyonychia congenita.
 

Next Steps

No specific treatment is required for chevron nails. The condition is typically self-resolving, and the nails usually return to a normal appearance as the child continues to grow. Parents were advised to monitor the nails for any changes or new symptoms and were reassured about the benign nature of the findings. Follow-up was scheduled to ensure the resolution of the condition as the child develops.

Conclusion

Chevron nails are an important consideration in the differential diagnosis of transverse nail ridging in infants and young children. While the condition is benign and self-limiting, it is crucial to differentiate it from other nail dystrophies, such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita, which may require further investigation or intervention. Awareness of chevron nails can help prevent unnecessary worry and provide reassurance to parents and caregivers.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Delano S, Belazarian L. Chevron nails: A normal variant in the pediatric population. Pediatr Dermatol. 2014 Jan-Feb;31(1):e24-5. doi: 10.1111/pde.12193.

John JM et al. Chevron nail — An under-recognised normal variant of nail development. Arch Dis Child. 2024 Jul 18;109(8):648. doi: 10.1136/archdischild-2024-326975.

Shuster S. The significance of chevron nails. Br J Dermatol. 1996;135:151–152. doi: 10.1046/j.1365-2133.1996.d01-961.x.

Starace M et al. Nail disorders in children. Skin Appendage Disord. 2018 Oct;4(4):217-229. doi: 10.1159/000486020.

Given the clinical presentation and the absence of other systemic or dermatological findings, the diagnosis of chevron nails was made.

Discussion

Chevron nails, also known as V-shaped nails or herringbone nails, are an uncommon but benign nail condition typically observed in infancy and early childhood. The condition is characterized by transverse ridges on the nails that converge towards the center, forming a V or chevron shape. This condition was first described by Perry et al. and later by Shuster et al., who explained that the condition might result from axial growth of the nail with synchronous growth occurring from a chevron-shaped growing edge of the nail root. Alternatively, Shuster suggested that sequential growth, with localized variation in the nail production rate, could propagate a wave from the center of the nail to the edge.

The etiology of chevron nails is not well understood, but it is believed to result from temporary disruptions in the nail matrix, possibly related to minor illness or physiological stress during infancy.

In the case of our 7-month-old patient, the history of mild upper respiratory infections might have contributed to the development of chevron nails. However, the lack of other significant illness, skin involvement, or systemic findings supports the benign and self-limiting nature of this condition. Parents were reassured that chevron nails typically resolve on their own as the child grows and that no specific treatment is necessary.
 

Differential Diagnosis

The differential diagnosis of transverse nail changes in children includes other conditions such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita.

Trachyonychia, also known as “sandpaper nails,” trachyonychia is characterized by the roughening of the nail surface, giving it a dull and ridged appearance. The condition may affect all 20 nails and is often associated with underlying dermatological conditions such as lichen planus or alopecia areata. Unlike chevron nails, trachyonychia presents with more diffuse nail changes and does not typically feature the distinct V-shaped ridging seen in this patient.

Lichen planus is an inflammatory condition that can affect the skin, mucous membranes, and nails. Nail involvement in lichen planus can lead to longitudinal ridging, thinning, and sometimes even complete nail loss. The absence of other characteristic features of lichen planus, such as violaceous papules on the skin or white lacy patterns on mucous membranes (Wickham striae), makes this diagnosis less likely in our patient.

Darier disease, also known as keratosis follicularis, is a genetic disorder characterized by greasy, warty papules primarily on seborrheic areas of the skin, nail abnormalities, and sometimes mucosal involvement. Nail changes in Darier disease include longitudinal red and white streaks, V-shaped notching at the free edge of the nails, and subungual hyperkeratosis. These nail changes are more severe and distinct than the simple transverse ridging seen in chevron nails. The absence of other clinical signs of Darier disease, such as skin papules or characteristic nail notching, makes this diagnosis unlikely in our patient.

Pachyonychia congenita is a rare genetic disorder characterized by thickened nails (pachyonychia), painful plantar keratoderma, and sometimes oral leukokeratosis. The condition typically presents with significant nail thickening and other systemic findings, which were absent in our patient. The distinct pattern of V-shaped ridging observed in chevron nails does not align with the typical presentation of pachyonychia congenita.
 

Next Steps

No specific treatment is required for chevron nails. The condition is typically self-resolving, and the nails usually return to a normal appearance as the child continues to grow. Parents were advised to monitor the nails for any changes or new symptoms and were reassured about the benign nature of the findings. Follow-up was scheduled to ensure the resolution of the condition as the child develops.

Conclusion

Chevron nails are an important consideration in the differential diagnosis of transverse nail ridging in infants and young children. While the condition is benign and self-limiting, it is crucial to differentiate it from other nail dystrophies, such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita, which may require further investigation or intervention. Awareness of chevron nails can help prevent unnecessary worry and provide reassurance to parents and caregivers.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Delano S, Belazarian L. Chevron nails: A normal variant in the pediatric population. Pediatr Dermatol. 2014 Jan-Feb;31(1):e24-5. doi: 10.1111/pde.12193.

John JM et al. Chevron nail — An under-recognised normal variant of nail development. Arch Dis Child. 2024 Jul 18;109(8):648. doi: 10.1136/archdischild-2024-326975.

Shuster S. The significance of chevron nails. Br J Dermatol. 1996;135:151–152. doi: 10.1046/j.1365-2133.1996.d01-961.x.

Starace M et al. Nail disorders in children. Skin Appendage Disord. 2018 Oct;4(4):217-229. doi: 10.1159/000486020.

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes. 

Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.

“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”

“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”

Dry fasting also can lead to electrolyte imbalances, and the risk is higher for those with diabetes due to potential underlying kidney issues, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”

Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
 

What Exactly Is Dry Fasting?

Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”

Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.

“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.

The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’

Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours. 

Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
 

What the Evidence Says

All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.

In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)

Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”

In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
 

What to Advise Patients

For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.

Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.

Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.

“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”

Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.

Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
 

A version of this article appeared on Medscape.com.

Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes. 

Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.

“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”

“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”

Dry fasting also can lead to electrolyte imbalances, and the risk is higher for those with diabetes due to potential underlying kidney issues, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”

Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
 

What Exactly Is Dry Fasting?

Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”

Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.

“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.

The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’

Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours. 

Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
 

What the Evidence Says

All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.

In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)

Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”

In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
 

What to Advise Patients

For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.

Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.

Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.

“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”

Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.

Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
 

A version of this article appeared on Medscape.com.

Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes. 

Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.

“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”

“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”

Dry fasting also can lead to electrolyte imbalances, and the risk is higher for those with diabetes due to potential underlying kidney issues, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”

Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
 

What Exactly Is Dry Fasting?

Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”

Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.

“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.

The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’

Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours. 

Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
 

What the Evidence Says

All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.

In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)

Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”

In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
 

What to Advise Patients

For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.

Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.

Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.

“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”

Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.

Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
 

A version of this article appeared on Medscape.com.

At least 25% of unresponsive patients with a disorder of consciousness show signs of brain activity, an estimate that is higher than previous studies suggest.

“We found that at least 1 in 4 patients who are unresponsive to commands might actually be quite present and highly cognitive,” said study investigator Nicholas D. Schiff, MD, Feil Family Brain & Mind Research Institute and Department of Neurology, Weill Cornell Medicine, Rockefeller University Hospital, New York.

“In other words, if you go to the bedside and carefully examine someone with a severe brain injury and find no evidence of responsiveness, no one has been able to give you an a priori number to say how likely you are to be wrong in thinking this person is actually unaware, not processing language, and not capable of high-level cognitive work. And the answer to that now is at least 1 in 4 times.”

The findings were published online in The New England Journal of Medicine.
 

Clinical Implications? 

Cognitive motor dissociation (CMD) is a condition whereby patients with a severe brain injury who are unresponsive to commands at the bedside show brain activity on functional MRI (fMRI) or electroencephalography (EEG) when presented with selective motor imagery commands, such as “imagine playing tennis,” or “ imagine opening and closing your hand.”

Previous research shows that CMD is present in 10%-20% of people with a disorder of consciousness, a rate similar to that in patients with acute or chronic brain injury.

Understanding that a patient who appears unconscious has signs of cognitive processing could change the way clinicians and family interact with such individuals. Unresponsive patients who are aware may eventually be able to harness emerging communication technologies such as brain-computer interfaces.

In addition, knowing an individual’s CMD status could aid in prognosis. “We know from one study that there’s a four times increased likelihood that patients will be independent in a year in their function if they have cognitive motor dissociation,” said Dr. Schiff.

Unlike most previous studies of CMD, which were conducted at single sites and had relatively small cohorts, this new study included 353 adults with a disorder of consciousness (mean age, 37.9 years; 64% male) at six multinational sites.

Participants were recruited using a variety of methods, including consecutive enrollment of critically ill patients in the intensive care unit and enrollment of those with chronic illness or injury who were in the postacute phase of brain injury.
 

Response to Commands

Study participants were at different stages of recovery from an acute brain injury that had occurred an average of 8 months before the study started.

To determine the presence or absence of an observable response to commands among participants, trained staff used the Coma Recovery Scale–Revised (CRS-R); scores on this instrument range from 0 to 23, and higher scores indicate better neurobehavioral function.

About 40% of individuals were diagnosed with coma or vegetative state, 29% with minimally conscious state–minus, and 22% with minimally conscious state–plus. In all, 10% had emerged from a minimally conscious state.

Researchers assessed response to timed and repeated commands using fMRI or EEG in participants without an observable response to verbal commands, including those with a behavioral diagnosis of coma, vegetative state, or minimally conscious state–minus, and in participants with an observable response to verbal commands.

Of the 353 study participants, 61% underwent at least one fMRI assessment and 74% at least one EEG assessment. Both fMRI and EEG were performed in 35% of participants.

Dr. Schiff explained the two assessment types provide slightly different information, in that they measuring different types of brain signals. He also noted that although “every medical center in the world” has EEG, many do not have fMRI.

The brain imaging assessments captured brain activity within the motor area of the frontal cortex when tasked with motor imagery.

Of the 241 participants deemed to be in a coma or vegetative state or minimally conscious state–minus on the basis of CRS-R score, 60 (25%) had a response to commands on task-based fMRI, task-based EEG, or both.

The percentage of participants with CMD varied across study sites, from 2% to 45%, but Dr. Schiff said the reason for this is unclear. 

The proportion of participants with CMD may have been even higher if all individuals had been assessed with both imaging techniques, he said.
 

Higher Rate of Awareness Than in Previous Research

The investigators noted that the percentage of participants with CMD in their study was up to 10 percentage points higher than in previous studies. This may be due to the multimodal approach that classified participants undergoing assessment with both fMRI and EEG on the basis of responses on either technique, they said. 

The median age was lower among participants with CMD than those without CMD (30.5 years vs 45.3 years).

Compared with participants without CMD, a higher percentage of those with such dissociation had brain trauma as an etiologic factor (65% vs 38%) and a diagnosis of minimally conscious state–minus on the CRS-R (53% vs 38%).

Among people with CMD, 18% were assessed with fMRI only, 22% with EEG only, and 60% with both fMRI and EEG.

Dr. Schiff noted that the use of both fMRI and EEG appears to be more sensitive in detecting brain activity during tasks compared with use of one of these techniques alone.

Of the 112 participants with a diagnosis of minimally conscious state–plus or who had emerged from the minimally conscious state, 38% had a response to commands on task-based fMRI, task-based EEG, or both. Among these participants, 23% were assessed with fMRI only, 19% with EEG only, and 58% with both fMRI and EEG.

Research shows “it’s very clear that people with severe brain injury continue to get better over time,” noted Dr. Schiff. “Every month and week matters, and so it probably is the case that a lot of these patients are picking up the level of recovery, and the later we go out to measure them, the more likely we are to find people who are CMD than not.”

These new results should prompt further study to explore whether detection of CMD can lead to improved outcomes, the investigators noted. “In addition, the standardization, validation, and simplification of task-based fMRI and EEG methods that are used to detect cognitive motor dissociation are needed to prompt widespread clinical integration of these techniques and investigation of the bioethical implications of the findings.”

All study participants with chronic brain injury had survived their initial illness or injury and had access to a research facility with advanced fMRI and EEG capabilities. “This survival bias may reflect greater cognitive reserve and resilience over time among the participants. As such, the results of our study may not be generalizable to the overall population of patients with cognitive motor dissociation,” the investigators wrote.

Another study limitation was that participating sites used heterogeneous strategies to acquire, analyze, and interpret data, which led to differences in the number, type, and ordering of the cognitive tasks assessed on fMRI and EEG.

“These differences, along with variations in recruitment strategies and participant characteristics, may have contributed to the unequal percentage of participants with cognitive motor dissociation observed at each site. Our findings may therefore not be generalizable across all centers,” the researchers wrote. 

Only a few academic medical centers have the specially trained personnel and techniques needed to assess patients for CMD — which, the researchers noted, limits the feasibility of performing these assessments in general practice.
 

Challenging Research

Commenting on the research, Aarti Sarwal, MD, professor of neurology and section chief, Neurocritical Care, Virginia Commonwealth University, Richmond, Virginia, noted that this was a “very challenging” study to perform, given that only a few academic centers are equipped to perform both fMRI and quantitative EEG analysis.

“In general, finding patients this far out, who have access to clinical, radiological, and electrophysiological testing and were provided good care enough to receive these, is a mammoth task in itself.” 

Dr. Sarwal said the study builds on efforts of the Curing Coma campaign , a clinical, scientific, and public health effort of the Neurocritical Care Society to tackle the concept of coma as a treatable medical entity.

“It continues to highlight the challenges of prognostication in acute brain injured patients by showing a higher presence of cognitive function than previously perceived,” she said.

Dr. Sarwal believes that the study’s largest impact is underscoring the need for more research into understanding the degree and quality of cognitive processing in patients with a disorder of consciousness. But it also underlines the need for a “healthy debate” on the cost/benefit analysis of pursuing such research, given the limited number of patients with access to resources. 

“This debate needs to include the caregivers and families outside the traditional realms of stakeholders overseeing the science.” 

Although communication with comatose patients is still “a ways away,” this research is “a step in the right direction,” said Dr. Sarwal. 

The study was funded by the James S. McDonnell Foundation and others. Dr. Schiff and Dr. Sarwal report no relevant financial disclosures.
 

A version of this article first appeared on Medscape.com.

At least 25% of unresponsive patients with a disorder of consciousness show signs of brain activity, an estimate that is higher than previous studies suggest.

“We found that at least 1 in 4 patients who are unresponsive to commands might actually be quite present and highly cognitive,” said study investigator Nicholas D. Schiff, MD, Feil Family Brain & Mind Research Institute and Department of Neurology, Weill Cornell Medicine, Rockefeller University Hospital, New York.

“In other words, if you go to the bedside and carefully examine someone with a severe brain injury and find no evidence of responsiveness, no one has been able to give you an a priori number to say how likely you are to be wrong in thinking this person is actually unaware, not processing language, and not capable of high-level cognitive work. And the answer to that now is at least 1 in 4 times.”

The findings were published online in The New England Journal of Medicine.
 

Clinical Implications? 

Cognitive motor dissociation (CMD) is a condition whereby patients with a severe brain injury who are unresponsive to commands at the bedside show brain activity on functional MRI (fMRI) or electroencephalography (EEG) when presented with selective motor imagery commands, such as “imagine playing tennis,” or “ imagine opening and closing your hand.”

Previous research shows that CMD is present in 10%-20% of people with a disorder of consciousness, a rate similar to that in patients with acute or chronic brain injury.

Understanding that a patient who appears unconscious has signs of cognitive processing could change the way clinicians and family interact with such individuals. Unresponsive patients who are aware may eventually be able to harness emerging communication technologies such as brain-computer interfaces.

In addition, knowing an individual’s CMD status could aid in prognosis. “We know from one study that there’s a four times increased likelihood that patients will be independent in a year in their function if they have cognitive motor dissociation,” said Dr. Schiff.

Unlike most previous studies of CMD, which were conducted at single sites and had relatively small cohorts, this new study included 353 adults with a disorder of consciousness (mean age, 37.9 years; 64% male) at six multinational sites.

Participants were recruited using a variety of methods, including consecutive enrollment of critically ill patients in the intensive care unit and enrollment of those with chronic illness or injury who were in the postacute phase of brain injury.
 

Response to Commands

Study participants were at different stages of recovery from an acute brain injury that had occurred an average of 8 months before the study started.

To determine the presence or absence of an observable response to commands among participants, trained staff used the Coma Recovery Scale–Revised (CRS-R); scores on this instrument range from 0 to 23, and higher scores indicate better neurobehavioral function.

About 40% of individuals were diagnosed with coma or vegetative state, 29% with minimally conscious state–minus, and 22% with minimally conscious state–plus. In all, 10% had emerged from a minimally conscious state.

Researchers assessed response to timed and repeated commands using fMRI or EEG in participants without an observable response to verbal commands, including those with a behavioral diagnosis of coma, vegetative state, or minimally conscious state–minus, and in participants with an observable response to verbal commands.

Of the 353 study participants, 61% underwent at least one fMRI assessment and 74% at least one EEG assessment. Both fMRI and EEG were performed in 35% of participants.

Dr. Schiff explained the two assessment types provide slightly different information, in that they measuring different types of brain signals. He also noted that although “every medical center in the world” has EEG, many do not have fMRI.

The brain imaging assessments captured brain activity within the motor area of the frontal cortex when tasked with motor imagery.

Of the 241 participants deemed to be in a coma or vegetative state or minimally conscious state–minus on the basis of CRS-R score, 60 (25%) had a response to commands on task-based fMRI, task-based EEG, or both.

The percentage of participants with CMD varied across study sites, from 2% to 45%, but Dr. Schiff said the reason for this is unclear. 

The proportion of participants with CMD may have been even higher if all individuals had been assessed with both imaging techniques, he said.
 

Higher Rate of Awareness Than in Previous Research

The investigators noted that the percentage of participants with CMD in their study was up to 10 percentage points higher than in previous studies. This may be due to the multimodal approach that classified participants undergoing assessment with both fMRI and EEG on the basis of responses on either technique, they said. 

The median age was lower among participants with CMD than those without CMD (30.5 years vs 45.3 years).

Compared with participants without CMD, a higher percentage of those with such dissociation had brain trauma as an etiologic factor (65% vs 38%) and a diagnosis of minimally conscious state–minus on the CRS-R (53% vs 38%).

Among people with CMD, 18% were assessed with fMRI only, 22% with EEG only, and 60% with both fMRI and EEG.

Dr. Schiff noted that the use of both fMRI and EEG appears to be more sensitive in detecting brain activity during tasks compared with use of one of these techniques alone.

Of the 112 participants with a diagnosis of minimally conscious state–plus or who had emerged from the minimally conscious state, 38% had a response to commands on task-based fMRI, task-based EEG, or both. Among these participants, 23% were assessed with fMRI only, 19% with EEG only, and 58% with both fMRI and EEG.

Research shows “it’s very clear that people with severe brain injury continue to get better over time,” noted Dr. Schiff. “Every month and week matters, and so it probably is the case that a lot of these patients are picking up the level of recovery, and the later we go out to measure them, the more likely we are to find people who are CMD than not.”

These new results should prompt further study to explore whether detection of CMD can lead to improved outcomes, the investigators noted. “In addition, the standardization, validation, and simplification of task-based fMRI and EEG methods that are used to detect cognitive motor dissociation are needed to prompt widespread clinical integration of these techniques and investigation of the bioethical implications of the findings.”

All study participants with chronic brain injury had survived their initial illness or injury and had access to a research facility with advanced fMRI and EEG capabilities. “This survival bias may reflect greater cognitive reserve and resilience over time among the participants. As such, the results of our study may not be generalizable to the overall population of patients with cognitive motor dissociation,” the investigators wrote.

Another study limitation was that participating sites used heterogeneous strategies to acquire, analyze, and interpret data, which led to differences in the number, type, and ordering of the cognitive tasks assessed on fMRI and EEG.

“These differences, along with variations in recruitment strategies and participant characteristics, may have contributed to the unequal percentage of participants with cognitive motor dissociation observed at each site. Our findings may therefore not be generalizable across all centers,” the researchers wrote. 

Only a few academic medical centers have the specially trained personnel and techniques needed to assess patients for CMD — which, the researchers noted, limits the feasibility of performing these assessments in general practice.
 

Challenging Research

Commenting on the research, Aarti Sarwal, MD, professor of neurology and section chief, Neurocritical Care, Virginia Commonwealth University, Richmond, Virginia, noted that this was a “very challenging” study to perform, given that only a few academic centers are equipped to perform both fMRI and quantitative EEG analysis.

“In general, finding patients this far out, who have access to clinical, radiological, and electrophysiological testing and were provided good care enough to receive these, is a mammoth task in itself.” 

Dr. Sarwal said the study builds on efforts of the Curing Coma campaign , a clinical, scientific, and public health effort of the Neurocritical Care Society to tackle the concept of coma as a treatable medical entity.

“It continues to highlight the challenges of prognostication in acute brain injured patients by showing a higher presence of cognitive function than previously perceived,” she said.

Dr. Sarwal believes that the study’s largest impact is underscoring the need for more research into understanding the degree and quality of cognitive processing in patients with a disorder of consciousness. But it also underlines the need for a “healthy debate” on the cost/benefit analysis of pursuing such research, given the limited number of patients with access to resources. 

“This debate needs to include the caregivers and families outside the traditional realms of stakeholders overseeing the science.” 

Although communication with comatose patients is still “a ways away,” this research is “a step in the right direction,” said Dr. Sarwal. 

The study was funded by the James S. McDonnell Foundation and others. Dr. Schiff and Dr. Sarwal report no relevant financial disclosures.
 

A version of this article first appeared on Medscape.com.

At least 25% of unresponsive patients with a disorder of consciousness show signs of brain activity, an estimate that is higher than previous studies suggest.

“We found that at least 1 in 4 patients who are unresponsive to commands might actually be quite present and highly cognitive,” said study investigator Nicholas D. Schiff, MD, Feil Family Brain & Mind Research Institute and Department of Neurology, Weill Cornell Medicine, Rockefeller University Hospital, New York.

“In other words, if you go to the bedside and carefully examine someone with a severe brain injury and find no evidence of responsiveness, no one has been able to give you an a priori number to say how likely you are to be wrong in thinking this person is actually unaware, not processing language, and not capable of high-level cognitive work. And the answer to that now is at least 1 in 4 times.”

The findings were published online in The New England Journal of Medicine.
 

Clinical Implications? 

Cognitive motor dissociation (CMD) is a condition whereby patients with a severe brain injury who are unresponsive to commands at the bedside show brain activity on functional MRI (fMRI) or electroencephalography (EEG) when presented with selective motor imagery commands, such as “imagine playing tennis,” or “ imagine opening and closing your hand.”

Previous research shows that CMD is present in 10%-20% of people with a disorder of consciousness, a rate similar to that in patients with acute or chronic brain injury.

Understanding that a patient who appears unconscious has signs of cognitive processing could change the way clinicians and family interact with such individuals. Unresponsive patients who are aware may eventually be able to harness emerging communication technologies such as brain-computer interfaces.

In addition, knowing an individual’s CMD status could aid in prognosis. “We know from one study that there’s a four times increased likelihood that patients will be independent in a year in their function if they have cognitive motor dissociation,” said Dr. Schiff.

Unlike most previous studies of CMD, which were conducted at single sites and had relatively small cohorts, this new study included 353 adults with a disorder of consciousness (mean age, 37.9 years; 64% male) at six multinational sites.

Participants were recruited using a variety of methods, including consecutive enrollment of critically ill patients in the intensive care unit and enrollment of those with chronic illness or injury who were in the postacute phase of brain injury.
 

Response to Commands

Study participants were at different stages of recovery from an acute brain injury that had occurred an average of 8 months before the study started.

To determine the presence or absence of an observable response to commands among participants, trained staff used the Coma Recovery Scale–Revised (CRS-R); scores on this instrument range from 0 to 23, and higher scores indicate better neurobehavioral function.

About 40% of individuals were diagnosed with coma or vegetative state, 29% with minimally conscious state–minus, and 22% with minimally conscious state–plus. In all, 10% had emerged from a minimally conscious state.

Researchers assessed response to timed and repeated commands using fMRI or EEG in participants without an observable response to verbal commands, including those with a behavioral diagnosis of coma, vegetative state, or minimally conscious state–minus, and in participants with an observable response to verbal commands.

Of the 353 study participants, 61% underwent at least one fMRI assessment and 74% at least one EEG assessment. Both fMRI and EEG were performed in 35% of participants.

Dr. Schiff explained the two assessment types provide slightly different information, in that they measuring different types of brain signals. He also noted that although “every medical center in the world” has EEG, many do not have fMRI.

The brain imaging assessments captured brain activity within the motor area of the frontal cortex when tasked with motor imagery.

Of the 241 participants deemed to be in a coma or vegetative state or minimally conscious state–minus on the basis of CRS-R score, 60 (25%) had a response to commands on task-based fMRI, task-based EEG, or both.

The percentage of participants with CMD varied across study sites, from 2% to 45%, but Dr. Schiff said the reason for this is unclear. 

The proportion of participants with CMD may have been even higher if all individuals had been assessed with both imaging techniques, he said.
 

Higher Rate of Awareness Than in Previous Research

The investigators noted that the percentage of participants with CMD in their study was up to 10 percentage points higher than in previous studies. This may be due to the multimodal approach that classified participants undergoing assessment with both fMRI and EEG on the basis of responses on either technique, they said. 

The median age was lower among participants with CMD than those without CMD (30.5 years vs 45.3 years).

Compared with participants without CMD, a higher percentage of those with such dissociation had brain trauma as an etiologic factor (65% vs 38%) and a diagnosis of minimally conscious state–minus on the CRS-R (53% vs 38%).

Among people with CMD, 18% were assessed with fMRI only, 22% with EEG only, and 60% with both fMRI and EEG.

Dr. Schiff noted that the use of both fMRI and EEG appears to be more sensitive in detecting brain activity during tasks compared with use of one of these techniques alone.

Of the 112 participants with a diagnosis of minimally conscious state–plus or who had emerged from the minimally conscious state, 38% had a response to commands on task-based fMRI, task-based EEG, or both. Among these participants, 23% were assessed with fMRI only, 19% with EEG only, and 58% with both fMRI and EEG.

Research shows “it’s very clear that people with severe brain injury continue to get better over time,” noted Dr. Schiff. “Every month and week matters, and so it probably is the case that a lot of these patients are picking up the level of recovery, and the later we go out to measure them, the more likely we are to find people who are CMD than not.”

These new results should prompt further study to explore whether detection of CMD can lead to improved outcomes, the investigators noted. “In addition, the standardization, validation, and simplification of task-based fMRI and EEG methods that are used to detect cognitive motor dissociation are needed to prompt widespread clinical integration of these techniques and investigation of the bioethical implications of the findings.”

All study participants with chronic brain injury had survived their initial illness or injury and had access to a research facility with advanced fMRI and EEG capabilities. “This survival bias may reflect greater cognitive reserve and resilience over time among the participants. As such, the results of our study may not be generalizable to the overall population of patients with cognitive motor dissociation,” the investigators wrote.

Another study limitation was that participating sites used heterogeneous strategies to acquire, analyze, and interpret data, which led to differences in the number, type, and ordering of the cognitive tasks assessed on fMRI and EEG.

“These differences, along with variations in recruitment strategies and participant characteristics, may have contributed to the unequal percentage of participants with cognitive motor dissociation observed at each site. Our findings may therefore not be generalizable across all centers,” the researchers wrote. 

Only a few academic medical centers have the specially trained personnel and techniques needed to assess patients for CMD — which, the researchers noted, limits the feasibility of performing these assessments in general practice.
 

Challenging Research

Commenting on the research, Aarti Sarwal, MD, professor of neurology and section chief, Neurocritical Care, Virginia Commonwealth University, Richmond, Virginia, noted that this was a “very challenging” study to perform, given that only a few academic centers are equipped to perform both fMRI and quantitative EEG analysis.

“In general, finding patients this far out, who have access to clinical, radiological, and electrophysiological testing and were provided good care enough to receive these, is a mammoth task in itself.” 

Dr. Sarwal said the study builds on efforts of the Curing Coma campaign , a clinical, scientific, and public health effort of the Neurocritical Care Society to tackle the concept of coma as a treatable medical entity.

“It continues to highlight the challenges of prognostication in acute brain injured patients by showing a higher presence of cognitive function than previously perceived,” she said.

Dr. Sarwal believes that the study’s largest impact is underscoring the need for more research into understanding the degree and quality of cognitive processing in patients with a disorder of consciousness. But it also underlines the need for a “healthy debate” on the cost/benefit analysis of pursuing such research, given the limited number of patients with access to resources. 

“This debate needs to include the caregivers and families outside the traditional realms of stakeholders overseeing the science.” 

Although communication with comatose patients is still “a ways away,” this research is “a step in the right direction,” said Dr. Sarwal. 

The study was funded by the James S. McDonnell Foundation and others. Dr. Schiff and Dr. Sarwal report no relevant financial disclosures.
 

A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.