A wide variety of hematologic, dermatologic, and solid organ malignancies are associated with pruritus, a large, single-center, retrospective study suggests.

Blacks with pruritus had a higher odds ratio of hematologic malignancies, among others, while whites had higher likelihood of liver, gastrointestinal, respiratory and gynecologic cancers, results of the study show.

Blacks with pruritus had higher ORs for hematologic and soft tissue malignancies including those of the muscle, fat, and peripheral nerve, investigators said, while whites had higher ORs for skin and liver malignancies.

The investigators also looked at the prevalence of skin eruptions in patients with pruritus and malignancy. “Eruption is variable by malignancy type and points to differing underlying mechanisms of pruritus,” they reported.

The highest rates of skin eruption were in patients with myeloid leukemia at 66%, followed by bone cancers at 58%, lymphocytic leukemia at 57%, multiple myeloma at 53%, and bronchus at 53%. The lowest rates of skin eruption were in patients with gallbladder and biliary tract, colon, pancreas, and liver malignancies.

Dr. Kwatra reported that he is an advisory board member for Menlo Therapeutics and Trevi Therapeutics.

SOURCE: Kwatra SG et al. J Am Acad Dermatol. 2018 Sep 11. doi: 10.1016/j.jaad.2018.08.044.

A wide variety of hematologic, dermatologic, and solid organ malignancies are associated with pruritus, a large, single-center, retrospective study suggests.

Blacks with pruritus had a higher odds ratio of hematologic malignancies, among others, while whites had higher likelihood of liver, gastrointestinal, respiratory and gynecologic cancers, results of the study show.

Blacks with pruritus had higher ORs for hematologic and soft tissue malignancies including those of the muscle, fat, and peripheral nerve, investigators said, while whites had higher ORs for skin and liver malignancies.

The investigators also looked at the prevalence of skin eruptions in patients with pruritus and malignancy. “Eruption is variable by malignancy type and points to differing underlying mechanisms of pruritus,” they reported.

The highest rates of skin eruption were in patients with myeloid leukemia at 66%, followed by bone cancers at 58%, lymphocytic leukemia at 57%, multiple myeloma at 53%, and bronchus at 53%. The lowest rates of skin eruption were in patients with gallbladder and biliary tract, colon, pancreas, and liver malignancies.

Dr. Kwatra reported that he is an advisory board member for Menlo Therapeutics and Trevi Therapeutics.

SOURCE: Kwatra SG et al. J Am Acad Dermatol. 2018 Sep 11. doi: 10.1016/j.jaad.2018.08.044.

A wide variety of hematologic, dermatologic, and solid organ malignancies are associated with pruritus, a large, single-center, retrospective study suggests.

Blacks with pruritus had a higher odds ratio of hematologic malignancies, among others, while whites had higher likelihood of liver, gastrointestinal, respiratory and gynecologic cancers, results of the study show.

Blacks with pruritus had higher ORs for hematologic and soft tissue malignancies including those of the muscle, fat, and peripheral nerve, investigators said, while whites had higher ORs for skin and liver malignancies.

The investigators also looked at the prevalence of skin eruptions in patients with pruritus and malignancy. “Eruption is variable by malignancy type and points to differing underlying mechanisms of pruritus,” they reported.

The highest rates of skin eruption were in patients with myeloid leukemia at 66%, followed by bone cancers at 58%, lymphocytic leukemia at 57%, multiple myeloma at 53%, and bronchus at 53%. The lowest rates of skin eruption were in patients with gallbladder and biliary tract, colon, pancreas, and liver malignancies.

Dr. Kwatra reported that he is an advisory board member for Menlo Therapeutics and Trevi Therapeutics.

SOURCE: Kwatra SG et al. J Am Acad Dermatol. 2018 Sep 11. doi: 10.1016/j.jaad.2018.08.044.

Patients with chronic back pain suspected of having axial spondyloarthritis (axSpA) should not undergo follow-up MRI of the sacroiliac joint (MRI-SI) within a year if they had a negative baseline MRI-SI, according to investigators.

It is very unlikely that a follow-up MRI-SI will yield new results, reported Pauline A. Bakker, MD, of the department of rheumatology at Leiden University Medical Centre, the Netherlands, and her colleagues.

Since gender and HLA-B27 status were closely associated with MRI-SI positivity, these factors should be considered when deciding to repeat an MRI-SI.

“Over the last decade, MRI rapidly gained ground and proved to be an important imaging technique in the diagnostic process of [nonradiographic] axial spondyloarthritis,” the investigators wrote in Arthritis and Rheumatology. “It has been shown that MRI can detect the early inflammatory stages of sacroiliitis months to years before structural damage can be detected on a conventional radiograph.”

Although MRI represents a diagnostic leap forward, questions of clinical application remain. “For example… if an MRI is completely normal and there is still a clinical suspicion of axSpA, should the MRI be repeated? And if so, after what period of follow-up? Or does this not contribute to the diagnostic process?”

To answer these questions, the investigators observed the “evolution of MRI lesions over a 3-month and 1-year time frame” in patients with early chronic back pain and suspected axSpA.

The prospective study involved 188 patients from the Spondyloarthritis Caught Early (SPACE) cohort. The authors commented that this is “an ideal cohort… since it includes a population of patients with back pain of short duration referred to rheumatologists with a suspicion of SpA [but without the mandatory presence of a single or multiple SpA features].”

Gender and HLA-B27 status were independently associated with a positive MRI-SI at any point in time. About 43% of HLA-B27-positive men had a positive MRI-SI, compared with just 7% of HLA-B27-negative women. The investigators advised that these associations be considered when deciding upon repeat MRI-SI.

“If a clinical suspicion [of axSpA] remains [for example, a patient develops other SpA features] it might be worthwhile to consider redoing an MRI in HLA-B27 positive patients,” the investigators wrote. “Likewise, there is a statistically significant difference between male and female patients with a negative baseline MRI, namely that in male patients more often a positive MRI at follow-up is seen [difference: 12% in men, 3% in women].”

The researchers reported having no conflicts of interest.

SOURCE: Bakker PA et al. Arthritis Rheumatol. 2018 Sep 11. doi: 10.1002/art.40718.

Patients with chronic back pain suspected of having axial spondyloarthritis (axSpA) should not undergo follow-up MRI of the sacroiliac joint (MRI-SI) within a year if they had a negative baseline MRI-SI, according to investigators.

It is very unlikely that a follow-up MRI-SI will yield new results, reported Pauline A. Bakker, MD, of the department of rheumatology at Leiden University Medical Centre, the Netherlands, and her colleagues.

Since gender and HLA-B27 status were closely associated with MRI-SI positivity, these factors should be considered when deciding to repeat an MRI-SI.

“Over the last decade, MRI rapidly gained ground and proved to be an important imaging technique in the diagnostic process of [nonradiographic] axial spondyloarthritis,” the investigators wrote in Arthritis and Rheumatology. “It has been shown that MRI can detect the early inflammatory stages of sacroiliitis months to years before structural damage can be detected on a conventional radiograph.”

Although MRI represents a diagnostic leap forward, questions of clinical application remain. “For example… if an MRI is completely normal and there is still a clinical suspicion of axSpA, should the MRI be repeated? And if so, after what period of follow-up? Or does this not contribute to the diagnostic process?”

To answer these questions, the investigators observed the “evolution of MRI lesions over a 3-month and 1-year time frame” in patients with early chronic back pain and suspected axSpA.

The prospective study involved 188 patients from the Spondyloarthritis Caught Early (SPACE) cohort. The authors commented that this is “an ideal cohort… since it includes a population of patients with back pain of short duration referred to rheumatologists with a suspicion of SpA [but without the mandatory presence of a single or multiple SpA features].”

Gender and HLA-B27 status were independently associated with a positive MRI-SI at any point in time. About 43% of HLA-B27-positive men had a positive MRI-SI, compared with just 7% of HLA-B27-negative women. The investigators advised that these associations be considered when deciding upon repeat MRI-SI.

“If a clinical suspicion [of axSpA] remains [for example, a patient develops other SpA features] it might be worthwhile to consider redoing an MRI in HLA-B27 positive patients,” the investigators wrote. “Likewise, there is a statistically significant difference between male and female patients with a negative baseline MRI, namely that in male patients more often a positive MRI at follow-up is seen [difference: 12% in men, 3% in women].”

The researchers reported having no conflicts of interest.

SOURCE: Bakker PA et al. Arthritis Rheumatol. 2018 Sep 11. doi: 10.1002/art.40718.

Patients with chronic back pain suspected of having axial spondyloarthritis (axSpA) should not undergo follow-up MRI of the sacroiliac joint (MRI-SI) within a year if they had a negative baseline MRI-SI, according to investigators.

It is very unlikely that a follow-up MRI-SI will yield new results, reported Pauline A. Bakker, MD, of the department of rheumatology at Leiden University Medical Centre, the Netherlands, and her colleagues.

Since gender and HLA-B27 status were closely associated with MRI-SI positivity, these factors should be considered when deciding to repeat an MRI-SI.

“Over the last decade, MRI rapidly gained ground and proved to be an important imaging technique in the diagnostic process of [nonradiographic] axial spondyloarthritis,” the investigators wrote in Arthritis and Rheumatology. “It has been shown that MRI can detect the early inflammatory stages of sacroiliitis months to years before structural damage can be detected on a conventional radiograph.”

Although MRI represents a diagnostic leap forward, questions of clinical application remain. “For example… if an MRI is completely normal and there is still a clinical suspicion of axSpA, should the MRI be repeated? And if so, after what period of follow-up? Or does this not contribute to the diagnostic process?”

To answer these questions, the investigators observed the “evolution of MRI lesions over a 3-month and 1-year time frame” in patients with early chronic back pain and suspected axSpA.

The prospective study involved 188 patients from the Spondyloarthritis Caught Early (SPACE) cohort. The authors commented that this is “an ideal cohort… since it includes a population of patients with back pain of short duration referred to rheumatologists with a suspicion of SpA [but without the mandatory presence of a single or multiple SpA features].”

Gender and HLA-B27 status were independently associated with a positive MRI-SI at any point in time. About 43% of HLA-B27-positive men had a positive MRI-SI, compared with just 7% of HLA-B27-negative women. The investigators advised that these associations be considered when deciding upon repeat MRI-SI.

“If a clinical suspicion [of axSpA] remains [for example, a patient develops other SpA features] it might be worthwhile to consider redoing an MRI in HLA-B27 positive patients,” the investigators wrote. “Likewise, there is a statistically significant difference between male and female patients with a negative baseline MRI, namely that in male patients more often a positive MRI at follow-up is seen [difference: 12% in men, 3% in women].”

The researchers reported having no conflicts of interest.

SOURCE: Bakker PA et al. Arthritis Rheumatol. 2018 Sep 11. doi: 10.1002/art.40718.

ATLANTA – Astrovirus and sapovirus in children visiting the ED with acute gastroenteritis have a similar natural history, which is also similar to that of norovirus, according to findings from a prospective cohort study.

Thanks to the increased use of molecular diagnostic testing, astrovirus and sapovirus (AsV and SaV) recently gained new appreciation as a cause of gastroenteritis, but little is known about their natural history.

The current findings from the Alberta Provincial Pediatric Enteric Infection Team (APPETITE) study provide some longitudinal insight regarding that history, Gillian A. M. Tarr, PhD, of the University of Calgary (Alta.), and her colleagues noted in a poster presentation at the International Conference on Emerging Infectious Diseases.

The investigators tested rectal swabs and stool samples from 2,590 children under age 18 years who had experienced at least three episodes of diarrhea and/or vomiting in 24 hours. AsV was detected in 84 children (3.2%), SaV was detected in 229 (8.8%), and norovirus (NoV) was detected in 655 (25%). After excluding those with coinfection, a total of 54, 144, and 478 children with AsV, SaV, and NoV, respectively, were included.

Vomiting occurred in 83%, 92%, and 98%; diarrhea occurred in 94%, 79% and 75%; and blood was present in the stool in 4.0%, 7.0%, and 3.5%, of those with AsV, SaV, and NoV, respectively, they reported.

The median maximal vomiting episodes per day was slightly lower for AsV versus SaV and NoV (about 3 vs. 5 and 7, respectively); the median maximal diarrhea episodes was slightly higher for AsV (about 5 vs. 4 for both SaV and NoV).

Vomiting duration was similar for AsV and SaV (about 3 days) and slightly longer than for NoV (about 2 days); median diarrhea duration was about 5 days for all three viruses.

sworcester@mdedge.com

ATLANTA – Astrovirus and sapovirus in children visiting the ED with acute gastroenteritis have a similar natural history, which is also similar to that of norovirus, according to findings from a prospective cohort study.

Thanks to the increased use of molecular diagnostic testing, astrovirus and sapovirus (AsV and SaV) recently gained new appreciation as a cause of gastroenteritis, but little is known about their natural history.

The current findings from the Alberta Provincial Pediatric Enteric Infection Team (APPETITE) study provide some longitudinal insight regarding that history, Gillian A. M. Tarr, PhD, of the University of Calgary (Alta.), and her colleagues noted in a poster presentation at the International Conference on Emerging Infectious Diseases.

The investigators tested rectal swabs and stool samples from 2,590 children under age 18 years who had experienced at least three episodes of diarrhea and/or vomiting in 24 hours. AsV was detected in 84 children (3.2%), SaV was detected in 229 (8.8%), and norovirus (NoV) was detected in 655 (25%). After excluding those with coinfection, a total of 54, 144, and 478 children with AsV, SaV, and NoV, respectively, were included.

Vomiting occurred in 83%, 92%, and 98%; diarrhea occurred in 94%, 79% and 75%; and blood was present in the stool in 4.0%, 7.0%, and 3.5%, of those with AsV, SaV, and NoV, respectively, they reported.

The median maximal vomiting episodes per day was slightly lower for AsV versus SaV and NoV (about 3 vs. 5 and 7, respectively); the median maximal diarrhea episodes was slightly higher for AsV (about 5 vs. 4 for both SaV and NoV).

Vomiting duration was similar for AsV and SaV (about 3 days) and slightly longer than for NoV (about 2 days); median diarrhea duration was about 5 days for all three viruses.

sworcester@mdedge.com

ATLANTA – Astrovirus and sapovirus in children visiting the ED with acute gastroenteritis have a similar natural history, which is also similar to that of norovirus, according to findings from a prospective cohort study.

Thanks to the increased use of molecular diagnostic testing, astrovirus and sapovirus (AsV and SaV) recently gained new appreciation as a cause of gastroenteritis, but little is known about their natural history.

The current findings from the Alberta Provincial Pediatric Enteric Infection Team (APPETITE) study provide some longitudinal insight regarding that history, Gillian A. M. Tarr, PhD, of the University of Calgary (Alta.), and her colleagues noted in a poster presentation at the International Conference on Emerging Infectious Diseases.

The investigators tested rectal swabs and stool samples from 2,590 children under age 18 years who had experienced at least three episodes of diarrhea and/or vomiting in 24 hours. AsV was detected in 84 children (3.2%), SaV was detected in 229 (8.8%), and norovirus (NoV) was detected in 655 (25%). After excluding those with coinfection, a total of 54, 144, and 478 children with AsV, SaV, and NoV, respectively, were included.

Vomiting occurred in 83%, 92%, and 98%; diarrhea occurred in 94%, 79% and 75%; and blood was present in the stool in 4.0%, 7.0%, and 3.5%, of those with AsV, SaV, and NoV, respectively, they reported.

The median maximal vomiting episodes per day was slightly lower for AsV versus SaV and NoV (about 3 vs. 5 and 7, respectively); the median maximal diarrhea episodes was slightly higher for AsV (about 5 vs. 4 for both SaV and NoV).

Vomiting duration was similar for AsV and SaV (about 3 days) and slightly longer than for NoV (about 2 days); median diarrhea duration was about 5 days for all three viruses.

sworcester@mdedge.com

SAN DIEGO – Noninvasive fat removal, such as laser treatment and cryolipolysis, is here to stay.

That’s what Mathew M. Avram, MD, JD, told attendees at the annual Masters of Aesthetics Symposium.

“It does not compare to liposuction, but many patients prefer these devices because there’s less downtime,” he said. “They don’t want pain. They don’t want time away from work.”

In the decade or so since the inception of the noninvasive body contouring field, noninvasive and minimally invasive devices have become far more popular than traditional liposuction, said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital in Boston. “It’s not even close. Among American Society for Dermatologic Surgery [ASDS] members, for every 1 liposuction, there are over 10 noninvasive body sculpting treatments.”

There were 408,000 body-sculpting procedures performed in 2017. More than half of those (208,000) were cryolipolysis, followed by use of radiofrequency (89,000), deoxycholic acid (46,000), laser lipolysis (25,000), “other” procedures (25,000), and tumescent liposuction (15,000), according to data from the ASDS.

“Each treatment has improved in efficacy with time,” Dr. Avram said.

Devices currently cleared by the Food and Drug Administration for the noninvasive removal of fat include ultrasound, lasers, low-level laser therapy, cryolipolysis, and radiofrequency. One of the most common is low-level laser therapy.

“There are several different devices on the market, but there’s no good histology to confirm mechanism of action, so you question what the efficacy is,” said Dr. Avram, who is also the immediate past president of the American Society for Laser Medicine and Surgery.

SculpSure

In the traditional laser domain, the one most commonly used for fat removal is SculpSure, an FDA-cleared hyperthermic 1,060-nm diode laser. It features four flat, nonsuction applicators, a contact cooling system, and it enables the user to treat more than one area in a 25-minute session. There is minimal absorption by melanin.

“You shouldn’t treat over tattoos, however, because if there’s black ink, the tattoo will absorb the wavelength,” Dr. Avram said. “It’s safe in all skin types and there are a variety of different configurations you can use to treat the desired area.”

Initially there is a 4-minute warm-up cycle to achieve the target temperature. Over the next 21 minutes, 1,060-nm energy is delivered via proprietary modulation, alternating between heat and cooling.

“There is definitely some pain with this device,” he said. “Whether or not it’s a relevant endpoint is not known at this point. But typically, if you’re destroying fat with heat there should be some pain. It’s relieved by a period of cooling. A submental fat treatment is now available. I have not personally used it, but it’s the same technology.”

CoolSculpting

Another popular technology is cryolipolysis (CoolSculpting), which was developed at Massachusetts General Hospital by R. Rox Anderson, MD, and Dieter Manstein, MD, PhD.

It’s FDA cleared for noninvasive fat removal and there have been more than 6 million cryolipolysis treatments performed around the world. The purported mechanism of action is selective crystallization of lipids and fat cells at temperatures below freezing. An inflammatory process results in fat reduction over 2-4 months.

“When it first started, cryolipolysis was designed to treat local areas like love handles in males,” Dr. Avram said. “Over time, applicators have been designed to treat different areas, most recently, one for the posterior upper arms and above the knees. There is now a larger, faster CoolSculpting applicator which results in a 35-minute treatment. It’s a little larger, there’s a little less pain, a lower temperature, and it’s a little bit more effective. This has been helpful in our practice in terms of getting more treatment cycles in a visit.”

Postprocedurally, massage may improve clinical results by mobilizing lipid crystals created from treatment.

Extracorporeal shock wave therapy

Another modality to consider is extracorporeal shock wave therapy, which is the application of mechanically generated external sound waves. “It’s not the same as ultrasound or focused ultrasound, and it’s FDA cleared for the treatment of cellulite,” Dr. Avram said.

EmSculpt

A newer innovation, known as High Intensity Focused Electromagnetic (HIFEM) technology (EmSculpt), induces 20,000 forced muscle contractions per session, which leads to supramaximal contractions that can’t be achieved through normal voluntary muscle action.

“The idea is that you’re getting hypertrophy of the muscle to get volumetric growth,” he said. “There’s believed to be a cascaded apoptotic effect, inducing apoptosis and fat disruption.”

Dr. Avram added that HIFEM is nonionizing, nonradiating, nonthermal, and it does not affect sensory nerves. “It’s designed to only stimulate motor neurons. Time will tell in terms of what the ultimate results are with that device.”

truSculpt

Some clinicians are using monopolar radiofrequency with truSculpt, the proprietary delivery of deep radiofrequency energy. This device increases fat temperature between 6 and 10 degrees Celsius with dual frequency at 1 and 2 MHz.

Published data show that 45 degrees Celsius sustained for 3 minutes resulted in a 60% loss of adipose tissue viability (Lasers Surg Med. 2009;41:745-50; Lasers Surg Med. 2010;42:361-70).

“The heat delivery induces cell apoptosis, leading to the removal of those cells by natural healing processes,” said Dr. Avram, who added that he has not used the device. “We need more clinical data to assess this as well.”

Selective photothermolysis

Another technology being evaluated for fat removal is selective photothermolysis, a concept developed at Massachusetts General Hospital in 1983. It extends the theory of selective photothermolysis to target the lipids that make up subcutaneous fat.

“The theory is that you must select a wavelength well absorbed by the target chromophore with a pulse duration shorter than the target’s thermal relaxation time,” Dr. Avram explained. “This produces selective, localized heating with focal destruction of the target with minimal damage to the surrounding tissue. It requires a deeply penetrating wavelength.”

Lipids are a tempting target “because they heat quickly and easily and they do not lose their heat easily to surrounding structures. You want to target fat selectively and confine thermal damage effectively,” he said.

Nearly 10 years ago, Dr. Avram and his associates evaluated the effects of noninvasive 1,210-nm laser exposure on the adipose tissue of 24 patients with skin types 1-5 (Laser Surg Med. 2009;41:401-7).

“The laser pulses were painful, which limited the efficacy,” he said.

The contact cooling device failed in some subjects, and two patients had bulla, but no scarring. Histologic evidence of laser-induced fat damage was observed in 89% of test sites at 4-7 weeks, but dermal damage was also seen.

“This was the first study to show histologic evidence of laser-induced damage to subcutaneous fat,” Dr. Avram said.

Development of selective photothermolysis technology fell off the wayside after the Great Recession of 2008, but it is still being evaluated at Massachusetts General Hospital and other centers.

To optimize the technology, Dr. Avram said that longer pulse durations may target larger volumes of fat. “Cooling is essential to protect the epidermis, as well as to control pain.”

Injectables

Injectables provide a new, minimally invasive means to achieve noninvasive fat removal, Dr. Avram noted.

“Many injectables of questionable efficacy and safety had been available internationally for years,” he said, but none had FDA clearance until 2015, when the agency gave ATX-101 (Kybella) the nod.

ATX-101 is a nonanimal-derived formulation of deoxycholic acid that causes preferential adipocytolysis. Data from a phase 3 trial presented at the 2014 American Society of Plastic Surgery and the American Society of Aesthetic Plastic Surgery meetings showed a statistically significant reduction in submental fat among subjects who received ATX-101, compared with placebo. It requires an average of 2-4 treatments.

“In my experience, it tends not to require that many, but based on MRI, as well as clinician and patient-reported outcomes, there are significant improvements in the visual impact of chin fat,” Dr. Avram said.

Most adverse events are mild to moderate in severity, primarily bruising, pain, and a sensation of numbness to the anesthesia. “They decrease in incidence and severity over successive treatments, and they infrequently lead to discontinuation of treatment,” he said.

For submental fat, clinicians can combine cryolipolysis and deoxycholic acid. “Here, the idea is to assess the amount of fat targeted for treatment,” Dr. Avram said. “If the fat fills the cryolipolysis cup, use cryolipolysis alone. If the fat does not fill the cup, inject deoxycholic acid for a more targeted treatment. If there is residual fat after cryolipolysis, consider treating more focally with deoxycholic acid.”

Both treatments can produce temporary marginal mandibular nerve injury. “It’s not common, but that’s something to include in your consent forms,” he said.

Dr. Avram reported that he has received consulting fees from Allergan, Merz Pharma, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis Biosystems, Invasix, and Zalea.

dbrunk@mdedge.com


 

SAN DIEGO – Noninvasive fat removal, such as laser treatment and cryolipolysis, is here to stay.

That’s what Mathew M. Avram, MD, JD, told attendees at the annual Masters of Aesthetics Symposium.

“It does not compare to liposuction, but many patients prefer these devices because there’s less downtime,” he said. “They don’t want pain. They don’t want time away from work.”

In the decade or so since the inception of the noninvasive body contouring field, noninvasive and minimally invasive devices have become far more popular than traditional liposuction, said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital in Boston. “It’s not even close. Among American Society for Dermatologic Surgery [ASDS] members, for every 1 liposuction, there are over 10 noninvasive body sculpting treatments.”

There were 408,000 body-sculpting procedures performed in 2017. More than half of those (208,000) were cryolipolysis, followed by use of radiofrequency (89,000), deoxycholic acid (46,000), laser lipolysis (25,000), “other” procedures (25,000), and tumescent liposuction (15,000), according to data from the ASDS.

“Each treatment has improved in efficacy with time,” Dr. Avram said.

Devices currently cleared by the Food and Drug Administration for the noninvasive removal of fat include ultrasound, lasers, low-level laser therapy, cryolipolysis, and radiofrequency. One of the most common is low-level laser therapy.

“There are several different devices on the market, but there’s no good histology to confirm mechanism of action, so you question what the efficacy is,” said Dr. Avram, who is also the immediate past president of the American Society for Laser Medicine and Surgery.

SculpSure

In the traditional laser domain, the one most commonly used for fat removal is SculpSure, an FDA-cleared hyperthermic 1,060-nm diode laser. It features four flat, nonsuction applicators, a contact cooling system, and it enables the user to treat more than one area in a 25-minute session. There is minimal absorption by melanin.

“You shouldn’t treat over tattoos, however, because if there’s black ink, the tattoo will absorb the wavelength,” Dr. Avram said. “It’s safe in all skin types and there are a variety of different configurations you can use to treat the desired area.”

Initially there is a 4-minute warm-up cycle to achieve the target temperature. Over the next 21 minutes, 1,060-nm energy is delivered via proprietary modulation, alternating between heat and cooling.

“There is definitely some pain with this device,” he said. “Whether or not it’s a relevant endpoint is not known at this point. But typically, if you’re destroying fat with heat there should be some pain. It’s relieved by a period of cooling. A submental fat treatment is now available. I have not personally used it, but it’s the same technology.”

CoolSculpting

Another popular technology is cryolipolysis (CoolSculpting), which was developed at Massachusetts General Hospital by R. Rox Anderson, MD, and Dieter Manstein, MD, PhD.

It’s FDA cleared for noninvasive fat removal and there have been more than 6 million cryolipolysis treatments performed around the world. The purported mechanism of action is selective crystallization of lipids and fat cells at temperatures below freezing. An inflammatory process results in fat reduction over 2-4 months.

“When it first started, cryolipolysis was designed to treat local areas like love handles in males,” Dr. Avram said. “Over time, applicators have been designed to treat different areas, most recently, one for the posterior upper arms and above the knees. There is now a larger, faster CoolSculpting applicator which results in a 35-minute treatment. It’s a little larger, there’s a little less pain, a lower temperature, and it’s a little bit more effective. This has been helpful in our practice in terms of getting more treatment cycles in a visit.”

Postprocedurally, massage may improve clinical results by mobilizing lipid crystals created from treatment.

Extracorporeal shock wave therapy

Another modality to consider is extracorporeal shock wave therapy, which is the application of mechanically generated external sound waves. “It’s not the same as ultrasound or focused ultrasound, and it’s FDA cleared for the treatment of cellulite,” Dr. Avram said.

EmSculpt

A newer innovation, known as High Intensity Focused Electromagnetic (HIFEM) technology (EmSculpt), induces 20,000 forced muscle contractions per session, which leads to supramaximal contractions that can’t be achieved through normal voluntary muscle action.

“The idea is that you’re getting hypertrophy of the muscle to get volumetric growth,” he said. “There’s believed to be a cascaded apoptotic effect, inducing apoptosis and fat disruption.”

Dr. Avram added that HIFEM is nonionizing, nonradiating, nonthermal, and it does not affect sensory nerves. “It’s designed to only stimulate motor neurons. Time will tell in terms of what the ultimate results are with that device.”

truSculpt

Some clinicians are using monopolar radiofrequency with truSculpt, the proprietary delivery of deep radiofrequency energy. This device increases fat temperature between 6 and 10 degrees Celsius with dual frequency at 1 and 2 MHz.

Published data show that 45 degrees Celsius sustained for 3 minutes resulted in a 60% loss of adipose tissue viability (Lasers Surg Med. 2009;41:745-50; Lasers Surg Med. 2010;42:361-70).

“The heat delivery induces cell apoptosis, leading to the removal of those cells by natural healing processes,” said Dr. Avram, who added that he has not used the device. “We need more clinical data to assess this as well.”

Selective photothermolysis

Another technology being evaluated for fat removal is selective photothermolysis, a concept developed at Massachusetts General Hospital in 1983. It extends the theory of selective photothermolysis to target the lipids that make up subcutaneous fat.

“The theory is that you must select a wavelength well absorbed by the target chromophore with a pulse duration shorter than the target’s thermal relaxation time,” Dr. Avram explained. “This produces selective, localized heating with focal destruction of the target with minimal damage to the surrounding tissue. It requires a deeply penetrating wavelength.”

Lipids are a tempting target “because they heat quickly and easily and they do not lose their heat easily to surrounding structures. You want to target fat selectively and confine thermal damage effectively,” he said.

Nearly 10 years ago, Dr. Avram and his associates evaluated the effects of noninvasive 1,210-nm laser exposure on the adipose tissue of 24 patients with skin types 1-5 (Laser Surg Med. 2009;41:401-7).

“The laser pulses were painful, which limited the efficacy,” he said.

The contact cooling device failed in some subjects, and two patients had bulla, but no scarring. Histologic evidence of laser-induced fat damage was observed in 89% of test sites at 4-7 weeks, but dermal damage was also seen.

“This was the first study to show histologic evidence of laser-induced damage to subcutaneous fat,” Dr. Avram said.

Development of selective photothermolysis technology fell off the wayside after the Great Recession of 2008, but it is still being evaluated at Massachusetts General Hospital and other centers.

To optimize the technology, Dr. Avram said that longer pulse durations may target larger volumes of fat. “Cooling is essential to protect the epidermis, as well as to control pain.”

Injectables

Injectables provide a new, minimally invasive means to achieve noninvasive fat removal, Dr. Avram noted.

“Many injectables of questionable efficacy and safety had been available internationally for years,” he said, but none had FDA clearance until 2015, when the agency gave ATX-101 (Kybella) the nod.

ATX-101 is a nonanimal-derived formulation of deoxycholic acid that causes preferential adipocytolysis. Data from a phase 3 trial presented at the 2014 American Society of Plastic Surgery and the American Society of Aesthetic Plastic Surgery meetings showed a statistically significant reduction in submental fat among subjects who received ATX-101, compared with placebo. It requires an average of 2-4 treatments.

“In my experience, it tends not to require that many, but based on MRI, as well as clinician and patient-reported outcomes, there are significant improvements in the visual impact of chin fat,” Dr. Avram said.

Most adverse events are mild to moderate in severity, primarily bruising, pain, and a sensation of numbness to the anesthesia. “They decrease in incidence and severity over successive treatments, and they infrequently lead to discontinuation of treatment,” he said.

For submental fat, clinicians can combine cryolipolysis and deoxycholic acid. “Here, the idea is to assess the amount of fat targeted for treatment,” Dr. Avram said. “If the fat fills the cryolipolysis cup, use cryolipolysis alone. If the fat does not fill the cup, inject deoxycholic acid for a more targeted treatment. If there is residual fat after cryolipolysis, consider treating more focally with deoxycholic acid.”

Both treatments can produce temporary marginal mandibular nerve injury. “It’s not common, but that’s something to include in your consent forms,” he said.

Dr. Avram reported that he has received consulting fees from Allergan, Merz Pharma, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis Biosystems, Invasix, and Zalea.

dbrunk@mdedge.com


 

SAN DIEGO – Noninvasive fat removal, such as laser treatment and cryolipolysis, is here to stay.

That’s what Mathew M. Avram, MD, JD, told attendees at the annual Masters of Aesthetics Symposium.

“It does not compare to liposuction, but many patients prefer these devices because there’s less downtime,” he said. “They don’t want pain. They don’t want time away from work.”

In the decade or so since the inception of the noninvasive body contouring field, noninvasive and minimally invasive devices have become far more popular than traditional liposuction, said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital in Boston. “It’s not even close. Among American Society for Dermatologic Surgery [ASDS] members, for every 1 liposuction, there are over 10 noninvasive body sculpting treatments.”

There were 408,000 body-sculpting procedures performed in 2017. More than half of those (208,000) were cryolipolysis, followed by use of radiofrequency (89,000), deoxycholic acid (46,000), laser lipolysis (25,000), “other” procedures (25,000), and tumescent liposuction (15,000), according to data from the ASDS.

“Each treatment has improved in efficacy with time,” Dr. Avram said.

Devices currently cleared by the Food and Drug Administration for the noninvasive removal of fat include ultrasound, lasers, low-level laser therapy, cryolipolysis, and radiofrequency. One of the most common is low-level laser therapy.

“There are several different devices on the market, but there’s no good histology to confirm mechanism of action, so you question what the efficacy is,” said Dr. Avram, who is also the immediate past president of the American Society for Laser Medicine and Surgery.

SculpSure

In the traditional laser domain, the one most commonly used for fat removal is SculpSure, an FDA-cleared hyperthermic 1,060-nm diode laser. It features four flat, nonsuction applicators, a contact cooling system, and it enables the user to treat more than one area in a 25-minute session. There is minimal absorption by melanin.

“You shouldn’t treat over tattoos, however, because if there’s black ink, the tattoo will absorb the wavelength,” Dr. Avram said. “It’s safe in all skin types and there are a variety of different configurations you can use to treat the desired area.”

Initially there is a 4-minute warm-up cycle to achieve the target temperature. Over the next 21 minutes, 1,060-nm energy is delivered via proprietary modulation, alternating between heat and cooling.

“There is definitely some pain with this device,” he said. “Whether or not it’s a relevant endpoint is not known at this point. But typically, if you’re destroying fat with heat there should be some pain. It’s relieved by a period of cooling. A submental fat treatment is now available. I have not personally used it, but it’s the same technology.”

CoolSculpting

Another popular technology is cryolipolysis (CoolSculpting), which was developed at Massachusetts General Hospital by R. Rox Anderson, MD, and Dieter Manstein, MD, PhD.

It’s FDA cleared for noninvasive fat removal and there have been more than 6 million cryolipolysis treatments performed around the world. The purported mechanism of action is selective crystallization of lipids and fat cells at temperatures below freezing. An inflammatory process results in fat reduction over 2-4 months.

“When it first started, cryolipolysis was designed to treat local areas like love handles in males,” Dr. Avram said. “Over time, applicators have been designed to treat different areas, most recently, one for the posterior upper arms and above the knees. There is now a larger, faster CoolSculpting applicator which results in a 35-minute treatment. It’s a little larger, there’s a little less pain, a lower temperature, and it’s a little bit more effective. This has been helpful in our practice in terms of getting more treatment cycles in a visit.”

Postprocedurally, massage may improve clinical results by mobilizing lipid crystals created from treatment.

Extracorporeal shock wave therapy

Another modality to consider is extracorporeal shock wave therapy, which is the application of mechanically generated external sound waves. “It’s not the same as ultrasound or focused ultrasound, and it’s FDA cleared for the treatment of cellulite,” Dr. Avram said.

EmSculpt

A newer innovation, known as High Intensity Focused Electromagnetic (HIFEM) technology (EmSculpt), induces 20,000 forced muscle contractions per session, which leads to supramaximal contractions that can’t be achieved through normal voluntary muscle action.

“The idea is that you’re getting hypertrophy of the muscle to get volumetric growth,” he said. “There’s believed to be a cascaded apoptotic effect, inducing apoptosis and fat disruption.”

Dr. Avram added that HIFEM is nonionizing, nonradiating, nonthermal, and it does not affect sensory nerves. “It’s designed to only stimulate motor neurons. Time will tell in terms of what the ultimate results are with that device.”

truSculpt

Some clinicians are using monopolar radiofrequency with truSculpt, the proprietary delivery of deep radiofrequency energy. This device increases fat temperature between 6 and 10 degrees Celsius with dual frequency at 1 and 2 MHz.

Published data show that 45 degrees Celsius sustained for 3 minutes resulted in a 60% loss of adipose tissue viability (Lasers Surg Med. 2009;41:745-50; Lasers Surg Med. 2010;42:361-70).

“The heat delivery induces cell apoptosis, leading to the removal of those cells by natural healing processes,” said Dr. Avram, who added that he has not used the device. “We need more clinical data to assess this as well.”

Selective photothermolysis

Another technology being evaluated for fat removal is selective photothermolysis, a concept developed at Massachusetts General Hospital in 1983. It extends the theory of selective photothermolysis to target the lipids that make up subcutaneous fat.

“The theory is that you must select a wavelength well absorbed by the target chromophore with a pulse duration shorter than the target’s thermal relaxation time,” Dr. Avram explained. “This produces selective, localized heating with focal destruction of the target with minimal damage to the surrounding tissue. It requires a deeply penetrating wavelength.”

Lipids are a tempting target “because they heat quickly and easily and they do not lose their heat easily to surrounding structures. You want to target fat selectively and confine thermal damage effectively,” he said.

Nearly 10 years ago, Dr. Avram and his associates evaluated the effects of noninvasive 1,210-nm laser exposure on the adipose tissue of 24 patients with skin types 1-5 (Laser Surg Med. 2009;41:401-7).

“The laser pulses were painful, which limited the efficacy,” he said.

The contact cooling device failed in some subjects, and two patients had bulla, but no scarring. Histologic evidence of laser-induced fat damage was observed in 89% of test sites at 4-7 weeks, but dermal damage was also seen.

“This was the first study to show histologic evidence of laser-induced damage to subcutaneous fat,” Dr. Avram said.

Development of selective photothermolysis technology fell off the wayside after the Great Recession of 2008, but it is still being evaluated at Massachusetts General Hospital and other centers.

To optimize the technology, Dr. Avram said that longer pulse durations may target larger volumes of fat. “Cooling is essential to protect the epidermis, as well as to control pain.”

Injectables

Injectables provide a new, minimally invasive means to achieve noninvasive fat removal, Dr. Avram noted.

“Many injectables of questionable efficacy and safety had been available internationally for years,” he said, but none had FDA clearance until 2015, when the agency gave ATX-101 (Kybella) the nod.

ATX-101 is a nonanimal-derived formulation of deoxycholic acid that causes preferential adipocytolysis. Data from a phase 3 trial presented at the 2014 American Society of Plastic Surgery and the American Society of Aesthetic Plastic Surgery meetings showed a statistically significant reduction in submental fat among subjects who received ATX-101, compared with placebo. It requires an average of 2-4 treatments.

“In my experience, it tends not to require that many, but based on MRI, as well as clinician and patient-reported outcomes, there are significant improvements in the visual impact of chin fat,” Dr. Avram said.

Most adverse events are mild to moderate in severity, primarily bruising, pain, and a sensation of numbness to the anesthesia. “They decrease in incidence and severity over successive treatments, and they infrequently lead to discontinuation of treatment,” he said.

For submental fat, clinicians can combine cryolipolysis and deoxycholic acid. “Here, the idea is to assess the amount of fat targeted for treatment,” Dr. Avram said. “If the fat fills the cryolipolysis cup, use cryolipolysis alone. If the fat does not fill the cup, inject deoxycholic acid for a more targeted treatment. If there is residual fat after cryolipolysis, consider treating more focally with deoxycholic acid.”

Both treatments can produce temporary marginal mandibular nerve injury. “It’s not common, but that’s something to include in your consent forms,” he said.

Dr. Avram reported that he has received consulting fees from Allergan, Merz Pharma, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis Biosystems, Invasix, and Zalea.

dbrunk@mdedge.com


 

CHICAGO – The risk of cardiovascular and hypotension-related events is higher with alpha-blockers than with other hypertension drugs, but almost 20 years after the pivotal ALLHAT trial first raised safety concerns, they are still widely used, according to investigators from the University of Ottawa.

ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) linked the alpha-blocker doxazosin (Cardura) to an increased risk of heart failure and stroke, which led to the early cessation of the doxazosin arm. Guidelines no longer include alpha-blockers among the primary options for hypertension (JAMA. 2000;283[15]:1967-75).

However, there’s been some doubt about ALLHAT; doxazosin patients had diuretics withdrawn as part of the study, which might have contributed to the increased risks. “A lot of arguments have been made that perhaps alpha-blockers aren’t that bad and maybe should still be used, so we took a second look,” said lead investigator and nephrologist Swapnil Hiremath, MD, an assistant professor of medicine at the University of Ottawa.

What he and his team found “confirmed and expanded on the findings of ALLHAT.” Apart from a few specific situations, “don’t prescribe alpha-blockers. If a patient is on an alpha-blocker, consider prescribing an alternative,” Dr. Hiremath said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.

The drugs are still widely used, according to the team’s review of Ontario health data. From 1995 to 2015, nearly 81,000 patients were prescribed alpha-blockers for hypertension, sometimes as monotherapy, with no real downward trend in prescriptions over time.

There are some selected indications for alpha-blockers, including intolerance of other antihypertensives, pheochromocytoma management, and resistant hypertension. “So I thought maybe there would be 5,000 or 10,000. The fact that we found almost 81,000 was an eye-opener. I’m pretty sure 81,000 patients in Ontario don’t have resistant hypertension,” Dr. Hiremath said.

Patients with benign prostatic hypertrophy, another indication, were excluded from the study.

M. Alexander Otto/MDedge News

“This is observational data, but it’s consistent with ALLHAT, and the outcomes are even worse. We didn’t in [subsequent] guidelines say that you should [never] use an alpha-blocker in hypertension. Maybe we should have,” said ALLHAT investigator William Cushman, MD, a professor of medicine and physiology at the University of Tennessee, Memphis.

There was no industry funding for the work, and the investigators reported having no financial disclosures. Dr. Cushman wasn’t involved in the work.

aotto@mdedge.com

SOURCE: Hiremath S et al. Joint Hypertension 2018, Abstract P375.

CHICAGO – The risk of cardiovascular and hypotension-related events is higher with alpha-blockers than with other hypertension drugs, but almost 20 years after the pivotal ALLHAT trial first raised safety concerns, they are still widely used, according to investigators from the University of Ottawa.

ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) linked the alpha-blocker doxazosin (Cardura) to an increased risk of heart failure and stroke, which led to the early cessation of the doxazosin arm. Guidelines no longer include alpha-blockers among the primary options for hypertension (JAMA. 2000;283[15]:1967-75).

However, there’s been some doubt about ALLHAT; doxazosin patients had diuretics withdrawn as part of the study, which might have contributed to the increased risks. “A lot of arguments have been made that perhaps alpha-blockers aren’t that bad and maybe should still be used, so we took a second look,” said lead investigator and nephrologist Swapnil Hiremath, MD, an assistant professor of medicine at the University of Ottawa.

What he and his team found “confirmed and expanded on the findings of ALLHAT.” Apart from a few specific situations, “don’t prescribe alpha-blockers. If a patient is on an alpha-blocker, consider prescribing an alternative,” Dr. Hiremath said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.

The drugs are still widely used, according to the team’s review of Ontario health data. From 1995 to 2015, nearly 81,000 patients were prescribed alpha-blockers for hypertension, sometimes as monotherapy, with no real downward trend in prescriptions over time.

There are some selected indications for alpha-blockers, including intolerance of other antihypertensives, pheochromocytoma management, and resistant hypertension. “So I thought maybe there would be 5,000 or 10,000. The fact that we found almost 81,000 was an eye-opener. I’m pretty sure 81,000 patients in Ontario don’t have resistant hypertension,” Dr. Hiremath said.

Patients with benign prostatic hypertrophy, another indication, were excluded from the study.

M. Alexander Otto/MDedge News

“This is observational data, but it’s consistent with ALLHAT, and the outcomes are even worse. We didn’t in [subsequent] guidelines say that you should [never] use an alpha-blocker in hypertension. Maybe we should have,” said ALLHAT investigator William Cushman, MD, a professor of medicine and physiology at the University of Tennessee, Memphis.

There was no industry funding for the work, and the investigators reported having no financial disclosures. Dr. Cushman wasn’t involved in the work.

aotto@mdedge.com

SOURCE: Hiremath S et al. Joint Hypertension 2018, Abstract P375.

CHICAGO – The risk of cardiovascular and hypotension-related events is higher with alpha-blockers than with other hypertension drugs, but almost 20 years after the pivotal ALLHAT trial first raised safety concerns, they are still widely used, according to investigators from the University of Ottawa.

ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) linked the alpha-blocker doxazosin (Cardura) to an increased risk of heart failure and stroke, which led to the early cessation of the doxazosin arm. Guidelines no longer include alpha-blockers among the primary options for hypertension (JAMA. 2000;283[15]:1967-75).

However, there’s been some doubt about ALLHAT; doxazosin patients had diuretics withdrawn as part of the study, which might have contributed to the increased risks. “A lot of arguments have been made that perhaps alpha-blockers aren’t that bad and maybe should still be used, so we took a second look,” said lead investigator and nephrologist Swapnil Hiremath, MD, an assistant professor of medicine at the University of Ottawa.

What he and his team found “confirmed and expanded on the findings of ALLHAT.” Apart from a few specific situations, “don’t prescribe alpha-blockers. If a patient is on an alpha-blocker, consider prescribing an alternative,” Dr. Hiremath said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.

The drugs are still widely used, according to the team’s review of Ontario health data. From 1995 to 2015, nearly 81,000 patients were prescribed alpha-blockers for hypertension, sometimes as monotherapy, with no real downward trend in prescriptions over time.

There are some selected indications for alpha-blockers, including intolerance of other antihypertensives, pheochromocytoma management, and resistant hypertension. “So I thought maybe there would be 5,000 or 10,000. The fact that we found almost 81,000 was an eye-opener. I’m pretty sure 81,000 patients in Ontario don’t have resistant hypertension,” Dr. Hiremath said.

Patients with benign prostatic hypertrophy, another indication, were excluded from the study.

M. Alexander Otto/MDedge News

“This is observational data, but it’s consistent with ALLHAT, and the outcomes are even worse. We didn’t in [subsequent] guidelines say that you should [never] use an alpha-blocker in hypertension. Maybe we should have,” said ALLHAT investigator William Cushman, MD, a professor of medicine and physiology at the University of Tennessee, Memphis.

There was no industry funding for the work, and the investigators reported having no financial disclosures. Dr. Cushman wasn’t involved in the work.

aotto@mdedge.com

SOURCE: Hiremath S et al. Joint Hypertension 2018, Abstract P375.

The Food and Drug Administration has approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraines in adults.

Fremanezumab-vfrm is an injectable anti–calcitonin gene-related peptide monoclonal antibody, the first ever approved by the FDA. It can be administered at a 225-mg dose every month or at a 675-mg dose every 3 months, according to a press release from Teva, the drug’s manufacturer.

FDA approval was based on results from two, phase 3 trials in patients with disabling migraines, one of which involved fremanezumab-vfrm alone, with the other involving the injection in tandem with an oral treatment.

In both trials, patients experienced a reduction of monthly migraine days over a 12-week period. The most common adverse event in both trials was injection site reactions.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States. About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days,” Stephen Silberstein, MD, director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, said in the Teva press release.

lfranki@mdedge.com

The Food and Drug Administration has approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraines in adults.

Fremanezumab-vfrm is an injectable anti–calcitonin gene-related peptide monoclonal antibody, the first ever approved by the FDA. It can be administered at a 225-mg dose every month or at a 675-mg dose every 3 months, according to a press release from Teva, the drug’s manufacturer.

FDA approval was based on results from two, phase 3 trials in patients with disabling migraines, one of which involved fremanezumab-vfrm alone, with the other involving the injection in tandem with an oral treatment.

In both trials, patients experienced a reduction of monthly migraine days over a 12-week period. The most common adverse event in both trials was injection site reactions.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States. About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days,” Stephen Silberstein, MD, director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, said in the Teva press release.

lfranki@mdedge.com

The Food and Drug Administration has approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraines in adults.

Fremanezumab-vfrm is an injectable anti–calcitonin gene-related peptide monoclonal antibody, the first ever approved by the FDA. It can be administered at a 225-mg dose every month or at a 675-mg dose every 3 months, according to a press release from Teva, the drug’s manufacturer.

FDA approval was based on results from two, phase 3 trials in patients with disabling migraines, one of which involved fremanezumab-vfrm alone, with the other involving the injection in tandem with an oral treatment.

In both trials, patients experienced a reduction of monthly migraine days over a 12-week period. The most common adverse event in both trials was injection site reactions.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States. About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days,” Stephen Silberstein, MD, director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, said in the Teva press release.

lfranki@mdedge.com

The European Commission has granted Shire marketing authorization for vonicog alfa (Veyvondi), a recombinant von Willebrand factor (rVWF) product.

The European Commission (EC) approved vonicog alfa for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults with von Willebrand disease (VWD) when desmopressin treatment alone is ineffective or not indicated.

The product was approved in the United States in 2015 for on-demand treatment and control of bleeding episodes in adults.

The approval means Shire is authorized to market vonicog alfa in the European Union as well as in Iceland, Lichtenstein, and Norway.

The EC’s approval of vonicog alfa was based on outcomes from three clinical trials. This includes a phase 1 study and a pair of phase 3 trials – one in a surgical setting and one in a nonsurgical setting.

Data from these studies are available in the Summary of Product Characteristics for vonicog alfa.The phase 1 trial (NCT00816660) enrolled patients with type 3 or severe type 1 VWD.

The goal was to assess the safety and pharmacokinetics of vonicog alfa combined at a fixed ratio with recombinant factor VIII – referred to as “rVWF-rFVIII.” The researchers compared rVWF-rFVIII with plasma-derived (pd) VWF combined with pdFVIII (pdVWF-pdFVIII).

jensmith@mdedge.com

The European Commission has granted Shire marketing authorization for vonicog alfa (Veyvondi), a recombinant von Willebrand factor (rVWF) product.

The European Commission (EC) approved vonicog alfa for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults with von Willebrand disease (VWD) when desmopressin treatment alone is ineffective or not indicated.

The product was approved in the United States in 2015 for on-demand treatment and control of bleeding episodes in adults.

The approval means Shire is authorized to market vonicog alfa in the European Union as well as in Iceland, Lichtenstein, and Norway.

The EC’s approval of vonicog alfa was based on outcomes from three clinical trials. This includes a phase 1 study and a pair of phase 3 trials – one in a surgical setting and one in a nonsurgical setting.

Data from these studies are available in the Summary of Product Characteristics for vonicog alfa.The phase 1 trial (NCT00816660) enrolled patients with type 3 or severe type 1 VWD.

The goal was to assess the safety and pharmacokinetics of vonicog alfa combined at a fixed ratio with recombinant factor VIII – referred to as “rVWF-rFVIII.” The researchers compared rVWF-rFVIII with plasma-derived (pd) VWF combined with pdFVIII (pdVWF-pdFVIII).

jensmith@mdedge.com

The European Commission has granted Shire marketing authorization for vonicog alfa (Veyvondi), a recombinant von Willebrand factor (rVWF) product.

The European Commission (EC) approved vonicog alfa for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults with von Willebrand disease (VWD) when desmopressin treatment alone is ineffective or not indicated.

The product was approved in the United States in 2015 for on-demand treatment and control of bleeding episodes in adults.

The approval means Shire is authorized to market vonicog alfa in the European Union as well as in Iceland, Lichtenstein, and Norway.

The EC’s approval of vonicog alfa was based on outcomes from three clinical trials. This includes a phase 1 study and a pair of phase 3 trials – one in a surgical setting and one in a nonsurgical setting.

Data from these studies are available in the Summary of Product Characteristics for vonicog alfa.The phase 1 trial (NCT00816660) enrolled patients with type 3 or severe type 1 VWD.

The goal was to assess the safety and pharmacokinetics of vonicog alfa combined at a fixed ratio with recombinant factor VIII – referred to as “rVWF-rFVIII.” The researchers compared rVWF-rFVIII with plasma-derived (pd) VWF combined with pdFVIII (pdVWF-pdFVIII).

jensmith@mdedge.com

ORLANDO – Most patients with type 2 diabetes mellitus stop taking their medication within a year, and nearly one-third stop within the first 3 months, a retrospective analysis of claims data for more than 324,000 patients suggests.

Boarding1Now/Thinkstock

The findings in this population of commercially insured adults are startling and highlight a need for interventions to improve treatment persistence, according to Lisa Latts, MD, deputy chief health officer for IBM Watson Health in Cambridge, Mass.

Dr. Latts and her colleagues reviewed medication claims data for 324,136 patients with at least one diagnosis for type 2 diabetes mellitus and one outpatient pharmacy claim for a type 2 diabetes medication after at least 12 prior months without such a claim.

Of those patients, 58% discontinued treatment within 12 months, 31% discontinued within the first 3 months, and 44% discontinued within 6 months, Dr. Latts reported at the annual scientific sessions of the American Diabetes Association.

“Less than half of those patients who discontinued had a restart within the following year. So what we’re seeing here is a huge percentage of individuals who had a diagnosis of type 2 diabetes, were prescribed a medication, and then did not continue the medication,” she said.

Of those who discontinued within the 12-month follow-up, 27% restarted therapy within 60 days and 39% restarted therapy anytime during the 12-month follow-up (mean treatment gap, 107 days). Of those who discontinued by 3 months, 45% restarted within a year (mean treatment gap, 112 days), and of those who discontinued by 6 months, 44% restarted within a year (mean treatment gap, 119 days).

Patients included in the review, which was a collaborative effort of IBM Watson Health and the ADA, had at least 12 months of continuous enrollment in the Truven Health MarketScan Commercial and Medicare Supplemental Databases between 2013 and 2017, before and after the therapy initiation date.

sworcester@mdedge.com

SOURCE: Latts L et al. ADA 2018, Abstract 135-OR.

ORLANDO – Most patients with type 2 diabetes mellitus stop taking their medication within a year, and nearly one-third stop within the first 3 months, a retrospective analysis of claims data for more than 324,000 patients suggests.

Boarding1Now/Thinkstock

The findings in this population of commercially insured adults are startling and highlight a need for interventions to improve treatment persistence, according to Lisa Latts, MD, deputy chief health officer for IBM Watson Health in Cambridge, Mass.

Dr. Latts and her colleagues reviewed medication claims data for 324,136 patients with at least one diagnosis for type 2 diabetes mellitus and one outpatient pharmacy claim for a type 2 diabetes medication after at least 12 prior months without such a claim.

Of those patients, 58% discontinued treatment within 12 months, 31% discontinued within the first 3 months, and 44% discontinued within 6 months, Dr. Latts reported at the annual scientific sessions of the American Diabetes Association.

“Less than half of those patients who discontinued had a restart within the following year. So what we’re seeing here is a huge percentage of individuals who had a diagnosis of type 2 diabetes, were prescribed a medication, and then did not continue the medication,” she said.

Of those who discontinued within the 12-month follow-up, 27% restarted therapy within 60 days and 39% restarted therapy anytime during the 12-month follow-up (mean treatment gap, 107 days). Of those who discontinued by 3 months, 45% restarted within a year (mean treatment gap, 112 days), and of those who discontinued by 6 months, 44% restarted within a year (mean treatment gap, 119 days).

Patients included in the review, which was a collaborative effort of IBM Watson Health and the ADA, had at least 12 months of continuous enrollment in the Truven Health MarketScan Commercial and Medicare Supplemental Databases between 2013 and 2017, before and after the therapy initiation date.

sworcester@mdedge.com

SOURCE: Latts L et al. ADA 2018, Abstract 135-OR.

ORLANDO – Most patients with type 2 diabetes mellitus stop taking their medication within a year, and nearly one-third stop within the first 3 months, a retrospective analysis of claims data for more than 324,000 patients suggests.

Boarding1Now/Thinkstock

The findings in this population of commercially insured adults are startling and highlight a need for interventions to improve treatment persistence, according to Lisa Latts, MD, deputy chief health officer for IBM Watson Health in Cambridge, Mass.

Dr. Latts and her colleagues reviewed medication claims data for 324,136 patients with at least one diagnosis for type 2 diabetes mellitus and one outpatient pharmacy claim for a type 2 diabetes medication after at least 12 prior months without such a claim.

Of those patients, 58% discontinued treatment within 12 months, 31% discontinued within the first 3 months, and 44% discontinued within 6 months, Dr. Latts reported at the annual scientific sessions of the American Diabetes Association.

“Less than half of those patients who discontinued had a restart within the following year. So what we’re seeing here is a huge percentage of individuals who had a diagnosis of type 2 diabetes, were prescribed a medication, and then did not continue the medication,” she said.

Of those who discontinued within the 12-month follow-up, 27% restarted therapy within 60 days and 39% restarted therapy anytime during the 12-month follow-up (mean treatment gap, 107 days). Of those who discontinued by 3 months, 45% restarted within a year (mean treatment gap, 112 days), and of those who discontinued by 6 months, 44% restarted within a year (mean treatment gap, 119 days).

Patients included in the review, which was a collaborative effort of IBM Watson Health and the ADA, had at least 12 months of continuous enrollment in the Truven Health MarketScan Commercial and Medicare Supplemental Databases between 2013 and 2017, before and after the therapy initiation date.

sworcester@mdedge.com

SOURCE: Latts L et al. ADA 2018, Abstract 135-OR.

multiple myeloma

BOSTON—Early results from a phase 1 trial suggest the chimeric antigen receptor (CAR) T-cell therapy P-BCMA-101 can produce responses in patients with relapsed/refractory multiple myeloma (MM).

All 11 patients treated have experienced some clinical response, with 8 patients achieving a partial response (PR) or better.

The most common adverse events were neutropenia and thrombocytopenia. One patient was suspected to have cytokine release syndrome, but the condition resolved without use of tociluzimab or steroids.

These results were presented at the 2018 CAR-TCR Summit by Eric Ostertag, MD, PhD, chief executive officer of Poseida Therapeutics Inc., the company developing P-BCMA-101.

Dr. Ostertag presented data on 11 patients with heavily pretreated MM. They had a median of six prior therapies. Their median age was 60, and 73% were considered high risk.

Prior to receiving P-BCMA-101, patients received conditioning with fludarabine (30 mg/m²) and cyclophosphamide (300 mg/m²) for 3 days.

Patients were then treated across three dose groups with average CAR T-cell doses of 51×10⁶ (n=3), 152×10⁶ (n=7), and 430×10⁶ (n=1).

As of August 10, 2018, all 11 patients were still on study.

There were no dose-limiting toxicities. Eight patients developed neutropenia, and 5 had thrombocytopenia.

Researchers suspected cytokine release syndrome in one patient, but the condition resolved without tociluzimab or steroid treatment. There was no neurotoxicity reported, and none of the patients required admission to an intensive care unit.

All patients showed improvement in biomarkers following treatment.

Ten patients were evaluable for response by International Myeloma Working Group criteria. Seven of these patients achieved at least a PR, including very good partial responses (VGPRs) and stringent complete response (CR).

The eleventh patient also responded to treatment, but this patient has oligosecretory disease and was only evaluable by PET. The patient had a near-CR by PET.

Poseida Therapeutics would not disclose additional details regarding how many patients achieved a PR, VGPR, or CR, but the company plans to release more information on response at an upcoming meeting.

“The latest data results show that P-BCMA-101 induces deep responses in a heavily pretreated population with relapsed/refractory multiple myeloma, with some patients reaching VGPR and even stringent CR at early efficacy assessments,” Dr. Ostertag said.

“We believe our advantages of a purified product, where all cells express the CAR molecule, and a product with high levels of stem cell memory T cells, producing a more gradual and prolonged immune response against tumor cells, provide a significantly better therapeutic index when compared with other CAR-T therapeutics. We are also encouraged that P-BCMA-101 is demonstrating significant efficacy even at doses that have been ineffective for other anti-BCMA CAR-T therapies and that our response rates continue to improve as the dose increases.”

This study (NCT03288493) is funded by the California Institute for Regenerative Medicine and Poseida Therapeutics.

multiple myeloma

BOSTON—Early results from a phase 1 trial suggest the chimeric antigen receptor (CAR) T-cell therapy P-BCMA-101 can produce responses in patients with relapsed/refractory multiple myeloma (MM).

All 11 patients treated have experienced some clinical response, with 8 patients achieving a partial response (PR) or better.

The most common adverse events were neutropenia and thrombocytopenia. One patient was suspected to have cytokine release syndrome, but the condition resolved without use of tociluzimab or steroids.

These results were presented at the 2018 CAR-TCR Summit by Eric Ostertag, MD, PhD, chief executive officer of Poseida Therapeutics Inc., the company developing P-BCMA-101.

Dr. Ostertag presented data on 11 patients with heavily pretreated MM. They had a median of six prior therapies. Their median age was 60, and 73% were considered high risk.

Prior to receiving P-BCMA-101, patients received conditioning with fludarabine (30 mg/m²) and cyclophosphamide (300 mg/m²) for 3 days.

Patients were then treated across three dose groups with average CAR T-cell doses of 51×10⁶ (n=3), 152×10⁶ (n=7), and 430×10⁶ (n=1).

As of August 10, 2018, all 11 patients were still on study.

There were no dose-limiting toxicities. Eight patients developed neutropenia, and 5 had thrombocytopenia.

Researchers suspected cytokine release syndrome in one patient, but the condition resolved without tociluzimab or steroid treatment. There was no neurotoxicity reported, and none of the patients required admission to an intensive care unit.

All patients showed improvement in biomarkers following treatment.

Ten patients were evaluable for response by International Myeloma Working Group criteria. Seven of these patients achieved at least a PR, including very good partial responses (VGPRs) and stringent complete response (CR).

The eleventh patient also responded to treatment, but this patient has oligosecretory disease and was only evaluable by PET. The patient had a near-CR by PET.

Poseida Therapeutics would not disclose additional details regarding how many patients achieved a PR, VGPR, or CR, but the company plans to release more information on response at an upcoming meeting.

“The latest data results show that P-BCMA-101 induces deep responses in a heavily pretreated population with relapsed/refractory multiple myeloma, with some patients reaching VGPR and even stringent CR at early efficacy assessments,” Dr. Ostertag said.

“We believe our advantages of a purified product, where all cells express the CAR molecule, and a product with high levels of stem cell memory T cells, producing a more gradual and prolonged immune response against tumor cells, provide a significantly better therapeutic index when compared with other CAR-T therapeutics. We are also encouraged that P-BCMA-101 is demonstrating significant efficacy even at doses that have been ineffective for other anti-BCMA CAR-T therapies and that our response rates continue to improve as the dose increases.”

This study (NCT03288493) is funded by the California Institute for Regenerative Medicine and Poseida Therapeutics.

multiple myeloma

BOSTON—Early results from a phase 1 trial suggest the chimeric antigen receptor (CAR) T-cell therapy P-BCMA-101 can produce responses in patients with relapsed/refractory multiple myeloma (MM).

All 11 patients treated have experienced some clinical response, with 8 patients achieving a partial response (PR) or better.

The most common adverse events were neutropenia and thrombocytopenia. One patient was suspected to have cytokine release syndrome, but the condition resolved without use of tociluzimab or steroids.

These results were presented at the 2018 CAR-TCR Summit by Eric Ostertag, MD, PhD, chief executive officer of Poseida Therapeutics Inc., the company developing P-BCMA-101.

Dr. Ostertag presented data on 11 patients with heavily pretreated MM. They had a median of six prior therapies. Their median age was 60, and 73% were considered high risk.

Prior to receiving P-BCMA-101, patients received conditioning with fludarabine (30 mg/m²) and cyclophosphamide (300 mg/m²) for 3 days.

Patients were then treated across three dose groups with average CAR T-cell doses of 51×10⁶ (n=3), 152×10⁶ (n=7), and 430×10⁶ (n=1).

As of August 10, 2018, all 11 patients were still on study.

There were no dose-limiting toxicities. Eight patients developed neutropenia, and 5 had thrombocytopenia.

Researchers suspected cytokine release syndrome in one patient, but the condition resolved without tociluzimab or steroid treatment. There was no neurotoxicity reported, and none of the patients required admission to an intensive care unit.

All patients showed improvement in biomarkers following treatment.

Ten patients were evaluable for response by International Myeloma Working Group criteria. Seven of these patients achieved at least a PR, including very good partial responses (VGPRs) and stringent complete response (CR).

The eleventh patient also responded to treatment, but this patient has oligosecretory disease and was only evaluable by PET. The patient had a near-CR by PET.

Poseida Therapeutics would not disclose additional details regarding how many patients achieved a PR, VGPR, or CR, but the company plans to release more information on response at an upcoming meeting.

“The latest data results show that P-BCMA-101 induces deep responses in a heavily pretreated population with relapsed/refractory multiple myeloma, with some patients reaching VGPR and even stringent CR at early efficacy assessments,” Dr. Ostertag said.

“We believe our advantages of a purified product, where all cells express the CAR molecule, and a product with high levels of stem cell memory T cells, producing a more gradual and prolonged immune response against tumor cells, provide a significantly better therapeutic index when compared with other CAR-T therapeutics. We are also encouraged that P-BCMA-101 is demonstrating significant efficacy even at doses that have been ineffective for other anti-BCMA CAR-T therapies and that our response rates continue to improve as the dose increases.”

This study (NCT03288493) is funded by the California Institute for Regenerative Medicine and Poseida Therapeutics.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

mlesney@mdedge.com

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

mlesney@mdedge.com

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

mlesney@mdedge.com

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.