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Big trial reassures on heart safety of testosterone in men
CHICAGO – , long-awaited results from a major clinical trial show.
Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.
In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.
And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.
The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.
The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.
Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.
“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.
These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
Findings apply only to men with bona fide testosterone deficiency
Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.
“Until now, we’ve had to say well, there might be a risk of strokes and heart attacks. This study does a lot to say that’s not a serious risk, in the first few years anyway, of testosterone therapy. We still need long-term follow-up in these patients, or others, to see what the long-term risks are, but it’s really reassuring,” added Dr. Anawalt, professor of medicine at the University of Washington, Seattle.
Both Dr. Bhasin and Dr. Anawalt said the TRAVERSE trial in men is similar in many ways to the Women’s Health Initiative (WHI). “[TRAVERSE] is not as big as [WHI], but it’s framed in a similar way to ask those safety questions and to weigh the risk and benefit,” Dr. Anawalt explained.
However, Dr. Anawalt stressed that the TRAVERSE safety data apply only to men with documented testosterone deficiency.
“It’s important to emphasize that this is a study of men with bona fide testosterone deficiency and symptoms. It doesn’t give carte blanche to prescribe to men with normal testosterone concentrations. It doesn’t tell us about the safety of that,” he noted.
Safety reassuring, but some concerns will require more investigation
TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.
The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.
Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.
Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).
There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).
“These adverse events were not expected,” the authors wrote.
Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.
Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
Finally, ‘real data on something we’ve been prescribing for decades’
Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”
He added that even among the few previous randomized clinical trials, only one, the TTrials series, had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.
Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”
At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.
“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.
Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
‘Big surprise’ and a mystery: Testosterone increased fracture risk
The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.
“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.
The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.
Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.
“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.
Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”
Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.
“This begs the question should we reorient the way we’re thinking about these men.”
The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 6/19/23.
CHICAGO – , long-awaited results from a major clinical trial show.
Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.
In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.
And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.
The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.
The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.
Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.
“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.
These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
Findings apply only to men with bona fide testosterone deficiency
Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.
“Until now, we’ve had to say well, there might be a risk of strokes and heart attacks. This study does a lot to say that’s not a serious risk, in the first few years anyway, of testosterone therapy. We still need long-term follow-up in these patients, or others, to see what the long-term risks are, but it’s really reassuring,” added Dr. Anawalt, professor of medicine at the University of Washington, Seattle.
Both Dr. Bhasin and Dr. Anawalt said the TRAVERSE trial in men is similar in many ways to the Women’s Health Initiative (WHI). “[TRAVERSE] is not as big as [WHI], but it’s framed in a similar way to ask those safety questions and to weigh the risk and benefit,” Dr. Anawalt explained.
However, Dr. Anawalt stressed that the TRAVERSE safety data apply only to men with documented testosterone deficiency.
“It’s important to emphasize that this is a study of men with bona fide testosterone deficiency and symptoms. It doesn’t give carte blanche to prescribe to men with normal testosterone concentrations. It doesn’t tell us about the safety of that,” he noted.
Safety reassuring, but some concerns will require more investigation
TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.
The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.
Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.
Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).
There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).
“These adverse events were not expected,” the authors wrote.
Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.
Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
Finally, ‘real data on something we’ve been prescribing for decades’
Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”
He added that even among the few previous randomized clinical trials, only one, the TTrials series, had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.
Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”
At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.
“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.
Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
‘Big surprise’ and a mystery: Testosterone increased fracture risk
The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.
“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.
The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.
Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.
“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.
Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”
Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.
“This begs the question should we reorient the way we’re thinking about these men.”
The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 6/19/23.
CHICAGO – , long-awaited results from a major clinical trial show.
Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.
In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.
And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.
The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.
The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.
Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.
“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.
These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
Findings apply only to men with bona fide testosterone deficiency
Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.
“Until now, we’ve had to say well, there might be a risk of strokes and heart attacks. This study does a lot to say that’s not a serious risk, in the first few years anyway, of testosterone therapy. We still need long-term follow-up in these patients, or others, to see what the long-term risks are, but it’s really reassuring,” added Dr. Anawalt, professor of medicine at the University of Washington, Seattle.
Both Dr. Bhasin and Dr. Anawalt said the TRAVERSE trial in men is similar in many ways to the Women’s Health Initiative (WHI). “[TRAVERSE] is not as big as [WHI], but it’s framed in a similar way to ask those safety questions and to weigh the risk and benefit,” Dr. Anawalt explained.
However, Dr. Anawalt stressed that the TRAVERSE safety data apply only to men with documented testosterone deficiency.
“It’s important to emphasize that this is a study of men with bona fide testosterone deficiency and symptoms. It doesn’t give carte blanche to prescribe to men with normal testosterone concentrations. It doesn’t tell us about the safety of that,” he noted.
Safety reassuring, but some concerns will require more investigation
TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.
The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.
Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.
Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).
There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).
“These adverse events were not expected,” the authors wrote.
Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.
Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
Finally, ‘real data on something we’ve been prescribing for decades’
Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”
He added that even among the few previous randomized clinical trials, only one, the TTrials series, had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.
Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”
At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.
“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.
Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
‘Big surprise’ and a mystery: Testosterone increased fracture risk
The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.
“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.
The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.
Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.
“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.
Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”
Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.
“This begs the question should we reorient the way we’re thinking about these men.”
The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 6/19/23.
AT ENDO 2023
Rehabilitation improves walk test results for post–pulmonary embolism patients with persistent dyspnea
In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.
The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown.
The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.
Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.
Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.
“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.
The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.
Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”
The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.
In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.
The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown.
The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.
Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.
Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.
“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.
The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.
Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”
The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.
In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.
The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown.
The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.
Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.
Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.
“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.
The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.
Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”
The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.
FROM THE JOURNAL CHEST
Depression drives metabolic syndrome
Previous research has established a connection between metabolic syndrome and depression, but data on the increased risk for depressed individuals to develop metabolic syndrome (MetS) are lacking, wrote Lara Onofre Ferriani, PhD, of Federal University of Espírito Santo, Vitoria, Brazil, and colleagues.
“Individuals with MetS and depression have increased levels of inflammatory markers, and it is speculated that inflammation could mediate this comorbidity,” they said.
In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 13,883 participants in the Brazilian Longitudinal Study of Adult Health; all were civil servants at universities in Brazil. The participants ranged from 35 to 74 years of age, with a mean age of 51.9 years; 54.3% were women; and 52.4% were white; the mean follow-up period was 3.8 years.
The primary outcome was the association between depression diagnosis and severity on components of MetS at baseline and over a 4-year period. Participants were classified by MetS trajectory as recovered, incident, or persistent, and classified by depression status as without depression or with a mild, moderate, or severe current depressive episode. Depression status was based on the Clinical Interview Schedule Revised. MetS components and diagnosis were based on the National Cholesterol Education Program Adult Treatment Panel III.
In a logistic regression analysis, baseline depression was positively associated with recovered, incident, and persistent MetS (odds ratios, 1.59, 1.45, and 1.70, respectively).
Depression at baseline also was significantly associated with separate components of MetS: large waist circumference, high triglycerides, low high-density lipoprotein cholesterol, and hyperglycemia, with odds ratios of 1.47, 1.23, 1.30, and 1.38, respectively.
Although not seen at baseline, a significant positive association between baseline depression and the presence of three or more MetS components was noted at follow-up, with a positive dose-response effect, the researchers wrote in their discussion.
Not all associations were statistically significant, but this was mainly because of the small number of cases of moderate and severe depression, they said. However, the magnitude of associations was greater in severe depression, when compared with moderate and mild, which suggests that the risk of MetS may be higher in this population, they added.
The study findings were limited by several factors including the possible misclassification of depression, inability to differentiate among depressive subtypes, and the potential lack of generalizability to other populations beyond Brazilian civil servants, the researchers noted.
However, the results were strengthened by the large sample size and support the role of depression as a risk factor for MetS, they said. More research is needed to determine a bidirectional relationship and to assess the trajectory of depression after MetS develops, but the findings “highlight the need to investigate and manage metabolic and cardiovascular alterations in the presence of depression in clinical settings,” they concluded.
The study was supported by the Brazilian Ministry of Health (Science and Technology Department) and the Brazilian Ministry of Science, Technology and Innovation FINEP and CNPq, and by the Coordenaçaõ de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). The researchers had no financial conflicts to disclose.
Previous research has established a connection between metabolic syndrome and depression, but data on the increased risk for depressed individuals to develop metabolic syndrome (MetS) are lacking, wrote Lara Onofre Ferriani, PhD, of Federal University of Espírito Santo, Vitoria, Brazil, and colleagues.
“Individuals with MetS and depression have increased levels of inflammatory markers, and it is speculated that inflammation could mediate this comorbidity,” they said.
In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 13,883 participants in the Brazilian Longitudinal Study of Adult Health; all were civil servants at universities in Brazil. The participants ranged from 35 to 74 years of age, with a mean age of 51.9 years; 54.3% were women; and 52.4% were white; the mean follow-up period was 3.8 years.
The primary outcome was the association between depression diagnosis and severity on components of MetS at baseline and over a 4-year period. Participants were classified by MetS trajectory as recovered, incident, or persistent, and classified by depression status as without depression or with a mild, moderate, or severe current depressive episode. Depression status was based on the Clinical Interview Schedule Revised. MetS components and diagnosis were based on the National Cholesterol Education Program Adult Treatment Panel III.
In a logistic regression analysis, baseline depression was positively associated with recovered, incident, and persistent MetS (odds ratios, 1.59, 1.45, and 1.70, respectively).
Depression at baseline also was significantly associated with separate components of MetS: large waist circumference, high triglycerides, low high-density lipoprotein cholesterol, and hyperglycemia, with odds ratios of 1.47, 1.23, 1.30, and 1.38, respectively.
Although not seen at baseline, a significant positive association between baseline depression and the presence of three or more MetS components was noted at follow-up, with a positive dose-response effect, the researchers wrote in their discussion.
Not all associations were statistically significant, but this was mainly because of the small number of cases of moderate and severe depression, they said. However, the magnitude of associations was greater in severe depression, when compared with moderate and mild, which suggests that the risk of MetS may be higher in this population, they added.
The study findings were limited by several factors including the possible misclassification of depression, inability to differentiate among depressive subtypes, and the potential lack of generalizability to other populations beyond Brazilian civil servants, the researchers noted.
However, the results were strengthened by the large sample size and support the role of depression as a risk factor for MetS, they said. More research is needed to determine a bidirectional relationship and to assess the trajectory of depression after MetS develops, but the findings “highlight the need to investigate and manage metabolic and cardiovascular alterations in the presence of depression in clinical settings,” they concluded.
The study was supported by the Brazilian Ministry of Health (Science and Technology Department) and the Brazilian Ministry of Science, Technology and Innovation FINEP and CNPq, and by the Coordenaçaõ de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). The researchers had no financial conflicts to disclose.
Previous research has established a connection between metabolic syndrome and depression, but data on the increased risk for depressed individuals to develop metabolic syndrome (MetS) are lacking, wrote Lara Onofre Ferriani, PhD, of Federal University of Espírito Santo, Vitoria, Brazil, and colleagues.
“Individuals with MetS and depression have increased levels of inflammatory markers, and it is speculated that inflammation could mediate this comorbidity,” they said.
In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 13,883 participants in the Brazilian Longitudinal Study of Adult Health; all were civil servants at universities in Brazil. The participants ranged from 35 to 74 years of age, with a mean age of 51.9 years; 54.3% were women; and 52.4% were white; the mean follow-up period was 3.8 years.
The primary outcome was the association between depression diagnosis and severity on components of MetS at baseline and over a 4-year period. Participants were classified by MetS trajectory as recovered, incident, or persistent, and classified by depression status as without depression or with a mild, moderate, or severe current depressive episode. Depression status was based on the Clinical Interview Schedule Revised. MetS components and diagnosis were based on the National Cholesterol Education Program Adult Treatment Panel III.
In a logistic regression analysis, baseline depression was positively associated with recovered, incident, and persistent MetS (odds ratios, 1.59, 1.45, and 1.70, respectively).
Depression at baseline also was significantly associated with separate components of MetS: large waist circumference, high triglycerides, low high-density lipoprotein cholesterol, and hyperglycemia, with odds ratios of 1.47, 1.23, 1.30, and 1.38, respectively.
Although not seen at baseline, a significant positive association between baseline depression and the presence of three or more MetS components was noted at follow-up, with a positive dose-response effect, the researchers wrote in their discussion.
Not all associations were statistically significant, but this was mainly because of the small number of cases of moderate and severe depression, they said. However, the magnitude of associations was greater in severe depression, when compared with moderate and mild, which suggests that the risk of MetS may be higher in this population, they added.
The study findings were limited by several factors including the possible misclassification of depression, inability to differentiate among depressive subtypes, and the potential lack of generalizability to other populations beyond Brazilian civil servants, the researchers noted.
However, the results were strengthened by the large sample size and support the role of depression as a risk factor for MetS, they said. More research is needed to determine a bidirectional relationship and to assess the trajectory of depression after MetS develops, but the findings “highlight the need to investigate and manage metabolic and cardiovascular alterations in the presence of depression in clinical settings,” they concluded.
The study was supported by the Brazilian Ministry of Health (Science and Technology Department) and the Brazilian Ministry of Science, Technology and Innovation FINEP and CNPq, and by the Coordenaçaõ de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF PSYCHIATRIC RESEARCH
Hospital patient catches on fire, highlighting need for prevention
On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.
Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.
Underreported, but likely dropping
Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.
The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.
In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.
A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.
The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
Accidents waiting to happen
How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.
But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
Safety protocols
The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.
“Many patients do not require a high concentration of oxygen during sedation,” he says.
When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.
In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
Making fire safety part of the preop routine
These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.
In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.
Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”
ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”
A version of this article originally appeared on Medscape.com.
On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.
Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.
Underreported, but likely dropping
Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.
The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.
In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.
A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.
The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
Accidents waiting to happen
How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.
But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
Safety protocols
The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.
“Many patients do not require a high concentration of oxygen during sedation,” he says.
When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.
In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
Making fire safety part of the preop routine
These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.
In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.
Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”
ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”
A version of this article originally appeared on Medscape.com.
On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.
Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.
Underreported, but likely dropping
Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.
The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.
In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.
A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.
The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
Accidents waiting to happen
How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.
But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
Safety protocols
The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.
“Many patients do not require a high concentration of oxygen during sedation,” he says.
When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.
In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
Making fire safety part of the preop routine
These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.
In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.
Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”
ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”
A version of this article originally appeared on Medscape.com.
The road to weight loss is paved with collusion and sabotage
Three big bumps on the weight-loss journey
The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.
Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.
Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.
Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.
Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”
The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.
“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.
Like we said before, weight loss is a journey. The right support can only improve the odds of success.
Robots vs. mosquitoes
If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.
Yet.
Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.
To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.
The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?
The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
This is knot what you were expecting
Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.
That’s not enough for you, is it? Fine, we were warned.
Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.
For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.
That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.
But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.
The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.
Three big bumps on the weight-loss journey
The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.
Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.
Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.
Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.
Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”
The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.
“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.
Like we said before, weight loss is a journey. The right support can only improve the odds of success.
Robots vs. mosquitoes
If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.
Yet.
Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.
To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.
The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?
The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
This is knot what you were expecting
Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.
That’s not enough for you, is it? Fine, we were warned.
Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.
For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.
That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.
But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.
The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.
Three big bumps on the weight-loss journey
The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.
Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.
Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.
Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.
Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”
The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.
“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.
Like we said before, weight loss is a journey. The right support can only improve the odds of success.
Robots vs. mosquitoes
If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.
Yet.
Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.
To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.
The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?
The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
This is knot what you were expecting
Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.
That’s not enough for you, is it? Fine, we were warned.
Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.
For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.
That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.
But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.
The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.
New bill would provide greater length of time to sue doctors
A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?
As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.
“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.
Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.
In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
Time of injury versus time of discovery
Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.
This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.
Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.
Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.
“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.
Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
Medical malpractice statutes of limitations by state
Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”
In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
Statutes of limitations by state
1 Year: California, Kentucky, Louisiana, Ohio, Tennessee
2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming
2.5 Years: New York
3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin
4 Years: Minnesota
To protect yourself
Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.
“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.
Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.
“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
Keep good records
If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.
“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
Keep an eye on malpractice insurance rates
It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.
He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.
“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”
Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.
“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.
In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
Key takeaways
Ultimately, to protect yourself and your practice, you can do the following:
- Know the statute of limitations and discovery rules for your state.
- Review your coverage with your insurer to better understand your liability.
- Keep accurate records for as long as your statute requires.
- Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.
“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”
A version of this article first appeared on Medscape.com.
A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?
As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.
“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.
Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.
In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
Time of injury versus time of discovery
Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.
This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.
Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.
Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.
“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.
Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
Medical malpractice statutes of limitations by state
Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”
In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
Statutes of limitations by state
1 Year: California, Kentucky, Louisiana, Ohio, Tennessee
2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming
2.5 Years: New York
3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin
4 Years: Minnesota
To protect yourself
Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.
“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.
Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.
“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
Keep good records
If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.
“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
Keep an eye on malpractice insurance rates
It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.
He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.
“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”
Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.
“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.
In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
Key takeaways
Ultimately, to protect yourself and your practice, you can do the following:
- Know the statute of limitations and discovery rules for your state.
- Review your coverage with your insurer to better understand your liability.
- Keep accurate records for as long as your statute requires.
- Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.
“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”
A version of this article first appeared on Medscape.com.
A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?
As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.
“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.
Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.
In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
Time of injury versus time of discovery
Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.
This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.
Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.
Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.
“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.
Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
Medical malpractice statutes of limitations by state
Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”
In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
Statutes of limitations by state
1 Year: California, Kentucky, Louisiana, Ohio, Tennessee
2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming
2.5 Years: New York
3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin
4 Years: Minnesota
To protect yourself
Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.
“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.
Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.
“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
Keep good records
If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.
“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
Keep an eye on malpractice insurance rates
It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.
He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.
“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”
Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.
“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.
In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
Key takeaways
Ultimately, to protect yourself and your practice, you can do the following:
- Know the statute of limitations and discovery rules for your state.
- Review your coverage with your insurer to better understand your liability.
- Keep accurate records for as long as your statute requires.
- Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.
“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”
A version of this article first appeared on Medscape.com.
Protecting your practice data
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
Support for minimally invasive mitral valve repair: Mini Mitral published
The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.
The full results are now published online in JAMA.
The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents.
However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.
An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.
Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.
The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.
For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.
The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.
This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.
Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.
Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.
Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.
There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.
“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
Approach ‘may appeal to patients’
In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.
“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.
“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.
The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.
A version of this article first appeared on Medscape.com.
The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.
The full results are now published online in JAMA.
The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents.
However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.
An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.
Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.
The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.
For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.
The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.
This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.
Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.
Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.
Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.
There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.
“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
Approach ‘may appeal to patients’
In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.
“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.
“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.
The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.
A version of this article first appeared on Medscape.com.
The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.
The full results are now published online in JAMA.
The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents.
However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.
An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.
Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.
The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.
For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.
The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.
This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.
Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.
Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.
Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.
There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.
“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
Approach ‘may appeal to patients’
In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.
“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.
“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.
The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.
A version of this article first appeared on Medscape.com.
AHA flags CV risk with lead, cadmium, and arsenic exposure
in a new scientific statement.
“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.
“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.
The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
Involuntary exposure harms the heart
Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.
These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.
Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.
Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.
“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.
“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.
Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.
“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.
“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”
Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
A version of this article originally appeared on Medscape.com.
in a new scientific statement.
“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.
“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.
The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
Involuntary exposure harms the heart
Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.
These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.
Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.
Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.
“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.
“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.
Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.
“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.
“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”
Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
A version of this article originally appeared on Medscape.com.
in a new scientific statement.
“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.
“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.
The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
Involuntary exposure harms the heart
Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.
These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.
Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.
Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.
“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.
“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.
Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.
“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.
“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”
Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
A version of this article originally appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Ticagrelor may reduce brain lesions after carotid stenting
MUNICH – secondary endpoint results of the PRECISE-MRI trial suggest.
More than 200 patients with carotid artery stenosis underwent MRI and were randomized to ticagrelor or clopidogrel before undergoing CAS. They then had two follow-up MRIs to assess the presence of emergent ischemic lesions.
Although the trial, which was stopped early, failed to show a difference between the two treatments in the primary endpoint – occurrence of at least one ischemic lesion – it did show that ticagrelor was associated with significant reductions in secondary endpoints including the total number and total volume of new lesions.
There were also significantly fewer cases of a composite of adverse clinical events with ticagrelor versus clopidogrel, but no difference in rates of hemorrhagic bleeds.
The research was presented at the annual European Stroke Organisation Conference .
Highlighting the failure of the trial to meet its primary endpoint, study presenter Leo Bonati, MD, head of the Stroke Center, Rena Rheinfelden, University Hospital Basel (Switzerland), pointed out that the proportion of patients with one or more ischemic brain lesions was “much higher than expected.”
Based on the secondary outcomes, the study nevertheless indicates that, “compared with clopidogrel, ticagrelor reduces the total burden of ischemic brain lesions occurring during CAS,” he said.
Ticagrelor is therefore a “safe alternative to clopidogrel as an add-on to aspirin to cover carotid artery stent procedures.”
Dr. Bonati cautioned, however, that the findings are preliminary.
‘Promising’ results
Session cochair Else Charlotte Sandset, MD, PhD, a consultant neurologist in the stroke unit, department of neurology, Oslo University Hospital, called the results “interesting” and “promising.”
She said in an interview that they “also provide us with an additional option” in the management of patients undergoing CAS.
Dr. Sandset suggested that “it may have been a little bit hard to prove the primary endpoint” chosen for the trial, but believes that the secondary endpoint results “are very interesting.”
“Of course, we would need more data and further trials to provide some reassurance that we can use ticagrelor in this fashion,” she said.
Major complication
Dr. Bonati began by noting that the major procedural complication of CAS is embolic stroke, but this may be prevented with optimized antiplatelet therapy.
Previous studies have shown that ticagrelor is superior to clopidogrel as an add-on to aspirin in reducing rates of major adverse cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention.
Adding the drug to aspirin is also superior to aspirin alone in preventing recurrent stroke in patients with minor stroke or transient ischemic attack, Dr. Bonati said.
To examine whether ticagrelor is superior to clopidogrel as an add-on to aspirin in preventing ischemic brain lesions during CAS, the team conducted a randomized, open, active-controlled trial.
They recruited patients with ≥ 50% symptomatic or asymptomatic carotid stenosis undergoing CAS in line with local guidelines and performed a baseline MRI scan and clinical examination.
The patients were then randomized to ticagrelor or clopidogrel plus aspirin 1-3 days before undergoing CAS. A second MRI and clinical examination, as well as an ultrasound scan, was performed at 1 to 3 days post-CAS, with a third set of examinations performed at 28-32 days after the procedure.
The study included 14 sites in Belgium, Germany, Italy, the Netherlands, Switzerland, and the United Kingdom. Enrollment was stopped after 209 of the originally planned 370 patients, “due to slow recruitment and a lack of further funding,” Dr. Bonati said.
Of those, 207 patients were included in the intention-to-treat safety analysis, and 172 in the per-protocol efficacy analysis.
The mean age of the patients was 69.0-69.5 years in the two treatment groups, and 67%-71% were male. Dr. Bonati noted that 52%-55% of the patients had symptomatic stenosis, and that in 83%-88% the stenosis was severe.
The majority (79%-82%) of patients had hypertension, alongside hypercholesterolemia, at 76% in both treatment groups.
Dr. Bonati showed that there was no significant difference in the primary efficacy outcome of the presence of at least new ischemic brain lesion on the second or third MRI, at 74.7% for patients given ticagrelor versus 79.8% with clopidogrel, or a relative risk of 0.94 (95% confidence interval, 0.79-1.10; P = .43).
However, there was a significant reduction in the number of new ischemic lesions, at a median of 2 (interquartile range, 0.5-5.5) with ticagrelor versus 3 with clopidogrel (IQR, 1-8), or an exponential beta value of 0.63 (95% CI, 0.42-0.95; P = .027).
Ticagrelor was also associated with a significant reduction in the total volume of lesions, at a median of 66 mcL (IQR, 2.5-2.19) versus 91 mcL (IQR, 25-394) for clopidogrel, or an exponential beta value of 0.30 (95% CI, 0.10-0.92; P = .030).
Patients assigned to ticagrelor also had a significantly lower rate of the primary clinical safety outcome, a composite of stroke, myocardial infarction, major bleeding, or cardiovascular death, at 2.9% versus 7.8% (relative risk, 0.36; 95% CI, 0.08-1.20). This was driven by a reduction in rates of post-CAS stroke.
Dr. Bonati noted that there was no significant difference in the presence of at least one hemorrhagic lesion after CAS, at 42.7% with ticagrelor and 47.6% in the clopidogrel group (RR, 0.90; 95% CI, 0.63-1.26).
There was also a similar rate of microbleeds between the two treatment groups, at 36.6% in patients given ticagrelor and 47.6% in those assigned to clopidogrel.
The study was investigator initiated and funded by an unrestricted research grant from AstraZeneca. No relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
MUNICH – secondary endpoint results of the PRECISE-MRI trial suggest.
More than 200 patients with carotid artery stenosis underwent MRI and were randomized to ticagrelor or clopidogrel before undergoing CAS. They then had two follow-up MRIs to assess the presence of emergent ischemic lesions.
Although the trial, which was stopped early, failed to show a difference between the two treatments in the primary endpoint – occurrence of at least one ischemic lesion – it did show that ticagrelor was associated with significant reductions in secondary endpoints including the total number and total volume of new lesions.
There were also significantly fewer cases of a composite of adverse clinical events with ticagrelor versus clopidogrel, but no difference in rates of hemorrhagic bleeds.
The research was presented at the annual European Stroke Organisation Conference .
Highlighting the failure of the trial to meet its primary endpoint, study presenter Leo Bonati, MD, head of the Stroke Center, Rena Rheinfelden, University Hospital Basel (Switzerland), pointed out that the proportion of patients with one or more ischemic brain lesions was “much higher than expected.”
Based on the secondary outcomes, the study nevertheless indicates that, “compared with clopidogrel, ticagrelor reduces the total burden of ischemic brain lesions occurring during CAS,” he said.
Ticagrelor is therefore a “safe alternative to clopidogrel as an add-on to aspirin to cover carotid artery stent procedures.”
Dr. Bonati cautioned, however, that the findings are preliminary.
‘Promising’ results
Session cochair Else Charlotte Sandset, MD, PhD, a consultant neurologist in the stroke unit, department of neurology, Oslo University Hospital, called the results “interesting” and “promising.”
She said in an interview that they “also provide us with an additional option” in the management of patients undergoing CAS.
Dr. Sandset suggested that “it may have been a little bit hard to prove the primary endpoint” chosen for the trial, but believes that the secondary endpoint results “are very interesting.”
“Of course, we would need more data and further trials to provide some reassurance that we can use ticagrelor in this fashion,” she said.
Major complication
Dr. Bonati began by noting that the major procedural complication of CAS is embolic stroke, but this may be prevented with optimized antiplatelet therapy.
Previous studies have shown that ticagrelor is superior to clopidogrel as an add-on to aspirin in reducing rates of major adverse cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention.
Adding the drug to aspirin is also superior to aspirin alone in preventing recurrent stroke in patients with minor stroke or transient ischemic attack, Dr. Bonati said.
To examine whether ticagrelor is superior to clopidogrel as an add-on to aspirin in preventing ischemic brain lesions during CAS, the team conducted a randomized, open, active-controlled trial.
They recruited patients with ≥ 50% symptomatic or asymptomatic carotid stenosis undergoing CAS in line with local guidelines and performed a baseline MRI scan and clinical examination.
The patients were then randomized to ticagrelor or clopidogrel plus aspirin 1-3 days before undergoing CAS. A second MRI and clinical examination, as well as an ultrasound scan, was performed at 1 to 3 days post-CAS, with a third set of examinations performed at 28-32 days after the procedure.
The study included 14 sites in Belgium, Germany, Italy, the Netherlands, Switzerland, and the United Kingdom. Enrollment was stopped after 209 of the originally planned 370 patients, “due to slow recruitment and a lack of further funding,” Dr. Bonati said.
Of those, 207 patients were included in the intention-to-treat safety analysis, and 172 in the per-protocol efficacy analysis.
The mean age of the patients was 69.0-69.5 years in the two treatment groups, and 67%-71% were male. Dr. Bonati noted that 52%-55% of the patients had symptomatic stenosis, and that in 83%-88% the stenosis was severe.
The majority (79%-82%) of patients had hypertension, alongside hypercholesterolemia, at 76% in both treatment groups.
Dr. Bonati showed that there was no significant difference in the primary efficacy outcome of the presence of at least new ischemic brain lesion on the second or third MRI, at 74.7% for patients given ticagrelor versus 79.8% with clopidogrel, or a relative risk of 0.94 (95% confidence interval, 0.79-1.10; P = .43).
However, there was a significant reduction in the number of new ischemic lesions, at a median of 2 (interquartile range, 0.5-5.5) with ticagrelor versus 3 with clopidogrel (IQR, 1-8), or an exponential beta value of 0.63 (95% CI, 0.42-0.95; P = .027).
Ticagrelor was also associated with a significant reduction in the total volume of lesions, at a median of 66 mcL (IQR, 2.5-2.19) versus 91 mcL (IQR, 25-394) for clopidogrel, or an exponential beta value of 0.30 (95% CI, 0.10-0.92; P = .030).
Patients assigned to ticagrelor also had a significantly lower rate of the primary clinical safety outcome, a composite of stroke, myocardial infarction, major bleeding, or cardiovascular death, at 2.9% versus 7.8% (relative risk, 0.36; 95% CI, 0.08-1.20). This was driven by a reduction in rates of post-CAS stroke.
Dr. Bonati noted that there was no significant difference in the presence of at least one hemorrhagic lesion after CAS, at 42.7% with ticagrelor and 47.6% in the clopidogrel group (RR, 0.90; 95% CI, 0.63-1.26).
There was also a similar rate of microbleeds between the two treatment groups, at 36.6% in patients given ticagrelor and 47.6% in those assigned to clopidogrel.
The study was investigator initiated and funded by an unrestricted research grant from AstraZeneca. No relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
MUNICH – secondary endpoint results of the PRECISE-MRI trial suggest.
More than 200 patients with carotid artery stenosis underwent MRI and were randomized to ticagrelor or clopidogrel before undergoing CAS. They then had two follow-up MRIs to assess the presence of emergent ischemic lesions.
Although the trial, which was stopped early, failed to show a difference between the two treatments in the primary endpoint – occurrence of at least one ischemic lesion – it did show that ticagrelor was associated with significant reductions in secondary endpoints including the total number and total volume of new lesions.
There were also significantly fewer cases of a composite of adverse clinical events with ticagrelor versus clopidogrel, but no difference in rates of hemorrhagic bleeds.
The research was presented at the annual European Stroke Organisation Conference .
Highlighting the failure of the trial to meet its primary endpoint, study presenter Leo Bonati, MD, head of the Stroke Center, Rena Rheinfelden, University Hospital Basel (Switzerland), pointed out that the proportion of patients with one or more ischemic brain lesions was “much higher than expected.”
Based on the secondary outcomes, the study nevertheless indicates that, “compared with clopidogrel, ticagrelor reduces the total burden of ischemic brain lesions occurring during CAS,” he said.
Ticagrelor is therefore a “safe alternative to clopidogrel as an add-on to aspirin to cover carotid artery stent procedures.”
Dr. Bonati cautioned, however, that the findings are preliminary.
‘Promising’ results
Session cochair Else Charlotte Sandset, MD, PhD, a consultant neurologist in the stroke unit, department of neurology, Oslo University Hospital, called the results “interesting” and “promising.”
She said in an interview that they “also provide us with an additional option” in the management of patients undergoing CAS.
Dr. Sandset suggested that “it may have been a little bit hard to prove the primary endpoint” chosen for the trial, but believes that the secondary endpoint results “are very interesting.”
“Of course, we would need more data and further trials to provide some reassurance that we can use ticagrelor in this fashion,” she said.
Major complication
Dr. Bonati began by noting that the major procedural complication of CAS is embolic stroke, but this may be prevented with optimized antiplatelet therapy.
Previous studies have shown that ticagrelor is superior to clopidogrel as an add-on to aspirin in reducing rates of major adverse cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention.
Adding the drug to aspirin is also superior to aspirin alone in preventing recurrent stroke in patients with minor stroke or transient ischemic attack, Dr. Bonati said.
To examine whether ticagrelor is superior to clopidogrel as an add-on to aspirin in preventing ischemic brain lesions during CAS, the team conducted a randomized, open, active-controlled trial.
They recruited patients with ≥ 50% symptomatic or asymptomatic carotid stenosis undergoing CAS in line with local guidelines and performed a baseline MRI scan and clinical examination.
The patients were then randomized to ticagrelor or clopidogrel plus aspirin 1-3 days before undergoing CAS. A second MRI and clinical examination, as well as an ultrasound scan, was performed at 1 to 3 days post-CAS, with a third set of examinations performed at 28-32 days after the procedure.
The study included 14 sites in Belgium, Germany, Italy, the Netherlands, Switzerland, and the United Kingdom. Enrollment was stopped after 209 of the originally planned 370 patients, “due to slow recruitment and a lack of further funding,” Dr. Bonati said.
Of those, 207 patients were included in the intention-to-treat safety analysis, and 172 in the per-protocol efficacy analysis.
The mean age of the patients was 69.0-69.5 years in the two treatment groups, and 67%-71% were male. Dr. Bonati noted that 52%-55% of the patients had symptomatic stenosis, and that in 83%-88% the stenosis was severe.
The majority (79%-82%) of patients had hypertension, alongside hypercholesterolemia, at 76% in both treatment groups.
Dr. Bonati showed that there was no significant difference in the primary efficacy outcome of the presence of at least new ischemic brain lesion on the second or third MRI, at 74.7% for patients given ticagrelor versus 79.8% with clopidogrel, or a relative risk of 0.94 (95% confidence interval, 0.79-1.10; P = .43).
However, there was a significant reduction in the number of new ischemic lesions, at a median of 2 (interquartile range, 0.5-5.5) with ticagrelor versus 3 with clopidogrel (IQR, 1-8), or an exponential beta value of 0.63 (95% CI, 0.42-0.95; P = .027).
Ticagrelor was also associated with a significant reduction in the total volume of lesions, at a median of 66 mcL (IQR, 2.5-2.19) versus 91 mcL (IQR, 25-394) for clopidogrel, or an exponential beta value of 0.30 (95% CI, 0.10-0.92; P = .030).
Patients assigned to ticagrelor also had a significantly lower rate of the primary clinical safety outcome, a composite of stroke, myocardial infarction, major bleeding, or cardiovascular death, at 2.9% versus 7.8% (relative risk, 0.36; 95% CI, 0.08-1.20). This was driven by a reduction in rates of post-CAS stroke.
Dr. Bonati noted that there was no significant difference in the presence of at least one hemorrhagic lesion after CAS, at 42.7% with ticagrelor and 47.6% in the clopidogrel group (RR, 0.90; 95% CI, 0.63-1.26).
There was also a similar rate of microbleeds between the two treatment groups, at 36.6% in patients given ticagrelor and 47.6% in those assigned to clopidogrel.
The study was investigator initiated and funded by an unrestricted research grant from AstraZeneca. No relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
FROM ESOC 2023