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FDA: New labeling warns against combining opioids, benzodiazepines
Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.
The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.
“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.
Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.
In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.
The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.
A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.
As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.
“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.
Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.
“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.
The current action is just “one part of a larger effort to address this epidemic.
“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”
Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”
“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.
“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.
Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.
The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.
“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.
Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.
In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.
The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.
A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.
As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.
“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.
Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.
“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.
The current action is just “one part of a larger effort to address this epidemic.
“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”
Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”
“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.
“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.
Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.
The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.
“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.
Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.
In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.
The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.
A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.
As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.
“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.
Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.
“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.
The current action is just “one part of a larger effort to address this epidemic.
“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”
Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”
“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.
“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.
Removal from play reduces concussion recovery time in athletes
Sport-related concussion (SRC) recovery time can be reduced if athletes are removed from game participation, according to R.J. Elbin, PhD, of the University of Arkansas, Fayetteville, and his associates.
In the prospective study, 95 athletes sought care for an SRC at a concussion specialty clinic between Sept. 1 and Dec. 1, 2014. The athletes were divided into two groups: those who continued to play after experiencing signs and symptoms of an SRC and those who were immediately removed from play. The played group took longer to recover (44 days) than did the removed group (22 days) (P = .003).
Post hoc analyses revealed that the played group demonstrated significantly worse verbal and visual memory, processing speed, and reaction time, and higher symptoms (all P less than or equal to .001), compared with the removed group at 1-7 days. From 8 to 30 days post injury, the played group demonstrated worse verbal memory (P = .009), visual memory (P less than or equal to .001), processing speed (P = .001), and greater symptoms (P = .001), compared with the removed group.
The study also showed that athletes in the played group were 8.80 times more likely to experience a protracted recovery, compared with athletes in the removed group (21 days or longer) (P less than .001). Athletes participated in a variety of sports including football, soccer, ice hockey, volleyball, field hockey, rugby, basketball, and wrestling.
“This study is the first to show that athletes who continue to play with an SRC experience a longer recovery and more time away from the sport,” researchers concluded. “These findings should be incorporated into SRC education and awareness programs for athletes, coaches, parents, and medical professionals.”
Find the full study in Pediatrics (doi: 10.1542/peds.2016-0910).
Sport-related concussion (SRC) recovery time can be reduced if athletes are removed from game participation, according to R.J. Elbin, PhD, of the University of Arkansas, Fayetteville, and his associates.
In the prospective study, 95 athletes sought care for an SRC at a concussion specialty clinic between Sept. 1 and Dec. 1, 2014. The athletes were divided into two groups: those who continued to play after experiencing signs and symptoms of an SRC and those who were immediately removed from play. The played group took longer to recover (44 days) than did the removed group (22 days) (P = .003).
Post hoc analyses revealed that the played group demonstrated significantly worse verbal and visual memory, processing speed, and reaction time, and higher symptoms (all P less than or equal to .001), compared with the removed group at 1-7 days. From 8 to 30 days post injury, the played group demonstrated worse verbal memory (P = .009), visual memory (P less than or equal to .001), processing speed (P = .001), and greater symptoms (P = .001), compared with the removed group.
The study also showed that athletes in the played group were 8.80 times more likely to experience a protracted recovery, compared with athletes in the removed group (21 days or longer) (P less than .001). Athletes participated in a variety of sports including football, soccer, ice hockey, volleyball, field hockey, rugby, basketball, and wrestling.
“This study is the first to show that athletes who continue to play with an SRC experience a longer recovery and more time away from the sport,” researchers concluded. “These findings should be incorporated into SRC education and awareness programs for athletes, coaches, parents, and medical professionals.”
Find the full study in Pediatrics (doi: 10.1542/peds.2016-0910).
Sport-related concussion (SRC) recovery time can be reduced if athletes are removed from game participation, according to R.J. Elbin, PhD, of the University of Arkansas, Fayetteville, and his associates.
In the prospective study, 95 athletes sought care for an SRC at a concussion specialty clinic between Sept. 1 and Dec. 1, 2014. The athletes were divided into two groups: those who continued to play after experiencing signs and symptoms of an SRC and those who were immediately removed from play. The played group took longer to recover (44 days) than did the removed group (22 days) (P = .003).
Post hoc analyses revealed that the played group demonstrated significantly worse verbal and visual memory, processing speed, and reaction time, and higher symptoms (all P less than or equal to .001), compared with the removed group at 1-7 days. From 8 to 30 days post injury, the played group demonstrated worse verbal memory (P = .009), visual memory (P less than or equal to .001), processing speed (P = .001), and greater symptoms (P = .001), compared with the removed group.
The study also showed that athletes in the played group were 8.80 times more likely to experience a protracted recovery, compared with athletes in the removed group (21 days or longer) (P less than .001). Athletes participated in a variety of sports including football, soccer, ice hockey, volleyball, field hockey, rugby, basketball, and wrestling.
“This study is the first to show that athletes who continue to play with an SRC experience a longer recovery and more time away from the sport,” researchers concluded. “These findings should be incorporated into SRC education and awareness programs for athletes, coaches, parents, and medical professionals.”
Find the full study in Pediatrics (doi: 10.1542/peds.2016-0910).
FROM PEDIATRICS
Roux-en-Y gastric bypass associated with long-term weight loss
Obese patients who underwent Roux-en-Y gastric bypass had higher percentages of weight loss at long-term follow-up, compared with obese patients who underwent other surgical procedures or who did not undergo surgery, according to a large, cohort study published in JAMA Surgery.
While prior research has clearly demonstrated that bariatric surgery is the most effective intervention for inducing weight loss among obese patients, the majority of those studies were short term; therefore, there is little known about the durability of weight loss following bariatric surgery, wrote Matthew Maciejewski, PhD, of Duke University, Durham, N.C., and Durham Veterans Affairs Medical Center and his associates.
This study compared the 10-year weight change in patients who underwent Roux-en-Y gastric bypass to patients who did not receive bariatric surgical intervention of any kind. A total of 1,787 patients who had undergone Roux-en-Y gastric bypass surgery were identified and matched by investigators to one or more patients with similar demographic characteristics (age, sex, race, body mass index, diabetes diagnosis). A total of 5,305 nonsurgical matches were selected for analysis. For the Roux-en-Y gastric bypass group, mean age was 52.1 years, and for the nonsurgical matches mean age was 52.2 years. Both groups were predominantly male (73.1% and 73.7%, respectively) and had high 10-year follow-up rates of 81.9% for surgical patients and 67.4% for nonsurgical matches (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2317).
The study’s primary outcome of percentage change in weight at 10-year follow-up, compared with baseline strongly favored Roux-en-Y gastric bypass over no surgical intervention. At the 10-year time point, patients who underwent Roux-en-Y gastric bypass had lost 21.3% more of their baseline weight than nonsurgical matches.
Remarkably, only 3.4% of patients who underwent Roux-en-Y gastric bypass were within 5% of their original baseline weight at 10 years while 55.5% of those who did not receive surgical intervention had regained most of their weight.
Additionally, investigators compared percentage change in weight at 4-year follow-up for obese patients who underwent either Roux-en-Y gastric bypass (n = 1,785), sleeve gastrectomy (n = 379), or adjustable gastric banding (n = 246). At this time point, patients who underwent Roux-en-Y gastric bypass had lost an average of 28% of their baseline weight while patients who underwent sleeve gastrectomy or adjustable gastric banding only lost 18% and 11% of their baseline weights, respectively.
“These results provide further evidence for the beneficial association between surgery and long-term weight loss that has been demonstrated in shorter-term studies of younger, predominantly female populations,” the investigators concluded.
This study was funded by the Department of Veterans Affairs. Dr. Maciejewski and four of his associates reported receiving financial compensation from or holding stock in various companies and institutions including the Department of Veterans Affairs.
On Twitter @jessnicolecraig
One of the most prevalent perceptions held by many is that most bariatric surgery patients will eventually gain all of their weight back. As illustrated in the article by Maciejewski et al., studies that follow up with a large cohort of bariatric surgery patients for more than a few years are limited and hampered by low rates of long-term follow-up. While the results of these studies generally imply that long-term weight loss is possible in most patients, poor follow-up leaves one to wonder whether this is a generalizable conclusion.
In the article by Maciejewski et al., it is remarkable that such a low number of gastric bypass patients (3%) regained weight back to within 5% of their baseline weight by 10 years. With the publication of the article by Maciejewski et al., the perception that all metabolic and bariatric surgery patients gain their weight back has become less valid.
Jon C. Gould, MD, is the chief of the division of general surgery at the Medical College of Wisconsin in Milwaukee. His comments were taken from his editorial accompanying the report by Dr. Maciejewski and his colleagues (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2301).
One of the most prevalent perceptions held by many is that most bariatric surgery patients will eventually gain all of their weight back. As illustrated in the article by Maciejewski et al., studies that follow up with a large cohort of bariatric surgery patients for more than a few years are limited and hampered by low rates of long-term follow-up. While the results of these studies generally imply that long-term weight loss is possible in most patients, poor follow-up leaves one to wonder whether this is a generalizable conclusion.
In the article by Maciejewski et al., it is remarkable that such a low number of gastric bypass patients (3%) regained weight back to within 5% of their baseline weight by 10 years. With the publication of the article by Maciejewski et al., the perception that all metabolic and bariatric surgery patients gain their weight back has become less valid.
Jon C. Gould, MD, is the chief of the division of general surgery at the Medical College of Wisconsin in Milwaukee. His comments were taken from his editorial accompanying the report by Dr. Maciejewski and his colleagues (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2301).
One of the most prevalent perceptions held by many is that most bariatric surgery patients will eventually gain all of their weight back. As illustrated in the article by Maciejewski et al., studies that follow up with a large cohort of bariatric surgery patients for more than a few years are limited and hampered by low rates of long-term follow-up. While the results of these studies generally imply that long-term weight loss is possible in most patients, poor follow-up leaves one to wonder whether this is a generalizable conclusion.
In the article by Maciejewski et al., it is remarkable that such a low number of gastric bypass patients (3%) regained weight back to within 5% of their baseline weight by 10 years. With the publication of the article by Maciejewski et al., the perception that all metabolic and bariatric surgery patients gain their weight back has become less valid.
Jon C. Gould, MD, is the chief of the division of general surgery at the Medical College of Wisconsin in Milwaukee. His comments were taken from his editorial accompanying the report by Dr. Maciejewski and his colleagues (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2301).
Obese patients who underwent Roux-en-Y gastric bypass had higher percentages of weight loss at long-term follow-up, compared with obese patients who underwent other surgical procedures or who did not undergo surgery, according to a large, cohort study published in JAMA Surgery.
While prior research has clearly demonstrated that bariatric surgery is the most effective intervention for inducing weight loss among obese patients, the majority of those studies were short term; therefore, there is little known about the durability of weight loss following bariatric surgery, wrote Matthew Maciejewski, PhD, of Duke University, Durham, N.C., and Durham Veterans Affairs Medical Center and his associates.
This study compared the 10-year weight change in patients who underwent Roux-en-Y gastric bypass to patients who did not receive bariatric surgical intervention of any kind. A total of 1,787 patients who had undergone Roux-en-Y gastric bypass surgery were identified and matched by investigators to one or more patients with similar demographic characteristics (age, sex, race, body mass index, diabetes diagnosis). A total of 5,305 nonsurgical matches were selected for analysis. For the Roux-en-Y gastric bypass group, mean age was 52.1 years, and for the nonsurgical matches mean age was 52.2 years. Both groups were predominantly male (73.1% and 73.7%, respectively) and had high 10-year follow-up rates of 81.9% for surgical patients and 67.4% for nonsurgical matches (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2317).
The study’s primary outcome of percentage change in weight at 10-year follow-up, compared with baseline strongly favored Roux-en-Y gastric bypass over no surgical intervention. At the 10-year time point, patients who underwent Roux-en-Y gastric bypass had lost 21.3% more of their baseline weight than nonsurgical matches.
Remarkably, only 3.4% of patients who underwent Roux-en-Y gastric bypass were within 5% of their original baseline weight at 10 years while 55.5% of those who did not receive surgical intervention had regained most of their weight.
Additionally, investigators compared percentage change in weight at 4-year follow-up for obese patients who underwent either Roux-en-Y gastric bypass (n = 1,785), sleeve gastrectomy (n = 379), or adjustable gastric banding (n = 246). At this time point, patients who underwent Roux-en-Y gastric bypass had lost an average of 28% of their baseline weight while patients who underwent sleeve gastrectomy or adjustable gastric banding only lost 18% and 11% of their baseline weights, respectively.
“These results provide further evidence for the beneficial association between surgery and long-term weight loss that has been demonstrated in shorter-term studies of younger, predominantly female populations,” the investigators concluded.
This study was funded by the Department of Veterans Affairs. Dr. Maciejewski and four of his associates reported receiving financial compensation from or holding stock in various companies and institutions including the Department of Veterans Affairs.
On Twitter @jessnicolecraig
Obese patients who underwent Roux-en-Y gastric bypass had higher percentages of weight loss at long-term follow-up, compared with obese patients who underwent other surgical procedures or who did not undergo surgery, according to a large, cohort study published in JAMA Surgery.
While prior research has clearly demonstrated that bariatric surgery is the most effective intervention for inducing weight loss among obese patients, the majority of those studies were short term; therefore, there is little known about the durability of weight loss following bariatric surgery, wrote Matthew Maciejewski, PhD, of Duke University, Durham, N.C., and Durham Veterans Affairs Medical Center and his associates.
This study compared the 10-year weight change in patients who underwent Roux-en-Y gastric bypass to patients who did not receive bariatric surgical intervention of any kind. A total of 1,787 patients who had undergone Roux-en-Y gastric bypass surgery were identified and matched by investigators to one or more patients with similar demographic characteristics (age, sex, race, body mass index, diabetes diagnosis). A total of 5,305 nonsurgical matches were selected for analysis. For the Roux-en-Y gastric bypass group, mean age was 52.1 years, and for the nonsurgical matches mean age was 52.2 years. Both groups were predominantly male (73.1% and 73.7%, respectively) and had high 10-year follow-up rates of 81.9% for surgical patients and 67.4% for nonsurgical matches (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2317).
The study’s primary outcome of percentage change in weight at 10-year follow-up, compared with baseline strongly favored Roux-en-Y gastric bypass over no surgical intervention. At the 10-year time point, patients who underwent Roux-en-Y gastric bypass had lost 21.3% more of their baseline weight than nonsurgical matches.
Remarkably, only 3.4% of patients who underwent Roux-en-Y gastric bypass were within 5% of their original baseline weight at 10 years while 55.5% of those who did not receive surgical intervention had regained most of their weight.
Additionally, investigators compared percentage change in weight at 4-year follow-up for obese patients who underwent either Roux-en-Y gastric bypass (n = 1,785), sleeve gastrectomy (n = 379), or adjustable gastric banding (n = 246). At this time point, patients who underwent Roux-en-Y gastric bypass had lost an average of 28% of their baseline weight while patients who underwent sleeve gastrectomy or adjustable gastric banding only lost 18% and 11% of their baseline weights, respectively.
“These results provide further evidence for the beneficial association between surgery and long-term weight loss that has been demonstrated in shorter-term studies of younger, predominantly female populations,” the investigators concluded.
This study was funded by the Department of Veterans Affairs. Dr. Maciejewski and four of his associates reported receiving financial compensation from or holding stock in various companies and institutions including the Department of Veterans Affairs.
On Twitter @jessnicolecraig
FROM JAMA SURGERY
Key clinical point: Roux-en-Y gastric bypass led to higher percentages of weight loss at long-term follow-up.
Major finding: Four years post treatment, patients who underwent Roux-en-Y gastric bypass lost an average of 28% of their baseline weight while patients who underwent sleeve gastrectomy or adjustable gastric banding lost only 18% and 11% of their baseline weights, respectively. At 10 years, patients who underwent Roux-en-Y had lost 21% more of their baseline weight than those who did not receive surgery.
Data source: Retrospective cohort study of 1,787 patients who had undergone Roux-en-Y gastric bypass surgery.
Disclosures: This study was funded by the Department of Veterans Affairs. Dr. Maciejewski and four of his associates reported receiving financial compensation from or holding stock in various companies and institutions including the Department of Veterans Affairs.
Vascular surgeons assisting nonvascular colleagues require depth/breadth of experience
Vascular surgeons called upon to provide intraoperative assistance should be prepared to undertake a wide range of repairs.
Nonvascular surgery patients who required any vascular repair had a higher incidence of the primary endpoint of death, myocardial infarction, or unplanned return to the operating room within 30 days post surgery. In addition, such cases accounted for almost 7% of the operative volume of the hospital’s vascular surgery service, according to the results of a retrospective record review of all 533 patients who underwent nonvascular surgery requiring intraoperative assistance by a vascular surgeon at Northwestern Memorial Hospital, Chicago, between January 2010 and June 2014.
After excluding 28 trauma patients and 226 who required placement of an inferior vena cava filter only, the remaining cohort of 299 patients were assessed. This cohort represented 6.9% of the entire operative output of the vascular surgery service at the hospital during the period assessed. The cohort comprised 49.5% men and a had mean patient age of 56.4 years, according to Tadaki M. Tomita, MD, and his colleagues at Northwestern University, Chicago.
Intraoperative assistance was requested by 12 different surgical subspecialties during the period studied, with the most common being neurosurgery (33.8%), orthopedic surgery (26.4%), urology (15.7%), and surgical oncology (6.7%). The major vascular surgeon participation by indications were spine exposure (52%), vascular reconstruction (19%), vascular control without hemorrhage (14.4%), and control of hemorrhage (14.4%), according to a report published online in JAMA Surgery (2016 Aug 3. doi: 10.1001/jamasurg.2016.2247).
For the entire cohort, 110 patients (36.8%) required vascular repairs, with 13 bypasses (4.4%), 18 patch angioplasties (6.0%), and 79 primary repairs (26.4%) performed; 64 cases were venous (21.4%) and 43 arterial (14.7%). The anatomic distribution in patients requiring vascular repair was 72.7% truncal and 27.4% peripheral.
Patients who required any vascular repair had a significantly higher incidence of the primary endpoint than did patients who did not require vascular repair (17.4% vs. 7.9%; P = .01), with five deaths, 16 MIs, and 20 unplanned returns to the OR.
“Vascular surgeons are often called on by nonvascular surgeons for assistance in the OR in a variety of clinical situations and anatomic locations,” the researchers stated. The vascular surgeon in all cases performed an open surgical exposure and open repair was performed in all cases that required vascular repair.
“While most consultations occurred preoperatively, a high proportion of emergent cases that are more likely to require vascular repair demonstrates the importance of having vascular surgeons immediately available at the hospital. To continue providing this valuable service, vascular trainees will need to continue to learn the full breadth of anatomic exposures and open vascular reconstructions,” the researchers concluded.
The authors reported that they had no disclosures.
Vascular surgeons called upon to provide intraoperative assistance should be prepared to undertake a wide range of repairs.
Nonvascular surgery patients who required any vascular repair had a higher incidence of the primary endpoint of death, myocardial infarction, or unplanned return to the operating room within 30 days post surgery. In addition, such cases accounted for almost 7% of the operative volume of the hospital’s vascular surgery service, according to the results of a retrospective record review of all 533 patients who underwent nonvascular surgery requiring intraoperative assistance by a vascular surgeon at Northwestern Memorial Hospital, Chicago, between January 2010 and June 2014.
After excluding 28 trauma patients and 226 who required placement of an inferior vena cava filter only, the remaining cohort of 299 patients were assessed. This cohort represented 6.9% of the entire operative output of the vascular surgery service at the hospital during the period assessed. The cohort comprised 49.5% men and a had mean patient age of 56.4 years, according to Tadaki M. Tomita, MD, and his colleagues at Northwestern University, Chicago.
Intraoperative assistance was requested by 12 different surgical subspecialties during the period studied, with the most common being neurosurgery (33.8%), orthopedic surgery (26.4%), urology (15.7%), and surgical oncology (6.7%). The major vascular surgeon participation by indications were spine exposure (52%), vascular reconstruction (19%), vascular control without hemorrhage (14.4%), and control of hemorrhage (14.4%), according to a report published online in JAMA Surgery (2016 Aug 3. doi: 10.1001/jamasurg.2016.2247).
For the entire cohort, 110 patients (36.8%) required vascular repairs, with 13 bypasses (4.4%), 18 patch angioplasties (6.0%), and 79 primary repairs (26.4%) performed; 64 cases were venous (21.4%) and 43 arterial (14.7%). The anatomic distribution in patients requiring vascular repair was 72.7% truncal and 27.4% peripheral.
Patients who required any vascular repair had a significantly higher incidence of the primary endpoint than did patients who did not require vascular repair (17.4% vs. 7.9%; P = .01), with five deaths, 16 MIs, and 20 unplanned returns to the OR.
“Vascular surgeons are often called on by nonvascular surgeons for assistance in the OR in a variety of clinical situations and anatomic locations,” the researchers stated. The vascular surgeon in all cases performed an open surgical exposure and open repair was performed in all cases that required vascular repair.
“While most consultations occurred preoperatively, a high proportion of emergent cases that are more likely to require vascular repair demonstrates the importance of having vascular surgeons immediately available at the hospital. To continue providing this valuable service, vascular trainees will need to continue to learn the full breadth of anatomic exposures and open vascular reconstructions,” the researchers concluded.
The authors reported that they had no disclosures.
Vascular surgeons called upon to provide intraoperative assistance should be prepared to undertake a wide range of repairs.
Nonvascular surgery patients who required any vascular repair had a higher incidence of the primary endpoint of death, myocardial infarction, or unplanned return to the operating room within 30 days post surgery. In addition, such cases accounted for almost 7% of the operative volume of the hospital’s vascular surgery service, according to the results of a retrospective record review of all 533 patients who underwent nonvascular surgery requiring intraoperative assistance by a vascular surgeon at Northwestern Memorial Hospital, Chicago, between January 2010 and June 2014.
After excluding 28 trauma patients and 226 who required placement of an inferior vena cava filter only, the remaining cohort of 299 patients were assessed. This cohort represented 6.9% of the entire operative output of the vascular surgery service at the hospital during the period assessed. The cohort comprised 49.5% men and a had mean patient age of 56.4 years, according to Tadaki M. Tomita, MD, and his colleagues at Northwestern University, Chicago.
Intraoperative assistance was requested by 12 different surgical subspecialties during the period studied, with the most common being neurosurgery (33.8%), orthopedic surgery (26.4%), urology (15.7%), and surgical oncology (6.7%). The major vascular surgeon participation by indications were spine exposure (52%), vascular reconstruction (19%), vascular control without hemorrhage (14.4%), and control of hemorrhage (14.4%), according to a report published online in JAMA Surgery (2016 Aug 3. doi: 10.1001/jamasurg.2016.2247).
For the entire cohort, 110 patients (36.8%) required vascular repairs, with 13 bypasses (4.4%), 18 patch angioplasties (6.0%), and 79 primary repairs (26.4%) performed; 64 cases were venous (21.4%) and 43 arterial (14.7%). The anatomic distribution in patients requiring vascular repair was 72.7% truncal and 27.4% peripheral.
Patients who required any vascular repair had a significantly higher incidence of the primary endpoint than did patients who did not require vascular repair (17.4% vs. 7.9%; P = .01), with five deaths, 16 MIs, and 20 unplanned returns to the OR.
“Vascular surgeons are often called on by nonvascular surgeons for assistance in the OR in a variety of clinical situations and anatomic locations,” the researchers stated. The vascular surgeon in all cases performed an open surgical exposure and open repair was performed in all cases that required vascular repair.
“While most consultations occurred preoperatively, a high proportion of emergent cases that are more likely to require vascular repair demonstrates the importance of having vascular surgeons immediately available at the hospital. To continue providing this valuable service, vascular trainees will need to continue to learn the full breadth of anatomic exposures and open vascular reconstructions,” the researchers concluded.
The authors reported that they had no disclosures.
FROM JAMA SURGERY
Key clinical point: Intraoperative assistance of vascular surgeons in nonvascular procedures accounted for nearly 7% of vascular work at a single institution and uniformly required open repair.
Major finding: Patients who required any intraoperative vascular repair had a higher incidence of the primary endpoint of death, myocardial infarction, or unplanned return to the operating room within 30 days post surgery.
Data source: The study was a retrospective review of all 299 patients undergoing nonvascular surgery who required intraoperative vascular surgery assistance at a single institution between January 2010 and June 2014.
Disclosures: The authors reported that they had no disclosures.
No VTE prophylaxis needed after joint surgery in patients with hemophilia
ORLANDO – In patients with hemophilia who have therapeutic factor levels at the time of joint replacement surgery, prophylaxis against venous thromboembolism (VTE) may be unnecessary.
In a cohort study of patients with hemophilia A or B who underwent total joint replacement surgery while being in proper hemostasis with therapeutic factor levels, there were no clinically evident episodes of venous thromboembolism, even though none of the patients had received perioperative anticoagulant prophylaxis, reported investigators from the National Hemophilia Center and Institute of Thrombosis and Hemostasis at the Sheba Medical Center in Tel Hashomer, Israel.
The data should be reassuring to clinicians whose patients with hemophilia require major orthopedic procedures, said lead author Dr. Anna Seltser, an orthopedic resident at Sheba Medical Center, in an interview.
“We have a lot of hemophilia patients who are not well treated because they live in the desert or distant communities, and we also sometimes treat patients from the Palestinian side of the Gaza Strip who don’t have access to care and need this type of surgery,” she said.
“We collected what I think is the biggest series of patients until now, we didn’t give any of them VTE prophylaxis, and none of them had any DVT [deep vein thrombosis], PE [pulmonary embolism], or similar complication,” she said.
Skip the heparin?
VTE prophylaxis with low-molecular-weight heparin, warfarin, or other anticoagulant agents is a common practice following orthopedic surgery in patients without bleeding disorders. But for patients with severe hemophilia, who often require major joint replacement surgery following years of bleeding-induced arthropathy, it’s unclear whether perioperative anticoagulation is beneficial, the investigators noted in a scientific poster at the World Federation of Hemophilia World Congress.
Dr. Seltser and colleagues therefore conducted a prospective cohort study of 50 patients with hemophilia A or B treated with major joint surgery and subsequent revisions from 1988 through 2015 at their center. In all, 47 patients had severe hemophilia A, 2 had mild hemophilia A, and 1 had hemophilia B.
The authors analyzed data on demographics, comorbidities, type of surgery, use of factor concentrates therapy around the time of surgery, and complications during follow-up, including massive hemorrhage, infections, implant loosening, DVT, and PE.
The patients underwent a total of 74 primary joint replacements (16 hips, 52 knees, and 6 ankles) and 23 revision surgeries.
As noted, there were no episodes of either DVT or PE among any of the patients. All but one complication occurred among patients undergoing total knee replacement. These included three cases of hemarthrosis, three limited-range-of-motion cases requiring closed manipulations, four soft-tissue hematomas, and one case each of superficial wound infection, urinary tract infection, pneumonia, and Candida infection of the tongue.
The only other complication was a case of disseminated intravascular coagulation, sepsis, and hemorrhagic shock in a patient who had undergone a revision (original procedure unspecified).
“Despite the concern that proper replacement factor therapy, applied before and after the surgery, may increase the risk for thromboembolic complications in patients with hemophilia undergoing joint replacement, our data show that prophylactic anticoagulation in this group of patients is not necessary,” the investigators concluded.
The study was internally funded. The investigators reported no conflicts of interest.
ORLANDO – In patients with hemophilia who have therapeutic factor levels at the time of joint replacement surgery, prophylaxis against venous thromboembolism (VTE) may be unnecessary.
In a cohort study of patients with hemophilia A or B who underwent total joint replacement surgery while being in proper hemostasis with therapeutic factor levels, there were no clinically evident episodes of venous thromboembolism, even though none of the patients had received perioperative anticoagulant prophylaxis, reported investigators from the National Hemophilia Center and Institute of Thrombosis and Hemostasis at the Sheba Medical Center in Tel Hashomer, Israel.
The data should be reassuring to clinicians whose patients with hemophilia require major orthopedic procedures, said lead author Dr. Anna Seltser, an orthopedic resident at Sheba Medical Center, in an interview.
“We have a lot of hemophilia patients who are not well treated because they live in the desert or distant communities, and we also sometimes treat patients from the Palestinian side of the Gaza Strip who don’t have access to care and need this type of surgery,” she said.
“We collected what I think is the biggest series of patients until now, we didn’t give any of them VTE prophylaxis, and none of them had any DVT [deep vein thrombosis], PE [pulmonary embolism], or similar complication,” she said.
Skip the heparin?
VTE prophylaxis with low-molecular-weight heparin, warfarin, or other anticoagulant agents is a common practice following orthopedic surgery in patients without bleeding disorders. But for patients with severe hemophilia, who often require major joint replacement surgery following years of bleeding-induced arthropathy, it’s unclear whether perioperative anticoagulation is beneficial, the investigators noted in a scientific poster at the World Federation of Hemophilia World Congress.
Dr. Seltser and colleagues therefore conducted a prospective cohort study of 50 patients with hemophilia A or B treated with major joint surgery and subsequent revisions from 1988 through 2015 at their center. In all, 47 patients had severe hemophilia A, 2 had mild hemophilia A, and 1 had hemophilia B.
The authors analyzed data on demographics, comorbidities, type of surgery, use of factor concentrates therapy around the time of surgery, and complications during follow-up, including massive hemorrhage, infections, implant loosening, DVT, and PE.
The patients underwent a total of 74 primary joint replacements (16 hips, 52 knees, and 6 ankles) and 23 revision surgeries.
As noted, there were no episodes of either DVT or PE among any of the patients. All but one complication occurred among patients undergoing total knee replacement. These included three cases of hemarthrosis, three limited-range-of-motion cases requiring closed manipulations, four soft-tissue hematomas, and one case each of superficial wound infection, urinary tract infection, pneumonia, and Candida infection of the tongue.
The only other complication was a case of disseminated intravascular coagulation, sepsis, and hemorrhagic shock in a patient who had undergone a revision (original procedure unspecified).
“Despite the concern that proper replacement factor therapy, applied before and after the surgery, may increase the risk for thromboembolic complications in patients with hemophilia undergoing joint replacement, our data show that prophylactic anticoagulation in this group of patients is not necessary,” the investigators concluded.
The study was internally funded. The investigators reported no conflicts of interest.
ORLANDO – In patients with hemophilia who have therapeutic factor levels at the time of joint replacement surgery, prophylaxis against venous thromboembolism (VTE) may be unnecessary.
In a cohort study of patients with hemophilia A or B who underwent total joint replacement surgery while being in proper hemostasis with therapeutic factor levels, there were no clinically evident episodes of venous thromboembolism, even though none of the patients had received perioperative anticoagulant prophylaxis, reported investigators from the National Hemophilia Center and Institute of Thrombosis and Hemostasis at the Sheba Medical Center in Tel Hashomer, Israel.
The data should be reassuring to clinicians whose patients with hemophilia require major orthopedic procedures, said lead author Dr. Anna Seltser, an orthopedic resident at Sheba Medical Center, in an interview.
“We have a lot of hemophilia patients who are not well treated because they live in the desert or distant communities, and we also sometimes treat patients from the Palestinian side of the Gaza Strip who don’t have access to care and need this type of surgery,” she said.
“We collected what I think is the biggest series of patients until now, we didn’t give any of them VTE prophylaxis, and none of them had any DVT [deep vein thrombosis], PE [pulmonary embolism], or similar complication,” she said.
Skip the heparin?
VTE prophylaxis with low-molecular-weight heparin, warfarin, or other anticoagulant agents is a common practice following orthopedic surgery in patients without bleeding disorders. But for patients with severe hemophilia, who often require major joint replacement surgery following years of bleeding-induced arthropathy, it’s unclear whether perioperative anticoagulation is beneficial, the investigators noted in a scientific poster at the World Federation of Hemophilia World Congress.
Dr. Seltser and colleagues therefore conducted a prospective cohort study of 50 patients with hemophilia A or B treated with major joint surgery and subsequent revisions from 1988 through 2015 at their center. In all, 47 patients had severe hemophilia A, 2 had mild hemophilia A, and 1 had hemophilia B.
The authors analyzed data on demographics, comorbidities, type of surgery, use of factor concentrates therapy around the time of surgery, and complications during follow-up, including massive hemorrhage, infections, implant loosening, DVT, and PE.
The patients underwent a total of 74 primary joint replacements (16 hips, 52 knees, and 6 ankles) and 23 revision surgeries.
As noted, there were no episodes of either DVT or PE among any of the patients. All but one complication occurred among patients undergoing total knee replacement. These included three cases of hemarthrosis, three limited-range-of-motion cases requiring closed manipulations, four soft-tissue hematomas, and one case each of superficial wound infection, urinary tract infection, pneumonia, and Candida infection of the tongue.
The only other complication was a case of disseminated intravascular coagulation, sepsis, and hemorrhagic shock in a patient who had undergone a revision (original procedure unspecified).
“Despite the concern that proper replacement factor therapy, applied before and after the surgery, may increase the risk for thromboembolic complications in patients with hemophilia undergoing joint replacement, our data show that prophylactic anticoagulation in this group of patients is not necessary,” the investigators concluded.
The study was internally funded. The investigators reported no conflicts of interest.
AT WFH 2016 WORLD CONGRESS
Key clinical point: Prophylaxis against thromboembolic events after orthopedic surgery in patients with hemophilia may not be necessary.
Major finding: There were no thromboembolic events after joint surgery without anticoagulant prophylaxis in patients with hemophilia A or B.
Data source: Cohort study of 50 patients with hemophilia A or B undergoing major joint replacement surgery.
Disclosures: The study was internally funded. The investigators reported no conflicts of interest.
MRI-guided thalamotomy significantly reduces hand tremors
MRI-guided focused ultrasound thalamotomy can significantly mitigate the severity of hand tremors in patients suffering from essential tremor, the most common type of movement disorder, according to a new study published in the New England Journal of Medicine.
“The use of ultrasound energy for the creation of discrete intracranial lesions... has been of interest since the middle of the 20th century,” wrote the investigators, led by W. Jeffrey Elias, MD, of the University of Virginia, Charlottesville. “Prospective pilot trials of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance in patients with essential tremor have shown reductions in hand tremor, improvements in quality of life, and minimal procedural morbidity.”
The trial enrolled a total of 76 patients with a mean age of 71 years and mean disease duration of nearly 17 years; 68% were men and 75% were white. At a 3:1 ratio, they were randomized into one of two cohorts: one underwent thalamotomy and the other received a “sham” procedure. The subjects were unaware which they received for the first 3 months. The Clinical Rating Scale for Tremor (CRST) and the Quality of Life in Essential Tremor Questionnaire (QUEST) was used to determine the severity of tremors at baseline, and at follow-ups conducted at 1, 3, 6, and 12 months post-procedure (N Engl J Med. 2016;375[8]:730-9).
The trial’s primary outcome of between-group difference in the change in tremor score from baseline to 3 months significantly favored thalamotomy (8.5-point improvement, from 18.1 to 9.6) over the sham procedure (0.2-point improvement, from 16.0 to 15.8). The mean between-group difference in the change in score of 8.3 points at 3 months decreased slightly to 7.2 points at 12 months. The tremor score (range, 0-32) was derived from part A of the CRST (three items: resting, postural, and action or intention components of hand tremor), and part B of the CRST (five tasks involving handwriting, drawing, and pouring), in the hand contralateral to the thalamotomy.
Thalamotomy patients also reported 46% better quality of life on QUEST at 3 months, compared with 3% better among sham-procedure patients.
There were adverse events in the thalamotomy cohort. At the 3-month follow-up, 36% of subjects experienced gait disturbance, 38% experienced paresthesias or some kind of numbness. The rates of these adverse events dropped to 9% and 14%, respectively, at the 12-month follow-up.
“Deep-brain stimulation is currently the surgical standard for medication-refractory essential tremor [but] a control group of patients undergoing deep-brain stimulation was not included in this trial; the two technologies were not compared,” the authors noted, indicating that such comparison could potentially be the next step for this research.
This study was supported by InSightec, the Focused Ultrasound Foundation, and the Binational Industrial Research and Development Foundation. Dr. Elias disclosed receiving grant support from InSightec and the Focused Ultrasound Foundation. Other coauthors disclosed receiving similar support.
There are several important concerns about this study. Its 12-month follow-up period is relatively short, so the sustained benefit at 2 years, 3 years, and 5 or more years is unknown. The tremor score of patients who underwent focused ultrasound thalamotomy increased by 23% from 1 month to 12 months, and it’s unclear whether this loss of efficacy is due to disease progression or tolerance. The typical estimates of the rate of disease progression in essential tremor make tolerance less likely. The loss of efficacy is also seen to some extent with deep-brain stimulation. Furthermore, some patients who underwent thalamotomy did not achieve large improvements in tremor. The percentage change was less than 20% in 9 of 56 patients.
It’s also worthwhile to note that focused ultrasound thalamotomy creates a fixed brain lesion, whereas with deep-brain stimulation there is the potential to adjust stimulator settings in order to obtain further therapeutic gains. The procedure also is not suitable for all patients, such as those with particularly thick skulls. The most common side effect involved altered sensation, which remained permanent in 14% of patients.
The procedure will take its place among other surgical procedures for medically refractory essential tremor. A head-to-head comparison with deep-brain stimulation would facilitate the direct comparison of the two approaches.
Elan D. Louis, MD, is the chief of the division of movement disorders and professor of neurology and epidemiology (chronic diseases) at Yale University, New Haven, Conn. His comments were taken from his editorial accompanying the report by Dr. Elias and his colleagues (N Engl J Med. 2016;375[8]:792-3).
There are several important concerns about this study. Its 12-month follow-up period is relatively short, so the sustained benefit at 2 years, 3 years, and 5 or more years is unknown. The tremor score of patients who underwent focused ultrasound thalamotomy increased by 23% from 1 month to 12 months, and it’s unclear whether this loss of efficacy is due to disease progression or tolerance. The typical estimates of the rate of disease progression in essential tremor make tolerance less likely. The loss of efficacy is also seen to some extent with deep-brain stimulation. Furthermore, some patients who underwent thalamotomy did not achieve large improvements in tremor. The percentage change was less than 20% in 9 of 56 patients.
It’s also worthwhile to note that focused ultrasound thalamotomy creates a fixed brain lesion, whereas with deep-brain stimulation there is the potential to adjust stimulator settings in order to obtain further therapeutic gains. The procedure also is not suitable for all patients, such as those with particularly thick skulls. The most common side effect involved altered sensation, which remained permanent in 14% of patients.
The procedure will take its place among other surgical procedures for medically refractory essential tremor. A head-to-head comparison with deep-brain stimulation would facilitate the direct comparison of the two approaches.
Elan D. Louis, MD, is the chief of the division of movement disorders and professor of neurology and epidemiology (chronic diseases) at Yale University, New Haven, Conn. His comments were taken from his editorial accompanying the report by Dr. Elias and his colleagues (N Engl J Med. 2016;375[8]:792-3).
There are several important concerns about this study. Its 12-month follow-up period is relatively short, so the sustained benefit at 2 years, 3 years, and 5 or more years is unknown. The tremor score of patients who underwent focused ultrasound thalamotomy increased by 23% from 1 month to 12 months, and it’s unclear whether this loss of efficacy is due to disease progression or tolerance. The typical estimates of the rate of disease progression in essential tremor make tolerance less likely. The loss of efficacy is also seen to some extent with deep-brain stimulation. Furthermore, some patients who underwent thalamotomy did not achieve large improvements in tremor. The percentage change was less than 20% in 9 of 56 patients.
It’s also worthwhile to note that focused ultrasound thalamotomy creates a fixed brain lesion, whereas with deep-brain stimulation there is the potential to adjust stimulator settings in order to obtain further therapeutic gains. The procedure also is not suitable for all patients, such as those with particularly thick skulls. The most common side effect involved altered sensation, which remained permanent in 14% of patients.
The procedure will take its place among other surgical procedures for medically refractory essential tremor. A head-to-head comparison with deep-brain stimulation would facilitate the direct comparison of the two approaches.
Elan D. Louis, MD, is the chief of the division of movement disorders and professor of neurology and epidemiology (chronic diseases) at Yale University, New Haven, Conn. His comments were taken from his editorial accompanying the report by Dr. Elias and his colleagues (N Engl J Med. 2016;375[8]:792-3).
MRI-guided focused ultrasound thalamotomy can significantly mitigate the severity of hand tremors in patients suffering from essential tremor, the most common type of movement disorder, according to a new study published in the New England Journal of Medicine.
“The use of ultrasound energy for the creation of discrete intracranial lesions... has been of interest since the middle of the 20th century,” wrote the investigators, led by W. Jeffrey Elias, MD, of the University of Virginia, Charlottesville. “Prospective pilot trials of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance in patients with essential tremor have shown reductions in hand tremor, improvements in quality of life, and minimal procedural morbidity.”
The trial enrolled a total of 76 patients with a mean age of 71 years and mean disease duration of nearly 17 years; 68% were men and 75% were white. At a 3:1 ratio, they were randomized into one of two cohorts: one underwent thalamotomy and the other received a “sham” procedure. The subjects were unaware which they received for the first 3 months. The Clinical Rating Scale for Tremor (CRST) and the Quality of Life in Essential Tremor Questionnaire (QUEST) was used to determine the severity of tremors at baseline, and at follow-ups conducted at 1, 3, 6, and 12 months post-procedure (N Engl J Med. 2016;375[8]:730-9).
The trial’s primary outcome of between-group difference in the change in tremor score from baseline to 3 months significantly favored thalamotomy (8.5-point improvement, from 18.1 to 9.6) over the sham procedure (0.2-point improvement, from 16.0 to 15.8). The mean between-group difference in the change in score of 8.3 points at 3 months decreased slightly to 7.2 points at 12 months. The tremor score (range, 0-32) was derived from part A of the CRST (three items: resting, postural, and action or intention components of hand tremor), and part B of the CRST (five tasks involving handwriting, drawing, and pouring), in the hand contralateral to the thalamotomy.
Thalamotomy patients also reported 46% better quality of life on QUEST at 3 months, compared with 3% better among sham-procedure patients.
There were adverse events in the thalamotomy cohort. At the 3-month follow-up, 36% of subjects experienced gait disturbance, 38% experienced paresthesias or some kind of numbness. The rates of these adverse events dropped to 9% and 14%, respectively, at the 12-month follow-up.
“Deep-brain stimulation is currently the surgical standard for medication-refractory essential tremor [but] a control group of patients undergoing deep-brain stimulation was not included in this trial; the two technologies were not compared,” the authors noted, indicating that such comparison could potentially be the next step for this research.
This study was supported by InSightec, the Focused Ultrasound Foundation, and the Binational Industrial Research and Development Foundation. Dr. Elias disclosed receiving grant support from InSightec and the Focused Ultrasound Foundation. Other coauthors disclosed receiving similar support.
MRI-guided focused ultrasound thalamotomy can significantly mitigate the severity of hand tremors in patients suffering from essential tremor, the most common type of movement disorder, according to a new study published in the New England Journal of Medicine.
“The use of ultrasound energy for the creation of discrete intracranial lesions... has been of interest since the middle of the 20th century,” wrote the investigators, led by W. Jeffrey Elias, MD, of the University of Virginia, Charlottesville. “Prospective pilot trials of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance in patients with essential tremor have shown reductions in hand tremor, improvements in quality of life, and minimal procedural morbidity.”
The trial enrolled a total of 76 patients with a mean age of 71 years and mean disease duration of nearly 17 years; 68% were men and 75% were white. At a 3:1 ratio, they were randomized into one of two cohorts: one underwent thalamotomy and the other received a “sham” procedure. The subjects were unaware which they received for the first 3 months. The Clinical Rating Scale for Tremor (CRST) and the Quality of Life in Essential Tremor Questionnaire (QUEST) was used to determine the severity of tremors at baseline, and at follow-ups conducted at 1, 3, 6, and 12 months post-procedure (N Engl J Med. 2016;375[8]:730-9).
The trial’s primary outcome of between-group difference in the change in tremor score from baseline to 3 months significantly favored thalamotomy (8.5-point improvement, from 18.1 to 9.6) over the sham procedure (0.2-point improvement, from 16.0 to 15.8). The mean between-group difference in the change in score of 8.3 points at 3 months decreased slightly to 7.2 points at 12 months. The tremor score (range, 0-32) was derived from part A of the CRST (three items: resting, postural, and action or intention components of hand tremor), and part B of the CRST (five tasks involving handwriting, drawing, and pouring), in the hand contralateral to the thalamotomy.
Thalamotomy patients also reported 46% better quality of life on QUEST at 3 months, compared with 3% better among sham-procedure patients.
There were adverse events in the thalamotomy cohort. At the 3-month follow-up, 36% of subjects experienced gait disturbance, 38% experienced paresthesias or some kind of numbness. The rates of these adverse events dropped to 9% and 14%, respectively, at the 12-month follow-up.
“Deep-brain stimulation is currently the surgical standard for medication-refractory essential tremor [but] a control group of patients undergoing deep-brain stimulation was not included in this trial; the two technologies were not compared,” the authors noted, indicating that such comparison could potentially be the next step for this research.
This study was supported by InSightec, the Focused Ultrasound Foundation, and the Binational Industrial Research and Development Foundation. Dr. Elias disclosed receiving grant support from InSightec and the Focused Ultrasound Foundation. Other coauthors disclosed receiving similar support.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: The severity of hand tremors in patients with essential tremor can be significantly reduced via use of MRI-guided focused ultrasound thalamotomy.
Major finding: Greater improvement was observed in the ultrasound thalamotomy cohort than in the control (sham treatment) cohort: 18.1 to 9.6 hand tremor score vs. 16.0 to 15.8, respectively.
Data source: A double-blind, randomized, sham-controlled cohort study of 76 patients with moderate-to-severe essential tremor.
Disclosures: Study supported by InSightec, the Focused Ultrasound Foundation, and the Binational Industrial Research and Development Foundation. Some coauthors reported potentially relevant disclosures.
Multifocal effort needed to rein in prescription prices
Enforcing more stringent requirements for exclusivity rights, ensuring timely generic drug availability, and providing greater opportunities for meaningful price negotiation by government payers could help combat high medication costs in the United States, according to an analysis published Aug. 23 in JAMA.
Per capita prescription drug spending in the United States exceeds that in all other countries, largely fueled by brand-name drug prices rising at rates far beyond the consumer price index. For example, in 2013, per capita spending on prescription drugs was $858, compared with an average of $400 for 19 other industrialized nations, according to the analysis conducted by Aaron S. Kesselheim, MD, of Brigham & Women’s Hospital, Boston, and colleagues. In addition, between 2008 and 2015, prices for the most commonly used brand-name drugs in the United States rose by 164%, far more than the consumer price index increased (12%), authors reported (JAMA 2016. doi: 10.1001/jama.2016.11237).
“We found that indeed, drug prices in the United States are much high than anywhere else in the world and the main contributors to that are the U.S. drug marketplace which allows drug companies to charge whatever the market will bear and then in many respects, places limitations on the ability of payers to try to negotiate lower drug prices,” Dr. Kesselheim said in a video interview for JAMA.
To reduce high drug prices, authors propose better federal oversight of drug makers who attempt to extend market exclusivity. For example, changing how the U.S. Patent and Trademark Office interprets novelty and non-obviousness when issuing drug patents could help avoid new secondary patents based on clinically irrelevant changes to active drug products. Other strategies outlined include:
• Decrease industry expenses. Reviews have pointed to the increasing expenditures for drug research and development, with the suggestion that steps be taken to make companies’ investments more efficient.
• Pass state laws permitting substitution of clinically similar drugs within the same class in carefully selected circumstances.
• Increase attention to the generic drug marketplace. Proposed federal legislation would forbid brand-name manufacturers from refusing to share samples of products with generic drug manufacturers for necessary bioequivalence studies.
• Authorize Medicare to negotiate prices of drugs paid for by Medicare Part D plans.
Physicians can also play a role in decreasing drug prices by discussing drug prices and choices with patients and limiting practices such as writing “dispense as written” prescriptions to avoid generic medications, Dr. Kesselheim noted. More education about drug costs and value-based prescribing integrated into physicians’ initial and continuing education could also be beneficial.
“There needs to be more education of patients and physicians about the implications of high drug prices and ways they can ensure that the prescribing they are doing is of highest value,” Dr. Kesselheim said in the video interview.
On Twitter @legal_med
Enforcing more stringent requirements for exclusivity rights, ensuring timely generic drug availability, and providing greater opportunities for meaningful price negotiation by government payers could help combat high medication costs in the United States, according to an analysis published Aug. 23 in JAMA.
Per capita prescription drug spending in the United States exceeds that in all other countries, largely fueled by brand-name drug prices rising at rates far beyond the consumer price index. For example, in 2013, per capita spending on prescription drugs was $858, compared with an average of $400 for 19 other industrialized nations, according to the analysis conducted by Aaron S. Kesselheim, MD, of Brigham & Women’s Hospital, Boston, and colleagues. In addition, between 2008 and 2015, prices for the most commonly used brand-name drugs in the United States rose by 164%, far more than the consumer price index increased (12%), authors reported (JAMA 2016. doi: 10.1001/jama.2016.11237).
“We found that indeed, drug prices in the United States are much high than anywhere else in the world and the main contributors to that are the U.S. drug marketplace which allows drug companies to charge whatever the market will bear and then in many respects, places limitations on the ability of payers to try to negotiate lower drug prices,” Dr. Kesselheim said in a video interview for JAMA.
To reduce high drug prices, authors propose better federal oversight of drug makers who attempt to extend market exclusivity. For example, changing how the U.S. Patent and Trademark Office interprets novelty and non-obviousness when issuing drug patents could help avoid new secondary patents based on clinically irrelevant changes to active drug products. Other strategies outlined include:
• Decrease industry expenses. Reviews have pointed to the increasing expenditures for drug research and development, with the suggestion that steps be taken to make companies’ investments more efficient.
• Pass state laws permitting substitution of clinically similar drugs within the same class in carefully selected circumstances.
• Increase attention to the generic drug marketplace. Proposed federal legislation would forbid brand-name manufacturers from refusing to share samples of products with generic drug manufacturers for necessary bioequivalence studies.
• Authorize Medicare to negotiate prices of drugs paid for by Medicare Part D plans.
Physicians can also play a role in decreasing drug prices by discussing drug prices and choices with patients and limiting practices such as writing “dispense as written” prescriptions to avoid generic medications, Dr. Kesselheim noted. More education about drug costs and value-based prescribing integrated into physicians’ initial and continuing education could also be beneficial.
“There needs to be more education of patients and physicians about the implications of high drug prices and ways they can ensure that the prescribing they are doing is of highest value,” Dr. Kesselheim said in the video interview.
On Twitter @legal_med
Enforcing more stringent requirements for exclusivity rights, ensuring timely generic drug availability, and providing greater opportunities for meaningful price negotiation by government payers could help combat high medication costs in the United States, according to an analysis published Aug. 23 in JAMA.
Per capita prescription drug spending in the United States exceeds that in all other countries, largely fueled by brand-name drug prices rising at rates far beyond the consumer price index. For example, in 2013, per capita spending on prescription drugs was $858, compared with an average of $400 for 19 other industrialized nations, according to the analysis conducted by Aaron S. Kesselheim, MD, of Brigham & Women’s Hospital, Boston, and colleagues. In addition, between 2008 and 2015, prices for the most commonly used brand-name drugs in the United States rose by 164%, far more than the consumer price index increased (12%), authors reported (JAMA 2016. doi: 10.1001/jama.2016.11237).
“We found that indeed, drug prices in the United States are much high than anywhere else in the world and the main contributors to that are the U.S. drug marketplace which allows drug companies to charge whatever the market will bear and then in many respects, places limitations on the ability of payers to try to negotiate lower drug prices,” Dr. Kesselheim said in a video interview for JAMA.
To reduce high drug prices, authors propose better federal oversight of drug makers who attempt to extend market exclusivity. For example, changing how the U.S. Patent and Trademark Office interprets novelty and non-obviousness when issuing drug patents could help avoid new secondary patents based on clinically irrelevant changes to active drug products. Other strategies outlined include:
• Decrease industry expenses. Reviews have pointed to the increasing expenditures for drug research and development, with the suggestion that steps be taken to make companies’ investments more efficient.
• Pass state laws permitting substitution of clinically similar drugs within the same class in carefully selected circumstances.
• Increase attention to the generic drug marketplace. Proposed federal legislation would forbid brand-name manufacturers from refusing to share samples of products with generic drug manufacturers for necessary bioequivalence studies.
• Authorize Medicare to negotiate prices of drugs paid for by Medicare Part D plans.
Physicians can also play a role in decreasing drug prices by discussing drug prices and choices with patients and limiting practices such as writing “dispense as written” prescriptions to avoid generic medications, Dr. Kesselheim noted. More education about drug costs and value-based prescribing integrated into physicians’ initial and continuing education could also be beneficial.
“There needs to be more education of patients and physicians about the implications of high drug prices and ways they can ensure that the prescribing they are doing is of highest value,” Dr. Kesselheim said in the video interview.
On Twitter @legal_med
FROM JAMA
Key clinical point: Enforcing more stringent requirements for exclusivity rights could lower medication costs.
Major finding: Per capita prescription drug spending in the United States exceeds that in all other countries.
Data source: Analysis of the peer-reviewed medical and health policy literature from January 2015 through July 2016.
Disclosures: Dr. Kesselheim reported no relevant financial conflicts of interest. The study was supported by two independent think tanks.
Power morcellation dropped, abdominal hysterectomy increased after FDA warning
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
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Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
|
|
Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
|
|
Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
FROM JAMA
Key clinical point: Electric power morcellation declined after the FDA recommended against using the technique during hysterectomy.
Major finding: Use of electric power morcellation peaked at 13.7% before the FDA recommendations, then declined to a low of 2.8%.
Data source: A retrospective database analysis involving 203,520 hysterectomies performed at more than 500 U.S. hospitals during 2013-2015.
Disclosures: The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
Multiarterial grafting survival exceeds conventional CABG, PCI
A large, 16-year single-center study of patients with multivessel disease has determined that multivessel coronary artery bypass grafting achieved longer survival than not only percutaneous coronary interventions, but also conventional coronary artery bypass grafting, researchers from the Mayo Clinic reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:369-79).
Lead author Chaim Locker, MD, and his colleagues said the use of what they called MultiArt, for multivessel arterial grafting, also known as MAG, “must increase.”
The evolution of bare-metal and then drug-eluting stents may have favored percutaneous coronary interventions (PCI) over coronary artery bypass grafting (CABG), but, Dr. Locker and his coauthors said, “Evidence is accumulating that late outcome of surgical revascularization is improved when at least two arterial grafts are used.”
The study analyzed results of 12,615 patients who had either isolated primary CABG (6,667) or PCI (5,948) from 1993 to 2009. Among the CABG patients, 5,712 had the more conventional approach involving arterial grafts into the left internal thoracic artery/saphenous vein (ITA/SV) and 955 had MAG. Patients in the PCI group had three different procedures: balloon angioplasty (1,020), drug-eluting stent (1,686), or bare-metal stent (3,242). The study excluded patients who had revascularization procedures after a heart attack.
While the overall 15-year survival for patients with CABG was lower than it was for those who had PCI (36% vs. 46%), the survival for those who had MAG was significantly higher: 65% vs. 31% for those who had left ITA/SV revascularization. 8-year survival for the MAG subgroup was also significantly higher than all other subgroups: 87% vs. 69% for left ITA/SV, 75% for bare-metal stent, 73% for balloon angioplasty, and 70% for drug-eluting stent.
Propensity matching found similar survivability for balloon angioplasty and left ITA/SV when compared with MAG: 66% for MAG vs. 57% for the former; and 64% for MAG vs. 56% for the latter. The researchers also estimated the hazard ratio during the first 5 years of follow-up and found that those who had bare-metal stents had “significantly worse” survival, compared with MAG, but that survival evened out after that. Survival in the bare-metal stent group was similar to that of the left ITA/SV group, but “significantly worse” during the first 5 years for those who had balloon angioplasty.
Dr. Locker and his colleagues acknowledged that multiple randomized studies have compared CABG and PCI over the years, but they said that in most of those studies “the enrolled patients were highly selected and likely did not represent the broader population of patients with MVD [multivessel disease] undergoing revascularization.” With the exception of the SYNTAX trial (Synergy Between PCI With Taxus and Cardiac Surgery) (N Engl J Med. 2009;360:961-72; Lancet. 2013;381:629-38), those studies did not report on the frequency of MAG within the study population. The Mayo study, on the other hand, included all treated patients, excluding those who had a previous heart attack.
However, MAG is used infrequently, Dr. Locker and his colleagues said. The average annual rate of MAG in their Mayo practice was 15.2%, higher than the 5% annual rate the Society of Thoracic Surgeons National Cardiac Surgery Database (J Thorac Cardiovasc Surg. 2012;143:273-81) reported, and higher than the 12% rate in Europe (Eur J Cardiothorac Surg. 2006;29: 486-91). The SYNTAX trial reported an annual MAG rate of 27.6% for all CABG cases.
“It seems clear that use of MultiArt should be more frequent in patients with MVD undergoing CABG,” Dr. Locker and his coauthors said. “MultiArt can be used in most patients with MVD, including diabetic patients and elderly patients, and this strategy will improve outcomes of surgical revascularization.”
Dr. Locker and his coauthors had no financial relationships to disclose.
One might wonder about the validity of another retrospective, single-center study comparing revascularization techniques, but the study by Dr. Locker and his colleagues is “compelling” for two reasons, Paul Kurlansky, MD, of Columbia University, New York, pointed out in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:380-1).
|
Dr. Paul Kurlansky |
Dr. Kurlansky noted the finding of equivalent survival at up to 8 years among propensity-matched patients who had left coronary artery bypass grafting with the use of a single internal thoracic artery with supplemental vein grafts (left ITA/SV) and those who received drug-eluting stents was “a bit more provocative” than some of the expected study results; and the reversal of the survival benefit of left ITA/SV, compared with both balloon angioplasty and bare-metal stents after 7 to 10 years was “more perturbing for the surgical community.”
This study underscores that increased use of multiple arterial grafting is essential to give patients the best revascularization option, even in the age of growing percutaneous interventions, Dr. Kurlansky said.
“Limitations notwithstanding, the message for the surgical community is clear – if we wish to have the opportunity to treat patients with advanced, multivessel coronary artery disease, we will need to more fully embrace a strategy of MAG,” he said.
Dr. Kurlansky had no financial relationships to disclose.
One might wonder about the validity of another retrospective, single-center study comparing revascularization techniques, but the study by Dr. Locker and his colleagues is “compelling” for two reasons, Paul Kurlansky, MD, of Columbia University, New York, pointed out in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:380-1).
|
|
Dr. Paul Kurlansky |
Dr. Kurlansky noted the finding of equivalent survival at up to 8 years among propensity-matched patients who had left coronary artery bypass grafting with the use of a single internal thoracic artery with supplemental vein grafts (left ITA/SV) and those who received drug-eluting stents was “a bit more provocative” than some of the expected study results; and the reversal of the survival benefit of left ITA/SV, compared with both balloon angioplasty and bare-metal stents after 7 to 10 years was “more perturbing for the surgical community.”
This study underscores that increased use of multiple arterial grafting is essential to give patients the best revascularization option, even in the age of growing percutaneous interventions, Dr. Kurlansky said.
“Limitations notwithstanding, the message for the surgical community is clear – if we wish to have the opportunity to treat patients with advanced, multivessel coronary artery disease, we will need to more fully embrace a strategy of MAG,” he said.
Dr. Kurlansky had no financial relationships to disclose.
One might wonder about the validity of another retrospective, single-center study comparing revascularization techniques, but the study by Dr. Locker and his colleagues is “compelling” for two reasons, Paul Kurlansky, MD, of Columbia University, New York, pointed out in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:380-1).
|
|
Dr. Paul Kurlansky |
Dr. Kurlansky noted the finding of equivalent survival at up to 8 years among propensity-matched patients who had left coronary artery bypass grafting with the use of a single internal thoracic artery with supplemental vein grafts (left ITA/SV) and those who received drug-eluting stents was “a bit more provocative” than some of the expected study results; and the reversal of the survival benefit of left ITA/SV, compared with both balloon angioplasty and bare-metal stents after 7 to 10 years was “more perturbing for the surgical community.”
This study underscores that increased use of multiple arterial grafting is essential to give patients the best revascularization option, even in the age of growing percutaneous interventions, Dr. Kurlansky said.
“Limitations notwithstanding, the message for the surgical community is clear – if we wish to have the opportunity to treat patients with advanced, multivessel coronary artery disease, we will need to more fully embrace a strategy of MAG,” he said.
Dr. Kurlansky had no financial relationships to disclose.
A large, 16-year single-center study of patients with multivessel disease has determined that multivessel coronary artery bypass grafting achieved longer survival than not only percutaneous coronary interventions, but also conventional coronary artery bypass grafting, researchers from the Mayo Clinic reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:369-79).
Lead author Chaim Locker, MD, and his colleagues said the use of what they called MultiArt, for multivessel arterial grafting, also known as MAG, “must increase.”
The evolution of bare-metal and then drug-eluting stents may have favored percutaneous coronary interventions (PCI) over coronary artery bypass grafting (CABG), but, Dr. Locker and his coauthors said, “Evidence is accumulating that late outcome of surgical revascularization is improved when at least two arterial grafts are used.”
The study analyzed results of 12,615 patients who had either isolated primary CABG (6,667) or PCI (5,948) from 1993 to 2009. Among the CABG patients, 5,712 had the more conventional approach involving arterial grafts into the left internal thoracic artery/saphenous vein (ITA/SV) and 955 had MAG. Patients in the PCI group had three different procedures: balloon angioplasty (1,020), drug-eluting stent (1,686), or bare-metal stent (3,242). The study excluded patients who had revascularization procedures after a heart attack.
While the overall 15-year survival for patients with CABG was lower than it was for those who had PCI (36% vs. 46%), the survival for those who had MAG was significantly higher: 65% vs. 31% for those who had left ITA/SV revascularization. 8-year survival for the MAG subgroup was also significantly higher than all other subgroups: 87% vs. 69% for left ITA/SV, 75% for bare-metal stent, 73% for balloon angioplasty, and 70% for drug-eluting stent.
Propensity matching found similar survivability for balloon angioplasty and left ITA/SV when compared with MAG: 66% for MAG vs. 57% for the former; and 64% for MAG vs. 56% for the latter. The researchers also estimated the hazard ratio during the first 5 years of follow-up and found that those who had bare-metal stents had “significantly worse” survival, compared with MAG, but that survival evened out after that. Survival in the bare-metal stent group was similar to that of the left ITA/SV group, but “significantly worse” during the first 5 years for those who had balloon angioplasty.
Dr. Locker and his colleagues acknowledged that multiple randomized studies have compared CABG and PCI over the years, but they said that in most of those studies “the enrolled patients were highly selected and likely did not represent the broader population of patients with MVD [multivessel disease] undergoing revascularization.” With the exception of the SYNTAX trial (Synergy Between PCI With Taxus and Cardiac Surgery) (N Engl J Med. 2009;360:961-72; Lancet. 2013;381:629-38), those studies did not report on the frequency of MAG within the study population. The Mayo study, on the other hand, included all treated patients, excluding those who had a previous heart attack.
However, MAG is used infrequently, Dr. Locker and his colleagues said. The average annual rate of MAG in their Mayo practice was 15.2%, higher than the 5% annual rate the Society of Thoracic Surgeons National Cardiac Surgery Database (J Thorac Cardiovasc Surg. 2012;143:273-81) reported, and higher than the 12% rate in Europe (Eur J Cardiothorac Surg. 2006;29: 486-91). The SYNTAX trial reported an annual MAG rate of 27.6% for all CABG cases.
“It seems clear that use of MultiArt should be more frequent in patients with MVD undergoing CABG,” Dr. Locker and his coauthors said. “MultiArt can be used in most patients with MVD, including diabetic patients and elderly patients, and this strategy will improve outcomes of surgical revascularization.”
Dr. Locker and his coauthors had no financial relationships to disclose.
A large, 16-year single-center study of patients with multivessel disease has determined that multivessel coronary artery bypass grafting achieved longer survival than not only percutaneous coronary interventions, but also conventional coronary artery bypass grafting, researchers from the Mayo Clinic reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:369-79).
Lead author Chaim Locker, MD, and his colleagues said the use of what they called MultiArt, for multivessel arterial grafting, also known as MAG, “must increase.”
The evolution of bare-metal and then drug-eluting stents may have favored percutaneous coronary interventions (PCI) over coronary artery bypass grafting (CABG), but, Dr. Locker and his coauthors said, “Evidence is accumulating that late outcome of surgical revascularization is improved when at least two arterial grafts are used.”
The study analyzed results of 12,615 patients who had either isolated primary CABG (6,667) or PCI (5,948) from 1993 to 2009. Among the CABG patients, 5,712 had the more conventional approach involving arterial grafts into the left internal thoracic artery/saphenous vein (ITA/SV) and 955 had MAG. Patients in the PCI group had three different procedures: balloon angioplasty (1,020), drug-eluting stent (1,686), or bare-metal stent (3,242). The study excluded patients who had revascularization procedures after a heart attack.
While the overall 15-year survival for patients with CABG was lower than it was for those who had PCI (36% vs. 46%), the survival for those who had MAG was significantly higher: 65% vs. 31% for those who had left ITA/SV revascularization. 8-year survival for the MAG subgroup was also significantly higher than all other subgroups: 87% vs. 69% for left ITA/SV, 75% for bare-metal stent, 73% for balloon angioplasty, and 70% for drug-eluting stent.
Propensity matching found similar survivability for balloon angioplasty and left ITA/SV when compared with MAG: 66% for MAG vs. 57% for the former; and 64% for MAG vs. 56% for the latter. The researchers also estimated the hazard ratio during the first 5 years of follow-up and found that those who had bare-metal stents had “significantly worse” survival, compared with MAG, but that survival evened out after that. Survival in the bare-metal stent group was similar to that of the left ITA/SV group, but “significantly worse” during the first 5 years for those who had balloon angioplasty.
Dr. Locker and his colleagues acknowledged that multiple randomized studies have compared CABG and PCI over the years, but they said that in most of those studies “the enrolled patients were highly selected and likely did not represent the broader population of patients with MVD [multivessel disease] undergoing revascularization.” With the exception of the SYNTAX trial (Synergy Between PCI With Taxus and Cardiac Surgery) (N Engl J Med. 2009;360:961-72; Lancet. 2013;381:629-38), those studies did not report on the frequency of MAG within the study population. The Mayo study, on the other hand, included all treated patients, excluding those who had a previous heart attack.
However, MAG is used infrequently, Dr. Locker and his colleagues said. The average annual rate of MAG in their Mayo practice was 15.2%, higher than the 5% annual rate the Society of Thoracic Surgeons National Cardiac Surgery Database (J Thorac Cardiovasc Surg. 2012;143:273-81) reported, and higher than the 12% rate in Europe (Eur J Cardiothorac Surg. 2006;29: 486-91). The SYNTAX trial reported an annual MAG rate of 27.6% for all CABG cases.
“It seems clear that use of MultiArt should be more frequent in patients with MVD undergoing CABG,” Dr. Locker and his coauthors said. “MultiArt can be used in most patients with MVD, including diabetic patients and elderly patients, and this strategy will improve outcomes of surgical revascularization.”
Dr. Locker and his coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Cardiac surgeons should use multiple arterial coronary artery bypass grafting (MAG) more frequently because it achieves superior survival, compared with conventional bypass surgery or percutaneous coronary interventions.
Major finding: The overall 8-year survival of those who had MAG was 87% vs. 69% for conventional coronary bypass surgery and 70%-75% for percutaneous procedures.
Data source: Retrospective, single-institution study of 12,615 patients with multivessel disease who had revascularization procedures at the Mayo Clinic from 1993 to 2009.
Disclosures: Dr. Locker and his coauthors had no financial relationships to disclose.
ACS Submits Comment Letter to CMS on MIPS and APMs
The American College of Surgeons (ACS) submitted a comment letter June 27 on the Centers for Medicare & Medicaid Services (CMS) proposed rule on implementation of certain provisions of MACRA. Specifically, the CMS set forth proposals on the two pathways by which MACRA replaces the sustainable growth rate (SGR) formula: the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). Among other issues, the ACS comments address the four components of MIPS: 1. quality, 2. resource use, 3. advancing care information, and 4. clinical practice improvement activities. The comments also address the criteria necessary for an APM model to be considered an “Advanced” APM, specifically: 1. use of certified electronic health records technology, 2. inclusion of quality measures comparable to MIPS, and 3. taking on more than nominal financial risk. Participation in an Advanced APM would exclude the clinician from participation in MIPS. For more information on the proposed rule or the comment letter, contact [email protected].
The American College of Surgeons (ACS) submitted a comment letter June 27 on the Centers for Medicare & Medicaid Services (CMS) proposed rule on implementation of certain provisions of MACRA. Specifically, the CMS set forth proposals on the two pathways by which MACRA replaces the sustainable growth rate (SGR) formula: the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). Among other issues, the ACS comments address the four components of MIPS: 1. quality, 2. resource use, 3. advancing care information, and 4. clinical practice improvement activities. The comments also address the criteria necessary for an APM model to be considered an “Advanced” APM, specifically: 1. use of certified electronic health records technology, 2. inclusion of quality measures comparable to MIPS, and 3. taking on more than nominal financial risk. Participation in an Advanced APM would exclude the clinician from participation in MIPS. For more information on the proposed rule or the comment letter, contact [email protected].
The American College of Surgeons (ACS) submitted a comment letter June 27 on the Centers for Medicare & Medicaid Services (CMS) proposed rule on implementation of certain provisions of MACRA. Specifically, the CMS set forth proposals on the two pathways by which MACRA replaces the sustainable growth rate (SGR) formula: the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). Among other issues, the ACS comments address the four components of MIPS: 1. quality, 2. resource use, 3. advancing care information, and 4. clinical practice improvement activities. The comments also address the criteria necessary for an APM model to be considered an “Advanced” APM, specifically: 1. use of certified electronic health records technology, 2. inclusion of quality measures comparable to MIPS, and 3. taking on more than nominal financial risk. Participation in an Advanced APM would exclude the clinician from participation in MIPS. For more information on the proposed rule or the comment letter, contact [email protected].