Leukemia no longer deadliest childhood cancer in US

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Leukemia no longer deadliest childhood cancer in US

Cancer patient

Photo by Bill Branson

Brain cancer has overtaken leukemia to become the deadliest childhood cancer in the US, according to a report from the US Centers for Disease Control and Prevention’s National Center for Health Statistics.

The report includes cancer mortality statistics from 1999 to 2014 pertaining to children and adolescents (ages 1 to 19).

In both 1999 and 2014, more than half of all cancer deaths in this population were attributable to leukemias or brain cancers.

In 1999, a greater percentage of deaths were attributed to leukemias than to brain cancers—29.7% and 23.7%, respectively.

But in 2014, brain cancer deaths exceeded leukemia deaths—29.9% and 24.9%, respectively.

The data also showed that, overall, cancer mortality has decreased among children and adolescents in the US.

The cancer death rate was 20% lower in 2014 than in 1999—2.28 deaths per 100,000 persons and 2.85 deaths per 100,000 persons, respectively.

Cancer death rates declined from 1999 to 2014 for all of the age groups studied (divided by 5-year increments) and for both sexes. However, cancer death rates were consistently higher for males than females.

In 2014, 54.8% of cancer deaths among children and adolescents were attributable to either leukemias or brain cancers.

The 2014 death rates by cancer site, from most common to least, were as follows:

  • Brain cancers (29.9%)
  • Leukemias (24.9%)
  • Bone and articular cartilage cancers (10.1%)
  • Cancers of the thyroid and other endocrine glands (9.0%)
  • Mesothelial and soft tissue cancers (7.7%)
  • Non-Hodgkin lymphomas (3.9%)
  • Cancers of the liver and intrahepatic bile ducts (2.0%)
  • Cancers of the kidney and renal pelvis (1.8%).

Data on the remaining cancer sites were not shown separately.

For more information, see the full report, “Declines in Cancer Death Rates Among Children and Adolescents in the United States, 1999–2014.”

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Cancer patient

Photo by Bill Branson

Brain cancer has overtaken leukemia to become the deadliest childhood cancer in the US, according to a report from the US Centers for Disease Control and Prevention’s National Center for Health Statistics.

The report includes cancer mortality statistics from 1999 to 2014 pertaining to children and adolescents (ages 1 to 19).

In both 1999 and 2014, more than half of all cancer deaths in this population were attributable to leukemias or brain cancers.

In 1999, a greater percentage of deaths were attributed to leukemias than to brain cancers—29.7% and 23.7%, respectively.

But in 2014, brain cancer deaths exceeded leukemia deaths—29.9% and 24.9%, respectively.

The data also showed that, overall, cancer mortality has decreased among children and adolescents in the US.

The cancer death rate was 20% lower in 2014 than in 1999—2.28 deaths per 100,000 persons and 2.85 deaths per 100,000 persons, respectively.

Cancer death rates declined from 1999 to 2014 for all of the age groups studied (divided by 5-year increments) and for both sexes. However, cancer death rates were consistently higher for males than females.

In 2014, 54.8% of cancer deaths among children and adolescents were attributable to either leukemias or brain cancers.

The 2014 death rates by cancer site, from most common to least, were as follows:

  • Brain cancers (29.9%)
  • Leukemias (24.9%)
  • Bone and articular cartilage cancers (10.1%)
  • Cancers of the thyroid and other endocrine glands (9.0%)
  • Mesothelial and soft tissue cancers (7.7%)
  • Non-Hodgkin lymphomas (3.9%)
  • Cancers of the liver and intrahepatic bile ducts (2.0%)
  • Cancers of the kidney and renal pelvis (1.8%).

Data on the remaining cancer sites were not shown separately.

For more information, see the full report, “Declines in Cancer Death Rates Among Children and Adolescents in the United States, 1999–2014.”

Cancer patient

Photo by Bill Branson

Brain cancer has overtaken leukemia to become the deadliest childhood cancer in the US, according to a report from the US Centers for Disease Control and Prevention’s National Center for Health Statistics.

The report includes cancer mortality statistics from 1999 to 2014 pertaining to children and adolescents (ages 1 to 19).

In both 1999 and 2014, more than half of all cancer deaths in this population were attributable to leukemias or brain cancers.

In 1999, a greater percentage of deaths were attributed to leukemias than to brain cancers—29.7% and 23.7%, respectively.

But in 2014, brain cancer deaths exceeded leukemia deaths—29.9% and 24.9%, respectively.

The data also showed that, overall, cancer mortality has decreased among children and adolescents in the US.

The cancer death rate was 20% lower in 2014 than in 1999—2.28 deaths per 100,000 persons and 2.85 deaths per 100,000 persons, respectively.

Cancer death rates declined from 1999 to 2014 for all of the age groups studied (divided by 5-year increments) and for both sexes. However, cancer death rates were consistently higher for males than females.

In 2014, 54.8% of cancer deaths among children and adolescents were attributable to either leukemias or brain cancers.

The 2014 death rates by cancer site, from most common to least, were as follows:

  • Brain cancers (29.9%)
  • Leukemias (24.9%)
  • Bone and articular cartilage cancers (10.1%)
  • Cancers of the thyroid and other endocrine glands (9.0%)
  • Mesothelial and soft tissue cancers (7.7%)
  • Non-Hodgkin lymphomas (3.9%)
  • Cancers of the liver and intrahepatic bile ducts (2.0%)
  • Cancers of the kidney and renal pelvis (1.8%).

Data on the remaining cancer sites were not shown separately.

For more information, see the full report, “Declines in Cancer Death Rates Among Children and Adolescents in the United States, 1999–2014.”

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Endobariatrics: Coming to a clinic near you

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SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work for all patients, but many patients resist having surgery. These devices are meant to fill the need for nonsurgical, “noninvasive” solutions to obesity management.

Courtesy Allurion TechnologiesElipse bariatric balloon

Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices. Surgeons, however, approach these innovations with caution, due in part to past experiences of rescuing patients with failed devices. “Some innovations get disseminated without adequate studies to demonstrate whether they are superior, or even equal in efficacy and safety to, well-established procedures for the same condition.  Even when they have been conducted, negative studies showing no difference may end up being rejected by journals and not published,” noted Karen Deveney, MD, FACS, professor of surgery, vice-chair for education in the department of surgery at Oregon Health & Science University, Portland, and co-Editor of ACS Surgery News.

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Courtesy Apollo EndosurgeryOverstich endoscopic bariatric device

Dr. Edmundowicz reviewed the latest developments presented at DDW.Self-assembling magnets for dual-path enteral anastomoses 

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Courtesy Aspire Bariatrics Inc.AspireAssist device

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon Therapeutics is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

 

 

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.  
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

Caveat emptor, all over again

Although many of these innovations will eventually achieve acceptable clinical results in trials and be adopted by both gastroenterologists and surgeons, a note of caution is in order, argues Tyler G. Hughes, MD, FACS, is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, coeditor of ACS Surgery News.

“The recent uptick in ‘non-surgical’ obesity treatment reverberates as history gets ready to repeat itself.  If surgeons don’t take the lead, two things are likely to happen.  First, ‘interventionists,’ ignorant of the lessons of yesterday will introduce foreign bodies into the soft GI tract only to see these ‘safe’ devices create surgical havoc or malabsorptive disasters. Second, instead of doing a complete spectrum of obesity procedures, surgeons will be left with the worst cases and fixing complications while the ‘interventionist’ (and I do not limit that to gastroenterologists) do the easy cases at prices three times the cost of the old way. Will this really benefit the patients?

Rather than permitting a race to the newest unproven device to satisfy public clamor, while conveniently making a tidy profit for anyone able to claim the title ‘interventionist,’ bariatric surgeons need to grab the endoscope with both hands and do the research and reporting for these new procedures. It starts with the need for every surgical resident to be proficient with the GI endoscopes and ends with surgeons seeing surgery in a wider view than through an incision,” Dr. Hughes said.

[email protected]

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SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work for all patients, but many patients resist having surgery. These devices are meant to fill the need for nonsurgical, “noninvasive” solutions to obesity management.

Courtesy Allurion TechnologiesElipse bariatric balloon

Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices. Surgeons, however, approach these innovations with caution, due in part to past experiences of rescuing patients with failed devices. “Some innovations get disseminated without adequate studies to demonstrate whether they are superior, or even equal in efficacy and safety to, well-established procedures for the same condition.  Even when they have been conducted, negative studies showing no difference may end up being rejected by journals and not published,” noted Karen Deveney, MD, FACS, professor of surgery, vice-chair for education in the department of surgery at Oregon Health & Science University, Portland, and co-Editor of ACS Surgery News.

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Courtesy Apollo EndosurgeryOverstich endoscopic bariatric device

Dr. Edmundowicz reviewed the latest developments presented at DDW.Self-assembling magnets for dual-path enteral anastomoses 

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Courtesy Aspire Bariatrics Inc.AspireAssist device

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon Therapeutics is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

 

 

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.  
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

Caveat emptor, all over again

Although many of these innovations will eventually achieve acceptable clinical results in trials and be adopted by both gastroenterologists and surgeons, a note of caution is in order, argues Tyler G. Hughes, MD, FACS, is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, coeditor of ACS Surgery News.

“The recent uptick in ‘non-surgical’ obesity treatment reverberates as history gets ready to repeat itself.  If surgeons don’t take the lead, two things are likely to happen.  First, ‘interventionists,’ ignorant of the lessons of yesterday will introduce foreign bodies into the soft GI tract only to see these ‘safe’ devices create surgical havoc or malabsorptive disasters. Second, instead of doing a complete spectrum of obesity procedures, surgeons will be left with the worst cases and fixing complications while the ‘interventionist’ (and I do not limit that to gastroenterologists) do the easy cases at prices three times the cost of the old way. Will this really benefit the patients?

Rather than permitting a race to the newest unproven device to satisfy public clamor, while conveniently making a tidy profit for anyone able to claim the title ‘interventionist,’ bariatric surgeons need to grab the endoscope with both hands and do the research and reporting for these new procedures. It starts with the need for every surgical resident to be proficient with the GI endoscopes and ends with surgeons seeing surgery in a wider view than through an incision,” Dr. Hughes said.

[email protected]

SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work for all patients, but many patients resist having surgery. These devices are meant to fill the need for nonsurgical, “noninvasive” solutions to obesity management.

Courtesy Allurion TechnologiesElipse bariatric balloon

Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices. Surgeons, however, approach these innovations with caution, due in part to past experiences of rescuing patients with failed devices. “Some innovations get disseminated without adequate studies to demonstrate whether they are superior, or even equal in efficacy and safety to, well-established procedures for the same condition.  Even when they have been conducted, negative studies showing no difference may end up being rejected by journals and not published,” noted Karen Deveney, MD, FACS, professor of surgery, vice-chair for education in the department of surgery at Oregon Health & Science University, Portland, and co-Editor of ACS Surgery News.

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Courtesy Apollo EndosurgeryOverstich endoscopic bariatric device

Dr. Edmundowicz reviewed the latest developments presented at DDW.Self-assembling magnets for dual-path enteral anastomoses 

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Courtesy Aspire Bariatrics Inc.AspireAssist device

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon Therapeutics is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

 

 

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.  
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

Caveat emptor, all over again

Although many of these innovations will eventually achieve acceptable clinical results in trials and be adopted by both gastroenterologists and surgeons, a note of caution is in order, argues Tyler G. Hughes, MD, FACS, is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, coeditor of ACS Surgery News.

“The recent uptick in ‘non-surgical’ obesity treatment reverberates as history gets ready to repeat itself.  If surgeons don’t take the lead, two things are likely to happen.  First, ‘interventionists,’ ignorant of the lessons of yesterday will introduce foreign bodies into the soft GI tract only to see these ‘safe’ devices create surgical havoc or malabsorptive disasters. Second, instead of doing a complete spectrum of obesity procedures, surgeons will be left with the worst cases and fixing complications while the ‘interventionist’ (and I do not limit that to gastroenterologists) do the easy cases at prices three times the cost of the old way. Will this really benefit the patients?

Rather than permitting a race to the newest unproven device to satisfy public clamor, while conveniently making a tidy profit for anyone able to claim the title ‘interventionist,’ bariatric surgeons need to grab the endoscope with both hands and do the research and reporting for these new procedures. It starts with the need for every surgical resident to be proficient with the GI endoscopes and ends with surgeons seeing surgery in a wider view than through an incision,” Dr. Hughes said.

[email protected]

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Commentary: New treatments for new patients – A call to action for bariatric surgeons

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Commentary: New treatments for new patients – A call to action for bariatric surgeons

How many common bile duct operations have you done lately? How about laparotomies for bleeding duodenal ulcers? How about central venous access catheters? How many procedures that you as a general surgeon may have done a few decades ago are now done primarily by endoscopists, radiologists, or others using minimal access for their procedures?

Now hold that thought, as we turn to the field of bariatric surgery.

Dr. Bruce Schirmer

Twenty years ago, in 1996, there were approximately 12,000 bariatric operations performed in the United States. From 1998 to 2004, that number increased to almost 136,000 per year (J Am Coll Surg. 2011;213:261-6). What was the reason? While other factors likely had some influence, the overwhelming factor was that laparoscopic bariatric surgery became available. Patients perceived this approach as less invasive. Primary care referring physicians did as well.

The rapid rise in laparoscopy boosted the popularity of bariatric surgery but since that bump, the bariatric surgery numbers have remained flat. Currently, less than 2% of eligible patients who are morbidly obese opt for surgical treatment each year – despite the fact that the safety of bariatric surgery has dramatically improved over the past 15 years. Currently the mortality rate for laparoscopic gastric bypass is at 0.15% (Ann Surg. 2014;259:123-30) and sleeve gastrectomy mortality is lower than that. Only appendectomy has a lower mortality rate among major abdominal operations. Despite the safety record, and despite over a decade of publications demonstrating the effectiveness of bariatric surgery in prolonging life, improving or eliminating comorbid medical problems of obesity, improving the quality of life of patients, and decreasing the cost of their medical care, there still has been no major new shift toward surgery by patients who would benefit from it.

What we are offering is not what these patients want. We as bariatric and metabolic surgeons must face the reality of that fact.

While endoscopic bariatric procedures are not new, their use to date has been limited to modifying existing operations, such as narrowing the anastomosis after gastric bypass for patients who are regaining weight. Such procedures have enjoyed at best mild to moderate short-term success, but poor long-term success.

The performance of a successful endoscopic sleeve gastrectomy, however, is a different issue. The sleeve gastrectomy has rapidly become the most popular bariatric operation. Its successful performance endoscopically (Endoscopy. 2015;47:164-6) should serve notice to bariatric surgeons that the time has come to learn to do endoscopic bariatric surgery. If effective, it almost certainly will be what patients seek in the future.

Societal stigmas, patient expectations, and our culture all drive the perception that obesity is a problem that individuals should be able to solve on their own. It is this firmly entrenched belief that is the foundation of the multi-billion dollar diet products industry. Yet the concept of having surgery to treat severe obesity is one that most severely obese patients do not easily embrace. A first-hand successful experience of a friend or relative is often needed for these individuals to consider a surgical procedure. While most patients with ultrasound-proven gallstones who are symptomatic will be referred to a surgeon by their primary care physician, how often is this true for the patient with a body mass index over 35?

The appeal of endoscopic procedures for patients and referring physicians is, of course, that these procedures are perceived as not really surgery. They are minimally invasive endoscopic procedures. The risk profile is very low. Why not consider it? patients may ask themselves. After all, you are not really having surgery.

Many of my bariatric colleagues will likely disagree with this recommendation to embrace endoscopic procedures. After all, the track record to date of many of these procedures and devices has not been impressive. All devices to date that have involved endoscopic treatment of obesity have either failed and been removed from the market, or are in their infancy still looking to establish efficacy (Clin Gastroenterol Hepatol. 2016;14:507-15). I have been vocally critical at symposia and national meetings of the concept of using an endoscopic suturing device to narrow the anastomosis of patients with a gastric bypass who are regaining weight. I have argued that the procedure is doomed to long-term minimal success or more likely flat-out failure. However, such a conservative approach that demands proof of long-term efficacy could predictably place us conservative curmudgeons on the sidelines of treating obesity when successful endoscopic procedures are available and become the sought-after option, just as laparoscopy became the sought-after option 17 years ago. How many surgeons offered primarily open bariatric operations after about 2005?

 

 

If we are to reach more than 1%-2% of the eligible patients who would benefit from treatment for morbid obesity and its related medical problems, then we need to take a different approach. We have about maximized how well we can do the surgical approach we now offer. It isn’t gaining in popularity among those who need it most. While we should not abandon the procedures that have been proven so effective, we should embrace new options for our patients.

It is certainly possible that the stigma of having surgery will resolve if a patient has an endoscopic procedure that is successful but only transiently. A more definitive operative procedure then may follow. Is that not ultimately better for that patient than having him or her never pursue a treatment for obesity? While this argument seems appropriate for the long-term overall patient good, the short-term increase in cost may make it a difficult sell to payers. But insurance companies are already doing their very best not to pay for highly medically effective and proven cost-effective bariatric surgery now. Only public pressure will force them to change – perhaps the public pressure of demand for endoscopic procedures.

Bariatric surgeons: It’s time to become bariatric endoscopists. If we want new patients, we need to adopt new treatments.

Dr. Schirmer is the Stephen H. Watts Professor of Surgery at the University of Virginia Health Sciences Center, Charlottesville.

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How many common bile duct operations have you done lately? How about laparotomies for bleeding duodenal ulcers? How about central venous access catheters? How many procedures that you as a general surgeon may have done a few decades ago are now done primarily by endoscopists, radiologists, or others using minimal access for their procedures?

Now hold that thought, as we turn to the field of bariatric surgery.

Dr. Bruce Schirmer

Twenty years ago, in 1996, there were approximately 12,000 bariatric operations performed in the United States. From 1998 to 2004, that number increased to almost 136,000 per year (J Am Coll Surg. 2011;213:261-6). What was the reason? While other factors likely had some influence, the overwhelming factor was that laparoscopic bariatric surgery became available. Patients perceived this approach as less invasive. Primary care referring physicians did as well.

The rapid rise in laparoscopy boosted the popularity of bariatric surgery but since that bump, the bariatric surgery numbers have remained flat. Currently, less than 2% of eligible patients who are morbidly obese opt for surgical treatment each year – despite the fact that the safety of bariatric surgery has dramatically improved over the past 15 years. Currently the mortality rate for laparoscopic gastric bypass is at 0.15% (Ann Surg. 2014;259:123-30) and sleeve gastrectomy mortality is lower than that. Only appendectomy has a lower mortality rate among major abdominal operations. Despite the safety record, and despite over a decade of publications demonstrating the effectiveness of bariatric surgery in prolonging life, improving or eliminating comorbid medical problems of obesity, improving the quality of life of patients, and decreasing the cost of their medical care, there still has been no major new shift toward surgery by patients who would benefit from it.

What we are offering is not what these patients want. We as bariatric and metabolic surgeons must face the reality of that fact.

While endoscopic bariatric procedures are not new, their use to date has been limited to modifying existing operations, such as narrowing the anastomosis after gastric bypass for patients who are regaining weight. Such procedures have enjoyed at best mild to moderate short-term success, but poor long-term success.

The performance of a successful endoscopic sleeve gastrectomy, however, is a different issue. The sleeve gastrectomy has rapidly become the most popular bariatric operation. Its successful performance endoscopically (Endoscopy. 2015;47:164-6) should serve notice to bariatric surgeons that the time has come to learn to do endoscopic bariatric surgery. If effective, it almost certainly will be what patients seek in the future.

Societal stigmas, patient expectations, and our culture all drive the perception that obesity is a problem that individuals should be able to solve on their own. It is this firmly entrenched belief that is the foundation of the multi-billion dollar diet products industry. Yet the concept of having surgery to treat severe obesity is one that most severely obese patients do not easily embrace. A first-hand successful experience of a friend or relative is often needed for these individuals to consider a surgical procedure. While most patients with ultrasound-proven gallstones who are symptomatic will be referred to a surgeon by their primary care physician, how often is this true for the patient with a body mass index over 35?

The appeal of endoscopic procedures for patients and referring physicians is, of course, that these procedures are perceived as not really surgery. They are minimally invasive endoscopic procedures. The risk profile is very low. Why not consider it? patients may ask themselves. After all, you are not really having surgery.

Many of my bariatric colleagues will likely disagree with this recommendation to embrace endoscopic procedures. After all, the track record to date of many of these procedures and devices has not been impressive. All devices to date that have involved endoscopic treatment of obesity have either failed and been removed from the market, or are in their infancy still looking to establish efficacy (Clin Gastroenterol Hepatol. 2016;14:507-15). I have been vocally critical at symposia and national meetings of the concept of using an endoscopic suturing device to narrow the anastomosis of patients with a gastric bypass who are regaining weight. I have argued that the procedure is doomed to long-term minimal success or more likely flat-out failure. However, such a conservative approach that demands proof of long-term efficacy could predictably place us conservative curmudgeons on the sidelines of treating obesity when successful endoscopic procedures are available and become the sought-after option, just as laparoscopy became the sought-after option 17 years ago. How many surgeons offered primarily open bariatric operations after about 2005?

 

 

If we are to reach more than 1%-2% of the eligible patients who would benefit from treatment for morbid obesity and its related medical problems, then we need to take a different approach. We have about maximized how well we can do the surgical approach we now offer. It isn’t gaining in popularity among those who need it most. While we should not abandon the procedures that have been proven so effective, we should embrace new options for our patients.

It is certainly possible that the stigma of having surgery will resolve if a patient has an endoscopic procedure that is successful but only transiently. A more definitive operative procedure then may follow. Is that not ultimately better for that patient than having him or her never pursue a treatment for obesity? While this argument seems appropriate for the long-term overall patient good, the short-term increase in cost may make it a difficult sell to payers. But insurance companies are already doing their very best not to pay for highly medically effective and proven cost-effective bariatric surgery now. Only public pressure will force them to change – perhaps the public pressure of demand for endoscopic procedures.

Bariatric surgeons: It’s time to become bariatric endoscopists. If we want new patients, we need to adopt new treatments.

Dr. Schirmer is the Stephen H. Watts Professor of Surgery at the University of Virginia Health Sciences Center, Charlottesville.

How many common bile duct operations have you done lately? How about laparotomies for bleeding duodenal ulcers? How about central venous access catheters? How many procedures that you as a general surgeon may have done a few decades ago are now done primarily by endoscopists, radiologists, or others using minimal access for their procedures?

Now hold that thought, as we turn to the field of bariatric surgery.

Dr. Bruce Schirmer

Twenty years ago, in 1996, there were approximately 12,000 bariatric operations performed in the United States. From 1998 to 2004, that number increased to almost 136,000 per year (J Am Coll Surg. 2011;213:261-6). What was the reason? While other factors likely had some influence, the overwhelming factor was that laparoscopic bariatric surgery became available. Patients perceived this approach as less invasive. Primary care referring physicians did as well.

The rapid rise in laparoscopy boosted the popularity of bariatric surgery but since that bump, the bariatric surgery numbers have remained flat. Currently, less than 2% of eligible patients who are morbidly obese opt for surgical treatment each year – despite the fact that the safety of bariatric surgery has dramatically improved over the past 15 years. Currently the mortality rate for laparoscopic gastric bypass is at 0.15% (Ann Surg. 2014;259:123-30) and sleeve gastrectomy mortality is lower than that. Only appendectomy has a lower mortality rate among major abdominal operations. Despite the safety record, and despite over a decade of publications demonstrating the effectiveness of bariatric surgery in prolonging life, improving or eliminating comorbid medical problems of obesity, improving the quality of life of patients, and decreasing the cost of their medical care, there still has been no major new shift toward surgery by patients who would benefit from it.

What we are offering is not what these patients want. We as bariatric and metabolic surgeons must face the reality of that fact.

While endoscopic bariatric procedures are not new, their use to date has been limited to modifying existing operations, such as narrowing the anastomosis after gastric bypass for patients who are regaining weight. Such procedures have enjoyed at best mild to moderate short-term success, but poor long-term success.

The performance of a successful endoscopic sleeve gastrectomy, however, is a different issue. The sleeve gastrectomy has rapidly become the most popular bariatric operation. Its successful performance endoscopically (Endoscopy. 2015;47:164-6) should serve notice to bariatric surgeons that the time has come to learn to do endoscopic bariatric surgery. If effective, it almost certainly will be what patients seek in the future.

Societal stigmas, patient expectations, and our culture all drive the perception that obesity is a problem that individuals should be able to solve on their own. It is this firmly entrenched belief that is the foundation of the multi-billion dollar diet products industry. Yet the concept of having surgery to treat severe obesity is one that most severely obese patients do not easily embrace. A first-hand successful experience of a friend or relative is often needed for these individuals to consider a surgical procedure. While most patients with ultrasound-proven gallstones who are symptomatic will be referred to a surgeon by their primary care physician, how often is this true for the patient with a body mass index over 35?

The appeal of endoscopic procedures for patients and referring physicians is, of course, that these procedures are perceived as not really surgery. They are minimally invasive endoscopic procedures. The risk profile is very low. Why not consider it? patients may ask themselves. After all, you are not really having surgery.

Many of my bariatric colleagues will likely disagree with this recommendation to embrace endoscopic procedures. After all, the track record to date of many of these procedures and devices has not been impressive. All devices to date that have involved endoscopic treatment of obesity have either failed and been removed from the market, or are in their infancy still looking to establish efficacy (Clin Gastroenterol Hepatol. 2016;14:507-15). I have been vocally critical at symposia and national meetings of the concept of using an endoscopic suturing device to narrow the anastomosis of patients with a gastric bypass who are regaining weight. I have argued that the procedure is doomed to long-term minimal success or more likely flat-out failure. However, such a conservative approach that demands proof of long-term efficacy could predictably place us conservative curmudgeons on the sidelines of treating obesity when successful endoscopic procedures are available and become the sought-after option, just as laparoscopy became the sought-after option 17 years ago. How many surgeons offered primarily open bariatric operations after about 2005?

 

 

If we are to reach more than 1%-2% of the eligible patients who would benefit from treatment for morbid obesity and its related medical problems, then we need to take a different approach. We have about maximized how well we can do the surgical approach we now offer. It isn’t gaining in popularity among those who need it most. While we should not abandon the procedures that have been proven so effective, we should embrace new options for our patients.

It is certainly possible that the stigma of having surgery will resolve if a patient has an endoscopic procedure that is successful but only transiently. A more definitive operative procedure then may follow. Is that not ultimately better for that patient than having him or her never pursue a treatment for obesity? While this argument seems appropriate for the long-term overall patient good, the short-term increase in cost may make it a difficult sell to payers. But insurance companies are already doing their very best not to pay for highly medically effective and proven cost-effective bariatric surgery now. Only public pressure will force them to change – perhaps the public pressure of demand for endoscopic procedures.

Bariatric surgeons: It’s time to become bariatric endoscopists. If we want new patients, we need to adopt new treatments.

Dr. Schirmer is the Stephen H. Watts Professor of Surgery at the University of Virginia Health Sciences Center, Charlottesville.

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The future of surgery

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Predicting the future has been a favorite topic of surgeons through the ages for addresses to august surgical societies.

Confident predictions of the future of surgery, however, have not always stood the test of time. Speaking at the University of Manchester’s Centenary celebration in 1973 at an international symposium on “Medicine in the 21st Century,” the noted surgeon J. Englebert Dunphy correctly predicted the prominence of joint-replacement procedures, but incorrectly asserted that medical advances would virtually eliminate the need for cholecystectomy through dissolution of gallstones and the need for surgical approaches to atherosclerosis through plaque prevention and dissolution. He accurately predicted that infections and sepsis would remain serious problems. But he missed the mark when he predicted that surgical pain would be eliminated by a pill that would block somatic nerve impulses without any respiratory or circulatory effects (Surgery. 1974 Mar;75:332-7). Technologic advances such as laparoscopic cholecystectomy, which emerged less than 20 years into the future, were not on his radar screen.

Change and disruptive technology

To be sure, the surgical procedures and methods have changed markedly since the time I trained in surgery in the 1970s. The most obvious change is the shift from large incisions to small ones, with the commensurate quick recovery and short hospital stays. This change is primarily because of the emergence of disruptive technology, a concept that has pervaded every avenue of our current lives, not just surgery: Think Uber, robotics in industry, the Internet, smartphones, and the miniaturization of just about every communication means. In medicine, these disruptive technologies have led to the emergence of the electronic health record, new imaging modalities, percutaneous interventional techniques, fiber optic endoscopy, laparoscopy, and endovascular surgery.

Maintaining capacity to do infrequent operations

During my training, H2 receptor antagonists and Helicobacter pylori came on the scene, with the result that ulcer operations almost disappeared from our surgical armamentarium; one of my most frequent operations as a senior and chief resident has become a rarity 40 years later for our trainees. And yet, a general surgeon must know how to perform an ulcer operation and which type is the best for a given circumstance, since perforated and bleeding ulcers are still seen, if infrequently. The perforated ulcer is seen most often in patients with multiple comorbidities who can least tolerate a complication and need one effective and well-executed operation if they are going to survive. How do we continue to teach residents these procedures when they have become infrequent?

There is perhaps some utility in keeping some aging surgeons around to teach residents on fresh cadavers, or to call them out of their assisted living facilities when needed for consultation! Now that the majority of operations in most places are being performed by minimally invasive surgical (MIS) methods, we may not need MIS fellowships or training much longer for trainees to become proficient in these skills, because it is the open operations that are less frequent. Our chief residents are much less secure about performing an open cholecystectomy, of which they have performed perhaps 5, than they are about performing laparoscopic cholecystectomy, of which they have performed 105.

Technologies on the verge of disrupting

Mark Aeder, MD, FACS, recently asked an important question in the ACS Communities thread on the future of surgery: What will the future disruptive innovations be? Which areas of surgery will bloom next?

There are many game-changing emerging technologies that could well turn out to be future “disruptors” of surgery as we know it. Cancer surgery is on track to be transformed by the development of genomics and personalized medicine and immunotherapy for melanoma and lung cancer.

The areas most likely to remain in the surgical realm are trauma, infections, and inflammation. Though safer cars, seatbelt laws, and helmet laws for motorcyclists have already decreased motor vehicle accidents and injury severity, we have still not produced a cure for stupidity or bad luck. Traumatic injuries will always be with us, and surgeons well trained in trauma management will continue to be needed. Appendicitis, cholecystitis, and diverticulitis will continue to require operations, even though inroads have begun with the studies showing success of antibiotic treatment for appendicitis and diverticulitis.

Keep current, avoid bandwagons

The key lesson, not only for our young surgeons-in-training but also for our seasoned surgeons, is to keep learning, keep networking, and keep adopting new techniques as soon as they show true evidence of success.

The best way for surgeons to remain prepared for whatever the future will bring is to stay current with innovations coming on the scene but not jump on the bandwagon too early and adopt new fads without substantial evidence of their soundness. A few retrospective case series reporting success with a new operation is insufficient evidence to try it out on the unsuspecting public. Although the completion of well-designed randomized trials with adequate follow-up takes time, it is better to stick with well-established and evidence-based techniques than rush to embrace an inadequately vetted procedure that may end up harming a patient.

 

 

Not all innovative devices or procedures rise to the level of being so truly “experimental” that they would require an institutional review board, and this ought to prompt an extra measure of caution by surgeons. Some “innovations,” such as the endobariatric devices reported elsewhere in this issue, represent novel variations of previous procedures but are as yet unvalidated by long-term studies. Responsible adoption of these novel procedures requires a full disclosure to the patient that the procedure or device is novel, without long-term evidence of success, and may entail unknown risks. Don’t let your enthusiasm to be an early adopter overcome your scientific and historic obligation to prevent harm to the patient.

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the co-Editor of ACS Surgery News.

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Predicting the future has been a favorite topic of surgeons through the ages for addresses to august surgical societies.

Confident predictions of the future of surgery, however, have not always stood the test of time. Speaking at the University of Manchester’s Centenary celebration in 1973 at an international symposium on “Medicine in the 21st Century,” the noted surgeon J. Englebert Dunphy correctly predicted the prominence of joint-replacement procedures, but incorrectly asserted that medical advances would virtually eliminate the need for cholecystectomy through dissolution of gallstones and the need for surgical approaches to atherosclerosis through plaque prevention and dissolution. He accurately predicted that infections and sepsis would remain serious problems. But he missed the mark when he predicted that surgical pain would be eliminated by a pill that would block somatic nerve impulses without any respiratory or circulatory effects (Surgery. 1974 Mar;75:332-7). Technologic advances such as laparoscopic cholecystectomy, which emerged less than 20 years into the future, were not on his radar screen.

Change and disruptive technology

To be sure, the surgical procedures and methods have changed markedly since the time I trained in surgery in the 1970s. The most obvious change is the shift from large incisions to small ones, with the commensurate quick recovery and short hospital stays. This change is primarily because of the emergence of disruptive technology, a concept that has pervaded every avenue of our current lives, not just surgery: Think Uber, robotics in industry, the Internet, smartphones, and the miniaturization of just about every communication means. In medicine, these disruptive technologies have led to the emergence of the electronic health record, new imaging modalities, percutaneous interventional techniques, fiber optic endoscopy, laparoscopy, and endovascular surgery.

Maintaining capacity to do infrequent operations

During my training, H2 receptor antagonists and Helicobacter pylori came on the scene, with the result that ulcer operations almost disappeared from our surgical armamentarium; one of my most frequent operations as a senior and chief resident has become a rarity 40 years later for our trainees. And yet, a general surgeon must know how to perform an ulcer operation and which type is the best for a given circumstance, since perforated and bleeding ulcers are still seen, if infrequently. The perforated ulcer is seen most often in patients with multiple comorbidities who can least tolerate a complication and need one effective and well-executed operation if they are going to survive. How do we continue to teach residents these procedures when they have become infrequent?

There is perhaps some utility in keeping some aging surgeons around to teach residents on fresh cadavers, or to call them out of their assisted living facilities when needed for consultation! Now that the majority of operations in most places are being performed by minimally invasive surgical (MIS) methods, we may not need MIS fellowships or training much longer for trainees to become proficient in these skills, because it is the open operations that are less frequent. Our chief residents are much less secure about performing an open cholecystectomy, of which they have performed perhaps 5, than they are about performing laparoscopic cholecystectomy, of which they have performed 105.

Technologies on the verge of disrupting

Mark Aeder, MD, FACS, recently asked an important question in the ACS Communities thread on the future of surgery: What will the future disruptive innovations be? Which areas of surgery will bloom next?

There are many game-changing emerging technologies that could well turn out to be future “disruptors” of surgery as we know it. Cancer surgery is on track to be transformed by the development of genomics and personalized medicine and immunotherapy for melanoma and lung cancer.

The areas most likely to remain in the surgical realm are trauma, infections, and inflammation. Though safer cars, seatbelt laws, and helmet laws for motorcyclists have already decreased motor vehicle accidents and injury severity, we have still not produced a cure for stupidity or bad luck. Traumatic injuries will always be with us, and surgeons well trained in trauma management will continue to be needed. Appendicitis, cholecystitis, and diverticulitis will continue to require operations, even though inroads have begun with the studies showing success of antibiotic treatment for appendicitis and diverticulitis.

Keep current, avoid bandwagons

The key lesson, not only for our young surgeons-in-training but also for our seasoned surgeons, is to keep learning, keep networking, and keep adopting new techniques as soon as they show true evidence of success.

The best way for surgeons to remain prepared for whatever the future will bring is to stay current with innovations coming on the scene but not jump on the bandwagon too early and adopt new fads without substantial evidence of their soundness. A few retrospective case series reporting success with a new operation is insufficient evidence to try it out on the unsuspecting public. Although the completion of well-designed randomized trials with adequate follow-up takes time, it is better to stick with well-established and evidence-based techniques than rush to embrace an inadequately vetted procedure that may end up harming a patient.

 

 

Not all innovative devices or procedures rise to the level of being so truly “experimental” that they would require an institutional review board, and this ought to prompt an extra measure of caution by surgeons. Some “innovations,” such as the endobariatric devices reported elsewhere in this issue, represent novel variations of previous procedures but are as yet unvalidated by long-term studies. Responsible adoption of these novel procedures requires a full disclosure to the patient that the procedure or device is novel, without long-term evidence of success, and may entail unknown risks. Don’t let your enthusiasm to be an early adopter overcome your scientific and historic obligation to prevent harm to the patient.

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the co-Editor of ACS Surgery News.

Predicting the future has been a favorite topic of surgeons through the ages for addresses to august surgical societies.

Confident predictions of the future of surgery, however, have not always stood the test of time. Speaking at the University of Manchester’s Centenary celebration in 1973 at an international symposium on “Medicine in the 21st Century,” the noted surgeon J. Englebert Dunphy correctly predicted the prominence of joint-replacement procedures, but incorrectly asserted that medical advances would virtually eliminate the need for cholecystectomy through dissolution of gallstones and the need for surgical approaches to atherosclerosis through plaque prevention and dissolution. He accurately predicted that infections and sepsis would remain serious problems. But he missed the mark when he predicted that surgical pain would be eliminated by a pill that would block somatic nerve impulses without any respiratory or circulatory effects (Surgery. 1974 Mar;75:332-7). Technologic advances such as laparoscopic cholecystectomy, which emerged less than 20 years into the future, were not on his radar screen.

Change and disruptive technology

To be sure, the surgical procedures and methods have changed markedly since the time I trained in surgery in the 1970s. The most obvious change is the shift from large incisions to small ones, with the commensurate quick recovery and short hospital stays. This change is primarily because of the emergence of disruptive technology, a concept that has pervaded every avenue of our current lives, not just surgery: Think Uber, robotics in industry, the Internet, smartphones, and the miniaturization of just about every communication means. In medicine, these disruptive technologies have led to the emergence of the electronic health record, new imaging modalities, percutaneous interventional techniques, fiber optic endoscopy, laparoscopy, and endovascular surgery.

Maintaining capacity to do infrequent operations

During my training, H2 receptor antagonists and Helicobacter pylori came on the scene, with the result that ulcer operations almost disappeared from our surgical armamentarium; one of my most frequent operations as a senior and chief resident has become a rarity 40 years later for our trainees. And yet, a general surgeon must know how to perform an ulcer operation and which type is the best for a given circumstance, since perforated and bleeding ulcers are still seen, if infrequently. The perforated ulcer is seen most often in patients with multiple comorbidities who can least tolerate a complication and need one effective and well-executed operation if they are going to survive. How do we continue to teach residents these procedures when they have become infrequent?

There is perhaps some utility in keeping some aging surgeons around to teach residents on fresh cadavers, or to call them out of their assisted living facilities when needed for consultation! Now that the majority of operations in most places are being performed by minimally invasive surgical (MIS) methods, we may not need MIS fellowships or training much longer for trainees to become proficient in these skills, because it is the open operations that are less frequent. Our chief residents are much less secure about performing an open cholecystectomy, of which they have performed perhaps 5, than they are about performing laparoscopic cholecystectomy, of which they have performed 105.

Technologies on the verge of disrupting

Mark Aeder, MD, FACS, recently asked an important question in the ACS Communities thread on the future of surgery: What will the future disruptive innovations be? Which areas of surgery will bloom next?

There are many game-changing emerging technologies that could well turn out to be future “disruptors” of surgery as we know it. Cancer surgery is on track to be transformed by the development of genomics and personalized medicine and immunotherapy for melanoma and lung cancer.

The areas most likely to remain in the surgical realm are trauma, infections, and inflammation. Though safer cars, seatbelt laws, and helmet laws for motorcyclists have already decreased motor vehicle accidents and injury severity, we have still not produced a cure for stupidity or bad luck. Traumatic injuries will always be with us, and surgeons well trained in trauma management will continue to be needed. Appendicitis, cholecystitis, and diverticulitis will continue to require operations, even though inroads have begun with the studies showing success of antibiotic treatment for appendicitis and diverticulitis.

Keep current, avoid bandwagons

The key lesson, not only for our young surgeons-in-training but also for our seasoned surgeons, is to keep learning, keep networking, and keep adopting new techniques as soon as they show true evidence of success.

The best way for surgeons to remain prepared for whatever the future will bring is to stay current with innovations coming on the scene but not jump on the bandwagon too early and adopt new fads without substantial evidence of their soundness. A few retrospective case series reporting success with a new operation is insufficient evidence to try it out on the unsuspecting public. Although the completion of well-designed randomized trials with adequate follow-up takes time, it is better to stick with well-established and evidence-based techniques than rush to embrace an inadequately vetted procedure that may end up harming a patient.

 

 

Not all innovative devices or procedures rise to the level of being so truly “experimental” that they would require an institutional review board, and this ought to prompt an extra measure of caution by surgeons. Some “innovations,” such as the endobariatric devices reported elsewhere in this issue, represent novel variations of previous procedures but are as yet unvalidated by long-term studies. Responsible adoption of these novel procedures requires a full disclosure to the patient that the procedure or device is novel, without long-term evidence of success, and may entail unknown risks. Don’t let your enthusiasm to be an early adopter overcome your scientific and historic obligation to prevent harm to the patient.

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the co-Editor of ACS Surgery News.

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Coming your way ... MIPS

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In this column, I will return to the topic of the Quality Payment Program (QPP), Centers for Medicare & Medicaid Services’ new payment program, currently scheduled to go into effect January 2017. The QPP has two tracks, the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs). Again, it is widely expected that for the first several years of the program, the vast majority of surgeons will participate in the QPP via the MIPS track.

 

Dr. Patrick V. Bailey

To briefly review from the July edition of this column, MIPS consists of four components:

1) Quality.

2) Resource Use.

3) Advancing Care Information (ACI).

4) Clinical Practice Improvement Activities (CPIA).

The Quality component replaces the Physician Quality Reporting System (PQRS), the Resource Use component replaces the Value-Based Modifier (VBM), the Advancing Care Information (ACI) component replaces the Electronic Health Record Meaningful Use (EHR-MU) program and is proposed to simplify the program by modifying requirements. The fourth component of MIPS, the Clinical Practice Improvement Activities (CPIA), is new.

MIPS participants will be assigned a Composite Performance Score based on their performance in all four components. As proposed for 2017, 50% of the MIPS Composite Performance Score will be based on performance in the Quality component, 25% will be based on the ACI component, 15% will be based on the CPIA, and 10% will be based on Resource Use. Thus, 75% of one’s score will be determined by performance in the Quality and ACI components. With that in mind, the remainder of this month’s column will be dedicated to the ACI with next month’s column focusing on the Quality component.

The Advancing Care Component (ACI)

As discussed above, the ACI component modifies and replaces the Electronic Health Record Meaningful Use (EHR-MU) program. As currently proposed, (and subject to change with release of the final rule in early November 2016), the score for ACI will be derived in two parts: a base score (50 points) and a performance score.

 

The threshold for achieving the base score remains an “all or nothing” proposition. Achieving the threshold is based upon reporting a yes/no statement OR the appropriate numerator and denominator for each measure, as required, for the following six objectives:

1) Protect Patient Health Information.

2) Electronic Prescribing.

3) Patient Electronic Access to Health Information.

4) Coordination of Care through Patient Engagement.

5) Health Information Exchange.

6) Public Health and Clinical Data Reporting.

Only after meeting the requirements for the base score is one eligible to receive additional performance score credit based on the level of performance on a subset of three of the objectives required to achieve the base score. Those three are:

1) Patient Electronic Access to Health Information.

2) Coordination of Care through Patient Engagement.

3) Health Information Exchange

There are a total of eight measures for these three objectives.

The two measures specific to the Patient Electronic Access objective are:

a) Patient Access Measure.

b) Patient-Specific Education Measure.

Coordination of Care through Patient Engagement is assessed based upon the following three measures:

a) View, Download, Transmit Measure.

b) Secure Messaging Measure.

c) Patient-Generated Health Data Measures.

For the Health Information Exchange objective, assessment is also based on three measures. They are:

a) Patient Record Exchange Measure.

b) Request/Accept Patient Care Record Measure.

c) Clinical Information Reconciliation Measure.

Scoring for each of these eight measures is based upon reporting both a numerator and denominator, thus facilitating the calculation of percentage score to which a point value is assigned. For example, a performance rate of 85 on one of the listed measures would earn 8.5 points toward the performance score. The sum of the points accumulated for these eight measures is added to Threshold Score to determine the final score for ACI. Again, 25% of one’s MIPS Composite Score is derived from performance in the ACI component.

It warrants repeating and re-emphasis that the above information is subject to modification pending the release of the MIPS Final Rule, expected in early November.

As mentioned above, the Quality component of MIPS replaces the PQRS. Quality assessment will comprise 50% of the MIPS Composite Score. In next month’s column, I will provide an outline of the changes CMS is proposing for the Quality assessment. As a preview, some good news can be found in the fact that the current MIPS Quality component proposal will require providers to report on a total of six measures as opposed to the previous PQRS requirement to report on nine.

Until next month …

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In this column, I will return to the topic of the Quality Payment Program (QPP), Centers for Medicare & Medicaid Services’ new payment program, currently scheduled to go into effect January 2017. The QPP has two tracks, the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs). Again, it is widely expected that for the first several years of the program, the vast majority of surgeons will participate in the QPP via the MIPS track.

 

Dr. Patrick V. Bailey

To briefly review from the July edition of this column, MIPS consists of four components:

1) Quality.

2) Resource Use.

3) Advancing Care Information (ACI).

4) Clinical Practice Improvement Activities (CPIA).

The Quality component replaces the Physician Quality Reporting System (PQRS), the Resource Use component replaces the Value-Based Modifier (VBM), the Advancing Care Information (ACI) component replaces the Electronic Health Record Meaningful Use (EHR-MU) program and is proposed to simplify the program by modifying requirements. The fourth component of MIPS, the Clinical Practice Improvement Activities (CPIA), is new.

MIPS participants will be assigned a Composite Performance Score based on their performance in all four components. As proposed for 2017, 50% of the MIPS Composite Performance Score will be based on performance in the Quality component, 25% will be based on the ACI component, 15% will be based on the CPIA, and 10% will be based on Resource Use. Thus, 75% of one’s score will be determined by performance in the Quality and ACI components. With that in mind, the remainder of this month’s column will be dedicated to the ACI with next month’s column focusing on the Quality component.

The Advancing Care Component (ACI)

As discussed above, the ACI component modifies and replaces the Electronic Health Record Meaningful Use (EHR-MU) program. As currently proposed, (and subject to change with release of the final rule in early November 2016), the score for ACI will be derived in two parts: a base score (50 points) and a performance score.

 

The threshold for achieving the base score remains an “all or nothing” proposition. Achieving the threshold is based upon reporting a yes/no statement OR the appropriate numerator and denominator for each measure, as required, for the following six objectives:

1) Protect Patient Health Information.

2) Electronic Prescribing.

3) Patient Electronic Access to Health Information.

4) Coordination of Care through Patient Engagement.

5) Health Information Exchange.

6) Public Health and Clinical Data Reporting.

Only after meeting the requirements for the base score is one eligible to receive additional performance score credit based on the level of performance on a subset of three of the objectives required to achieve the base score. Those three are:

1) Patient Electronic Access to Health Information.

2) Coordination of Care through Patient Engagement.

3) Health Information Exchange

There are a total of eight measures for these three objectives.

The two measures specific to the Patient Electronic Access objective are:

a) Patient Access Measure.

b) Patient-Specific Education Measure.

Coordination of Care through Patient Engagement is assessed based upon the following three measures:

a) View, Download, Transmit Measure.

b) Secure Messaging Measure.

c) Patient-Generated Health Data Measures.

For the Health Information Exchange objective, assessment is also based on three measures. They are:

a) Patient Record Exchange Measure.

b) Request/Accept Patient Care Record Measure.

c) Clinical Information Reconciliation Measure.

Scoring for each of these eight measures is based upon reporting both a numerator and denominator, thus facilitating the calculation of percentage score to which a point value is assigned. For example, a performance rate of 85 on one of the listed measures would earn 8.5 points toward the performance score. The sum of the points accumulated for these eight measures is added to Threshold Score to determine the final score for ACI. Again, 25% of one’s MIPS Composite Score is derived from performance in the ACI component.

It warrants repeating and re-emphasis that the above information is subject to modification pending the release of the MIPS Final Rule, expected in early November.

As mentioned above, the Quality component of MIPS replaces the PQRS. Quality assessment will comprise 50% of the MIPS Composite Score. In next month’s column, I will provide an outline of the changes CMS is proposing for the Quality assessment. As a preview, some good news can be found in the fact that the current MIPS Quality component proposal will require providers to report on a total of six measures as opposed to the previous PQRS requirement to report on nine.

Until next month …

In this column, I will return to the topic of the Quality Payment Program (QPP), Centers for Medicare & Medicaid Services’ new payment program, currently scheduled to go into effect January 2017. The QPP has two tracks, the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs). Again, it is widely expected that for the first several years of the program, the vast majority of surgeons will participate in the QPP via the MIPS track.

 

Dr. Patrick V. Bailey

To briefly review from the July edition of this column, MIPS consists of four components:

1) Quality.

2) Resource Use.

3) Advancing Care Information (ACI).

4) Clinical Practice Improvement Activities (CPIA).

The Quality component replaces the Physician Quality Reporting System (PQRS), the Resource Use component replaces the Value-Based Modifier (VBM), the Advancing Care Information (ACI) component replaces the Electronic Health Record Meaningful Use (EHR-MU) program and is proposed to simplify the program by modifying requirements. The fourth component of MIPS, the Clinical Practice Improvement Activities (CPIA), is new.

MIPS participants will be assigned a Composite Performance Score based on their performance in all four components. As proposed for 2017, 50% of the MIPS Composite Performance Score will be based on performance in the Quality component, 25% will be based on the ACI component, 15% will be based on the CPIA, and 10% will be based on Resource Use. Thus, 75% of one’s score will be determined by performance in the Quality and ACI components. With that in mind, the remainder of this month’s column will be dedicated to the ACI with next month’s column focusing on the Quality component.

The Advancing Care Component (ACI)

As discussed above, the ACI component modifies and replaces the Electronic Health Record Meaningful Use (EHR-MU) program. As currently proposed, (and subject to change with release of the final rule in early November 2016), the score for ACI will be derived in two parts: a base score (50 points) and a performance score.

 

The threshold for achieving the base score remains an “all or nothing” proposition. Achieving the threshold is based upon reporting a yes/no statement OR the appropriate numerator and denominator for each measure, as required, for the following six objectives:

1) Protect Patient Health Information.

2) Electronic Prescribing.

3) Patient Electronic Access to Health Information.

4) Coordination of Care through Patient Engagement.

5) Health Information Exchange.

6) Public Health and Clinical Data Reporting.

Only after meeting the requirements for the base score is one eligible to receive additional performance score credit based on the level of performance on a subset of three of the objectives required to achieve the base score. Those three are:

1) Patient Electronic Access to Health Information.

2) Coordination of Care through Patient Engagement.

3) Health Information Exchange

There are a total of eight measures for these three objectives.

The two measures specific to the Patient Electronic Access objective are:

a) Patient Access Measure.

b) Patient-Specific Education Measure.

Coordination of Care through Patient Engagement is assessed based upon the following three measures:

a) View, Download, Transmit Measure.

b) Secure Messaging Measure.

c) Patient-Generated Health Data Measures.

For the Health Information Exchange objective, assessment is also based on three measures. They are:

a) Patient Record Exchange Measure.

b) Request/Accept Patient Care Record Measure.

c) Clinical Information Reconciliation Measure.

Scoring for each of these eight measures is based upon reporting both a numerator and denominator, thus facilitating the calculation of percentage score to which a point value is assigned. For example, a performance rate of 85 on one of the listed measures would earn 8.5 points toward the performance score. The sum of the points accumulated for these eight measures is added to Threshold Score to determine the final score for ACI. Again, 25% of one’s MIPS Composite Score is derived from performance in the ACI component.

It warrants repeating and re-emphasis that the above information is subject to modification pending the release of the MIPS Final Rule, expected in early November.

As mentioned above, the Quality component of MIPS replaces the PQRS. Quality assessment will comprise 50% of the MIPS Composite Score. In next month’s column, I will provide an outline of the changes CMS is proposing for the Quality assessment. As a preview, some good news can be found in the fact that the current MIPS Quality component proposal will require providers to report on a total of six measures as opposed to the previous PQRS requirement to report on nine.

Until next month …

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Accredited bariatric surgery centers have fewer postoperative complications

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A recent review of published medical studies indicates that patients who have weight loss operations at nonaccredited bariatric surgery facilities in the United States are up to 1.4 times more likely to experience serious postoperative complications and more than twice as likely to die after the procedure in comparison with patients who undergo these procedures at accredited bariatric surgery centers. The study authors also report that accredited bariatric centers have lower costs than do nonaccredited centers. These results, which are posted on the Journal of the American College of Surgeons (JACS) website in advance of print publication, represent the first comprehensive review of the best available evidence comparing bariatric surgery results in accredited U.S. centers with outcomes at nonaccredited U.S. centers.

“A preponderance of scientific evidence demonstrates that bariatric surgery becomes safer with accreditation of the surgical center,” said principal investigator John Morton, MD, MPH, FACS, FASMBS, chief of bariatric and minimally invasive surgery at Stanford University School of Medicine in California. “Accreditation makes a big difference.” The American College of Surgeons (ACS) and the American Society of Metabolic and Bariatric Surgeons (ASMBS) merged their accreditation programs in 2012 to create the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, and more than 700 centers in the country now hold this accreditation. This credential signifies that a surgical facility has met rigorous standards for high-quality surgical care.

Reducing the odds of complications

In their review article, Dr. Morton and first author Dan Azagury, MD, also a bariatric and general surgeon at Stanford, included 13 studies published between 2009 and 2014, comprising more than 1.5 million patients. Dr. Morton acknowledged that a number of patients might be duplicates because some studies used the same national database.

Eight of 11 studies that evaluated postoperative complications found that undergoing a bariatric operation in an accredited facility reduced the odds of experiencing a serious complication by 9 percent to 39 percent (odds ratios of 1.09 to 1.39), the researchers reported. The difference was reportedly even more pronounced for the risk of death occurring in the hospital or up to 90 days postoperatively. Six of eight studies that reported mortality showed that the odds of dying after a bariatric procedure, while low at an accredited center, were 2.26 to 3.57 times higher at a nonaccredited facility.

Nearly all the studies used risk adjustment, which compensates for different levels of patient risk and which experts believe makes results more accurate. Only three studies (23 percent) failed to show a significant benefit of accreditation.

Reducing costs

Drs. Morton and Azagury also analyzed studies that reported average hospital charges and found lower costs at accredited centers. “Accredited bariatric surgical centers provide not only safer care but also less expensive care,” Dr. Morton said. A systematic review was the best way to study this issue, according to Dr. Morton. He said most insurers today will not cover surgical care at nonaccredited bariatric centers, making it difficult to perform a randomized controlled clinical trial. In 2013, the Centers for Medicare & Medicaid Services (CMS) stopped requiring Medicare beneficiaries to undergo bariatric operations at accredited bariatric centers as a condition of coverage.

Meanwhile, a growing number of patients are choosing surgical treatment for obesity – widely considered the most effective long-term weight-loss therapy. An estimated 179,000 patients underwent gastric bypass, gastric banding, and other bariatric operations in 2013 compared with 158,000 two years earlier, according to the ASMBS.

“These results provide important information that can be used to guide future policy decisions. Perhaps CMS should revisit this policy again,” Dr. Morton suggested.

Read the JACS article at www.journalacs.org/article/S1072-7515(16)30267-8/fulltext.

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A recent review of published medical studies indicates that patients who have weight loss operations at nonaccredited bariatric surgery facilities in the United States are up to 1.4 times more likely to experience serious postoperative complications and more than twice as likely to die after the procedure in comparison with patients who undergo these procedures at accredited bariatric surgery centers. The study authors also report that accredited bariatric centers have lower costs than do nonaccredited centers. These results, which are posted on the Journal of the American College of Surgeons (JACS) website in advance of print publication, represent the first comprehensive review of the best available evidence comparing bariatric surgery results in accredited U.S. centers with outcomes at nonaccredited U.S. centers.

“A preponderance of scientific evidence demonstrates that bariatric surgery becomes safer with accreditation of the surgical center,” said principal investigator John Morton, MD, MPH, FACS, FASMBS, chief of bariatric and minimally invasive surgery at Stanford University School of Medicine in California. “Accreditation makes a big difference.” The American College of Surgeons (ACS) and the American Society of Metabolic and Bariatric Surgeons (ASMBS) merged their accreditation programs in 2012 to create the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, and more than 700 centers in the country now hold this accreditation. This credential signifies that a surgical facility has met rigorous standards for high-quality surgical care.

Reducing the odds of complications

In their review article, Dr. Morton and first author Dan Azagury, MD, also a bariatric and general surgeon at Stanford, included 13 studies published between 2009 and 2014, comprising more than 1.5 million patients. Dr. Morton acknowledged that a number of patients might be duplicates because some studies used the same national database.

Eight of 11 studies that evaluated postoperative complications found that undergoing a bariatric operation in an accredited facility reduced the odds of experiencing a serious complication by 9 percent to 39 percent (odds ratios of 1.09 to 1.39), the researchers reported. The difference was reportedly even more pronounced for the risk of death occurring in the hospital or up to 90 days postoperatively. Six of eight studies that reported mortality showed that the odds of dying after a bariatric procedure, while low at an accredited center, were 2.26 to 3.57 times higher at a nonaccredited facility.

Nearly all the studies used risk adjustment, which compensates for different levels of patient risk and which experts believe makes results more accurate. Only three studies (23 percent) failed to show a significant benefit of accreditation.

Reducing costs

Drs. Morton and Azagury also analyzed studies that reported average hospital charges and found lower costs at accredited centers. “Accredited bariatric surgical centers provide not only safer care but also less expensive care,” Dr. Morton said. A systematic review was the best way to study this issue, according to Dr. Morton. He said most insurers today will not cover surgical care at nonaccredited bariatric centers, making it difficult to perform a randomized controlled clinical trial. In 2013, the Centers for Medicare & Medicaid Services (CMS) stopped requiring Medicare beneficiaries to undergo bariatric operations at accredited bariatric centers as a condition of coverage.

Meanwhile, a growing number of patients are choosing surgical treatment for obesity – widely considered the most effective long-term weight-loss therapy. An estimated 179,000 patients underwent gastric bypass, gastric banding, and other bariatric operations in 2013 compared with 158,000 two years earlier, according to the ASMBS.

“These results provide important information that can be used to guide future policy decisions. Perhaps CMS should revisit this policy again,” Dr. Morton suggested.

Read the JACS article at www.journalacs.org/article/S1072-7515(16)30267-8/fulltext.

A recent review of published medical studies indicates that patients who have weight loss operations at nonaccredited bariatric surgery facilities in the United States are up to 1.4 times more likely to experience serious postoperative complications and more than twice as likely to die after the procedure in comparison with patients who undergo these procedures at accredited bariatric surgery centers. The study authors also report that accredited bariatric centers have lower costs than do nonaccredited centers. These results, which are posted on the Journal of the American College of Surgeons (JACS) website in advance of print publication, represent the first comprehensive review of the best available evidence comparing bariatric surgery results in accredited U.S. centers with outcomes at nonaccredited U.S. centers.

“A preponderance of scientific evidence demonstrates that bariatric surgery becomes safer with accreditation of the surgical center,” said principal investigator John Morton, MD, MPH, FACS, FASMBS, chief of bariatric and minimally invasive surgery at Stanford University School of Medicine in California. “Accreditation makes a big difference.” The American College of Surgeons (ACS) and the American Society of Metabolic and Bariatric Surgeons (ASMBS) merged their accreditation programs in 2012 to create the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, and more than 700 centers in the country now hold this accreditation. This credential signifies that a surgical facility has met rigorous standards for high-quality surgical care.

Reducing the odds of complications

In their review article, Dr. Morton and first author Dan Azagury, MD, also a bariatric and general surgeon at Stanford, included 13 studies published between 2009 and 2014, comprising more than 1.5 million patients. Dr. Morton acknowledged that a number of patients might be duplicates because some studies used the same national database.

Eight of 11 studies that evaluated postoperative complications found that undergoing a bariatric operation in an accredited facility reduced the odds of experiencing a serious complication by 9 percent to 39 percent (odds ratios of 1.09 to 1.39), the researchers reported. The difference was reportedly even more pronounced for the risk of death occurring in the hospital or up to 90 days postoperatively. Six of eight studies that reported mortality showed that the odds of dying after a bariatric procedure, while low at an accredited center, were 2.26 to 3.57 times higher at a nonaccredited facility.

Nearly all the studies used risk adjustment, which compensates for different levels of patient risk and which experts believe makes results more accurate. Only three studies (23 percent) failed to show a significant benefit of accreditation.

Reducing costs

Drs. Morton and Azagury also analyzed studies that reported average hospital charges and found lower costs at accredited centers. “Accredited bariatric surgical centers provide not only safer care but also less expensive care,” Dr. Morton said. A systematic review was the best way to study this issue, according to Dr. Morton. He said most insurers today will not cover surgical care at nonaccredited bariatric centers, making it difficult to perform a randomized controlled clinical trial. In 2013, the Centers for Medicare & Medicaid Services (CMS) stopped requiring Medicare beneficiaries to undergo bariatric operations at accredited bariatric centers as a condition of coverage.

Meanwhile, a growing number of patients are choosing surgical treatment for obesity – widely considered the most effective long-term weight-loss therapy. An estimated 179,000 patients underwent gastric bypass, gastric banding, and other bariatric operations in 2013 compared with 158,000 two years earlier, according to the ASMBS.

“These results provide important information that can be used to guide future policy decisions. Perhaps CMS should revisit this policy again,” Dr. Morton suggested.

Read the JACS article at www.journalacs.org/article/S1072-7515(16)30267-8/fulltext.

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TQIP now in all 50 states and Washington, D.C.

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The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) is now in all 50 states and Washington, D.C. The ACS TQIP program reached this milestone on Aug. 2 with the addition of Meritus Medical Center in Hagerstown, Md., a Level III TQIP Site.

The TQIP pilot program began in 2009 with 23 centers, and the full TQIP program launched in 2010 with 65 centers. In 2014, Pediatric TQIP was added, and on July 1 of this year, Level III TQIP was launched. TQIP now has 561 enrolled sites (420 Level I and II Adult Sites, 40 Level III Sites, and 101 Pediatric Sites) and anticipates continued growth this year.

TQIP standardizes the collection and measurement of trauma data to generate quality improvement strategies and reduce disparities in trauma care nationwide. TQIP collects data from trauma centers, provides feedback about center performance, and identifies institutional improvements for better patient outcomes. TQIP provides hospitals with risk-adjusted benchmarking for accurate national comparisons. In addition, TQIP provides education and training to help trauma center staff improve the quality of their data and accurately interpret their benchmark reports. The program fosters clinical improvements with the support of Best Practice Guidelines (https://www.facs.org/quality-programs/trauma/tqip/best-practice), which allow enrolled centers to network and share best practice information at the TQIP annual meeting (https://www.facs.org/quality-programs/trauma/tqip/meeting) through the TQIP Google group (https://groups.google.com/forum/#!forum/trauma-quality-improvement-program---tqip), and in Web conferences.

For more information, visit the TQIP website (www.facs.org/quality-programs/trauma/tqip).

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The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) is now in all 50 states and Washington, D.C. The ACS TQIP program reached this milestone on Aug. 2 with the addition of Meritus Medical Center in Hagerstown, Md., a Level III TQIP Site.

The TQIP pilot program began in 2009 with 23 centers, and the full TQIP program launched in 2010 with 65 centers. In 2014, Pediatric TQIP was added, and on July 1 of this year, Level III TQIP was launched. TQIP now has 561 enrolled sites (420 Level I and II Adult Sites, 40 Level III Sites, and 101 Pediatric Sites) and anticipates continued growth this year.

TQIP standardizes the collection and measurement of trauma data to generate quality improvement strategies and reduce disparities in trauma care nationwide. TQIP collects data from trauma centers, provides feedback about center performance, and identifies institutional improvements for better patient outcomes. TQIP provides hospitals with risk-adjusted benchmarking for accurate national comparisons. In addition, TQIP provides education and training to help trauma center staff improve the quality of their data and accurately interpret their benchmark reports. The program fosters clinical improvements with the support of Best Practice Guidelines (https://www.facs.org/quality-programs/trauma/tqip/best-practice), which allow enrolled centers to network and share best practice information at the TQIP annual meeting (https://www.facs.org/quality-programs/trauma/tqip/meeting) through the TQIP Google group (https://groups.google.com/forum/#!forum/trauma-quality-improvement-program---tqip), and in Web conferences.

For more information, visit the TQIP website (www.facs.org/quality-programs/trauma/tqip).

The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) is now in all 50 states and Washington, D.C. The ACS TQIP program reached this milestone on Aug. 2 with the addition of Meritus Medical Center in Hagerstown, Md., a Level III TQIP Site.

The TQIP pilot program began in 2009 with 23 centers, and the full TQIP program launched in 2010 with 65 centers. In 2014, Pediatric TQIP was added, and on July 1 of this year, Level III TQIP was launched. TQIP now has 561 enrolled sites (420 Level I and II Adult Sites, 40 Level III Sites, and 101 Pediatric Sites) and anticipates continued growth this year.

TQIP standardizes the collection and measurement of trauma data to generate quality improvement strategies and reduce disparities in trauma care nationwide. TQIP collects data from trauma centers, provides feedback about center performance, and identifies institutional improvements for better patient outcomes. TQIP provides hospitals with risk-adjusted benchmarking for accurate national comparisons. In addition, TQIP provides education and training to help trauma center staff improve the quality of their data and accurately interpret their benchmark reports. The program fosters clinical improvements with the support of Best Practice Guidelines (https://www.facs.org/quality-programs/trauma/tqip/best-practice), which allow enrolled centers to network and share best practice information at the TQIP annual meeting (https://www.facs.org/quality-programs/trauma/tqip/meeting) through the TQIP Google group (https://groups.google.com/forum/#!forum/trauma-quality-improvement-program---tqip), and in Web conferences.

For more information, visit the TQIP website (www.facs.org/quality-programs/trauma/tqip).

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Join Dr. Richardson for TTP Program Meet and Greet at Clinical Congress

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J. David Richardson, MD, FACS, 2015-2016 President of the American College of Surgeons (ACS) and Chair of the ACS Committee on Transition to Practice (TTP) Program in General Surgery, will host an informal Meet and Greet during the ACS Clinical Congress 2016, 12:00 noon – 1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. Dr. Richardson will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program at https://www.facs.org/education/program/ttp. Dennis W. Ashley, MD, FACS, FCCM, TTP chief of the Mercer University School of Medicine Program, Cordele, GA, which has successfully incorporated the TTP Program, will join Dr. Richardson at the Meet and Greet. Contact [email protected] for more information or stop by the Division of Education booth at the Clinical Congress and learn more about this growing program.

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J. David Richardson, MD, FACS, 2015-2016 President of the American College of Surgeons (ACS) and Chair of the ACS Committee on Transition to Practice (TTP) Program in General Surgery, will host an informal Meet and Greet during the ACS Clinical Congress 2016, 12:00 noon – 1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. Dr. Richardson will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program at https://www.facs.org/education/program/ttp. Dennis W. Ashley, MD, FACS, FCCM, TTP chief of the Mercer University School of Medicine Program, Cordele, GA, which has successfully incorporated the TTP Program, will join Dr. Richardson at the Meet and Greet. Contact [email protected] for more information or stop by the Division of Education booth at the Clinical Congress and learn more about this growing program.

J. David Richardson, MD, FACS, 2015-2016 President of the American College of Surgeons (ACS) and Chair of the ACS Committee on Transition to Practice (TTP) Program in General Surgery, will host an informal Meet and Greet during the ACS Clinical Congress 2016, 12:00 noon – 1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. Dr. Richardson will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program at https://www.facs.org/education/program/ttp. Dennis W. Ashley, MD, FACS, FCCM, TTP chief of the Mercer University School of Medicine Program, Cordele, GA, which has successfully incorporated the TTP Program, will join Dr. Richardson at the Meet and Greet. Contact [email protected] for more information or stop by the Division of Education booth at the Clinical Congress and learn more about this growing program.

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ACS Issues Statement on Operating Room Attire

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The American College of Surgeons (ACS) has finalized a statement on professional attire for surgeons in and out of the operating room (OR). The new ACS guideline for appropriate attire is based on principles of professionalism, common sense, decorum, and the available evidence. It includes the following provisions:

• Soiled scrubs and/or hats should be changed as soon as feasible and certainly before speaking with family members after an operation.

• Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.

• Dangling masks should not be worn at any time.

• Operating room scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover.

• OR scrubs should not be worn at any time outside of the hospital perimeter.

• OR scrubs should be changed at least daily.

• During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.

• Jewelry worn on the head or neck, where the items might fall into or contaminate the sterile field, should be removed or appropriately covered during procedures.

• The ACS encourages surgeons to wear clean, appropriate professional attire (not scrubs) during all patient encounters outside of the OR.

The ACS Statement on Operating Room Attire provides detailed guidelines on wearing the skullcap in a way that ensures patient safety and facilitates enforcement of the standard on wearing scrubs only within the perimeter of the hospital by suggesting the adoption of distinctively colored scrub suits for OR personnel.

In addition, the ACS is collaborating with the Centers for Medicare & Medicaid Services and The Joint Commission to ensure that their policies and regulatory oversight activities are aligned with the College’s recommendations.

The statement will be published in the October Bulletin.

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The American College of Surgeons (ACS) has finalized a statement on professional attire for surgeons in and out of the operating room (OR). The new ACS guideline for appropriate attire is based on principles of professionalism, common sense, decorum, and the available evidence. It includes the following provisions:

• Soiled scrubs and/or hats should be changed as soon as feasible and certainly before speaking with family members after an operation.

• Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.

• Dangling masks should not be worn at any time.

• Operating room scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover.

• OR scrubs should not be worn at any time outside of the hospital perimeter.

• OR scrubs should be changed at least daily.

• During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.

• Jewelry worn on the head or neck, where the items might fall into or contaminate the sterile field, should be removed or appropriately covered during procedures.

• The ACS encourages surgeons to wear clean, appropriate professional attire (not scrubs) during all patient encounters outside of the OR.

The ACS Statement on Operating Room Attire provides detailed guidelines on wearing the skullcap in a way that ensures patient safety and facilitates enforcement of the standard on wearing scrubs only within the perimeter of the hospital by suggesting the adoption of distinctively colored scrub suits for OR personnel.

In addition, the ACS is collaborating with the Centers for Medicare & Medicaid Services and The Joint Commission to ensure that their policies and regulatory oversight activities are aligned with the College’s recommendations.

The statement will be published in the October Bulletin.

The American College of Surgeons (ACS) has finalized a statement on professional attire for surgeons in and out of the operating room (OR). The new ACS guideline for appropriate attire is based on principles of professionalism, common sense, decorum, and the available evidence. It includes the following provisions:

• Soiled scrubs and/or hats should be changed as soon as feasible and certainly before speaking with family members after an operation.

• Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.

• Dangling masks should not be worn at any time.

• Operating room scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover.

• OR scrubs should not be worn at any time outside of the hospital perimeter.

• OR scrubs should be changed at least daily.

• During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.

• Jewelry worn on the head or neck, where the items might fall into or contaminate the sterile field, should be removed or appropriately covered during procedures.

• The ACS encourages surgeons to wear clean, appropriate professional attire (not scrubs) during all patient encounters outside of the OR.

The ACS Statement on Operating Room Attire provides detailed guidelines on wearing the skullcap in a way that ensures patient safety and facilitates enforcement of the standard on wearing scrubs only within the perimeter of the hospital by suggesting the adoption of distinctively colored scrub suits for OR personnel.

In addition, the ACS is collaborating with the Centers for Medicare & Medicaid Services and The Joint Commission to ensure that their policies and regulatory oversight activities are aligned with the College’s recommendations.

The statement will be published in the October Bulletin.

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Register online for the seventh annual American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) Scientific Meeting and Training, November 5-7 at the Omni Orlando Resort at ChampionsGate, FL. Register for the conference at https://www.compusystems.com/servlet/ar?evt_uid=785.

The meeting will convene trauma medical directors, program managers, coordinators, and registrars from participating and prospective TQIP hospitals. J. Wayne Meredith, MD, FACS, MCCM, Winston-Salem, NC, the 2014 recipient of the ACS Distinguished Service Award and Past-Medical Director, ACS Trauma Programs, will deliver the keynote address. The program will include sessions for new TQIP centers, new staff at existing centers, and participants in need of a TQIP refresher. Breakout sessions focused on registrar and abstractor concerns, matters that relate to the trauma medical director and trauma program manager-focused issues will enhance the learning experience and instruct participants in their role on the TQIP team.

Visit the TQIP annual meeting website at https://www.facs.org/tqipmeeting to view the conference schedule and obtain information about lodging, transportation, and a social outing to Cirque du Soleil. For more information, contact ACS TQIP staff at [email protected].

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Register online for the seventh annual American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) Scientific Meeting and Training, November 5-7 at the Omni Orlando Resort at ChampionsGate, FL. Register for the conference at https://www.compusystems.com/servlet/ar?evt_uid=785.

The meeting will convene trauma medical directors, program managers, coordinators, and registrars from participating and prospective TQIP hospitals. J. Wayne Meredith, MD, FACS, MCCM, Winston-Salem, NC, the 2014 recipient of the ACS Distinguished Service Award and Past-Medical Director, ACS Trauma Programs, will deliver the keynote address. The program will include sessions for new TQIP centers, new staff at existing centers, and participants in need of a TQIP refresher. Breakout sessions focused on registrar and abstractor concerns, matters that relate to the trauma medical director and trauma program manager-focused issues will enhance the learning experience and instruct participants in their role on the TQIP team.

Visit the TQIP annual meeting website at https://www.facs.org/tqipmeeting to view the conference schedule and obtain information about lodging, transportation, and a social outing to Cirque du Soleil. For more information, contact ACS TQIP staff at [email protected].

Register online for the seventh annual American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) Scientific Meeting and Training, November 5-7 at the Omni Orlando Resort at ChampionsGate, FL. Register for the conference at https://www.compusystems.com/servlet/ar?evt_uid=785.

The meeting will convene trauma medical directors, program managers, coordinators, and registrars from participating and prospective TQIP hospitals. J. Wayne Meredith, MD, FACS, MCCM, Winston-Salem, NC, the 2014 recipient of the ACS Distinguished Service Award and Past-Medical Director, ACS Trauma Programs, will deliver the keynote address. The program will include sessions for new TQIP centers, new staff at existing centers, and participants in need of a TQIP refresher. Breakout sessions focused on registrar and abstractor concerns, matters that relate to the trauma medical director and trauma program manager-focused issues will enhance the learning experience and instruct participants in their role on the TQIP team.

Visit the TQIP annual meeting website at https://www.facs.org/tqipmeeting to view the conference schedule and obtain information about lodging, transportation, and a social outing to Cirque du Soleil. For more information, contact ACS TQIP staff at [email protected].

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