General Surgery

Despite the lack of a clear-cut cost-effectiveness case, it appears that the use of robotics in surgery is on its way to becoming the norm.

What may help make that cost-effectiveness case is time, as the hardware becomes cheaper and the technology becomes more widespread.

“I think there are many surgeons who are doing robotic surgery who truly believe that the current of state of the art will bear only a partial resemblance to the state of the art 5-10 years from now,” Dr. Henry Pitt, chief quality officer of the Temple University Health System, Philadelphia, said in an interview. “And part of the persistence by many of the robotic surgeons, while they fully understand that what they are doing is not cost effective now, is that they believe that the next few generations of this technology will become the state of the art and will become cost effective.”

Dr. Pitt, an ACS Fellow, compared the evolution of robotic surgery to that of computers and the application of Moore’s Law, by which the technology advances rapidly while the price eventually comes down.

Spread of robot-assisted surgery

Research by the surgical robot industry and independent investigators shows that use of robotics is on an upward climb. A presentation at the 2015 American College of Surgeons Clinical Congress reveals that, based on retrospective review of the Nationwide Inpatient Sample from 2009-2012 using the ICD-9 code that identifies robot-assisted procedures, there were 113,022 robot-assisted procedures in that period.

In 2009, there were 21,006 procedures, with the volume growing to 33,713 in 2012. Perhaps more telling about the use of robotics is that it is not confined to specialties with a proven track record such as gynecology and urology. The study, led by Dr. G. Paul Wright of Grand Rapids Medical Education Partners and Michigan State University, shows an increase in robotics use in general surgery procedures by 4.5-fold from 2009-2012, with steady increases each year. General surgery accounted for 11.8% of robot-assisted cases in 2012, Dr. Wright and colleagues reported.

Dr. Wright suggested a number of factors contributing to the “surprising” growth of robotics in general surgery.

“I think the growth is stimulated, at least in part, by market forces,” he said in an interview. “For patients who are the consumers of health care, they are often drawn to [surgeons] whom they perceive to be on the cutting edge. Robotic surgery certainly offers that intrigue. With greater access to the technology, if a patient is seeking a robotic surgery that you do not offer as a surgeon, they can likely find that elsewhere, potentially at your competitor. Another driving force is potentially the ease of suturing with the robot which more resembles open surgery while advanced laparoscopic suturing in tight spaces is a more limited skill set among general surgeons.”

Dr. Wright added that “some of the stigma of robotic surgery is dissolving among surgeons as they become more familiar with the technology. I also believe the market forces will help drive down costs in robotics which may help to increase utilization as well.”

Industry touts cost effectiveness

And while Dr. Pitt is looking forward, the industry is energetically promoting the cost effectiveness of robotics today. Intuitive Surgical Inc., manufacturer of the da Vinci surgery robot presented in a recent press briefing data culled from literature found on PubMed showing that robotic surgery, at least with their product, is cost effective now (view the report at http://goo.gl/AfAuT3).  But in recent years, the large number of clinical trials comparing robotic vs. laparoscopic surgery for colorectal disease, for example, is equivocal. For many procedures, trials appear to show similar between laparoscopic and robot-assisted approaches, with the main factors in play being length of operation time, hospital stay, and surgical site infection.   

According to Intuitive Surgical’s manager of clinical economics, Andrew Yiu, a review of peer-reviewed articles that featured nationwide cohorts of comparisons and included comparisons to both open and laparoscopic procedures outcomes shows improvements across a variety of procedures in terms of hospital stay, lower conversion rates, reduced complications, reduced 30-day readmissions, and improved patient satisfaction, though outcomes were more pronounced in some areas compared with others. Highlighting one procedure in particular – benign hysterectomy – Mr. Yiu noted that rates of minor and major complications associated with robotic vs. laparoscopic surgery were relatively similar but that the conversion rate to open surgery from laparoscopic surgery was 3.9%, compared with 0.9% for da Vinci–assisted surgery.

Overall, Intuitive Surgical calculated the potential savings on the episode of care with the da Vinci system at $1,087 vs. laparoscopic procedures and $2,996 over open surgery.

The company is currently promoting its da Vinci IX Surgical System. Cleared by the Food and Drug Administration in April 2014, Intuitive Surgical says that this latest version has broader capabilities than earlier generations and has been optimized for complex, multiquadrant surgeries.

Costs and other trade-offs

In some ways, robot-assisted surgery is following the same path as laparoscopic surgery, observed Dr. Tyler Hughes of the department of general surgery at McPherson (Kan.) Hospital.

“Certainly, we had the issue back in the late ‘80s and early ‘90s of laparoscopy,” Dr. Hughes said in an interview. “Was it cost effective? Because at the time $30,000 or $40,000 for a laparoscopic set-up seemed like a horse-choking amount of money. However, it converted a 5-day in-the-hospital experience to a 4-hour day-surgery experience. The nonclinical benefits to the patient were so enormous that it took the whole place by storm.”

Dr. Hughes, an ACS Fellow, suggested that the leap in savings elsewhere in the episode of care when using laparoscopic surgery over open surgery is not being mirrored in the robotic space and suggested that money should be spent in other areas of need.

“Cost is going to choke the future if we’re not careful. We need nurses. We need infrastructure. We need to be careful to buy things that really make a big difference,” he said.

In a study presented by at the ACS Clinical Congress on a cost-benefit analysis of robotic vs. laparoscopic colectomy, Anastasia Postoev, a fourth-year medical student at Caribbean Medical University in Willemstad, Curacao and her colleagues found little difference in clinical outcomes but higher costs as a result of added time needed to prepare the robot for surgery. The study showed that the potential up-front costs can be  $1 to $2 million for the robot in addition to ongoing costs related to training and maintenance. Dr. Hughes said. “It is a terrific marketing tool in the sense that you can certainly attract a lot of people to a hospital with robotic surgery, but whether or not those outcomes are truly different and the cost of those outcomes are justifiable is yet to be determined.”

The ease of use of robotics, however, could end up being a double-edged sword, particularly if there are areas of the country where robotics may not be as pervasive, or in cases when a conversion to open surgery might be required.

“It is a real concern that trainees are being taught robotic surgery for what is not really needed to be robotic in the mainstream,” Dr. Hughes said. “Then they come out with less experience with straight stick laparoscopy and we’ve certainly seen lots of problems in the laparoscopic range for people once they get to the point that they have to convert to open. We really don’t have a large volume of trainee experience in complex open surgery. That’s a big problem. Robotics certainly isn’t going to make that a lot better.”  

[email protected]

Despite the lack of a clear-cut cost-effectiveness case, it appears that the use of robotics in surgery is on its way to becoming the norm.

What may help make that cost-effectiveness case is time, as the hardware becomes cheaper and the technology becomes more widespread.

“I think there are many surgeons who are doing robotic surgery who truly believe that the current of state of the art will bear only a partial resemblance to the state of the art 5-10 years from now,” Dr. Henry Pitt, chief quality officer of the Temple University Health System, Philadelphia, said in an interview. “And part of the persistence by many of the robotic surgeons, while they fully understand that what they are doing is not cost effective now, is that they believe that the next few generations of this technology will become the state of the art and will become cost effective.”

Dr. Pitt, an ACS Fellow, compared the evolution of robotic surgery to that of computers and the application of Moore’s Law, by which the technology advances rapidly while the price eventually comes down.

Spread of robot-assisted surgery

Research by the surgical robot industry and independent investigators shows that use of robotics is on an upward climb. A presentation at the 2015 American College of Surgeons Clinical Congress reveals that, based on retrospective review of the Nationwide Inpatient Sample from 2009-2012 using the ICD-9 code that identifies robot-assisted procedures, there were 113,022 robot-assisted procedures in that period.

In 2009, there were 21,006 procedures, with the volume growing to 33,713 in 2012. Perhaps more telling about the use of robotics is that it is not confined to specialties with a proven track record such as gynecology and urology. The study, led by Dr. G. Paul Wright of Grand Rapids Medical Education Partners and Michigan State University, shows an increase in robotics use in general surgery procedures by 4.5-fold from 2009-2012, with steady increases each year. General surgery accounted for 11.8% of robot-assisted cases in 2012, Dr. Wright and colleagues reported.

Dr. Wright suggested a number of factors contributing to the “surprising” growth of robotics in general surgery.

“I think the growth is stimulated, at least in part, by market forces,” he said in an interview. “For patients who are the consumers of health care, they are often drawn to [surgeons] whom they perceive to be on the cutting edge. Robotic surgery certainly offers that intrigue. With greater access to the technology, if a patient is seeking a robotic surgery that you do not offer as a surgeon, they can likely find that elsewhere, potentially at your competitor. Another driving force is potentially the ease of suturing with the robot which more resembles open surgery while advanced laparoscopic suturing in tight spaces is a more limited skill set among general surgeons.”

Dr. Wright added that “some of the stigma of robotic surgery is dissolving among surgeons as they become more familiar with the technology. I also believe the market forces will help drive down costs in robotics which may help to increase utilization as well.”

Industry touts cost effectiveness

And while Dr. Pitt is looking forward, the industry is energetically promoting the cost effectiveness of robotics today. Intuitive Surgical Inc., manufacturer of the da Vinci surgery robot presented in a recent press briefing data culled from literature found on PubMed showing that robotic surgery, at least with their product, is cost effective now (view the report at http://goo.gl/AfAuT3).  But in recent years, the large number of clinical trials comparing robotic vs. laparoscopic surgery for colorectal disease, for example, is equivocal. For many procedures, trials appear to show similar between laparoscopic and robot-assisted approaches, with the main factors in play being length of operation time, hospital stay, and surgical site infection.   

According to Intuitive Surgical’s manager of clinical economics, Andrew Yiu, a review of peer-reviewed articles that featured nationwide cohorts of comparisons and included comparisons to both open and laparoscopic procedures outcomes shows improvements across a variety of procedures in terms of hospital stay, lower conversion rates, reduced complications, reduced 30-day readmissions, and improved patient satisfaction, though outcomes were more pronounced in some areas compared with others. Highlighting one procedure in particular – benign hysterectomy – Mr. Yiu noted that rates of minor and major complications associated with robotic vs. laparoscopic surgery were relatively similar but that the conversion rate to open surgery from laparoscopic surgery was 3.9%, compared with 0.9% for da Vinci–assisted surgery.

Overall, Intuitive Surgical calculated the potential savings on the episode of care with the da Vinci system at $1,087 vs. laparoscopic procedures and $2,996 over open surgery.

The company is currently promoting its da Vinci IX Surgical System. Cleared by the Food and Drug Administration in April 2014, Intuitive Surgical says that this latest version has broader capabilities than earlier generations and has been optimized for complex, multiquadrant surgeries.

Costs and other trade-offs

In some ways, robot-assisted surgery is following the same path as laparoscopic surgery, observed Dr. Tyler Hughes of the department of general surgery at McPherson (Kan.) Hospital.

“Certainly, we had the issue back in the late ‘80s and early ‘90s of laparoscopy,” Dr. Hughes said in an interview. “Was it cost effective? Because at the time $30,000 or $40,000 for a laparoscopic set-up seemed like a horse-choking amount of money. However, it converted a 5-day in-the-hospital experience to a 4-hour day-surgery experience. The nonclinical benefits to the patient were so enormous that it took the whole place by storm.”

Dr. Hughes, an ACS Fellow, suggested that the leap in savings elsewhere in the episode of care when using laparoscopic surgery over open surgery is not being mirrored in the robotic space and suggested that money should be spent in other areas of need.

“Cost is going to choke the future if we’re not careful. We need nurses. We need infrastructure. We need to be careful to buy things that really make a big difference,” he said.

In a study presented by at the ACS Clinical Congress on a cost-benefit analysis of robotic vs. laparoscopic colectomy, Anastasia Postoev, a fourth-year medical student at Caribbean Medical University in Willemstad, Curacao and her colleagues found little difference in clinical outcomes but higher costs as a result of added time needed to prepare the robot for surgery. The study showed that the potential up-front costs can be  $1 to $2 million for the robot in addition to ongoing costs related to training and maintenance. Dr. Hughes said. “It is a terrific marketing tool in the sense that you can certainly attract a lot of people to a hospital with robotic surgery, but whether or not those outcomes are truly different and the cost of those outcomes are justifiable is yet to be determined.”

The ease of use of robotics, however, could end up being a double-edged sword, particularly if there are areas of the country where robotics may not be as pervasive, or in cases when a conversion to open surgery might be required.

“It is a real concern that trainees are being taught robotic surgery for what is not really needed to be robotic in the mainstream,” Dr. Hughes said. “Then they come out with less experience with straight stick laparoscopy and we’ve certainly seen lots of problems in the laparoscopic range for people once they get to the point that they have to convert to open. We really don’t have a large volume of trainee experience in complex open surgery. That’s a big problem. Robotics certainly isn’t going to make that a lot better.”  

[email protected]

Despite the lack of a clear-cut cost-effectiveness case, it appears that the use of robotics in surgery is on its way to becoming the norm.

What may help make that cost-effectiveness case is time, as the hardware becomes cheaper and the technology becomes more widespread.

“I think there are many surgeons who are doing robotic surgery who truly believe that the current of state of the art will bear only a partial resemblance to the state of the art 5-10 years from now,” Dr. Henry Pitt, chief quality officer of the Temple University Health System, Philadelphia, said in an interview. “And part of the persistence by many of the robotic surgeons, while they fully understand that what they are doing is not cost effective now, is that they believe that the next few generations of this technology will become the state of the art and will become cost effective.”

Dr. Pitt, an ACS Fellow, compared the evolution of robotic surgery to that of computers and the application of Moore’s Law, by which the technology advances rapidly while the price eventually comes down.

Spread of robot-assisted surgery

Research by the surgical robot industry and independent investigators shows that use of robotics is on an upward climb. A presentation at the 2015 American College of Surgeons Clinical Congress reveals that, based on retrospective review of the Nationwide Inpatient Sample from 2009-2012 using the ICD-9 code that identifies robot-assisted procedures, there were 113,022 robot-assisted procedures in that period.

In 2009, there were 21,006 procedures, with the volume growing to 33,713 in 2012. Perhaps more telling about the use of robotics is that it is not confined to specialties with a proven track record such as gynecology and urology. The study, led by Dr. G. Paul Wright of Grand Rapids Medical Education Partners and Michigan State University, shows an increase in robotics use in general surgery procedures by 4.5-fold from 2009-2012, with steady increases each year. General surgery accounted for 11.8% of robot-assisted cases in 2012, Dr. Wright and colleagues reported.

Dr. Wright suggested a number of factors contributing to the “surprising” growth of robotics in general surgery.

“I think the growth is stimulated, at least in part, by market forces,” he said in an interview. “For patients who are the consumers of health care, they are often drawn to [surgeons] whom they perceive to be on the cutting edge. Robotic surgery certainly offers that intrigue. With greater access to the technology, if a patient is seeking a robotic surgery that you do not offer as a surgeon, they can likely find that elsewhere, potentially at your competitor. Another driving force is potentially the ease of suturing with the robot which more resembles open surgery while advanced laparoscopic suturing in tight spaces is a more limited skill set among general surgeons.”

Dr. Wright added that “some of the stigma of robotic surgery is dissolving among surgeons as they become more familiar with the technology. I also believe the market forces will help drive down costs in robotics which may help to increase utilization as well.”

Industry touts cost effectiveness

And while Dr. Pitt is looking forward, the industry is energetically promoting the cost effectiveness of robotics today. Intuitive Surgical Inc., manufacturer of the da Vinci surgery robot presented in a recent press briefing data culled from literature found on PubMed showing that robotic surgery, at least with their product, is cost effective now (view the report at http://goo.gl/AfAuT3).  But in recent years, the large number of clinical trials comparing robotic vs. laparoscopic surgery for colorectal disease, for example, is equivocal. For many procedures, trials appear to show similar between laparoscopic and robot-assisted approaches, with the main factors in play being length of operation time, hospital stay, and surgical site infection.   

According to Intuitive Surgical’s manager of clinical economics, Andrew Yiu, a review of peer-reviewed articles that featured nationwide cohorts of comparisons and included comparisons to both open and laparoscopic procedures outcomes shows improvements across a variety of procedures in terms of hospital stay, lower conversion rates, reduced complications, reduced 30-day readmissions, and improved patient satisfaction, though outcomes were more pronounced in some areas compared with others. Highlighting one procedure in particular – benign hysterectomy – Mr. Yiu noted that rates of minor and major complications associated with robotic vs. laparoscopic surgery were relatively similar but that the conversion rate to open surgery from laparoscopic surgery was 3.9%, compared with 0.9% for da Vinci–assisted surgery.

Overall, Intuitive Surgical calculated the potential savings on the episode of care with the da Vinci system at $1,087 vs. laparoscopic procedures and $2,996 over open surgery.

The company is currently promoting its da Vinci IX Surgical System. Cleared by the Food and Drug Administration in April 2014, Intuitive Surgical says that this latest version has broader capabilities than earlier generations and has been optimized for complex, multiquadrant surgeries.

Costs and other trade-offs

In some ways, robot-assisted surgery is following the same path as laparoscopic surgery, observed Dr. Tyler Hughes of the department of general surgery at McPherson (Kan.) Hospital.

“Certainly, we had the issue back in the late ‘80s and early ‘90s of laparoscopy,” Dr. Hughes said in an interview. “Was it cost effective? Because at the time $30,000 or $40,000 for a laparoscopic set-up seemed like a horse-choking amount of money. However, it converted a 5-day in-the-hospital experience to a 4-hour day-surgery experience. The nonclinical benefits to the patient were so enormous that it took the whole place by storm.”

Dr. Hughes, an ACS Fellow, suggested that the leap in savings elsewhere in the episode of care when using laparoscopic surgery over open surgery is not being mirrored in the robotic space and suggested that money should be spent in other areas of need.

“Cost is going to choke the future if we’re not careful. We need nurses. We need infrastructure. We need to be careful to buy things that really make a big difference,” he said.

In a study presented by at the ACS Clinical Congress on a cost-benefit analysis of robotic vs. laparoscopic colectomy, Anastasia Postoev, a fourth-year medical student at Caribbean Medical University in Willemstad, Curacao and her colleagues found little difference in clinical outcomes but higher costs as a result of added time needed to prepare the robot for surgery. The study showed that the potential up-front costs can be  $1 to $2 million for the robot in addition to ongoing costs related to training and maintenance. Dr. Hughes said. “It is a terrific marketing tool in the sense that you can certainly attract a lot of people to a hospital with robotic surgery, but whether or not those outcomes are truly different and the cost of those outcomes are justifiable is yet to be determined.”

The ease of use of robotics, however, could end up being a double-edged sword, particularly if there are areas of the country where robotics may not be as pervasive, or in cases when a conversion to open surgery might be required.

“It is a real concern that trainees are being taught robotic surgery for what is not really needed to be robotic in the mainstream,” Dr. Hughes said. “Then they come out with less experience with straight stick laparoscopy and we’ve certainly seen lots of problems in the laparoscopic range for people once they get to the point that they have to convert to open. We really don’t have a large volume of trainee experience in complex open surgery. That’s a big problem. Robotics certainly isn’t going to make that a lot better.”  

[email protected]

CHICAGO – Patients receiving the LINX magnetic sphincter device for gastroesophageal reflux disease (GERD) at a community hospital have outcomes comparable with those achieved at the best academic centers, a study suggests.

“This is a safe and effective operation that, importantly, is very reproducible in the community setting,” Dr. F. Paul “Tripp” Buckley III said at the annual clinical congress of the American College of Surgeons. “Unlike a Nissen [fundoplication] where you have to have 50 [surgeries completed] to be considered an expert and then do over 35 a year to continue to have great outcomes, this is a highly teachable event and can be employed out in the community with little hesitation.”

Courtesy of Torax Medical Inc.

The magnetic sphincter augmentation device (LINX, Torax Medical) was approved in the United States in 2012 for the treatment of GERD and consists of a series of interlinked titanium-encased magnets implanted laparoscopically around the esophagus. The magnets augment a weak lower esophageal sphincter and avoid some of the complications of fundoplication, said Dr. Buckley, who disclosed serving as a proctor and speaker for Torax.

In the 5-year study leading to its approval, 64% of patients achieved the primary outcome of normalization of esophageal acid exposure or at least a 50% reduction in exposure at 1 year after sphincter augmentation and 93% of patients cut their use of proton-pump inhibitors (PPIs) by at least 50%. Six serious adverse events occurred (N Engl J Med. 2013;368:719-27).

Dr. Buckley, of Scott & White Health in Round Rock, Tex., and his associates evaluated their first 102 patients undergoing magnetic sphincter augmentation under general anesthesia at two community hospitals. GERD health-related quality of life (GERD-HRQL) scores were compared before and after surgery and overall results were compared with the clinical trial data. The highest possible total GERD-HRQL score is 75 (worst symptoms) and lowest score 0 (no symptoms).

The community and clinical trial cohorts were similar in age (median, 54 vs. 53 years), sex (both 52% male), median body mass index (both 28 kg/m²), and PPI use (98% vs. 100%), which was a requirement for trial entry.

After patients in the community underwent magnetic sphincter augmentation, PPI use decreased from 98% to 8%, median GERD-HRQL scores declined from 27 to 5, and patient satisfaction with GERD rose from 8% to 84%, which fell short of the satisfaction rate in the clinical trial (84% vs. 94%; P = .05), Dr. Buckley said.

Patrice Wendling/Frontline Medical News

The reduction in PPI use, however, was similar with that reported in the clinical trial, as was the percentage achieving at least 50% improvement in GERD-HRQL scores (86% vs. 92%), and operative times (median 49 vs. 36 minutes), he noted.

Device removal was rare at 1% in the community vs. 6% in the trial (P = .06).

Lower rates of dilation were noted in the community (9% vs. 19%; P = .04), perhaps because of refinements in technique and postoperative management, Dr. Buckley said.

“We know with this device you have to eat normally after implantation so that it will open and close within the scar capsule that’s naturally going to form,” he noted. “You have some patients that scar very tightly and you’ve got other patients that have a little bit of pain with eating and then suddenly they’re back on a liquid diet, which is a death knell for the success of this operation. So you really have to talk with these patients. I tell folks, ‘This is not a fix-it-and-forget-it type of operation.’ You’re going to get to know these patients pretty well, particularly in the early postoperative period.”

Final results recently reported with 5 years of follow-up in the clinical trial showed that 85% of patients were free from daily dependence on PPIs, heartburn was reduced from 89% to 12%, and moderate or severe regurgitation declined from 57% to 1.2%. No migrations or malfunctions occurred (J Laparoendosc Adv Surg Tech A. 2015 Oct;25[10]:787-92).

“One key aspect of this operation, and we think one of the reasons for its success and lack of migrations of the device, is that we keep the phrenoesophogeal ligament intact, so you are never in the mediastinum,” Dr. Buckley said. “For those of us who do a lot of Nissens, you end up blowing through it every time. But here when you keep it intact, you can roll it up on the distal esophagus and you can really reduce the hiatal hernia pretty significantly, even pretty large ones.”

A 3-cm cutoff was used for hiatal hernias in the trial and is recommended for early adoption in the community. A study is planned looking at hernias greater than 3 cm with no upper limit, where the minimal dissection method cannot reduce the hernia and full dissection is required, and the only requirement is that the patient have normal esophageal motility, he said.

Discussant Dr. Douglas Smink from Brigham and Women’s Hospital in Boston, said, “[There is a] lot of interest in this procedure obviously and it’s really nice to see what it’s like outside of the trials and to see your data is very similar.”

He went on to ask whether Dr. Buckley is still recommending fundoplication and, if so, in whom.

The LINX device has supplanted a classic Nissen fundoplication as the first-line operation in patients with good esophageal motility, although the device is not entirely covered by insurance, Dr. Buckley said.

“Basically, I tell patients I think it’s a marginally better operation. It’s not leaps and bounds, but it’s a marginally better operation,” he said, adding that though there has been concern about erosions, their erosion rate is zero and thus far, only seven erosions out of nearly 4,000 devices placed.

[email protected]

CHICAGO – Patients receiving the LINX magnetic sphincter device for gastroesophageal reflux disease (GERD) at a community hospital have outcomes comparable with those achieved at the best academic centers, a study suggests.

“This is a safe and effective operation that, importantly, is very reproducible in the community setting,” Dr. F. Paul “Tripp” Buckley III said at the annual clinical congress of the American College of Surgeons. “Unlike a Nissen [fundoplication] where you have to have 50 [surgeries completed] to be considered an expert and then do over 35 a year to continue to have great outcomes, this is a highly teachable event and can be employed out in the community with little hesitation.”

Courtesy of Torax Medical Inc.

The magnetic sphincter augmentation device (LINX, Torax Medical) was approved in the United States in 2012 for the treatment of GERD and consists of a series of interlinked titanium-encased magnets implanted laparoscopically around the esophagus. The magnets augment a weak lower esophageal sphincter and avoid some of the complications of fundoplication, said Dr. Buckley, who disclosed serving as a proctor and speaker for Torax.

In the 5-year study leading to its approval, 64% of patients achieved the primary outcome of normalization of esophageal acid exposure or at least a 50% reduction in exposure at 1 year after sphincter augmentation and 93% of patients cut their use of proton-pump inhibitors (PPIs) by at least 50%. Six serious adverse events occurred (N Engl J Med. 2013;368:719-27).

Dr. Buckley, of Scott & White Health in Round Rock, Tex., and his associates evaluated their first 102 patients undergoing magnetic sphincter augmentation under general anesthesia at two community hospitals. GERD health-related quality of life (GERD-HRQL) scores were compared before and after surgery and overall results were compared with the clinical trial data. The highest possible total GERD-HRQL score is 75 (worst symptoms) and lowest score 0 (no symptoms).

The community and clinical trial cohorts were similar in age (median, 54 vs. 53 years), sex (both 52% male), median body mass index (both 28 kg/m²), and PPI use (98% vs. 100%), which was a requirement for trial entry.

After patients in the community underwent magnetic sphincter augmentation, PPI use decreased from 98% to 8%, median GERD-HRQL scores declined from 27 to 5, and patient satisfaction with GERD rose from 8% to 84%, which fell short of the satisfaction rate in the clinical trial (84% vs. 94%; P = .05), Dr. Buckley said.

Patrice Wendling/Frontline Medical News

The reduction in PPI use, however, was similar with that reported in the clinical trial, as was the percentage achieving at least 50% improvement in GERD-HRQL scores (86% vs. 92%), and operative times (median 49 vs. 36 minutes), he noted.

Device removal was rare at 1% in the community vs. 6% in the trial (P = .06).

Lower rates of dilation were noted in the community (9% vs. 19%; P = .04), perhaps because of refinements in technique and postoperative management, Dr. Buckley said.

“We know with this device you have to eat normally after implantation so that it will open and close within the scar capsule that’s naturally going to form,” he noted. “You have some patients that scar very tightly and you’ve got other patients that have a little bit of pain with eating and then suddenly they’re back on a liquid diet, which is a death knell for the success of this operation. So you really have to talk with these patients. I tell folks, ‘This is not a fix-it-and-forget-it type of operation.’ You’re going to get to know these patients pretty well, particularly in the early postoperative period.”

Final results recently reported with 5 years of follow-up in the clinical trial showed that 85% of patients were free from daily dependence on PPIs, heartburn was reduced from 89% to 12%, and moderate or severe regurgitation declined from 57% to 1.2%. No migrations or malfunctions occurred (J Laparoendosc Adv Surg Tech A. 2015 Oct;25[10]:787-92).

“One key aspect of this operation, and we think one of the reasons for its success and lack of migrations of the device, is that we keep the phrenoesophogeal ligament intact, so you are never in the mediastinum,” Dr. Buckley said. “For those of us who do a lot of Nissens, you end up blowing through it every time. But here when you keep it intact, you can roll it up on the distal esophagus and you can really reduce the hiatal hernia pretty significantly, even pretty large ones.”

A 3-cm cutoff was used for hiatal hernias in the trial and is recommended for early adoption in the community. A study is planned looking at hernias greater than 3 cm with no upper limit, where the minimal dissection method cannot reduce the hernia and full dissection is required, and the only requirement is that the patient have normal esophageal motility, he said.

Discussant Dr. Douglas Smink from Brigham and Women’s Hospital in Boston, said, “[There is a] lot of interest in this procedure obviously and it’s really nice to see what it’s like outside of the trials and to see your data is very similar.”

He went on to ask whether Dr. Buckley is still recommending fundoplication and, if so, in whom.

The LINX device has supplanted a classic Nissen fundoplication as the first-line operation in patients with good esophageal motility, although the device is not entirely covered by insurance, Dr. Buckley said.

“Basically, I tell patients I think it’s a marginally better operation. It’s not leaps and bounds, but it’s a marginally better operation,” he said, adding that though there has been concern about erosions, their erosion rate is zero and thus far, only seven erosions out of nearly 4,000 devices placed.

[email protected]

CHICAGO – Patients receiving the LINX magnetic sphincter device for gastroesophageal reflux disease (GERD) at a community hospital have outcomes comparable with those achieved at the best academic centers, a study suggests.

“This is a safe and effective operation that, importantly, is very reproducible in the community setting,” Dr. F. Paul “Tripp” Buckley III said at the annual clinical congress of the American College of Surgeons. “Unlike a Nissen [fundoplication] where you have to have 50 [surgeries completed] to be considered an expert and then do over 35 a year to continue to have great outcomes, this is a highly teachable event and can be employed out in the community with little hesitation.”

Courtesy of Torax Medical Inc.

The magnetic sphincter augmentation device (LINX, Torax Medical) was approved in the United States in 2012 for the treatment of GERD and consists of a series of interlinked titanium-encased magnets implanted laparoscopically around the esophagus. The magnets augment a weak lower esophageal sphincter and avoid some of the complications of fundoplication, said Dr. Buckley, who disclosed serving as a proctor and speaker for Torax.

In the 5-year study leading to its approval, 64% of patients achieved the primary outcome of normalization of esophageal acid exposure or at least a 50% reduction in exposure at 1 year after sphincter augmentation and 93% of patients cut their use of proton-pump inhibitors (PPIs) by at least 50%. Six serious adverse events occurred (N Engl J Med. 2013;368:719-27).

Dr. Buckley, of Scott & White Health in Round Rock, Tex., and his associates evaluated their first 102 patients undergoing magnetic sphincter augmentation under general anesthesia at two community hospitals. GERD health-related quality of life (GERD-HRQL) scores were compared before and after surgery and overall results were compared with the clinical trial data. The highest possible total GERD-HRQL score is 75 (worst symptoms) and lowest score 0 (no symptoms).

The community and clinical trial cohorts were similar in age (median, 54 vs. 53 years), sex (both 52% male), median body mass index (both 28 kg/m²), and PPI use (98% vs. 100%), which was a requirement for trial entry.

After patients in the community underwent magnetic sphincter augmentation, PPI use decreased from 98% to 8%, median GERD-HRQL scores declined from 27 to 5, and patient satisfaction with GERD rose from 8% to 84%, which fell short of the satisfaction rate in the clinical trial (84% vs. 94%; P = .05), Dr. Buckley said.

Patrice Wendling/Frontline Medical News

The reduction in PPI use, however, was similar with that reported in the clinical trial, as was the percentage achieving at least 50% improvement in GERD-HRQL scores (86% vs. 92%), and operative times (median 49 vs. 36 minutes), he noted.

Device removal was rare at 1% in the community vs. 6% in the trial (P = .06).

Lower rates of dilation were noted in the community (9% vs. 19%; P = .04), perhaps because of refinements in technique and postoperative management, Dr. Buckley said.

“We know with this device you have to eat normally after implantation so that it will open and close within the scar capsule that’s naturally going to form,” he noted. “You have some patients that scar very tightly and you’ve got other patients that have a little bit of pain with eating and then suddenly they’re back on a liquid diet, which is a death knell for the success of this operation. So you really have to talk with these patients. I tell folks, ‘This is not a fix-it-and-forget-it type of operation.’ You’re going to get to know these patients pretty well, particularly in the early postoperative period.”

Final results recently reported with 5 years of follow-up in the clinical trial showed that 85% of patients were free from daily dependence on PPIs, heartburn was reduced from 89% to 12%, and moderate or severe regurgitation declined from 57% to 1.2%. No migrations or malfunctions occurred (J Laparoendosc Adv Surg Tech A. 2015 Oct;25[10]:787-92).

“One key aspect of this operation, and we think one of the reasons for its success and lack of migrations of the device, is that we keep the phrenoesophogeal ligament intact, so you are never in the mediastinum,” Dr. Buckley said. “For those of us who do a lot of Nissens, you end up blowing through it every time. But here when you keep it intact, you can roll it up on the distal esophagus and you can really reduce the hiatal hernia pretty significantly, even pretty large ones.”

A 3-cm cutoff was used for hiatal hernias in the trial and is recommended for early adoption in the community. A study is planned looking at hernias greater than 3 cm with no upper limit, where the minimal dissection method cannot reduce the hernia and full dissection is required, and the only requirement is that the patient have normal esophageal motility, he said.

Discussant Dr. Douglas Smink from Brigham and Women’s Hospital in Boston, said, “[There is a] lot of interest in this procedure obviously and it’s really nice to see what it’s like outside of the trials and to see your data is very similar.”

He went on to ask whether Dr. Buckley is still recommending fundoplication and, if so, in whom.

The LINX device has supplanted a classic Nissen fundoplication as the first-line operation in patients with good esophageal motility, although the device is not entirely covered by insurance, Dr. Buckley said.

“Basically, I tell patients I think it’s a marginally better operation. It’s not leaps and bounds, but it’s a marginally better operation,” he said, adding that though there has been concern about erosions, their erosion rate is zero and thus far, only seven erosions out of nearly 4,000 devices placed.

[email protected]

Medication errors or adverse drug events after surgery occur in as many as one in twenty perioperative medication administrations, according to data published online in the journal Anesthesiology.

A prospective observational study of 277 surgical operations and 3,671 medication administrations found 193 cases (5.3%) involved a medication error or adverse drug event, nearly four-fifths (79.3%) of which were preventable and 68.9% of which were serious (Anesthesiology. 2015 Oct. doi:10.1097/ALN.0000000000000904).

Among the 51 medication errors that led to adverse reactions, nearly half were the result of inappropriate medication doses and 31.4% were due to omitted medications or failure to act, but the most common overall error type was a labeling error.

The medications most commonly associated with errors were propofol, phenylephrine, and fentanyl, and operations greater than 6 hours in duration or with 13 or more medication administrations were associated with a significantly greater risk of errors.

“Examples of technology-based interventions [to minimize perioperative MEs and/or ADEs] include bar code–assisted syringe labeling systems, point-of-care bar code–assisted anesthesia documentation systems, specific drug decision support, and alerts,” wrote the study’s lead author Dr. Karen C. Nanji of Massachusetts General Hospital in Boston, and her coauthors.

The study was supported by the Doctors Company Foundation and the National Institute of General Medical Sciences of the National Institutes of Health. One coauthor – Dr. David Bates – declared financial interests in medical decision support software, as well as funding and positions with a variety of medical technology companies.

Medication errors or adverse drug events after surgery occur in as many as one in twenty perioperative medication administrations, according to data published online in the journal Anesthesiology.

A prospective observational study of 277 surgical operations and 3,671 medication administrations found 193 cases (5.3%) involved a medication error or adverse drug event, nearly four-fifths (79.3%) of which were preventable and 68.9% of which were serious (Anesthesiology. 2015 Oct. doi:10.1097/ALN.0000000000000904).

Among the 51 medication errors that led to adverse reactions, nearly half were the result of inappropriate medication doses and 31.4% were due to omitted medications or failure to act, but the most common overall error type was a labeling error.

The medications most commonly associated with errors were propofol, phenylephrine, and fentanyl, and operations greater than 6 hours in duration or with 13 or more medication administrations were associated with a significantly greater risk of errors.

“Examples of technology-based interventions [to minimize perioperative MEs and/or ADEs] include bar code–assisted syringe labeling systems, point-of-care bar code–assisted anesthesia documentation systems, specific drug decision support, and alerts,” wrote the study’s lead author Dr. Karen C. Nanji of Massachusetts General Hospital in Boston, and her coauthors.

The study was supported by the Doctors Company Foundation and the National Institute of General Medical Sciences of the National Institutes of Health. One coauthor – Dr. David Bates – declared financial interests in medical decision support software, as well as funding and positions with a variety of medical technology companies.

Medication errors or adverse drug events after surgery occur in as many as one in twenty perioperative medication administrations, according to data published online in the journal Anesthesiology.

A prospective observational study of 277 surgical operations and 3,671 medication administrations found 193 cases (5.3%) involved a medication error or adverse drug event, nearly four-fifths (79.3%) of which were preventable and 68.9% of which were serious (Anesthesiology. 2015 Oct. doi:10.1097/ALN.0000000000000904).

Among the 51 medication errors that led to adverse reactions, nearly half were the result of inappropriate medication doses and 31.4% were due to omitted medications or failure to act, but the most common overall error type was a labeling error.

The medications most commonly associated with errors were propofol, phenylephrine, and fentanyl, and operations greater than 6 hours in duration or with 13 or more medication administrations were associated with a significantly greater risk of errors.

“Examples of technology-based interventions [to minimize perioperative MEs and/or ADEs] include bar code–assisted syringe labeling systems, point-of-care bar code–assisted anesthesia documentation systems, specific drug decision support, and alerts,” wrote the study’s lead author Dr. Karen C. Nanji of Massachusetts General Hospital in Boston, and her coauthors.

The study was supported by the Doctors Company Foundation and the National Institute of General Medical Sciences of the National Institutes of Health. One coauthor – Dr. David Bates – declared financial interests in medical decision support software, as well as funding and positions with a variety of medical technology companies.

Concurrent colorectal surgery and mesh herniorrhaphy can be done safely, according to findings from a case-matched study based on American College of Surgeons National Surgical Quality Improvement Program data.

“Our study suggests that mesh repair for [ventral hernia] in the setting of [colorectal surgery] does not worsen 30-day postoperative outcomes,” wrote Dr. Cigdem Benlice and colleagues of the Cleveland Clinic. The study was published in the American Journal of Surgery (2015; 210[4]:766-771]

These two operations are undertaken concurrently in part to save patients from further procedures and anesthesia, but the practice is limited by safety concerns. The complications anticipated include intra-abdominal adhesions, chronic draining sinus, chronic enteric fistula, chronic wound infection, and mesh migration. Any one of these complications could entail further surgical interventions.

Dr. Benlice and her colleagues used the national, validated, risk-adjusted American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database to look at short-term outcomes after concurrent ventral hernia repair (VHR) and colorectal surgery (CS), and the risk factors associated with complications. Data on 2,250 patients having CS and VHR operations simultaneously from 2005 to 2010 were reviewed. Patients having simultaneous VHR with mesh and CS (262) were matched closely with those having both procedures but without mesh (524). The case-matching criteria included diagnosis, type of bowel procedure, and American Society of Anesthesiologists (ASA) class, and follow-up was limited to 30 days.

In a comparison of the mesh and nonmesh groups, morbidity rates were found to be similar (32% vs. 30%, P = .58) as were mortality rates (3.4% vs. 2.1%, P = .27). The rate of deep surgical site infections (3.8% vs. 2.7%, P = .38) were similar between the two groups, and wound disruptions (3.1% vs. 3.1%) rates were the same. The length of hospital stay was also comparable. Mean operating time, however, proved longer in patients who had hernia repair using mesh (196 minutes vs. 164 minutes, P less than .001).

A multivariate analysis showed that open colorectal procedures, III or IV ASA class, smoking, and preoperative open wound or wound infection were significant and independent risk factors (odds ratios, 2.67, 2.51, 2.06, and 2.27, respectively) for surgical site infection.

The limitations of this study reflect some of the limitations of the ACS-NSQIP database. Long-term follow-up, hernia size, type of mesh used, and type of technique used in the operation could not be assessed using the available data. In addition, further analysis of the subgroups of patients with surgical site infections would be needed to examine the impact of mesh (and types of mesh) use on clean-contaminated cases. Researchers noted that at the Cleveland Clinic, type of mesh (biologic vs. nonbiologic) used has been found to have no impact on rates of wound and mesh infection and hernia recurrence, but they were unable to do this kind of analysis with the available data for simultaneous bowel and hernia repair surgery.

The researchers concluded, “the large cohort and strict inclusion, exclusion, and case-matching criteria strengthen the clinical value of this study. When performed simultaneously with CS, VHR with mesh can be performed without increasing perioperative and short-term postoperative morbidity.”

The researchers had no relevant disclosures.

Concurrent colorectal surgery and mesh herniorrhaphy can be done safely, according to findings from a case-matched study based on American College of Surgeons National Surgical Quality Improvement Program data.

“Our study suggests that mesh repair for [ventral hernia] in the setting of [colorectal surgery] does not worsen 30-day postoperative outcomes,” wrote Dr. Cigdem Benlice and colleagues of the Cleveland Clinic. The study was published in the American Journal of Surgery (2015; 210[4]:766-771]

These two operations are undertaken concurrently in part to save patients from further procedures and anesthesia, but the practice is limited by safety concerns. The complications anticipated include intra-abdominal adhesions, chronic draining sinus, chronic enteric fistula, chronic wound infection, and mesh migration. Any one of these complications could entail further surgical interventions.

Dr. Benlice and her colleagues used the national, validated, risk-adjusted American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database to look at short-term outcomes after concurrent ventral hernia repair (VHR) and colorectal surgery (CS), and the risk factors associated with complications. Data on 2,250 patients having CS and VHR operations simultaneously from 2005 to 2010 were reviewed. Patients having simultaneous VHR with mesh and CS (262) were matched closely with those having both procedures but without mesh (524). The case-matching criteria included diagnosis, type of bowel procedure, and American Society of Anesthesiologists (ASA) class, and follow-up was limited to 30 days.

In a comparison of the mesh and nonmesh groups, morbidity rates were found to be similar (32% vs. 30%, P = .58) as were mortality rates (3.4% vs. 2.1%, P = .27). The rate of deep surgical site infections (3.8% vs. 2.7%, P = .38) were similar between the two groups, and wound disruptions (3.1% vs. 3.1%) rates were the same. The length of hospital stay was also comparable. Mean operating time, however, proved longer in patients who had hernia repair using mesh (196 minutes vs. 164 minutes, P less than .001).

A multivariate analysis showed that open colorectal procedures, III or IV ASA class, smoking, and preoperative open wound or wound infection were significant and independent risk factors (odds ratios, 2.67, 2.51, 2.06, and 2.27, respectively) for surgical site infection.

The limitations of this study reflect some of the limitations of the ACS-NSQIP database. Long-term follow-up, hernia size, type of mesh used, and type of technique used in the operation could not be assessed using the available data. In addition, further analysis of the subgroups of patients with surgical site infections would be needed to examine the impact of mesh (and types of mesh) use on clean-contaminated cases. Researchers noted that at the Cleveland Clinic, type of mesh (biologic vs. nonbiologic) used has been found to have no impact on rates of wound and mesh infection and hernia recurrence, but they were unable to do this kind of analysis with the available data for simultaneous bowel and hernia repair surgery.

The researchers concluded, “the large cohort and strict inclusion, exclusion, and case-matching criteria strengthen the clinical value of this study. When performed simultaneously with CS, VHR with mesh can be performed without increasing perioperative and short-term postoperative morbidity.”

The researchers had no relevant disclosures.

Concurrent colorectal surgery and mesh herniorrhaphy can be done safely, according to findings from a case-matched study based on American College of Surgeons National Surgical Quality Improvement Program data.

“Our study suggests that mesh repair for [ventral hernia] in the setting of [colorectal surgery] does not worsen 30-day postoperative outcomes,” wrote Dr. Cigdem Benlice and colleagues of the Cleveland Clinic. The study was published in the American Journal of Surgery (2015; 210[4]:766-771]

These two operations are undertaken concurrently in part to save patients from further procedures and anesthesia, but the practice is limited by safety concerns. The complications anticipated include intra-abdominal adhesions, chronic draining sinus, chronic enteric fistula, chronic wound infection, and mesh migration. Any one of these complications could entail further surgical interventions.

Dr. Benlice and her colleagues used the national, validated, risk-adjusted American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database to look at short-term outcomes after concurrent ventral hernia repair (VHR) and colorectal surgery (CS), and the risk factors associated with complications. Data on 2,250 patients having CS and VHR operations simultaneously from 2005 to 2010 were reviewed. Patients having simultaneous VHR with mesh and CS (262) were matched closely with those having both procedures but without mesh (524). The case-matching criteria included diagnosis, type of bowel procedure, and American Society of Anesthesiologists (ASA) class, and follow-up was limited to 30 days.

In a comparison of the mesh and nonmesh groups, morbidity rates were found to be similar (32% vs. 30%, P = .58) as were mortality rates (3.4% vs. 2.1%, P = .27). The rate of deep surgical site infections (3.8% vs. 2.7%, P = .38) were similar between the two groups, and wound disruptions (3.1% vs. 3.1%) rates were the same. The length of hospital stay was also comparable. Mean operating time, however, proved longer in patients who had hernia repair using mesh (196 minutes vs. 164 minutes, P less than .001).

A multivariate analysis showed that open colorectal procedures, III or IV ASA class, smoking, and preoperative open wound or wound infection were significant and independent risk factors (odds ratios, 2.67, 2.51, 2.06, and 2.27, respectively) for surgical site infection.

The limitations of this study reflect some of the limitations of the ACS-NSQIP database. Long-term follow-up, hernia size, type of mesh used, and type of technique used in the operation could not be assessed using the available data. In addition, further analysis of the subgroups of patients with surgical site infections would be needed to examine the impact of mesh (and types of mesh) use on clean-contaminated cases. Researchers noted that at the Cleveland Clinic, type of mesh (biologic vs. nonbiologic) used has been found to have no impact on rates of wound and mesh infection and hernia recurrence, but they were unable to do this kind of analysis with the available data for simultaneous bowel and hernia repair surgery.

The researchers concluded, “the large cohort and strict inclusion, exclusion, and case-matching criteria strengthen the clinical value of this study. When performed simultaneously with CS, VHR with mesh can be performed without increasing perioperative and short-term postoperative morbidity.”

The researchers had no relevant disclosures.

Obesity has been officially declared a global epidemic by the World Health Organization. In virtually every region of the world, obesity’s adverse health effects are a well-documented public health crisis that affects people of all ages. In light of poor long-term weight management reported in most traditional diet strategies, attention has shifted to gastric bypass surgery as an effective treatment option for obesity.

Bariatric weight loss procedures are associated with numerous health benefits in patients: dramatic weight loss, rapid improvement in blood glucose levels, blood pressure stabilization, and resolution of obesity-related orthopedic problems. It’s not surprising, then, that gastric bypass surgery is a life-changing event for many patients.

Recently however, it has become clear that “life-changing” interventions do not always mean happy endings. Alongside these encouraging postsurgical outcomes are alarming counterintuitive reports of increased self-harm events. A recent study published in JAMA Surgery by Junaid A. Bhatti, Ph.D., of the department of evaluative clinical sciences, Sunnybrook Research Institute, Toronto, and the department of surgery, University of Toronto, and colleagues reported an increase in suicide attempts among postoperative gastric bypass patients (JAMA Surg. 2015 Oct 7. doi: 10.1001/jamasurg.2015.3414). The study conducted at Sunnybrook found that the rate of self-harm emergencies from attempted suicide was four times higher in these patients, compared with the general population.

Most gastric bypass surgery programs require a pre-op mental health evaluation. This is not enough, according to Dr. Peter F. Crookes, associate professor* of Bariatric Surgery at Keck Hospital of the University of Southern California, Los Angeles. Dr. Crookes’s clinical experiences and my (Dr. Baron’s) 20-plus years of conducting psychiatric evaluations on bypass patients have revealed more vexing issues regarding psychiatric illnesses occurring in morbidly obese patients. The requirement has been established for presurgical psychiatric assessment, but long-term post-surgical emotional and behavioral challenges need to be evaluated as well. In addition to primary mental illness, obese patients are at risk for stress-related exacerbations of preexisting psychopathology. After a body-altering surgical procedure like gastric bypass, maladaptive coping strategies are likely to complicate a patient’s physical AND emotional long-term recovery.

Many factors play into the development of these psychiatric symptoms, not the least of which are coping and emotional support systems. Literature on obesity and psychiatry has revealed connections between weight status and issues, such as childhood trauma, especially sexual abuse in childhood. While some patients claim that their weight loss surgery was the best thing they ever did for themselves, other patients have reported to me after significant weight loss: “I feel like a fat person trapped in a skinny body.” This surgery is not just body altering but can be identity altering. Patients also have reported relationship issues after significant weight loss. Relationship dynamics for both partners can become strained as a result of perceived changes in sexual attractiveness.

Given the short- and long-term consequences, it is essential for psychiatrists and other mental health care providers to work closely with the bypass surgical team at 1 month, 3 months, and 1-year postsurgical follow-up visits. These follow-ups are particularly important for patients who experience depression, relationship stress, or worsened psychiatric symptoms. In 2004, Dr. Crookes coauthored a then controversial study concerning bariatric surgery for obese patients with a formal diagnosis of schizophrenia or schizoaffective disorder (Obes Surg. 2004 Mar;14[3]:349-52). Historically, bariatric surgeons had avoided operating on these patients. However, his study showed that when psychotic symptoms were controlled postoperatively, these patients’ weight loss results were comparable to those of nonpsychotic patients.

Quality of life after gastric bypass depends on much more than a decrease in the number on the scale or clothing label. These reports demonstrate that psychiatrists play an important role in the overall biopsychosocial outcome of the patient.

Dr. Baron is professor of clinical psychiatry and interim chair of the department of psychiatry at the University of Southern California, Los Angeles. He also serves as director of the Global Center for Exercise, Psychiatry and Sports at USC. Ms. In addition, Dr. Baron is former chair of the department of psychiatry at Temple University, Philadelphia, where he directed the psychiatric component of the Bariatric Surgery program. Ms. Uno is a third-year medical student at USC.

*Correction, 10/29/2015: An earlier version of this story misstated the title of Dr. Crookes.

Obesity has been officially declared a global epidemic by the World Health Organization. In virtually every region of the world, obesity’s adverse health effects are a well-documented public health crisis that affects people of all ages. In light of poor long-term weight management reported in most traditional diet strategies, attention has shifted to gastric bypass surgery as an effective treatment option for obesity.

Bariatric weight loss procedures are associated with numerous health benefits in patients: dramatic weight loss, rapid improvement in blood glucose levels, blood pressure stabilization, and resolution of obesity-related orthopedic problems. It’s not surprising, then, that gastric bypass surgery is a life-changing event for many patients.

Recently however, it has become clear that “life-changing” interventions do not always mean happy endings. Alongside these encouraging postsurgical outcomes are alarming counterintuitive reports of increased self-harm events. A recent study published in JAMA Surgery by Junaid A. Bhatti, Ph.D., of the department of evaluative clinical sciences, Sunnybrook Research Institute, Toronto, and the department of surgery, University of Toronto, and colleagues reported an increase in suicide attempts among postoperative gastric bypass patients (JAMA Surg. 2015 Oct 7. doi: 10.1001/jamasurg.2015.3414). The study conducted at Sunnybrook found that the rate of self-harm emergencies from attempted suicide was four times higher in these patients, compared with the general population.

Most gastric bypass surgery programs require a pre-op mental health evaluation. This is not enough, according to Dr. Peter F. Crookes, associate professor* of Bariatric Surgery at Keck Hospital of the University of Southern California, Los Angeles. Dr. Crookes’s clinical experiences and my (Dr. Baron’s) 20-plus years of conducting psychiatric evaluations on bypass patients have revealed more vexing issues regarding psychiatric illnesses occurring in morbidly obese patients. The requirement has been established for presurgical psychiatric assessment, but long-term post-surgical emotional and behavioral challenges need to be evaluated as well. In addition to primary mental illness, obese patients are at risk for stress-related exacerbations of preexisting psychopathology. After a body-altering surgical procedure like gastric bypass, maladaptive coping strategies are likely to complicate a patient’s physical AND emotional long-term recovery.

Many factors play into the development of these psychiatric symptoms, not the least of which are coping and emotional support systems. Literature on obesity and psychiatry has revealed connections between weight status and issues, such as childhood trauma, especially sexual abuse in childhood. While some patients claim that their weight loss surgery was the best thing they ever did for themselves, other patients have reported to me after significant weight loss: “I feel like a fat person trapped in a skinny body.” This surgery is not just body altering but can be identity altering. Patients also have reported relationship issues after significant weight loss. Relationship dynamics for both partners can become strained as a result of perceived changes in sexual attractiveness.

Given the short- and long-term consequences, it is essential for psychiatrists and other mental health care providers to work closely with the bypass surgical team at 1 month, 3 months, and 1-year postsurgical follow-up visits. These follow-ups are particularly important for patients who experience depression, relationship stress, or worsened psychiatric symptoms. In 2004, Dr. Crookes coauthored a then controversial study concerning bariatric surgery for obese patients with a formal diagnosis of schizophrenia or schizoaffective disorder (Obes Surg. 2004 Mar;14[3]:349-52). Historically, bariatric surgeons had avoided operating on these patients. However, his study showed that when psychotic symptoms were controlled postoperatively, these patients’ weight loss results were comparable to those of nonpsychotic patients.

Quality of life after gastric bypass depends on much more than a decrease in the number on the scale or clothing label. These reports demonstrate that psychiatrists play an important role in the overall biopsychosocial outcome of the patient.

Dr. Baron is professor of clinical psychiatry and interim chair of the department of psychiatry at the University of Southern California, Los Angeles. He also serves as director of the Global Center for Exercise, Psychiatry and Sports at USC. Ms. In addition, Dr. Baron is former chair of the department of psychiatry at Temple University, Philadelphia, where he directed the psychiatric component of the Bariatric Surgery program. Ms. Uno is a third-year medical student at USC.

*Correction, 10/29/2015: An earlier version of this story misstated the title of Dr. Crookes.

Obesity has been officially declared a global epidemic by the World Health Organization. In virtually every region of the world, obesity’s adverse health effects are a well-documented public health crisis that affects people of all ages. In light of poor long-term weight management reported in most traditional diet strategies, attention has shifted to gastric bypass surgery as an effective treatment option for obesity.

Bariatric weight loss procedures are associated with numerous health benefits in patients: dramatic weight loss, rapid improvement in blood glucose levels, blood pressure stabilization, and resolution of obesity-related orthopedic problems. It’s not surprising, then, that gastric bypass surgery is a life-changing event for many patients.

Recently however, it has become clear that “life-changing” interventions do not always mean happy endings. Alongside these encouraging postsurgical outcomes are alarming counterintuitive reports of increased self-harm events. A recent study published in JAMA Surgery by Junaid A. Bhatti, Ph.D., of the department of evaluative clinical sciences, Sunnybrook Research Institute, Toronto, and the department of surgery, University of Toronto, and colleagues reported an increase in suicide attempts among postoperative gastric bypass patients (JAMA Surg. 2015 Oct 7. doi: 10.1001/jamasurg.2015.3414). The study conducted at Sunnybrook found that the rate of self-harm emergencies from attempted suicide was four times higher in these patients, compared with the general population.

Most gastric bypass surgery programs require a pre-op mental health evaluation. This is not enough, according to Dr. Peter F. Crookes, associate professor* of Bariatric Surgery at Keck Hospital of the University of Southern California, Los Angeles. Dr. Crookes’s clinical experiences and my (Dr. Baron’s) 20-plus years of conducting psychiatric evaluations on bypass patients have revealed more vexing issues regarding psychiatric illnesses occurring in morbidly obese patients. The requirement has been established for presurgical psychiatric assessment, but long-term post-surgical emotional and behavioral challenges need to be evaluated as well. In addition to primary mental illness, obese patients are at risk for stress-related exacerbations of preexisting psychopathology. After a body-altering surgical procedure like gastric bypass, maladaptive coping strategies are likely to complicate a patient’s physical AND emotional long-term recovery.

Many factors play into the development of these psychiatric symptoms, not the least of which are coping and emotional support systems. Literature on obesity and psychiatry has revealed connections between weight status and issues, such as childhood trauma, especially sexual abuse in childhood. While some patients claim that their weight loss surgery was the best thing they ever did for themselves, other patients have reported to me after significant weight loss: “I feel like a fat person trapped in a skinny body.” This surgery is not just body altering but can be identity altering. Patients also have reported relationship issues after significant weight loss. Relationship dynamics for both partners can become strained as a result of perceived changes in sexual attractiveness.

Given the short- and long-term consequences, it is essential for psychiatrists and other mental health care providers to work closely with the bypass surgical team at 1 month, 3 months, and 1-year postsurgical follow-up visits. These follow-ups are particularly important for patients who experience depression, relationship stress, or worsened psychiatric symptoms. In 2004, Dr. Crookes coauthored a then controversial study concerning bariatric surgery for obese patients with a formal diagnosis of schizophrenia or schizoaffective disorder (Obes Surg. 2004 Mar;14[3]:349-52). Historically, bariatric surgeons had avoided operating on these patients. However, his study showed that when psychotic symptoms were controlled postoperatively, these patients’ weight loss results were comparable to those of nonpsychotic patients.

Quality of life after gastric bypass depends on much more than a decrease in the number on the scale or clothing label. These reports demonstrate that psychiatrists play an important role in the overall biopsychosocial outcome of the patient.

Dr. Baron is professor of clinical psychiatry and interim chair of the department of psychiatry at the University of Southern California, Los Angeles. He also serves as director of the Global Center for Exercise, Psychiatry and Sports at USC. Ms. In addition, Dr. Baron is former chair of the department of psychiatry at Temple University, Philadelphia, where he directed the psychiatric component of the Bariatric Surgery program. Ms. Uno is a third-year medical student at USC.

*Correction, 10/29/2015: An earlier version of this story misstated the title of Dr. Crookes.

An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.

A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.

Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.

The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.

In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”

Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).

[email protected]

An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.

A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.

Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.

The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.

In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”

Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).

[email protected]

An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.

A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.

Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.

The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.

In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”

Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).

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