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The drive to cut readmissions after bariatric surgery continues with DROP project
SAN DIEGO – John Morton, MD, started his bariatric surgery career about the same time that demand for gastric bypass and other bariatric procedures began to skyrocket. But a troubling trend emerged.
“About 10-15 years ago, bariatric surgery had a problem when it came to mortality,” Dr. Morton said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. “You can’t move forward without looking back.”
A 2005 study of early mortality among Medicare beneficiaries undergoing bariatric procedures found a 30-day mortality of 9% and a 1-year mortality of 21% (JAMA 2005 Oct. 19;294[15]:1903-8). Such data prompted Dr. Morton and other leaders in the field to push for accreditation in the field. In 2012, the ACS Bariatric Surgery Center Network program and the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Centers of Excellence program were extended accreditation in the joint Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). As a result, the mortality rate among patients undergoing bariatric procedures has dropped nearly 10-fold and now stands at 1 out of 1,000, said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. “That’s been a real success story for us,” he said. “Part of it has been the accreditation program, having the resources in place to accomplish those goals.”
Of the 802 participating centers in MBSAQIP, 647 are accredited. “One of the reasons we see such good results at accredited centers is the fact that they work as a multidisciplinary team, where you have the nutritionist, the psychologist, the internist, and the anesthesiologist working together,” said Dr. Morton, immediate past president of the American Society for Metabolic and Bariatric Surgery. “When you have that team, it allows you to marshal your resources, do appropriate risk assessment, and get those processes in place to have the very best outcomes.”
In an effort to reduce hospital readmissions among bariatric surgery patients, MBSAQIP launched a national project called Decreasing Readmissions through Opportunities Provided (DROP), which currently has 129 participating hospitals. “If you drill down on the reasons for bariatric surgery readmissions, many are preventable: dehydration, nausea, medication side effects, and patient expectations,” Dr. Morton said. “I have a formula called the Morton Formula: happiness equals reality divided by expectations. If you set expectations accordingly, you’ll get a happier patient. If my patients know they’re going to be discharged in 1 day, they can plan accordingly.”
These concepts were adopted from a study that Dr. Morton and his associates carried out at Stanford Health Care in an effort to reduce readmissions for complications within 30 days to below the national average. It involved “straightforward” strategy including improving patient education, discharge planning, and giving patients a direct phone number to call. “Anybody who has called a health center and has had to go through that phone tree knows how difficult that can be, so we provide a direct number,” he said. “The postop phone call is critical, because that’s a way to nip readmissions in the bud. We do same-day appointments so they come and see us in the clinic rather than going to the ER and getting the enormous workup. Infusion centers are our best friend, because many of these patients come in dehydrated.”
After implementing these strategies, the rate of readmission for complications at Stanford fell from 8% to 2.5%. This led to the creation of a readmission bundle for the DROP project with steps for preoperative, intraoperative, and postoperative aspects of care. For example, preoperatively, “we make sure that they have a postop appointment made [and] rather than waiting to give them a prescription when they get discharged, we make sure that they have those prescriptions earlier at the preoperative visit,” he said. “They are provided the clinic phone number and patients watch video vignettes from all members of the team: surgeon, nurse, nutritionist, pharmacist, and psychologist. Rather than the education being dependent on [the surgeon’s schedule], they can get the same dose of education and even watch these over and over again if they want to.”
Surgeons who participate in the DROP project also stratify high-risk patients by consulting with their primary care physicians and case managers to achieve optimal outcomes. They address modifiable risk factors. “Weight gain prior to bariatric surgery is not ideal, so we want to address that, and have a hemoglobin A1c of less than 10%,” Dr. Morton said. Patients receive a “HELP” card, which instructs them to contact the treating clinic if they have abdominal pain, dehydration, nausea and vomiting, diarrhea, and fatigue.
The inpatient part of the bundle includes a “clinical roadmap” with a fixed length of stay. “There are expectations every single day about what’s going to happen to their care,” Dr. Morton said. “We give them a water bottle with the logo of the hospital. It’s a reminder for them to stay hydrated. They have a nutritional consult and they go through a checklist before they get discharged.”
The postoperative component of the DROP bundle includes a phone call to the patient following discharge. “They also get an appointment with a nutritionist within a month of surgery,” he said. “We treat readmissions seriously, like a complication.”
Data from a study of 18,296 primary bariatric surgery patients gleaned from 2012 ACS-NSQIP Participant Use Data Files found a 30-day readmission rate of 5.2% (Am J Surg 2016 Jul;212[1]:76-80). Compared with the patients’ counterparts who did not require readmission within 30 days, risk factors for those who did included body mass index greater than 50 kg/m2 (30.2% vs. 24.6%, respectively; P = .001); longer operative time (132 vs. 115 minutes; P = .001); length of stay greater than 4 days (9.57% vs. 3.36%; P = .001); surgical site infection (15.5% vs. 1.15%; P less than .001); urinary tract infection (3.15% vs. .65%; P less than .001), and deep vein thrombosis (3.58% vs. .13%; P less than .001). Common reasons for readmissions were GI-related (45%), dietary (33.5%), and bleeding (6.57%). Dr. Morton went on to report preliminary findings from 19,648 cases included in the DROP project, which began collecting data in March 2015 and has a yearlong goal of reducing national admission rates by 20%. The preintervention readmission rate was 4.79%. By the end of October 2015 the readmission rate had dropped to 4.30%. “One of the things we realized is that the hospitals with the higher readmission rates were the ones who had the greatest improvement,” Dr. Morton said. “They went from about 8% down to about 5.51%. We anticipate that for each quarter that we do this, we’ll continue to see improvement.”
Individual center results were made available in late January 2016 and reviewed with mentors. “They also received aggregated reports to see how they stacked up others as a benchmark,” Dr. Morton said.
Final results from DROP are expected to be released later in 2016.
Dr. Morton reported having no financial disclosures.
SAN DIEGO – John Morton, MD, started his bariatric surgery career about the same time that demand for gastric bypass and other bariatric procedures began to skyrocket. But a troubling trend emerged.
“About 10-15 years ago, bariatric surgery had a problem when it came to mortality,” Dr. Morton said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. “You can’t move forward without looking back.”
A 2005 study of early mortality among Medicare beneficiaries undergoing bariatric procedures found a 30-day mortality of 9% and a 1-year mortality of 21% (JAMA 2005 Oct. 19;294[15]:1903-8). Such data prompted Dr. Morton and other leaders in the field to push for accreditation in the field. In 2012, the ACS Bariatric Surgery Center Network program and the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Centers of Excellence program were extended accreditation in the joint Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). As a result, the mortality rate among patients undergoing bariatric procedures has dropped nearly 10-fold and now stands at 1 out of 1,000, said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. “That’s been a real success story for us,” he said. “Part of it has been the accreditation program, having the resources in place to accomplish those goals.”
Of the 802 participating centers in MBSAQIP, 647 are accredited. “One of the reasons we see such good results at accredited centers is the fact that they work as a multidisciplinary team, where you have the nutritionist, the psychologist, the internist, and the anesthesiologist working together,” said Dr. Morton, immediate past president of the American Society for Metabolic and Bariatric Surgery. “When you have that team, it allows you to marshal your resources, do appropriate risk assessment, and get those processes in place to have the very best outcomes.”
In an effort to reduce hospital readmissions among bariatric surgery patients, MBSAQIP launched a national project called Decreasing Readmissions through Opportunities Provided (DROP), which currently has 129 participating hospitals. “If you drill down on the reasons for bariatric surgery readmissions, many are preventable: dehydration, nausea, medication side effects, and patient expectations,” Dr. Morton said. “I have a formula called the Morton Formula: happiness equals reality divided by expectations. If you set expectations accordingly, you’ll get a happier patient. If my patients know they’re going to be discharged in 1 day, they can plan accordingly.”
These concepts were adopted from a study that Dr. Morton and his associates carried out at Stanford Health Care in an effort to reduce readmissions for complications within 30 days to below the national average. It involved “straightforward” strategy including improving patient education, discharge planning, and giving patients a direct phone number to call. “Anybody who has called a health center and has had to go through that phone tree knows how difficult that can be, so we provide a direct number,” he said. “The postop phone call is critical, because that’s a way to nip readmissions in the bud. We do same-day appointments so they come and see us in the clinic rather than going to the ER and getting the enormous workup. Infusion centers are our best friend, because many of these patients come in dehydrated.”
After implementing these strategies, the rate of readmission for complications at Stanford fell from 8% to 2.5%. This led to the creation of a readmission bundle for the DROP project with steps for preoperative, intraoperative, and postoperative aspects of care. For example, preoperatively, “we make sure that they have a postop appointment made [and] rather than waiting to give them a prescription when they get discharged, we make sure that they have those prescriptions earlier at the preoperative visit,” he said. “They are provided the clinic phone number and patients watch video vignettes from all members of the team: surgeon, nurse, nutritionist, pharmacist, and psychologist. Rather than the education being dependent on [the surgeon’s schedule], they can get the same dose of education and even watch these over and over again if they want to.”
Surgeons who participate in the DROP project also stratify high-risk patients by consulting with their primary care physicians and case managers to achieve optimal outcomes. They address modifiable risk factors. “Weight gain prior to bariatric surgery is not ideal, so we want to address that, and have a hemoglobin A1c of less than 10%,” Dr. Morton said. Patients receive a “HELP” card, which instructs them to contact the treating clinic if they have abdominal pain, dehydration, nausea and vomiting, diarrhea, and fatigue.
The inpatient part of the bundle includes a “clinical roadmap” with a fixed length of stay. “There are expectations every single day about what’s going to happen to their care,” Dr. Morton said. “We give them a water bottle with the logo of the hospital. It’s a reminder for them to stay hydrated. They have a nutritional consult and they go through a checklist before they get discharged.”
The postoperative component of the DROP bundle includes a phone call to the patient following discharge. “They also get an appointment with a nutritionist within a month of surgery,” he said. “We treat readmissions seriously, like a complication.”
Data from a study of 18,296 primary bariatric surgery patients gleaned from 2012 ACS-NSQIP Participant Use Data Files found a 30-day readmission rate of 5.2% (Am J Surg 2016 Jul;212[1]:76-80). Compared with the patients’ counterparts who did not require readmission within 30 days, risk factors for those who did included body mass index greater than 50 kg/m2 (30.2% vs. 24.6%, respectively; P = .001); longer operative time (132 vs. 115 minutes; P = .001); length of stay greater than 4 days (9.57% vs. 3.36%; P = .001); surgical site infection (15.5% vs. 1.15%; P less than .001); urinary tract infection (3.15% vs. .65%; P less than .001), and deep vein thrombosis (3.58% vs. .13%; P less than .001). Common reasons for readmissions were GI-related (45%), dietary (33.5%), and bleeding (6.57%). Dr. Morton went on to report preliminary findings from 19,648 cases included in the DROP project, which began collecting data in March 2015 and has a yearlong goal of reducing national admission rates by 20%. The preintervention readmission rate was 4.79%. By the end of October 2015 the readmission rate had dropped to 4.30%. “One of the things we realized is that the hospitals with the higher readmission rates were the ones who had the greatest improvement,” Dr. Morton said. “They went from about 8% down to about 5.51%. We anticipate that for each quarter that we do this, we’ll continue to see improvement.”
Individual center results were made available in late January 2016 and reviewed with mentors. “They also received aggregated reports to see how they stacked up others as a benchmark,” Dr. Morton said.
Final results from DROP are expected to be released later in 2016.
Dr. Morton reported having no financial disclosures.
SAN DIEGO – John Morton, MD, started his bariatric surgery career about the same time that demand for gastric bypass and other bariatric procedures began to skyrocket. But a troubling trend emerged.
“About 10-15 years ago, bariatric surgery had a problem when it came to mortality,” Dr. Morton said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. “You can’t move forward without looking back.”
A 2005 study of early mortality among Medicare beneficiaries undergoing bariatric procedures found a 30-day mortality of 9% and a 1-year mortality of 21% (JAMA 2005 Oct. 19;294[15]:1903-8). Such data prompted Dr. Morton and other leaders in the field to push for accreditation in the field. In 2012, the ACS Bariatric Surgery Center Network program and the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Centers of Excellence program were extended accreditation in the joint Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). As a result, the mortality rate among patients undergoing bariatric procedures has dropped nearly 10-fold and now stands at 1 out of 1,000, said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. “That’s been a real success story for us,” he said. “Part of it has been the accreditation program, having the resources in place to accomplish those goals.”
Of the 802 participating centers in MBSAQIP, 647 are accredited. “One of the reasons we see such good results at accredited centers is the fact that they work as a multidisciplinary team, where you have the nutritionist, the psychologist, the internist, and the anesthesiologist working together,” said Dr. Morton, immediate past president of the American Society for Metabolic and Bariatric Surgery. “When you have that team, it allows you to marshal your resources, do appropriate risk assessment, and get those processes in place to have the very best outcomes.”
In an effort to reduce hospital readmissions among bariatric surgery patients, MBSAQIP launched a national project called Decreasing Readmissions through Opportunities Provided (DROP), which currently has 129 participating hospitals. “If you drill down on the reasons for bariatric surgery readmissions, many are preventable: dehydration, nausea, medication side effects, and patient expectations,” Dr. Morton said. “I have a formula called the Morton Formula: happiness equals reality divided by expectations. If you set expectations accordingly, you’ll get a happier patient. If my patients know they’re going to be discharged in 1 day, they can plan accordingly.”
These concepts were adopted from a study that Dr. Morton and his associates carried out at Stanford Health Care in an effort to reduce readmissions for complications within 30 days to below the national average. It involved “straightforward” strategy including improving patient education, discharge planning, and giving patients a direct phone number to call. “Anybody who has called a health center and has had to go through that phone tree knows how difficult that can be, so we provide a direct number,” he said. “The postop phone call is critical, because that’s a way to nip readmissions in the bud. We do same-day appointments so they come and see us in the clinic rather than going to the ER and getting the enormous workup. Infusion centers are our best friend, because many of these patients come in dehydrated.”
After implementing these strategies, the rate of readmission for complications at Stanford fell from 8% to 2.5%. This led to the creation of a readmission bundle for the DROP project with steps for preoperative, intraoperative, and postoperative aspects of care. For example, preoperatively, “we make sure that they have a postop appointment made [and] rather than waiting to give them a prescription when they get discharged, we make sure that they have those prescriptions earlier at the preoperative visit,” he said. “They are provided the clinic phone number and patients watch video vignettes from all members of the team: surgeon, nurse, nutritionist, pharmacist, and psychologist. Rather than the education being dependent on [the surgeon’s schedule], they can get the same dose of education and even watch these over and over again if they want to.”
Surgeons who participate in the DROP project also stratify high-risk patients by consulting with their primary care physicians and case managers to achieve optimal outcomes. They address modifiable risk factors. “Weight gain prior to bariatric surgery is not ideal, so we want to address that, and have a hemoglobin A1c of less than 10%,” Dr. Morton said. Patients receive a “HELP” card, which instructs them to contact the treating clinic if they have abdominal pain, dehydration, nausea and vomiting, diarrhea, and fatigue.
The inpatient part of the bundle includes a “clinical roadmap” with a fixed length of stay. “There are expectations every single day about what’s going to happen to their care,” Dr. Morton said. “We give them a water bottle with the logo of the hospital. It’s a reminder for them to stay hydrated. They have a nutritional consult and they go through a checklist before they get discharged.”
The postoperative component of the DROP bundle includes a phone call to the patient following discharge. “They also get an appointment with a nutritionist within a month of surgery,” he said. “We treat readmissions seriously, like a complication.”
Data from a study of 18,296 primary bariatric surgery patients gleaned from 2012 ACS-NSQIP Participant Use Data Files found a 30-day readmission rate of 5.2% (Am J Surg 2016 Jul;212[1]:76-80). Compared with the patients’ counterparts who did not require readmission within 30 days, risk factors for those who did included body mass index greater than 50 kg/m2 (30.2% vs. 24.6%, respectively; P = .001); longer operative time (132 vs. 115 minutes; P = .001); length of stay greater than 4 days (9.57% vs. 3.36%; P = .001); surgical site infection (15.5% vs. 1.15%; P less than .001); urinary tract infection (3.15% vs. .65%; P less than .001), and deep vein thrombosis (3.58% vs. .13%; P less than .001). Common reasons for readmissions were GI-related (45%), dietary (33.5%), and bleeding (6.57%). Dr. Morton went on to report preliminary findings from 19,648 cases included in the DROP project, which began collecting data in March 2015 and has a yearlong goal of reducing national admission rates by 20%. The preintervention readmission rate was 4.79%. By the end of October 2015 the readmission rate had dropped to 4.30%. “One of the things we realized is that the hospitals with the higher readmission rates were the ones who had the greatest improvement,” Dr. Morton said. “They went from about 8% down to about 5.51%. We anticipate that for each quarter that we do this, we’ll continue to see improvement.”
Individual center results were made available in late January 2016 and reviewed with mentors. “They also received aggregated reports to see how they stacked up others as a benchmark,” Dr. Morton said.
Final results from DROP are expected to be released later in 2016.
Dr. Morton reported having no financial disclosures.
EXPERT ANALYSIS AT THE ACS NSQIP NATIONAL CONFERENCE
Blood management strategy leads to cost savings, less waste
SAN DIEGO – A process intended to optimize blood management led to a 30% reduction in blood use and a savings of $2 million, results from a single-center study showed.
“Blood is a limited resource and we have a responsibility as a health care provider to optimize the use of a resource that is difficult to get and only available through altruistic donations,” lead study author Barbara J. Martin, RN, said in a press release. The study was presented in a poster session at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.
In an effort to evaluate how they could implement evidence-based guidelines around restrictive transfusion, Ms. Martin and her colleagues at Vanderbilt University Medical Center, Nashville, Tenn., first changed provider orders to support a single unit order and then follow-up order for more blood if necessary. The previous process was to order two units of blood, which was at times more blood than was needed. “The data on restrictive transfusion has been out for years documenting that patients have better outcomes with a more restrictive transfusion strategy,” Ms. Martin, of the Vanderbilt Center for Clinical Improvement, said in the press release. “We were looking at whether we could guide providers to treat symptomatic anemia with a single unit of blood rather than the usual two units.”
The researchers enhanced the Computerized Provider Order Entry (CPOE) system to allow blood ordering practices to be based on a specific assessment of each case rather than on a standard order of two units. As a result, red blood cell transfusions at Vanderbilt declined from 675 units per 1,000 discharges in 2011 to 432 units per 1,000 discharges in 2015, a decrease of more than 30%.
In an effort to reduce inefficiencies in the way blood is ordered, transported, and stored, Ms. Martin and her multidisciplinary team developed the following guidelines for perioperative handling:
• When more than one unit of blood is ordered, it is sent in a cooler rather than the pneumatic tube.
• Coolers are reconfigured to optimize temperature management.
• A specific staff member is tasked with “ownership” of the blood products, including returning unused product to the blood bank.
• Individual unit wastage is reported to clinical leaders for review; aggregate data are reported monthly.
After implementation of these practices, fewer than 80 units of blood were wasted at Vanderbilt in 2015, a drop from 300 in 2011. Collectively, the blood management strategies resulted in a savings of $2 million. Ms. Martin said that such guidelines can be implemented at other medical centers, but “you have to prioritize what your initiatives are. At Vanderbilt we had a lot of opportunities with blood transfusion and blood wastage and we made huge gains. Any incremental improvement would take additional resources.”
The researchers reported having no relevant disclosures.
SAN DIEGO – A process intended to optimize blood management led to a 30% reduction in blood use and a savings of $2 million, results from a single-center study showed.
“Blood is a limited resource and we have a responsibility as a health care provider to optimize the use of a resource that is difficult to get and only available through altruistic donations,” lead study author Barbara J. Martin, RN, said in a press release. The study was presented in a poster session at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.
In an effort to evaluate how they could implement evidence-based guidelines around restrictive transfusion, Ms. Martin and her colleagues at Vanderbilt University Medical Center, Nashville, Tenn., first changed provider orders to support a single unit order and then follow-up order for more blood if necessary. The previous process was to order two units of blood, which was at times more blood than was needed. “The data on restrictive transfusion has been out for years documenting that patients have better outcomes with a more restrictive transfusion strategy,” Ms. Martin, of the Vanderbilt Center for Clinical Improvement, said in the press release. “We were looking at whether we could guide providers to treat symptomatic anemia with a single unit of blood rather than the usual two units.”
The researchers enhanced the Computerized Provider Order Entry (CPOE) system to allow blood ordering practices to be based on a specific assessment of each case rather than on a standard order of two units. As a result, red blood cell transfusions at Vanderbilt declined from 675 units per 1,000 discharges in 2011 to 432 units per 1,000 discharges in 2015, a decrease of more than 30%.
In an effort to reduce inefficiencies in the way blood is ordered, transported, and stored, Ms. Martin and her multidisciplinary team developed the following guidelines for perioperative handling:
• When more than one unit of blood is ordered, it is sent in a cooler rather than the pneumatic tube.
• Coolers are reconfigured to optimize temperature management.
• A specific staff member is tasked with “ownership” of the blood products, including returning unused product to the blood bank.
• Individual unit wastage is reported to clinical leaders for review; aggregate data are reported monthly.
After implementation of these practices, fewer than 80 units of blood were wasted at Vanderbilt in 2015, a drop from 300 in 2011. Collectively, the blood management strategies resulted in a savings of $2 million. Ms. Martin said that such guidelines can be implemented at other medical centers, but “you have to prioritize what your initiatives are. At Vanderbilt we had a lot of opportunities with blood transfusion and blood wastage and we made huge gains. Any incremental improvement would take additional resources.”
The researchers reported having no relevant disclosures.
SAN DIEGO – A process intended to optimize blood management led to a 30% reduction in blood use and a savings of $2 million, results from a single-center study showed.
“Blood is a limited resource and we have a responsibility as a health care provider to optimize the use of a resource that is difficult to get and only available through altruistic donations,” lead study author Barbara J. Martin, RN, said in a press release. The study was presented in a poster session at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.
In an effort to evaluate how they could implement evidence-based guidelines around restrictive transfusion, Ms. Martin and her colleagues at Vanderbilt University Medical Center, Nashville, Tenn., first changed provider orders to support a single unit order and then follow-up order for more blood if necessary. The previous process was to order two units of blood, which was at times more blood than was needed. “The data on restrictive transfusion has been out for years documenting that patients have better outcomes with a more restrictive transfusion strategy,” Ms. Martin, of the Vanderbilt Center for Clinical Improvement, said in the press release. “We were looking at whether we could guide providers to treat symptomatic anemia with a single unit of blood rather than the usual two units.”
The researchers enhanced the Computerized Provider Order Entry (CPOE) system to allow blood ordering practices to be based on a specific assessment of each case rather than on a standard order of two units. As a result, red blood cell transfusions at Vanderbilt declined from 675 units per 1,000 discharges in 2011 to 432 units per 1,000 discharges in 2015, a decrease of more than 30%.
In an effort to reduce inefficiencies in the way blood is ordered, transported, and stored, Ms. Martin and her multidisciplinary team developed the following guidelines for perioperative handling:
• When more than one unit of blood is ordered, it is sent in a cooler rather than the pneumatic tube.
• Coolers are reconfigured to optimize temperature management.
• A specific staff member is tasked with “ownership” of the blood products, including returning unused product to the blood bank.
• Individual unit wastage is reported to clinical leaders for review; aggregate data are reported monthly.
After implementation of these practices, fewer than 80 units of blood were wasted at Vanderbilt in 2015, a drop from 300 in 2011. Collectively, the blood management strategies resulted in a savings of $2 million. Ms. Martin said that such guidelines can be implemented at other medical centers, but “you have to prioritize what your initiatives are. At Vanderbilt we had a lot of opportunities with blood transfusion and blood wastage and we made huge gains. Any incremental improvement would take additional resources.”
The researchers reported having no relevant disclosures.
AT THE ACS NSQIP NATIONAL CONFERENCE
Key clinical point: A multidisciplinary effort to improve the process of blood product management led to a significantly reduced use of blood products.
Major finding: Red blood cell transfusions declined from 675 units per 1,000 discharges in 2011 to 432 units per 1,000 discharges in 2015, a decrease of more than 30%.
Data source: An alteration of the Computerized Provider Order Entry (CPOE) system at Vanderbilt University Medical Center to allow blood ordering practices to be based on a specific assessment of each case rather than on a standard order of two units.
Disclosures: The researchers reported having no financial disclosures.
Subtotal fenestrating cholecystectomy: Optimal ‘bailout’ for difficult cases
Subtotal fenestrating cholecystectomy with drain placement appears optimal, compared with the reconstituting procedure, for experienced surgeons seeking a “bailout” operation in both open and minimally invasive cholecystectomy where the critical view of safety (CVS) is not easily attainable, according to a report written on behalf of the SAGES Safe Cholecystectomy Task Force 2015.
The rise in laparoscopic cholecystectomy has been associated with an increase in the rate of bile duct injury, most commonly when secure ductal identification using CVS is not possible because of an inflamed hepatocystic triangle occluding the cystic duct, cystic artery, and cystic plate. In such cases, a safe and effective bailout technique (one not requiring a second operation) must be decided upon in preference to simply closing and proceeding to a later open procedure, according to Steven M. Strasberg, MD, of Washington University in Saint Louis and his colleagues (J Am Coll Surg. 2016;222:89-96).
In order to clarify the two most common and effective “partial cholecystectomy” procedures being performed, Dr. Strasburg and his colleagues have suggested the use of the term “subtotal” in place of “partial” and the terms “fenestrating” vs. “reconstituting,” to define whether there is an open or closed gallbladder remnant, respectively, after the procedure.
In subtotal fenestrating cholecystectomy, the free peritonealized portion of the gallbladder is excised, except for a tip at the lowest portion that acts as a shield to protect against inadvertently entering the hepatocystic triangle, according to the authors. There is no sealed lumen remaining, thus the cystic duct requires closure. The cystic duct may be closed from the inside with a purse-string suture. Attempts to ligate the cystic duct outside the gallbladder may injure the common bile duct and can potentially result in fistulas.
In subtotal reconstituting cholecystectomy, the free peritonealized portion of the gallbladder is excised, but the lowest portion of the gallbladder is closed with sutures or staples and reconstitutes an intact lumen in which stones may be re-formed, which can in turn require reoperation.
“Whether the subtotal cholecystectomy is ‘fenestrating’ or ‘reconstituting’ depends on whether the lowest part of the gallbladder is left open (fenestrating) or closed (reconstituting) and not on the amount of gallbladder that is left attached to the liver,” according to the authors.
Subtotal fenestrating cholecystectomy is most likely done when an open approach is used, whereas subtotal reconstituting cholecystectomies are probably easier to do laparoscopically and are preferred by surgeons doing minimally invasive procedures, they said.
Despite the fact that there have been no head-to-head comparisons of fenestrating vs. reconstituting techniques, the authors said they prefer the fenestrating method, although the technique chosen may be based on the experience of the surgeon, they noted.
“The principle is that a subtotal fenestrating cholecystectomy is a standard operation that should be used liberally when surgeons encounter difficulty getting to the CVS,” the authors wrote. “We believe that clarification of the procedures and what they are called will help to choose which type of procedure to select, and it will also facilitate the performance of clinical studies in this area,“ they concluded.
The authors reported having no relevant financial disclosures.
A transcript of an interactive discussion of this paper and topic is available online (www.journalacs.org/RAS-ACS-discussion-2016).
Subtotal fenestrating cholecystectomy with drain placement appears optimal, compared with the reconstituting procedure, for experienced surgeons seeking a “bailout” operation in both open and minimally invasive cholecystectomy where the critical view of safety (CVS) is not easily attainable, according to a report written on behalf of the SAGES Safe Cholecystectomy Task Force 2015.
The rise in laparoscopic cholecystectomy has been associated with an increase in the rate of bile duct injury, most commonly when secure ductal identification using CVS is not possible because of an inflamed hepatocystic triangle occluding the cystic duct, cystic artery, and cystic plate. In such cases, a safe and effective bailout technique (one not requiring a second operation) must be decided upon in preference to simply closing and proceeding to a later open procedure, according to Steven M. Strasberg, MD, of Washington University in Saint Louis and his colleagues (J Am Coll Surg. 2016;222:89-96).
In order to clarify the two most common and effective “partial cholecystectomy” procedures being performed, Dr. Strasburg and his colleagues have suggested the use of the term “subtotal” in place of “partial” and the terms “fenestrating” vs. “reconstituting,” to define whether there is an open or closed gallbladder remnant, respectively, after the procedure.
In subtotal fenestrating cholecystectomy, the free peritonealized portion of the gallbladder is excised, except for a tip at the lowest portion that acts as a shield to protect against inadvertently entering the hepatocystic triangle, according to the authors. There is no sealed lumen remaining, thus the cystic duct requires closure. The cystic duct may be closed from the inside with a purse-string suture. Attempts to ligate the cystic duct outside the gallbladder may injure the common bile duct and can potentially result in fistulas.
In subtotal reconstituting cholecystectomy, the free peritonealized portion of the gallbladder is excised, but the lowest portion of the gallbladder is closed with sutures or staples and reconstitutes an intact lumen in which stones may be re-formed, which can in turn require reoperation.
“Whether the subtotal cholecystectomy is ‘fenestrating’ or ‘reconstituting’ depends on whether the lowest part of the gallbladder is left open (fenestrating) or closed (reconstituting) and not on the amount of gallbladder that is left attached to the liver,” according to the authors.
Subtotal fenestrating cholecystectomy is most likely done when an open approach is used, whereas subtotal reconstituting cholecystectomies are probably easier to do laparoscopically and are preferred by surgeons doing minimally invasive procedures, they said.
Despite the fact that there have been no head-to-head comparisons of fenestrating vs. reconstituting techniques, the authors said they prefer the fenestrating method, although the technique chosen may be based on the experience of the surgeon, they noted.
“The principle is that a subtotal fenestrating cholecystectomy is a standard operation that should be used liberally when surgeons encounter difficulty getting to the CVS,” the authors wrote. “We believe that clarification of the procedures and what they are called will help to choose which type of procedure to select, and it will also facilitate the performance of clinical studies in this area,“ they concluded.
The authors reported having no relevant financial disclosures.
A transcript of an interactive discussion of this paper and topic is available online (www.journalacs.org/RAS-ACS-discussion-2016).
Subtotal fenestrating cholecystectomy with drain placement appears optimal, compared with the reconstituting procedure, for experienced surgeons seeking a “bailout” operation in both open and minimally invasive cholecystectomy where the critical view of safety (CVS) is not easily attainable, according to a report written on behalf of the SAGES Safe Cholecystectomy Task Force 2015.
The rise in laparoscopic cholecystectomy has been associated with an increase in the rate of bile duct injury, most commonly when secure ductal identification using CVS is not possible because of an inflamed hepatocystic triangle occluding the cystic duct, cystic artery, and cystic plate. In such cases, a safe and effective bailout technique (one not requiring a second operation) must be decided upon in preference to simply closing and proceeding to a later open procedure, according to Steven M. Strasberg, MD, of Washington University in Saint Louis and his colleagues (J Am Coll Surg. 2016;222:89-96).
In order to clarify the two most common and effective “partial cholecystectomy” procedures being performed, Dr. Strasburg and his colleagues have suggested the use of the term “subtotal” in place of “partial” and the terms “fenestrating” vs. “reconstituting,” to define whether there is an open or closed gallbladder remnant, respectively, after the procedure.
In subtotal fenestrating cholecystectomy, the free peritonealized portion of the gallbladder is excised, except for a tip at the lowest portion that acts as a shield to protect against inadvertently entering the hepatocystic triangle, according to the authors. There is no sealed lumen remaining, thus the cystic duct requires closure. The cystic duct may be closed from the inside with a purse-string suture. Attempts to ligate the cystic duct outside the gallbladder may injure the common bile duct and can potentially result in fistulas.
In subtotal reconstituting cholecystectomy, the free peritonealized portion of the gallbladder is excised, but the lowest portion of the gallbladder is closed with sutures or staples and reconstitutes an intact lumen in which stones may be re-formed, which can in turn require reoperation.
“Whether the subtotal cholecystectomy is ‘fenestrating’ or ‘reconstituting’ depends on whether the lowest part of the gallbladder is left open (fenestrating) or closed (reconstituting) and not on the amount of gallbladder that is left attached to the liver,” according to the authors.
Subtotal fenestrating cholecystectomy is most likely done when an open approach is used, whereas subtotal reconstituting cholecystectomies are probably easier to do laparoscopically and are preferred by surgeons doing minimally invasive procedures, they said.
Despite the fact that there have been no head-to-head comparisons of fenestrating vs. reconstituting techniques, the authors said they prefer the fenestrating method, although the technique chosen may be based on the experience of the surgeon, they noted.
“The principle is that a subtotal fenestrating cholecystectomy is a standard operation that should be used liberally when surgeons encounter difficulty getting to the CVS,” the authors wrote. “We believe that clarification of the procedures and what they are called will help to choose which type of procedure to select, and it will also facilitate the performance of clinical studies in this area,“ they concluded.
The authors reported having no relevant financial disclosures.
A transcript of an interactive discussion of this paper and topic is available online (www.journalacs.org/RAS-ACS-discussion-2016).
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Key clinical point: Subtotal fenestrating cholecystectomy should be used liberally when surgeons have difficulty getting to the critical view of safety (CVS).
Major finding: Subtotal fenestrating cholecystectomy with drain placement, despite its difficulty in laparoscopic cases, should be the procedure of choice for experienced surgeons in both open and minimally invasive procedures where the CVS is not safely attainable.
Data source: An expert analysis of historical data and the literature to determine optimal surgical technique, on behalf of the SAGES Safe Cholecystectomy Task Force 2015.
Disclosures: The authors reported having no relevant financial disclosures.
Fresh Press: ACS Surgery News digital July issue is available on the website
The July issue of ACS Surgery News in digital format is available online. Use the mobile app to download or view as a pdf.
This month’s issue features coverage of the report, “A National Trauma Care System: Integrating Civilian and Military Trauma Systems to Achieve Zero Preventable Deaths After Injury,” released by the National Academies of Sciences, Engineering, and Medicine. The report, supported in part by the American College of Surgeons, gives a detailed list of policy recommendations that would create a unified trauma response system incorporating lessons learned from combat mission with the aim of eliminating unnecessary deaths in civilian trauma situations (p. 1).
Looking for some summer reading? Dr. Carol Scott-Conner, moderator of the ACS Communities Surgeon Writers discussion group, reviews three books by surgeons that should be of special interest to the readers of ACS Surgery News. All three works concern personal experience and reflections on the profession (p. 4).
Don’t miss the story (p. 7) on peer review hearings and how best to approach this situation. These hearings should be informative and educational, but can also play out in unexpected ways. Be prepared!
The July issue of ACS Surgery News in digital format is available online. Use the mobile app to download or view as a pdf.
This month’s issue features coverage of the report, “A National Trauma Care System: Integrating Civilian and Military Trauma Systems to Achieve Zero Preventable Deaths After Injury,” released by the National Academies of Sciences, Engineering, and Medicine. The report, supported in part by the American College of Surgeons, gives a detailed list of policy recommendations that would create a unified trauma response system incorporating lessons learned from combat mission with the aim of eliminating unnecessary deaths in civilian trauma situations (p. 1).
Looking for some summer reading? Dr. Carol Scott-Conner, moderator of the ACS Communities Surgeon Writers discussion group, reviews three books by surgeons that should be of special interest to the readers of ACS Surgery News. All three works concern personal experience and reflections on the profession (p. 4).
Don’t miss the story (p. 7) on peer review hearings and how best to approach this situation. These hearings should be informative and educational, but can also play out in unexpected ways. Be prepared!
The July issue of ACS Surgery News in digital format is available online. Use the mobile app to download or view as a pdf.
This month’s issue features coverage of the report, “A National Trauma Care System: Integrating Civilian and Military Trauma Systems to Achieve Zero Preventable Deaths After Injury,” released by the National Academies of Sciences, Engineering, and Medicine. The report, supported in part by the American College of Surgeons, gives a detailed list of policy recommendations that would create a unified trauma response system incorporating lessons learned from combat mission with the aim of eliminating unnecessary deaths in civilian trauma situations (p. 1).
Looking for some summer reading? Dr. Carol Scott-Conner, moderator of the ACS Communities Surgeon Writers discussion group, reviews three books by surgeons that should be of special interest to the readers of ACS Surgery News. All three works concern personal experience and reflections on the profession (p. 4).
Don’t miss the story (p. 7) on peer review hearings and how best to approach this situation. These hearings should be informative and educational, but can also play out in unexpected ways. Be prepared!
Good Reading – Surgeon writers share their experiences with a wider audience
Are you casting about for a good book for yourself – maybe something to take on a long plane ride? Or are you looking for something for a young person interested in a career in surgery? Consider reading (or giving) a book written by a fellow surgeon.
To find such books, visit the ACS Surgeon Writers topic on the ACS Communities site. After just 6 months, this community has grown to 180 active members who share information on writing contests and conferences, pass on tips on mutual problems, and celebrate publications ranging from articles to full-length books. To participate in the dialogue, add your voice (and your publications) to our membership list. To find a book by a fellow surgeon, go through the files that form a sort of virtual bookshelf under the “Library” section. Don’t worry, you won’t find any thick surgical textbooks there, but rather books written for a wider audience. Fantasy, fiction, patient education, and memoir are all represented.
I’ve picked three memoirs to get you started. One is an anthology of pieces written by female surgeons. The second will take you into the world of transplant surgery. In the third, you accompany the surgeon-author to South Sudan on a mission for Doctors Without Borders (MSF). These true accounts, written by fellow surgeons, have the power to transport you into a world similar to, yet different from, your own surgical milieu.
Being a Woman Surgeon: Sixty Women Share Their Stories is a generous anthology collected and edited by Preeti John, MD, FACS. These short chapters are bite-sized reading tidbits that can be enjoyed in a few moments of spare time. You can read the book from cover to cover or dip into it randomly. It’s a great book to give to that young woman in your life – daughter, granddaughter, or mentee – who is thinking of a career in any of the surgical specialties (including, of course, general surgery). Female pediatric surgeons, orthopedic surgeons, general surgeons, and some leaders in the field of surgery contributed to this book.
Dr. John organized them by topic and by specialty, and included some interviews and poems at the end. It’s a generous slice of life. Surgeons share formative experiences from their training, the evolution of their careers, choice of paths, and the unfolding of their lives.
Last Night in the OR: A Transplant Surgeon’s Odyssey by Bud Shaw, MD, FACS, takes the reader along on a journey from the early days of liver transplant into the modern era. Many things in this book will resonate with the surgeon-reader. Three chapters aptly subtitled “Initiation” open the book. The year is 1981, and Dr. Shaw has just completed his surgical residency and begun a transplant fellowship in Pittsburgh. The humbling transformation from confident chief resident to beginner will ring true with any surgeon who has done a challenging fellowship. After an account of the first days’ chaotic, blinding confusion he ends with the admission that even abusive words, spoken in the heat of the moment, became phrases that he would “…in the distance of time and place, yearn to hear again.” Many who trained under the giants, in an era remote from work-hour limitations and political correctness, can identify with this sentiment.
The book threads nonlinearly, like memory itself, through time and space. Shaw includes his own experience with illness, and recounts how his surgeon-father reduced an inguinal hernia that could have been an ominous inguinal lymph node for his son. His father “was ninety years old then and he couldn’t remember what he’d had for breakfast, but he could still fix me with his hands.”
Ajak’s Song by Kenneth Waxman, MD, FACS, takes the reader to South Sudan with MSF. The account captures the frustrations and uncertainties of working in such an austere environment. General surgeons contemplating such a tour of duty will be interested in the medical details, including management of chronic osteomyelitis. From one such case comes the title of the book. Ajak, a young woman, develops a chronic open wound with exposed tibia after surviving a snake bite. Her path to the MSF hospital staffed by Dr. Waxman is circuitous, and she has already endured considerable treatment through an escalating series of healers. Amputation seems inevitable, but a plan is made to attempt to clean and heal the wound. Multiple operations are required. After her first procedure (and each subsequent one), Ajak awakens from anesthesia with a smile on her face, singing a song of thanks. As the small team waits with their young patient until she is ready to return to the ward, “Ajak repeatedly sings her lovely song.” By the end of the book, the reader will come to hear Ajak’s song as well.
For more good reading, go to the ACS Surgeon Writers Community Library. All the books listed are available through online booksellers and many are in bricks-and-mortar stores as well.
Dr. Scott-Conner is professor emeritus of surgery at the University of Iowa Carver College of Medicine. Visit Dr. Scott-Conner’s website (www.scott-conner.com) for information on ordering her works of fiction and nonfiction.
Are you casting about for a good book for yourself – maybe something to take on a long plane ride? Or are you looking for something for a young person interested in a career in surgery? Consider reading (or giving) a book written by a fellow surgeon.
To find such books, visit the ACS Surgeon Writers topic on the ACS Communities site. After just 6 months, this community has grown to 180 active members who share information on writing contests and conferences, pass on tips on mutual problems, and celebrate publications ranging from articles to full-length books. To participate in the dialogue, add your voice (and your publications) to our membership list. To find a book by a fellow surgeon, go through the files that form a sort of virtual bookshelf under the “Library” section. Don’t worry, you won’t find any thick surgical textbooks there, but rather books written for a wider audience. Fantasy, fiction, patient education, and memoir are all represented.
I’ve picked three memoirs to get you started. One is an anthology of pieces written by female surgeons. The second will take you into the world of transplant surgery. In the third, you accompany the surgeon-author to South Sudan on a mission for Doctors Without Borders (MSF). These true accounts, written by fellow surgeons, have the power to transport you into a world similar to, yet different from, your own surgical milieu.
Being a Woman Surgeon: Sixty Women Share Their Stories is a generous anthology collected and edited by Preeti John, MD, FACS. These short chapters are bite-sized reading tidbits that can be enjoyed in a few moments of spare time. You can read the book from cover to cover or dip into it randomly. It’s a great book to give to that young woman in your life – daughter, granddaughter, or mentee – who is thinking of a career in any of the surgical specialties (including, of course, general surgery). Female pediatric surgeons, orthopedic surgeons, general surgeons, and some leaders in the field of surgery contributed to this book.
Dr. John organized them by topic and by specialty, and included some interviews and poems at the end. It’s a generous slice of life. Surgeons share formative experiences from their training, the evolution of their careers, choice of paths, and the unfolding of their lives.
Last Night in the OR: A Transplant Surgeon’s Odyssey by Bud Shaw, MD, FACS, takes the reader along on a journey from the early days of liver transplant into the modern era. Many things in this book will resonate with the surgeon-reader. Three chapters aptly subtitled “Initiation” open the book. The year is 1981, and Dr. Shaw has just completed his surgical residency and begun a transplant fellowship in Pittsburgh. The humbling transformation from confident chief resident to beginner will ring true with any surgeon who has done a challenging fellowship. After an account of the first days’ chaotic, blinding confusion he ends with the admission that even abusive words, spoken in the heat of the moment, became phrases that he would “…in the distance of time and place, yearn to hear again.” Many who trained under the giants, in an era remote from work-hour limitations and political correctness, can identify with this sentiment.
The book threads nonlinearly, like memory itself, through time and space. Shaw includes his own experience with illness, and recounts how his surgeon-father reduced an inguinal hernia that could have been an ominous inguinal lymph node for his son. His father “was ninety years old then and he couldn’t remember what he’d had for breakfast, but he could still fix me with his hands.”
Ajak’s Song by Kenneth Waxman, MD, FACS, takes the reader to South Sudan with MSF. The account captures the frustrations and uncertainties of working in such an austere environment. General surgeons contemplating such a tour of duty will be interested in the medical details, including management of chronic osteomyelitis. From one such case comes the title of the book. Ajak, a young woman, develops a chronic open wound with exposed tibia after surviving a snake bite. Her path to the MSF hospital staffed by Dr. Waxman is circuitous, and she has already endured considerable treatment through an escalating series of healers. Amputation seems inevitable, but a plan is made to attempt to clean and heal the wound. Multiple operations are required. After her first procedure (and each subsequent one), Ajak awakens from anesthesia with a smile on her face, singing a song of thanks. As the small team waits with their young patient until she is ready to return to the ward, “Ajak repeatedly sings her lovely song.” By the end of the book, the reader will come to hear Ajak’s song as well.
For more good reading, go to the ACS Surgeon Writers Community Library. All the books listed are available through online booksellers and many are in bricks-and-mortar stores as well.
Dr. Scott-Conner is professor emeritus of surgery at the University of Iowa Carver College of Medicine. Visit Dr. Scott-Conner’s website (www.scott-conner.com) for information on ordering her works of fiction and nonfiction.
Are you casting about for a good book for yourself – maybe something to take on a long plane ride? Or are you looking for something for a young person interested in a career in surgery? Consider reading (or giving) a book written by a fellow surgeon.
To find such books, visit the ACS Surgeon Writers topic on the ACS Communities site. After just 6 months, this community has grown to 180 active members who share information on writing contests and conferences, pass on tips on mutual problems, and celebrate publications ranging from articles to full-length books. To participate in the dialogue, add your voice (and your publications) to our membership list. To find a book by a fellow surgeon, go through the files that form a sort of virtual bookshelf under the “Library” section. Don’t worry, you won’t find any thick surgical textbooks there, but rather books written for a wider audience. Fantasy, fiction, patient education, and memoir are all represented.
I’ve picked three memoirs to get you started. One is an anthology of pieces written by female surgeons. The second will take you into the world of transplant surgery. In the third, you accompany the surgeon-author to South Sudan on a mission for Doctors Without Borders (MSF). These true accounts, written by fellow surgeons, have the power to transport you into a world similar to, yet different from, your own surgical milieu.
Being a Woman Surgeon: Sixty Women Share Their Stories is a generous anthology collected and edited by Preeti John, MD, FACS. These short chapters are bite-sized reading tidbits that can be enjoyed in a few moments of spare time. You can read the book from cover to cover or dip into it randomly. It’s a great book to give to that young woman in your life – daughter, granddaughter, or mentee – who is thinking of a career in any of the surgical specialties (including, of course, general surgery). Female pediatric surgeons, orthopedic surgeons, general surgeons, and some leaders in the field of surgery contributed to this book.
Dr. John organized them by topic and by specialty, and included some interviews and poems at the end. It’s a generous slice of life. Surgeons share formative experiences from their training, the evolution of their careers, choice of paths, and the unfolding of their lives.
Last Night in the OR: A Transplant Surgeon’s Odyssey by Bud Shaw, MD, FACS, takes the reader along on a journey from the early days of liver transplant into the modern era. Many things in this book will resonate with the surgeon-reader. Three chapters aptly subtitled “Initiation” open the book. The year is 1981, and Dr. Shaw has just completed his surgical residency and begun a transplant fellowship in Pittsburgh. The humbling transformation from confident chief resident to beginner will ring true with any surgeon who has done a challenging fellowship. After an account of the first days’ chaotic, blinding confusion he ends with the admission that even abusive words, spoken in the heat of the moment, became phrases that he would “…in the distance of time and place, yearn to hear again.” Many who trained under the giants, in an era remote from work-hour limitations and political correctness, can identify with this sentiment.
The book threads nonlinearly, like memory itself, through time and space. Shaw includes his own experience with illness, and recounts how his surgeon-father reduced an inguinal hernia that could have been an ominous inguinal lymph node for his son. His father “was ninety years old then and he couldn’t remember what he’d had for breakfast, but he could still fix me with his hands.”
Ajak’s Song by Kenneth Waxman, MD, FACS, takes the reader to South Sudan with MSF. The account captures the frustrations and uncertainties of working in such an austere environment. General surgeons contemplating such a tour of duty will be interested in the medical details, including management of chronic osteomyelitis. From one such case comes the title of the book. Ajak, a young woman, develops a chronic open wound with exposed tibia after surviving a snake bite. Her path to the MSF hospital staffed by Dr. Waxman is circuitous, and she has already endured considerable treatment through an escalating series of healers. Amputation seems inevitable, but a plan is made to attempt to clean and heal the wound. Multiple operations are required. After her first procedure (and each subsequent one), Ajak awakens from anesthesia with a smile on her face, singing a song of thanks. As the small team waits with their young patient until she is ready to return to the ward, “Ajak repeatedly sings her lovely song.” By the end of the book, the reader will come to hear Ajak’s song as well.
For more good reading, go to the ACS Surgeon Writers Community Library. All the books listed are available through online booksellers and many are in bricks-and-mortar stores as well.
Dr. Scott-Conner is professor emeritus of surgery at the University of Iowa Carver College of Medicine. Visit Dr. Scott-Conner’s website (www.scott-conner.com) for information on ordering her works of fiction and nonfiction.
New antibiotics targeting MDR pathogens are expensive, but not impressive
The U.S. Food and Drug Administration has approved a number of new antibiotics targeting multidrug-resistant bacteria in the past 5 years, but the new drugs have not led to a substantial improvement in patient outcomes when compared with existing antibiotics, according to a recent analysis in the Annals of Internal Medicine.
The eight new antibiotics approved by the FDA between January 2010 and December 2015 were ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane/tazobactam, and ceftazidime/avibactam. Of those eight drugs, only three showed in vitro activity against the so-called ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species). Only one drug, fidaxomicin, demonstrated in vitro activity against an urgent-threat pathogen from the Centers for Disease Control and Prevention, Clostridium difficile. Bedaquiline was the only new antibiotic specifically indicated for a disease from a multidrug-resistant pathogen, although the investigators said most of the drugs demonstrated in vitro activity against gram-positive drug-resistant pathogens.
Importantly, the authors noted that in vitro activity does not necessarily reflect benefits on actual patient clinical outcomes, as exemplified by such drugs as tigecycline and doripenem.
The researchers found what they called “important deficiencies in the clinical trials leading to approval of these new antibiotic products.” Most pivotal trial designs were primarily noninferiority trials, and the antibiotics were not studied to evaluate whether they have substantial benefits in efficacy over what is currently available, they noted. Additionally, none of the trials evaluated direct patient outcomes as primary end points, and some drugs did not have confirmatory evidence from a second independent trial or did not have any confirmatory trials.
Researchers also examined the prices of a single dose of the new antibiotics. The prices ranged from $1,195 to $4,183 (4-14 days of ceftolozane/tazobactam for acute pyelonephritis and intra-abdominal infections) to $69,702 (24 weeks of bedaquiline) – quite a premium for antibiotics showing unclear evidence of additional benefit.
“As antibiotic innovation continues to move forward, greater attention needs to be paid to incentives for developing high-quality new products with demonstrated superiority to existing products on outcomes in patients with multidrug-resistant disease, replacing the current focus on quantity and presumed future benefits,” researchers concluded.
Read the full study in the Annals of Internal Medicine (doi: 10.7326/M16-0291).
The U.S. Food and Drug Administration has approved a number of new antibiotics targeting multidrug-resistant bacteria in the past 5 years, but the new drugs have not led to a substantial improvement in patient outcomes when compared with existing antibiotics, according to a recent analysis in the Annals of Internal Medicine.
The eight new antibiotics approved by the FDA between January 2010 and December 2015 were ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane/tazobactam, and ceftazidime/avibactam. Of those eight drugs, only three showed in vitro activity against the so-called ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species). Only one drug, fidaxomicin, demonstrated in vitro activity against an urgent-threat pathogen from the Centers for Disease Control and Prevention, Clostridium difficile. Bedaquiline was the only new antibiotic specifically indicated for a disease from a multidrug-resistant pathogen, although the investigators said most of the drugs demonstrated in vitro activity against gram-positive drug-resistant pathogens.
Importantly, the authors noted that in vitro activity does not necessarily reflect benefits on actual patient clinical outcomes, as exemplified by such drugs as tigecycline and doripenem.
The researchers found what they called “important deficiencies in the clinical trials leading to approval of these new antibiotic products.” Most pivotal trial designs were primarily noninferiority trials, and the antibiotics were not studied to evaluate whether they have substantial benefits in efficacy over what is currently available, they noted. Additionally, none of the trials evaluated direct patient outcomes as primary end points, and some drugs did not have confirmatory evidence from a second independent trial or did not have any confirmatory trials.
Researchers also examined the prices of a single dose of the new antibiotics. The prices ranged from $1,195 to $4,183 (4-14 days of ceftolozane/tazobactam for acute pyelonephritis and intra-abdominal infections) to $69,702 (24 weeks of bedaquiline) – quite a premium for antibiotics showing unclear evidence of additional benefit.
“As antibiotic innovation continues to move forward, greater attention needs to be paid to incentives for developing high-quality new products with demonstrated superiority to existing products on outcomes in patients with multidrug-resistant disease, replacing the current focus on quantity and presumed future benefits,” researchers concluded.
Read the full study in the Annals of Internal Medicine (doi: 10.7326/M16-0291).
The U.S. Food and Drug Administration has approved a number of new antibiotics targeting multidrug-resistant bacteria in the past 5 years, but the new drugs have not led to a substantial improvement in patient outcomes when compared with existing antibiotics, according to a recent analysis in the Annals of Internal Medicine.
The eight new antibiotics approved by the FDA between January 2010 and December 2015 were ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane/tazobactam, and ceftazidime/avibactam. Of those eight drugs, only three showed in vitro activity against the so-called ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species). Only one drug, fidaxomicin, demonstrated in vitro activity against an urgent-threat pathogen from the Centers for Disease Control and Prevention, Clostridium difficile. Bedaquiline was the only new antibiotic specifically indicated for a disease from a multidrug-resistant pathogen, although the investigators said most of the drugs demonstrated in vitro activity against gram-positive drug-resistant pathogens.
Importantly, the authors noted that in vitro activity does not necessarily reflect benefits on actual patient clinical outcomes, as exemplified by such drugs as tigecycline and doripenem.
The researchers found what they called “important deficiencies in the clinical trials leading to approval of these new antibiotic products.” Most pivotal trial designs were primarily noninferiority trials, and the antibiotics were not studied to evaluate whether they have substantial benefits in efficacy over what is currently available, they noted. Additionally, none of the trials evaluated direct patient outcomes as primary end points, and some drugs did not have confirmatory evidence from a second independent trial or did not have any confirmatory trials.
Researchers also examined the prices of a single dose of the new antibiotics. The prices ranged from $1,195 to $4,183 (4-14 days of ceftolozane/tazobactam for acute pyelonephritis and intra-abdominal infections) to $69,702 (24 weeks of bedaquiline) – quite a premium for antibiotics showing unclear evidence of additional benefit.
“As antibiotic innovation continues to move forward, greater attention needs to be paid to incentives for developing high-quality new products with demonstrated superiority to existing products on outcomes in patients with multidrug-resistant disease, replacing the current focus on quantity and presumed future benefits,” researchers concluded.
Read the full study in the Annals of Internal Medicine (doi: 10.7326/M16-0291).
FROM ANNALS OF INTERNAL MEDICINE
Endobariatrics: Coming to a clinic near you
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 too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
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.
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.
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 (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.
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 too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
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.
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.
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 (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.
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 too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
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.
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.
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 (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.
AT DDW® 2016
Endoscopic, laparoscopic pseudocyst drainage comparable if necrotic debris minimal
SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.
Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.
Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.
Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.
Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.
Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.
Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.
Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.
Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.
Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.
Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.
There was no industry funding for the work, and Dr. Garg had no disclosures.
SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.
Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.
Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.
Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.
Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.
Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.
Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.
Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.
Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.
Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.
Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.
There was no industry funding for the work, and Dr. Garg had no disclosures.
SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.
Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.
Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.
Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.
Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.
Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.
Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.
Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.
Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.
Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.
Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.
There was no industry funding for the work, and Dr. Garg had no disclosures.
AT DDW 2016
Key clinical point: Choosing between endoscopic and laparoscopic drainage for pancreatic pseudocysts comes down to local expertise and the amount of necrotic tissue that needs to be removed.
Major finding: Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups.
Data source: Randomized trial with 60 patients.
Disclosures: There was no industry funding for the work, and the presenter had no disclosures.
Bariatric surgery good deal for diabetes, but…
NEW ORLEANS – If the yardstick for measuring the cost-effectiveness of an operation or a medical treatment is that it costs less than $50,000 for each quality-adjusted life-year gained, then weight-loss surgery as a treatment for type 2 diabetes is cost-effective.
However, more long-term follow-up is needed to determine the true value of metabolic or bariatric surgery such as gastric bypass, compared with medical treatment for type 2 diabetes. Studies of bariatric surgery in the nondiabetic population found it was most cost-effective in the following scenarios: in women; in the morbidly obese vs. the moderately obese; in patients with obesity-related comorbidities including diabetes; when the procedures were performed laparoscopically; and when the studies themselves received industry support.
In people with diabetes, the results were similar. “Diabetes metabolic surgery is more cost-effective early in the course of type 2 diabetes compared to later in the course, when performed laparoscopically, and again when the study received support from industry,” reported Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan School of Public Health in Ann Arbor and director of the Michigan Center for Diabetes Translational Research.
He reviewed 11 economic analyses of bariatric surgery and concluded that all exceeded the benchmark for cost-effectiveness based on the cost per quality-adjusted life-year (QALY) gained. Six studies evaluated the general population of obese people and found that the cost-effectiveness ratios ranged from $1,600 to $44,000 per QALY gained. The remaining five studies involved obese patients with type 2 diabetes, two of which reported cost-effectiveness ratios of $2,000 to $23,000 per QALY gained; and the remaining three studies actually reporting a cost-savings. “In other words, the money spent on these interventions was more than recouped in the savings resulting from reduced downstream medical costs,” Dr. Herman reported at the American Diabetes Association scientific sessions.
The studies that found gastric bypass cost-saving in diabetes are noteworthy, Dr. Herman said. “If an intervention is more effective and less costly than a comparator intervention, then it is cost-saving, and that really is an unusual finding in health or medicine; perhaps 10% or 15% of interventions turn out to be cost-saving,” he said. “These are interventions that we want to adopt and put into practice pretty much without question.”
By the same measure, if an intervention is more costly and less effective, it’s easy to dismiss “out of hand,” Dr. Herman said. However, interpreting some of the studies he evaluated was more nuanced. “The problem occurs when a new treatment is both more effective but more costly, which was the case with two of the five analyses of metabolic surgery, and all of the analysis of bariatric surgery in the nondiabetic population,” he said
While gastric bypass surgery for type 2 diabetes is a good value, Dr. Herman added a few caveats. “When one looks at other interventions in similar categories, metformin for diabetes prevention has recently been shown to be cost-saving,” he said. He also said surgery is more cost-effective than marginally cost-effective interventions like intensive glycemic management for people with newly diagnosed type 2 diabetes or retinal screening every year vs. every 2 years.
One key issue with the existing evidence on cost-effectiveness of metabolic surgery for type 2 diabetes that Dr. Herman elucidated is how the studies accounted for participants lost to follow-up. “We know that a patient lost to follow-up may have a less favorable outcome than one who returns for follow-up,” he said. There are two ways studies can account for lost patients: the available-case analysis, which assumes that the patients lost to follow-up have the same rates of remission; and the attrition-adjusted available case follow-up, which uses a worst-case imputation. “I would argue that to account for attrition bias, remission rates calculated using the cases available for follow-up should be adjusted using worst-case imputation,” Dr. Herman said.
He pointed out another limitation when calculating the value of gastric bypass surgery for type 2 diabetes: “There are no randomized clinical trials of metabolic surgery that describe its long-term impact on diabetes treatments, complications, comorbidities, and survival. And it really is going be very important to get these data to confirm the cost-effectiveness of metabolic surgery.”
Among the shortcomings of the existing literature he noted are the assumptions that treatment-related adverse events are self-limited, that body mass index (BMI) achieved up to 5 years after surgery will remain stable, and that diabetes will not relapse. “The data are pretty good now on reversal, remission, hernia repair, and those sorts of things, but we need to look at longer downstream costs associated with surgery, including the need for cholecystectomy, joint replacements, and nutritional deficiencies that may occur and do clearly have financial implications,” he said.
At the same time, the analyses on gastric bypass surgery for type 2 diabetes could be more favorable if they account for improvements in health-related quality-of-life and rely less on cross-sectional data. Dr. Herman said, “I would argue that using cross-sectional data to estimate changes in health-related quality of life as a function of BMI underestimates the improvements on health-related quality-of-life associated with weight loss and will in fact underestimate the cost utility of interventions for obesity treatment,” he said.
Dr. Herman added, “Clearly the evidence to date suggests that metabolic surgery is cost-effective, but I’ll be more assured when I see longer-term follow-up.”
Dr. Herman has no financial relationships to disclose.
NEW ORLEANS – If the yardstick for measuring the cost-effectiveness of an operation or a medical treatment is that it costs less than $50,000 for each quality-adjusted life-year gained, then weight-loss surgery as a treatment for type 2 diabetes is cost-effective.
However, more long-term follow-up is needed to determine the true value of metabolic or bariatric surgery such as gastric bypass, compared with medical treatment for type 2 diabetes. Studies of bariatric surgery in the nondiabetic population found it was most cost-effective in the following scenarios: in women; in the morbidly obese vs. the moderately obese; in patients with obesity-related comorbidities including diabetes; when the procedures were performed laparoscopically; and when the studies themselves received industry support.
In people with diabetes, the results were similar. “Diabetes metabolic surgery is more cost-effective early in the course of type 2 diabetes compared to later in the course, when performed laparoscopically, and again when the study received support from industry,” reported Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan School of Public Health in Ann Arbor and director of the Michigan Center for Diabetes Translational Research.
He reviewed 11 economic analyses of bariatric surgery and concluded that all exceeded the benchmark for cost-effectiveness based on the cost per quality-adjusted life-year (QALY) gained. Six studies evaluated the general population of obese people and found that the cost-effectiveness ratios ranged from $1,600 to $44,000 per QALY gained. The remaining five studies involved obese patients with type 2 diabetes, two of which reported cost-effectiveness ratios of $2,000 to $23,000 per QALY gained; and the remaining three studies actually reporting a cost-savings. “In other words, the money spent on these interventions was more than recouped in the savings resulting from reduced downstream medical costs,” Dr. Herman reported at the American Diabetes Association scientific sessions.
The studies that found gastric bypass cost-saving in diabetes are noteworthy, Dr. Herman said. “If an intervention is more effective and less costly than a comparator intervention, then it is cost-saving, and that really is an unusual finding in health or medicine; perhaps 10% or 15% of interventions turn out to be cost-saving,” he said. “These are interventions that we want to adopt and put into practice pretty much without question.”
By the same measure, if an intervention is more costly and less effective, it’s easy to dismiss “out of hand,” Dr. Herman said. However, interpreting some of the studies he evaluated was more nuanced. “The problem occurs when a new treatment is both more effective but more costly, which was the case with two of the five analyses of metabolic surgery, and all of the analysis of bariatric surgery in the nondiabetic population,” he said
While gastric bypass surgery for type 2 diabetes is a good value, Dr. Herman added a few caveats. “When one looks at other interventions in similar categories, metformin for diabetes prevention has recently been shown to be cost-saving,” he said. He also said surgery is more cost-effective than marginally cost-effective interventions like intensive glycemic management for people with newly diagnosed type 2 diabetes or retinal screening every year vs. every 2 years.
One key issue with the existing evidence on cost-effectiveness of metabolic surgery for type 2 diabetes that Dr. Herman elucidated is how the studies accounted for participants lost to follow-up. “We know that a patient lost to follow-up may have a less favorable outcome than one who returns for follow-up,” he said. There are two ways studies can account for lost patients: the available-case analysis, which assumes that the patients lost to follow-up have the same rates of remission; and the attrition-adjusted available case follow-up, which uses a worst-case imputation. “I would argue that to account for attrition bias, remission rates calculated using the cases available for follow-up should be adjusted using worst-case imputation,” Dr. Herman said.
He pointed out another limitation when calculating the value of gastric bypass surgery for type 2 diabetes: “There are no randomized clinical trials of metabolic surgery that describe its long-term impact on diabetes treatments, complications, comorbidities, and survival. And it really is going be very important to get these data to confirm the cost-effectiveness of metabolic surgery.”
Among the shortcomings of the existing literature he noted are the assumptions that treatment-related adverse events are self-limited, that body mass index (BMI) achieved up to 5 years after surgery will remain stable, and that diabetes will not relapse. “The data are pretty good now on reversal, remission, hernia repair, and those sorts of things, but we need to look at longer downstream costs associated with surgery, including the need for cholecystectomy, joint replacements, and nutritional deficiencies that may occur and do clearly have financial implications,” he said.
At the same time, the analyses on gastric bypass surgery for type 2 diabetes could be more favorable if they account for improvements in health-related quality-of-life and rely less on cross-sectional data. Dr. Herman said, “I would argue that using cross-sectional data to estimate changes in health-related quality of life as a function of BMI underestimates the improvements on health-related quality-of-life associated with weight loss and will in fact underestimate the cost utility of interventions for obesity treatment,” he said.
Dr. Herman added, “Clearly the evidence to date suggests that metabolic surgery is cost-effective, but I’ll be more assured when I see longer-term follow-up.”
Dr. Herman has no financial relationships to disclose.
NEW ORLEANS – If the yardstick for measuring the cost-effectiveness of an operation or a medical treatment is that it costs less than $50,000 for each quality-adjusted life-year gained, then weight-loss surgery as a treatment for type 2 diabetes is cost-effective.
However, more long-term follow-up is needed to determine the true value of metabolic or bariatric surgery such as gastric bypass, compared with medical treatment for type 2 diabetes. Studies of bariatric surgery in the nondiabetic population found it was most cost-effective in the following scenarios: in women; in the morbidly obese vs. the moderately obese; in patients with obesity-related comorbidities including diabetes; when the procedures were performed laparoscopically; and when the studies themselves received industry support.
In people with diabetes, the results were similar. “Diabetes metabolic surgery is more cost-effective early in the course of type 2 diabetes compared to later in the course, when performed laparoscopically, and again when the study received support from industry,” reported Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan School of Public Health in Ann Arbor and director of the Michigan Center for Diabetes Translational Research.
He reviewed 11 economic analyses of bariatric surgery and concluded that all exceeded the benchmark for cost-effectiveness based on the cost per quality-adjusted life-year (QALY) gained. Six studies evaluated the general population of obese people and found that the cost-effectiveness ratios ranged from $1,600 to $44,000 per QALY gained. The remaining five studies involved obese patients with type 2 diabetes, two of which reported cost-effectiveness ratios of $2,000 to $23,000 per QALY gained; and the remaining three studies actually reporting a cost-savings. “In other words, the money spent on these interventions was more than recouped in the savings resulting from reduced downstream medical costs,” Dr. Herman reported at the American Diabetes Association scientific sessions.
The studies that found gastric bypass cost-saving in diabetes are noteworthy, Dr. Herman said. “If an intervention is more effective and less costly than a comparator intervention, then it is cost-saving, and that really is an unusual finding in health or medicine; perhaps 10% or 15% of interventions turn out to be cost-saving,” he said. “These are interventions that we want to adopt and put into practice pretty much without question.”
By the same measure, if an intervention is more costly and less effective, it’s easy to dismiss “out of hand,” Dr. Herman said. However, interpreting some of the studies he evaluated was more nuanced. “The problem occurs when a new treatment is both more effective but more costly, which was the case with two of the five analyses of metabolic surgery, and all of the analysis of bariatric surgery in the nondiabetic population,” he said
While gastric bypass surgery for type 2 diabetes is a good value, Dr. Herman added a few caveats. “When one looks at other interventions in similar categories, metformin for diabetes prevention has recently been shown to be cost-saving,” he said. He also said surgery is more cost-effective than marginally cost-effective interventions like intensive glycemic management for people with newly diagnosed type 2 diabetes or retinal screening every year vs. every 2 years.
One key issue with the existing evidence on cost-effectiveness of metabolic surgery for type 2 diabetes that Dr. Herman elucidated is how the studies accounted for participants lost to follow-up. “We know that a patient lost to follow-up may have a less favorable outcome than one who returns for follow-up,” he said. There are two ways studies can account for lost patients: the available-case analysis, which assumes that the patients lost to follow-up have the same rates of remission; and the attrition-adjusted available case follow-up, which uses a worst-case imputation. “I would argue that to account for attrition bias, remission rates calculated using the cases available for follow-up should be adjusted using worst-case imputation,” Dr. Herman said.
He pointed out another limitation when calculating the value of gastric bypass surgery for type 2 diabetes: “There are no randomized clinical trials of metabolic surgery that describe its long-term impact on diabetes treatments, complications, comorbidities, and survival. And it really is going be very important to get these data to confirm the cost-effectiveness of metabolic surgery.”
Among the shortcomings of the existing literature he noted are the assumptions that treatment-related adverse events are self-limited, that body mass index (BMI) achieved up to 5 years after surgery will remain stable, and that diabetes will not relapse. “The data are pretty good now on reversal, remission, hernia repair, and those sorts of things, but we need to look at longer downstream costs associated with surgery, including the need for cholecystectomy, joint replacements, and nutritional deficiencies that may occur and do clearly have financial implications,” he said.
At the same time, the analyses on gastric bypass surgery for type 2 diabetes could be more favorable if they account for improvements in health-related quality-of-life and rely less on cross-sectional data. Dr. Herman said, “I would argue that using cross-sectional data to estimate changes in health-related quality of life as a function of BMI underestimates the improvements on health-related quality-of-life associated with weight loss and will in fact underestimate the cost utility of interventions for obesity treatment,” he said.
Dr. Herman added, “Clearly the evidence to date suggests that metabolic surgery is cost-effective, but I’ll be more assured when I see longer-term follow-up.”
Dr. Herman has no financial relationships to disclose.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Bariatric or metabolic surgery is a cost-effective treatment for type 2 diabetes.
Major finding: Cost-effectiveness ratios of $2,000-$23,000 for bariatric surgery in people with type 2 diabetes fall below the cost-effectiveness threshold.
Data source: Review of 11 economic analyses of bariatric surgery, including six studies of bariatric surgery in people with type 2 diabetes.
Disclosures: Dr. Herman reported having no financial disclosures.
Fresh Press: ACS Surgery News digital June issue is live on the website
The June issue of ACS Surgery News is available online. Use the mobile app to download or view as a pdf.
This month’s issue features coverage of a study of outcomes of common operations in critical access hospitals. The findings suggest that these smaller, rural hospitals are competitive with larger medical centers in costs and postop complications for appendectomy, cholecystectomy, colectomy, and hernia repair.
Don’t miss Dr. Tyler G. Hughes’s report on his visit with colleagues of the Royal Australasian College of Surgeons. He found some differences and many striking similarities when it comes to challenges faced by surgeons.
The April feature, “Operating with Pain” (2016, p. 1), provoked comments from readers on personal experiences and recommendations around the topic of pain and workplace injury. A sample of these responses can be found on p. 4.
The June issue of ACS Surgery News is available online. Use the mobile app to download or view as a pdf.
This month’s issue features coverage of a study of outcomes of common operations in critical access hospitals. The findings suggest that these smaller, rural hospitals are competitive with larger medical centers in costs and postop complications for appendectomy, cholecystectomy, colectomy, and hernia repair.
Don’t miss Dr. Tyler G. Hughes’s report on his visit with colleagues of the Royal Australasian College of Surgeons. He found some differences and many striking similarities when it comes to challenges faced by surgeons.
The April feature, “Operating with Pain” (2016, p. 1), provoked comments from readers on personal experiences and recommendations around the topic of pain and workplace injury. A sample of these responses can be found on p. 4.
The June issue of ACS Surgery News is available online. Use the mobile app to download or view as a pdf.
This month’s issue features coverage of a study of outcomes of common operations in critical access hospitals. The findings suggest that these smaller, rural hospitals are competitive with larger medical centers in costs and postop complications for appendectomy, cholecystectomy, colectomy, and hernia repair.
Don’t miss Dr. Tyler G. Hughes’s report on his visit with colleagues of the Royal Australasian College of Surgeons. He found some differences and many striking similarities when it comes to challenges faced by surgeons.
The April feature, “Operating with Pain” (2016, p. 1), provoked comments from readers on personal experiences and recommendations around the topic of pain and workplace injury. A sample of these responses can be found on p. 4.
