User login
Bariatric revision mortality linked to age, comorbidities
WASHINGTON – and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.
Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.
In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).
Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.
The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.
The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.
On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.
In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.
The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.
She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.
Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.
SOURCE: Popov VB et al. DDW 2018, Abstract 324.
WASHINGTON – and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.
Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.
In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).
Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.
The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.
The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.
On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.
In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.
The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.
She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.
Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.
SOURCE: Popov VB et al. DDW 2018, Abstract 324.
WASHINGTON – and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.
Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.
In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).
Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.
The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.
The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.
On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.
In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.
The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.
She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.
Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.
SOURCE: Popov VB et al. DDW 2018, Abstract 324.
REPORTING FROM DDW 2018
Key clinical point: Revisional bariatric procedures may carry a greater mortality risk than previous studies have suggested.
Major finding: The mortality rate in the sample was 2.1%.
Study details: The 2014 Nationwide Inpatient Sample database, comprising 14,280 patients who underwent revisional bariatric surgery.
Disclosures: Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.
Source: Popov VB et al. DDW 2018, Abstract 324.
Beyond the sleeve and RYGB: The frontier of bariatric procedures
BOSTON – Though are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.
A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.
One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.
In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.
The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”
A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.
In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.
Parsing safety and efficacy of this procedure isn’t easy, given the studies at hand, said Dr. McKenzie: “The data are plagued by short follow-up, low numbers, and inconsistent quality.” Of the 14 case series following 1,045 patients, none include randomized controlled data, he said.
The data that are available show total body weight loss in the 34%-39% range, with little difference between losses seen at 1 year and 2 years.
However, said Dr. McKenzie, one 100-patient case series showed that SADI-S patients averaged 2.5 bowel movements daily after the procedure, and two patients needed surgical revision because they were experiencing malnutrition. Anemia, vitamin B12 and D deficiencies, and folate deficiency are all commonly seen two years after SADI-S procedures, he said.
“The OADS procedure is very effective, although better data are needed before drawing conclusions,” said Dr. McKenzie.
A gastric bypass variation known as the “mini” bypass, or the one anastomosis gastric bypass (OAGB), is another less common bariatric technique. In this procedure, a small gastric pouch is created that forms the working stomach, which is then connected to the duodenum with bypassing of a significant portion (up to 200 cm) of the small intestine. This procedure causes both restrictive and malabsorptive weight loss, and is usually performed using minimally invasive surgery.
Four randomized controlled trials exist, said Dr. McKenzie, that compare OAGB variously to Roux-en-Y gastric bypass (RYGB) and to sleeve gastrectomy. In an 80-patient study that compared OAGB with RYGB at two years post-procedure, excess weight loss was similar, at 60% for OAGB versus 64% for RYGB ( Ann Surg. 2005;24[1]20-8). However, morbidity was less for OAGB recipients (8% vs 20%, P less than .05).
Another study looked at OAGB and sleeve gastrectomy in 60 patients, following them for 5 years. Total body weight loss was similar between groups at 20%-23%, said Dr. McKenzie (Obes Surg. 2014;24[9]1552-62).
“But what about bile reflux?” asked Dr. McKenzie. He pointed out that in OAGB, digestive juices enter the digestive path very close to the outlet of the new, surgically created stomach, affording the potential for significant reflux. Calling for further study of the frequency of bile reflux and potential long-term sequelae, he advised caution with this otherwise attractive procedure.
Those caring for bariatric patients may also see the consequences of “rogue” procedures on occasion: “Interest in metabolic surgery has led to some ‘original’ procedures, many of which are not based on firm science,” said Dr. McKenzie. An exemplar of an understudied procedure is the sleeve gastrectomy with a loop bipartition, with results that have been published in case reports, but whose longer-term outcomes are unknown.
“Caution is advised regarding operations that are devised outside of study protocols,” said Dr. McKenzie.
Dr. McKenzie reported that he had no relevant financial disclosures.
SOURCE: McKenzie, T. AACE 2018, presentation SGS4.
BOSTON – Though are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.
A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.
One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.
In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.
The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”
A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.
In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.
Parsing safety and efficacy of this procedure isn’t easy, given the studies at hand, said Dr. McKenzie: “The data are plagued by short follow-up, low numbers, and inconsistent quality.” Of the 14 case series following 1,045 patients, none include randomized controlled data, he said.
The data that are available show total body weight loss in the 34%-39% range, with little difference between losses seen at 1 year and 2 years.
However, said Dr. McKenzie, one 100-patient case series showed that SADI-S patients averaged 2.5 bowel movements daily after the procedure, and two patients needed surgical revision because they were experiencing malnutrition. Anemia, vitamin B12 and D deficiencies, and folate deficiency are all commonly seen two years after SADI-S procedures, he said.
“The OADS procedure is very effective, although better data are needed before drawing conclusions,” said Dr. McKenzie.
A gastric bypass variation known as the “mini” bypass, or the one anastomosis gastric bypass (OAGB), is another less common bariatric technique. In this procedure, a small gastric pouch is created that forms the working stomach, which is then connected to the duodenum with bypassing of a significant portion (up to 200 cm) of the small intestine. This procedure causes both restrictive and malabsorptive weight loss, and is usually performed using minimally invasive surgery.
Four randomized controlled trials exist, said Dr. McKenzie, that compare OAGB variously to Roux-en-Y gastric bypass (RYGB) and to sleeve gastrectomy. In an 80-patient study that compared OAGB with RYGB at two years post-procedure, excess weight loss was similar, at 60% for OAGB versus 64% for RYGB ( Ann Surg. 2005;24[1]20-8). However, morbidity was less for OAGB recipients (8% vs 20%, P less than .05).
Another study looked at OAGB and sleeve gastrectomy in 60 patients, following them for 5 years. Total body weight loss was similar between groups at 20%-23%, said Dr. McKenzie (Obes Surg. 2014;24[9]1552-62).
“But what about bile reflux?” asked Dr. McKenzie. He pointed out that in OAGB, digestive juices enter the digestive path very close to the outlet of the new, surgically created stomach, affording the potential for significant reflux. Calling for further study of the frequency of bile reflux and potential long-term sequelae, he advised caution with this otherwise attractive procedure.
Those caring for bariatric patients may also see the consequences of “rogue” procedures on occasion: “Interest in metabolic surgery has led to some ‘original’ procedures, many of which are not based on firm science,” said Dr. McKenzie. An exemplar of an understudied procedure is the sleeve gastrectomy with a loop bipartition, with results that have been published in case reports, but whose longer-term outcomes are unknown.
“Caution is advised regarding operations that are devised outside of study protocols,” said Dr. McKenzie.
Dr. McKenzie reported that he had no relevant financial disclosures.
SOURCE: McKenzie, T. AACE 2018, presentation SGS4.
BOSTON – Though are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.
A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.
One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.
In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.
The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”
A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.
In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.
Parsing safety and efficacy of this procedure isn’t easy, given the studies at hand, said Dr. McKenzie: “The data are plagued by short follow-up, low numbers, and inconsistent quality.” Of the 14 case series following 1,045 patients, none include randomized controlled data, he said.
The data that are available show total body weight loss in the 34%-39% range, with little difference between losses seen at 1 year and 2 years.
However, said Dr. McKenzie, one 100-patient case series showed that SADI-S patients averaged 2.5 bowel movements daily after the procedure, and two patients needed surgical revision because they were experiencing malnutrition. Anemia, vitamin B12 and D deficiencies, and folate deficiency are all commonly seen two years after SADI-S procedures, he said.
“The OADS procedure is very effective, although better data are needed before drawing conclusions,” said Dr. McKenzie.
A gastric bypass variation known as the “mini” bypass, or the one anastomosis gastric bypass (OAGB), is another less common bariatric technique. In this procedure, a small gastric pouch is created that forms the working stomach, which is then connected to the duodenum with bypassing of a significant portion (up to 200 cm) of the small intestine. This procedure causes both restrictive and malabsorptive weight loss, and is usually performed using minimally invasive surgery.
Four randomized controlled trials exist, said Dr. McKenzie, that compare OAGB variously to Roux-en-Y gastric bypass (RYGB) and to sleeve gastrectomy. In an 80-patient study that compared OAGB with RYGB at two years post-procedure, excess weight loss was similar, at 60% for OAGB versus 64% for RYGB ( Ann Surg. 2005;24[1]20-8). However, morbidity was less for OAGB recipients (8% vs 20%, P less than .05).
Another study looked at OAGB and sleeve gastrectomy in 60 patients, following them for 5 years. Total body weight loss was similar between groups at 20%-23%, said Dr. McKenzie (Obes Surg. 2014;24[9]1552-62).
“But what about bile reflux?” asked Dr. McKenzie. He pointed out that in OAGB, digestive juices enter the digestive path very close to the outlet of the new, surgically created stomach, affording the potential for significant reflux. Calling for further study of the frequency of bile reflux and potential long-term sequelae, he advised caution with this otherwise attractive procedure.
Those caring for bariatric patients may also see the consequences of “rogue” procedures on occasion: “Interest in metabolic surgery has led to some ‘original’ procedures, many of which are not based on firm science,” said Dr. McKenzie. An exemplar of an understudied procedure is the sleeve gastrectomy with a loop bipartition, with results that have been published in case reports, but whose longer-term outcomes are unknown.
“Caution is advised regarding operations that are devised outside of study protocols,” said Dr. McKenzie.
Dr. McKenzie reported that he had no relevant financial disclosures.
SOURCE: McKenzie, T. AACE 2018, presentation SGS4.
EXPERT ANALYSIS FROM AACE 2018
The case for bariatric surgery to manage CV risk in diabetes
BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes ( health over the lifespan.
“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.
At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.
Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).
Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.
From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.
The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m2 and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m2 is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.
The body of data that support long-term metabolic and cardiovascular benefits of bariatric surgery as obesity therapy is growing, said Dr. Hurley. A large prospective observational study by the American College of Surgeons’ Bariatric Surgery Center Network followed 28,616 patients, finding that Roux-en-Y gastric bypass (RYGB) was most effective in improving or resolving CVD comorbidities. At 1 year post surgery, 83% of RYGB patients saw improvement or resolution of T2D; the figure was 79% for hypertension and 66% for dyslipidemia (Ann Surg. 2011;254[3]:410-20).
Weight loss for patients receiving bariatric procedures has generally been durable: for laparoscopic RYGB patients tracked to 7 years after surgery, 75% had maintained at least a 20% weight loss (JAMA Surg. 2018;153[5]427-34).
Longer-term clinical follow-up points toward favorable metabolic and cardiovascular outcomes, said Dr. Hurley, citing data from the Swedish Obese Subjects (SOS) trial. This study followed over 4,000 patients with high BMIs (at least 34 kg/m2 for men and 38 kg/m2 for women) over 10 years. At that point, 36% of gastric bypass patients, compared with 13% of non-surgical high BMI patients, saw resolution of T2D, a significant difference. Triglyceride levels also fell significantly more for the bypass recipients. Hypertension was resolved in just 19% of patients at 10 years, a non-significant difference from the 11% of control patients. Data from the same patient set also showed a significant reduction in total cardiovascular events in the surgical versus non-surgical patients (n = 49 vs. 28, hazard ratio 0.83, log-rank P = .05). Fatal cardiovascular events were significantly lower for patients who had received bariatric surgery, with a 24% decline in mortality for bariatric surgery patients at about 11 years post surgery.
Canadian data showed even greater reductions in mortality, with an 89% decrease in mortality after RYGB, compared with non-surgical patients at the 5-year mark (Ann Surg 2004;240:416-24).
In trials that afforded a direct comparison of medical therapy and bariatric surgery obesity and diabetes, Dr. Hurley said that randomized trials generally show no change to modest change in HbA1c levels with medical management. By contrast, patients in the surgical arms showed a range of improvement ranging from a reduction of just under 1% to reductions of over 5%, with an average reduction of more than 2% across the trials.
Separating out data from the randomized controlled trials with patient BMIs averaging 35 kg/m2 or less, odds ratios still favored bariatric surgery over medication therapy for diabetes-related outcomes in this lower-BMI population, said Dr. Hurley (Diabetes Care 2016;39:924-33).
More data come from a recently reported randomized trial that assigned patients with T2D and a mean BMI of 37 kg/m2 (range, 27-43) to intensive medical therapy, or either sleeve gastrectomy (SG) or RYGB. The study, which had a 90% completion rate at the 5-year mark, found that both surgical procedures were significantly more effective at reducing HbA1c to 6% or less 12 months into the study (P less than .001).
At the 60-month mark, 45% of the RYGB and 25% of the SG patients were on no diabetes medications, while just 2% of the medical therapy arm had stopped all medications, and 40% of this group remained on insulin 5 years into the study, said Dr. Hurley (N Engl J Med. 2017;376:641-651).
“For treatment of type 2 diabetes and cardiovascular co-morbidities, long-term goals often are met following bariatric surgery versus behavior change,” said Dr. Hurley.
Dr. Hurley reported that he had no financial disclosures.
koakes@mdedge.com
SOURCE: Hurley, D. AACE 2018, Session SGS-4.
BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes ( health over the lifespan.
“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.
At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.
Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).
Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.
From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.
The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m2 and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m2 is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.
The body of data that support long-term metabolic and cardiovascular benefits of bariatric surgery as obesity therapy is growing, said Dr. Hurley. A large prospective observational study by the American College of Surgeons’ Bariatric Surgery Center Network followed 28,616 patients, finding that Roux-en-Y gastric bypass (RYGB) was most effective in improving or resolving CVD comorbidities. At 1 year post surgery, 83% of RYGB patients saw improvement or resolution of T2D; the figure was 79% for hypertension and 66% for dyslipidemia (Ann Surg. 2011;254[3]:410-20).
Weight loss for patients receiving bariatric procedures has generally been durable: for laparoscopic RYGB patients tracked to 7 years after surgery, 75% had maintained at least a 20% weight loss (JAMA Surg. 2018;153[5]427-34).
Longer-term clinical follow-up points toward favorable metabolic and cardiovascular outcomes, said Dr. Hurley, citing data from the Swedish Obese Subjects (SOS) trial. This study followed over 4,000 patients with high BMIs (at least 34 kg/m2 for men and 38 kg/m2 for women) over 10 years. At that point, 36% of gastric bypass patients, compared with 13% of non-surgical high BMI patients, saw resolution of T2D, a significant difference. Triglyceride levels also fell significantly more for the bypass recipients. Hypertension was resolved in just 19% of patients at 10 years, a non-significant difference from the 11% of control patients. Data from the same patient set also showed a significant reduction in total cardiovascular events in the surgical versus non-surgical patients (n = 49 vs. 28, hazard ratio 0.83, log-rank P = .05). Fatal cardiovascular events were significantly lower for patients who had received bariatric surgery, with a 24% decline in mortality for bariatric surgery patients at about 11 years post surgery.
Canadian data showed even greater reductions in mortality, with an 89% decrease in mortality after RYGB, compared with non-surgical patients at the 5-year mark (Ann Surg 2004;240:416-24).
In trials that afforded a direct comparison of medical therapy and bariatric surgery obesity and diabetes, Dr. Hurley said that randomized trials generally show no change to modest change in HbA1c levels with medical management. By contrast, patients in the surgical arms showed a range of improvement ranging from a reduction of just under 1% to reductions of over 5%, with an average reduction of more than 2% across the trials.
Separating out data from the randomized controlled trials with patient BMIs averaging 35 kg/m2 or less, odds ratios still favored bariatric surgery over medication therapy for diabetes-related outcomes in this lower-BMI population, said Dr. Hurley (Diabetes Care 2016;39:924-33).
More data come from a recently reported randomized trial that assigned patients with T2D and a mean BMI of 37 kg/m2 (range, 27-43) to intensive medical therapy, or either sleeve gastrectomy (SG) or RYGB. The study, which had a 90% completion rate at the 5-year mark, found that both surgical procedures were significantly more effective at reducing HbA1c to 6% or less 12 months into the study (P less than .001).
At the 60-month mark, 45% of the RYGB and 25% of the SG patients were on no diabetes medications, while just 2% of the medical therapy arm had stopped all medications, and 40% of this group remained on insulin 5 years into the study, said Dr. Hurley (N Engl J Med. 2017;376:641-651).
“For treatment of type 2 diabetes and cardiovascular co-morbidities, long-term goals often are met following bariatric surgery versus behavior change,” said Dr. Hurley.
Dr. Hurley reported that he had no financial disclosures.
koakes@mdedge.com
SOURCE: Hurley, D. AACE 2018, Session SGS-4.
BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes ( health over the lifespan.
“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.
At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.
Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).
Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.
From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.
The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m2 and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m2 is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.
The body of data that support long-term metabolic and cardiovascular benefits of bariatric surgery as obesity therapy is growing, said Dr. Hurley. A large prospective observational study by the American College of Surgeons’ Bariatric Surgery Center Network followed 28,616 patients, finding that Roux-en-Y gastric bypass (RYGB) was most effective in improving or resolving CVD comorbidities. At 1 year post surgery, 83% of RYGB patients saw improvement or resolution of T2D; the figure was 79% for hypertension and 66% for dyslipidemia (Ann Surg. 2011;254[3]:410-20).
Weight loss for patients receiving bariatric procedures has generally been durable: for laparoscopic RYGB patients tracked to 7 years after surgery, 75% had maintained at least a 20% weight loss (JAMA Surg. 2018;153[5]427-34).
Longer-term clinical follow-up points toward favorable metabolic and cardiovascular outcomes, said Dr. Hurley, citing data from the Swedish Obese Subjects (SOS) trial. This study followed over 4,000 patients with high BMIs (at least 34 kg/m2 for men and 38 kg/m2 for women) over 10 years. At that point, 36% of gastric bypass patients, compared with 13% of non-surgical high BMI patients, saw resolution of T2D, a significant difference. Triglyceride levels also fell significantly more for the bypass recipients. Hypertension was resolved in just 19% of patients at 10 years, a non-significant difference from the 11% of control patients. Data from the same patient set also showed a significant reduction in total cardiovascular events in the surgical versus non-surgical patients (n = 49 vs. 28, hazard ratio 0.83, log-rank P = .05). Fatal cardiovascular events were significantly lower for patients who had received bariatric surgery, with a 24% decline in mortality for bariatric surgery patients at about 11 years post surgery.
Canadian data showed even greater reductions in mortality, with an 89% decrease in mortality after RYGB, compared with non-surgical patients at the 5-year mark (Ann Surg 2004;240:416-24).
In trials that afforded a direct comparison of medical therapy and bariatric surgery obesity and diabetes, Dr. Hurley said that randomized trials generally show no change to modest change in HbA1c levels with medical management. By contrast, patients in the surgical arms showed a range of improvement ranging from a reduction of just under 1% to reductions of over 5%, with an average reduction of more than 2% across the trials.
Separating out data from the randomized controlled trials with patient BMIs averaging 35 kg/m2 or less, odds ratios still favored bariatric surgery over medication therapy for diabetes-related outcomes in this lower-BMI population, said Dr. Hurley (Diabetes Care 2016;39:924-33).
More data come from a recently reported randomized trial that assigned patients with T2D and a mean BMI of 37 kg/m2 (range, 27-43) to intensive medical therapy, or either sleeve gastrectomy (SG) or RYGB. The study, which had a 90% completion rate at the 5-year mark, found that both surgical procedures were significantly more effective at reducing HbA1c to 6% or less 12 months into the study (P less than .001).
At the 60-month mark, 45% of the RYGB and 25% of the SG patients were on no diabetes medications, while just 2% of the medical therapy arm had stopped all medications, and 40% of this group remained on insulin 5 years into the study, said Dr. Hurley (N Engl J Med. 2017;376:641-651).
“For treatment of type 2 diabetes and cardiovascular co-morbidities, long-term goals often are met following bariatric surgery versus behavior change,” said Dr. Hurley.
Dr. Hurley reported that he had no financial disclosures.
koakes@mdedge.com
SOURCE: Hurley, D. AACE 2018, Session SGS-4.
EXPERT ANALYSIS FROM AACE 2018
FDA alerts clinicians to gastric balloon deaths
according to an alert from the Food and Drug Administration issued on June 4.
Seven of these deaths occurred in patients in the United States; four involved the ORBERA Intragastric Balloon System, and three involved the ReShape Integrated Dual Balloon System.
The FDA has approved updated labeling for the ORBERA and ReShape balloon systems in the United States. The labels contain more information about possible death associated with the use of these devices in the United States. The manufacturers’ sites, Apollo Endosurgery and ReShape Lifesciences, provide more details about the new labeling.
In a letter to health care providers, the FDA advised clinicians to educate bariatric surgery patients about the symptoms of complications from balloon procedures, including not only gastric perforation but also esophageal perforation, balloon deflation, gastrointestinal obstruction, and ulceration. In addition, the FDA reminded clinicians to monitor patients during the entire course of treatment for additional complications, including acute pancreatitis and spontaneous hyperinflation.
Any adverse events involving intragastric balloon systems should be reported to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
according to an alert from the Food and Drug Administration issued on June 4.
Seven of these deaths occurred in patients in the United States; four involved the ORBERA Intragastric Balloon System, and three involved the ReShape Integrated Dual Balloon System.
The FDA has approved updated labeling for the ORBERA and ReShape balloon systems in the United States. The labels contain more information about possible death associated with the use of these devices in the United States. The manufacturers’ sites, Apollo Endosurgery and ReShape Lifesciences, provide more details about the new labeling.
In a letter to health care providers, the FDA advised clinicians to educate bariatric surgery patients about the symptoms of complications from balloon procedures, including not only gastric perforation but also esophageal perforation, balloon deflation, gastrointestinal obstruction, and ulceration. In addition, the FDA reminded clinicians to monitor patients during the entire course of treatment for additional complications, including acute pancreatitis and spontaneous hyperinflation.
Any adverse events involving intragastric balloon systems should be reported to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
according to an alert from the Food and Drug Administration issued on June 4.
Seven of these deaths occurred in patients in the United States; four involved the ORBERA Intragastric Balloon System, and three involved the ReShape Integrated Dual Balloon System.
The FDA has approved updated labeling for the ORBERA and ReShape balloon systems in the United States. The labels contain more information about possible death associated with the use of these devices in the United States. The manufacturers’ sites, Apollo Endosurgery and ReShape Lifesciences, provide more details about the new labeling.
In a letter to health care providers, the FDA advised clinicians to educate bariatric surgery patients about the symptoms of complications from balloon procedures, including not only gastric perforation but also esophageal perforation, balloon deflation, gastrointestinal obstruction, and ulceration. In addition, the FDA reminded clinicians to monitor patients during the entire course of treatment for additional complications, including acute pancreatitis and spontaneous hyperinflation.
Any adverse events involving intragastric balloon systems should be reported to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Bismuth subgallate cuts stool smell after duodenal switch
SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.
Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.
“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.
Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.
Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.
Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.
“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.
Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.
Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.
The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.
The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.
The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.
SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.
SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.
Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.
“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.
Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.
Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.
Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.
“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.
Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.
Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.
The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.
The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.
The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.
SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.
SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.
Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.
“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.
Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.
Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.
Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.
“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.
Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.
Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.
The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.
The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.
The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.
SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.
REPORTING FROM SAGES 2018
Key clinical point: Bismuth subgallate (Devrom) is a big help for an embarrassing and underappreciated problem after loop duodenal switch: stool odor.
Major finding: Patients reported about a 1.5-point improvement on 4-point scales rating stool and flatulence odor and their concerns about them.
Study details: Randomized, placebo-controlled trial with 36 patients
Disclosures: The investigators reported an unrestricted educational grant from Parthenon, the makers of the tested product.
Source: Zaveri H et al. SAGES 2018, Abstract S028.
VIDEO: First year after bariatric surgery critical for HbA1c improvement
BOSTON – Acute weight loss during the first year after bariatric surgery has a significant effect on hemoglobin A1c level improvement at 5 years’ follow-up, according to a study presented at the annual meeting of the American Association of Clinical Endocrinologists.
The data presented could help clinicians understand when and where to focus their efforts to help patients optimize weight loss in order to see the best long-term benefits of the procedure, according to presenter Keren Zhou, MD, an endocrinology fellow at the Cleveland Clinic.
“Clinicians need to really focus on that first year weight loss after bariatric surgery to try and optimize 5-year A1c outcomes,” said Dr. Zhou. “It also answers another question people have been having, which is how much does weight regain after bariatric surgery really matter? What we’ve been able to show here is that weight regain didn’t look very correlated at all.”
Dr. Zhou and her colleagues developed the ancillary study using data from the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial, specifically looking at 96 patients: 49 who underwent bariatric surgery and 47 who had a sleeve gastrectomy.
Patients were majority female, on average 48 years old, with a mean body mass index of 36.5 and HbA1c level of 9.4.
Overall, bariatric surgery patients lost an average of 27.2% in the first year, and regained around 8.2% from the first to fifth year, while sleeve gastrectomy lost and regained 25.1% and 9.4% respectively.
When comparing weight loss in the first year and HbA1c levels, Dr. Zhou and her colleagues found a significant correlation for both bariatric surgery and sleeve gastrectomy patients (r +.34; P = .0006).
“It was interesting because when we graphically represented the weight changes in addition to the A1c over time, we found that they actually correlated quite closely, but it was only when we did the statistical analysis on the numbers that we found that [in both groups] people who lost less weight had a higher A1c at the 5-year mark,” said Dr. Zhou.
In the non–multivariable analysis, however, investigators found a more significant correlation between weight regain and HbA1c levels in gastrectomy patients, however these findings changed when Dr. Zhou and her fellow investigators controlled for insulin use and baseline C-peptide.
In continuing studies, Dr. Zhou and her team will dive deeper into why these correlations exist, as right now they can only speculate.
Dr. Zhou reported no relevant financial disclosures.
SOURCE: Zhou K et al. AACE 18. Abstract 240-F.
BOSTON – Acute weight loss during the first year after bariatric surgery has a significant effect on hemoglobin A1c level improvement at 5 years’ follow-up, according to a study presented at the annual meeting of the American Association of Clinical Endocrinologists.
The data presented could help clinicians understand when and where to focus their efforts to help patients optimize weight loss in order to see the best long-term benefits of the procedure, according to presenter Keren Zhou, MD, an endocrinology fellow at the Cleveland Clinic.
“Clinicians need to really focus on that first year weight loss after bariatric surgery to try and optimize 5-year A1c outcomes,” said Dr. Zhou. “It also answers another question people have been having, which is how much does weight regain after bariatric surgery really matter? What we’ve been able to show here is that weight regain didn’t look very correlated at all.”
Dr. Zhou and her colleagues developed the ancillary study using data from the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial, specifically looking at 96 patients: 49 who underwent bariatric surgery and 47 who had a sleeve gastrectomy.
Patients were majority female, on average 48 years old, with a mean body mass index of 36.5 and HbA1c level of 9.4.
Overall, bariatric surgery patients lost an average of 27.2% in the first year, and regained around 8.2% from the first to fifth year, while sleeve gastrectomy lost and regained 25.1% and 9.4% respectively.
When comparing weight loss in the first year and HbA1c levels, Dr. Zhou and her colleagues found a significant correlation for both bariatric surgery and sleeve gastrectomy patients (r +.34; P = .0006).
“It was interesting because when we graphically represented the weight changes in addition to the A1c over time, we found that they actually correlated quite closely, but it was only when we did the statistical analysis on the numbers that we found that [in both groups] people who lost less weight had a higher A1c at the 5-year mark,” said Dr. Zhou.
In the non–multivariable analysis, however, investigators found a more significant correlation between weight regain and HbA1c levels in gastrectomy patients, however these findings changed when Dr. Zhou and her fellow investigators controlled for insulin use and baseline C-peptide.
In continuing studies, Dr. Zhou and her team will dive deeper into why these correlations exist, as right now they can only speculate.
Dr. Zhou reported no relevant financial disclosures.
SOURCE: Zhou K et al. AACE 18. Abstract 240-F.
BOSTON – Acute weight loss during the first year after bariatric surgery has a significant effect on hemoglobin A1c level improvement at 5 years’ follow-up, according to a study presented at the annual meeting of the American Association of Clinical Endocrinologists.
The data presented could help clinicians understand when and where to focus their efforts to help patients optimize weight loss in order to see the best long-term benefits of the procedure, according to presenter Keren Zhou, MD, an endocrinology fellow at the Cleveland Clinic.
“Clinicians need to really focus on that first year weight loss after bariatric surgery to try and optimize 5-year A1c outcomes,” said Dr. Zhou. “It also answers another question people have been having, which is how much does weight regain after bariatric surgery really matter? What we’ve been able to show here is that weight regain didn’t look very correlated at all.”
Dr. Zhou and her colleagues developed the ancillary study using data from the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial, specifically looking at 96 patients: 49 who underwent bariatric surgery and 47 who had a sleeve gastrectomy.
Patients were majority female, on average 48 years old, with a mean body mass index of 36.5 and HbA1c level of 9.4.
Overall, bariatric surgery patients lost an average of 27.2% in the first year, and regained around 8.2% from the first to fifth year, while sleeve gastrectomy lost and regained 25.1% and 9.4% respectively.
When comparing weight loss in the first year and HbA1c levels, Dr. Zhou and her colleagues found a significant correlation for both bariatric surgery and sleeve gastrectomy patients (r +.34; P = .0006).
“It was interesting because when we graphically represented the weight changes in addition to the A1c over time, we found that they actually correlated quite closely, but it was only when we did the statistical analysis on the numbers that we found that [in both groups] people who lost less weight had a higher A1c at the 5-year mark,” said Dr. Zhou.
In the non–multivariable analysis, however, investigators found a more significant correlation between weight regain and HbA1c levels in gastrectomy patients, however these findings changed when Dr. Zhou and her fellow investigators controlled for insulin use and baseline C-peptide.
In continuing studies, Dr. Zhou and her team will dive deeper into why these correlations exist, as right now they can only speculate.
Dr. Zhou reported no relevant financial disclosures.
SOURCE: Zhou K et al. AACE 18. Abstract 240-F.
REPORTING FROM AACE 18
Key clinical point:
Major finding: Change in weight within the first year was significantly correlated with lower HbA1c levels at 5 years (P = .0003).
Study details: Ancillary study of 96 patients who underwent either bariatric surgery or sleeve gastrectomy and participated in the STAMPEDE study.
Disclosures: Presenter reported no relevant financial disclosures.
Source: Zhou K et al. AACE 18. Abstract 240-F.
Figure-of-eight overstitch keeps endoscopic stents in place
SEATTLE – Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.
Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.
Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.
Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).
The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,
The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.
“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.
Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.
Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.
Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.
Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.
Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.
In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.
The investigators did not report any relevant disclosures, and there was no outside funding.
SEATTLE – Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.
Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.
Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.
Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).
The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,
The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.
“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.
Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.
Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.
Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.
Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.
Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.
In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.
The investigators did not report any relevant disclosures, and there was no outside funding.
SEATTLE – Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.
Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.
Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.
Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).
The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,
The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.
“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.
Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.
Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.
Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.
Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.
Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.
In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.
The investigators did not report any relevant disclosures, and there was no outside funding.
REPORTING FROM SAGES 2018
Key clinical point: Consider fixation when endoscopic stents are used for bariatric surgery leaks.
Major finding: Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.
Study details: A review of 37 leak cases
Disclosures: The investigators did not report any relevant disclosures, and there was no outside funding.
VTE risk after bariatric surgery should be assessed
SEATTLE – Preop thromboelastometry can identify patients who need extra according to a prospective investigation of 40 patients at Conemaugh Memorial Medical Center in Johnstown, Pa.
Enoxaparin 40 mg twice daily just wasn’t enough for people who were hypercoagulable before surgery. The goal of the study was to find the best way to prevent venous thromboembolism (VTE) after weight loss surgery. At present, there’s no consensus on prophylaxis dosing, timing, duration, or even what agent to use for these patients. Conemaugh uses postop enoxaparin, a low-molecular-weight heparin. Among many other options, some hospitals opt for preop dosing with traditional heparin, which is less expensive.
The Conemaugh team turned to thromboelastometry (TEM) to look at the question of VTE risk in bariatric surgery patients. The test gauges coagulation status by measuring elasticity as a small blood sample clots over a few minutes. The investigators found that patients who were hypercoagulable before surgery were likely to be hypercoagulable afterwards. The finding argues for baseline TEM testing to guide postop anticoagulation.
The problem is that bariatric services don’t often have access to TEM equipment, and insurance doesn’t cover the $60 test. In this instance, the Lake Erie College of Osteopathic Medicine in Erie, Pa., had the equipment and covered the testing for the study.
The patients had TEM at baseline and then received 40 mg of enoxaparin about 4 hours after surgery – mostly laparoscopic gastric bypasses – and a second dose about 12 hours after the first. TEM was repeated about 2 hours after the second dose.
At baseline, 2 (5%) of the patients were hypocoagulable, 15 (37.5%) were normal, and 23 (57.5%) were hypercoagulable. On postop TEM, 17 patients (42.5%) were normal and 23 (57.5%) were hypercoagulable: “These 23 were inadequately anticoagulated,” said lead investigator Daniel Urias, MD, a general surgery resident at the medical center.
“There was an association between being normal at baseline and being normal postop, and being hypercoagulable at baseline and hypercoagulable postop. We didn’t anticipate finding such similarity between the numbers. Our suspicion that baseline status plays a major role is holding true,” Dr. Urias said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
When patients test hypercoagulable at baseline, “we are [now] leaning towards [enoxaparin] 60 mg twice daily,” he said.
Ultimately, anticoagulation TEM could be used to titrate patients into the normal range. For best outcomes, it’s likely that “obese patients require goal-directed therapy instead of weight-based or fixed dosing,” he said, but nothing is going to happen until insurance steps up.
The patients did not have underlying coagulopathies, and 33 (82.5%) were women; the average age was 44 years and average body mass index was 43.6 kg/m2. The mean preop Caprini score was 4, indicating moderate VTE risk. Surgery lasted about 200 minutes. Patients were out of bed and walking on postop day 0.
The investigators had no relevant disclosures.
SOURCE: Urias D et al. World Congress of Endoscopic Surgery hosted by SAGES & CAGS abstract S023.
SEATTLE – Preop thromboelastometry can identify patients who need extra according to a prospective investigation of 40 patients at Conemaugh Memorial Medical Center in Johnstown, Pa.
Enoxaparin 40 mg twice daily just wasn’t enough for people who were hypercoagulable before surgery. The goal of the study was to find the best way to prevent venous thromboembolism (VTE) after weight loss surgery. At present, there’s no consensus on prophylaxis dosing, timing, duration, or even what agent to use for these patients. Conemaugh uses postop enoxaparin, a low-molecular-weight heparin. Among many other options, some hospitals opt for preop dosing with traditional heparin, which is less expensive.
The Conemaugh team turned to thromboelastometry (TEM) to look at the question of VTE risk in bariatric surgery patients. The test gauges coagulation status by measuring elasticity as a small blood sample clots over a few minutes. The investigators found that patients who were hypercoagulable before surgery were likely to be hypercoagulable afterwards. The finding argues for baseline TEM testing to guide postop anticoagulation.
The problem is that bariatric services don’t often have access to TEM equipment, and insurance doesn’t cover the $60 test. In this instance, the Lake Erie College of Osteopathic Medicine in Erie, Pa., had the equipment and covered the testing for the study.
The patients had TEM at baseline and then received 40 mg of enoxaparin about 4 hours after surgery – mostly laparoscopic gastric bypasses – and a second dose about 12 hours after the first. TEM was repeated about 2 hours after the second dose.
At baseline, 2 (5%) of the patients were hypocoagulable, 15 (37.5%) were normal, and 23 (57.5%) were hypercoagulable. On postop TEM, 17 patients (42.5%) were normal and 23 (57.5%) were hypercoagulable: “These 23 were inadequately anticoagulated,” said lead investigator Daniel Urias, MD, a general surgery resident at the medical center.
“There was an association between being normal at baseline and being normal postop, and being hypercoagulable at baseline and hypercoagulable postop. We didn’t anticipate finding such similarity between the numbers. Our suspicion that baseline status plays a major role is holding true,” Dr. Urias said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
When patients test hypercoagulable at baseline, “we are [now] leaning towards [enoxaparin] 60 mg twice daily,” he said.
Ultimately, anticoagulation TEM could be used to titrate patients into the normal range. For best outcomes, it’s likely that “obese patients require goal-directed therapy instead of weight-based or fixed dosing,” he said, but nothing is going to happen until insurance steps up.
The patients did not have underlying coagulopathies, and 33 (82.5%) were women; the average age was 44 years and average body mass index was 43.6 kg/m2. The mean preop Caprini score was 4, indicating moderate VTE risk. Surgery lasted about 200 minutes. Patients were out of bed and walking on postop day 0.
The investigators had no relevant disclosures.
SOURCE: Urias D et al. World Congress of Endoscopic Surgery hosted by SAGES & CAGS abstract S023.
SEATTLE – Preop thromboelastometry can identify patients who need extra according to a prospective investigation of 40 patients at Conemaugh Memorial Medical Center in Johnstown, Pa.
Enoxaparin 40 mg twice daily just wasn’t enough for people who were hypercoagulable before surgery. The goal of the study was to find the best way to prevent venous thromboembolism (VTE) after weight loss surgery. At present, there’s no consensus on prophylaxis dosing, timing, duration, or even what agent to use for these patients. Conemaugh uses postop enoxaparin, a low-molecular-weight heparin. Among many other options, some hospitals opt for preop dosing with traditional heparin, which is less expensive.
The Conemaugh team turned to thromboelastometry (TEM) to look at the question of VTE risk in bariatric surgery patients. The test gauges coagulation status by measuring elasticity as a small blood sample clots over a few minutes. The investigators found that patients who were hypercoagulable before surgery were likely to be hypercoagulable afterwards. The finding argues for baseline TEM testing to guide postop anticoagulation.
The problem is that bariatric services don’t often have access to TEM equipment, and insurance doesn’t cover the $60 test. In this instance, the Lake Erie College of Osteopathic Medicine in Erie, Pa., had the equipment and covered the testing for the study.
The patients had TEM at baseline and then received 40 mg of enoxaparin about 4 hours after surgery – mostly laparoscopic gastric bypasses – and a second dose about 12 hours after the first. TEM was repeated about 2 hours after the second dose.
At baseline, 2 (5%) of the patients were hypocoagulable, 15 (37.5%) were normal, and 23 (57.5%) were hypercoagulable. On postop TEM, 17 patients (42.5%) were normal and 23 (57.5%) were hypercoagulable: “These 23 were inadequately anticoagulated,” said lead investigator Daniel Urias, MD, a general surgery resident at the medical center.
“There was an association between being normal at baseline and being normal postop, and being hypercoagulable at baseline and hypercoagulable postop. We didn’t anticipate finding such similarity between the numbers. Our suspicion that baseline status plays a major role is holding true,” Dr. Urias said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
When patients test hypercoagulable at baseline, “we are [now] leaning towards [enoxaparin] 60 mg twice daily,” he said.
Ultimately, anticoagulation TEM could be used to titrate patients into the normal range. For best outcomes, it’s likely that “obese patients require goal-directed therapy instead of weight-based or fixed dosing,” he said, but nothing is going to happen until insurance steps up.
The patients did not have underlying coagulopathies, and 33 (82.5%) were women; the average age was 44 years and average body mass index was 43.6 kg/m2. The mean preop Caprini score was 4, indicating moderate VTE risk. Surgery lasted about 200 minutes. Patients were out of bed and walking on postop day 0.
The investigators had no relevant disclosures.
SOURCE: Urias D et al. World Congress of Endoscopic Surgery hosted by SAGES & CAGS abstract S023.
REPORTING FROM SAGES 2018
Key clinical point: Preoperative thromboelastometry identifies patients who need extra anticoagulation against venous thromboembolism following bariatric surgery.
Major finding: Baseline and postop coagulation were similar: 37.5% vs. 42.5% were normal and 57.5% vs 57.5% were hypercoagulable.
Study details: Prospective study of 40 bariatric surgery patients.
Disclosures: The investigators did not have any relevant disclosures. The Lake Erie College of Osteopathic Medicine paid for the testing.
Source: Urias D et al. World Congress of Endoscopic Surgery hosted by SAGES & CAGS abstract S023.
PVT after sleeve gastrectomy treatable with anticoagulants
can be effectively treated with extended postoperative anticoagulation therapy, findings from a large-scale, retrospective study indicate.
The research was conducted using data from medical records of created by physicians from five Australian bariatric centers, reported Stephanie Bee Ming Tan, MBBS, of the Gold Coast University Hospital, Queensland, Australia, and her associates in the journal Surgery for Obesity and Related Diseases. Following elective laparoscopic sleeve gastrectomy (LSG), a total of 18 (0.3%) of the 5,951 obese patients were diagnosed with portomesenteric vein thrombosis (PVT). The PVT-affected population was a mean age of 44 years and 61% were women. All of these patients had at least one venous thrombosis systematic predisposition factor such as morbid obesity (50%), smoking (50%), or a personal or family history of a clotting disorder (39%).
All study patients were given thromboprophylaxis of low-molecular-weight heparin (LMWH) or unfractionated heparin plus mechanical thromboprophylaxis during admission for LSG and at discharge when surgeons identified them as high risk.
PVT following LSG can be difficult to diagnose because presenting symptoms tend to be nonspecific. Within an average of 13 days following surgery, 77% of patients diagnosed with PVT reported abdominal pain, 33% reported nausea and vomiting, and also reported less common symptoms that included shoulder tip pain, problems in tolerating fluids, constipation, and diarrhea. Final diagnosis of PVT was determined with independent or a combination of CT and duplex ultrasound.
Complications from PVT can have serious consequences, including abdominal swelling from fluid accumulation, enlarged esophageal veins, terminal esophageal bleeding, and bowel infarction. As with admission thromboprophylaxis treatments, patients diagnosed with PVT received varied anticoagulation treatments with most, in equal numbers, receiving either LMWH or a heparin infusion, and the remaining 12% receiving anticoagulation with rivaroxaban and warfarin. Adjustments were made following initial treatments such that 37% and 66% of patients continued with longer-term therapy on LMWH or warfarin, respectively. Treatments generally lasted 3-6 months with only 11% continuing on warfarin because of a history of clotting disorder. The anticoagulation treatments were successful with the majority (94%) of patients with only one patient requiring surgical intervention.
Follow-up with the patients who had a PVT diagnosis of more than 6 months (with an average of 10 months) showed the overall success of the post-LSG anticoagulation and surgical therapies, without any mortalities.
The authors summarized earlier theories about confounding health conditions that may contribute to the development of PVT and the risks for PVT linked to laparoscopic surgery. In this retrospective study, they noted that PVT incidence following LSG was low at 0.3% but was still higher than with two other bariatric operative methods and suggested intraoperative and postoperative factors that could contribute to this difference. Because of the nonspecific early symptoms and the difficulty of diagnosing PVT, the investigators recommended that physicians be vigilant for this postoperative complication in LSG patients, and use “cross-sectional imagining with CT of the abdomen” for diagnosis. Furthermore, with diagnosed PVT “anticoagulation for 3 to 6 months with a target international normalized ratio of 2:3 is recommended unless the patient has additional risk factors and [is] therefore indicated for longer treatment.”
The authors reported that they had no conflicts of interest.
SOURCE: Tan SBM et al. Surg Obes Relat Dis. 2018 Mar;14:271-6.
can be effectively treated with extended postoperative anticoagulation therapy, findings from a large-scale, retrospective study indicate.
The research was conducted using data from medical records of created by physicians from five Australian bariatric centers, reported Stephanie Bee Ming Tan, MBBS, of the Gold Coast University Hospital, Queensland, Australia, and her associates in the journal Surgery for Obesity and Related Diseases. Following elective laparoscopic sleeve gastrectomy (LSG), a total of 18 (0.3%) of the 5,951 obese patients were diagnosed with portomesenteric vein thrombosis (PVT). The PVT-affected population was a mean age of 44 years and 61% were women. All of these patients had at least one venous thrombosis systematic predisposition factor such as morbid obesity (50%), smoking (50%), or a personal or family history of a clotting disorder (39%).
All study patients were given thromboprophylaxis of low-molecular-weight heparin (LMWH) or unfractionated heparin plus mechanical thromboprophylaxis during admission for LSG and at discharge when surgeons identified them as high risk.
PVT following LSG can be difficult to diagnose because presenting symptoms tend to be nonspecific. Within an average of 13 days following surgery, 77% of patients diagnosed with PVT reported abdominal pain, 33% reported nausea and vomiting, and also reported less common symptoms that included shoulder tip pain, problems in tolerating fluids, constipation, and diarrhea. Final diagnosis of PVT was determined with independent or a combination of CT and duplex ultrasound.
Complications from PVT can have serious consequences, including abdominal swelling from fluid accumulation, enlarged esophageal veins, terminal esophageal bleeding, and bowel infarction. As with admission thromboprophylaxis treatments, patients diagnosed with PVT received varied anticoagulation treatments with most, in equal numbers, receiving either LMWH or a heparin infusion, and the remaining 12% receiving anticoagulation with rivaroxaban and warfarin. Adjustments were made following initial treatments such that 37% and 66% of patients continued with longer-term therapy on LMWH or warfarin, respectively. Treatments generally lasted 3-6 months with only 11% continuing on warfarin because of a history of clotting disorder. The anticoagulation treatments were successful with the majority (94%) of patients with only one patient requiring surgical intervention.
Follow-up with the patients who had a PVT diagnosis of more than 6 months (with an average of 10 months) showed the overall success of the post-LSG anticoagulation and surgical therapies, without any mortalities.
The authors summarized earlier theories about confounding health conditions that may contribute to the development of PVT and the risks for PVT linked to laparoscopic surgery. In this retrospective study, they noted that PVT incidence following LSG was low at 0.3% but was still higher than with two other bariatric operative methods and suggested intraoperative and postoperative factors that could contribute to this difference. Because of the nonspecific early symptoms and the difficulty of diagnosing PVT, the investigators recommended that physicians be vigilant for this postoperative complication in LSG patients, and use “cross-sectional imagining with CT of the abdomen” for diagnosis. Furthermore, with diagnosed PVT “anticoagulation for 3 to 6 months with a target international normalized ratio of 2:3 is recommended unless the patient has additional risk factors and [is] therefore indicated for longer treatment.”
The authors reported that they had no conflicts of interest.
SOURCE: Tan SBM et al. Surg Obes Relat Dis. 2018 Mar;14:271-6.
can be effectively treated with extended postoperative anticoagulation therapy, findings from a large-scale, retrospective study indicate.
The research was conducted using data from medical records of created by physicians from five Australian bariatric centers, reported Stephanie Bee Ming Tan, MBBS, of the Gold Coast University Hospital, Queensland, Australia, and her associates in the journal Surgery for Obesity and Related Diseases. Following elective laparoscopic sleeve gastrectomy (LSG), a total of 18 (0.3%) of the 5,951 obese patients were diagnosed with portomesenteric vein thrombosis (PVT). The PVT-affected population was a mean age of 44 years and 61% were women. All of these patients had at least one venous thrombosis systematic predisposition factor such as morbid obesity (50%), smoking (50%), or a personal or family history of a clotting disorder (39%).
All study patients were given thromboprophylaxis of low-molecular-weight heparin (LMWH) or unfractionated heparin plus mechanical thromboprophylaxis during admission for LSG and at discharge when surgeons identified them as high risk.
PVT following LSG can be difficult to diagnose because presenting symptoms tend to be nonspecific. Within an average of 13 days following surgery, 77% of patients diagnosed with PVT reported abdominal pain, 33% reported nausea and vomiting, and also reported less common symptoms that included shoulder tip pain, problems in tolerating fluids, constipation, and diarrhea. Final diagnosis of PVT was determined with independent or a combination of CT and duplex ultrasound.
Complications from PVT can have serious consequences, including abdominal swelling from fluid accumulation, enlarged esophageal veins, terminal esophageal bleeding, and bowel infarction. As with admission thromboprophylaxis treatments, patients diagnosed with PVT received varied anticoagulation treatments with most, in equal numbers, receiving either LMWH or a heparin infusion, and the remaining 12% receiving anticoagulation with rivaroxaban and warfarin. Adjustments were made following initial treatments such that 37% and 66% of patients continued with longer-term therapy on LMWH or warfarin, respectively. Treatments generally lasted 3-6 months with only 11% continuing on warfarin because of a history of clotting disorder. The anticoagulation treatments were successful with the majority (94%) of patients with only one patient requiring surgical intervention.
Follow-up with the patients who had a PVT diagnosis of more than 6 months (with an average of 10 months) showed the overall success of the post-LSG anticoagulation and surgical therapies, without any mortalities.
The authors summarized earlier theories about confounding health conditions that may contribute to the development of PVT and the risks for PVT linked to laparoscopic surgery. In this retrospective study, they noted that PVT incidence following LSG was low at 0.3% but was still higher than with two other bariatric operative methods and suggested intraoperative and postoperative factors that could contribute to this difference. Because of the nonspecific early symptoms and the difficulty of diagnosing PVT, the investigators recommended that physicians be vigilant for this postoperative complication in LSG patients, and use “cross-sectional imagining with CT of the abdomen” for diagnosis. Furthermore, with diagnosed PVT “anticoagulation for 3 to 6 months with a target international normalized ratio of 2:3 is recommended unless the patient has additional risk factors and [is] therefore indicated for longer treatment.”
The authors reported that they had no conflicts of interest.
SOURCE: Tan SBM et al. Surg Obes Relat Dis. 2018 Mar;14:271-6.
FROM SURGERY FOR OBESITY AND RELATED DISEASES
Key clinical point: Anticoagulation treatments effectively managed most portomesenteric vein thrombosis cases following laparoscopic sleeve gastrectomy.
Major finding: PVT is rare (0.3%) but occurs more frequently with laparoscopic sleeve gastrectomy, compared with other bariatric surgery procedures.
Study details: A multicenter, retrospective study conducted in Australia from 2007 to 2016 with 5,951 adult obese patients who received elective laparoscopic sleeve gastrectomy.
Disclosures: The authors reported no conflicts of interest.
Source: Tan SBM et al. Surg Obes Relat Dis. Mar 2018;14:271-6.
VIDEO: Intestinal remodeling contributes to HbA1c drop after Roux-en-Y gastric bypass
CHICAGO – Of medical and surgical tactics to tackle long-term weight loss, , and gene expression in the Roux limb may hold the key to the surgery’s efficacy, according to an ongoing study.
“We know that Roux-en-Y gastric bypass surgery is highly effective as not only a weight-loss therapy, but more and more we’re appreciating its role as a diabetes therapy as well,” said Margaret Stefater, MD, PhD, speaking in an interview at the annual meeting of the Endocrine Society.
The study, she said, was designed to learn more about the intestine’s contribution to the salubrious effect that Roux-en-Y surgery has on diabetes.
“We used microarray in order to characterize gene expression in the intestine” to gain a broad understanding of the processes that are altered after surgery, said Dr. Stefater, a pediatric endocrinology fellow at Boston Children’s Hospital. More specifically, though, the study looked at an individual’s changes in gene expression over time and correlated those changes with that patient’s clinical picture.
The data reported by Dr. Stefater and shared in a press conference, represent part of an ongoing longitudinal prospective study of 32 patients.
“The study aims to characterize gene expression for the first postoperative year,” and findings from the first 6 postoperative months of 19 patients were shared at the meeting, said Dr. Stefater. “This is the first look at our cohort.”
So far, she and her colleagues have compared gene expression using microarray at 1 month and 6 months post-surgery, comparing change across time and change from baseline data.
From hundreds of candidate genes, Dr. Stefater and her colleagues have developed a smaller gene list that, even in the first postoperative month, is predictive of changes in hemoglobin A1c levels over time. “Remarkably, the changes in a select list of genes out to 1 month is actually able to predict hemoglobin A1c levels out to 1 year,” she said. “This speaks to the fact that biological reprogramming in the intestine is somehow related to glycemic response in patients.
“We hope that by understanding these processes, we can home in on those processes that are most likely to be mechanistically responsible for these changes, and then to reverse-engineer this surgery to identify processes or targets which may be good places to start when we think about creating better, or nonsurgical, therapies for people who have obesity and diabetes,” said Dr. Stefater.
Dr. Stefater reported no relevant financial disclosures.
SOURCE: Stefater MA et al. ENDO 2018, Abstract OR 12-6.
CHICAGO – Of medical and surgical tactics to tackle long-term weight loss, , and gene expression in the Roux limb may hold the key to the surgery’s efficacy, according to an ongoing study.
“We know that Roux-en-Y gastric bypass surgery is highly effective as not only a weight-loss therapy, but more and more we’re appreciating its role as a diabetes therapy as well,” said Margaret Stefater, MD, PhD, speaking in an interview at the annual meeting of the Endocrine Society.
The study, she said, was designed to learn more about the intestine’s contribution to the salubrious effect that Roux-en-Y surgery has on diabetes.
“We used microarray in order to characterize gene expression in the intestine” to gain a broad understanding of the processes that are altered after surgery, said Dr. Stefater, a pediatric endocrinology fellow at Boston Children’s Hospital. More specifically, though, the study looked at an individual’s changes in gene expression over time and correlated those changes with that patient’s clinical picture.
The data reported by Dr. Stefater and shared in a press conference, represent part of an ongoing longitudinal prospective study of 32 patients.
“The study aims to characterize gene expression for the first postoperative year,” and findings from the first 6 postoperative months of 19 patients were shared at the meeting, said Dr. Stefater. “This is the first look at our cohort.”
So far, she and her colleagues have compared gene expression using microarray at 1 month and 6 months post-surgery, comparing change across time and change from baseline data.
From hundreds of candidate genes, Dr. Stefater and her colleagues have developed a smaller gene list that, even in the first postoperative month, is predictive of changes in hemoglobin A1c levels over time. “Remarkably, the changes in a select list of genes out to 1 month is actually able to predict hemoglobin A1c levels out to 1 year,” she said. “This speaks to the fact that biological reprogramming in the intestine is somehow related to glycemic response in patients.
“We hope that by understanding these processes, we can home in on those processes that are most likely to be mechanistically responsible for these changes, and then to reverse-engineer this surgery to identify processes or targets which may be good places to start when we think about creating better, or nonsurgical, therapies for people who have obesity and diabetes,” said Dr. Stefater.
Dr. Stefater reported no relevant financial disclosures.
SOURCE: Stefater MA et al. ENDO 2018, Abstract OR 12-6.
CHICAGO – Of medical and surgical tactics to tackle long-term weight loss, , and gene expression in the Roux limb may hold the key to the surgery’s efficacy, according to an ongoing study.
“We know that Roux-en-Y gastric bypass surgery is highly effective as not only a weight-loss therapy, but more and more we’re appreciating its role as a diabetes therapy as well,” said Margaret Stefater, MD, PhD, speaking in an interview at the annual meeting of the Endocrine Society.
The study, she said, was designed to learn more about the intestine’s contribution to the salubrious effect that Roux-en-Y surgery has on diabetes.
“We used microarray in order to characterize gene expression in the intestine” to gain a broad understanding of the processes that are altered after surgery, said Dr. Stefater, a pediatric endocrinology fellow at Boston Children’s Hospital. More specifically, though, the study looked at an individual’s changes in gene expression over time and correlated those changes with that patient’s clinical picture.
The data reported by Dr. Stefater and shared in a press conference, represent part of an ongoing longitudinal prospective study of 32 patients.
“The study aims to characterize gene expression for the first postoperative year,” and findings from the first 6 postoperative months of 19 patients were shared at the meeting, said Dr. Stefater. “This is the first look at our cohort.”
So far, she and her colleagues have compared gene expression using microarray at 1 month and 6 months post-surgery, comparing change across time and change from baseline data.
From hundreds of candidate genes, Dr. Stefater and her colleagues have developed a smaller gene list that, even in the first postoperative month, is predictive of changes in hemoglobin A1c levels over time. “Remarkably, the changes in a select list of genes out to 1 month is actually able to predict hemoglobin A1c levels out to 1 year,” she said. “This speaks to the fact that biological reprogramming in the intestine is somehow related to glycemic response in patients.
“We hope that by understanding these processes, we can home in on those processes that are most likely to be mechanistically responsible for these changes, and then to reverse-engineer this surgery to identify processes or targets which may be good places to start when we think about creating better, or nonsurgical, therapies for people who have obesity and diabetes,” said Dr. Stefater.
Dr. Stefater reported no relevant financial disclosures.
SOURCE: Stefater MA et al. ENDO 2018, Abstract OR 12-6.
REPORTING FROM ENDO 2018
