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Point/Counterpoint: Is intraoperative drain placement essential during pancreatectomy?
Yes, placing drains is essential.
It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.
Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.
A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).
A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).
Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.
Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).
Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.
I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.
Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.
No, drain placement is not always necessary.
Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.
There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.
Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.
We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.
When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.
A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.
If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.
I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.
There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.
Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.
Yes, placing drains is essential.
It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.
Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.
A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).
A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).
Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.
Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).
Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.
I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.
Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.
No, drain placement is not always necessary.
Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.
There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.
Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.
We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.
When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.
A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.
If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.
I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.
There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.
Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.
Yes, placing drains is essential.
It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.
Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.
A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).
A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).
Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.
Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).
Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.
I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.
Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.
No, drain placement is not always necessary.
Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.
There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.
Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.
We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.
When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.
A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.
If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.
I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.
There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.
Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.
Temporary tissue expanders optimize radiotherapy after mastectomy
LAS VEGAS – Radiation oncologists at the University of Texas MD Anderson Cancer Center, Houston, were able to complete 98% of their radiotherapy plans when women received temporary tissue expanders, instead of immediate reconstructions, at the time of skin-sparing mastectomy, in a series of 384 women, most with stage 2-3 breast cancer.
The expanders – saline-filled bags commonly used in plastic surgery to create new skin – were kept in place but deflated for radiotherapy, which allowed for optimal access to treatment fields; the final reconstruction, successful in 90% of women, came a median of 7 months following radiation.
“The shape and volume of the reconstruction” – and the need to avoid damaging the new breast – “got in the way of putting radiation where we wanted it to be. We ended up having bad radiotherapy plans, patients not getting skin-sparing mastectomies, and high probabilities of radiation complications to the reconstruction,” said investigator Eric Strom, MD, professor of radiation oncology at MD Anderson.
Radiologists and plastic and oncologic surgeons collaborated to try tissue expanders instead. “We wanted the advantage of skin-sparing mastectomy without the disadvantages” of immediate reconstruction, Dr. Strom said at the American Society of Breast Surgeons annual meeting.
With the new approach, “radiotherapy is superior. We don’t have to compromise our plans. I can put radiation everywhere it needs to be, without frying the heart” and almost completely avoiding the lungs, he said.
The 5-year rates of locoregional control, disease-free survival, and overall survival were 99.2%, 86.1%, and 92.4%, respectively, which “is extraordinary” in patients with stage 2-3 breast cancer, and likely due at least in part to optimal radiotherapy, he said.
Tissue expanders also keep the skin envelope open so it’s able to receive a graft at final reconstruction; abdominal skin doesn’t have to brought up to recreate the breast.
“This approach lessens negative interactions between breast reconstruction and [radiotherapy] and offers patients what they most desire: a high probability of freedom from cancer and optimal final aesthetic outcome,” said Zeina Ayoub, MD, a radiation oncology fellow at Anderson who presented the findings.
The median age of the women was 44 years, and almost all were node positive. Radiation was delivered to the chest wall and regional lymphatics, including the internal mammary chain.
Fifty women (13.0%) required explantation after radiation but before reconstruction, most commonly because of cellulitis; even so, more than half went on to final reconstruction.
Abdominal autologous reconstruction was the most common type, followed by latissimus dorsi–based reconstruction, and exchange of the tissue expander with an implant.
Dr. Ayoub and Dr. Strom had no relevant disclosures.
LAS VEGAS – Radiation oncologists at the University of Texas MD Anderson Cancer Center, Houston, were able to complete 98% of their radiotherapy plans when women received temporary tissue expanders, instead of immediate reconstructions, at the time of skin-sparing mastectomy, in a series of 384 women, most with stage 2-3 breast cancer.
The expanders – saline-filled bags commonly used in plastic surgery to create new skin – were kept in place but deflated for radiotherapy, which allowed for optimal access to treatment fields; the final reconstruction, successful in 90% of women, came a median of 7 months following radiation.
“The shape and volume of the reconstruction” – and the need to avoid damaging the new breast – “got in the way of putting radiation where we wanted it to be. We ended up having bad radiotherapy plans, patients not getting skin-sparing mastectomies, and high probabilities of radiation complications to the reconstruction,” said investigator Eric Strom, MD, professor of radiation oncology at MD Anderson.
Radiologists and plastic and oncologic surgeons collaborated to try tissue expanders instead. “We wanted the advantage of skin-sparing mastectomy without the disadvantages” of immediate reconstruction, Dr. Strom said at the American Society of Breast Surgeons annual meeting.
With the new approach, “radiotherapy is superior. We don’t have to compromise our plans. I can put radiation everywhere it needs to be, without frying the heart” and almost completely avoiding the lungs, he said.
The 5-year rates of locoregional control, disease-free survival, and overall survival were 99.2%, 86.1%, and 92.4%, respectively, which “is extraordinary” in patients with stage 2-3 breast cancer, and likely due at least in part to optimal radiotherapy, he said.
Tissue expanders also keep the skin envelope open so it’s able to receive a graft at final reconstruction; abdominal skin doesn’t have to brought up to recreate the breast.
“This approach lessens negative interactions between breast reconstruction and [radiotherapy] and offers patients what they most desire: a high probability of freedom from cancer and optimal final aesthetic outcome,” said Zeina Ayoub, MD, a radiation oncology fellow at Anderson who presented the findings.
The median age of the women was 44 years, and almost all were node positive. Radiation was delivered to the chest wall and regional lymphatics, including the internal mammary chain.
Fifty women (13.0%) required explantation after radiation but before reconstruction, most commonly because of cellulitis; even so, more than half went on to final reconstruction.
Abdominal autologous reconstruction was the most common type, followed by latissimus dorsi–based reconstruction, and exchange of the tissue expander with an implant.
Dr. Ayoub and Dr. Strom had no relevant disclosures.
LAS VEGAS – Radiation oncologists at the University of Texas MD Anderson Cancer Center, Houston, were able to complete 98% of their radiotherapy plans when women received temporary tissue expanders, instead of immediate reconstructions, at the time of skin-sparing mastectomy, in a series of 384 women, most with stage 2-3 breast cancer.
The expanders – saline-filled bags commonly used in plastic surgery to create new skin – were kept in place but deflated for radiotherapy, which allowed for optimal access to treatment fields; the final reconstruction, successful in 90% of women, came a median of 7 months following radiation.
“The shape and volume of the reconstruction” – and the need to avoid damaging the new breast – “got in the way of putting radiation where we wanted it to be. We ended up having bad radiotherapy plans, patients not getting skin-sparing mastectomies, and high probabilities of radiation complications to the reconstruction,” said investigator Eric Strom, MD, professor of radiation oncology at MD Anderson.
Radiologists and plastic and oncologic surgeons collaborated to try tissue expanders instead. “We wanted the advantage of skin-sparing mastectomy without the disadvantages” of immediate reconstruction, Dr. Strom said at the American Society of Breast Surgeons annual meeting.
With the new approach, “radiotherapy is superior. We don’t have to compromise our plans. I can put radiation everywhere it needs to be, without frying the heart” and almost completely avoiding the lungs, he said.
The 5-year rates of locoregional control, disease-free survival, and overall survival were 99.2%, 86.1%, and 92.4%, respectively, which “is extraordinary” in patients with stage 2-3 breast cancer, and likely due at least in part to optimal radiotherapy, he said.
Tissue expanders also keep the skin envelope open so it’s able to receive a graft at final reconstruction; abdominal skin doesn’t have to brought up to recreate the breast.
“This approach lessens negative interactions between breast reconstruction and [radiotherapy] and offers patients what they most desire: a high probability of freedom from cancer and optimal final aesthetic outcome,” said Zeina Ayoub, MD, a radiation oncology fellow at Anderson who presented the findings.
The median age of the women was 44 years, and almost all were node positive. Radiation was delivered to the chest wall and regional lymphatics, including the internal mammary chain.
Fifty women (13.0%) required explantation after radiation but before reconstruction, most commonly because of cellulitis; even so, more than half went on to final reconstruction.
Abdominal autologous reconstruction was the most common type, followed by latissimus dorsi–based reconstruction, and exchange of the tissue expander with an implant.
Dr. Ayoub and Dr. Strom had no relevant disclosures.
AT ASBS 2017
Key clinical point:
Major finding: The 5-year rates of locoregional control, disease-free survival, and overall survival were 99.2%, 86.1%, and 92.4%, respectively, likely due at least in part to optimal radiotherapy.
Data source: Review of 384 patients.
Disclosures: The investigators said they had no relevant disclosures.
Robotic-assisted IHR causes fewer complications in obese patients
Obese people undergoing inguinal hernia repair experienced fewer complications when the surgery was robotic assisted, compared to open repairs, according to Ramachandra Kolachalam, MD, and his associates.
A total of 148 robotic-assisted repairs (RHRs) and 113 open repairs were included in the study. Of open repair (OHR) patients, 11.5% experienced postoperative complications post discharge, compared with only 2.7% of RHR patients. OHR patients also had lower rates of concomitant procedures (16.8% vs. 29.7%) and bilateral repairs (11.5% vs. 35.1%). Morbidity rates did not differ significantly between the groups.
“Robotic-assisted inguinal hernia repair could lead to increased acceptance of minimally invasive hernia repair with the associated clinical benefits to patients, including those who are obese with higher comorbidities and higher American Surgery Association scores. A prospective study of obesity in RHR is warranted to confirm our findings,” the investigators concluded.
Find the full study in Surgical Endoscopy (2017. doi: 10.1007/s00464-017-5665-z).
Obese people undergoing inguinal hernia repair experienced fewer complications when the surgery was robotic assisted, compared to open repairs, according to Ramachandra Kolachalam, MD, and his associates.
A total of 148 robotic-assisted repairs (RHRs) and 113 open repairs were included in the study. Of open repair (OHR) patients, 11.5% experienced postoperative complications post discharge, compared with only 2.7% of RHR patients. OHR patients also had lower rates of concomitant procedures (16.8% vs. 29.7%) and bilateral repairs (11.5% vs. 35.1%). Morbidity rates did not differ significantly between the groups.
“Robotic-assisted inguinal hernia repair could lead to increased acceptance of minimally invasive hernia repair with the associated clinical benefits to patients, including those who are obese with higher comorbidities and higher American Surgery Association scores. A prospective study of obesity in RHR is warranted to confirm our findings,” the investigators concluded.
Find the full study in Surgical Endoscopy (2017. doi: 10.1007/s00464-017-5665-z).
Obese people undergoing inguinal hernia repair experienced fewer complications when the surgery was robotic assisted, compared to open repairs, according to Ramachandra Kolachalam, MD, and his associates.
A total of 148 robotic-assisted repairs (RHRs) and 113 open repairs were included in the study. Of open repair (OHR) patients, 11.5% experienced postoperative complications post discharge, compared with only 2.7% of RHR patients. OHR patients also had lower rates of concomitant procedures (16.8% vs. 29.7%) and bilateral repairs (11.5% vs. 35.1%). Morbidity rates did not differ significantly between the groups.
“Robotic-assisted inguinal hernia repair could lead to increased acceptance of minimally invasive hernia repair with the associated clinical benefits to patients, including those who are obese with higher comorbidities and higher American Surgery Association scores. A prospective study of obesity in RHR is warranted to confirm our findings,” the investigators concluded.
Find the full study in Surgical Endoscopy (2017. doi: 10.1007/s00464-017-5665-z).
FROM SURGICAL ENDOSCOPY
VA/DOD elevate psychotherapy over medication in updated PTSD guidelines
MIAMI – New federal clinical practice guidelines for treating posttraumatic stress disorder move trauma-focused psychotherapy ahead of pharmacotherapy as first-line treatment.
“That is quite a statement that is being made, and it’s a big shift in our treatment guidelines,” Lori L. Davis, MD, said at a meeting of the American Society of Clinical Psychopharmacology, formerly the New Clinical Drug Evaluation Unit meeting. Dr. Davis, who coauthored the update for the Departments of Veterans Affairs and of Defense, discussed the guidelines at the meeting in advance of their release this summer.
The guidelines, dated June 2017 and based on evidence reviewed through March 2016, specify that evidence is strong for first-line psychotherapy that includes some form of exposure and/or cognitive restructuring. Such therapies include prolonged exposure, cognitive processing, eye movement desensitization and reprocessing, narrative exposure therapy, brief eclectic psychotherapy, and PTSD-specific cognitive-behavioral therapy.
The Management of Posttraumatic Stress Work Group found that evidence was weakest for non–trauma-focused therapies, such as stress inoculation training and present-centered and interpersonal psychotherapy. Manualized group therapy also was rated as weak, but insufficient evidence was found to rate one type of group therapy over another.
Insufficient evidence also was cited for psychotherapies not specified in other recommendations, such as dialectical behavior therapy, skills training in affect and interpersonal regulation, acceptance and commitment therapy (ACT), seeking safety therapy, or supportive counseling.
“Some of these treatments have been found to be effective for the treatment of other disorders (e.g., ACT for [major depressive disorder]),” the work group members wrote, “but do not have evidence of efficacy in patients with PTSD.”
The recommendations are based on a review of literature from the past 20 years and are congruent with other treatment guidelines internationally, according to Sheila A.M. Rausch, PhD, who directs mental health research and program evaluation for the VA Ann Arbor Healthcare System in Michigan, is a work group member, and served as a panelist at the meeting.
“What is striking is that, based on people reviewing all the evidence out there – and there are different methodologies for doing so – regardless, [the different groups] tend to come to the same conclusions,” Dr. Rausch said.
The updated guidelines cite insufficient evidence for making any recommendations for augmented or combined treatments of psychotherapy and pharmacotherapy.
Medications considered to have a strong evidence base for monotherapy were sertraline, paroxetine, fluoxetine, and venlafaxine. In cases in which a person declines psychotherapy, those medications are recommended as first-line treatment.
Prazosin, typically used to managing nightmares tied to PTSD, received a “suggest against” recommendation, in part because of the discovery of a publication bias, according to Dr. Davis, who is associate chief of staff for research and development at the Tuscaloosa (Ala.) VA Medical Center and a clinical professor of psychiatry and behavioral neurobiology at the University of Alabama in Birmingham and Tuscaloosa. She noted that the work group remained unsure of “how to grapple with this” news that the study drug did not break from placebo in the treatment of nightmares in more than 300 combat veterans with PTSD.
“We are not trying to tell you not to use antidepressants for major depressive disorder or panic disorders that are often comorbid with PTSD, so you have to keep that in mind as you read these guidelines,” Dr. Davis said. Many patients already take antidepressants because they are easily accessed in primary care practices, she added.
The work group found that evidence generally was weak against atypical antipsychotics – particularly in light of the known adverse side effects of those drugs. However, the group singled out risperidone. “We suggest against treatment of PTSD with quetiapine, olanzapine, and other atypical antipsychotics (except for risperidone, which is a ‘strong against,’ see recommendation 20),” the guidelines suggest.
They also “suggested against” two antidepressants – citalopram and amitriptyline, a tricyclic. The quality of evidence for those drugs was deemed low. Two drugs – lamotrigine and topiramate – also received “suggested against” rankings, and the evidence for the use of those drugs was deemed very low.
Meanwhile, the work group wrote that the quality of evidence was low and “recommended against” the use of three other drugs: divalproex, tiagabine, and guanfacine. They also found the quality of evidence to be very low for the drug class of benzodiazepines and four drugs – risperidone, D-cycloserine, ketamine, and hydrocortisone. They also found insufficient evidence to recommend complementary and integrative health (CIH) practices such as meditation and yoga for treating PTSD. The work group did offer a caveat, however. “It is important to clarify that we are not recommending against the treatments but rather are saying that, at this time, the research does not support the use of any CIH practice for the primary treatment of PTSD.”
Cannabis and its derivatives also were recommended against by the work group because of a “lack of evidence for their efficacy, known adverse effects, and associated risks.”
Dr. Davis said the work group’s findings underscored a crisis in pharmacotherapeutic research in PTSD. Since 2006, there have been only four industry-sponsored drugs for PTSD. “I find it kind of sad,” she said.
Currently, Dr. Rausch’s own study for the VA focuses on comparing the effects of combination therapies for PTSD in the context of patient preferences, in order to tailor the treatments accordingly. In 223 returning veterans with PTSD, she and her colleagues are conducting a head-to-head comparison of prolonged exposure therapy plus placebo, prolonged exposure plus sertraline, and sertraline plus emotion memory management therapy to determine how starting a patient on both kinds of treatments simultaneously affect response.
“It’s clinically important to find out what is really going on in the brain and body,” she said. “Although we know we have therapies that work, we need to find answers for partial responders ... and how to increase the speed and magnitude of response.”
Dr. Davis’s research is funded in part by the VA, Forest, Merck, Tonix, and Otsuka, for whom she also acts as a consultant. Dr. Rausch did not have any disclosures.
[email protected]
On Twitter @whitneymcknight
MIAMI – New federal clinical practice guidelines for treating posttraumatic stress disorder move trauma-focused psychotherapy ahead of pharmacotherapy as first-line treatment.
“That is quite a statement that is being made, and it’s a big shift in our treatment guidelines,” Lori L. Davis, MD, said at a meeting of the American Society of Clinical Psychopharmacology, formerly the New Clinical Drug Evaluation Unit meeting. Dr. Davis, who coauthored the update for the Departments of Veterans Affairs and of Defense, discussed the guidelines at the meeting in advance of their release this summer.
The guidelines, dated June 2017 and based on evidence reviewed through March 2016, specify that evidence is strong for first-line psychotherapy that includes some form of exposure and/or cognitive restructuring. Such therapies include prolonged exposure, cognitive processing, eye movement desensitization and reprocessing, narrative exposure therapy, brief eclectic psychotherapy, and PTSD-specific cognitive-behavioral therapy.
The Management of Posttraumatic Stress Work Group found that evidence was weakest for non–trauma-focused therapies, such as stress inoculation training and present-centered and interpersonal psychotherapy. Manualized group therapy also was rated as weak, but insufficient evidence was found to rate one type of group therapy over another.
Insufficient evidence also was cited for psychotherapies not specified in other recommendations, such as dialectical behavior therapy, skills training in affect and interpersonal regulation, acceptance and commitment therapy (ACT), seeking safety therapy, or supportive counseling.
“Some of these treatments have been found to be effective for the treatment of other disorders (e.g., ACT for [major depressive disorder]),” the work group members wrote, “but do not have evidence of efficacy in patients with PTSD.”
The recommendations are based on a review of literature from the past 20 years and are congruent with other treatment guidelines internationally, according to Sheila A.M. Rausch, PhD, who directs mental health research and program evaluation for the VA Ann Arbor Healthcare System in Michigan, is a work group member, and served as a panelist at the meeting.
“What is striking is that, based on people reviewing all the evidence out there – and there are different methodologies for doing so – regardless, [the different groups] tend to come to the same conclusions,” Dr. Rausch said.
The updated guidelines cite insufficient evidence for making any recommendations for augmented or combined treatments of psychotherapy and pharmacotherapy.
Medications considered to have a strong evidence base for monotherapy were sertraline, paroxetine, fluoxetine, and venlafaxine. In cases in which a person declines psychotherapy, those medications are recommended as first-line treatment.
Prazosin, typically used to managing nightmares tied to PTSD, received a “suggest against” recommendation, in part because of the discovery of a publication bias, according to Dr. Davis, who is associate chief of staff for research and development at the Tuscaloosa (Ala.) VA Medical Center and a clinical professor of psychiatry and behavioral neurobiology at the University of Alabama in Birmingham and Tuscaloosa. She noted that the work group remained unsure of “how to grapple with this” news that the study drug did not break from placebo in the treatment of nightmares in more than 300 combat veterans with PTSD.
“We are not trying to tell you not to use antidepressants for major depressive disorder or panic disorders that are often comorbid with PTSD, so you have to keep that in mind as you read these guidelines,” Dr. Davis said. Many patients already take antidepressants because they are easily accessed in primary care practices, she added.
The work group found that evidence generally was weak against atypical antipsychotics – particularly in light of the known adverse side effects of those drugs. However, the group singled out risperidone. “We suggest against treatment of PTSD with quetiapine, olanzapine, and other atypical antipsychotics (except for risperidone, which is a ‘strong against,’ see recommendation 20),” the guidelines suggest.
They also “suggested against” two antidepressants – citalopram and amitriptyline, a tricyclic. The quality of evidence for those drugs was deemed low. Two drugs – lamotrigine and topiramate – also received “suggested against” rankings, and the evidence for the use of those drugs was deemed very low.
Meanwhile, the work group wrote that the quality of evidence was low and “recommended against” the use of three other drugs: divalproex, tiagabine, and guanfacine. They also found the quality of evidence to be very low for the drug class of benzodiazepines and four drugs – risperidone, D-cycloserine, ketamine, and hydrocortisone. They also found insufficient evidence to recommend complementary and integrative health (CIH) practices such as meditation and yoga for treating PTSD. The work group did offer a caveat, however. “It is important to clarify that we are not recommending against the treatments but rather are saying that, at this time, the research does not support the use of any CIH practice for the primary treatment of PTSD.”
Cannabis and its derivatives also were recommended against by the work group because of a “lack of evidence for their efficacy, known adverse effects, and associated risks.”
Dr. Davis said the work group’s findings underscored a crisis in pharmacotherapeutic research in PTSD. Since 2006, there have been only four industry-sponsored drugs for PTSD. “I find it kind of sad,” she said.
Currently, Dr. Rausch’s own study for the VA focuses on comparing the effects of combination therapies for PTSD in the context of patient preferences, in order to tailor the treatments accordingly. In 223 returning veterans with PTSD, she and her colleagues are conducting a head-to-head comparison of prolonged exposure therapy plus placebo, prolonged exposure plus sertraline, and sertraline plus emotion memory management therapy to determine how starting a patient on both kinds of treatments simultaneously affect response.
“It’s clinically important to find out what is really going on in the brain and body,” she said. “Although we know we have therapies that work, we need to find answers for partial responders ... and how to increase the speed and magnitude of response.”
Dr. Davis’s research is funded in part by the VA, Forest, Merck, Tonix, and Otsuka, for whom she also acts as a consultant. Dr. Rausch did not have any disclosures.
[email protected]
On Twitter @whitneymcknight
MIAMI – New federal clinical practice guidelines for treating posttraumatic stress disorder move trauma-focused psychotherapy ahead of pharmacotherapy as first-line treatment.
“That is quite a statement that is being made, and it’s a big shift in our treatment guidelines,” Lori L. Davis, MD, said at a meeting of the American Society of Clinical Psychopharmacology, formerly the New Clinical Drug Evaluation Unit meeting. Dr. Davis, who coauthored the update for the Departments of Veterans Affairs and of Defense, discussed the guidelines at the meeting in advance of their release this summer.
The guidelines, dated June 2017 and based on evidence reviewed through March 2016, specify that evidence is strong for first-line psychotherapy that includes some form of exposure and/or cognitive restructuring. Such therapies include prolonged exposure, cognitive processing, eye movement desensitization and reprocessing, narrative exposure therapy, brief eclectic psychotherapy, and PTSD-specific cognitive-behavioral therapy.
The Management of Posttraumatic Stress Work Group found that evidence was weakest for non–trauma-focused therapies, such as stress inoculation training and present-centered and interpersonal psychotherapy. Manualized group therapy also was rated as weak, but insufficient evidence was found to rate one type of group therapy over another.
Insufficient evidence also was cited for psychotherapies not specified in other recommendations, such as dialectical behavior therapy, skills training in affect and interpersonal regulation, acceptance and commitment therapy (ACT), seeking safety therapy, or supportive counseling.
“Some of these treatments have been found to be effective for the treatment of other disorders (e.g., ACT for [major depressive disorder]),” the work group members wrote, “but do not have evidence of efficacy in patients with PTSD.”
The recommendations are based on a review of literature from the past 20 years and are congruent with other treatment guidelines internationally, according to Sheila A.M. Rausch, PhD, who directs mental health research and program evaluation for the VA Ann Arbor Healthcare System in Michigan, is a work group member, and served as a panelist at the meeting.
“What is striking is that, based on people reviewing all the evidence out there – and there are different methodologies for doing so – regardless, [the different groups] tend to come to the same conclusions,” Dr. Rausch said.
The updated guidelines cite insufficient evidence for making any recommendations for augmented or combined treatments of psychotherapy and pharmacotherapy.
Medications considered to have a strong evidence base for monotherapy were sertraline, paroxetine, fluoxetine, and venlafaxine. In cases in which a person declines psychotherapy, those medications are recommended as first-line treatment.
Prazosin, typically used to managing nightmares tied to PTSD, received a “suggest against” recommendation, in part because of the discovery of a publication bias, according to Dr. Davis, who is associate chief of staff for research and development at the Tuscaloosa (Ala.) VA Medical Center and a clinical professor of psychiatry and behavioral neurobiology at the University of Alabama in Birmingham and Tuscaloosa. She noted that the work group remained unsure of “how to grapple with this” news that the study drug did not break from placebo in the treatment of nightmares in more than 300 combat veterans with PTSD.
“We are not trying to tell you not to use antidepressants for major depressive disorder or panic disorders that are often comorbid with PTSD, so you have to keep that in mind as you read these guidelines,” Dr. Davis said. Many patients already take antidepressants because they are easily accessed in primary care practices, she added.
The work group found that evidence generally was weak against atypical antipsychotics – particularly in light of the known adverse side effects of those drugs. However, the group singled out risperidone. “We suggest against treatment of PTSD with quetiapine, olanzapine, and other atypical antipsychotics (except for risperidone, which is a ‘strong against,’ see recommendation 20),” the guidelines suggest.
They also “suggested against” two antidepressants – citalopram and amitriptyline, a tricyclic. The quality of evidence for those drugs was deemed low. Two drugs – lamotrigine and topiramate – also received “suggested against” rankings, and the evidence for the use of those drugs was deemed very low.
Meanwhile, the work group wrote that the quality of evidence was low and “recommended against” the use of three other drugs: divalproex, tiagabine, and guanfacine. They also found the quality of evidence to be very low for the drug class of benzodiazepines and four drugs – risperidone, D-cycloserine, ketamine, and hydrocortisone. They also found insufficient evidence to recommend complementary and integrative health (CIH) practices such as meditation and yoga for treating PTSD. The work group did offer a caveat, however. “It is important to clarify that we are not recommending against the treatments but rather are saying that, at this time, the research does not support the use of any CIH practice for the primary treatment of PTSD.”
Cannabis and its derivatives also were recommended against by the work group because of a “lack of evidence for their efficacy, known adverse effects, and associated risks.”
Dr. Davis said the work group’s findings underscored a crisis in pharmacotherapeutic research in PTSD. Since 2006, there have been only four industry-sponsored drugs for PTSD. “I find it kind of sad,” she said.
Currently, Dr. Rausch’s own study for the VA focuses on comparing the effects of combination therapies for PTSD in the context of patient preferences, in order to tailor the treatments accordingly. In 223 returning veterans with PTSD, she and her colleagues are conducting a head-to-head comparison of prolonged exposure therapy plus placebo, prolonged exposure plus sertraline, and sertraline plus emotion memory management therapy to determine how starting a patient on both kinds of treatments simultaneously affect response.
“It’s clinically important to find out what is really going on in the brain and body,” she said. “Although we know we have therapies that work, we need to find answers for partial responders ... and how to increase the speed and magnitude of response.”
Dr. Davis’s research is funded in part by the VA, Forest, Merck, Tonix, and Otsuka, for whom she also acts as a consultant. Dr. Rausch did not have any disclosures.
[email protected]
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE ASCP ANNUAL MEETING
Prior resections increase anastomotic leak risk in Crohn’s
SEATTLE – The risk of anastomotic leaks after bowel resection for Crohn’s disease is more than three times higher in patients who have had prior resections, according to a review of 206 patients at Lahey Hospital and Medical Center in Burlington, Mass.
There were 20 anastomotic leaks within 30 days of resection in those patients, giving an overall leakage rate of 10%. Among the 123 patients who were having their first resection, however, the rate was 5% (6/123). The risk jumped to 17% in the 83 who had prior resections (14/83) and 23% (7) among the 30 patients who had two or more prior resections, which is “substantially higher than we talk about in the clinic when we are counseling these people,” said lead investigator Forrest Johnston, MD, a colorectal surgery fellow at Lahey.
The findings are important because prior resections have not, until now, been formally recognized as a risk factor for anastomotic leaks, and repeat resections are common in Crohn’s. “When you see patients for repeat intestinal resections, you have to look at them as a higher risk population in terms of your counseling and algorithms,” Dr. Johnston said at the American Society of Colon and Rectal Surgeons annual meeting. In addition, to mitigate the increased risk, Crohn’s patients who have repeat resections need additional attention to correct modifiable risk factors before surgery, such as steroid use and malnutrition. “Some of these patients are pushed through the clinic,” but “they deserve a bit more time.”
The heightened risk is also “another factor that might tip you one way or another” in choosing surgical options. “It’s certainly something to think about,” he said.
The new and prior resection patients in the study were well matched in terms of known risk factors for leakage, including age, sex, preoperative serum albumin, and use of immune suppressing medications. “The increased risk of leak is not explained by preoperative nutritional status or medication use,” Dr. Johnston said.
Estimated blood loss, OR time, types of procedures, hand-sewn versus stapled anastomoses, and other surgical variables were also similar.
The lack of significant differences between the groups raises the question of why repeat resections leak more. “That’s the million dollar question. My thought is that repeat resections indicate a greater severity of Crohn’s disease. I think there’s microvascular disease that’s affecting their tissue integrity, but we don’t appreciate it at the time of their anastomosis. If it was obvious at the time of surgery, patients wouldn’t be put together. They’d just get a stoma and be done with it,” Dr. Johnston said
About 80% of both first-time and repeat procedures were ileocolic resections secondary to obstruction, generally without bowel prep. Repeat procedures were performed a mean of 15 years after the first operation. Most initial resections were done laparoscopically, and a good portion of repeat procedures were open. Anorectal cases were excluded from the analysis.
Dr. Johnston said his team looked into the issue after noticing that repeat patients “seemed to leak a little bit more than we expected.”
The investigators had no conflicts of interest.
SEATTLE – The risk of anastomotic leaks after bowel resection for Crohn’s disease is more than three times higher in patients who have had prior resections, according to a review of 206 patients at Lahey Hospital and Medical Center in Burlington, Mass.
There were 20 anastomotic leaks within 30 days of resection in those patients, giving an overall leakage rate of 10%. Among the 123 patients who were having their first resection, however, the rate was 5% (6/123). The risk jumped to 17% in the 83 who had prior resections (14/83) and 23% (7) among the 30 patients who had two or more prior resections, which is “substantially higher than we talk about in the clinic when we are counseling these people,” said lead investigator Forrest Johnston, MD, a colorectal surgery fellow at Lahey.
The findings are important because prior resections have not, until now, been formally recognized as a risk factor for anastomotic leaks, and repeat resections are common in Crohn’s. “When you see patients for repeat intestinal resections, you have to look at them as a higher risk population in terms of your counseling and algorithms,” Dr. Johnston said at the American Society of Colon and Rectal Surgeons annual meeting. In addition, to mitigate the increased risk, Crohn’s patients who have repeat resections need additional attention to correct modifiable risk factors before surgery, such as steroid use and malnutrition. “Some of these patients are pushed through the clinic,” but “they deserve a bit more time.”
The heightened risk is also “another factor that might tip you one way or another” in choosing surgical options. “It’s certainly something to think about,” he said.
The new and prior resection patients in the study were well matched in terms of known risk factors for leakage, including age, sex, preoperative serum albumin, and use of immune suppressing medications. “The increased risk of leak is not explained by preoperative nutritional status or medication use,” Dr. Johnston said.
Estimated blood loss, OR time, types of procedures, hand-sewn versus stapled anastomoses, and other surgical variables were also similar.
The lack of significant differences between the groups raises the question of why repeat resections leak more. “That’s the million dollar question. My thought is that repeat resections indicate a greater severity of Crohn’s disease. I think there’s microvascular disease that’s affecting their tissue integrity, but we don’t appreciate it at the time of their anastomosis. If it was obvious at the time of surgery, patients wouldn’t be put together. They’d just get a stoma and be done with it,” Dr. Johnston said
About 80% of both first-time and repeat procedures were ileocolic resections secondary to obstruction, generally without bowel prep. Repeat procedures were performed a mean of 15 years after the first operation. Most initial resections were done laparoscopically, and a good portion of repeat procedures were open. Anorectal cases were excluded from the analysis.
Dr. Johnston said his team looked into the issue after noticing that repeat patients “seemed to leak a little bit more than we expected.”
The investigators had no conflicts of interest.
SEATTLE – The risk of anastomotic leaks after bowel resection for Crohn’s disease is more than three times higher in patients who have had prior resections, according to a review of 206 patients at Lahey Hospital and Medical Center in Burlington, Mass.
There were 20 anastomotic leaks within 30 days of resection in those patients, giving an overall leakage rate of 10%. Among the 123 patients who were having their first resection, however, the rate was 5% (6/123). The risk jumped to 17% in the 83 who had prior resections (14/83) and 23% (7) among the 30 patients who had two or more prior resections, which is “substantially higher than we talk about in the clinic when we are counseling these people,” said lead investigator Forrest Johnston, MD, a colorectal surgery fellow at Lahey.
The findings are important because prior resections have not, until now, been formally recognized as a risk factor for anastomotic leaks, and repeat resections are common in Crohn’s. “When you see patients for repeat intestinal resections, you have to look at them as a higher risk population in terms of your counseling and algorithms,” Dr. Johnston said at the American Society of Colon and Rectal Surgeons annual meeting. In addition, to mitigate the increased risk, Crohn’s patients who have repeat resections need additional attention to correct modifiable risk factors before surgery, such as steroid use and malnutrition. “Some of these patients are pushed through the clinic,” but “they deserve a bit more time.”
The heightened risk is also “another factor that might tip you one way or another” in choosing surgical options. “It’s certainly something to think about,” he said.
The new and prior resection patients in the study were well matched in terms of known risk factors for leakage, including age, sex, preoperative serum albumin, and use of immune suppressing medications. “The increased risk of leak is not explained by preoperative nutritional status or medication use,” Dr. Johnston said.
Estimated blood loss, OR time, types of procedures, hand-sewn versus stapled anastomoses, and other surgical variables were also similar.
The lack of significant differences between the groups raises the question of why repeat resections leak more. “That’s the million dollar question. My thought is that repeat resections indicate a greater severity of Crohn’s disease. I think there’s microvascular disease that’s affecting their tissue integrity, but we don’t appreciate it at the time of their anastomosis. If it was obvious at the time of surgery, patients wouldn’t be put together. They’d just get a stoma and be done with it,” Dr. Johnston said
About 80% of both first-time and repeat procedures were ileocolic resections secondary to obstruction, generally without bowel prep. Repeat procedures were performed a mean of 15 years after the first operation. Most initial resections were done laparoscopically, and a good portion of repeat procedures were open. Anorectal cases were excluded from the analysis.
Dr. Johnston said his team looked into the issue after noticing that repeat patients “seemed to leak a little bit more than we expected.”
The investigators had no conflicts of interest.
AT ASCRS 2017
Key clinical point:
Major finding: The number of prior resections correlated almost perfectly with an increasing risk of anastomotic leakage (r = 0.998); the odds ratio for leakage with prior resection, compared with initial resection, was 3.5 (95% confidence interval, 1.3-9.4; P less than .005).
Data source: A review of 206 Crohn’ patients.
Disclosures: The investigators had no conflicts of interest.
No easy answers for parastomal hernia repair
SEATTLE – At present, laparoscopic Sugarbaker repair is probably the best surgical option for parastomal hernias when stomas can’t be reversed, according to Mark Gudgeon, MS, FRCS, a consultant general surgeon at the Frimley Park Hospital in England.
Parastomal hernias are common in colorectal surgery; more than a quarter of ileostomy stomas and well over half of colostomy stomas herniate within 10 years of placement, leading to pain, leakage, appliance problems, and embarrassment for patients. There’s also the risk of bowel obstruction and strangulation. “It’s something that’s a challenge to all of us. It’s a very difficult problem,” Dr. Gudgeon said at the American Society of Colon and Rectal Surgeons annual meeting.
It can be difficult to decide whether or not to even offer patients a surgical fix because they often fail, and sometimes lead to fistulas and well-known mesh complications. Obese patients are “a no-go because they do not do well, and neither do smokers. Both are things patients have an opportunity to correct before we go ahead with surgery,” Dr. Gudgeon said.
On top of that, about 6% of repair patients die from complications. Patients “don’t believe that at first, but when you rub it in, a lot of them will change their minds” about surgery. “These patients don’t do well,” so avoid surgery when possible, he said. “Pain can be dealt with; leakage can be dealt with; cosmesis can be accepted,” especially with the help of stoma specialists who are experts in the art of appliance fit and support garments, Dr. Gudgeon said.
If the decision to operate is made, forget about suture repair, Dr. Gudgeon recommended. It should be “abandoned. I know it still goes on, but the evidence speaks for itself: [hernias] just come back again.”
Dr. Gudgeon suggested that it may be best to reverse the stoma, if possible, and repair the defect. Relocating the stoma “is always an attractive alternative,” and laparoscopic mesh keyhole repairs are straightforward. But the risk of recurrence is high, he said.
The Food and Drug Administration recently found that there’s not much difference between synthetic and biologic mesh, so Dr. Gudgeon said he usually opts for synthetics because they are less expensive.
He reported speakers’ fees from Intuitive, Medtronic, and Cook Medical.
SEATTLE – At present, laparoscopic Sugarbaker repair is probably the best surgical option for parastomal hernias when stomas can’t be reversed, according to Mark Gudgeon, MS, FRCS, a consultant general surgeon at the Frimley Park Hospital in England.
Parastomal hernias are common in colorectal surgery; more than a quarter of ileostomy stomas and well over half of colostomy stomas herniate within 10 years of placement, leading to pain, leakage, appliance problems, and embarrassment for patients. There’s also the risk of bowel obstruction and strangulation. “It’s something that’s a challenge to all of us. It’s a very difficult problem,” Dr. Gudgeon said at the American Society of Colon and Rectal Surgeons annual meeting.
It can be difficult to decide whether or not to even offer patients a surgical fix because they often fail, and sometimes lead to fistulas and well-known mesh complications. Obese patients are “a no-go because they do not do well, and neither do smokers. Both are things patients have an opportunity to correct before we go ahead with surgery,” Dr. Gudgeon said.
On top of that, about 6% of repair patients die from complications. Patients “don’t believe that at first, but when you rub it in, a lot of them will change their minds” about surgery. “These patients don’t do well,” so avoid surgery when possible, he said. “Pain can be dealt with; leakage can be dealt with; cosmesis can be accepted,” especially with the help of stoma specialists who are experts in the art of appliance fit and support garments, Dr. Gudgeon said.
If the decision to operate is made, forget about suture repair, Dr. Gudgeon recommended. It should be “abandoned. I know it still goes on, but the evidence speaks for itself: [hernias] just come back again.”
Dr. Gudgeon suggested that it may be best to reverse the stoma, if possible, and repair the defect. Relocating the stoma “is always an attractive alternative,” and laparoscopic mesh keyhole repairs are straightforward. But the risk of recurrence is high, he said.
The Food and Drug Administration recently found that there’s not much difference between synthetic and biologic mesh, so Dr. Gudgeon said he usually opts for synthetics because they are less expensive.
He reported speakers’ fees from Intuitive, Medtronic, and Cook Medical.
SEATTLE – At present, laparoscopic Sugarbaker repair is probably the best surgical option for parastomal hernias when stomas can’t be reversed, according to Mark Gudgeon, MS, FRCS, a consultant general surgeon at the Frimley Park Hospital in England.
Parastomal hernias are common in colorectal surgery; more than a quarter of ileostomy stomas and well over half of colostomy stomas herniate within 10 years of placement, leading to pain, leakage, appliance problems, and embarrassment for patients. There’s also the risk of bowel obstruction and strangulation. “It’s something that’s a challenge to all of us. It’s a very difficult problem,” Dr. Gudgeon said at the American Society of Colon and Rectal Surgeons annual meeting.
It can be difficult to decide whether or not to even offer patients a surgical fix because they often fail, and sometimes lead to fistulas and well-known mesh complications. Obese patients are “a no-go because they do not do well, and neither do smokers. Both are things patients have an opportunity to correct before we go ahead with surgery,” Dr. Gudgeon said.
On top of that, about 6% of repair patients die from complications. Patients “don’t believe that at first, but when you rub it in, a lot of them will change their minds” about surgery. “These patients don’t do well,” so avoid surgery when possible, he said. “Pain can be dealt with; leakage can be dealt with; cosmesis can be accepted,” especially with the help of stoma specialists who are experts in the art of appliance fit and support garments, Dr. Gudgeon said.
If the decision to operate is made, forget about suture repair, Dr. Gudgeon recommended. It should be “abandoned. I know it still goes on, but the evidence speaks for itself: [hernias] just come back again.”
Dr. Gudgeon suggested that it may be best to reverse the stoma, if possible, and repair the defect. Relocating the stoma “is always an attractive alternative,” and laparoscopic mesh keyhole repairs are straightforward. But the risk of recurrence is high, he said.
The Food and Drug Administration recently found that there’s not much difference between synthetic and biologic mesh, so Dr. Gudgeon said he usually opts for synthetics because they are less expensive.
He reported speakers’ fees from Intuitive, Medtronic, and Cook Medical.
EXPERT ANALYSIS AT THE ASCRS ANNUAL MEETING
Increased risk of death even in lower-risk PPI users
Proton pump inhibitors (PPIs) are associated with a significantly higher risk of death than are H2 receptor antagonists, according to a 5-year longitudinal cohort study.
The study, published online in BMJ Open, found that increased risk of death was evident even in people without gastrointestinal conditions, and it increased with longer duration of use.
Yan Xie, PhD, of the VA Saint Louis Health Care System and coauthors, wrote that PPIs are linked to a range of serious adverse outcomes – such as acute interstitial nephritis, chronic kidney disease, incident dementia, and Clostridium difficile infection – each of which is associated with higher risk of mortality.
“Whether PPI use is associated with excess risk of death is not known and has not been examined in large epidemiological studies spanning a sufficiently long duration of follow-up.”
In this study, a cohort of 349,312 veterans initiated on acid-suppression therapy was followed for a mean duration of 5.71 years (BMJ Open 2017. July 4;7:e015735. doi: 10.1136/bmjopen-2016-015735).
Researchers saw a 25% higher risk of death in the 275,977 participants treated with PPIs, compared with that in those who were treated with H2 receptor antagonists (95% confidence interval, 1.23-1.28), after adjusting for factors such as estimated glomerular filtration rate, age, hospitalizations, and a range of comorbidities, including gastrointestinal disorders.
When PPI use was compared with no PPI use, there was a 15% increase in the risk of death (95% CI, 1.14-1.15). When compared with no known exposure to any acid suppression therapy, the increased risk of death was 23% (95% CI, 1.22-1.24).
In an attempt to look at the risk of death in a lower-risk cohort, the researchers analyzed a subgroup of participants who did not have the conditions for which PPIs are normally prescribed, such as gastroesophageal reflux disease, upper gastrointestinal tract bleeding, ulcer disease, Helicobacter pylori infection, and Barrett’s esophagus.
However, even in this lower-risk cohort, the study still showed a 24% increase in the risk of death with PPIs, compared with that in H2 receptor antagonists (95% CI, 1.21-1.27); a 19% increase with PPIs, compared with no PPIs; and a 22% increase with PPIs, compared with no acid suppression.
Duration of exposure to PPIs was also associated with increasing risk of death. Participants who had taken PPIs for fewer than 90 days in total only had a 5% increase in risk, while those taking them for 361-720 days had a 51% increased risk of death.
“Although our results should not deter prescription and use of PPIs where medically indicated, they may be used to encourage and promote pharmacovigilance and emphasize the need to exercise judicious use of PPIs and limit use and duration of therapy to instances where there is a clear medical indication and where benefit outweighs potential risk,” the authors wrote.
“Standardized guidelines for initiating PPI prescription may lead to reduced overuse [and] regular review of prescription and over-the-counter medications, and deprescription, where a medical indication for PPI treatment ceases to exist, may be a meritorious approach.”
Examining possible physiologic mechanisms to explain the increased risk of death, the authors noted that animal studies suggested PPIs may limit the liver’s capacity to regenerate.
PPIs are also associated with increased activity of the heme oxygenase-1 enzyme in gastric and endothelial cells and impairment of lysosomal acidification and proteostasis and may alter gene expression in the cellular retinol metabolism pathway and the complement and coagulation cascades pathway.
However, the clinical mediator of the heightened risk of death was likely one of the adverse events linked to PPI use, they said.
No conflicts of interest were declared.
Proton pump inhibitors (PPIs) are associated with a significantly higher risk of death than are H2 receptor antagonists, according to a 5-year longitudinal cohort study.
The study, published online in BMJ Open, found that increased risk of death was evident even in people without gastrointestinal conditions, and it increased with longer duration of use.
Yan Xie, PhD, of the VA Saint Louis Health Care System and coauthors, wrote that PPIs are linked to a range of serious adverse outcomes – such as acute interstitial nephritis, chronic kidney disease, incident dementia, and Clostridium difficile infection – each of which is associated with higher risk of mortality.
“Whether PPI use is associated with excess risk of death is not known and has not been examined in large epidemiological studies spanning a sufficiently long duration of follow-up.”
In this study, a cohort of 349,312 veterans initiated on acid-suppression therapy was followed for a mean duration of 5.71 years (BMJ Open 2017. July 4;7:e015735. doi: 10.1136/bmjopen-2016-015735).
Researchers saw a 25% higher risk of death in the 275,977 participants treated with PPIs, compared with that in those who were treated with H2 receptor antagonists (95% confidence interval, 1.23-1.28), after adjusting for factors such as estimated glomerular filtration rate, age, hospitalizations, and a range of comorbidities, including gastrointestinal disorders.
When PPI use was compared with no PPI use, there was a 15% increase in the risk of death (95% CI, 1.14-1.15). When compared with no known exposure to any acid suppression therapy, the increased risk of death was 23% (95% CI, 1.22-1.24).
In an attempt to look at the risk of death in a lower-risk cohort, the researchers analyzed a subgroup of participants who did not have the conditions for which PPIs are normally prescribed, such as gastroesophageal reflux disease, upper gastrointestinal tract bleeding, ulcer disease, Helicobacter pylori infection, and Barrett’s esophagus.
However, even in this lower-risk cohort, the study still showed a 24% increase in the risk of death with PPIs, compared with that in H2 receptor antagonists (95% CI, 1.21-1.27); a 19% increase with PPIs, compared with no PPIs; and a 22% increase with PPIs, compared with no acid suppression.
Duration of exposure to PPIs was also associated with increasing risk of death. Participants who had taken PPIs for fewer than 90 days in total only had a 5% increase in risk, while those taking them for 361-720 days had a 51% increased risk of death.
“Although our results should not deter prescription and use of PPIs where medically indicated, they may be used to encourage and promote pharmacovigilance and emphasize the need to exercise judicious use of PPIs and limit use and duration of therapy to instances where there is a clear medical indication and where benefit outweighs potential risk,” the authors wrote.
“Standardized guidelines for initiating PPI prescription may lead to reduced overuse [and] regular review of prescription and over-the-counter medications, and deprescription, where a medical indication for PPI treatment ceases to exist, may be a meritorious approach.”
Examining possible physiologic mechanisms to explain the increased risk of death, the authors noted that animal studies suggested PPIs may limit the liver’s capacity to regenerate.
PPIs are also associated with increased activity of the heme oxygenase-1 enzyme in gastric and endothelial cells and impairment of lysosomal acidification and proteostasis and may alter gene expression in the cellular retinol metabolism pathway and the complement and coagulation cascades pathway.
However, the clinical mediator of the heightened risk of death was likely one of the adverse events linked to PPI use, they said.
No conflicts of interest were declared.
Proton pump inhibitors (PPIs) are associated with a significantly higher risk of death than are H2 receptor antagonists, according to a 5-year longitudinal cohort study.
The study, published online in BMJ Open, found that increased risk of death was evident even in people without gastrointestinal conditions, and it increased with longer duration of use.
Yan Xie, PhD, of the VA Saint Louis Health Care System and coauthors, wrote that PPIs are linked to a range of serious adverse outcomes – such as acute interstitial nephritis, chronic kidney disease, incident dementia, and Clostridium difficile infection – each of which is associated with higher risk of mortality.
“Whether PPI use is associated with excess risk of death is not known and has not been examined in large epidemiological studies spanning a sufficiently long duration of follow-up.”
In this study, a cohort of 349,312 veterans initiated on acid-suppression therapy was followed for a mean duration of 5.71 years (BMJ Open 2017. July 4;7:e015735. doi: 10.1136/bmjopen-2016-015735).
Researchers saw a 25% higher risk of death in the 275,977 participants treated with PPIs, compared with that in those who were treated with H2 receptor antagonists (95% confidence interval, 1.23-1.28), after adjusting for factors such as estimated glomerular filtration rate, age, hospitalizations, and a range of comorbidities, including gastrointestinal disorders.
When PPI use was compared with no PPI use, there was a 15% increase in the risk of death (95% CI, 1.14-1.15). When compared with no known exposure to any acid suppression therapy, the increased risk of death was 23% (95% CI, 1.22-1.24).
In an attempt to look at the risk of death in a lower-risk cohort, the researchers analyzed a subgroup of participants who did not have the conditions for which PPIs are normally prescribed, such as gastroesophageal reflux disease, upper gastrointestinal tract bleeding, ulcer disease, Helicobacter pylori infection, and Barrett’s esophagus.
However, even in this lower-risk cohort, the study still showed a 24% increase in the risk of death with PPIs, compared with that in H2 receptor antagonists (95% CI, 1.21-1.27); a 19% increase with PPIs, compared with no PPIs; and a 22% increase with PPIs, compared with no acid suppression.
Duration of exposure to PPIs was also associated with increasing risk of death. Participants who had taken PPIs for fewer than 90 days in total only had a 5% increase in risk, while those taking them for 361-720 days had a 51% increased risk of death.
“Although our results should not deter prescription and use of PPIs where medically indicated, they may be used to encourage and promote pharmacovigilance and emphasize the need to exercise judicious use of PPIs and limit use and duration of therapy to instances where there is a clear medical indication and where benefit outweighs potential risk,” the authors wrote.
“Standardized guidelines for initiating PPI prescription may lead to reduced overuse [and] regular review of prescription and over-the-counter medications, and deprescription, where a medical indication for PPI treatment ceases to exist, may be a meritorious approach.”
Examining possible physiologic mechanisms to explain the increased risk of death, the authors noted that animal studies suggested PPIs may limit the liver’s capacity to regenerate.
PPIs are also associated with increased activity of the heme oxygenase-1 enzyme in gastric and endothelial cells and impairment of lysosomal acidification and proteostasis and may alter gene expression in the cellular retinol metabolism pathway and the complement and coagulation cascades pathway.
However, the clinical mediator of the heightened risk of death was likely one of the adverse events linked to PPI use, they said.
No conflicts of interest were declared.
FROM BMJ OPEN
Key clinical point: Proton pump inhibitors are associated with a significantly higher risk of death, even among people without the gastrointestinal conditions for which the drugs are normally prescribed.
Major finding: People taking PPIs have a 25% higher risk of death, compared with those taking H2 receptor antagonists.
Data source: A longitudinal cohort study in 349,312 veterans.
Disclosures: No conflicts of interest were declared.
Hospital isolates C. difficile carriers and rates drop
NEW ORLEANS – A Montreal hospital grappling with high Clostridium difficile infections rates launched an intervention in October 2013 to screen patients at admission and detect asymptomatic carriers, and investigators found 4.8% of 7,599 people admitted through the ED over 15 months were carriers of C. difficile.
To protect Jewish General Hospital physicians, staff and other patients from potential transmission, these patients were placed in isolation. However, because they were fairly numerous – 1 in 20 admissions – and because infectious disease (ID) experts feared a substantial backlash, these patients were put in less restrictive isolation. They were permitted to share rooms as long as the dividing curtains remained drawn, for example. In addition, clinicians could skip wearing traditional isolation hats and gowns.
The ID team at the hospital considered the intervention a success. “It is estimated we prevented 64 cases over 15 months,” Dr. Longtin said during a packed session at the annual meeting of the American Society for Microbiology.
The hospital’s C. difficile rate dropped from 6.9 per 10,000 patient-days before the screening and isolation protocol to 3.0 per 10,000 during the intervention. The difference was statically significant (P less than .001).
“Compared to other hospitals in the province, we used to be in the middle of the pack [for C. difficile infection rates], and now we are the lowest,” Dr. Longtin said.
Asymptomatic carriers were detected using rectal sampling with sterile swab and polymerase chain reaction analysis. Testing was performed 7 days a week and analyzed once daily, with results generated within 24 hours and documented in the patient chart. Only patients admitted through the ED were screened, which prompted some questions from colleagues, Dr. Longtin said. However, he defends this approach because the 30% or so of patients admitted from the ED tend to spend more days on the ward. The risk of becoming colonized increases steadily with duration of hospitalization. This occurs despite isolating patients with C. difficile infection. Initial results of the study were published in JAMA Internal Medicine (2016 Jun 1;176[6]:796-804).
Risk to health care workers
C. difficile carriers are contagious, but not as much as people with C. difficile infection, Dr. Longtin said. In one study, the microorganism was present on the skin of 61% of symptomatic carriers versus 78% of those infected (Clin Infect Dis. 2007 Oct 15;45[8]:992-8). In addition, C. difficile present on patient skin can be transferred to health care worker hands, even up to 6 weeks after resolution of associated diarrhea (Infect Control Hosp Epidemiol. 2016 Apr;37[4]:475-7).
Prior to the intervention, C. difficile prevention at Jewish General involved guidelines that “have not really changed in the last 20 years,” Dr. Longtin said. Contact precautions around infected patients, hand hygiene, environmental cleaning, and antibiotic stewardship were the main strategies.
“Despite all these measures, we were not completely blocking dissemination of C difficile in our hospital,” Dr. Longtin said. He added that soap and water are better than alcohol for C. difficile, “but honestly not very good. Even the best hand hygiene technique is poorly effective to remove C. difficile. On the other hand – get it? – gloves are very effective. We felt we had to combine hand washing with gloves.”
Hand hygiene compliance increased from 37% to 50% during the intervention, and Dr. Longtin expected further improvements over time.
Risk to other patients
“Transmission of C. difficile cannot only be explained by infected patients in a hospital, so likely carriers also play a role,” Dr. Longtin said.
Another set of investigators found that hospital patients exposed to a carrier of C. difficile had nearly twice the risk of acquiring the infection (odds ratio, 1.79) (Gastroenterology. 2017 Apr;152[5]:1031-41.e2).
“For every patient with C. difficile infection, it’s estimated there are 5-7 C. difficile carriers, so they are numerous as well,” he said.
The bigger picture
During the study period, the C. difficile infection trends did not significantly change on the city level, further supporting the effectiveness of the carrier screen-and-isolate strategy.
There was slight increase in antibiotic use during the intervention period, Dr. Longtin said. “The only type of antibiotics that really decreased were vancomycin and metronidazole... which suggests in turn there were fewer cases of C. difficile infection.”
Long-term follow-up is ongoing, Dr. Longtin said. “We have more than 3 years of intervention. In the past year, our rate was 2.2 per 10,000 patient-days.”
Unanswered questions include the generalizability of the results “because we’re a very pro–infection control hospital,” he said. In addition, a formal cost-benefit analysis of this strategy would be worthwhile in the future.
Dr. Longtin is a consultant for AMG Medical and receives research support from Merck and BD Medical.
NEW ORLEANS – A Montreal hospital grappling with high Clostridium difficile infections rates launched an intervention in October 2013 to screen patients at admission and detect asymptomatic carriers, and investigators found 4.8% of 7,599 people admitted through the ED over 15 months were carriers of C. difficile.
To protect Jewish General Hospital physicians, staff and other patients from potential transmission, these patients were placed in isolation. However, because they were fairly numerous – 1 in 20 admissions – and because infectious disease (ID) experts feared a substantial backlash, these patients were put in less restrictive isolation. They were permitted to share rooms as long as the dividing curtains remained drawn, for example. In addition, clinicians could skip wearing traditional isolation hats and gowns.
The ID team at the hospital considered the intervention a success. “It is estimated we prevented 64 cases over 15 months,” Dr. Longtin said during a packed session at the annual meeting of the American Society for Microbiology.
The hospital’s C. difficile rate dropped from 6.9 per 10,000 patient-days before the screening and isolation protocol to 3.0 per 10,000 during the intervention. The difference was statically significant (P less than .001).
“Compared to other hospitals in the province, we used to be in the middle of the pack [for C. difficile infection rates], and now we are the lowest,” Dr. Longtin said.
Asymptomatic carriers were detected using rectal sampling with sterile swab and polymerase chain reaction analysis. Testing was performed 7 days a week and analyzed once daily, with results generated within 24 hours and documented in the patient chart. Only patients admitted through the ED were screened, which prompted some questions from colleagues, Dr. Longtin said. However, he defends this approach because the 30% or so of patients admitted from the ED tend to spend more days on the ward. The risk of becoming colonized increases steadily with duration of hospitalization. This occurs despite isolating patients with C. difficile infection. Initial results of the study were published in JAMA Internal Medicine (2016 Jun 1;176[6]:796-804).
Risk to health care workers
C. difficile carriers are contagious, but not as much as people with C. difficile infection, Dr. Longtin said. In one study, the microorganism was present on the skin of 61% of symptomatic carriers versus 78% of those infected (Clin Infect Dis. 2007 Oct 15;45[8]:992-8). In addition, C. difficile present on patient skin can be transferred to health care worker hands, even up to 6 weeks after resolution of associated diarrhea (Infect Control Hosp Epidemiol. 2016 Apr;37[4]:475-7).
Prior to the intervention, C. difficile prevention at Jewish General involved guidelines that “have not really changed in the last 20 years,” Dr. Longtin said. Contact precautions around infected patients, hand hygiene, environmental cleaning, and antibiotic stewardship were the main strategies.
“Despite all these measures, we were not completely blocking dissemination of C difficile in our hospital,” Dr. Longtin said. He added that soap and water are better than alcohol for C. difficile, “but honestly not very good. Even the best hand hygiene technique is poorly effective to remove C. difficile. On the other hand – get it? – gloves are very effective. We felt we had to combine hand washing with gloves.”
Hand hygiene compliance increased from 37% to 50% during the intervention, and Dr. Longtin expected further improvements over time.
Risk to other patients
“Transmission of C. difficile cannot only be explained by infected patients in a hospital, so likely carriers also play a role,” Dr. Longtin said.
Another set of investigators found that hospital patients exposed to a carrier of C. difficile had nearly twice the risk of acquiring the infection (odds ratio, 1.79) (Gastroenterology. 2017 Apr;152[5]:1031-41.e2).
“For every patient with C. difficile infection, it’s estimated there are 5-7 C. difficile carriers, so they are numerous as well,” he said.
The bigger picture
During the study period, the C. difficile infection trends did not significantly change on the city level, further supporting the effectiveness of the carrier screen-and-isolate strategy.
There was slight increase in antibiotic use during the intervention period, Dr. Longtin said. “The only type of antibiotics that really decreased were vancomycin and metronidazole... which suggests in turn there were fewer cases of C. difficile infection.”
Long-term follow-up is ongoing, Dr. Longtin said. “We have more than 3 years of intervention. In the past year, our rate was 2.2 per 10,000 patient-days.”
Unanswered questions include the generalizability of the results “because we’re a very pro–infection control hospital,” he said. In addition, a formal cost-benefit analysis of this strategy would be worthwhile in the future.
Dr. Longtin is a consultant for AMG Medical and receives research support from Merck and BD Medical.
NEW ORLEANS – A Montreal hospital grappling with high Clostridium difficile infections rates launched an intervention in October 2013 to screen patients at admission and detect asymptomatic carriers, and investigators found 4.8% of 7,599 people admitted through the ED over 15 months were carriers of C. difficile.
To protect Jewish General Hospital physicians, staff and other patients from potential transmission, these patients were placed in isolation. However, because they were fairly numerous – 1 in 20 admissions – and because infectious disease (ID) experts feared a substantial backlash, these patients were put in less restrictive isolation. They were permitted to share rooms as long as the dividing curtains remained drawn, for example. In addition, clinicians could skip wearing traditional isolation hats and gowns.
The ID team at the hospital considered the intervention a success. “It is estimated we prevented 64 cases over 15 months,” Dr. Longtin said during a packed session at the annual meeting of the American Society for Microbiology.
The hospital’s C. difficile rate dropped from 6.9 per 10,000 patient-days before the screening and isolation protocol to 3.0 per 10,000 during the intervention. The difference was statically significant (P less than .001).
“Compared to other hospitals in the province, we used to be in the middle of the pack [for C. difficile infection rates], and now we are the lowest,” Dr. Longtin said.
Asymptomatic carriers were detected using rectal sampling with sterile swab and polymerase chain reaction analysis. Testing was performed 7 days a week and analyzed once daily, with results generated within 24 hours and documented in the patient chart. Only patients admitted through the ED were screened, which prompted some questions from colleagues, Dr. Longtin said. However, he defends this approach because the 30% or so of patients admitted from the ED tend to spend more days on the ward. The risk of becoming colonized increases steadily with duration of hospitalization. This occurs despite isolating patients with C. difficile infection. Initial results of the study were published in JAMA Internal Medicine (2016 Jun 1;176[6]:796-804).
Risk to health care workers
C. difficile carriers are contagious, but not as much as people with C. difficile infection, Dr. Longtin said. In one study, the microorganism was present on the skin of 61% of symptomatic carriers versus 78% of those infected (Clin Infect Dis. 2007 Oct 15;45[8]:992-8). In addition, C. difficile present on patient skin can be transferred to health care worker hands, even up to 6 weeks after resolution of associated diarrhea (Infect Control Hosp Epidemiol. 2016 Apr;37[4]:475-7).
Prior to the intervention, C. difficile prevention at Jewish General involved guidelines that “have not really changed in the last 20 years,” Dr. Longtin said. Contact precautions around infected patients, hand hygiene, environmental cleaning, and antibiotic stewardship were the main strategies.
“Despite all these measures, we were not completely blocking dissemination of C difficile in our hospital,” Dr. Longtin said. He added that soap and water are better than alcohol for C. difficile, “but honestly not very good. Even the best hand hygiene technique is poorly effective to remove C. difficile. On the other hand – get it? – gloves are very effective. We felt we had to combine hand washing with gloves.”
Hand hygiene compliance increased from 37% to 50% during the intervention, and Dr. Longtin expected further improvements over time.
Risk to other patients
“Transmission of C. difficile cannot only be explained by infected patients in a hospital, so likely carriers also play a role,” Dr. Longtin said.
Another set of investigators found that hospital patients exposed to a carrier of C. difficile had nearly twice the risk of acquiring the infection (odds ratio, 1.79) (Gastroenterology. 2017 Apr;152[5]:1031-41.e2).
“For every patient with C. difficile infection, it’s estimated there are 5-7 C. difficile carriers, so they are numerous as well,” he said.
The bigger picture
During the study period, the C. difficile infection trends did not significantly change on the city level, further supporting the effectiveness of the carrier screen-and-isolate strategy.
There was slight increase in antibiotic use during the intervention period, Dr. Longtin said. “The only type of antibiotics that really decreased were vancomycin and metronidazole... which suggests in turn there were fewer cases of C. difficile infection.”
Long-term follow-up is ongoing, Dr. Longtin said. “We have more than 3 years of intervention. In the past year, our rate was 2.2 per 10,000 patient-days.”
Unanswered questions include the generalizability of the results “because we’re a very pro–infection control hospital,” he said. In addition, a formal cost-benefit analysis of this strategy would be worthwhile in the future.
Dr. Longtin is a consultant for AMG Medical and receives research support from Merck and BD Medical.
AT ASM MICROBE 2017
Key clinical point: Identification and isolation of asymptomatic carriers of Clostridium difficile decreased a hospital’s infection rates over time.
Major finding: (P less than .001).
Data source: A study of 7,599 people screened at admission through the ED at an acute care hospital.
Disclosures: Dr. Longtin is a consultant for AMG Medical and receives research support from Merck and BD Medical.
Add-on aripiprazole shows modest improvement over bupropion in depression
In men with major depressive disorder (MMD) who were not responding well to an antidepressant treatment, adding aripiprazole resulted in a modest increase in the likelihood of remission, compared with switching to bupropion monotherapy, according to results from a new randomized study.
The findings, published online July 11 in JAMA, come from a randomized, single-blinded trial enrolling more than 1,500 Veterans Health Administration patients (85% men; mean age, 54) with persistent MDD symptoms despite a trial of at least 1 antidepressant drug (JAMA. 2017;318[2]:132-45.).
The VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D) study, led by Somaia Mohamed, MD, PhD, of the VA Connecticut Healthcare System in West Haven, Conn., and carried out at 35 Veterans Health Administration treatment centers, was designed to help answer some of the lingering questions about augmentation strategies that the landmark, federally funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, from 2006, could not answer.
While the STAR*D investigators found bupropion to be an effective switching and augmentation agent in people who had failed citalopram monotherapy, the study was not powered to compare results for switching and augmentation. Nor did STAR*D include augmentation with atypical antipsychotics such as aripiprazole, a treatment strategy that was not yet in wide use.
The VAST-D study also differed from most depression trials in that most of the patients were men. The main outcome was clinical remission within 12 weeks of initiating one of the three treatment strategies. Subjects were randomized to augmentation of current treatment with aripiprazole 2-15 mg (n = 505) or bupropion 150-400 mg (n = 506) or were switched from current treatment to bupropion monotherapy (n = 511).
Remission rates during the first 12 weeks were 22% for patients switched from their current drug to bupropion, 27% for those who augmented treatment with bupropion, and 29% for those who augmented treatment with aripiprazole, though the difference in remission reached statistical significance only for the adjunctive aripiprazole group vs. the bupropion monotherapy group (relative risk, 1.30; 95% confidence interval, 1.05-1.60; P = .02).
Clinical response, as measured using two validated scoring systems, was higher (74%) in the aripiprazole group at 12 weeks, compared with the bupropion only (62%) or bupropion augmentation (66%) groups, a difference that reached statistical significance. Anxiety was more commonly reported among patients in the bupropion groups, while somnolence, akathisia, and weight gain were more frequently reported among patients treated with aripiprazole.
Though aripiprazole augmentation was seen associated with a higher rate of remission and greater response, Dr. Mohamed and her colleagues cautioned that, “given the small effect size and adverse effects” associated with the atypical antipsychotic drug, “further analysis, including cost-effectiveness, is needed to understand the net utility of this approach.”
The Department of Veterans Affairs sponsored the study. Bristol-Myers Squibb provided aripiprazole to investigators. Of the study’s 16 listed coauthors, 5 reported financial relationships with Bristol-Myers Squibb or other manufacturers.
“The modest advantage of aripiprazole augmentation over the two other treatment options in the VAST-D study suggests that this approach should be considered earlier by clinicians for patients with MDD who have an inadequate response to antidepressant therapies,” Maurizio Fava, MD, wrote in an editorial accompanying the study published by JAMA.
He also pointed out that the demographic makeup of the patients study was largely male, which is significantly different “from the usual study population in large trials of MDD, in which women typically far exceed the proportion of male study participants, as was the case with STAR*D.”
Dr. Fava cited the differences in the proportion of patients with posttraumatic stress disorder in the VAST-D and STAR*D study. In VAST-D, 44%-48% had PTSD, compared with a rate of 17% in the STAR*D cohort. “Did such enrichment potentially favor one of the treatment options of VAST-D? Although a placebo-controlled study of bupropion in chronic PTSD showed no benefit of this therapy, a meta-analysis of eight randomized, double-blind, placebo-controlled clinical trials of atypical antipsychotics for the treatment of PTSD found that these agents may be superior to placebo,” Dr. Fava wrote.
Finally, he cited the differences in mean age of onset of MDD in the two studies. In the VAST-D study, the mean age of onset ranged from 36 to 38 years and compared with a mean age of onset of 25 in STAR*D. “The older age of onset of MDD in the VAST-D study suggests that, in many cases, the MDD may have been secondary to other psychiatric conditions, such as PTSD. Therefore, there might be some significant neurobiological differences between the two populations,” Dr. Fava wrote (JAMA. 2017;318[2]:126-8).
Dr. Fava is affiliated with the division of clinical research at Massachusetts General Hospital, Boston. He reported financial relationships with numerous pharmaceutical companies.
“The modest advantage of aripiprazole augmentation over the two other treatment options in the VAST-D study suggests that this approach should be considered earlier by clinicians for patients with MDD who have an inadequate response to antidepressant therapies,” Maurizio Fava, MD, wrote in an editorial accompanying the study published by JAMA.
He also pointed out that the demographic makeup of the patients study was largely male, which is significantly different “from the usual study population in large trials of MDD, in which women typically far exceed the proportion of male study participants, as was the case with STAR*D.”
Dr. Fava cited the differences in the proportion of patients with posttraumatic stress disorder in the VAST-D and STAR*D study. In VAST-D, 44%-48% had PTSD, compared with a rate of 17% in the STAR*D cohort. “Did such enrichment potentially favor one of the treatment options of VAST-D? Although a placebo-controlled study of bupropion in chronic PTSD showed no benefit of this therapy, a meta-analysis of eight randomized, double-blind, placebo-controlled clinical trials of atypical antipsychotics for the treatment of PTSD found that these agents may be superior to placebo,” Dr. Fava wrote.
Finally, he cited the differences in mean age of onset of MDD in the two studies. In the VAST-D study, the mean age of onset ranged from 36 to 38 years and compared with a mean age of onset of 25 in STAR*D. “The older age of onset of MDD in the VAST-D study suggests that, in many cases, the MDD may have been secondary to other psychiatric conditions, such as PTSD. Therefore, there might be some significant neurobiological differences between the two populations,” Dr. Fava wrote (JAMA. 2017;318[2]:126-8).
Dr. Fava is affiliated with the division of clinical research at Massachusetts General Hospital, Boston. He reported financial relationships with numerous pharmaceutical companies.
“The modest advantage of aripiprazole augmentation over the two other treatment options in the VAST-D study suggests that this approach should be considered earlier by clinicians for patients with MDD who have an inadequate response to antidepressant therapies,” Maurizio Fava, MD, wrote in an editorial accompanying the study published by JAMA.
He also pointed out that the demographic makeup of the patients study was largely male, which is significantly different “from the usual study population in large trials of MDD, in which women typically far exceed the proportion of male study participants, as was the case with STAR*D.”
Dr. Fava cited the differences in the proportion of patients with posttraumatic stress disorder in the VAST-D and STAR*D study. In VAST-D, 44%-48% had PTSD, compared with a rate of 17% in the STAR*D cohort. “Did such enrichment potentially favor one of the treatment options of VAST-D? Although a placebo-controlled study of bupropion in chronic PTSD showed no benefit of this therapy, a meta-analysis of eight randomized, double-blind, placebo-controlled clinical trials of atypical antipsychotics for the treatment of PTSD found that these agents may be superior to placebo,” Dr. Fava wrote.
Finally, he cited the differences in mean age of onset of MDD in the two studies. In the VAST-D study, the mean age of onset ranged from 36 to 38 years and compared with a mean age of onset of 25 in STAR*D. “The older age of onset of MDD in the VAST-D study suggests that, in many cases, the MDD may have been secondary to other psychiatric conditions, such as PTSD. Therefore, there might be some significant neurobiological differences between the two populations,” Dr. Fava wrote (JAMA. 2017;318[2]:126-8).
Dr. Fava is affiliated with the division of clinical research at Massachusetts General Hospital, Boston. He reported financial relationships with numerous pharmaceutical companies.
In men with major depressive disorder (MMD) who were not responding well to an antidepressant treatment, adding aripiprazole resulted in a modest increase in the likelihood of remission, compared with switching to bupropion monotherapy, according to results from a new randomized study.
The findings, published online July 11 in JAMA, come from a randomized, single-blinded trial enrolling more than 1,500 Veterans Health Administration patients (85% men; mean age, 54) with persistent MDD symptoms despite a trial of at least 1 antidepressant drug (JAMA. 2017;318[2]:132-45.).
The VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D) study, led by Somaia Mohamed, MD, PhD, of the VA Connecticut Healthcare System in West Haven, Conn., and carried out at 35 Veterans Health Administration treatment centers, was designed to help answer some of the lingering questions about augmentation strategies that the landmark, federally funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, from 2006, could not answer.
While the STAR*D investigators found bupropion to be an effective switching and augmentation agent in people who had failed citalopram monotherapy, the study was not powered to compare results for switching and augmentation. Nor did STAR*D include augmentation with atypical antipsychotics such as aripiprazole, a treatment strategy that was not yet in wide use.
The VAST-D study also differed from most depression trials in that most of the patients were men. The main outcome was clinical remission within 12 weeks of initiating one of the three treatment strategies. Subjects were randomized to augmentation of current treatment with aripiprazole 2-15 mg (n = 505) or bupropion 150-400 mg (n = 506) or were switched from current treatment to bupropion monotherapy (n = 511).
Remission rates during the first 12 weeks were 22% for patients switched from their current drug to bupropion, 27% for those who augmented treatment with bupropion, and 29% for those who augmented treatment with aripiprazole, though the difference in remission reached statistical significance only for the adjunctive aripiprazole group vs. the bupropion monotherapy group (relative risk, 1.30; 95% confidence interval, 1.05-1.60; P = .02).
Clinical response, as measured using two validated scoring systems, was higher (74%) in the aripiprazole group at 12 weeks, compared with the bupropion only (62%) or bupropion augmentation (66%) groups, a difference that reached statistical significance. Anxiety was more commonly reported among patients in the bupropion groups, while somnolence, akathisia, and weight gain were more frequently reported among patients treated with aripiprazole.
Though aripiprazole augmentation was seen associated with a higher rate of remission and greater response, Dr. Mohamed and her colleagues cautioned that, “given the small effect size and adverse effects” associated with the atypical antipsychotic drug, “further analysis, including cost-effectiveness, is needed to understand the net utility of this approach.”
The Department of Veterans Affairs sponsored the study. Bristol-Myers Squibb provided aripiprazole to investigators. Of the study’s 16 listed coauthors, 5 reported financial relationships with Bristol-Myers Squibb or other manufacturers.
In men with major depressive disorder (MMD) who were not responding well to an antidepressant treatment, adding aripiprazole resulted in a modest increase in the likelihood of remission, compared with switching to bupropion monotherapy, according to results from a new randomized study.
The findings, published online July 11 in JAMA, come from a randomized, single-blinded trial enrolling more than 1,500 Veterans Health Administration patients (85% men; mean age, 54) with persistent MDD symptoms despite a trial of at least 1 antidepressant drug (JAMA. 2017;318[2]:132-45.).
The VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D) study, led by Somaia Mohamed, MD, PhD, of the VA Connecticut Healthcare System in West Haven, Conn., and carried out at 35 Veterans Health Administration treatment centers, was designed to help answer some of the lingering questions about augmentation strategies that the landmark, federally funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, from 2006, could not answer.
While the STAR*D investigators found bupropion to be an effective switching and augmentation agent in people who had failed citalopram monotherapy, the study was not powered to compare results for switching and augmentation. Nor did STAR*D include augmentation with atypical antipsychotics such as aripiprazole, a treatment strategy that was not yet in wide use.
The VAST-D study also differed from most depression trials in that most of the patients were men. The main outcome was clinical remission within 12 weeks of initiating one of the three treatment strategies. Subjects were randomized to augmentation of current treatment with aripiprazole 2-15 mg (n = 505) or bupropion 150-400 mg (n = 506) or were switched from current treatment to bupropion monotherapy (n = 511).
Remission rates during the first 12 weeks were 22% for patients switched from their current drug to bupropion, 27% for those who augmented treatment with bupropion, and 29% for those who augmented treatment with aripiprazole, though the difference in remission reached statistical significance only for the adjunctive aripiprazole group vs. the bupropion monotherapy group (relative risk, 1.30; 95% confidence interval, 1.05-1.60; P = .02).
Clinical response, as measured using two validated scoring systems, was higher (74%) in the aripiprazole group at 12 weeks, compared with the bupropion only (62%) or bupropion augmentation (66%) groups, a difference that reached statistical significance. Anxiety was more commonly reported among patients in the bupropion groups, while somnolence, akathisia, and weight gain were more frequently reported among patients treated with aripiprazole.
Though aripiprazole augmentation was seen associated with a higher rate of remission and greater response, Dr. Mohamed and her colleagues cautioned that, “given the small effect size and adverse effects” associated with the atypical antipsychotic drug, “further analysis, including cost-effectiveness, is needed to understand the net utility of this approach.”
The Department of Veterans Affairs sponsored the study. Bristol-Myers Squibb provided aripiprazole to investigators. Of the study’s 16 listed coauthors, 5 reported financial relationships with Bristol-Myers Squibb or other manufacturers.
FROM JAMA
Key clinical point: Aripiprazole added to a current antidepressant was associated with a modestly higher remission rate among men with MDD than was switching to bupropion monotherapy.
Major finding: Remission by 12 weeks was 28.9% among patients receiving add-on aripiprazole, vs. 22.3% for bupropion alone (RR, 1.30; 95% CI, 1.05-1.60; P = 0.02).
Data source: A randomized, single-blinded multicenter trial enrolling more than 1,500 patients (85% men) with persistent MDD despite treatment.
Disclosures: The Veterans Health Administration sponsored the study. One of the study drugs was donated by a manufacturer, and 5 of 16 coauthors disclosed financial conflicts of interest.
Counsel low-risk patients case by case on diet, exercise
Clinical judgment should drive referrals for diet and exercise behavioral counseling for adults with a low risk for cardiovascular disease (CVD), according to a new recommendation statement from the U.S. Preventive Services Task Force published online July 11 in JAMA.
“Persons who are interested and ready to make behavioral changes may be most likely to benefit from behavioral counseling,” according to the statement (JAMA 2017 Jul 11;318:167-74. doi: 10.1001/jama.2017.7171).
The recommendation is a C, which means that clinicians should consider patient preferences and clinical judgment, wrote David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, and his colleagues.
To assess the value of behavioral counseling in adults at low risk for cardiovascular disease, the USPSTF reviewed 88 trials including more than 120 interventions related to a healthful diet, physical activity, or both. None of the trials included in the review noted specific adverse events related to counseling.
Although the evidence was insufficient to support benefits from behavioral counseling for reducing death or CVD rates, the data showed that behavioral counseling was associated with improved systolic and diastolic blood pressure levels, cholesterol, body mass index, and waist circumference over 6-12 months.
In data from 34 trials, behavior counseling resulted in significant changes to several CVD risk factors, with average improvements of –1.26 mm Hg for systolic blood pressure, –0.49 mm Hg for diastolic blood pressure, –2.85 mg/dL for total cholesterol, –0.41 kg/m2 for body mass index, –1.04 kg for weight, and –0.19 cm for waist circumference.
The current recommendation updates the 2012 recommendations that primary care clinicians “selectively provide or refer patients who do not have hypertension, dyslipidemia, diabetes, or CVD to behavioral counseling to promote a healthful diet and physical activity rather than incorporating counseling into the routine care of adults.”
Separate USPSTF recommendations focus on behavioral counseling in adults with risk factors including obesity, abnormal blood glucose levels, diabetes, or CVD, therefore, the current recommendation “focuses on persons without these risk factors,” the researchers noted.
In the evidence report accompanying the recommendations, Carrie D. Patnode, PhD, of Kaiser Permanente in Portland, Ore., and her colleagues concluded that higher-intensity interventions may promote greater improvements in health outcomes, but that “there is very limited evidence on longer-term intermediate and health outcomes or on harmful effects of these interventions” (JAMA 2017;318:175-93. doi: 10.1001/jama.2017.3303).
The researchers had no financial conflicts to disclose.
“The evidence is strong, consistent, and persuasive that CVD risk factor prevention and treatment are associated with lower rates of CVD,” wrote Philip Greenland, MD, and Valentin Fuster, MD, PhD, in an accompanying editorial (JAMA 2017 Jul 11;318:130-1). “There are no universally effective solutions to accomplish this, but certain principles apply. Recommended dietary patterns focus on meals high in vegetables, fruit, whole grains, seafood, legumes, and nuts; moderate in low-fat and nonfat dairy products; lower in red and processed meat, foods and beverages containing added sugar, and refined grains,” they said. In addition, “physical activity must be encouraged in children and adults and emphasize a regular and consistent commitment to daily exercise habits. Research findings support the need to begin interventions in preschool children, [and should] involve the family, and continue lifelong,” they noted.
Although the guidelines address the challenges faced by clinicians in controlling CVD risk factors, “risk factor control in the clinical setting begins with risk assessment, aims at targeting all risk factors above ideal levels, and moves patients in measured steps toward more ideal cardiovascular health,” the editorialists said.
Dr. Greenland is affiliated with the department of preventive medicine at Northwestern University, Chicago. Dr. Fuster is director of the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, N.Y. They had no financial conflicts to disclose.
“The evidence is strong, consistent, and persuasive that CVD risk factor prevention and treatment are associated with lower rates of CVD,” wrote Philip Greenland, MD, and Valentin Fuster, MD, PhD, in an accompanying editorial (JAMA 2017 Jul 11;318:130-1). “There are no universally effective solutions to accomplish this, but certain principles apply. Recommended dietary patterns focus on meals high in vegetables, fruit, whole grains, seafood, legumes, and nuts; moderate in low-fat and nonfat dairy products; lower in red and processed meat, foods and beverages containing added sugar, and refined grains,” they said. In addition, “physical activity must be encouraged in children and adults and emphasize a regular and consistent commitment to daily exercise habits. Research findings support the need to begin interventions in preschool children, [and should] involve the family, and continue lifelong,” they noted.
Although the guidelines address the challenges faced by clinicians in controlling CVD risk factors, “risk factor control in the clinical setting begins with risk assessment, aims at targeting all risk factors above ideal levels, and moves patients in measured steps toward more ideal cardiovascular health,” the editorialists said.
Dr. Greenland is affiliated with the department of preventive medicine at Northwestern University, Chicago. Dr. Fuster is director of the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, N.Y. They had no financial conflicts to disclose.
“The evidence is strong, consistent, and persuasive that CVD risk factor prevention and treatment are associated with lower rates of CVD,” wrote Philip Greenland, MD, and Valentin Fuster, MD, PhD, in an accompanying editorial (JAMA 2017 Jul 11;318:130-1). “There are no universally effective solutions to accomplish this, but certain principles apply. Recommended dietary patterns focus on meals high in vegetables, fruit, whole grains, seafood, legumes, and nuts; moderate in low-fat and nonfat dairy products; lower in red and processed meat, foods and beverages containing added sugar, and refined grains,” they said. In addition, “physical activity must be encouraged in children and adults and emphasize a regular and consistent commitment to daily exercise habits. Research findings support the need to begin interventions in preschool children, [and should] involve the family, and continue lifelong,” they noted.
Although the guidelines address the challenges faced by clinicians in controlling CVD risk factors, “risk factor control in the clinical setting begins with risk assessment, aims at targeting all risk factors above ideal levels, and moves patients in measured steps toward more ideal cardiovascular health,” the editorialists said.
Dr. Greenland is affiliated with the department of preventive medicine at Northwestern University, Chicago. Dr. Fuster is director of the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, N.Y. They had no financial conflicts to disclose.
Clinical judgment should drive referrals for diet and exercise behavioral counseling for adults with a low risk for cardiovascular disease (CVD), according to a new recommendation statement from the U.S. Preventive Services Task Force published online July 11 in JAMA.
“Persons who are interested and ready to make behavioral changes may be most likely to benefit from behavioral counseling,” according to the statement (JAMA 2017 Jul 11;318:167-74. doi: 10.1001/jama.2017.7171).
The recommendation is a C, which means that clinicians should consider patient preferences and clinical judgment, wrote David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, and his colleagues.
To assess the value of behavioral counseling in adults at low risk for cardiovascular disease, the USPSTF reviewed 88 trials including more than 120 interventions related to a healthful diet, physical activity, or both. None of the trials included in the review noted specific adverse events related to counseling.
Although the evidence was insufficient to support benefits from behavioral counseling for reducing death or CVD rates, the data showed that behavioral counseling was associated with improved systolic and diastolic blood pressure levels, cholesterol, body mass index, and waist circumference over 6-12 months.
In data from 34 trials, behavior counseling resulted in significant changes to several CVD risk factors, with average improvements of –1.26 mm Hg for systolic blood pressure, –0.49 mm Hg for diastolic blood pressure, –2.85 mg/dL for total cholesterol, –0.41 kg/m2 for body mass index, –1.04 kg for weight, and –0.19 cm for waist circumference.
The current recommendation updates the 2012 recommendations that primary care clinicians “selectively provide or refer patients who do not have hypertension, dyslipidemia, diabetes, or CVD to behavioral counseling to promote a healthful diet and physical activity rather than incorporating counseling into the routine care of adults.”
Separate USPSTF recommendations focus on behavioral counseling in adults with risk factors including obesity, abnormal blood glucose levels, diabetes, or CVD, therefore, the current recommendation “focuses on persons without these risk factors,” the researchers noted.
In the evidence report accompanying the recommendations, Carrie D. Patnode, PhD, of Kaiser Permanente in Portland, Ore., and her colleagues concluded that higher-intensity interventions may promote greater improvements in health outcomes, but that “there is very limited evidence on longer-term intermediate and health outcomes or on harmful effects of these interventions” (JAMA 2017;318:175-93. doi: 10.1001/jama.2017.3303).
The researchers had no financial conflicts to disclose.
Clinical judgment should drive referrals for diet and exercise behavioral counseling for adults with a low risk for cardiovascular disease (CVD), according to a new recommendation statement from the U.S. Preventive Services Task Force published online July 11 in JAMA.
“Persons who are interested and ready to make behavioral changes may be most likely to benefit from behavioral counseling,” according to the statement (JAMA 2017 Jul 11;318:167-74. doi: 10.1001/jama.2017.7171).
The recommendation is a C, which means that clinicians should consider patient preferences and clinical judgment, wrote David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, and his colleagues.
To assess the value of behavioral counseling in adults at low risk for cardiovascular disease, the USPSTF reviewed 88 trials including more than 120 interventions related to a healthful diet, physical activity, or both. None of the trials included in the review noted specific adverse events related to counseling.
Although the evidence was insufficient to support benefits from behavioral counseling for reducing death or CVD rates, the data showed that behavioral counseling was associated with improved systolic and diastolic blood pressure levels, cholesterol, body mass index, and waist circumference over 6-12 months.
In data from 34 trials, behavior counseling resulted in significant changes to several CVD risk factors, with average improvements of –1.26 mm Hg for systolic blood pressure, –0.49 mm Hg for diastolic blood pressure, –2.85 mg/dL for total cholesterol, –0.41 kg/m2 for body mass index, –1.04 kg for weight, and –0.19 cm for waist circumference.
The current recommendation updates the 2012 recommendations that primary care clinicians “selectively provide or refer patients who do not have hypertension, dyslipidemia, diabetes, or CVD to behavioral counseling to promote a healthful diet and physical activity rather than incorporating counseling into the routine care of adults.”
Separate USPSTF recommendations focus on behavioral counseling in adults with risk factors including obesity, abnormal blood glucose levels, diabetes, or CVD, therefore, the current recommendation “focuses on persons without these risk factors,” the researchers noted.
In the evidence report accompanying the recommendations, Carrie D. Patnode, PhD, of Kaiser Permanente in Portland, Ore., and her colleagues concluded that higher-intensity interventions may promote greater improvements in health outcomes, but that “there is very limited evidence on longer-term intermediate and health outcomes or on harmful effects of these interventions” (JAMA 2017;318:175-93. doi: 10.1001/jama.2017.3303).
The researchers had no financial conflicts to disclose.
FROM JAMA
Key clinical point: Even adults with no CVD risk factors benefit from behavioral counseling about diet and exercise, according to the USPSTF.
Major finding: In 34 trials involving intermediate outcomes, behavior counseling was associated with significant improvements in systolic blood pressure, diastolic blood pressure, total cholesterol, BMI, weight, and waist circumference.
Data source: The data come from a USPSTF review of 88 trials and more 120 interventions.
Disclosures: The researchers had no relevant financial conflicts to disclose.