An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.
Dr. Curt J Daniels
Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.
The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.
“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.
Better road map
The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.
“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”
The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.
Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.
“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.
More than just anatomy
Dr. Robert Jaquiss
In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.
A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.
Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.
“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”
For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.
Research directions
Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.
For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.
“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.
The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.
An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.
Dr. Curt J Daniels
Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.
The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.
“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.
Better road map
The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.
“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”
The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.
Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.
“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.
More than just anatomy
Dr. Robert Jaquiss
In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.
A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.
Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.
“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”
For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.
Research directions
Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.
For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.
“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.
The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.
An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.
Dr. Curt J Daniels
Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.
The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.
“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.
Better road map
The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.
“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”
The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.
Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.
“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.
More than just anatomy
Dr. Robert Jaquiss
In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.
A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.
Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.
“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”
For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.
Research directions
Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.
For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.
“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.
The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.
ORLANDO – Fractured hip patients managed according to enhanced recovery principles had substantially lower morbidity and mortality, compared with patients treated before the intervention, an investigator reported at the American College of Surgeons Quality and Safety Conference.
Courtesy Martin Allred
Lila Gottenbos
These patients had a lower pneumonia rate and were more often discharged to home from acute care after the program was implemented, according to Lila Gottenbos, RN, BSN, of Langley (B.C.) Memorial Hospital.
The intervention incorporated some traditional enhanced recovery after surgery (ERAS) process measures, along with others that were not so traditional, Ms. Gottenbos said. “Implementing ERAS in a fractured hip patient population is possible, and by doing so, more patients go home faster to their previous places of residence with fewer complications.”
A multidisciplinary team at Langley Memorial Hospital, a 200-bed community hospital with approximately 6,000 surgical procedures performed each year, has used ERAS measures in their colorectal patient population since 2013. Those measures have been successful in creating a sustained reduction in morbidity and length of stay, according to Ms. Gottenbos.
The team began searching for other patient populations who might also benefit. They chose to focus on the fractured hip population, which in 2015 had a 9.7% mortality rate, 17% morbidity rate, 5% pneumonia rate, and 19% rate of discharge to home from acute care. “We looked at this data and we realized we had a significant opportunity to do better for our patients,” Ms. Gottenbos told meeting attendees.
The team developed ERAS-based process measures tailored specifically to pre- and postoperative challenges in the fractured hip patient population, Ms. Gottenbos said. Measures included preoperative patient and family education, elimination of prolonged preoperative NPO status, early mobilization, assessment of mentation, and use of standardized order sets. The protocol has been applied to every hip fracture patient who has had surgery from January 2016 to the present. The hospital averages 110 of these procedures per year.
Fractured hip mortality dropped after the modified ERAS process measures were adopted, Ms. Gottenbos reported. Measured to 30 days postoperatively, mortality decreased from 9.7% in 2015 to 4.2% by 2017. Similarly, fractured hip morbidity within 30 days, excluding transfusion, dropped from 17.7% in 2015 to 11.7% in 2017, and fractured hip pneumonia dropped from 5.4% to 2.5%.
Perhaps the most telling evidence of success, according to the presenter, was the increase in the number of patients going home from acute care: “Before ERAS, fractured hip patients were going home to their place of residence less than 20% of the time from the acute care setting, meaning they were languishing in the hospital, in a convalescent unit, in a rehab unit, or worse, residential care,” she said. “We’ve been able to increase that to over 43%.”
The program is ongoing. A multidisciplinary team meets monthly to review outcomes data and devise strategies to improve compliance with the process measures. “It’s an iterative process, and it’s one that’s worked very well for us so far,” Ms. Gottenbos remarked.
ORLANDO – Fractured hip patients managed according to enhanced recovery principles had substantially lower morbidity and mortality, compared with patients treated before the intervention, an investigator reported at the American College of Surgeons Quality and Safety Conference.
Courtesy Martin Allred
Lila Gottenbos
These patients had a lower pneumonia rate and were more often discharged to home from acute care after the program was implemented, according to Lila Gottenbos, RN, BSN, of Langley (B.C.) Memorial Hospital.
The intervention incorporated some traditional enhanced recovery after surgery (ERAS) process measures, along with others that were not so traditional, Ms. Gottenbos said. “Implementing ERAS in a fractured hip patient population is possible, and by doing so, more patients go home faster to their previous places of residence with fewer complications.”
A multidisciplinary team at Langley Memorial Hospital, a 200-bed community hospital with approximately 6,000 surgical procedures performed each year, has used ERAS measures in their colorectal patient population since 2013. Those measures have been successful in creating a sustained reduction in morbidity and length of stay, according to Ms. Gottenbos.
The team began searching for other patient populations who might also benefit. They chose to focus on the fractured hip population, which in 2015 had a 9.7% mortality rate, 17% morbidity rate, 5% pneumonia rate, and 19% rate of discharge to home from acute care. “We looked at this data and we realized we had a significant opportunity to do better for our patients,” Ms. Gottenbos told meeting attendees.
The team developed ERAS-based process measures tailored specifically to pre- and postoperative challenges in the fractured hip patient population, Ms. Gottenbos said. Measures included preoperative patient and family education, elimination of prolonged preoperative NPO status, early mobilization, assessment of mentation, and use of standardized order sets. The protocol has been applied to every hip fracture patient who has had surgery from January 2016 to the present. The hospital averages 110 of these procedures per year.
Fractured hip mortality dropped after the modified ERAS process measures were adopted, Ms. Gottenbos reported. Measured to 30 days postoperatively, mortality decreased from 9.7% in 2015 to 4.2% by 2017. Similarly, fractured hip morbidity within 30 days, excluding transfusion, dropped from 17.7% in 2015 to 11.7% in 2017, and fractured hip pneumonia dropped from 5.4% to 2.5%.
Perhaps the most telling evidence of success, according to the presenter, was the increase in the number of patients going home from acute care: “Before ERAS, fractured hip patients were going home to their place of residence less than 20% of the time from the acute care setting, meaning they were languishing in the hospital, in a convalescent unit, in a rehab unit, or worse, residential care,” she said. “We’ve been able to increase that to over 43%.”
The program is ongoing. A multidisciplinary team meets monthly to review outcomes data and devise strategies to improve compliance with the process measures. “It’s an iterative process, and it’s one that’s worked very well for us so far,” Ms. Gottenbos remarked.
The investigator had no disclosures.
ORLANDO – Fractured hip patients managed according to enhanced recovery principles had substantially lower morbidity and mortality, compared with patients treated before the intervention, an investigator reported at the American College of Surgeons Quality and Safety Conference.
Courtesy Martin Allred
Lila Gottenbos
These patients had a lower pneumonia rate and were more often discharged to home from acute care after the program was implemented, according to Lila Gottenbos, RN, BSN, of Langley (B.C.) Memorial Hospital.
The intervention incorporated some traditional enhanced recovery after surgery (ERAS) process measures, along with others that were not so traditional, Ms. Gottenbos said. “Implementing ERAS in a fractured hip patient population is possible, and by doing so, more patients go home faster to their previous places of residence with fewer complications.”
A multidisciplinary team at Langley Memorial Hospital, a 200-bed community hospital with approximately 6,000 surgical procedures performed each year, has used ERAS measures in their colorectal patient population since 2013. Those measures have been successful in creating a sustained reduction in morbidity and length of stay, according to Ms. Gottenbos.
The team began searching for other patient populations who might also benefit. They chose to focus on the fractured hip population, which in 2015 had a 9.7% mortality rate, 17% morbidity rate, 5% pneumonia rate, and 19% rate of discharge to home from acute care. “We looked at this data and we realized we had a significant opportunity to do better for our patients,” Ms. Gottenbos told meeting attendees.
The team developed ERAS-based process measures tailored specifically to pre- and postoperative challenges in the fractured hip patient population, Ms. Gottenbos said. Measures included preoperative patient and family education, elimination of prolonged preoperative NPO status, early mobilization, assessment of mentation, and use of standardized order sets. The protocol has been applied to every hip fracture patient who has had surgery from January 2016 to the present. The hospital averages 110 of these procedures per year.
Fractured hip mortality dropped after the modified ERAS process measures were adopted, Ms. Gottenbos reported. Measured to 30 days postoperatively, mortality decreased from 9.7% in 2015 to 4.2% by 2017. Similarly, fractured hip morbidity within 30 days, excluding transfusion, dropped from 17.7% in 2015 to 11.7% in 2017, and fractured hip pneumonia dropped from 5.4% to 2.5%.
Perhaps the most telling evidence of success, according to the presenter, was the increase in the number of patients going home from acute care: “Before ERAS, fractured hip patients were going home to their place of residence less than 20% of the time from the acute care setting, meaning they were languishing in the hospital, in a convalescent unit, in a rehab unit, or worse, residential care,” she said. “We’ve been able to increase that to over 43%.”
The program is ongoing. A multidisciplinary team meets monthly to review outcomes data and devise strategies to improve compliance with the process measures. “It’s an iterative process, and it’s one that’s worked very well for us so far,” Ms. Gottenbos remarked.
Key clinical point: Fractured hip patients managed with the ERAS protocol had improved outcomes.
Major finding: After implementation of the ERAS protocol, 43% of fractured hip patients were discharged to home, which is up from 20% before the project.
Study details: More than 200 patients treated for hip fracture during 2016-2017 at the Langley (B.C.) Memorial Hospital.
Disclosures: The investigator had no disclosures. .
Disqus Comments
Default
Consolidated Pubs: Do Not Show Source Publication Logo
ORLANDO – In patients with resectable hepatobiliary malignancies, percutaneous biliary drainage was associated with an increased risk of death or serious morbidity versus endoscopic drainage, results of a recent retrospective study show.
decade3d/thinkstockphotos.com
Patients undergoing percutaneous transhepatic biliary drainage did have more preoperative comorbidities, compared with those undergoing endoscopic biliary stenting, according researcher Q. Lina Hu, MD, an American College of Surgeons Clinical Scholar-in-Residence.
“Nevertheless, compared to endoscopic drainage, percutaneous drainage was associated with a significantly increased morbidity and mortality, even after adjustment for measured confounders,” Dr. Hu said a presentation at the American College of Surgeons Quality and Safety Conference.
Patients with resectable hepatobiliary malignancies often present with biliary obstruction, which may increase risk of perioperative morbidity and mortality, said Dr. Hu, a general surgery resident at University of California, Los Angeles.
“Preoperative biliary drainage is thought to reduce this risk by resolving cholestasis and preserving liver function,” she said.
However, the preferred drainage technique is not established, she added.
The endoscopic approach approximates normal physiologic drainage, she said, but is associated with complications including pancreatitis and cholangitis. By contrast, percutaneous drainage has a lower contamination risk and higher rate of success, but involves external catheters and has catheter-related complications.
To evaluate associations between preoperative drainage technique and postoperative outcomes, Dr. Hu and her colleagues queried the ACS National Surgical Quality Improvement Program (NSQIP) Procedure-Targeted Hepatectomy Database. They identified 527 patients who underwent preoperative biliary drainage prior to resection between 2014 and 2017, of whom about 80% underwent endoscopic drainage and 20% underwent percutaneous drainage. The primary outcome of their analysis was 30-day death or serious morbidity.
Patients who were selected for percutaneous drainage had significantly more preoperative comorbidities, including higher American Society of Anesthesiologists class, recent weight loss, and lower albumin levels, Dr. Hu said.
Death or serious morbidity occurred in 250 of the patients, or approximately 48% of the cohort.
In unadjusted analysis, the incidence of death or serious morbidity was significantly more frequent in the percutaneous group, compared with endoscopic group. The percutaneous group also had greater odds of surgical site infection, liver failure, bile leakage, and prolonged length of stay.
Those associations remained significant for death or serious morbidity and surgical site infection in both multivariable– and propensity score–adjusted models, Dr. Hu said.
In a propensity score–matched model, 93 patients who received percutaneous drainage were matched one-to-one to 93 patients who received endoscopic drainage based on relevant baseline characteristics. In that rigorous analysis, the odds ratio for death or serious morbidity was 2.17 (95% confidence interval, 1.16-4.09), according to the report.
“Death and serious morbidity was significantly associated with percutaneous drainage across all models, suggesting that patients receiving percutaneous drainage were more likely to experience an adverse event, compared to patients receiving endoscopic drainage,” Dr. Hu said.
However, Dr. Hu acknowledged the limitations of the retrospective study, noting that propensity score adjustment and matching accounts for measured confounders. “It obviously cannot account for any unmeasured confounders,” she said.
Dr. Hu reported funding from the Agency for Healthcare Research and Quality related to her position. She had no disclosures related to her presentation.
ORLANDO – In patients with resectable hepatobiliary malignancies, percutaneous biliary drainage was associated with an increased risk of death or serious morbidity versus endoscopic drainage, results of a recent retrospective study show.
decade3d/thinkstockphotos.com
Patients undergoing percutaneous transhepatic biliary drainage did have more preoperative comorbidities, compared with those undergoing endoscopic biliary stenting, according researcher Q. Lina Hu, MD, an American College of Surgeons Clinical Scholar-in-Residence.
“Nevertheless, compared to endoscopic drainage, percutaneous drainage was associated with a significantly increased morbidity and mortality, even after adjustment for measured confounders,” Dr. Hu said a presentation at the American College of Surgeons Quality and Safety Conference.
Patients with resectable hepatobiliary malignancies often present with biliary obstruction, which may increase risk of perioperative morbidity and mortality, said Dr. Hu, a general surgery resident at University of California, Los Angeles.
“Preoperative biliary drainage is thought to reduce this risk by resolving cholestasis and preserving liver function,” she said.
However, the preferred drainage technique is not established, she added.
The endoscopic approach approximates normal physiologic drainage, she said, but is associated with complications including pancreatitis and cholangitis. By contrast, percutaneous drainage has a lower contamination risk and higher rate of success, but involves external catheters and has catheter-related complications.
To evaluate associations between preoperative drainage technique and postoperative outcomes, Dr. Hu and her colleagues queried the ACS National Surgical Quality Improvement Program (NSQIP) Procedure-Targeted Hepatectomy Database. They identified 527 patients who underwent preoperative biliary drainage prior to resection between 2014 and 2017, of whom about 80% underwent endoscopic drainage and 20% underwent percutaneous drainage. The primary outcome of their analysis was 30-day death or serious morbidity.
Patients who were selected for percutaneous drainage had significantly more preoperative comorbidities, including higher American Society of Anesthesiologists class, recent weight loss, and lower albumin levels, Dr. Hu said.
Death or serious morbidity occurred in 250 of the patients, or approximately 48% of the cohort.
In unadjusted analysis, the incidence of death or serious morbidity was significantly more frequent in the percutaneous group, compared with endoscopic group. The percutaneous group also had greater odds of surgical site infection, liver failure, bile leakage, and prolonged length of stay.
Those associations remained significant for death or serious morbidity and surgical site infection in both multivariable– and propensity score–adjusted models, Dr. Hu said.
In a propensity score–matched model, 93 patients who received percutaneous drainage were matched one-to-one to 93 patients who received endoscopic drainage based on relevant baseline characteristics. In that rigorous analysis, the odds ratio for death or serious morbidity was 2.17 (95% confidence interval, 1.16-4.09), according to the report.
“Death and serious morbidity was significantly associated with percutaneous drainage across all models, suggesting that patients receiving percutaneous drainage were more likely to experience an adverse event, compared to patients receiving endoscopic drainage,” Dr. Hu said.
However, Dr. Hu acknowledged the limitations of the retrospective study, noting that propensity score adjustment and matching accounts for measured confounders. “It obviously cannot account for any unmeasured confounders,” she said.
Dr. Hu reported funding from the Agency for Healthcare Research and Quality related to her position. She had no disclosures related to her presentation.
ORLANDO – In patients with resectable hepatobiliary malignancies, percutaneous biliary drainage was associated with an increased risk of death or serious morbidity versus endoscopic drainage, results of a recent retrospective study show.
decade3d/thinkstockphotos.com
Patients undergoing percutaneous transhepatic biliary drainage did have more preoperative comorbidities, compared with those undergoing endoscopic biliary stenting, according researcher Q. Lina Hu, MD, an American College of Surgeons Clinical Scholar-in-Residence.
“Nevertheless, compared to endoscopic drainage, percutaneous drainage was associated with a significantly increased morbidity and mortality, even after adjustment for measured confounders,” Dr. Hu said a presentation at the American College of Surgeons Quality and Safety Conference.
Patients with resectable hepatobiliary malignancies often present with biliary obstruction, which may increase risk of perioperative morbidity and mortality, said Dr. Hu, a general surgery resident at University of California, Los Angeles.
“Preoperative biliary drainage is thought to reduce this risk by resolving cholestasis and preserving liver function,” she said.
However, the preferred drainage technique is not established, she added.
The endoscopic approach approximates normal physiologic drainage, she said, but is associated with complications including pancreatitis and cholangitis. By contrast, percutaneous drainage has a lower contamination risk and higher rate of success, but involves external catheters and has catheter-related complications.
To evaluate associations between preoperative drainage technique and postoperative outcomes, Dr. Hu and her colleagues queried the ACS National Surgical Quality Improvement Program (NSQIP) Procedure-Targeted Hepatectomy Database. They identified 527 patients who underwent preoperative biliary drainage prior to resection between 2014 and 2017, of whom about 80% underwent endoscopic drainage and 20% underwent percutaneous drainage. The primary outcome of their analysis was 30-day death or serious morbidity.
Patients who were selected for percutaneous drainage had significantly more preoperative comorbidities, including higher American Society of Anesthesiologists class, recent weight loss, and lower albumin levels, Dr. Hu said.
Death or serious morbidity occurred in 250 of the patients, or approximately 48% of the cohort.
In unadjusted analysis, the incidence of death or serious morbidity was significantly more frequent in the percutaneous group, compared with endoscopic group. The percutaneous group also had greater odds of surgical site infection, liver failure, bile leakage, and prolonged length of stay.
Those associations remained significant for death or serious morbidity and surgical site infection in both multivariable– and propensity score–adjusted models, Dr. Hu said.
In a propensity score–matched model, 93 patients who received percutaneous drainage were matched one-to-one to 93 patients who received endoscopic drainage based on relevant baseline characteristics. In that rigorous analysis, the odds ratio for death or serious morbidity was 2.17 (95% confidence interval, 1.16-4.09), according to the report.
“Death and serious morbidity was significantly associated with percutaneous drainage across all models, suggesting that patients receiving percutaneous drainage were more likely to experience an adverse event, compared to patients receiving endoscopic drainage,” Dr. Hu said.
However, Dr. Hu acknowledged the limitations of the retrospective study, noting that propensity score adjustment and matching accounts for measured confounders. “It obviously cannot account for any unmeasured confounders,” she said.
Dr. Hu reported funding from the Agency for Healthcare Research and Quality related to her position. She had no disclosures related to her presentation.
Key clinical point: Percutaneous biliary drainage for resectable hepatobiliary cancer was associated with an increased risk of death or serious morbidity, compared with endoscopic drainage.
Major finding: For patients having percutaneous biliary drainage, the odds ratio for death or serious morbidity was 2.17 (95% confidence interval, 1.16-4.09).
Study details: Cohort of 327 patients in the ACS NSQIP database who underwent preoperative biliary drainage.
Disclosures: The investigators had no disclosures.
Disqus Comments
Default
Consolidated Pubs: Do Not Show Source Publication Logo
Orlando – Clinical N2 disease may be a negative predictor of pathological complete response (PCR) after neoadjuvant chemoradiotherapy for rectal cancer, an analysis of a large, multicenter database has suggested.
jacoblund/Thinkstock
In multivariate regression, pretreatment N2 stage was the only variable significantly associated with failure of achieving pathologic complete response, according to Ebram Salama, MD, of Sir Mortimer B. Davis Jewish General Hospital at McGill University, Montreal.
“We should be reconsidering putting these patients in watch-and-wait protocols,” Dr. Salama said in an oral abstract presentation at the American College of Surgeons Quality and Safety Conference.
The analysis included 369 elective cases of cT2-4 N0-2 rectal cancer that were treated with neoadjuvant chemoradiotherapy during 2016 from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) proctectomy-specific database.
Of those cases, 53 (14.4%) achieved PCR, a proportion consistent with what has been reported previously in medical literature, Dr. Salama noted during his presentation.
The multivariate analysis revealed that pretreatment N2 stage was a negative predictor of PCR with an odds ratio of 0.18 (95% confidence interval, 0.04-0.82; P = .026), according to presented data.
By contrast, Dr. Salama said, there were no significant associations between response and other variables, including pretreatment N1 stage, pretreatment T stage, tumor location, gender, or body mass index.
Dr. Salama acknowledged limitations of this retrospective study, including a lack of data on other variables of interest, such as carcinoembryonic antigen, tumor size, imaging characteristics, molecular markers, and the time interval between chemoradiotherapy and surgery.
“We obviously need more data to evaluate other predictive factors in achieving a complete pathological response,” he said, adding that it’s also unclear whether the results of the present study could be generalized to institutions not participating in ACS NSQIP.
Dr. Salama presented the research on behalf of Nathalie Wong-Chong, MD, also of McGill University. He had no conflicts of interest to report for his presentation.
Orlando – Clinical N2 disease may be a negative predictor of pathological complete response (PCR) after neoadjuvant chemoradiotherapy for rectal cancer, an analysis of a large, multicenter database has suggested.
jacoblund/Thinkstock
In multivariate regression, pretreatment N2 stage was the only variable significantly associated with failure of achieving pathologic complete response, according to Ebram Salama, MD, of Sir Mortimer B. Davis Jewish General Hospital at McGill University, Montreal.
“We should be reconsidering putting these patients in watch-and-wait protocols,” Dr. Salama said in an oral abstract presentation at the American College of Surgeons Quality and Safety Conference.
The analysis included 369 elective cases of cT2-4 N0-2 rectal cancer that were treated with neoadjuvant chemoradiotherapy during 2016 from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) proctectomy-specific database.
Of those cases, 53 (14.4%) achieved PCR, a proportion consistent with what has been reported previously in medical literature, Dr. Salama noted during his presentation.
The multivariate analysis revealed that pretreatment N2 stage was a negative predictor of PCR with an odds ratio of 0.18 (95% confidence interval, 0.04-0.82; P = .026), according to presented data.
By contrast, Dr. Salama said, there were no significant associations between response and other variables, including pretreatment N1 stage, pretreatment T stage, tumor location, gender, or body mass index.
Dr. Salama acknowledged limitations of this retrospective study, including a lack of data on other variables of interest, such as carcinoembryonic antigen, tumor size, imaging characteristics, molecular markers, and the time interval between chemoradiotherapy and surgery.
“We obviously need more data to evaluate other predictive factors in achieving a complete pathological response,” he said, adding that it’s also unclear whether the results of the present study could be generalized to institutions not participating in ACS NSQIP.
Dr. Salama presented the research on behalf of Nathalie Wong-Chong, MD, also of McGill University. He had no conflicts of interest to report for his presentation.
Orlando – Clinical N2 disease may be a negative predictor of pathological complete response (PCR) after neoadjuvant chemoradiotherapy for rectal cancer, an analysis of a large, multicenter database has suggested.
jacoblund/Thinkstock
In multivariate regression, pretreatment N2 stage was the only variable significantly associated with failure of achieving pathologic complete response, according to Ebram Salama, MD, of Sir Mortimer B. Davis Jewish General Hospital at McGill University, Montreal.
“We should be reconsidering putting these patients in watch-and-wait protocols,” Dr. Salama said in an oral abstract presentation at the American College of Surgeons Quality and Safety Conference.
The analysis included 369 elective cases of cT2-4 N0-2 rectal cancer that were treated with neoadjuvant chemoradiotherapy during 2016 from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) proctectomy-specific database.
Of those cases, 53 (14.4%) achieved PCR, a proportion consistent with what has been reported previously in medical literature, Dr. Salama noted during his presentation.
The multivariate analysis revealed that pretreatment N2 stage was a negative predictor of PCR with an odds ratio of 0.18 (95% confidence interval, 0.04-0.82; P = .026), according to presented data.
By contrast, Dr. Salama said, there were no significant associations between response and other variables, including pretreatment N1 stage, pretreatment T stage, tumor location, gender, or body mass index.
Dr. Salama acknowledged limitations of this retrospective study, including a lack of data on other variables of interest, such as carcinoembryonic antigen, tumor size, imaging characteristics, molecular markers, and the time interval between chemoradiotherapy and surgery.
“We obviously need more data to evaluate other predictive factors in achieving a complete pathological response,” he said, adding that it’s also unclear whether the results of the present study could be generalized to institutions not participating in ACS NSQIP.
Dr. Salama presented the research on behalf of Nathalie Wong-Chong, MD, also of McGill University. He had no conflicts of interest to report for his presentation.
Key clinical point: N2 disease may be a negative predictor of pathological complete response after neoadjuvant chemoradiotherapy for rectal cancer.
Major finding: Pretreatment N2 stage was a negative predictor of complete pathological response, with an odds ratio of 0.18 (95% confidence interval, 0.04-0.82; P = .026).
Study details: A study of 369 elective cases of cT2-4 N0-2 rectal cancer treated with neoadjuvant chemoradiotherapy from 2016 in the ACS NSQIP proctectomy-specific database.
Disclosures: Dr. Salama had no conflicts of interest to report for his presentation.
Disqus Comments
Default
Consolidated Pubs: Do Not Show Source Publication Logo
The number of U.S. emergency department visits for acute pancreatitis associated with alcohol abuse, chronic pancreatitis history, and younger age was on the rise in recent years, an analysis of a nationally representative database has suggested.
Katarzyna Bialasiewicz/Thinkstock
Meanwhile, hospital admissions and length of stay dropped, but ED and inpatient charges increased, according to the analysis by Sushil K. Garg, MD, of the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn., and his coauthors.
“This study identifies important patient populations, specifically young patients with alcohol abuse, to target in order to develop programs to assist in reduction of ED utilization for acute pancreatitis,” Dr. Garg and his colleagues reported in the Journal of Clinical Gastroenterology.
The retrospective analysis was focused on nearly 2.2 million ED visits during 2006-2012 in the National Emergency Department Sample (NEDS) database. The cohort was limited to adults at least 18 years of age with a primary diagnosis of acute pancreatitis.
Overall, there was a nonsignificant 5.5% increase in visits per 10,000 U.S. population during 2006-2012, the researchers found. However, the total number of ED visits in this sample increased significantly – from 292,902 in 2006 to a peak of 326,376, an average rate of increase of 7,213 visits per year (P = .0086), according to the report.
Younger patients had a significant increase in the number of pancreatitis-related ED visits over the study period, while older patients had a significant decrease, according to investigators. Visits were up 9.2% for patients aged 18-44 years and 8.6% for those aged 45-64 but down 13.4% for patients aged 65-84 years and 20.1% for those aged 85 years or older.
The incidence of visits secondary to biliary disease was virtually flat over time, Dr. Garg and his coinvestigators found when looking at visits grouped by the most common presenting etiologies. By contrast, there were significant increases in visits for acute pancreatitis associated with alcohol abuse or chronic pancreatitis.
Specifically, acute pancreatitis associated with biliary disease averaged 20.7% of yearly pancreatitis-related ED visits and did not significantly change over time, the researchers reported.
By contrast, acute pancreatitis associated with alcohol abuse, which accounted for 24.1% of visits on average, increased by 15.9% over the study period, an increase driven by an increase among age groups younger than 65 years.
Acute pancreatitis associated with chronic pancreatitis, which made up 11.5% of visits on average, increased “substantially” in all age groups, according to study authors, with the largest increase in the group aged 45-64 years. Overall, the percentage increase over 7 years was 59.5%.
Rates of hospitalization decreased significantly over time, from 76.2% in 2006 to 72.7% in 2012 (P = .0026), and likewise, the length of stay dropped from 5.36 to 4.64 days (P = .0001), according to the analysis.
Inpatient charges, adjusted for inflation and expressed in 2012 dollars, increased from $32,130.63 to $34,652.00 (P = .0011), an average rate of increase of $489/year.
Predictors of hospitalization included age older than 84 years, alcohol use, smoking, and a Charlson comorbidity score of 1 or greater, according to the results of a multivariate regression analysis.
“Factors which may place patients at higher risk for severe or complicated acute pancreatitis requiring admission, such as obesity, alcohol use, and increasing age, are identified and should be explored in further studies and potentially targeted to improve ED and inpatient care,” Dr. Garg and his coauthors said.
Dr. Garg and his coauthors had no disclosures related to the study.
The number of U.S. emergency department visits for acute pancreatitis associated with alcohol abuse, chronic pancreatitis history, and younger age was on the rise in recent years, an analysis of a nationally representative database has suggested.
Katarzyna Bialasiewicz/Thinkstock
Meanwhile, hospital admissions and length of stay dropped, but ED and inpatient charges increased, according to the analysis by Sushil K. Garg, MD, of the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn., and his coauthors.
“This study identifies important patient populations, specifically young patients with alcohol abuse, to target in order to develop programs to assist in reduction of ED utilization for acute pancreatitis,” Dr. Garg and his colleagues reported in the Journal of Clinical Gastroenterology.
The retrospective analysis was focused on nearly 2.2 million ED visits during 2006-2012 in the National Emergency Department Sample (NEDS) database. The cohort was limited to adults at least 18 years of age with a primary diagnosis of acute pancreatitis.
Overall, there was a nonsignificant 5.5% increase in visits per 10,000 U.S. population during 2006-2012, the researchers found. However, the total number of ED visits in this sample increased significantly – from 292,902 in 2006 to a peak of 326,376, an average rate of increase of 7,213 visits per year (P = .0086), according to the report.
Younger patients had a significant increase in the number of pancreatitis-related ED visits over the study period, while older patients had a significant decrease, according to investigators. Visits were up 9.2% for patients aged 18-44 years and 8.6% for those aged 45-64 but down 13.4% for patients aged 65-84 years and 20.1% for those aged 85 years or older.
The incidence of visits secondary to biliary disease was virtually flat over time, Dr. Garg and his coinvestigators found when looking at visits grouped by the most common presenting etiologies. By contrast, there were significant increases in visits for acute pancreatitis associated with alcohol abuse or chronic pancreatitis.
Specifically, acute pancreatitis associated with biliary disease averaged 20.7% of yearly pancreatitis-related ED visits and did not significantly change over time, the researchers reported.
By contrast, acute pancreatitis associated with alcohol abuse, which accounted for 24.1% of visits on average, increased by 15.9% over the study period, an increase driven by an increase among age groups younger than 65 years.
Acute pancreatitis associated with chronic pancreatitis, which made up 11.5% of visits on average, increased “substantially” in all age groups, according to study authors, with the largest increase in the group aged 45-64 years. Overall, the percentage increase over 7 years was 59.5%.
Rates of hospitalization decreased significantly over time, from 76.2% in 2006 to 72.7% in 2012 (P = .0026), and likewise, the length of stay dropped from 5.36 to 4.64 days (P = .0001), according to the analysis.
Inpatient charges, adjusted for inflation and expressed in 2012 dollars, increased from $32,130.63 to $34,652.00 (P = .0011), an average rate of increase of $489/year.
Predictors of hospitalization included age older than 84 years, alcohol use, smoking, and a Charlson comorbidity score of 1 or greater, according to the results of a multivariate regression analysis.
“Factors which may place patients at higher risk for severe or complicated acute pancreatitis requiring admission, such as obesity, alcohol use, and increasing age, are identified and should be explored in further studies and potentially targeted to improve ED and inpatient care,” Dr. Garg and his coauthors said.
Dr. Garg and his coauthors had no disclosures related to the study.
The number of U.S. emergency department visits for acute pancreatitis associated with alcohol abuse, chronic pancreatitis history, and younger age was on the rise in recent years, an analysis of a nationally representative database has suggested.
Katarzyna Bialasiewicz/Thinkstock
Meanwhile, hospital admissions and length of stay dropped, but ED and inpatient charges increased, according to the analysis by Sushil K. Garg, MD, of the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn., and his coauthors.
“This study identifies important patient populations, specifically young patients with alcohol abuse, to target in order to develop programs to assist in reduction of ED utilization for acute pancreatitis,” Dr. Garg and his colleagues reported in the Journal of Clinical Gastroenterology.
The retrospective analysis was focused on nearly 2.2 million ED visits during 2006-2012 in the National Emergency Department Sample (NEDS) database. The cohort was limited to adults at least 18 years of age with a primary diagnosis of acute pancreatitis.
Overall, there was a nonsignificant 5.5% increase in visits per 10,000 U.S. population during 2006-2012, the researchers found. However, the total number of ED visits in this sample increased significantly – from 292,902 in 2006 to a peak of 326,376, an average rate of increase of 7,213 visits per year (P = .0086), according to the report.
Younger patients had a significant increase in the number of pancreatitis-related ED visits over the study period, while older patients had a significant decrease, according to investigators. Visits were up 9.2% for patients aged 18-44 years and 8.6% for those aged 45-64 but down 13.4% for patients aged 65-84 years and 20.1% for those aged 85 years or older.
The incidence of visits secondary to biliary disease was virtually flat over time, Dr. Garg and his coinvestigators found when looking at visits grouped by the most common presenting etiologies. By contrast, there were significant increases in visits for acute pancreatitis associated with alcohol abuse or chronic pancreatitis.
Specifically, acute pancreatitis associated with biliary disease averaged 20.7% of yearly pancreatitis-related ED visits and did not significantly change over time, the researchers reported.
By contrast, acute pancreatitis associated with alcohol abuse, which accounted for 24.1% of visits on average, increased by 15.9% over the study period, an increase driven by an increase among age groups younger than 65 years.
Acute pancreatitis associated with chronic pancreatitis, which made up 11.5% of visits on average, increased “substantially” in all age groups, according to study authors, with the largest increase in the group aged 45-64 years. Overall, the percentage increase over 7 years was 59.5%.
Rates of hospitalization decreased significantly over time, from 76.2% in 2006 to 72.7% in 2012 (P = .0026), and likewise, the length of stay dropped from 5.36 to 4.64 days (P = .0001), according to the analysis.
Inpatient charges, adjusted for inflation and expressed in 2012 dollars, increased from $32,130.63 to $34,652.00 (P = .0011), an average rate of increase of $489/year.
Predictors of hospitalization included age older than 84 years, alcohol use, smoking, and a Charlson comorbidity score of 1 or greater, according to the results of a multivariate regression analysis.
“Factors which may place patients at higher risk for severe or complicated acute pancreatitis requiring admission, such as obesity, alcohol use, and increasing age, are identified and should be explored in further studies and potentially targeted to improve ED and inpatient care,” Dr. Garg and his coauthors said.
Dr. Garg and his coauthors had no disclosures related to the study.
Key clinical point: The number of U.S. emergency visits for acute pancreatitis associated with alcohol abuse, chronic pancreatitis, and younger age has risen in recent years.
Major finding: From 2006 to 2012, visits were up about 9% for patients under 65 years of age, 15.9% for acute pancreatitis associated with alcohol abuse, and 59.5% for acute on chronic pancreatitis.
Study details: Retrospective analysis of ED visits during 2006-2012 for nearly 2.2 million adults.
Disclosures: The authors had no disclosures.
Source: Garg SK et al. J Clin Gastroenterol. 2018 Apr 6. doi: 10.1097/MCG.0000000000001030.
Disqus Comments
Default
Consolidated Pubs: Do Not Show Source Publication Logo
ORLANDO – Widespread implementation of enhanced recovery protocols at the state level resulted in a significant reduction in length of stay and complications in patients undergoing elective colectomy, an analysis shows.
The benefits were particularly pronounced in the subset of patients undergoing laparoscopic colectomy in the retrospective analysis, which included data for treated at four institutions in the Virginia Surgical Quality Collaborative Workgroup.
While the benefits of enhanced recovery after surgery (ERAS) are well known, most of the published data has come from single-institution experiences, according to investigator Traci L. Hedrick, MD, FACS, of the University of Virginia, Charlottesville.
At the American College of Surgeons Quality and Safety Conference, Dr. Hedrick presented risk-adjusted National Surgical Quality Improvement Program (NSQIP) data for 2,971 consecutive procedures during 2012-2016 at the University of Virginia, Winchester Medical Center, Carilion Clinic, and Inova Fairfax.
“Institutions came and went from the collaborative during this time period, so we focused on those institutions that maintained in the collaborative throughout the entire study protocol,” Dr. Hedrick said in her presentation.
Of the 2,971 procedures, about half (1,460) were performed after implementation of enhanced recovery protocols. Laparoscopic and open procedures were analyzed separately due to a substantial shift toward laparoscopic procedures, mainly during the 2012-2014 period, Dr. Hedrick said.
Among laparoscopic cases, there was a significant 1-day reduction in median length of stay, dropping from 4 days for pre–enhanced recovery protocol cases to 3 days for post–enhanced recovery protocol cases, Dr. Hedrick reported.
Observed morbidity also dropped significantly from 14.8% to 8.9% for the pre– and post–enhanced recovery cases, and the readmission rate fell significantly from 13% to 8.8%.
For open cases, there was a significant 1-day drop in median length of stay, from 4 to 3 days, but no significant differences in observed morbidity or readmission rates, according to Dr. Hedrick.
“As more of the patients were done laparoscopically, that really selected out the more complicated patients that were undergoing open procedures,” she said.
The protocols implemented by institutions in the Virginia collaborative group were generally uniform in important tenants of enhanced recovery, such as opioid minimization and avoidance of fasting, but specific elements were left up to each institution to improve buy-in, according to Dr. Hedrick.
“A lot of our protocols are very similar, particularly with regards to the order set,” Dr. Hedrick explained, “[but] I really am a firm believer in not being very strict about exactly what to use, because it’s so dependent on preference at the local level.”
The Virginia Surgical Quality Collaborative Workgroup is one of 20 regional ACS NSQIP collaboratives with the objective of improving surgical outcomes through multi-institutional collaboration, Dr. Hedrick said.
Dr. Hedrick and her coinvestigators had no relevant disclosures to report.
ORLANDO – Widespread implementation of enhanced recovery protocols at the state level resulted in a significant reduction in length of stay and complications in patients undergoing elective colectomy, an analysis shows.
The benefits were particularly pronounced in the subset of patients undergoing laparoscopic colectomy in the retrospective analysis, which included data for treated at four institutions in the Virginia Surgical Quality Collaborative Workgroup.
While the benefits of enhanced recovery after surgery (ERAS) are well known, most of the published data has come from single-institution experiences, according to investigator Traci L. Hedrick, MD, FACS, of the University of Virginia, Charlottesville.
At the American College of Surgeons Quality and Safety Conference, Dr. Hedrick presented risk-adjusted National Surgical Quality Improvement Program (NSQIP) data for 2,971 consecutive procedures during 2012-2016 at the University of Virginia, Winchester Medical Center, Carilion Clinic, and Inova Fairfax.
“Institutions came and went from the collaborative during this time period, so we focused on those institutions that maintained in the collaborative throughout the entire study protocol,” Dr. Hedrick said in her presentation.
Of the 2,971 procedures, about half (1,460) were performed after implementation of enhanced recovery protocols. Laparoscopic and open procedures were analyzed separately due to a substantial shift toward laparoscopic procedures, mainly during the 2012-2014 period, Dr. Hedrick said.
Among laparoscopic cases, there was a significant 1-day reduction in median length of stay, dropping from 4 days for pre–enhanced recovery protocol cases to 3 days for post–enhanced recovery protocol cases, Dr. Hedrick reported.
Observed morbidity also dropped significantly from 14.8% to 8.9% for the pre– and post–enhanced recovery cases, and the readmission rate fell significantly from 13% to 8.8%.
For open cases, there was a significant 1-day drop in median length of stay, from 4 to 3 days, but no significant differences in observed morbidity or readmission rates, according to Dr. Hedrick.
“As more of the patients were done laparoscopically, that really selected out the more complicated patients that were undergoing open procedures,” she said.
The protocols implemented by institutions in the Virginia collaborative group were generally uniform in important tenants of enhanced recovery, such as opioid minimization and avoidance of fasting, but specific elements were left up to each institution to improve buy-in, according to Dr. Hedrick.
“A lot of our protocols are very similar, particularly with regards to the order set,” Dr. Hedrick explained, “[but] I really am a firm believer in not being very strict about exactly what to use, because it’s so dependent on preference at the local level.”
The Virginia Surgical Quality Collaborative Workgroup is one of 20 regional ACS NSQIP collaboratives with the objective of improving surgical outcomes through multi-institutional collaboration, Dr. Hedrick said.
Dr. Hedrick and her coinvestigators had no relevant disclosures to report.
ORLANDO – Widespread implementation of enhanced recovery protocols at the state level resulted in a significant reduction in length of stay and complications in patients undergoing elective colectomy, an analysis shows.
The benefits were particularly pronounced in the subset of patients undergoing laparoscopic colectomy in the retrospective analysis, which included data for treated at four institutions in the Virginia Surgical Quality Collaborative Workgroup.
While the benefits of enhanced recovery after surgery (ERAS) are well known, most of the published data has come from single-institution experiences, according to investigator Traci L. Hedrick, MD, FACS, of the University of Virginia, Charlottesville.
At the American College of Surgeons Quality and Safety Conference, Dr. Hedrick presented risk-adjusted National Surgical Quality Improvement Program (NSQIP) data for 2,971 consecutive procedures during 2012-2016 at the University of Virginia, Winchester Medical Center, Carilion Clinic, and Inova Fairfax.
“Institutions came and went from the collaborative during this time period, so we focused on those institutions that maintained in the collaborative throughout the entire study protocol,” Dr. Hedrick said in her presentation.
Of the 2,971 procedures, about half (1,460) were performed after implementation of enhanced recovery protocols. Laparoscopic and open procedures were analyzed separately due to a substantial shift toward laparoscopic procedures, mainly during the 2012-2014 period, Dr. Hedrick said.
Among laparoscopic cases, there was a significant 1-day reduction in median length of stay, dropping from 4 days for pre–enhanced recovery protocol cases to 3 days for post–enhanced recovery protocol cases, Dr. Hedrick reported.
Observed morbidity also dropped significantly from 14.8% to 8.9% for the pre– and post–enhanced recovery cases, and the readmission rate fell significantly from 13% to 8.8%.
For open cases, there was a significant 1-day drop in median length of stay, from 4 to 3 days, but no significant differences in observed morbidity or readmission rates, according to Dr. Hedrick.
“As more of the patients were done laparoscopically, that really selected out the more complicated patients that were undergoing open procedures,” she said.
The protocols implemented by institutions in the Virginia collaborative group were generally uniform in important tenants of enhanced recovery, such as opioid minimization and avoidance of fasting, but specific elements were left up to each institution to improve buy-in, according to Dr. Hedrick.
“A lot of our protocols are very similar, particularly with regards to the order set,” Dr. Hedrick explained, “[but] I really am a firm believer in not being very strict about exactly what to use, because it’s so dependent on preference at the local level.”
The Virginia Surgical Quality Collaborative Workgroup is one of 20 regional ACS NSQIP collaboratives with the objective of improving surgical outcomes through multi-institutional collaboration, Dr. Hedrick said.
Dr. Hedrick and her coinvestigators had no relevant disclosures to report.
ORLANDO – The inferior outcomes associated with right-sided colon cancers might be mitigated if a higher lymph node harvest is obtained, a retrospective study suggested.
jacoblund/Thinkstock
Among patients with right-sided cancers, the rate of survival improved when 22 or more lymph nodes were harvested during operations, according to the study results presented at the American College of Surgeons Quality and Safety Conference.
“These data may provide indirect evidence for complete mesocolic excision to obtain a higher lymph node harvest to improve survival,” said investigator Arman Erkan, MD, of the Center for Colon and Rectal Surgery at Florida Hospital Orlando, in an oral abstract presentation.
This study adds new perspective on recent studies that have also demonstrated worse outcomes for right-sided versus left-sided tumors, which may be related to differences in levels of vascular ligation and nodal harvest. In addition, many studies to date have been limited in their ability to evaluate that hypothesis because of small sample size or other factors, he said in his presentation.
Accordingly, Dr. Erkan and his colleagues queried the National Cancer Database for colectomies for nonmetastatic colon adenocarcinoma occurring between 2004 and 2014, evaluating a total of 504,958 patient records, of which 273,198 were for right-sided tumors. To minimize bias, they used propensity score matching, leaving 148,540 patients in each group for the primary analysis.
Right-sided tumors were associated with inferior 5-year survival for patients with stage II and III disease (P less than .001 for right vs. left in both analyses), the investigators found.
In multivariate analysis, they found a significant interaction between right-sided tumors and a lymph node harvest of greater than 22 nodes toward increased survival, with a hazard ratio of 0.87 (95% confidence interval, 0.84-0.90). “This indicates that survival after right-sided resections can be improved if more than 22 nodes are harvested during the surgery,” Dr. Erkan said.
The difference was most pronounced in stage III of the disease, he added.
Study coauthor Lawrence Lee, MD, a colorectal surgeon at McGill University, said in a related press release that the study findings might prompt surgeons to reevaluate the types of procedures they perform in patients with right-sided tumors. “These patients may need a more extensive resection than is considered to be standard for them.”
Dr. Erkan, Dr. Lee, and other coinvestigators reported no conflicts of interest related to their research.
ORLANDO – The inferior outcomes associated with right-sided colon cancers might be mitigated if a higher lymph node harvest is obtained, a retrospective study suggested.
jacoblund/Thinkstock
Among patients with right-sided cancers, the rate of survival improved when 22 or more lymph nodes were harvested during operations, according to the study results presented at the American College of Surgeons Quality and Safety Conference.
“These data may provide indirect evidence for complete mesocolic excision to obtain a higher lymph node harvest to improve survival,” said investigator Arman Erkan, MD, of the Center for Colon and Rectal Surgery at Florida Hospital Orlando, in an oral abstract presentation.
This study adds new perspective on recent studies that have also demonstrated worse outcomes for right-sided versus left-sided tumors, which may be related to differences in levels of vascular ligation and nodal harvest. In addition, many studies to date have been limited in their ability to evaluate that hypothesis because of small sample size or other factors, he said in his presentation.
Accordingly, Dr. Erkan and his colleagues queried the National Cancer Database for colectomies for nonmetastatic colon adenocarcinoma occurring between 2004 and 2014, evaluating a total of 504,958 patient records, of which 273,198 were for right-sided tumors. To minimize bias, they used propensity score matching, leaving 148,540 patients in each group for the primary analysis.
Right-sided tumors were associated with inferior 5-year survival for patients with stage II and III disease (P less than .001 for right vs. left in both analyses), the investigators found.
In multivariate analysis, they found a significant interaction between right-sided tumors and a lymph node harvest of greater than 22 nodes toward increased survival, with a hazard ratio of 0.87 (95% confidence interval, 0.84-0.90). “This indicates that survival after right-sided resections can be improved if more than 22 nodes are harvested during the surgery,” Dr. Erkan said.
The difference was most pronounced in stage III of the disease, he added.
Study coauthor Lawrence Lee, MD, a colorectal surgeon at McGill University, said in a related press release that the study findings might prompt surgeons to reevaluate the types of procedures they perform in patients with right-sided tumors. “These patients may need a more extensive resection than is considered to be standard for them.”
Dr. Erkan, Dr. Lee, and other coinvestigators reported no conflicts of interest related to their research.
ORLANDO – The inferior outcomes associated with right-sided colon cancers might be mitigated if a higher lymph node harvest is obtained, a retrospective study suggested.
jacoblund/Thinkstock
Among patients with right-sided cancers, the rate of survival improved when 22 or more lymph nodes were harvested during operations, according to the study results presented at the American College of Surgeons Quality and Safety Conference.
“These data may provide indirect evidence for complete mesocolic excision to obtain a higher lymph node harvest to improve survival,” said investigator Arman Erkan, MD, of the Center for Colon and Rectal Surgery at Florida Hospital Orlando, in an oral abstract presentation.
This study adds new perspective on recent studies that have also demonstrated worse outcomes for right-sided versus left-sided tumors, which may be related to differences in levels of vascular ligation and nodal harvest. In addition, many studies to date have been limited in their ability to evaluate that hypothesis because of small sample size or other factors, he said in his presentation.
Accordingly, Dr. Erkan and his colleagues queried the National Cancer Database for colectomies for nonmetastatic colon adenocarcinoma occurring between 2004 and 2014, evaluating a total of 504,958 patient records, of which 273,198 were for right-sided tumors. To minimize bias, they used propensity score matching, leaving 148,540 patients in each group for the primary analysis.
Right-sided tumors were associated with inferior 5-year survival for patients with stage II and III disease (P less than .001 for right vs. left in both analyses), the investigators found.
In multivariate analysis, they found a significant interaction between right-sided tumors and a lymph node harvest of greater than 22 nodes toward increased survival, with a hazard ratio of 0.87 (95% confidence interval, 0.84-0.90). “This indicates that survival after right-sided resections can be improved if more than 22 nodes are harvested during the surgery,” Dr. Erkan said.
The difference was most pronounced in stage III of the disease, he added.
Study coauthor Lawrence Lee, MD, a colorectal surgeon at McGill University, said in a related press release that the study findings might prompt surgeons to reevaluate the types of procedures they perform in patients with right-sided tumors. “These patients may need a more extensive resection than is considered to be standard for them.”
Dr. Erkan, Dr. Lee, and other coinvestigators reported no conflicts of interest related to their research.
General pediatricians and subspecialists need to provide early and ongoing counseling about infertility and sexual dysfunction for at-risk patients, the American Academy of Pediatrics (AAP) has said in its first-ever clinical report on how to address these potentially sensitive topics.
Examples of pediatric populations at risk for infertility/and or sexual dysfunction include those with hematologic and oncologic disorders such as genitourinary cancer, genetic disorders such as Down syndrome, rheumatologic disorders such as rheumatoid arthritis, and endocrine disorders such as diabetes.
Counseling should include discussion of possible management and psychosocial support options for patients who have conditions or who need treatments that might impair reproductive capacity or sexual functioning, according to the policy statement, published July 30 in Pediatrics.
“We want children to feel safe asking questions, as a lack of information can lead to inaccurate beliefs or distress over time, through young adulthood,” Leena Nahata, MD, a pediatric physician in the endocrinology division at Nationwide Children’s Hospital, Columbus, Ohio, and her coauthors, wrote in an AAP statement.
The policy statement lists five specific recommendations for counseling at-risk pediatric populations on fertility and sexual function:
1. Early discussion is essential, and should start either with parents in infancy, or at the soonest time point where the patient could be affected.
2. “Developmentally sensitive approaches” should be used to deliver complete information about patients’ conditions, accounting for changes in patients’ concerns, perspectives, and comprehension level as they mature.
3. Evidence-based interventions and recommendations should be used, and when evidence is not available, that information needs to be shared with families to facilitate decision-making.
4. Interdisciplinary teams need strategies to discuss risks and interventions in a “direct but sensitive manner” allowing time for questions and considerations; teams also should identify which provider will discuss each risk and potential intervention, and when those discussions will occur.
5. Documentation of discussions and their outcomes are critical to ensure clear communication between health care providers and smooth transition to adult care.
Although team physicians have the best grasp of relevant medical issues, behavioral health specialists are “best equipped” to comprehend cultural, developmental, and family psychosocial issues, and to engage children in decision making, according Dr. Nahata, also affiliated with the Ohio State University, Columbus, and her coauthors.
“By having ongoing discussions, we are more likely to establish a sense of safety and trust, while helping youth and family make informed decisions,” coauthor Amy C. Tishelman, PhD, of the departments of endocrinology and psychiatry, Boston Children’s Hospital and Harvard Medical School, Boston, said in the AAP statement announcing the new guidelines.
Gwendolyn P. Quinn, PhD, of the department of obstetrics and gynecology, New York University Langone Medical Center, served as a third coauthor of the report.
In the AAP statement, Dr. Quinn noted differences in child and adolescent counseling needs, stating that adolescents might express concerns about pregnancy or might need information on contraception to avoid sexually transmitted diseases.
By contrast, detailed discussions about sexual function or fertility might not be appropriate for younger children, who nevertheless might exhibit interest and curiosity in their bodies, and should be made comfortable to ask questions. Open-ended prompts such as “How are you feeling about your body?” could be helpful for children approaching adolescence, according to the policy statement.
Dr. Nahata, Dr. Quinn, and Dr. Tishelman reported that they had no financial relationships relevant to their report, no external funding, and no potential conflicts of interest to disclose.
General pediatricians and subspecialists need to provide early and ongoing counseling about infertility and sexual dysfunction for at-risk patients, the American Academy of Pediatrics (AAP) has said in its first-ever clinical report on how to address these potentially sensitive topics.
Examples of pediatric populations at risk for infertility/and or sexual dysfunction include those with hematologic and oncologic disorders such as genitourinary cancer, genetic disorders such as Down syndrome, rheumatologic disorders such as rheumatoid arthritis, and endocrine disorders such as diabetes.
Counseling should include discussion of possible management and psychosocial support options for patients who have conditions or who need treatments that might impair reproductive capacity or sexual functioning, according to the policy statement, published July 30 in Pediatrics.
“We want children to feel safe asking questions, as a lack of information can lead to inaccurate beliefs or distress over time, through young adulthood,” Leena Nahata, MD, a pediatric physician in the endocrinology division at Nationwide Children’s Hospital, Columbus, Ohio, and her coauthors, wrote in an AAP statement.
The policy statement lists five specific recommendations for counseling at-risk pediatric populations on fertility and sexual function:
1. Early discussion is essential, and should start either with parents in infancy, or at the soonest time point where the patient could be affected.
2. “Developmentally sensitive approaches” should be used to deliver complete information about patients’ conditions, accounting for changes in patients’ concerns, perspectives, and comprehension level as they mature.
3. Evidence-based interventions and recommendations should be used, and when evidence is not available, that information needs to be shared with families to facilitate decision-making.
4. Interdisciplinary teams need strategies to discuss risks and interventions in a “direct but sensitive manner” allowing time for questions and considerations; teams also should identify which provider will discuss each risk and potential intervention, and when those discussions will occur.
5. Documentation of discussions and their outcomes are critical to ensure clear communication between health care providers and smooth transition to adult care.
Although team physicians have the best grasp of relevant medical issues, behavioral health specialists are “best equipped” to comprehend cultural, developmental, and family psychosocial issues, and to engage children in decision making, according Dr. Nahata, also affiliated with the Ohio State University, Columbus, and her coauthors.
“By having ongoing discussions, we are more likely to establish a sense of safety and trust, while helping youth and family make informed decisions,” coauthor Amy C. Tishelman, PhD, of the departments of endocrinology and psychiatry, Boston Children’s Hospital and Harvard Medical School, Boston, said in the AAP statement announcing the new guidelines.
Gwendolyn P. Quinn, PhD, of the department of obstetrics and gynecology, New York University Langone Medical Center, served as a third coauthor of the report.
In the AAP statement, Dr. Quinn noted differences in child and adolescent counseling needs, stating that adolescents might express concerns about pregnancy or might need information on contraception to avoid sexually transmitted diseases.
By contrast, detailed discussions about sexual function or fertility might not be appropriate for younger children, who nevertheless might exhibit interest and curiosity in their bodies, and should be made comfortable to ask questions. Open-ended prompts such as “How are you feeling about your body?” could be helpful for children approaching adolescence, according to the policy statement.
Dr. Nahata, Dr. Quinn, and Dr. Tishelman reported that they had no financial relationships relevant to their report, no external funding, and no potential conflicts of interest to disclose.
General pediatricians and subspecialists need to provide early and ongoing counseling about infertility and sexual dysfunction for at-risk patients, the American Academy of Pediatrics (AAP) has said in its first-ever clinical report on how to address these potentially sensitive topics.
Examples of pediatric populations at risk for infertility/and or sexual dysfunction include those with hematologic and oncologic disorders such as genitourinary cancer, genetic disorders such as Down syndrome, rheumatologic disorders such as rheumatoid arthritis, and endocrine disorders such as diabetes.
Counseling should include discussion of possible management and psychosocial support options for patients who have conditions or who need treatments that might impair reproductive capacity or sexual functioning, according to the policy statement, published July 30 in Pediatrics.
“We want children to feel safe asking questions, as a lack of information can lead to inaccurate beliefs or distress over time, through young adulthood,” Leena Nahata, MD, a pediatric physician in the endocrinology division at Nationwide Children’s Hospital, Columbus, Ohio, and her coauthors, wrote in an AAP statement.
The policy statement lists five specific recommendations for counseling at-risk pediatric populations on fertility and sexual function:
1. Early discussion is essential, and should start either with parents in infancy, or at the soonest time point where the patient could be affected.
2. “Developmentally sensitive approaches” should be used to deliver complete information about patients’ conditions, accounting for changes in patients’ concerns, perspectives, and comprehension level as they mature.
3. Evidence-based interventions and recommendations should be used, and when evidence is not available, that information needs to be shared with families to facilitate decision-making.
4. Interdisciplinary teams need strategies to discuss risks and interventions in a “direct but sensitive manner” allowing time for questions and considerations; teams also should identify which provider will discuss each risk and potential intervention, and when those discussions will occur.
5. Documentation of discussions and their outcomes are critical to ensure clear communication between health care providers and smooth transition to adult care.
Although team physicians have the best grasp of relevant medical issues, behavioral health specialists are “best equipped” to comprehend cultural, developmental, and family psychosocial issues, and to engage children in decision making, according Dr. Nahata, also affiliated with the Ohio State University, Columbus, and her coauthors.
“By having ongoing discussions, we are more likely to establish a sense of safety and trust, while helping youth and family make informed decisions,” coauthor Amy C. Tishelman, PhD, of the departments of endocrinology and psychiatry, Boston Children’s Hospital and Harvard Medical School, Boston, said in the AAP statement announcing the new guidelines.
Gwendolyn P. Quinn, PhD, of the department of obstetrics and gynecology, New York University Langone Medical Center, served as a third coauthor of the report.
In the AAP statement, Dr. Quinn noted differences in child and adolescent counseling needs, stating that adolescents might express concerns about pregnancy or might need information on contraception to avoid sexually transmitted diseases.
By contrast, detailed discussions about sexual function or fertility might not be appropriate for younger children, who nevertheless might exhibit interest and curiosity in their bodies, and should be made comfortable to ask questions. Open-ended prompts such as “How are you feeling about your body?” could be helpful for children approaching adolescence, according to the policy statement.
Dr. Nahata, Dr. Quinn, and Dr. Tishelman reported that they had no financial relationships relevant to their report, no external funding, and no potential conflicts of interest to disclose.
Circulating tumor cells could be used to stratify patients with hormone receptor (HR)–positive, HER2-negative breast cancer for late recurrence risk, results of a secondary analysis of a randomized clinical trial suggest.
Risk of late clinical recurrence was about 13-fold higher among HR-positive patients with a positive circulating tumor cell (CTC) assay result, according to results of the study, published in JAMA Oncology.
“This prospectively conducted study offers a high level of evidence supporting the association between a positive CTC assay result and risk of clinical recurrence,” said Joseph A. Sparano, MD, of Albert Einstein College of Medicine, New York, and his coauthors.
The present study is the first to show that this CTC assay may play a role in determining late clinical recurrence after local and systemic adjuvant therapy, according to the investigators. The assay (CellSearch) is cleared by the Food and Drug Administration for enumeration of CTCs in patients with metastatic breast cancer.
The study is a secondary analysis of E5103, a phase 3 trial of adjuvant doxorubicin and cyclophosphamide followed by paclitaxel with bevacizumab in patients with HER2-negative stage II-III breast cancer. Investigators included a total of 547 patients who had no clinical evidence of recurrence between 4.5 and 7.5 years of registration in that trial.
Positive CTC assay results occurred in 26 of those patients (4.8%), they found.
At a median follow-up of 2.6 years, 24 patients had a clinical recurrence, including 23 HR-positive patients and just 1 HR-negative patient. Accordingly, the investigators focused most of their further analysis on the HR-positive subset.
A total of 7 of 23 patients with HR-positive disease (30.4%) had a positive CTC assay result.
A positive CTC result in HR-positive patients was associated with a 13.1-fold increased risk of recurrence, multivariate analysis showed.
Higher CTC burden appeared to be associated with a numerically higher recurrence risk in HR-positive patients, the investigators found. They saw recurrences in 16 of 335 patients with a CTC count of 0 cells per 7.5 mL blood (4.8%), compared with 2 of 12 patients with 1 cell per 7.5 mL blood (16.7%), and 5 of 6 patients with 2 or more cells per 7.5 mL (83.3%).
Taken together, these results provided proof of concept to support additional investigations of the CTC assay and other blood-based biomarker tests in the setting of late clinical recurrence in HR-positive patients, the researchers said.
They acknowledged several limitations of this study: It was small, it had relatively short follow-up, and it did not evaluate the CTC assay in the context of other assays.
“Notwithstanding proof of concept, further evaluation is required to confirm the clinical validity and determine the clinical utility of performing the CTC assay in this context,” Dr. Sparano and his coauthors wrote.
Late recurrences, or those that occur more than 5 years after diagnosis, account for about half of all recurrences among HR-positive receptive breast cancers, Dr. Sparano and his colleagues said.
The researchers had no conflicts of interest to report. The study was supported by grants from the National Cancer Institute, National Institutes of Health, Breast Cancer Research Foundation, and Susan G. Komen Foundation.
Circulating tumor cells could be used to stratify patients with hormone receptor (HR)–positive, HER2-negative breast cancer for late recurrence risk, results of a secondary analysis of a randomized clinical trial suggest.
Risk of late clinical recurrence was about 13-fold higher among HR-positive patients with a positive circulating tumor cell (CTC) assay result, according to results of the study, published in JAMA Oncology.
“This prospectively conducted study offers a high level of evidence supporting the association between a positive CTC assay result and risk of clinical recurrence,” said Joseph A. Sparano, MD, of Albert Einstein College of Medicine, New York, and his coauthors.
The present study is the first to show that this CTC assay may play a role in determining late clinical recurrence after local and systemic adjuvant therapy, according to the investigators. The assay (CellSearch) is cleared by the Food and Drug Administration for enumeration of CTCs in patients with metastatic breast cancer.
The study is a secondary analysis of E5103, a phase 3 trial of adjuvant doxorubicin and cyclophosphamide followed by paclitaxel with bevacizumab in patients with HER2-negative stage II-III breast cancer. Investigators included a total of 547 patients who had no clinical evidence of recurrence between 4.5 and 7.5 years of registration in that trial.
Positive CTC assay results occurred in 26 of those patients (4.8%), they found.
At a median follow-up of 2.6 years, 24 patients had a clinical recurrence, including 23 HR-positive patients and just 1 HR-negative patient. Accordingly, the investigators focused most of their further analysis on the HR-positive subset.
A total of 7 of 23 patients with HR-positive disease (30.4%) had a positive CTC assay result.
A positive CTC result in HR-positive patients was associated with a 13.1-fold increased risk of recurrence, multivariate analysis showed.
Higher CTC burden appeared to be associated with a numerically higher recurrence risk in HR-positive patients, the investigators found. They saw recurrences in 16 of 335 patients with a CTC count of 0 cells per 7.5 mL blood (4.8%), compared with 2 of 12 patients with 1 cell per 7.5 mL blood (16.7%), and 5 of 6 patients with 2 or more cells per 7.5 mL (83.3%).
Taken together, these results provided proof of concept to support additional investigations of the CTC assay and other blood-based biomarker tests in the setting of late clinical recurrence in HR-positive patients, the researchers said.
They acknowledged several limitations of this study: It was small, it had relatively short follow-up, and it did not evaluate the CTC assay in the context of other assays.
“Notwithstanding proof of concept, further evaluation is required to confirm the clinical validity and determine the clinical utility of performing the CTC assay in this context,” Dr. Sparano and his coauthors wrote.
Late recurrences, or those that occur more than 5 years after diagnosis, account for about half of all recurrences among HR-positive receptive breast cancers, Dr. Sparano and his colleagues said.
The researchers had no conflicts of interest to report. The study was supported by grants from the National Cancer Institute, National Institutes of Health, Breast Cancer Research Foundation, and Susan G. Komen Foundation.
Circulating tumor cells could be used to stratify patients with hormone receptor (HR)–positive, HER2-negative breast cancer for late recurrence risk, results of a secondary analysis of a randomized clinical trial suggest.
Risk of late clinical recurrence was about 13-fold higher among HR-positive patients with a positive circulating tumor cell (CTC) assay result, according to results of the study, published in JAMA Oncology.
“This prospectively conducted study offers a high level of evidence supporting the association between a positive CTC assay result and risk of clinical recurrence,” said Joseph A. Sparano, MD, of Albert Einstein College of Medicine, New York, and his coauthors.
The present study is the first to show that this CTC assay may play a role in determining late clinical recurrence after local and systemic adjuvant therapy, according to the investigators. The assay (CellSearch) is cleared by the Food and Drug Administration for enumeration of CTCs in patients with metastatic breast cancer.
The study is a secondary analysis of E5103, a phase 3 trial of adjuvant doxorubicin and cyclophosphamide followed by paclitaxel with bevacizumab in patients with HER2-negative stage II-III breast cancer. Investigators included a total of 547 patients who had no clinical evidence of recurrence between 4.5 and 7.5 years of registration in that trial.
Positive CTC assay results occurred in 26 of those patients (4.8%), they found.
At a median follow-up of 2.6 years, 24 patients had a clinical recurrence, including 23 HR-positive patients and just 1 HR-negative patient. Accordingly, the investigators focused most of their further analysis on the HR-positive subset.
A total of 7 of 23 patients with HR-positive disease (30.4%) had a positive CTC assay result.
A positive CTC result in HR-positive patients was associated with a 13.1-fold increased risk of recurrence, multivariate analysis showed.
Higher CTC burden appeared to be associated with a numerically higher recurrence risk in HR-positive patients, the investigators found. They saw recurrences in 16 of 335 patients with a CTC count of 0 cells per 7.5 mL blood (4.8%), compared with 2 of 12 patients with 1 cell per 7.5 mL blood (16.7%), and 5 of 6 patients with 2 or more cells per 7.5 mL (83.3%).
Taken together, these results provided proof of concept to support additional investigations of the CTC assay and other blood-based biomarker tests in the setting of late clinical recurrence in HR-positive patients, the researchers said.
They acknowledged several limitations of this study: It was small, it had relatively short follow-up, and it did not evaluate the CTC assay in the context of other assays.
“Notwithstanding proof of concept, further evaluation is required to confirm the clinical validity and determine the clinical utility of performing the CTC assay in this context,” Dr. Sparano and his coauthors wrote.
Late recurrences, or those that occur more than 5 years after diagnosis, account for about half of all recurrences among HR-positive receptive breast cancers, Dr. Sparano and his colleagues said.
The researchers had no conflicts of interest to report. The study was supported by grants from the National Cancer Institute, National Institutes of Health, Breast Cancer Research Foundation, and Susan G. Komen Foundation.
Key clinical point: Circulating tumor cells (CTC) may help to evaluate late recurrence risk in patients with HER2-negative breast cancer.
Major finding: A positive CTC result was associated with a 13.1-fold increased risk of recurrence in hormone receptor–positive patients.
Study details: Secondary analysis of a randomized clinical trial including 547 patients with HER2-negative stage II-III breast cancer.
Disclosures: The study was supported by grants from the National Cancer Institute, National Institutes of Health, Breast Cancer Research Foundation, and Susan G. Komen Foundation. The authors reported no conflicts of interest.
Children who undergo allogeneic blood or marrow transplantation (BMT) remain at an elevated risk of premature death even 25 years after the procedure, results of large, retrospective cohort study suggest.
Despite a significant decrease over several decades, the risk of all-cause mortality remained elevated, compared with the general population, according to this study of individuals who had BMT performed in childhood between 1974 and 2010.
“These findings emphasize the need for lifelong follow-up care after allogeneic BMT performed in childhood,” reported Anna Sällfors Holmqvist, MD, PhD, of the department of clinical sciences at Skåne University Hospital, Lund University, Sweden, and her associates.
Screening, preventive care, and counseling need to be part of that long-term follow-up, Dr. Holmqvist and her colleagues reported in JAMA Oncology.
Their retrospective analysis included 1,388 individuals who lived at least 2 years after allogeneic BMT performed in childhood at one of three centers: the University of Alabama at Birmingham; the University of Minnesota, Minneapolis; and City of Hope, Duarte, Calif.
There were 295 deaths over a median of 14.9 years of follow-up, for an overall survival rate of 79.3% at 20 years after BMT, reported Dr. Holmqvist and her associates. The three leading causes of death were infection or chronic graft-versus-host disease in 49.6% of cases, primary disease in 24.6%, and later malignancies in 18.4%.
Relative to the general population, the cohort had a 14.4-fold increased risk of premature death (95% confidence interval, 12.8-16.1), compared with the general population. Relative mortality was highest 2-5 years after BMT and dropped substantially after that but remained elevated – even 25 years or more after the procedure, the investigators noted.
Mortality decreased significantly over the 3 decades evaluated in this study. The rate of all-cause, 10-year cumulative mortality was 18.9% before 1990, 12.9% from 1990 to 1999, and 11.0% from 2000 to 2010 (P = .002).
That decrease in cumulative mortality over time could not be explained by changes in transplant practice over those three time periods, according to results of a mediation analysis performed by Dr. Holmqvist and her associates.
That finding suggests that unmeasured variables might underlie the decrease in late mortality, the investigators said.
Those unmeasured variables might include supportive care strategies, management of chronic graft-versus-host disease, or improved patient selection, they noted.
Dr. Holmqvist and her associates cited as one limitation their reliance on death certificates for causes of death. In addition, the causes of death for 51 of the 295 deceased patients were lacking.
The study was supported in part by grants from the National Cancer Institute, the Leukemia Lymphoma Society, and the Swedish Childhood Cancer Foundation. Dr. Holmqvist and her associates reported no conflicts of interest.
Children who undergo allogeneic blood or marrow transplantation (BMT) remain at an elevated risk of premature death even 25 years after the procedure, results of large, retrospective cohort study suggest.
Despite a significant decrease over several decades, the risk of all-cause mortality remained elevated, compared with the general population, according to this study of individuals who had BMT performed in childhood between 1974 and 2010.
“These findings emphasize the need for lifelong follow-up care after allogeneic BMT performed in childhood,” reported Anna Sällfors Holmqvist, MD, PhD, of the department of clinical sciences at Skåne University Hospital, Lund University, Sweden, and her associates.
Screening, preventive care, and counseling need to be part of that long-term follow-up, Dr. Holmqvist and her colleagues reported in JAMA Oncology.
Their retrospective analysis included 1,388 individuals who lived at least 2 years after allogeneic BMT performed in childhood at one of three centers: the University of Alabama at Birmingham; the University of Minnesota, Minneapolis; and City of Hope, Duarte, Calif.
There were 295 deaths over a median of 14.9 years of follow-up, for an overall survival rate of 79.3% at 20 years after BMT, reported Dr. Holmqvist and her associates. The three leading causes of death were infection or chronic graft-versus-host disease in 49.6% of cases, primary disease in 24.6%, and later malignancies in 18.4%.
Relative to the general population, the cohort had a 14.4-fold increased risk of premature death (95% confidence interval, 12.8-16.1), compared with the general population. Relative mortality was highest 2-5 years after BMT and dropped substantially after that but remained elevated – even 25 years or more after the procedure, the investigators noted.
Mortality decreased significantly over the 3 decades evaluated in this study. The rate of all-cause, 10-year cumulative mortality was 18.9% before 1990, 12.9% from 1990 to 1999, and 11.0% from 2000 to 2010 (P = .002).
That decrease in cumulative mortality over time could not be explained by changes in transplant practice over those three time periods, according to results of a mediation analysis performed by Dr. Holmqvist and her associates.
That finding suggests that unmeasured variables might underlie the decrease in late mortality, the investigators said.
Those unmeasured variables might include supportive care strategies, management of chronic graft-versus-host disease, or improved patient selection, they noted.
Dr. Holmqvist and her associates cited as one limitation their reliance on death certificates for causes of death. In addition, the causes of death for 51 of the 295 deceased patients were lacking.
The study was supported in part by grants from the National Cancer Institute, the Leukemia Lymphoma Society, and the Swedish Childhood Cancer Foundation. Dr. Holmqvist and her associates reported no conflicts of interest.
Children who undergo allogeneic blood or marrow transplantation (BMT) remain at an elevated risk of premature death even 25 years after the procedure, results of large, retrospective cohort study suggest.
Despite a significant decrease over several decades, the risk of all-cause mortality remained elevated, compared with the general population, according to this study of individuals who had BMT performed in childhood between 1974 and 2010.
“These findings emphasize the need for lifelong follow-up care after allogeneic BMT performed in childhood,” reported Anna Sällfors Holmqvist, MD, PhD, of the department of clinical sciences at Skåne University Hospital, Lund University, Sweden, and her associates.
Screening, preventive care, and counseling need to be part of that long-term follow-up, Dr. Holmqvist and her colleagues reported in JAMA Oncology.
Their retrospective analysis included 1,388 individuals who lived at least 2 years after allogeneic BMT performed in childhood at one of three centers: the University of Alabama at Birmingham; the University of Minnesota, Minneapolis; and City of Hope, Duarte, Calif.
There were 295 deaths over a median of 14.9 years of follow-up, for an overall survival rate of 79.3% at 20 years after BMT, reported Dr. Holmqvist and her associates. The three leading causes of death were infection or chronic graft-versus-host disease in 49.6% of cases, primary disease in 24.6%, and later malignancies in 18.4%.
Relative to the general population, the cohort had a 14.4-fold increased risk of premature death (95% confidence interval, 12.8-16.1), compared with the general population. Relative mortality was highest 2-5 years after BMT and dropped substantially after that but remained elevated – even 25 years or more after the procedure, the investigators noted.
Mortality decreased significantly over the 3 decades evaluated in this study. The rate of all-cause, 10-year cumulative mortality was 18.9% before 1990, 12.9% from 1990 to 1999, and 11.0% from 2000 to 2010 (P = .002).
That decrease in cumulative mortality over time could not be explained by changes in transplant practice over those three time periods, according to results of a mediation analysis performed by Dr. Holmqvist and her associates.
That finding suggests that unmeasured variables might underlie the decrease in late mortality, the investigators said.
Those unmeasured variables might include supportive care strategies, management of chronic graft-versus-host disease, or improved patient selection, they noted.
Dr. Holmqvist and her associates cited as one limitation their reliance on death certificates for causes of death. In addition, the causes of death for 51 of the 295 deceased patients were lacking.
The study was supported in part by grants from the National Cancer Institute, the Leukemia Lymphoma Society, and the Swedish Childhood Cancer Foundation. Dr. Holmqvist and her associates reported no conflicts of interest.
Key clinical point: Individuals undergoing allogeneic blood or marrow transplantation (BMT) in childhood require careful follow-up for many years because of a persistent elevated risk of premature death.
Major finding: Risk of premature death was increased 14.4-fold, compared with the general population (95% confidence interval, 12.8-16.1).
Study details: A retrospective cohort study including 1,388 individuals living 2 years or more after allogeneic BMT performed in childhood.
Disclosures: The study was supported in part by grants from the National Cancer Institute, the Leukemia Lymphoma Society, and the Swedish Childhood Cancer Foundation. Dr. Holmqvist and her coauthors reported no conflicts of interest.
Source: Holmqvist AS et al. JAMA Oncol. 2018 Jul 26. doi: 10.1001/jamaoncol.2018.2453.
Disqus Comments
Default
Consolidated Pubs: Do Not Show Source Publication Logo