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Low rate of occult uterine malignancy with vaginal morcellation
ORLANDO – The Food and Drug Administration’s 2014 warning that laparoscopic power morcellation during hysterectomy or myomectomy could spread unsuspected cancerous tissue had a chilling effect across the specialty, but what about the risks associated with morcellation during vaginal hysterectomy?
“There is only one case of morcellation during vaginal hysterectomy with a leiomyosarcoma recorded in the literature,” Megan N. Wasson, DO, a fellow in minimally invasive gynecologic surgery at the Mayo Clinic in Phoenix said at the meeting sponsored by AAGL. “It is really unclear if vaginal and electromechanical morcellation carry the same inherent risk.”
To find out more, Dr. Wasson and her colleagues identified 2,296 patients who underwent total vaginal hysterectomy at one of three academic medical centers. A total of 611 of these women had uterine removal with uncontained morcellation via cold-knife wedge resection. The investigators assessed this group for incidence of occult malignancy, perioperative outcomes, and long-term survival in a retrospective cohort study.
Of the 611 women who underwent morcellation during the study, five patients had an occult malignancy, for a rate less than one percent, 0.82%. Three patients had a stage IA, grade I endometrial adenocarcinoma, and two patients had a low-grade stromal sarcoma. No patients had a leiomyosarcoma.
This group of five patients had a mean age of 49 years, a mean BMI of 32 kg/m2 and a median parity of two. Abnormal uterine bleeding was the indication for surgery for all five patients with a malignancy. The mean uterine weight was elevated at 231 g. One patient with endometrial adenocarcinoma later underwent pelvic lymphadenectomy and vaginal brachytherapy.
“So far, thankfully, all of these patients show no evidence of disease recurrence,” Dr. Wasson said. All five patients are alive, with a mean disease-free survival of 43 months among those with endometrial adenocarcinoma and 37 months for the low-grade stroma sarcoma patients.
“Overall, the incidence of occult uterine carcinoma at the time of vaginal hysterectomy is less than 1%,” Dr. Wasson said. “Thankfully, it does not appear to have a negative effect on patient outcomes when it occurs.”
More research is needed, however. “The risk is very limited in terms of what we know,” she said. “We investigated cancer in this study, but there is also a risk of dissemination of benign conditions.”
All patients underwent a preoperative evaluation that included sampling of the lining of the uterus and imaging. “Out of the five patients with carcinomas, two of the adenocarcinomas had completely benign preoperative sampling and one had hyperplasia, which unfortunately did develop into occult disease,” Dr. Wasson said. “We wouldn’t recommend morcellating any patient with hyperplasia. In the two patients with low-grade stromal sarcoma, neither had any hyperplasia on preoperative sampling.”
Following the 2014 FDA Safety Communication on power morcellation, the AAGL released its own guidance on morcellation during uterine tissue extraction. The AAGL recommended that clinicians avoid morcellation for any patient who had a premalignant or malignant condition or who was at risk for malignancy, and use caution when considering morcellation. “This was for all types of morcellation, including electromechanical and vaginal morcellation,” Dr. Wasson said.
“This was in response to studies and awareness of increased risk of disease with morcellation – specifically leiomyosarcomas – for dissemination of disease in the abdomen and pelvis, but also for an increased risk of recurrence,” she said. “This means, in turn, that patients can have decreased overall survival and disease-free survival, so this is very important when we are talking to our patients.”
Dr. Wasson reported having no relevant financial disclosures.
ORLANDO – The Food and Drug Administration’s 2014 warning that laparoscopic power morcellation during hysterectomy or myomectomy could spread unsuspected cancerous tissue had a chilling effect across the specialty, but what about the risks associated with morcellation during vaginal hysterectomy?
“There is only one case of morcellation during vaginal hysterectomy with a leiomyosarcoma recorded in the literature,” Megan N. Wasson, DO, a fellow in minimally invasive gynecologic surgery at the Mayo Clinic in Phoenix said at the meeting sponsored by AAGL. “It is really unclear if vaginal and electromechanical morcellation carry the same inherent risk.”
To find out more, Dr. Wasson and her colleagues identified 2,296 patients who underwent total vaginal hysterectomy at one of three academic medical centers. A total of 611 of these women had uterine removal with uncontained morcellation via cold-knife wedge resection. The investigators assessed this group for incidence of occult malignancy, perioperative outcomes, and long-term survival in a retrospective cohort study.
Of the 611 women who underwent morcellation during the study, five patients had an occult malignancy, for a rate less than one percent, 0.82%. Three patients had a stage IA, grade I endometrial adenocarcinoma, and two patients had a low-grade stromal sarcoma. No patients had a leiomyosarcoma.
This group of five patients had a mean age of 49 years, a mean BMI of 32 kg/m2 and a median parity of two. Abnormal uterine bleeding was the indication for surgery for all five patients with a malignancy. The mean uterine weight was elevated at 231 g. One patient with endometrial adenocarcinoma later underwent pelvic lymphadenectomy and vaginal brachytherapy.
“So far, thankfully, all of these patients show no evidence of disease recurrence,” Dr. Wasson said. All five patients are alive, with a mean disease-free survival of 43 months among those with endometrial adenocarcinoma and 37 months for the low-grade stroma sarcoma patients.
“Overall, the incidence of occult uterine carcinoma at the time of vaginal hysterectomy is less than 1%,” Dr. Wasson said. “Thankfully, it does not appear to have a negative effect on patient outcomes when it occurs.”
More research is needed, however. “The risk is very limited in terms of what we know,” she said. “We investigated cancer in this study, but there is also a risk of dissemination of benign conditions.”
All patients underwent a preoperative evaluation that included sampling of the lining of the uterus and imaging. “Out of the five patients with carcinomas, two of the adenocarcinomas had completely benign preoperative sampling and one had hyperplasia, which unfortunately did develop into occult disease,” Dr. Wasson said. “We wouldn’t recommend morcellating any patient with hyperplasia. In the two patients with low-grade stromal sarcoma, neither had any hyperplasia on preoperative sampling.”
Following the 2014 FDA Safety Communication on power morcellation, the AAGL released its own guidance on morcellation during uterine tissue extraction. The AAGL recommended that clinicians avoid morcellation for any patient who had a premalignant or malignant condition or who was at risk for malignancy, and use caution when considering morcellation. “This was for all types of morcellation, including electromechanical and vaginal morcellation,” Dr. Wasson said.
“This was in response to studies and awareness of increased risk of disease with morcellation – specifically leiomyosarcomas – for dissemination of disease in the abdomen and pelvis, but also for an increased risk of recurrence,” she said. “This means, in turn, that patients can have decreased overall survival and disease-free survival, so this is very important when we are talking to our patients.”
Dr. Wasson reported having no relevant financial disclosures.
ORLANDO – The Food and Drug Administration’s 2014 warning that laparoscopic power morcellation during hysterectomy or myomectomy could spread unsuspected cancerous tissue had a chilling effect across the specialty, but what about the risks associated with morcellation during vaginal hysterectomy?
“There is only one case of morcellation during vaginal hysterectomy with a leiomyosarcoma recorded in the literature,” Megan N. Wasson, DO, a fellow in minimally invasive gynecologic surgery at the Mayo Clinic in Phoenix said at the meeting sponsored by AAGL. “It is really unclear if vaginal and electromechanical morcellation carry the same inherent risk.”
To find out more, Dr. Wasson and her colleagues identified 2,296 patients who underwent total vaginal hysterectomy at one of three academic medical centers. A total of 611 of these women had uterine removal with uncontained morcellation via cold-knife wedge resection. The investigators assessed this group for incidence of occult malignancy, perioperative outcomes, and long-term survival in a retrospective cohort study.
Of the 611 women who underwent morcellation during the study, five patients had an occult malignancy, for a rate less than one percent, 0.82%. Three patients had a stage IA, grade I endometrial adenocarcinoma, and two patients had a low-grade stromal sarcoma. No patients had a leiomyosarcoma.
This group of five patients had a mean age of 49 years, a mean BMI of 32 kg/m2 and a median parity of two. Abnormal uterine bleeding was the indication for surgery for all five patients with a malignancy. The mean uterine weight was elevated at 231 g. One patient with endometrial adenocarcinoma later underwent pelvic lymphadenectomy and vaginal brachytherapy.
“So far, thankfully, all of these patients show no evidence of disease recurrence,” Dr. Wasson said. All five patients are alive, with a mean disease-free survival of 43 months among those with endometrial adenocarcinoma and 37 months for the low-grade stroma sarcoma patients.
“Overall, the incidence of occult uterine carcinoma at the time of vaginal hysterectomy is less than 1%,” Dr. Wasson said. “Thankfully, it does not appear to have a negative effect on patient outcomes when it occurs.”
More research is needed, however. “The risk is very limited in terms of what we know,” she said. “We investigated cancer in this study, but there is also a risk of dissemination of benign conditions.”
All patients underwent a preoperative evaluation that included sampling of the lining of the uterus and imaging. “Out of the five patients with carcinomas, two of the adenocarcinomas had completely benign preoperative sampling and one had hyperplasia, which unfortunately did develop into occult disease,” Dr. Wasson said. “We wouldn’t recommend morcellating any patient with hyperplasia. In the two patients with low-grade stromal sarcoma, neither had any hyperplasia on preoperative sampling.”
Following the 2014 FDA Safety Communication on power morcellation, the AAGL released its own guidance on morcellation during uterine tissue extraction. The AAGL recommended that clinicians avoid morcellation for any patient who had a premalignant or malignant condition or who was at risk for malignancy, and use caution when considering morcellation. “This was for all types of morcellation, including electromechanical and vaginal morcellation,” Dr. Wasson said.
“This was in response to studies and awareness of increased risk of disease with morcellation – specifically leiomyosarcomas – for dissemination of disease in the abdomen and pelvis, but also for an increased risk of recurrence,” she said. “This means, in turn, that patients can have decreased overall survival and disease-free survival, so this is very important when we are talking to our patients.”
Dr. Wasson reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Key clinical point:
Major finding: Of 611 patients who underwent morcellation during total vaginal hysterectomy, five patients (0.82%) had occult uterine carcinoma.
Data source: A retrospective cohort study of 611 women who had uterine removal with uncontained morcellation.
Disclosures: Dr. Wasson reported having no relevant financial disclosures.
Should surgeons change gloves during total laparoscopic hysterectomy?
ORLANDO – Many gynecologic surgeons change gloves, gowns, and even surgical drapes during total laparoscopic hysterectomy to prevent bacterial infections, but little data support the practice.
In a small study of women undergoing total laparoscopic hysterectomy, investigators found that the overall risk of infection from contaminated gowns, gloves, and instruments was very low, with bacterial growth below the infection threshold in 98.9% of samples and no surgical site infections reported during 6 weeks of follow-up after surgery.
“Tradition dictates that even after both fields have been prepped, we refer to the perineum and vagina as ‘dirty,’ and the abdomen as ‘clean,’ ” Dr. Shockley said, “And surgeons habitually change their gown and gloves when inadvertent contact with the perineum or vagina occurs.”
To elucidate the true pathogen picture, Dr. Shockley and her colleagues assessed 31 women undergoing total laparoscopic hysterectomy for a benign indication during 2016. They evaluated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus.
All patients received perioperative antibiotic prophylaxis and standard, separate perineovaginal and abdominal prep with chlorhexidine. Investigators swabbed the vaginal fornices and abdomen at six sites, as well as the surgeon’s gloves following placement of the uterine manipulator, tips of instruments used to close the vaginal cuff, uterine fundus after extraction, and surgeon’s gloves following removal of the uterus.
They detected no anaerobic bacterial growth from samples taken from the abdomen, in the vagina, or on the tips of instruments used for cuff closure. Similarly, there was no aerobic growth observed in the vagina of any patient. However, they did detect aerobic bacterial growth in the abdomen, which in all cases was consistent with skin flora.
Three patients demonstrated some growth with the surgeon’s gloves following manipulator placement. Nearly one-third – 32% – of surgeon’s gloves cultured bacteria after removal of the uterus. One sample yielded cumulative growth for a bacterial count considered high enough to potentially cause infection, defined as more than 5,000 colony-forming units (CFU) per milliliter. This was the highest growth sample out of the 180 samples collected.
Additionally, 39% of samples from the uterine fundus were positive, a higher percentage than at any other site, Dr. Shockley reported. “And the one sample with growth exceeding 5,000 CFU/mL – you guessed it – was from the same patient.”
Bacterial growth was scant on the instrument tips used to close the vaginal cuffs.
Overall, bacterial growth in 98.9% of samples was below the infection threshold. “We did not identify any post–surgical site infections during 6 weeks of follow-up,” Dr. Shockley said at the meeting sponsored by AAGL.
“This study does provide a good description and count of the bacteria encountered during total laparoscopic hysterectomy. They are unlikely to cause surgical site infections … but based on concentration and frequency of bacterial growth on the surgeon’s gloves after specimen extraction, we would recommend if you are going to change gloves, do it after this step, before turning your attention back to the abdomen for vaginal cuff closure,” she said.
But changing gloves after placing the Foley and uterine manipulator “seems to be a wasted exercise,” Dr. Shockley said. “There was no growth on the vaginal fornices of any patient.”
The bacteria on the gloves in those three cases developed very low colony counts. “Yes, there was growth after the removal of the specimen, but with the exception of one patient, the colony counts were all below 5,000,” she said. “I think we need more data to reassure ourselves [attire changes are] unnecessary at every step of the [total laparoscopic hysterectomy].”
The study was supported by an educational grant from the Foundation of the AAGL Jerome J. Hoffman Endowment. Dr. Shockley reported having no relevant financial disclosures.
ORLANDO – Many gynecologic surgeons change gloves, gowns, and even surgical drapes during total laparoscopic hysterectomy to prevent bacterial infections, but little data support the practice.
In a small study of women undergoing total laparoscopic hysterectomy, investigators found that the overall risk of infection from contaminated gowns, gloves, and instruments was very low, with bacterial growth below the infection threshold in 98.9% of samples and no surgical site infections reported during 6 weeks of follow-up after surgery.
“Tradition dictates that even after both fields have been prepped, we refer to the perineum and vagina as ‘dirty,’ and the abdomen as ‘clean,’ ” Dr. Shockley said, “And surgeons habitually change their gown and gloves when inadvertent contact with the perineum or vagina occurs.”
To elucidate the true pathogen picture, Dr. Shockley and her colleagues assessed 31 women undergoing total laparoscopic hysterectomy for a benign indication during 2016. They evaluated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus.
All patients received perioperative antibiotic prophylaxis and standard, separate perineovaginal and abdominal prep with chlorhexidine. Investigators swabbed the vaginal fornices and abdomen at six sites, as well as the surgeon’s gloves following placement of the uterine manipulator, tips of instruments used to close the vaginal cuff, uterine fundus after extraction, and surgeon’s gloves following removal of the uterus.
They detected no anaerobic bacterial growth from samples taken from the abdomen, in the vagina, or on the tips of instruments used for cuff closure. Similarly, there was no aerobic growth observed in the vagina of any patient. However, they did detect aerobic bacterial growth in the abdomen, which in all cases was consistent with skin flora.
Three patients demonstrated some growth with the surgeon’s gloves following manipulator placement. Nearly one-third – 32% – of surgeon’s gloves cultured bacteria after removal of the uterus. One sample yielded cumulative growth for a bacterial count considered high enough to potentially cause infection, defined as more than 5,000 colony-forming units (CFU) per milliliter. This was the highest growth sample out of the 180 samples collected.
Additionally, 39% of samples from the uterine fundus were positive, a higher percentage than at any other site, Dr. Shockley reported. “And the one sample with growth exceeding 5,000 CFU/mL – you guessed it – was from the same patient.”
Bacterial growth was scant on the instrument tips used to close the vaginal cuffs.
Overall, bacterial growth in 98.9% of samples was below the infection threshold. “We did not identify any post–surgical site infections during 6 weeks of follow-up,” Dr. Shockley said at the meeting sponsored by AAGL.
“This study does provide a good description and count of the bacteria encountered during total laparoscopic hysterectomy. They are unlikely to cause surgical site infections … but based on concentration and frequency of bacterial growth on the surgeon’s gloves after specimen extraction, we would recommend if you are going to change gloves, do it after this step, before turning your attention back to the abdomen for vaginal cuff closure,” she said.
But changing gloves after placing the Foley and uterine manipulator “seems to be a wasted exercise,” Dr. Shockley said. “There was no growth on the vaginal fornices of any patient.”
The bacteria on the gloves in those three cases developed very low colony counts. “Yes, there was growth after the removal of the specimen, but with the exception of one patient, the colony counts were all below 5,000,” she said. “I think we need more data to reassure ourselves [attire changes are] unnecessary at every step of the [total laparoscopic hysterectomy].”
The study was supported by an educational grant from the Foundation of the AAGL Jerome J. Hoffman Endowment. Dr. Shockley reported having no relevant financial disclosures.
ORLANDO – Many gynecologic surgeons change gloves, gowns, and even surgical drapes during total laparoscopic hysterectomy to prevent bacterial infections, but little data support the practice.
In a small study of women undergoing total laparoscopic hysterectomy, investigators found that the overall risk of infection from contaminated gowns, gloves, and instruments was very low, with bacterial growth below the infection threshold in 98.9% of samples and no surgical site infections reported during 6 weeks of follow-up after surgery.
“Tradition dictates that even after both fields have been prepped, we refer to the perineum and vagina as ‘dirty,’ and the abdomen as ‘clean,’ ” Dr. Shockley said, “And surgeons habitually change their gown and gloves when inadvertent contact with the perineum or vagina occurs.”
To elucidate the true pathogen picture, Dr. Shockley and her colleagues assessed 31 women undergoing total laparoscopic hysterectomy for a benign indication during 2016. They evaluated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus.
All patients received perioperative antibiotic prophylaxis and standard, separate perineovaginal and abdominal prep with chlorhexidine. Investigators swabbed the vaginal fornices and abdomen at six sites, as well as the surgeon’s gloves following placement of the uterine manipulator, tips of instruments used to close the vaginal cuff, uterine fundus after extraction, and surgeon’s gloves following removal of the uterus.
They detected no anaerobic bacterial growth from samples taken from the abdomen, in the vagina, or on the tips of instruments used for cuff closure. Similarly, there was no aerobic growth observed in the vagina of any patient. However, they did detect aerobic bacterial growth in the abdomen, which in all cases was consistent with skin flora.
Three patients demonstrated some growth with the surgeon’s gloves following manipulator placement. Nearly one-third – 32% – of surgeon’s gloves cultured bacteria after removal of the uterus. One sample yielded cumulative growth for a bacterial count considered high enough to potentially cause infection, defined as more than 5,000 colony-forming units (CFU) per milliliter. This was the highest growth sample out of the 180 samples collected.
Additionally, 39% of samples from the uterine fundus were positive, a higher percentage than at any other site, Dr. Shockley reported. “And the one sample with growth exceeding 5,000 CFU/mL – you guessed it – was from the same patient.”
Bacterial growth was scant on the instrument tips used to close the vaginal cuffs.
Overall, bacterial growth in 98.9% of samples was below the infection threshold. “We did not identify any post–surgical site infections during 6 weeks of follow-up,” Dr. Shockley said at the meeting sponsored by AAGL.
“This study does provide a good description and count of the bacteria encountered during total laparoscopic hysterectomy. They are unlikely to cause surgical site infections … but based on concentration and frequency of bacterial growth on the surgeon’s gloves after specimen extraction, we would recommend if you are going to change gloves, do it after this step, before turning your attention back to the abdomen for vaginal cuff closure,” she said.
But changing gloves after placing the Foley and uterine manipulator “seems to be a wasted exercise,” Dr. Shockley said. “There was no growth on the vaginal fornices of any patient.”
The bacteria on the gloves in those three cases developed very low colony counts. “Yes, there was growth after the removal of the specimen, but with the exception of one patient, the colony counts were all below 5,000,” she said. “I think we need more data to reassure ourselves [attire changes are] unnecessary at every step of the [total laparoscopic hysterectomy].”
The study was supported by an educational grant from the Foundation of the AAGL Jerome J. Hoffman Endowment. Dr. Shockley reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Key clinical point:
Major finding: Bacterial concentrations did not exceed thresholds required to trigger potential infection in almost 99% of cultures.
Data source: A study of 31 women undergoing total laparoscopic hysterectomy for benign indications in 2016.
Disclosures: The study was supported by an educational grant from the Foundation of the AAGL Jerome J. Hoffman Endowment. Dr. Shockley reported having no relevant financial disclosures.
Tumor boards linked to improved survival in hepatocellular carcinoma
BOSTON – Veterans were about 13% less likely to die within 5 years of hepatocellular carcinoma diagnosis when multidisciplinary tumor boards managed their care than if they did not, according to a large, multicenter observational study.
Seeing a hepatologist or surgeon within 30 days of diagnosis also significantly improved 5-year overall survival, even after controlling for age, race, Charlson-Deyo comorbidity index, Barcelona Clinic Liver Cancer (BCLC) stage, academic center and geographic region of care, and the distance patients lived from the nearest Veterans Affairs transplant center, Marina Serper, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases. “More studies are needed to understand how to best use multidisciplinary tumor boards to improve the care of patients with hepatocellular carcinoma,” she said.
Outcomes data for hepatocellular carcinoma mostly come from clinical trials; transplant centers; and Surveillance, Epidemiology, and End Results-Medicare analyses, noted Dr. Serper of the University of Pennsylvania in Philadelphia.
For a better look at veterans, she and her associates combined administrative, laboratory, and death data with medical chart reviews and information from the Organ Procurement and Transplantation Network’s Standard Transplant Analysis and Research file. The initial cohort included more than 6,800 veterans whose ICD-9CM diagnosis code indicated a malignant hepatic neoplasm. Excluding patients with neoplasms such as cholangiocarcinoma and those managed outside the VA left 3,989 VA patients with hepatocellular carcinoma.
In the multivariable analysis, use of multidisciplinary tumor boards was associated with a statistically significant 13% improvement in 5-year overall survival (hazard ratio, 0.87; 95% confidence interval, 0.81-0.94; P less than .001). Improved survival also was linked with seeing certain specialists within 30 days of diagnosis, including hepatologists (HR, 0.77; P less than .001) and surgeons (HR, 0.72; P less than .001). Consulting with a hepatologist within 30 days of diagnosis, however, did not improve the chances of receiving curative therapy, such as liver transplantation, resection, local ablation, transarterial chemoembolization, or Y-90 radioembolization.
Care also varied substantially geographically and by academic affiliation, Dr. Serper noted. “Treatment of hepatocellular carcinoma is complex, as it depends as much on liver function as it does on tumor staging,” she emphasized. “Studies to improve multidisciplinary approaches for hepatocellular carcinoma in the community are needed to increase rates of curative therapy and improve clinical outcomes.”
Patients in this study averaged 62 years of age at diagnosis, 54% were white, 36% were within Milan criteria, and 45% had a Child-Turcotte-Pugh score of B or higher. Nearly 18% had macrovascular invasion at diagnosis, and 7% had metastatic disease. Nearly two-thirds of patients were BCLC stage A or B at diagnosis, and more than a third had underlying alcohol misuse and chronic hepatitis C virus infection.
The work was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA’s HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no relevant financial disclosures.
BOSTON – Veterans were about 13% less likely to die within 5 years of hepatocellular carcinoma diagnosis when multidisciplinary tumor boards managed their care than if they did not, according to a large, multicenter observational study.
Seeing a hepatologist or surgeon within 30 days of diagnosis also significantly improved 5-year overall survival, even after controlling for age, race, Charlson-Deyo comorbidity index, Barcelona Clinic Liver Cancer (BCLC) stage, academic center and geographic region of care, and the distance patients lived from the nearest Veterans Affairs transplant center, Marina Serper, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases. “More studies are needed to understand how to best use multidisciplinary tumor boards to improve the care of patients with hepatocellular carcinoma,” she said.
Outcomes data for hepatocellular carcinoma mostly come from clinical trials; transplant centers; and Surveillance, Epidemiology, and End Results-Medicare analyses, noted Dr. Serper of the University of Pennsylvania in Philadelphia.
For a better look at veterans, she and her associates combined administrative, laboratory, and death data with medical chart reviews and information from the Organ Procurement and Transplantation Network’s Standard Transplant Analysis and Research file. The initial cohort included more than 6,800 veterans whose ICD-9CM diagnosis code indicated a malignant hepatic neoplasm. Excluding patients with neoplasms such as cholangiocarcinoma and those managed outside the VA left 3,989 VA patients with hepatocellular carcinoma.
In the multivariable analysis, use of multidisciplinary tumor boards was associated with a statistically significant 13% improvement in 5-year overall survival (hazard ratio, 0.87; 95% confidence interval, 0.81-0.94; P less than .001). Improved survival also was linked with seeing certain specialists within 30 days of diagnosis, including hepatologists (HR, 0.77; P less than .001) and surgeons (HR, 0.72; P less than .001). Consulting with a hepatologist within 30 days of diagnosis, however, did not improve the chances of receiving curative therapy, such as liver transplantation, resection, local ablation, transarterial chemoembolization, or Y-90 radioembolization.
Care also varied substantially geographically and by academic affiliation, Dr. Serper noted. “Treatment of hepatocellular carcinoma is complex, as it depends as much on liver function as it does on tumor staging,” she emphasized. “Studies to improve multidisciplinary approaches for hepatocellular carcinoma in the community are needed to increase rates of curative therapy and improve clinical outcomes.”
Patients in this study averaged 62 years of age at diagnosis, 54% were white, 36% were within Milan criteria, and 45% had a Child-Turcotte-Pugh score of B or higher. Nearly 18% had macrovascular invasion at diagnosis, and 7% had metastatic disease. Nearly two-thirds of patients were BCLC stage A or B at diagnosis, and more than a third had underlying alcohol misuse and chronic hepatitis C virus infection.
The work was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA’s HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no relevant financial disclosures.
BOSTON – Veterans were about 13% less likely to die within 5 years of hepatocellular carcinoma diagnosis when multidisciplinary tumor boards managed their care than if they did not, according to a large, multicenter observational study.
Seeing a hepatologist or surgeon within 30 days of diagnosis also significantly improved 5-year overall survival, even after controlling for age, race, Charlson-Deyo comorbidity index, Barcelona Clinic Liver Cancer (BCLC) stage, academic center and geographic region of care, and the distance patients lived from the nearest Veterans Affairs transplant center, Marina Serper, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases. “More studies are needed to understand how to best use multidisciplinary tumor boards to improve the care of patients with hepatocellular carcinoma,” she said.
Outcomes data for hepatocellular carcinoma mostly come from clinical trials; transplant centers; and Surveillance, Epidemiology, and End Results-Medicare analyses, noted Dr. Serper of the University of Pennsylvania in Philadelphia.
For a better look at veterans, she and her associates combined administrative, laboratory, and death data with medical chart reviews and information from the Organ Procurement and Transplantation Network’s Standard Transplant Analysis and Research file. The initial cohort included more than 6,800 veterans whose ICD-9CM diagnosis code indicated a malignant hepatic neoplasm. Excluding patients with neoplasms such as cholangiocarcinoma and those managed outside the VA left 3,989 VA patients with hepatocellular carcinoma.
In the multivariable analysis, use of multidisciplinary tumor boards was associated with a statistically significant 13% improvement in 5-year overall survival (hazard ratio, 0.87; 95% confidence interval, 0.81-0.94; P less than .001). Improved survival also was linked with seeing certain specialists within 30 days of diagnosis, including hepatologists (HR, 0.77; P less than .001) and surgeons (HR, 0.72; P less than .001). Consulting with a hepatologist within 30 days of diagnosis, however, did not improve the chances of receiving curative therapy, such as liver transplantation, resection, local ablation, transarterial chemoembolization, or Y-90 radioembolization.
Care also varied substantially geographically and by academic affiliation, Dr. Serper noted. “Treatment of hepatocellular carcinoma is complex, as it depends as much on liver function as it does on tumor staging,” she emphasized. “Studies to improve multidisciplinary approaches for hepatocellular carcinoma in the community are needed to increase rates of curative therapy and improve clinical outcomes.”
Patients in this study averaged 62 years of age at diagnosis, 54% were white, 36% were within Milan criteria, and 45% had a Child-Turcotte-Pugh score of B or higher. Nearly 18% had macrovascular invasion at diagnosis, and 7% had metastatic disease. Nearly two-thirds of patients were BCLC stage A or B at diagnosis, and more than a third had underlying alcohol misuse and chronic hepatitis C virus infection.
The work was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA’s HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no relevant financial disclosures.
AT THE LIVER MEETING 2016
Key clinical point: The use of multidisciplinary tumor boards was associated with significantly improved overall survival in patients with hepatocellular carcinoma.
Major finding: The risk of death within 5 years dropped by about 13% (hazard ratio, 0.87; 95% confidence interval, 0.81-0.94; P less than .001).
Data source: A retrospective study of 3,989 Veterans Affairs patients with hepatocellular carcinoma.
Disclosures: The work was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA’s HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no relevant financial disclosures.
Discharging select diverticulitis patients from the ED found to be acceptable
CORONADO, CALIF. – Among patients diagnosed with diverticulitis via CT scan in the emergency department who were discharged home, only 13% required a return visit to the hospital, results from a long-term retrospective analysis demonstrated.
“In select patients whose assessment includes a CT scan, discharge to home from the emergency department with treatment for diverticulitis is safe,” study author Anne-Marie Sirany, MD, said at the annual meeting of the Western Surgical Association.
A few years ago, researchers conducted a randomized trial to evaluate the treatment of uncomplicated diverticulitis (Ann Surg. 2014;259[1]:38-44). Patients were diagnosed with diverticulitis in the emergency department and randomized to either hospital admission or outpatient management at home. The investigators found no significant differences between the readmission rates of the inpatient and outpatient groups, but the health care costs were three times lower in the outpatient group. Dr. Sirany and her associates set out to compare the outcomes of patients diagnosed with and treated for diverticulitis in the emergency department who were discharged to home, versus those who were admitted to the hospital. They reviewed the medical records of 240 patients with a primary diagnosis of diverticulitis by CT scan who were evaluated in the emergency department at one of four hospitals and one academic medical center from September 2010 to January 2012. The primary outcome was hospital readmission or return to the emergency department within 30 days, while the secondary outcomes were recurrent diverticulitis or surgical resection for diverticulitis.
The mean age of the 240 patients was 59 years, 45% were men, 22% had a Charlson Comorbidity Index (CCI) of greater than 2, and 7.5% were on steroids or immunosuppressant medications. More than half (62%) were admitted to the hospital, while the remaining 38% were discharged home on oral antibiotics. Compared with patients discharged home, those admitted to the hospital were more likely to be older than age 65 (43% vs. 24%, respectively; P = .003), have a CCI of 2 or greater (28% vs. 13%; P = .007), were more likely to be on immunosuppressant or steroid medications (11% vs. 1%; P = .003), show extraluminal air on CT (30% vs. 7%; P less than .0001), or show abscess on CT (19% vs. 1%; P less than .0001). “Of note: We did not have any patients who had CT scan findings of pneumoperitoneum who were discharged home, and 48% of patients admitted to the hospital had uncomplicated diverticulitis,” she said.
After a median follow-up of 37 months, no significant differences were observed between patients discharged to home and those admitted to the hospital in readmission or return to the emergency department (13% vs. 14%), recurrent diverticulitis (23% in each group), or in colon resection at subsequent encounter (16% vs. 19%). “Among patients discharged to home, only one patient required emergency surgery, and this was 20 months after their index admission,” Dr. Sirany said. “We think that the low rate of readmission in patients discharged home demonstrates that this is a safe approach to management of patients with diverticulitis, when using information from the CT scan.”
Closer analysis of patients who were discharged home revealed that six patients had extraluminal air on CT scan, three of whom returned to the emergency department or were admitted to the hospital. In addition, 11% of those with uncomplicated diverticulitis returned to the emergency department or were admitted to the hospital.
Dr. Sirany acknowledged certain limitations of the study, including its retrospective design, a lack of complete follow-up for all patients, and the fact that it included patients with recurrent diverticulitis. “Despite the limitations, we recommend that young, relatively healthy patients, with uncomplicated findings on CT scan, can be discharged to home and managed as an outpatient,” she said. “In an era where there’s increasing attention to health care costs, we need to think more critically about which patients need to be admitted for management of uncomplicated diverticulitis.” She reported having no financial disclosures.
[email protected]
CORONADO, CALIF. – Among patients diagnosed with diverticulitis via CT scan in the emergency department who were discharged home, only 13% required a return visit to the hospital, results from a long-term retrospective analysis demonstrated.
“In select patients whose assessment includes a CT scan, discharge to home from the emergency department with treatment for diverticulitis is safe,” study author Anne-Marie Sirany, MD, said at the annual meeting of the Western Surgical Association.
A few years ago, researchers conducted a randomized trial to evaluate the treatment of uncomplicated diverticulitis (Ann Surg. 2014;259[1]:38-44). Patients were diagnosed with diverticulitis in the emergency department and randomized to either hospital admission or outpatient management at home. The investigators found no significant differences between the readmission rates of the inpatient and outpatient groups, but the health care costs were three times lower in the outpatient group. Dr. Sirany and her associates set out to compare the outcomes of patients diagnosed with and treated for diverticulitis in the emergency department who were discharged to home, versus those who were admitted to the hospital. They reviewed the medical records of 240 patients with a primary diagnosis of diverticulitis by CT scan who were evaluated in the emergency department at one of four hospitals and one academic medical center from September 2010 to January 2012. The primary outcome was hospital readmission or return to the emergency department within 30 days, while the secondary outcomes were recurrent diverticulitis or surgical resection for diverticulitis.
The mean age of the 240 patients was 59 years, 45% were men, 22% had a Charlson Comorbidity Index (CCI) of greater than 2, and 7.5% were on steroids or immunosuppressant medications. More than half (62%) were admitted to the hospital, while the remaining 38% were discharged home on oral antibiotics. Compared with patients discharged home, those admitted to the hospital were more likely to be older than age 65 (43% vs. 24%, respectively; P = .003), have a CCI of 2 or greater (28% vs. 13%; P = .007), were more likely to be on immunosuppressant or steroid medications (11% vs. 1%; P = .003), show extraluminal air on CT (30% vs. 7%; P less than .0001), or show abscess on CT (19% vs. 1%; P less than .0001). “Of note: We did not have any patients who had CT scan findings of pneumoperitoneum who were discharged home, and 48% of patients admitted to the hospital had uncomplicated diverticulitis,” she said.
After a median follow-up of 37 months, no significant differences were observed between patients discharged to home and those admitted to the hospital in readmission or return to the emergency department (13% vs. 14%), recurrent diverticulitis (23% in each group), or in colon resection at subsequent encounter (16% vs. 19%). “Among patients discharged to home, only one patient required emergency surgery, and this was 20 months after their index admission,” Dr. Sirany said. “We think that the low rate of readmission in patients discharged home demonstrates that this is a safe approach to management of patients with diverticulitis, when using information from the CT scan.”
Closer analysis of patients who were discharged home revealed that six patients had extraluminal air on CT scan, three of whom returned to the emergency department or were admitted to the hospital. In addition, 11% of those with uncomplicated diverticulitis returned to the emergency department or were admitted to the hospital.
Dr. Sirany acknowledged certain limitations of the study, including its retrospective design, a lack of complete follow-up for all patients, and the fact that it included patients with recurrent diverticulitis. “Despite the limitations, we recommend that young, relatively healthy patients, with uncomplicated findings on CT scan, can be discharged to home and managed as an outpatient,” she said. “In an era where there’s increasing attention to health care costs, we need to think more critically about which patients need to be admitted for management of uncomplicated diverticulitis.” She reported having no financial disclosures.
[email protected]
CORONADO, CALIF. – Among patients diagnosed with diverticulitis via CT scan in the emergency department who were discharged home, only 13% required a return visit to the hospital, results from a long-term retrospective analysis demonstrated.
“In select patients whose assessment includes a CT scan, discharge to home from the emergency department with treatment for diverticulitis is safe,” study author Anne-Marie Sirany, MD, said at the annual meeting of the Western Surgical Association.
A few years ago, researchers conducted a randomized trial to evaluate the treatment of uncomplicated diverticulitis (Ann Surg. 2014;259[1]:38-44). Patients were diagnosed with diverticulitis in the emergency department and randomized to either hospital admission or outpatient management at home. The investigators found no significant differences between the readmission rates of the inpatient and outpatient groups, but the health care costs were three times lower in the outpatient group. Dr. Sirany and her associates set out to compare the outcomes of patients diagnosed with and treated for diverticulitis in the emergency department who were discharged to home, versus those who were admitted to the hospital. They reviewed the medical records of 240 patients with a primary diagnosis of diverticulitis by CT scan who were evaluated in the emergency department at one of four hospitals and one academic medical center from September 2010 to January 2012. The primary outcome was hospital readmission or return to the emergency department within 30 days, while the secondary outcomes were recurrent diverticulitis or surgical resection for diverticulitis.
The mean age of the 240 patients was 59 years, 45% were men, 22% had a Charlson Comorbidity Index (CCI) of greater than 2, and 7.5% were on steroids or immunosuppressant medications. More than half (62%) were admitted to the hospital, while the remaining 38% were discharged home on oral antibiotics. Compared with patients discharged home, those admitted to the hospital were more likely to be older than age 65 (43% vs. 24%, respectively; P = .003), have a CCI of 2 or greater (28% vs. 13%; P = .007), were more likely to be on immunosuppressant or steroid medications (11% vs. 1%; P = .003), show extraluminal air on CT (30% vs. 7%; P less than .0001), or show abscess on CT (19% vs. 1%; P less than .0001). “Of note: We did not have any patients who had CT scan findings of pneumoperitoneum who were discharged home, and 48% of patients admitted to the hospital had uncomplicated diverticulitis,” she said.
After a median follow-up of 37 months, no significant differences were observed between patients discharged to home and those admitted to the hospital in readmission or return to the emergency department (13% vs. 14%), recurrent diverticulitis (23% in each group), or in colon resection at subsequent encounter (16% vs. 19%). “Among patients discharged to home, only one patient required emergency surgery, and this was 20 months after their index admission,” Dr. Sirany said. “We think that the low rate of readmission in patients discharged home demonstrates that this is a safe approach to management of patients with diverticulitis, when using information from the CT scan.”
Closer analysis of patients who were discharged home revealed that six patients had extraluminal air on CT scan, three of whom returned to the emergency department or were admitted to the hospital. In addition, 11% of those with uncomplicated diverticulitis returned to the emergency department or were admitted to the hospital.
Dr. Sirany acknowledged certain limitations of the study, including its retrospective design, a lack of complete follow-up for all patients, and the fact that it included patients with recurrent diverticulitis. “Despite the limitations, we recommend that young, relatively healthy patients, with uncomplicated findings on CT scan, can be discharged to home and managed as an outpatient,” she said. “In an era where there’s increasing attention to health care costs, we need to think more critically about which patients need to be admitted for management of uncomplicated diverticulitis.” She reported having no financial disclosures.
[email protected]
AT WSA 2016
Key clinical point:
Major finding: After a median follow-up of 37 months, no significant differences were observed between patients discharged to home and those admitted to the hospital in readmission or return to the emergency department (13% vs. 14%, respectively).
Data source: A retrospective review of 240 patients with a primary diagnosis of diverticulitis by CT scan who were evaluated in the emergency department at one of four hospitals and one academic medical center from September 2010 to January 2012.
Disclosures: Dr. Sirany reported having no financial disclosures.
Emergent colon cancer resection does not negatively affect patient outcomes
CORONADO, CALIF. – With the exception of patients that present with perforation, emergent resection of colon cancers does not appear to adversely affect operative outcomes or patient survival, a 3-year analysis of data showed.
At the annual meeting of the Western Surgical Association, Jason W. Smith, MD, said that of the estimated 106,100 new cases of colon cancer each year, 6%-30% of patients have symptoms or late complications related to the disease that require an emergency intervention, often leading to dismal outcomes. “The problem with many existing studies of emergent colon cancer resections is that they tend to throw everybody into one large group, making it difficult to compare some of these patients,” said Dr. Smith, a trauma surgeon in the department of surgery at the University of Louisville (Ky.) School of Medicine. “Our thought was, if we provide an appropriate oncologic resection at the time of our initial management in these patients when they come to the emergency department, can we affect the similar rate of overall outcomes for these patients with regard to their cancer prognosis?”
Of the 117 patients in the emergent group, 35 had a perforation and 82 had an emergent resection. In an unmatched analysis comparing perforation, emergent resection, and elective resection, the patients who presented with a perforation had a much higher Charlson Comorbidity Index (CCI) score and a higher American Society of Anesthesiologists (ASA) class. They tended to be on vasopressors or suffering from inflammatory response related to their perforation, they had lower levels of blood pressure and hemoglobin, and they had much higher rates of 30-day mortality and overall 30-day morbidity, compared with their counterparts in the other two groups. Of the eight deaths that occurred in patients with colon perforation, four were related to sepsis and multiple organ failure, one to respiratory failure/acute respiratory distress syndrome, one to acute MI, one to exacerbation of chronic lung disease, and one to transition to palliative care due to cancer diagnosis. “So the overall predominance of the deaths associated in the first 30 days were related to the inflammatory responses associated with that perforation, not specific to the cancer itself,” Dr. Smith said. At the same time, the ASA and CCI scores were not different between those with morbidity/mortality and those who survived. “So it’s difficult to identify these patients out of the gate,” he said.
When the researchers more closely examined data from patients with a perforation, 27 of 35 (77%) survived at 30 days. Survival at 1, 2, and 3 years was 78%, 57%, and 43%, respectively. “This is a mixture of stage II and stage IV patients, so they’re difficult to compare and difficult to standardize across the board,” Dr. Smith noted. “But what you see is that their survival is not significantly different related to their disease if you discount the inflammatory process. Our initial thought was that for these perforated cancers, what we really need to do is provide the appropriate oncologic resection management [in order to] get the same oncologic outcomes.”
Next, the researchers compared the 82 patients who presented without a perforation but required an emergent operation with 82 of the elective surgery patients, matched for age, gender, the CCI, ASA class, oncology stage, and body mass index. There were no differences between the two groups in terms of R0 resection, the number of lymph nodes sampled, or estimated blood loss. However, compared with patients in the elective resection group, those in the emergent resection group had higher rates of ostomy placement (30% vs. 10%, respectively; P = .01), and a longer hospital length of stay (an average of 18 vs. 12 days; P = .0007). “Most of that difference occurred on the front end of hospital stays,” Dr. Smith said. “Their postoperative days were not significantly different.”
As for long-term outcomes, more than 90% of all patients in both groups received chemotherapy within the first year postprocedure, and overall time to initiation of chemotherapy was not significantly different in the emergent vs. elective groups (6.6 vs. 5.5 weeks, respectively; P = .43). However, patients suffering postsurgical complications had an increased risk of delayed chemotherapy.
In a risk-adjusted analysis, overall survival at 3 years was not different between the emergent and elective operation groups (hazard ratio, 1.1; P = .54). Similarly, disease-free survival was not different at 3 years between the two groups (HR, 1.06; P = .84). Independent predictors of poor long-term outcome included age greater than 70 (HR, 1.45; P less than 0.03); elevated ASA class (HR, 2.99 for class III vs. class I-II; P = .08; and HR, 7.45 for ASA class IV vs. I-II; P = .03); presence of residual disease (HR, 3.08; P less than .001), and advanced cancer stage.
He acknowledged certain limitations of the study, including the fact that it was a blinded retrospective cohort with the potential for unrecognized bias, and that it measured 3-year survival instead of 5-year survival data.
“Emergent resection of nonperforated colon cancers does not appear to adversely affect operative outcomes or patient survival when proper oncologic principles are applied to their initial management,” Dr. Smith concluded. “Outcome differences in patients suffering perforation may correlate with the physiologic derangements associated with the perforation rather than the oncologic disease; thus, every effort should be made to provide an appropriate oncologic operation.” He reported having no financial disclosures.
[email protected]
CORONADO, CALIF. – With the exception of patients that present with perforation, emergent resection of colon cancers does not appear to adversely affect operative outcomes or patient survival, a 3-year analysis of data showed.
At the annual meeting of the Western Surgical Association, Jason W. Smith, MD, said that of the estimated 106,100 new cases of colon cancer each year, 6%-30% of patients have symptoms or late complications related to the disease that require an emergency intervention, often leading to dismal outcomes. “The problem with many existing studies of emergent colon cancer resections is that they tend to throw everybody into one large group, making it difficult to compare some of these patients,” said Dr. Smith, a trauma surgeon in the department of surgery at the University of Louisville (Ky.) School of Medicine. “Our thought was, if we provide an appropriate oncologic resection at the time of our initial management in these patients when they come to the emergency department, can we affect the similar rate of overall outcomes for these patients with regard to their cancer prognosis?”
Of the 117 patients in the emergent group, 35 had a perforation and 82 had an emergent resection. In an unmatched analysis comparing perforation, emergent resection, and elective resection, the patients who presented with a perforation had a much higher Charlson Comorbidity Index (CCI) score and a higher American Society of Anesthesiologists (ASA) class. They tended to be on vasopressors or suffering from inflammatory response related to their perforation, they had lower levels of blood pressure and hemoglobin, and they had much higher rates of 30-day mortality and overall 30-day morbidity, compared with their counterparts in the other two groups. Of the eight deaths that occurred in patients with colon perforation, four were related to sepsis and multiple organ failure, one to respiratory failure/acute respiratory distress syndrome, one to acute MI, one to exacerbation of chronic lung disease, and one to transition to palliative care due to cancer diagnosis. “So the overall predominance of the deaths associated in the first 30 days were related to the inflammatory responses associated with that perforation, not specific to the cancer itself,” Dr. Smith said. At the same time, the ASA and CCI scores were not different between those with morbidity/mortality and those who survived. “So it’s difficult to identify these patients out of the gate,” he said.
When the researchers more closely examined data from patients with a perforation, 27 of 35 (77%) survived at 30 days. Survival at 1, 2, and 3 years was 78%, 57%, and 43%, respectively. “This is a mixture of stage II and stage IV patients, so they’re difficult to compare and difficult to standardize across the board,” Dr. Smith noted. “But what you see is that their survival is not significantly different related to their disease if you discount the inflammatory process. Our initial thought was that for these perforated cancers, what we really need to do is provide the appropriate oncologic resection management [in order to] get the same oncologic outcomes.”
Next, the researchers compared the 82 patients who presented without a perforation but required an emergent operation with 82 of the elective surgery patients, matched for age, gender, the CCI, ASA class, oncology stage, and body mass index. There were no differences between the two groups in terms of R0 resection, the number of lymph nodes sampled, or estimated blood loss. However, compared with patients in the elective resection group, those in the emergent resection group had higher rates of ostomy placement (30% vs. 10%, respectively; P = .01), and a longer hospital length of stay (an average of 18 vs. 12 days; P = .0007). “Most of that difference occurred on the front end of hospital stays,” Dr. Smith said. “Their postoperative days were not significantly different.”
As for long-term outcomes, more than 90% of all patients in both groups received chemotherapy within the first year postprocedure, and overall time to initiation of chemotherapy was not significantly different in the emergent vs. elective groups (6.6 vs. 5.5 weeks, respectively; P = .43). However, patients suffering postsurgical complications had an increased risk of delayed chemotherapy.
In a risk-adjusted analysis, overall survival at 3 years was not different between the emergent and elective operation groups (hazard ratio, 1.1; P = .54). Similarly, disease-free survival was not different at 3 years between the two groups (HR, 1.06; P = .84). Independent predictors of poor long-term outcome included age greater than 70 (HR, 1.45; P less than 0.03); elevated ASA class (HR, 2.99 for class III vs. class I-II; P = .08; and HR, 7.45 for ASA class IV vs. I-II; P = .03); presence of residual disease (HR, 3.08; P less than .001), and advanced cancer stage.
He acknowledged certain limitations of the study, including the fact that it was a blinded retrospective cohort with the potential for unrecognized bias, and that it measured 3-year survival instead of 5-year survival data.
“Emergent resection of nonperforated colon cancers does not appear to adversely affect operative outcomes or patient survival when proper oncologic principles are applied to their initial management,” Dr. Smith concluded. “Outcome differences in patients suffering perforation may correlate with the physiologic derangements associated with the perforation rather than the oncologic disease; thus, every effort should be made to provide an appropriate oncologic operation.” He reported having no financial disclosures.
[email protected]
CORONADO, CALIF. – With the exception of patients that present with perforation, emergent resection of colon cancers does not appear to adversely affect operative outcomes or patient survival, a 3-year analysis of data showed.
At the annual meeting of the Western Surgical Association, Jason W. Smith, MD, said that of the estimated 106,100 new cases of colon cancer each year, 6%-30% of patients have symptoms or late complications related to the disease that require an emergency intervention, often leading to dismal outcomes. “The problem with many existing studies of emergent colon cancer resections is that they tend to throw everybody into one large group, making it difficult to compare some of these patients,” said Dr. Smith, a trauma surgeon in the department of surgery at the University of Louisville (Ky.) School of Medicine. “Our thought was, if we provide an appropriate oncologic resection at the time of our initial management in these patients when they come to the emergency department, can we affect the similar rate of overall outcomes for these patients with regard to their cancer prognosis?”
Of the 117 patients in the emergent group, 35 had a perforation and 82 had an emergent resection. In an unmatched analysis comparing perforation, emergent resection, and elective resection, the patients who presented with a perforation had a much higher Charlson Comorbidity Index (CCI) score and a higher American Society of Anesthesiologists (ASA) class. They tended to be on vasopressors or suffering from inflammatory response related to their perforation, they had lower levels of blood pressure and hemoglobin, and they had much higher rates of 30-day mortality and overall 30-day morbidity, compared with their counterparts in the other two groups. Of the eight deaths that occurred in patients with colon perforation, four were related to sepsis and multiple organ failure, one to respiratory failure/acute respiratory distress syndrome, one to acute MI, one to exacerbation of chronic lung disease, and one to transition to palliative care due to cancer diagnosis. “So the overall predominance of the deaths associated in the first 30 days were related to the inflammatory responses associated with that perforation, not specific to the cancer itself,” Dr. Smith said. At the same time, the ASA and CCI scores were not different between those with morbidity/mortality and those who survived. “So it’s difficult to identify these patients out of the gate,” he said.
When the researchers more closely examined data from patients with a perforation, 27 of 35 (77%) survived at 30 days. Survival at 1, 2, and 3 years was 78%, 57%, and 43%, respectively. “This is a mixture of stage II and stage IV patients, so they’re difficult to compare and difficult to standardize across the board,” Dr. Smith noted. “But what you see is that their survival is not significantly different related to their disease if you discount the inflammatory process. Our initial thought was that for these perforated cancers, what we really need to do is provide the appropriate oncologic resection management [in order to] get the same oncologic outcomes.”
Next, the researchers compared the 82 patients who presented without a perforation but required an emergent operation with 82 of the elective surgery patients, matched for age, gender, the CCI, ASA class, oncology stage, and body mass index. There were no differences between the two groups in terms of R0 resection, the number of lymph nodes sampled, or estimated blood loss. However, compared with patients in the elective resection group, those in the emergent resection group had higher rates of ostomy placement (30% vs. 10%, respectively; P = .01), and a longer hospital length of stay (an average of 18 vs. 12 days; P = .0007). “Most of that difference occurred on the front end of hospital stays,” Dr. Smith said. “Their postoperative days were not significantly different.”
As for long-term outcomes, more than 90% of all patients in both groups received chemotherapy within the first year postprocedure, and overall time to initiation of chemotherapy was not significantly different in the emergent vs. elective groups (6.6 vs. 5.5 weeks, respectively; P = .43). However, patients suffering postsurgical complications had an increased risk of delayed chemotherapy.
In a risk-adjusted analysis, overall survival at 3 years was not different between the emergent and elective operation groups (hazard ratio, 1.1; P = .54). Similarly, disease-free survival was not different at 3 years between the two groups (HR, 1.06; P = .84). Independent predictors of poor long-term outcome included age greater than 70 (HR, 1.45; P less than 0.03); elevated ASA class (HR, 2.99 for class III vs. class I-II; P = .08; and HR, 7.45 for ASA class IV vs. I-II; P = .03); presence of residual disease (HR, 3.08; P less than .001), and advanced cancer stage.
He acknowledged certain limitations of the study, including the fact that it was a blinded retrospective cohort with the potential for unrecognized bias, and that it measured 3-year survival instead of 5-year survival data.
“Emergent resection of nonperforated colon cancers does not appear to adversely affect operative outcomes or patient survival when proper oncologic principles are applied to their initial management,” Dr. Smith concluded. “Outcome differences in patients suffering perforation may correlate with the physiologic derangements associated with the perforation rather than the oncologic disease; thus, every effort should be made to provide an appropriate oncologic operation.” He reported having no financial disclosures.
[email protected]
AT WSA 2016
Key clinical point:
Major finding: In a risk-adjusted analysis, overall survival at 3 years was not different between the emergent and elective operation groups (HR, 1.1; P = .54).
Data source: A retrospective review of 548 elective and emergent colectomies for colon cancer performed at the University of Louisville (Ky.) from 2011 to 2015.
Disclosures: Dr. Smith reported having no financial disclosures.
Risk stratification important for aortic valve disease in pregnancy
CHICAGO – Pregnancy-associated hemodynamic and physiologic changes can challenge hearts with diseased aortic valves. Understanding pregnancy’s toll on the body can help physicians take better care of pregnant women with aortic stenosis or aortic regurgitation, said Patrick T. O’Gara, MD. “This is a relatively infrequent condition, and it causes all of us a great deal of apprehension,” he said.
Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston, walked attendees through current recommendations for caring for pregnant women with aortic valve disease in a presentation at the annual Heart Valve Summit.
When talking to women with aortic valve disease, it’s important to let them know that a pregnancy during which they experience an adverse maternal cardiac event appears to increase their risk for later events as well, said Dr. O’Gara. One study of pregnancy in women with aortic valve disease, said Dr. O’Gara, found that the risk of later events for women who had had a cardiac event in pregnancy was 27% plus or minus 9 percentage points in the 5 years following pregnancy, while the risk was just 15% plus or minus 3 percentage points for women whose pregnancies were not complicated by cardiac adverse events (P = .02) (Heart. 2010 Oct;96(20):1656-61).
The World Health Organization classification of pregnancy risk, said Dr. O’Gara, provides some guidance. Patients who are WHO class III are considered to be high risk; pregnancy in these individuals calls for counseling and a multidisciplinary care team. Patients who fall into this class are those with mechanical heart valves, those with Marfan syndrome and aortic involvement with a valve diameter of 40-45 mm, and those with bicuspid aortic valve disease with a valve diameter of 45-50 mm.
WHO class IV patients, according to the guidelines, are at prohibitive risk. These patients should consider terminating a pregnancy if one occurs. Conditions that place women into WHO class IV include symptomatic severe aortic stenosis (AS), severe left ventricular dysfunction with an ejection fraction less than 40%, and severe coarctation of the aorta. Women with Marfan syndrome with aortic valve diameters greater than 45 mm and women with bicuspid aortic valves and a diameter over 50 mm also fall into this category of prohibitive risk.
If a physician is lucky enough to have a pre-conception relationship with a patient, then a host of considerations can come into play. In addition to cardiac risk stratification, obstetric and intrapartum risk to the mother as well as neonatal risk should be considered. Some factors to take into account are maternal life expectancy and potential long-term complications to the mother from pregnancy and childbirth.
Plasma volume increases rapidly through the first trimester, plateauing about halfway through pregnancy. With this normal dilutional anemia, “Most normal pregnancies are accompanied by a grade II systolic murmur, best heard at the upper left sternal border,” said Dr. O’Gara. Since stroke volume and heart rate both also increase through pregnancy, cardiac output goes up as well.
“Importantly, systemic vascular resistance is reduced throughout pregnancy,” said Dr. O’Gara. Consequently, “regurgitant heart valve problems are generally much better tolerated than stenotic lesions in pregnancy. That’s physiologic principle number one.”
In labor, abrupt hemodynamic changes include increases in cardiac output, heart rate, blood pressure, and venous return. “Labor and delivery are very stressful hemodynamic times for women,” said Dr. O’Gara.
In the immediate postpartum period, uterine contraction results in a return of a significant amount of blood to the maternal circulation. This effectively creates an autotransfusion, with resulting increased preload and cardiac output. The inferior vena cava is also freed from the pressure of a gravid uterus, increasing venous return further. Finally, there’s also a marked increase in systemic vascular resistance.
Aside from the risk of adverse cardiac events, other adverse outcomes for women can include an increased risk of premature rupture of membranes and postpartum hemorrhage. For the neonate, preterm birth and respiratory distress are more likely. Newborns are more likely to be small for gestational age, to suffer intraventricular hemorrhage, and to die. Depending on the parental genetic status, the infant may be at risk of congenital heart disease as well.
Neonatal risk may also be increased, said Dr. O’Gara. Some maternal conditions that can increase risk for the infant include a baseline New York Heart Association (NYHA) class of greater than II or having cyanosis; having a left heart obstruction; being a smoker; having a multiple gestation; having a mechanical heart valve; and taking an oral anticoagulant.
Ideally, a full discussion would include a genetic referral if indicated, as well as coordination with a gynecologist or primary care provider to provide contraception and to assist with planning for and optimizing outcomes of a pregnancy.
The American College of Cardiology and the American Heart Association have issued guidelines that include a class I recommendation regarding valve intervention before pregnancy for symptomatic patients with severe AS (those with aortic velocity of at least 4.0 m/sec, or mean pressure gradient greater than 41 mm Hg; stage D). For patients who meet the same hemodynamic criteria for severe AS but who are asymptomatic (stage C), the guidelines have a class IIa recommendation that pre-pregnancy valve intervention is “reasonable.” These recommendations have level C evidence supporting them.
However, another class IIa recommendation for patients with severe AS who are already pregnant advises valve intervention only in the case of hemodynamic deterioration, or the development of NYHA class III to IV heart failure symptoms. This is backed by grade B evidence, according to the associations.
For aortic regurgitation (AR), a level I recommendation advises valve repair or replacement before pregnancy if patients are symptomatic and have severe (stage D) regurgitation. Pregnant patients with severe regurgitation should only be considered for a valve operation if they have refractory NYHA class IV heart failure symptoms. These recommendations have level C evidence supporting them.
Since AR is better tolerated in pregnancy than AS, the nature of the valve disease is one of many factors to consider when deciding whether to perform intervention before the patient becomes pregnant. Plans for future pregnancy may also affect the choice of prosthesis, as anticoagulation management during pregnancy can be extremely tricky.
The recommendations overall make clear that, based on available evidence, “there should be a high threshold for intervention during pregnancy,” said Dr. O’Gara. And no one should go it alone when taking care of these complicated patients. “Care of pregnant women with heart disease requires coordination with a multidisciplinary team,” he said.
Dr. O’Gara reported no relevant disclosures.
[email protected]
On Twitter @karioakes
CHICAGO – Pregnancy-associated hemodynamic and physiologic changes can challenge hearts with diseased aortic valves. Understanding pregnancy’s toll on the body can help physicians take better care of pregnant women with aortic stenosis or aortic regurgitation, said Patrick T. O’Gara, MD. “This is a relatively infrequent condition, and it causes all of us a great deal of apprehension,” he said.
Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston, walked attendees through current recommendations for caring for pregnant women with aortic valve disease in a presentation at the annual Heart Valve Summit.
When talking to women with aortic valve disease, it’s important to let them know that a pregnancy during which they experience an adverse maternal cardiac event appears to increase their risk for later events as well, said Dr. O’Gara. One study of pregnancy in women with aortic valve disease, said Dr. O’Gara, found that the risk of later events for women who had had a cardiac event in pregnancy was 27% plus or minus 9 percentage points in the 5 years following pregnancy, while the risk was just 15% plus or minus 3 percentage points for women whose pregnancies were not complicated by cardiac adverse events (P = .02) (Heart. 2010 Oct;96(20):1656-61).
The World Health Organization classification of pregnancy risk, said Dr. O’Gara, provides some guidance. Patients who are WHO class III are considered to be high risk; pregnancy in these individuals calls for counseling and a multidisciplinary care team. Patients who fall into this class are those with mechanical heart valves, those with Marfan syndrome and aortic involvement with a valve diameter of 40-45 mm, and those with bicuspid aortic valve disease with a valve diameter of 45-50 mm.
WHO class IV patients, according to the guidelines, are at prohibitive risk. These patients should consider terminating a pregnancy if one occurs. Conditions that place women into WHO class IV include symptomatic severe aortic stenosis (AS), severe left ventricular dysfunction with an ejection fraction less than 40%, and severe coarctation of the aorta. Women with Marfan syndrome with aortic valve diameters greater than 45 mm and women with bicuspid aortic valves and a diameter over 50 mm also fall into this category of prohibitive risk.
If a physician is lucky enough to have a pre-conception relationship with a patient, then a host of considerations can come into play. In addition to cardiac risk stratification, obstetric and intrapartum risk to the mother as well as neonatal risk should be considered. Some factors to take into account are maternal life expectancy and potential long-term complications to the mother from pregnancy and childbirth.
Plasma volume increases rapidly through the first trimester, plateauing about halfway through pregnancy. With this normal dilutional anemia, “Most normal pregnancies are accompanied by a grade II systolic murmur, best heard at the upper left sternal border,” said Dr. O’Gara. Since stroke volume and heart rate both also increase through pregnancy, cardiac output goes up as well.
“Importantly, systemic vascular resistance is reduced throughout pregnancy,” said Dr. O’Gara. Consequently, “regurgitant heart valve problems are generally much better tolerated than stenotic lesions in pregnancy. That’s physiologic principle number one.”
In labor, abrupt hemodynamic changes include increases in cardiac output, heart rate, blood pressure, and venous return. “Labor and delivery are very stressful hemodynamic times for women,” said Dr. O’Gara.
In the immediate postpartum period, uterine contraction results in a return of a significant amount of blood to the maternal circulation. This effectively creates an autotransfusion, with resulting increased preload and cardiac output. The inferior vena cava is also freed from the pressure of a gravid uterus, increasing venous return further. Finally, there’s also a marked increase in systemic vascular resistance.
Aside from the risk of adverse cardiac events, other adverse outcomes for women can include an increased risk of premature rupture of membranes and postpartum hemorrhage. For the neonate, preterm birth and respiratory distress are more likely. Newborns are more likely to be small for gestational age, to suffer intraventricular hemorrhage, and to die. Depending on the parental genetic status, the infant may be at risk of congenital heart disease as well.
Neonatal risk may also be increased, said Dr. O’Gara. Some maternal conditions that can increase risk for the infant include a baseline New York Heart Association (NYHA) class of greater than II or having cyanosis; having a left heart obstruction; being a smoker; having a multiple gestation; having a mechanical heart valve; and taking an oral anticoagulant.
Ideally, a full discussion would include a genetic referral if indicated, as well as coordination with a gynecologist or primary care provider to provide contraception and to assist with planning for and optimizing outcomes of a pregnancy.
The American College of Cardiology and the American Heart Association have issued guidelines that include a class I recommendation regarding valve intervention before pregnancy for symptomatic patients with severe AS (those with aortic velocity of at least 4.0 m/sec, or mean pressure gradient greater than 41 mm Hg; stage D). For patients who meet the same hemodynamic criteria for severe AS but who are asymptomatic (stage C), the guidelines have a class IIa recommendation that pre-pregnancy valve intervention is “reasonable.” These recommendations have level C evidence supporting them.
However, another class IIa recommendation for patients with severe AS who are already pregnant advises valve intervention only in the case of hemodynamic deterioration, or the development of NYHA class III to IV heart failure symptoms. This is backed by grade B evidence, according to the associations.
For aortic regurgitation (AR), a level I recommendation advises valve repair or replacement before pregnancy if patients are symptomatic and have severe (stage D) regurgitation. Pregnant patients with severe regurgitation should only be considered for a valve operation if they have refractory NYHA class IV heart failure symptoms. These recommendations have level C evidence supporting them.
Since AR is better tolerated in pregnancy than AS, the nature of the valve disease is one of many factors to consider when deciding whether to perform intervention before the patient becomes pregnant. Plans for future pregnancy may also affect the choice of prosthesis, as anticoagulation management during pregnancy can be extremely tricky.
The recommendations overall make clear that, based on available evidence, “there should be a high threshold for intervention during pregnancy,” said Dr. O’Gara. And no one should go it alone when taking care of these complicated patients. “Care of pregnant women with heart disease requires coordination with a multidisciplinary team,” he said.
Dr. O’Gara reported no relevant disclosures.
[email protected]
On Twitter @karioakes
CHICAGO – Pregnancy-associated hemodynamic and physiologic changes can challenge hearts with diseased aortic valves. Understanding pregnancy’s toll on the body can help physicians take better care of pregnant women with aortic stenosis or aortic regurgitation, said Patrick T. O’Gara, MD. “This is a relatively infrequent condition, and it causes all of us a great deal of apprehension,” he said.
Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston, walked attendees through current recommendations for caring for pregnant women with aortic valve disease in a presentation at the annual Heart Valve Summit.
When talking to women with aortic valve disease, it’s important to let them know that a pregnancy during which they experience an adverse maternal cardiac event appears to increase their risk for later events as well, said Dr. O’Gara. One study of pregnancy in women with aortic valve disease, said Dr. O’Gara, found that the risk of later events for women who had had a cardiac event in pregnancy was 27% plus or minus 9 percentage points in the 5 years following pregnancy, while the risk was just 15% plus or minus 3 percentage points for women whose pregnancies were not complicated by cardiac adverse events (P = .02) (Heart. 2010 Oct;96(20):1656-61).
The World Health Organization classification of pregnancy risk, said Dr. O’Gara, provides some guidance. Patients who are WHO class III are considered to be high risk; pregnancy in these individuals calls for counseling and a multidisciplinary care team. Patients who fall into this class are those with mechanical heart valves, those with Marfan syndrome and aortic involvement with a valve diameter of 40-45 mm, and those with bicuspid aortic valve disease with a valve diameter of 45-50 mm.
WHO class IV patients, according to the guidelines, are at prohibitive risk. These patients should consider terminating a pregnancy if one occurs. Conditions that place women into WHO class IV include symptomatic severe aortic stenosis (AS), severe left ventricular dysfunction with an ejection fraction less than 40%, and severe coarctation of the aorta. Women with Marfan syndrome with aortic valve diameters greater than 45 mm and women with bicuspid aortic valves and a diameter over 50 mm also fall into this category of prohibitive risk.
If a physician is lucky enough to have a pre-conception relationship with a patient, then a host of considerations can come into play. In addition to cardiac risk stratification, obstetric and intrapartum risk to the mother as well as neonatal risk should be considered. Some factors to take into account are maternal life expectancy and potential long-term complications to the mother from pregnancy and childbirth.
Plasma volume increases rapidly through the first trimester, plateauing about halfway through pregnancy. With this normal dilutional anemia, “Most normal pregnancies are accompanied by a grade II systolic murmur, best heard at the upper left sternal border,” said Dr. O’Gara. Since stroke volume and heart rate both also increase through pregnancy, cardiac output goes up as well.
“Importantly, systemic vascular resistance is reduced throughout pregnancy,” said Dr. O’Gara. Consequently, “regurgitant heart valve problems are generally much better tolerated than stenotic lesions in pregnancy. That’s physiologic principle number one.”
In labor, abrupt hemodynamic changes include increases in cardiac output, heart rate, blood pressure, and venous return. “Labor and delivery are very stressful hemodynamic times for women,” said Dr. O’Gara.
In the immediate postpartum period, uterine contraction results in a return of a significant amount of blood to the maternal circulation. This effectively creates an autotransfusion, with resulting increased preload and cardiac output. The inferior vena cava is also freed from the pressure of a gravid uterus, increasing venous return further. Finally, there’s also a marked increase in systemic vascular resistance.
Aside from the risk of adverse cardiac events, other adverse outcomes for women can include an increased risk of premature rupture of membranes and postpartum hemorrhage. For the neonate, preterm birth and respiratory distress are more likely. Newborns are more likely to be small for gestational age, to suffer intraventricular hemorrhage, and to die. Depending on the parental genetic status, the infant may be at risk of congenital heart disease as well.
Neonatal risk may also be increased, said Dr. O’Gara. Some maternal conditions that can increase risk for the infant include a baseline New York Heart Association (NYHA) class of greater than II or having cyanosis; having a left heart obstruction; being a smoker; having a multiple gestation; having a mechanical heart valve; and taking an oral anticoagulant.
Ideally, a full discussion would include a genetic referral if indicated, as well as coordination with a gynecologist or primary care provider to provide contraception and to assist with planning for and optimizing outcomes of a pregnancy.
The American College of Cardiology and the American Heart Association have issued guidelines that include a class I recommendation regarding valve intervention before pregnancy for symptomatic patients with severe AS (those with aortic velocity of at least 4.0 m/sec, or mean pressure gradient greater than 41 mm Hg; stage D). For patients who meet the same hemodynamic criteria for severe AS but who are asymptomatic (stage C), the guidelines have a class IIa recommendation that pre-pregnancy valve intervention is “reasonable.” These recommendations have level C evidence supporting them.
However, another class IIa recommendation for patients with severe AS who are already pregnant advises valve intervention only in the case of hemodynamic deterioration, or the development of NYHA class III to IV heart failure symptoms. This is backed by grade B evidence, according to the associations.
For aortic regurgitation (AR), a level I recommendation advises valve repair or replacement before pregnancy if patients are symptomatic and have severe (stage D) regurgitation. Pregnant patients with severe regurgitation should only be considered for a valve operation if they have refractory NYHA class IV heart failure symptoms. These recommendations have level C evidence supporting them.
Since AR is better tolerated in pregnancy than AS, the nature of the valve disease is one of many factors to consider when deciding whether to perform intervention before the patient becomes pregnant. Plans for future pregnancy may also affect the choice of prosthesis, as anticoagulation management during pregnancy can be extremely tricky.
The recommendations overall make clear that, based on available evidence, “there should be a high threshold for intervention during pregnancy,” said Dr. O’Gara. And no one should go it alone when taking care of these complicated patients. “Care of pregnant women with heart disease requires coordination with a multidisciplinary team,” he said.
Dr. O’Gara reported no relevant disclosures.
[email protected]
On Twitter @karioakes
EXPERT ANALYSIS FROM THE HEART VALVE SUMMIT
ACGME seeks to return trainees’ maximum shifts to 24 hours
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The proposed changes are “encouraging and courageous,” according to R. James Valentine, MD, FACS, president of the Western Surgical Association.
“This is a real world scenario,” said Dr. Valentine, professor of vascular surgery at Vanderbilt University, Nashville, Tenn. “Medicine is such a complex system. It is not easily constrained by time limitations.”
Requiring a physician to transition a patient’s care at a specific time may help promote the trainee’s well-being; however, it also “robs the resident of the opportunity to see the disease progress and to see the response to the treatment that is being offered. The new rules help strike a balance between bedside education and rest,” he added.
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The proposal is open to public comment through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The proposed changes are “encouraging and courageous,” according to R. James Valentine, MD, FACS, president of the Western Surgical Association.
“This is a real world scenario,” said Dr. Valentine, professor of vascular surgery at Vanderbilt University, Nashville, Tenn. “Medicine is such a complex system. It is not easily constrained by time limitations.”
Requiring a physician to transition a patient’s care at a specific time may help promote the trainee’s well-being; however, it also “robs the resident of the opportunity to see the disease progress and to see the response to the treatment that is being offered. The new rules help strike a balance between bedside education and rest,” he added.
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The proposal is open to public comment through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The proposed changes are “encouraging and courageous,” according to R. James Valentine, MD, FACS, president of the Western Surgical Association.
“This is a real world scenario,” said Dr. Valentine, professor of vascular surgery at Vanderbilt University, Nashville, Tenn. “Medicine is such a complex system. It is not easily constrained by time limitations.”
Requiring a physician to transition a patient’s care at a specific time may help promote the trainee’s well-being; however, it also “robs the resident of the opportunity to see the disease progress and to see the response to the treatment that is being offered. The new rules help strike a balance between bedside education and rest,” he added.
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The proposal is open to public comment through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.
VIDEO: Biologics: Proposed guideline addresses perioperative management
WASHINGTON – Biologic agents should be stopped prior to elective total knee or hip arthroplasty in patients with rheumatic diseases, according to a draft guideline developed by the American College of Rheumatology and the American Association of Hip and Knee Surgeons.
The guideline, which address the perioperative management of antirheumatic medications in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, juvenile idiopathic arthritis (JIA), or lupus who are undergoing such surgery, is currently under review, Dr. Susan Goodman, MD, coprincipal investigator, reported at the annual meeting of the American College of Rheumatology.
The draft guideline was created because “guidance was needed for common clinical situations, even where data were sparse. We didn’t want to configure treatment mandates – that’s not what these are,” Dr. Goodman of Cornell University, New York, said.
The recommendations are conditional, she said, meaning that the benefits probably outweigh the harms, that the recommendations apply to most but not all patients, and that future research may lead to changes.
“They’re also preference sensitive,” she said, explaining that patients’ values and preferences should be carefully considered, as they might differ from those of the patient panel consulted during guideline development; the panel expressed greater concern about the risk of infection following surgery than about perioperative flares resulting from medication discontinuation.
Based on agreement by at least 80% of a voting panel which considered available evidence in the context of their clinical experience along with the input from the patient panel, the draft guideline states that:
• Current doses of methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine should be continued in patients with rheumatic diseases undergoing elective hip and knee replacement. This recommendation is based on an extensive literature review that showed the infection rate is decreased in patients who continue these medications, Dr. Goodman said.
• All biologics should be withheld prior to surgery in patients with inflammatory arthritis, and surgery should be planned for the end of the dosing cycle. This matter wasn’t specifically addressed in the literature; however, numerous randomized controlled trials outside of the surgical setting demonstrate an increased risk of infection associated with their use, she noted.
“All of the biologic medications were found to be associated with an increased risk of infection,” she said. “Because of this and the level of importance patients place on minimizing infection risk, we’ve recommended that biologics be withheld prior to surgery.”
• Tofacitinib, which was considered in a separate oral, targeted therapy category, should be withheld for at least 7 days prior to surgery in patients with RA, spondyloarthritis, and JIA. Data from systematic reviews and meta-analyses showed an increased risk of infection with tofacitinib, although more research is needed in order to “firm up” this recommendation, Dr. Goodman said.
• In lupus patients, rituximab and belimumab should be withheld prior to surgery, and surgery should be planned for the end of the dosing period.
“Again, this was not answered in the literature. We depended on observational studies that we reviewed that did show that patients with severe active lupus were at much higher risk for adverse events. But since rituximab isn’t approved by the [Food and Drug Administration] for use in lupus, and belimumab isn’t approved for use in severe lupus – and those seem to be the high-risk patients – we thought withholding them was more prudent,” she said.
• Patients with severe lupus should continue on current doses of methotrexate, mycophenolic acid, azathioprine, mizoribine, cyclosporine, and tacrolimus through surgery. This recommendation is based on indirect data from experience in organ transplant patients.
• All medications should be discontinued in patients whose lupus is not severe.
“Our recommendation is to withhold for 7 days to 2-5 days after surgery in the absence of any wound healing complications or any other complications,” she said, noting that the literature does not directly address this; the recommendation is based on indirect evidence in patients with either active infection or who are at risk for infection.
“We thought that careful monitoring of the patient would permit us to identify flare and intervene quickly. … and that, for mild cases of lupus, the morbidity associated with infection might not be greater than the morbidity associated with the disease flare,” she said.
• Biologics should be restarted once surgical wounds show evidence of healing and there is no clinical evidence of infection. The literature does not directly address this; the recommendation is based on the rationale for use of these medications in patients with either active infection or risk for infection.
• Current daily doses of glucocorticoids, rather than supraphysiologic doses, should be continued in adults with RA, lupus, or inflammatory arthritis. A meta-analysis and systematic review of randomized controlled trial data and observational data showed no hemodynamic difference between daily doses and stress doses.
“In addition, there are abundant observational data demonstrating an increase in infection in patients on chronic steroids greater than 15 mg, and we thought that part of the optimization of the patient would be getting them on the lowest possible steroid dose,” she said, stressing that this refers only to adults receiving glucocorticoids for their rheumatic disease, and not to those with a history of JIA who may have received steroids during development, or to those receiving glucocorticoids for primary, adrenal, or hypothalamic disease.
According to Dr. Goodman, the time is right for the introduction of these recommendations, because the increased use of disease-modifying drugs and biologics means that most patients coming in for these surgeries will be taking these medications.
Further, despite the widespread use of the medications, the rate of total knee and hip arthroplasty surgeries among patients with rheumatic diseases is about the same as it was 20 or 30 years ago – and their risk for devastating complications, including infections, remains high, she said, noting that appropriate medication management provides an opportunity to mitigate risk.
Coprincipal investigator, Bryan Springer, MD, further emphasized the importance of the guideline, noting that the 5-year survival among rheumatic disease patients who develop certain perioperative complications is lower than for many common cancers, and that the literature offers little guidance on managing medications in the perioperative period.
“We now have a document that’s based on the available evidence, and also based on expert opinion, to help us manage these patients much more thoroughly in the perioperative period,” Dr. Springer, an orthopedic surgeon in Charlotte, N.C., said during a press briefing on the guideline.
Dr. Springer highlighted the value of the unique collaboration between the ACR and the AAHKS, calling the effort a win both for patients, and for “collaborative efforts, collaborative research, which we just really don’t do enough of,” he said. “I hope this is a huge step towards that direction.”
This guideline development process was funded by the ACR and AAHKS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WASHINGTON – Biologic agents should be stopped prior to elective total knee or hip arthroplasty in patients with rheumatic diseases, according to a draft guideline developed by the American College of Rheumatology and the American Association of Hip and Knee Surgeons.
The guideline, which address the perioperative management of antirheumatic medications in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, juvenile idiopathic arthritis (JIA), or lupus who are undergoing such surgery, is currently under review, Dr. Susan Goodman, MD, coprincipal investigator, reported at the annual meeting of the American College of Rheumatology.
The draft guideline was created because “guidance was needed for common clinical situations, even where data were sparse. We didn’t want to configure treatment mandates – that’s not what these are,” Dr. Goodman of Cornell University, New York, said.
The recommendations are conditional, she said, meaning that the benefits probably outweigh the harms, that the recommendations apply to most but not all patients, and that future research may lead to changes.
“They’re also preference sensitive,” she said, explaining that patients’ values and preferences should be carefully considered, as they might differ from those of the patient panel consulted during guideline development; the panel expressed greater concern about the risk of infection following surgery than about perioperative flares resulting from medication discontinuation.
Based on agreement by at least 80% of a voting panel which considered available evidence in the context of their clinical experience along with the input from the patient panel, the draft guideline states that:
• Current doses of methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine should be continued in patients with rheumatic diseases undergoing elective hip and knee replacement. This recommendation is based on an extensive literature review that showed the infection rate is decreased in patients who continue these medications, Dr. Goodman said.
• All biologics should be withheld prior to surgery in patients with inflammatory arthritis, and surgery should be planned for the end of the dosing cycle. This matter wasn’t specifically addressed in the literature; however, numerous randomized controlled trials outside of the surgical setting demonstrate an increased risk of infection associated with their use, she noted.
“All of the biologic medications were found to be associated with an increased risk of infection,” she said. “Because of this and the level of importance patients place on minimizing infection risk, we’ve recommended that biologics be withheld prior to surgery.”
• Tofacitinib, which was considered in a separate oral, targeted therapy category, should be withheld for at least 7 days prior to surgery in patients with RA, spondyloarthritis, and JIA. Data from systematic reviews and meta-analyses showed an increased risk of infection with tofacitinib, although more research is needed in order to “firm up” this recommendation, Dr. Goodman said.
• In lupus patients, rituximab and belimumab should be withheld prior to surgery, and surgery should be planned for the end of the dosing period.
“Again, this was not answered in the literature. We depended on observational studies that we reviewed that did show that patients with severe active lupus were at much higher risk for adverse events. But since rituximab isn’t approved by the [Food and Drug Administration] for use in lupus, and belimumab isn’t approved for use in severe lupus – and those seem to be the high-risk patients – we thought withholding them was more prudent,” she said.
• Patients with severe lupus should continue on current doses of methotrexate, mycophenolic acid, azathioprine, mizoribine, cyclosporine, and tacrolimus through surgery. This recommendation is based on indirect data from experience in organ transplant patients.
• All medications should be discontinued in patients whose lupus is not severe.
“Our recommendation is to withhold for 7 days to 2-5 days after surgery in the absence of any wound healing complications or any other complications,” she said, noting that the literature does not directly address this; the recommendation is based on indirect evidence in patients with either active infection or who are at risk for infection.
“We thought that careful monitoring of the patient would permit us to identify flare and intervene quickly. … and that, for mild cases of lupus, the morbidity associated with infection might not be greater than the morbidity associated with the disease flare,” she said.
• Biologics should be restarted once surgical wounds show evidence of healing and there is no clinical evidence of infection. The literature does not directly address this; the recommendation is based on the rationale for use of these medications in patients with either active infection or risk for infection.
• Current daily doses of glucocorticoids, rather than supraphysiologic doses, should be continued in adults with RA, lupus, or inflammatory arthritis. A meta-analysis and systematic review of randomized controlled trial data and observational data showed no hemodynamic difference between daily doses and stress doses.
“In addition, there are abundant observational data demonstrating an increase in infection in patients on chronic steroids greater than 15 mg, and we thought that part of the optimization of the patient would be getting them on the lowest possible steroid dose,” she said, stressing that this refers only to adults receiving glucocorticoids for their rheumatic disease, and not to those with a history of JIA who may have received steroids during development, or to those receiving glucocorticoids for primary, adrenal, or hypothalamic disease.
According to Dr. Goodman, the time is right for the introduction of these recommendations, because the increased use of disease-modifying drugs and biologics means that most patients coming in for these surgeries will be taking these medications.
Further, despite the widespread use of the medications, the rate of total knee and hip arthroplasty surgeries among patients with rheumatic diseases is about the same as it was 20 or 30 years ago – and their risk for devastating complications, including infections, remains high, she said, noting that appropriate medication management provides an opportunity to mitigate risk.
Coprincipal investigator, Bryan Springer, MD, further emphasized the importance of the guideline, noting that the 5-year survival among rheumatic disease patients who develop certain perioperative complications is lower than for many common cancers, and that the literature offers little guidance on managing medications in the perioperative period.
“We now have a document that’s based on the available evidence, and also based on expert opinion, to help us manage these patients much more thoroughly in the perioperative period,” Dr. Springer, an orthopedic surgeon in Charlotte, N.C., said during a press briefing on the guideline.
Dr. Springer highlighted the value of the unique collaboration between the ACR and the AAHKS, calling the effort a win both for patients, and for “collaborative efforts, collaborative research, which we just really don’t do enough of,” he said. “I hope this is a huge step towards that direction.”
This guideline development process was funded by the ACR and AAHKS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WASHINGTON – Biologic agents should be stopped prior to elective total knee or hip arthroplasty in patients with rheumatic diseases, according to a draft guideline developed by the American College of Rheumatology and the American Association of Hip and Knee Surgeons.
The guideline, which address the perioperative management of antirheumatic medications in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, juvenile idiopathic arthritis (JIA), or lupus who are undergoing such surgery, is currently under review, Dr. Susan Goodman, MD, coprincipal investigator, reported at the annual meeting of the American College of Rheumatology.
The draft guideline was created because “guidance was needed for common clinical situations, even where data were sparse. We didn’t want to configure treatment mandates – that’s not what these are,” Dr. Goodman of Cornell University, New York, said.
The recommendations are conditional, she said, meaning that the benefits probably outweigh the harms, that the recommendations apply to most but not all patients, and that future research may lead to changes.
“They’re also preference sensitive,” she said, explaining that patients’ values and preferences should be carefully considered, as they might differ from those of the patient panel consulted during guideline development; the panel expressed greater concern about the risk of infection following surgery than about perioperative flares resulting from medication discontinuation.
Based on agreement by at least 80% of a voting panel which considered available evidence in the context of their clinical experience along with the input from the patient panel, the draft guideline states that:
• Current doses of methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine should be continued in patients with rheumatic diseases undergoing elective hip and knee replacement. This recommendation is based on an extensive literature review that showed the infection rate is decreased in patients who continue these medications, Dr. Goodman said.
• All biologics should be withheld prior to surgery in patients with inflammatory arthritis, and surgery should be planned for the end of the dosing cycle. This matter wasn’t specifically addressed in the literature; however, numerous randomized controlled trials outside of the surgical setting demonstrate an increased risk of infection associated with their use, she noted.
“All of the biologic medications were found to be associated with an increased risk of infection,” she said. “Because of this and the level of importance patients place on minimizing infection risk, we’ve recommended that biologics be withheld prior to surgery.”
• Tofacitinib, which was considered in a separate oral, targeted therapy category, should be withheld for at least 7 days prior to surgery in patients with RA, spondyloarthritis, and JIA. Data from systematic reviews and meta-analyses showed an increased risk of infection with tofacitinib, although more research is needed in order to “firm up” this recommendation, Dr. Goodman said.
• In lupus patients, rituximab and belimumab should be withheld prior to surgery, and surgery should be planned for the end of the dosing period.
“Again, this was not answered in the literature. We depended on observational studies that we reviewed that did show that patients with severe active lupus were at much higher risk for adverse events. But since rituximab isn’t approved by the [Food and Drug Administration] for use in lupus, and belimumab isn’t approved for use in severe lupus – and those seem to be the high-risk patients – we thought withholding them was more prudent,” she said.
• Patients with severe lupus should continue on current doses of methotrexate, mycophenolic acid, azathioprine, mizoribine, cyclosporine, and tacrolimus through surgery. This recommendation is based on indirect data from experience in organ transplant patients.
• All medications should be discontinued in patients whose lupus is not severe.
“Our recommendation is to withhold for 7 days to 2-5 days after surgery in the absence of any wound healing complications or any other complications,” she said, noting that the literature does not directly address this; the recommendation is based on indirect evidence in patients with either active infection or who are at risk for infection.
“We thought that careful monitoring of the patient would permit us to identify flare and intervene quickly. … and that, for mild cases of lupus, the morbidity associated with infection might not be greater than the morbidity associated with the disease flare,” she said.
• Biologics should be restarted once surgical wounds show evidence of healing and there is no clinical evidence of infection. The literature does not directly address this; the recommendation is based on the rationale for use of these medications in patients with either active infection or risk for infection.
• Current daily doses of glucocorticoids, rather than supraphysiologic doses, should be continued in adults with RA, lupus, or inflammatory arthritis. A meta-analysis and systematic review of randomized controlled trial data and observational data showed no hemodynamic difference between daily doses and stress doses.
“In addition, there are abundant observational data demonstrating an increase in infection in patients on chronic steroids greater than 15 mg, and we thought that part of the optimization of the patient would be getting them on the lowest possible steroid dose,” she said, stressing that this refers only to adults receiving glucocorticoids for their rheumatic disease, and not to those with a history of JIA who may have received steroids during development, or to those receiving glucocorticoids for primary, adrenal, or hypothalamic disease.
According to Dr. Goodman, the time is right for the introduction of these recommendations, because the increased use of disease-modifying drugs and biologics means that most patients coming in for these surgeries will be taking these medications.
Further, despite the widespread use of the medications, the rate of total knee and hip arthroplasty surgeries among patients with rheumatic diseases is about the same as it was 20 or 30 years ago – and their risk for devastating complications, including infections, remains high, she said, noting that appropriate medication management provides an opportunity to mitigate risk.
Coprincipal investigator, Bryan Springer, MD, further emphasized the importance of the guideline, noting that the 5-year survival among rheumatic disease patients who develop certain perioperative complications is lower than for many common cancers, and that the literature offers little guidance on managing medications in the perioperative period.
“We now have a document that’s based on the available evidence, and also based on expert opinion, to help us manage these patients much more thoroughly in the perioperative period,” Dr. Springer, an orthopedic surgeon in Charlotte, N.C., said during a press briefing on the guideline.
Dr. Springer highlighted the value of the unique collaboration between the ACR and the AAHKS, calling the effort a win both for patients, and for “collaborative efforts, collaborative research, which we just really don’t do enough of,” he said. “I hope this is a huge step towards that direction.”
This guideline development process was funded by the ACR and AAHKS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE ACR ANNUAL MEETING
VIDEO: Bariatric surgery may protect against heart failure
NEW ORLEANS – Results of a new 40,000-patient Swedish observational study provide the strongest evidence to date suggesting a causal relationship between bariatric surgery and reduced risk of heart failure, according to Johan Sundström, MD.
The study, which included patients drawn from two large Swedish national registries, demonstrated that bariatric surgery was associated with a 46% reduction in the incidence of heart failure during a median 4.1 years of follow-up, compared with an intensive lifestyle modification program for weight loss.
“These are observational data, but it’s a very large study population – and probably there will never be a large randomized trial of bariatric surgery versus weight loss through intensive lifestyle modification as a means of reducing the risk of heart failure,” Dr. Sundström, professor of epidemiology and a cardiologist at Uppsala (Sweden) University, said at the American Heart Association scientific sessions.
The study included 25,804 bariatric surgery patients in SOReg, the Scandinavian Obesity Surgery Registry, and a matched comparator group of 13,701 participants in a Swedish national registry of obese participants in a commercial Sweden-based intensive structural lifestyle modification program for weight loss called Itrim. The two groups were matched for baseline body mass index, which was a mean of 41.5 kg, and numerous other demographic factors and comorbid conditions. Participants weighed an average of 119 kg at baseline. None of the subjects had a history of heart failure.
The bariatric surgery group lost substantially more weight than did the lifestyle modification group: an average loss of about 35 kg after 1 year, which was 18.8 kg more than in the lifestyle modification group. After 2 years, the bariatric surgery group had an average of 22.6 kg more weight loss than did the comparison group.
The primary outcome was hospitalization for new-onset heart failure during a median 4.1 years of follow-up. Subjects were well below the age range when the incidence of heart failure accelerates – they averaged 41 years of age – but 73 of them did develop heart failure during follow-up. The incidence was 46% lower in the bariatric surgery patients. This supports the study hypothesis that bariatric surgery leads to a low incidence of new-onset heart failure, compared with intensive lifestyle modification because of its larger weight loss effect.
When Dr. Sundström and his coinvestigators combined the two study groups, they found that a 10-kg weight loss at 1 year was associated with a 23% reduction in the risk of heart failure during follow-up, irrespective of whether the weight loss was achieved surgically or through the lifestyle program.
“A great way of studying causality is to take away the exposure and note what happens to the outcome. If there’s a causal link, then if you take away the risk factor – in this case, obesity – the disease should go away,” he explained in a video interview.
The reduced risk of heart failure in the bariatric surgery patients wasn’t because of fewer acute MIs. Indeed, their acute MI rate during follow-up was similar to that of the lifestyle modification group. But bariatric surgery was associated with relative risk reductions of 35%-37% for atrial fibrillation or need for diabetes or blood pressure–lowering medications at 1 year – and atrial fibrillation, diabetes, and hypertension are all established risk factors for heart failure, Dr. Sundström noted.
The Itrim intensive lifestyle modification program entailed an initial very-low-energy diet for the first 3 months in order to achieve massive weight loss, followed by a 9-month maintenance program involving motivational counseling, exercise, behavioral therapy, and a restricted diet.
Dr. Sundström said he and his coinvestigators plan to continue the study and expand it to look at differences in additional cardiovascular endpoints as patients age.
The study was funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, Uppsala University, the Karolinska Institute, and the Swedish Research Council. Dr. Sundström reported serving as a scientific advisor to Itrim.
NEW ORLEANS – Results of a new 40,000-patient Swedish observational study provide the strongest evidence to date suggesting a causal relationship between bariatric surgery and reduced risk of heart failure, according to Johan Sundström, MD.
The study, which included patients drawn from two large Swedish national registries, demonstrated that bariatric surgery was associated with a 46% reduction in the incidence of heart failure during a median 4.1 years of follow-up, compared with an intensive lifestyle modification program for weight loss.
“These are observational data, but it’s a very large study population – and probably there will never be a large randomized trial of bariatric surgery versus weight loss through intensive lifestyle modification as a means of reducing the risk of heart failure,” Dr. Sundström, professor of epidemiology and a cardiologist at Uppsala (Sweden) University, said at the American Heart Association scientific sessions.
The study included 25,804 bariatric surgery patients in SOReg, the Scandinavian Obesity Surgery Registry, and a matched comparator group of 13,701 participants in a Swedish national registry of obese participants in a commercial Sweden-based intensive structural lifestyle modification program for weight loss called Itrim. The two groups were matched for baseline body mass index, which was a mean of 41.5 kg, and numerous other demographic factors and comorbid conditions. Participants weighed an average of 119 kg at baseline. None of the subjects had a history of heart failure.
The bariatric surgery group lost substantially more weight than did the lifestyle modification group: an average loss of about 35 kg after 1 year, which was 18.8 kg more than in the lifestyle modification group. After 2 years, the bariatric surgery group had an average of 22.6 kg more weight loss than did the comparison group.
The primary outcome was hospitalization for new-onset heart failure during a median 4.1 years of follow-up. Subjects were well below the age range when the incidence of heart failure accelerates – they averaged 41 years of age – but 73 of them did develop heart failure during follow-up. The incidence was 46% lower in the bariatric surgery patients. This supports the study hypothesis that bariatric surgery leads to a low incidence of new-onset heart failure, compared with intensive lifestyle modification because of its larger weight loss effect.
When Dr. Sundström and his coinvestigators combined the two study groups, they found that a 10-kg weight loss at 1 year was associated with a 23% reduction in the risk of heart failure during follow-up, irrespective of whether the weight loss was achieved surgically or through the lifestyle program.
“A great way of studying causality is to take away the exposure and note what happens to the outcome. If there’s a causal link, then if you take away the risk factor – in this case, obesity – the disease should go away,” he explained in a video interview.
The reduced risk of heart failure in the bariatric surgery patients wasn’t because of fewer acute MIs. Indeed, their acute MI rate during follow-up was similar to that of the lifestyle modification group. But bariatric surgery was associated with relative risk reductions of 35%-37% for atrial fibrillation or need for diabetes or blood pressure–lowering medications at 1 year – and atrial fibrillation, diabetes, and hypertension are all established risk factors for heart failure, Dr. Sundström noted.
The Itrim intensive lifestyle modification program entailed an initial very-low-energy diet for the first 3 months in order to achieve massive weight loss, followed by a 9-month maintenance program involving motivational counseling, exercise, behavioral therapy, and a restricted diet.
Dr. Sundström said he and his coinvestigators plan to continue the study and expand it to look at differences in additional cardiovascular endpoints as patients age.
The study was funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, Uppsala University, the Karolinska Institute, and the Swedish Research Council. Dr. Sundström reported serving as a scientific advisor to Itrim.
NEW ORLEANS – Results of a new 40,000-patient Swedish observational study provide the strongest evidence to date suggesting a causal relationship between bariatric surgery and reduced risk of heart failure, according to Johan Sundström, MD.
The study, which included patients drawn from two large Swedish national registries, demonstrated that bariatric surgery was associated with a 46% reduction in the incidence of heart failure during a median 4.1 years of follow-up, compared with an intensive lifestyle modification program for weight loss.
“These are observational data, but it’s a very large study population – and probably there will never be a large randomized trial of bariatric surgery versus weight loss through intensive lifestyle modification as a means of reducing the risk of heart failure,” Dr. Sundström, professor of epidemiology and a cardiologist at Uppsala (Sweden) University, said at the American Heart Association scientific sessions.
The study included 25,804 bariatric surgery patients in SOReg, the Scandinavian Obesity Surgery Registry, and a matched comparator group of 13,701 participants in a Swedish national registry of obese participants in a commercial Sweden-based intensive structural lifestyle modification program for weight loss called Itrim. The two groups were matched for baseline body mass index, which was a mean of 41.5 kg, and numerous other demographic factors and comorbid conditions. Participants weighed an average of 119 kg at baseline. None of the subjects had a history of heart failure.
The bariatric surgery group lost substantially more weight than did the lifestyle modification group: an average loss of about 35 kg after 1 year, which was 18.8 kg more than in the lifestyle modification group. After 2 years, the bariatric surgery group had an average of 22.6 kg more weight loss than did the comparison group.
The primary outcome was hospitalization for new-onset heart failure during a median 4.1 years of follow-up. Subjects were well below the age range when the incidence of heart failure accelerates – they averaged 41 years of age – but 73 of them did develop heart failure during follow-up. The incidence was 46% lower in the bariatric surgery patients. This supports the study hypothesis that bariatric surgery leads to a low incidence of new-onset heart failure, compared with intensive lifestyle modification because of its larger weight loss effect.
When Dr. Sundström and his coinvestigators combined the two study groups, they found that a 10-kg weight loss at 1 year was associated with a 23% reduction in the risk of heart failure during follow-up, irrespective of whether the weight loss was achieved surgically or through the lifestyle program.
“A great way of studying causality is to take away the exposure and note what happens to the outcome. If there’s a causal link, then if you take away the risk factor – in this case, obesity – the disease should go away,” he explained in a video interview.
The reduced risk of heart failure in the bariatric surgery patients wasn’t because of fewer acute MIs. Indeed, their acute MI rate during follow-up was similar to that of the lifestyle modification group. But bariatric surgery was associated with relative risk reductions of 35%-37% for atrial fibrillation or need for diabetes or blood pressure–lowering medications at 1 year – and atrial fibrillation, diabetes, and hypertension are all established risk factors for heart failure, Dr. Sundström noted.
The Itrim intensive lifestyle modification program entailed an initial very-low-energy diet for the first 3 months in order to achieve massive weight loss, followed by a 9-month maintenance program involving motivational counseling, exercise, behavioral therapy, and a restricted diet.
Dr. Sundström said he and his coinvestigators plan to continue the study and expand it to look at differences in additional cardiovascular endpoints as patients age.
The study was funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, Uppsala University, the Karolinska Institute, and the Swedish Research Council. Dr. Sundström reported serving as a scientific advisor to Itrim.
AT THE AHA SCIENTIFIC SESSIONS 2016
Key clinical point:
Major finding: The incidence of new-onset heart failure was 46% lower during follow-up after bariatric surgery than among participants in an intensive lifestyle modification program for weight loss.
Data source: This observational registry study followed nearly 26,000 Swedish bariatric surgery patients and 14,000 matched participants in a commercial intensive lifestyle modification program for a median of 4.1 years.
Disclosures: The study was funded by the U.S. National Institutes of Diabetes and Digestive and Kidney Diseases, Uppsala University, the Karolinska Institute, and the Swedish Research Council. The presenter reported serving as a scientific advisor to Itrim.
Continue DMARDs, biologics in RA surgery patients
WASHINGTON – The perioperative use of disease-modifying antirheumatic drug monotherapy or combined therapy with methotrexate and a tumor necrosis factor (TNF) inhibitor is not associated with increased rates of postoperative infectious complications or wound infections in patients with rheumatoid arthritis, according to findings from a retrospective review of more than 9,000 surgeries.
With respect to monotherapy, treatment was continued in 1,951 of 2,601 surgeries among patients receiving methotrexate, in 1,496 of 2,012 surgeries among patients receiving hydroxychloroquine, and in 508 of 652 surgeries among patient receiving leflunomide. The odds ratios for postoperative infection (including urinary tract, pneumonia, or sepsis) and postoperative wound infection, respectively, were 0.79 and 0.77 with methotrexate continuation, 0.93 and 0.86 with hydroxychloroquine continuation, and 0.78 and 0.87 with leflunomide continuation, Hsin-Hsuan Juo, MD, reported at the annual meeting of the American College of Rheumatology.
Data for this study were derived from the U.S. Department of Veterans Affairs administrative database and surgical quality registry. Rheumatoid arthritis patients who underwent a surgical procedure and who were on at least one disease-modifying antirheumatic drug (DMARD) or one biologic agent in the perioperative period during the study period of Oct. 1, 1999, through Sept. 30, 2009, were included. Subjects had a mean age of 67 years, and 91% were men.
The finding that the continuation of DMARD monotherapy or the combination of methotrexate and TNF inhibitor therapy for RA in the perioperative setting was not associated with increased rates of overall postoperative infectious complications and wound infections is important, because many patients are advised to stop taking these drugs prior to surgery because of concerns about increased susceptibility to infection. Discontinuing RA medication can increase the risk of disease flares requiring treatment with prednisone, which can further increase the risk of postsurgical complications, Dr. Juo said.
Clear, consistent guidance on the continuation of treatment among RA patients undergoing surgery has been lacking, she said, noting that guidelines over the years from the ACR, the British Society for Rheumatology, and the Canadian Rheumatology Association have differed in their recommendations.
A new draft guideline reported the morning of Dr. Juo’s presentation at the ACR annual meeting recommended continuing DMARDs but discontinuing biologics prior to surgery, but that guideline is limited to orthopedic surgery among patients with various rheumatic diseases.
“With literature review, the results are conflicting as well; some recommend continuing medication, and others recommend discontinuing medications prior to surgery,” she said.
The current findings, though limited by the study’s observational design and generally older, male population, suggest that continuing antirheumatic medications during the perioperative period is not associated with increased rates of postoperative complications.
“Our study results suggest that discontinuing DMARDs and biologic agents prior to surgery may not be necessary. Therefore, being on DMARDs or biologic agents should not preclude patients from receiving urgent surgeries,” Dr. Juo concluded.
Dr. Juo reported having no disclosures.
WASHINGTON – The perioperative use of disease-modifying antirheumatic drug monotherapy or combined therapy with methotrexate and a tumor necrosis factor (TNF) inhibitor is not associated with increased rates of postoperative infectious complications or wound infections in patients with rheumatoid arthritis, according to findings from a retrospective review of more than 9,000 surgeries.
With respect to monotherapy, treatment was continued in 1,951 of 2,601 surgeries among patients receiving methotrexate, in 1,496 of 2,012 surgeries among patients receiving hydroxychloroquine, and in 508 of 652 surgeries among patient receiving leflunomide. The odds ratios for postoperative infection (including urinary tract, pneumonia, or sepsis) and postoperative wound infection, respectively, were 0.79 and 0.77 with methotrexate continuation, 0.93 and 0.86 with hydroxychloroquine continuation, and 0.78 and 0.87 with leflunomide continuation, Hsin-Hsuan Juo, MD, reported at the annual meeting of the American College of Rheumatology.
Data for this study were derived from the U.S. Department of Veterans Affairs administrative database and surgical quality registry. Rheumatoid arthritis patients who underwent a surgical procedure and who were on at least one disease-modifying antirheumatic drug (DMARD) or one biologic agent in the perioperative period during the study period of Oct. 1, 1999, through Sept. 30, 2009, were included. Subjects had a mean age of 67 years, and 91% were men.
The finding that the continuation of DMARD monotherapy or the combination of methotrexate and TNF inhibitor therapy for RA in the perioperative setting was not associated with increased rates of overall postoperative infectious complications and wound infections is important, because many patients are advised to stop taking these drugs prior to surgery because of concerns about increased susceptibility to infection. Discontinuing RA medication can increase the risk of disease flares requiring treatment with prednisone, which can further increase the risk of postsurgical complications, Dr. Juo said.
Clear, consistent guidance on the continuation of treatment among RA patients undergoing surgery has been lacking, she said, noting that guidelines over the years from the ACR, the British Society for Rheumatology, and the Canadian Rheumatology Association have differed in their recommendations.
A new draft guideline reported the morning of Dr. Juo’s presentation at the ACR annual meeting recommended continuing DMARDs but discontinuing biologics prior to surgery, but that guideline is limited to orthopedic surgery among patients with various rheumatic diseases.
“With literature review, the results are conflicting as well; some recommend continuing medication, and others recommend discontinuing medications prior to surgery,” she said.
The current findings, though limited by the study’s observational design and generally older, male population, suggest that continuing antirheumatic medications during the perioperative period is not associated with increased rates of postoperative complications.
“Our study results suggest that discontinuing DMARDs and biologic agents prior to surgery may not be necessary. Therefore, being on DMARDs or biologic agents should not preclude patients from receiving urgent surgeries,” Dr. Juo concluded.
Dr. Juo reported having no disclosures.
WASHINGTON – The perioperative use of disease-modifying antirheumatic drug monotherapy or combined therapy with methotrexate and a tumor necrosis factor (TNF) inhibitor is not associated with increased rates of postoperative infectious complications or wound infections in patients with rheumatoid arthritis, according to findings from a retrospective review of more than 9,000 surgeries.
With respect to monotherapy, treatment was continued in 1,951 of 2,601 surgeries among patients receiving methotrexate, in 1,496 of 2,012 surgeries among patients receiving hydroxychloroquine, and in 508 of 652 surgeries among patient receiving leflunomide. The odds ratios for postoperative infection (including urinary tract, pneumonia, or sepsis) and postoperative wound infection, respectively, were 0.79 and 0.77 with methotrexate continuation, 0.93 and 0.86 with hydroxychloroquine continuation, and 0.78 and 0.87 with leflunomide continuation, Hsin-Hsuan Juo, MD, reported at the annual meeting of the American College of Rheumatology.
Data for this study were derived from the U.S. Department of Veterans Affairs administrative database and surgical quality registry. Rheumatoid arthritis patients who underwent a surgical procedure and who were on at least one disease-modifying antirheumatic drug (DMARD) or one biologic agent in the perioperative period during the study period of Oct. 1, 1999, through Sept. 30, 2009, were included. Subjects had a mean age of 67 years, and 91% were men.
The finding that the continuation of DMARD monotherapy or the combination of methotrexate and TNF inhibitor therapy for RA in the perioperative setting was not associated with increased rates of overall postoperative infectious complications and wound infections is important, because many patients are advised to stop taking these drugs prior to surgery because of concerns about increased susceptibility to infection. Discontinuing RA medication can increase the risk of disease flares requiring treatment with prednisone, which can further increase the risk of postsurgical complications, Dr. Juo said.
Clear, consistent guidance on the continuation of treatment among RA patients undergoing surgery has been lacking, she said, noting that guidelines over the years from the ACR, the British Society for Rheumatology, and the Canadian Rheumatology Association have differed in their recommendations.
A new draft guideline reported the morning of Dr. Juo’s presentation at the ACR annual meeting recommended continuing DMARDs but discontinuing biologics prior to surgery, but that guideline is limited to orthopedic surgery among patients with various rheumatic diseases.
“With literature review, the results are conflicting as well; some recommend continuing medication, and others recommend discontinuing medications prior to surgery,” she said.
The current findings, though limited by the study’s observational design and generally older, male population, suggest that continuing antirheumatic medications during the perioperative period is not associated with increased rates of postoperative complications.
“Our study results suggest that discontinuing DMARDs and biologic agents prior to surgery may not be necessary. Therefore, being on DMARDs or biologic agents should not preclude patients from receiving urgent surgeries,” Dr. Juo concluded.
Dr. Juo reported having no disclosures.
AT THE ACR ANNUAL MEETING
Key clinical point:
Major finding: Odds ratios for postoperative infection and postoperative wound infection, respectively, were 0.79 and 0.77 with methotrexate continuation, 0.93 and 0.86 with hydroxychloroquine continuation, 0.78 and 0.87 with leflunomide continuation, and 0.35 and 0.38 with combined methotrexate/TNF inhibitor continuation.
Data source: A retrospective review of more than 9,000 surgeries.
Disclosures: Dr. Juo reported having no disclosures.