Transcatheter implantation of the Tendyne mitral valve replacement device for treatment of mitral regurgitation in patients at prohibitive surgical risk because of severe mitral annular calcification showed considerable promise in a small feasibility study, Paul Sorajja, MD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News

There is a huge unmet need for safe and effective therapies for severe mitral annular calcification (MAC).

“Severe MAC often precludes surgical treatment, and there’s a poor prognosis in patients with MAC and mitral regurgitation when untreated, with 2-year survival of about 60% in some studies,” noted Dr. Sorajja, a cardiologist at the Minneapolis Heart Institute Foundation.

Attempts at repurposing transcatheter aortic valves for use in the mitral location have been largely unsatisfactory, he added.

The 6-month outcomes in the 11 patients who received the Tendyne device in the multicenter U.S. feasibility study featured low rates of mortality and nonfatal adverse events, elimination of mitral regurgitation, marked improvement on quality of life measures, and a mean gradient of 4.1 mm Hg. The acute procedural outcomes were encouraging as well.

“We had technical success in 11 of 11 patients, no procedural mortality or left ventricular outflow tract obstruction, no valve embolization or malposition, and no conversion to open heart surgery,” he said.

There was one death caused by mesenteric ischemia 16 days post Tendyne implantation. One patient experienced a nondisabling stroke at day 4. Two patients developed new-onset atrial fibrillation, one of whom cardioverted to sinus rhythm. And one patient had a moderate paravalvular leak that resolved with placement of a plug at 3 months. There were no MIs.

At baseline, 9 of 11 patients were New York Heart Association functional class III and the others were class II. At 6 months, six patients were class I, four were class II, and one was class III. The average score on the Kansas City Cardiomyopathy Questionnaire improved from 45.9 at baseline to 65.5 at 1 month, 77.4 at 3 months, and 70.3 at 6 months.

This was a highly selected study population with a Society of Thoracic Surgery Predicted Risk of Mortality score of 9.03%. Part of the screening process for study participation involved preprocedural CT imaging with simulated device overlay in order to identify candidates who were likely to have an optimal device fit.

Discussant Francesco Maisano, MD, was impressed by how well this simulation resembled the actual results as depicted in side-by-side pre- and postprocedural CT images presented by Dr. Sorajja.

“What really surprised me was the correlation between preprocedural simulation data and the actual CT scan after the procedure. This trial shows that the simulation works, and also that Tendyne is a great alternative to aortic valve-in-MAC for these very-high-risk patients,” said Dr. Maisano, professor of cardiac surgery at the University of Zürich and a pioneer of catheter-based mitral and tricuspid interventions.

Earlier this year the Tendyne device was approved in Europe for patients with mitral regurgitation who aren’t candidates for surgical valve replacement or transcatheter mitral valve repair. The approval does not, however, extend to MAC. The Abbott device remains investigational in the United States, where the pivotal SUMMIT trial is underway. In one arm of the trial, patients with mitral regurgitation are being randomized to the investigational Tendyne device or to Abbott’s MitraClip, which is approved for that indication. In the other arm, patients with severe MAC at prohibitive surgical risk will get the Tendyne device. Results are expected in 2020.

Dr. Sorajja reported receiving research grants from and serving as a consultant to Abbott, the feasibility study sponsor, as well as to several other medical device companies, as did Dr. Maisano.

[email protected]

Transcatheter implantation of the Tendyne mitral valve replacement device for treatment of mitral regurgitation in patients at prohibitive surgical risk because of severe mitral annular calcification showed considerable promise in a small feasibility study, Paul Sorajja, MD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News

There is a huge unmet need for safe and effective therapies for severe mitral annular calcification (MAC).

“Severe MAC often precludes surgical treatment, and there’s a poor prognosis in patients with MAC and mitral regurgitation when untreated, with 2-year survival of about 60% in some studies,” noted Dr. Sorajja, a cardiologist at the Minneapolis Heart Institute Foundation.

Attempts at repurposing transcatheter aortic valves for use in the mitral location have been largely unsatisfactory, he added.

The 6-month outcomes in the 11 patients who received the Tendyne device in the multicenter U.S. feasibility study featured low rates of mortality and nonfatal adverse events, elimination of mitral regurgitation, marked improvement on quality of life measures, and a mean gradient of 4.1 mm Hg. The acute procedural outcomes were encouraging as well.

“We had technical success in 11 of 11 patients, no procedural mortality or left ventricular outflow tract obstruction, no valve embolization or malposition, and no conversion to open heart surgery,” he said.

There was one death caused by mesenteric ischemia 16 days post Tendyne implantation. One patient experienced a nondisabling stroke at day 4. Two patients developed new-onset atrial fibrillation, one of whom cardioverted to sinus rhythm. And one patient had a moderate paravalvular leak that resolved with placement of a plug at 3 months. There were no MIs.

At baseline, 9 of 11 patients were New York Heart Association functional class III and the others were class II. At 6 months, six patients were class I, four were class II, and one was class III. The average score on the Kansas City Cardiomyopathy Questionnaire improved from 45.9 at baseline to 65.5 at 1 month, 77.4 at 3 months, and 70.3 at 6 months.

This was a highly selected study population with a Society of Thoracic Surgery Predicted Risk of Mortality score of 9.03%. Part of the screening process for study participation involved preprocedural CT imaging with simulated device overlay in order to identify candidates who were likely to have an optimal device fit.

Discussant Francesco Maisano, MD, was impressed by how well this simulation resembled the actual results as depicted in side-by-side pre- and postprocedural CT images presented by Dr. Sorajja.

“What really surprised me was the correlation between preprocedural simulation data and the actual CT scan after the procedure. This trial shows that the simulation works, and also that Tendyne is a great alternative to aortic valve-in-MAC for these very-high-risk patients,” said Dr. Maisano, professor of cardiac surgery at the University of Zürich and a pioneer of catheter-based mitral and tricuspid interventions.

Earlier this year the Tendyne device was approved in Europe for patients with mitral regurgitation who aren’t candidates for surgical valve replacement or transcatheter mitral valve repair. The approval does not, however, extend to MAC. The Abbott device remains investigational in the United States, where the pivotal SUMMIT trial is underway. In one arm of the trial, patients with mitral regurgitation are being randomized to the investigational Tendyne device or to Abbott’s MitraClip, which is approved for that indication. In the other arm, patients with severe MAC at prohibitive surgical risk will get the Tendyne device. Results are expected in 2020.

Dr. Sorajja reported receiving research grants from and serving as a consultant to Abbott, the feasibility study sponsor, as well as to several other medical device companies, as did Dr. Maisano.

[email protected]

Transcatheter implantation of the Tendyne mitral valve replacement device for treatment of mitral regurgitation in patients at prohibitive surgical risk because of severe mitral annular calcification showed considerable promise in a small feasibility study, Paul Sorajja, MD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News

There is a huge unmet need for safe and effective therapies for severe mitral annular calcification (MAC).

“Severe MAC often precludes surgical treatment, and there’s a poor prognosis in patients with MAC and mitral regurgitation when untreated, with 2-year survival of about 60% in some studies,” noted Dr. Sorajja, a cardiologist at the Minneapolis Heart Institute Foundation.

Attempts at repurposing transcatheter aortic valves for use in the mitral location have been largely unsatisfactory, he added.

The 6-month outcomes in the 11 patients who received the Tendyne device in the multicenter U.S. feasibility study featured low rates of mortality and nonfatal adverse events, elimination of mitral regurgitation, marked improvement on quality of life measures, and a mean gradient of 4.1 mm Hg. The acute procedural outcomes were encouraging as well.

“We had technical success in 11 of 11 patients, no procedural mortality or left ventricular outflow tract obstruction, no valve embolization or malposition, and no conversion to open heart surgery,” he said.

There was one death caused by mesenteric ischemia 16 days post Tendyne implantation. One patient experienced a nondisabling stroke at day 4. Two patients developed new-onset atrial fibrillation, one of whom cardioverted to sinus rhythm. And one patient had a moderate paravalvular leak that resolved with placement of a plug at 3 months. There were no MIs.

At baseline, 9 of 11 patients were New York Heart Association functional class III and the others were class II. At 6 months, six patients were class I, four were class II, and one was class III. The average score on the Kansas City Cardiomyopathy Questionnaire improved from 45.9 at baseline to 65.5 at 1 month, 77.4 at 3 months, and 70.3 at 6 months.

This was a highly selected study population with a Society of Thoracic Surgery Predicted Risk of Mortality score of 9.03%. Part of the screening process for study participation involved preprocedural CT imaging with simulated device overlay in order to identify candidates who were likely to have an optimal device fit.

Discussant Francesco Maisano, MD, was impressed by how well this simulation resembled the actual results as depicted in side-by-side pre- and postprocedural CT images presented by Dr. Sorajja.

“What really surprised me was the correlation between preprocedural simulation data and the actual CT scan after the procedure. This trial shows that the simulation works, and also that Tendyne is a great alternative to aortic valve-in-MAC for these very-high-risk patients,” said Dr. Maisano, professor of cardiac surgery at the University of Zürich and a pioneer of catheter-based mitral and tricuspid interventions.

Earlier this year the Tendyne device was approved in Europe for patients with mitral regurgitation who aren’t candidates for surgical valve replacement or transcatheter mitral valve repair. The approval does not, however, extend to MAC. The Abbott device remains investigational in the United States, where the pivotal SUMMIT trial is underway. In one arm of the trial, patients with mitral regurgitation are being randomized to the investigational Tendyne device or to Abbott’s MitraClip, which is approved for that indication. In the other arm, patients with severe MAC at prohibitive surgical risk will get the Tendyne device. Results are expected in 2020.

Dr. Sorajja reported receiving research grants from and serving as a consultant to Abbott, the feasibility study sponsor, as well as to several other medical device companies, as did Dr. Maisano.

[email protected]

A “favorable” lifestyle was associated with a reduced risk of breast cancer even among women at high genetic risk for the disease in a study of more than 90,000 women, researchers reported.

The findings suggest that, regardless of genetic risk, women may be able to reduce their risk of developing breast cancer by getting adequate levels of exercise; maintaining a healthy weight; and limiting or eliminating use of alcohol, oral contraceptives, and hormone replacement therapy.

Kawthar Al Ajmi, MSc, of the University of Manchester (England), and colleagues published these findings in JAMA Network Open.

With almost a quarter of breast cancers thought to be preventable in the United Kingdom, “it is important to understand the contribution of modifiable risk factors ... and how they affect or add to the inherited genetic factors,” the researchers wrote.

To that end, the team reviewed 91,217 white, postmenopausal women in the United Kingdom Biobank, an ongoing longitudinal study of the contribution of genetic, environmental, and lifestyle risk factors in disease. There were 2,728 women who developed breast cancer at a median follow-up of 10 years.

The investigators used a polygenic risk score to categorize subjects as low, intermediate, or high genetic risk. The score was constructed using 305 single-nucleotide variants.

Within each risk group, the researchers divided women by the presence or absence of five lifestyle factors previously associated with a lower risk of breast cancer: healthy weight, regular exercise, no use of hormone replacement therapy beyond 5 years, no oral contraceptive use, and alcohol intake no more than twice a week.

Women with four or more of these factors were deemed to have a favorable lifestyle. Women with two or three factors had an intermediate lifestyle, and women with fewer factors had an unfavorable lifestyle.
 

Results

The data showed an association between breast cancer and a body mass index of 25 or higher (relative risk, 1.14), no regular physical activity (RR, 1.12), alcohol intake at least three times per week (RR, 1.11), and use of hormone replacement therapy for 5 or more years (RR, 1.23). History of oral contraceptive use was not associated with breast cancer risk (RR, 1.02), but this factor remained a part of the lifestyle classification.

In the low genetic risk group, an intermediate lifestyle (hazard ratio, 1.40; 95% CI, 1.09-1.80) and an unfavorable lifestyle (HR, 1.63; 95% CI, 1.14-2.34) were both associated with a higher risk of breast cancer, compared with a favorable lifestyle.

In the intermediate genetic risk group, intermediate (HR, 1.37; 95% CI, 1.12-1.68) and unfavorable lifestyles (HR 1.94; 95% CI, 1.46-2.58) were again associated with higher breast cancer risk, compared with a favorable lifestyle .

Even in the high genetic risk group, intermediate (HR, 1.13; 95% CI, 0.98-1.31) and unfavorable lifestyles (HR, 1.39; 95% CI, 1.11-1.74) were associated with increased breast cancer risk. Results were adjusted for both age and family history.

In the end, “a healthier lifestyle ... appeared to be associated with a reduced level of risk for [breast cancer], even if the women were at higher genetic risk,” the researchers wrote. “Our findings suggest that women may be able to alter or reduce their risk of developing [breast cancer] by following healthier lifestyles,” regardless of genetic predisposition.
 

‘Surprising’ findings

It’s “surprising that these lifestyle changes lowered the risk of breast cancer,” said Charles Shapiro, MD, of the Icahn School of Medicine at Mount Sinai in New York, who was not involved in this study.

The study “requires replication,” he said. “On the other hand, these lifestyle changes promote overall health and certainly are associated with decreased risks of cardiovascular disease, the number one killer of women.”

“Patients always want to know what they can do above and beyond screening mammograms to reduce their risk of developing breast cancer,” said William Gradishar, MD, of Northwestern University in Chicago, who was not involved in the study.

“These data should empower patients that they can impact on their overall health and reduce the risk of developing breast cancer,” he said.

Among the study’s limitations, it’s unclear how the findings apply to nonwhite, nonpostmenopausal women, and the analysis did not differentiate between breast cancer subtypes.

In addition, although oral contraceptives have been linked to breast cancer in the past, there was no association in this study. Possible explanations could be that the investigators did not take into account duration of use, age of last use, and type or oral contraceptive used, they noted.

This research was funded by the National Institute for Health Research Manchester Biomedical Research Centre, the Alan Turing Institute, and a Cancer Research UK Integrated Cancer Epidemiology Programme grant. The investigators, Dr. Gradishar, and Dr. Shapiro have no relevant disclosures.

[email protected]

SOURCE: Al Ajmi K et al. JAMA Netw Open. 2020;3(4):e203760.

A “favorable” lifestyle was associated with a reduced risk of breast cancer even among women at high genetic risk for the disease in a study of more than 90,000 women, researchers reported.

The findings suggest that, regardless of genetic risk, women may be able to reduce their risk of developing breast cancer by getting adequate levels of exercise; maintaining a healthy weight; and limiting or eliminating use of alcohol, oral contraceptives, and hormone replacement therapy.

Kawthar Al Ajmi, MSc, of the University of Manchester (England), and colleagues published these findings in JAMA Network Open.

With almost a quarter of breast cancers thought to be preventable in the United Kingdom, “it is important to understand the contribution of modifiable risk factors ... and how they affect or add to the inherited genetic factors,” the researchers wrote.

To that end, the team reviewed 91,217 white, postmenopausal women in the United Kingdom Biobank, an ongoing longitudinal study of the contribution of genetic, environmental, and lifestyle risk factors in disease. There were 2,728 women who developed breast cancer at a median follow-up of 10 years.

The investigators used a polygenic risk score to categorize subjects as low, intermediate, or high genetic risk. The score was constructed using 305 single-nucleotide variants.

Within each risk group, the researchers divided women by the presence or absence of five lifestyle factors previously associated with a lower risk of breast cancer: healthy weight, regular exercise, no use of hormone replacement therapy beyond 5 years, no oral contraceptive use, and alcohol intake no more than twice a week.

Women with four or more of these factors were deemed to have a favorable lifestyle. Women with two or three factors had an intermediate lifestyle, and women with fewer factors had an unfavorable lifestyle.
 

Results

The data showed an association between breast cancer and a body mass index of 25 or higher (relative risk, 1.14), no regular physical activity (RR, 1.12), alcohol intake at least three times per week (RR, 1.11), and use of hormone replacement therapy for 5 or more years (RR, 1.23). History of oral contraceptive use was not associated with breast cancer risk (RR, 1.02), but this factor remained a part of the lifestyle classification.

In the low genetic risk group, an intermediate lifestyle (hazard ratio, 1.40; 95% CI, 1.09-1.80) and an unfavorable lifestyle (HR, 1.63; 95% CI, 1.14-2.34) were both associated with a higher risk of breast cancer, compared with a favorable lifestyle.

In the intermediate genetic risk group, intermediate (HR, 1.37; 95% CI, 1.12-1.68) and unfavorable lifestyles (HR 1.94; 95% CI, 1.46-2.58) were again associated with higher breast cancer risk, compared with a favorable lifestyle .

Even in the high genetic risk group, intermediate (HR, 1.13; 95% CI, 0.98-1.31) and unfavorable lifestyles (HR, 1.39; 95% CI, 1.11-1.74) were associated with increased breast cancer risk. Results were adjusted for both age and family history.

In the end, “a healthier lifestyle ... appeared to be associated with a reduced level of risk for [breast cancer], even if the women were at higher genetic risk,” the researchers wrote. “Our findings suggest that women may be able to alter or reduce their risk of developing [breast cancer] by following healthier lifestyles,” regardless of genetic predisposition.
 

‘Surprising’ findings

It’s “surprising that these lifestyle changes lowered the risk of breast cancer,” said Charles Shapiro, MD, of the Icahn School of Medicine at Mount Sinai in New York, who was not involved in this study.

The study “requires replication,” he said. “On the other hand, these lifestyle changes promote overall health and certainly are associated with decreased risks of cardiovascular disease, the number one killer of women.”

“Patients always want to know what they can do above and beyond screening mammograms to reduce their risk of developing breast cancer,” said William Gradishar, MD, of Northwestern University in Chicago, who was not involved in the study.

“These data should empower patients that they can impact on their overall health and reduce the risk of developing breast cancer,” he said.

Among the study’s limitations, it’s unclear how the findings apply to nonwhite, nonpostmenopausal women, and the analysis did not differentiate between breast cancer subtypes.

In addition, although oral contraceptives have been linked to breast cancer in the past, there was no association in this study. Possible explanations could be that the investigators did not take into account duration of use, age of last use, and type or oral contraceptive used, they noted.

This research was funded by the National Institute for Health Research Manchester Biomedical Research Centre, the Alan Turing Institute, and a Cancer Research UK Integrated Cancer Epidemiology Programme grant. The investigators, Dr. Gradishar, and Dr. Shapiro have no relevant disclosures.

[email protected]

SOURCE: Al Ajmi K et al. JAMA Netw Open. 2020;3(4):e203760.

A “favorable” lifestyle was associated with a reduced risk of breast cancer even among women at high genetic risk for the disease in a study of more than 90,000 women, researchers reported.

The findings suggest that, regardless of genetic risk, women may be able to reduce their risk of developing breast cancer by getting adequate levels of exercise; maintaining a healthy weight; and limiting or eliminating use of alcohol, oral contraceptives, and hormone replacement therapy.

Kawthar Al Ajmi, MSc, of the University of Manchester (England), and colleagues published these findings in JAMA Network Open.

With almost a quarter of breast cancers thought to be preventable in the United Kingdom, “it is important to understand the contribution of modifiable risk factors ... and how they affect or add to the inherited genetic factors,” the researchers wrote.

To that end, the team reviewed 91,217 white, postmenopausal women in the United Kingdom Biobank, an ongoing longitudinal study of the contribution of genetic, environmental, and lifestyle risk factors in disease. There were 2,728 women who developed breast cancer at a median follow-up of 10 years.

The investigators used a polygenic risk score to categorize subjects as low, intermediate, or high genetic risk. The score was constructed using 305 single-nucleotide variants.

Within each risk group, the researchers divided women by the presence or absence of five lifestyle factors previously associated with a lower risk of breast cancer: healthy weight, regular exercise, no use of hormone replacement therapy beyond 5 years, no oral contraceptive use, and alcohol intake no more than twice a week.

Women with four or more of these factors were deemed to have a favorable lifestyle. Women with two or three factors had an intermediate lifestyle, and women with fewer factors had an unfavorable lifestyle.
 

Results

The data showed an association between breast cancer and a body mass index of 25 or higher (relative risk, 1.14), no regular physical activity (RR, 1.12), alcohol intake at least three times per week (RR, 1.11), and use of hormone replacement therapy for 5 or more years (RR, 1.23). History of oral contraceptive use was not associated with breast cancer risk (RR, 1.02), but this factor remained a part of the lifestyle classification.

In the low genetic risk group, an intermediate lifestyle (hazard ratio, 1.40; 95% CI, 1.09-1.80) and an unfavorable lifestyle (HR, 1.63; 95% CI, 1.14-2.34) were both associated with a higher risk of breast cancer, compared with a favorable lifestyle.

In the intermediate genetic risk group, intermediate (HR, 1.37; 95% CI, 1.12-1.68) and unfavorable lifestyles (HR 1.94; 95% CI, 1.46-2.58) were again associated with higher breast cancer risk, compared with a favorable lifestyle .

Even in the high genetic risk group, intermediate (HR, 1.13; 95% CI, 0.98-1.31) and unfavorable lifestyles (HR, 1.39; 95% CI, 1.11-1.74) were associated with increased breast cancer risk. Results were adjusted for both age and family history.

In the end, “a healthier lifestyle ... appeared to be associated with a reduced level of risk for [breast cancer], even if the women were at higher genetic risk,” the researchers wrote. “Our findings suggest that women may be able to alter or reduce their risk of developing [breast cancer] by following healthier lifestyles,” regardless of genetic predisposition.
 

‘Surprising’ findings

It’s “surprising that these lifestyle changes lowered the risk of breast cancer,” said Charles Shapiro, MD, of the Icahn School of Medicine at Mount Sinai in New York, who was not involved in this study.

The study “requires replication,” he said. “On the other hand, these lifestyle changes promote overall health and certainly are associated with decreased risks of cardiovascular disease, the number one killer of women.”

“Patients always want to know what they can do above and beyond screening mammograms to reduce their risk of developing breast cancer,” said William Gradishar, MD, of Northwestern University in Chicago, who was not involved in the study.

“These data should empower patients that they can impact on their overall health and reduce the risk of developing breast cancer,” he said.

Among the study’s limitations, it’s unclear how the findings apply to nonwhite, nonpostmenopausal women, and the analysis did not differentiate between breast cancer subtypes.

In addition, although oral contraceptives have been linked to breast cancer in the past, there was no association in this study. Possible explanations could be that the investigators did not take into account duration of use, age of last use, and type or oral contraceptive used, they noted.

This research was funded by the National Institute for Health Research Manchester Biomedical Research Centre, the Alan Turing Institute, and a Cancer Research UK Integrated Cancer Epidemiology Programme grant. The investigators, Dr. Gradishar, and Dr. Shapiro have no relevant disclosures.

[email protected]

SOURCE: Al Ajmi K et al. JAMA Netw Open. 2020;3(4):e203760.

The definition of stage IV renal cell carcinoma (RCC) should be expanded to include lymph node–positive stage III disease, according to a population-level cohort study published in Cancer.

While patients with lymph node–negative stage III disease had superior overall survival at 5 years, survival rates were similar between patients with node–positive stage III disease and stage IV disease. This supports reclassifying stage III node-positive RCC to stage IV, according to researchers.

“Prior institutional studies have indicated that, among patients with stage III disease, those with lymph node disease have worse oncologic outcomes and experience survival that is similar to that of patients with American Joint Committee on Cancer (AJCC) stage IV disease,” wrote Arnav Srivastava, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and colleagues.

The researchers used data from the National Cancer Database to identify patients with AJCC stage III or stage IV RCC who had undergone nephrectomy and lymph node dissection.

The cohort included 8,988 patients, 6,587 of whom had node–negative stage III disease, 2,218 of whom had node–positive stage III disease, and 183 of whom had stage IV metastatic disease. The researchers compared relative survival between staging groups.

The 5-year overall survival rate was 61.9% in patients with node–negative stage III RCC (95% confidence interval, 60.3%-63.4%), 22.7% in patients with node-positive stage III RCC (95% CI, 20.6%-24.9%), and 15.6% in patients with stage IV RCC (95% CI, 11.1%-23.8%).

“Patients with lymph node–positive stage III disease and those with stage IV disease were found to have overlapping 95% CIs when measuring 5-year survival; both demonstrated similar mortality,” the researchers reported. They further noted that these findings remained unchanged when patients were stratified by clear cell and non–clear cell histology.

In an accompanying editorial, Daniel D. Shapiro, MD, of the University of Texas MD Anderson Cancer Center, Houston, and E. Jason Abel, MD, of the University of Wisconsin–Madison, said the study results suggest the clinical phenotype of patients with isolated lymph node metastases is different from other stage III RCCs.

“Future editions of the AJCC staging system [should] recognize the increased risk with [lymph node–positive stage III] tumors and consider reclassification of [these] tumors as stage IV tumors so that baseline risks are more accurately measured in these rare populations,” they recommended.

Dr. Srivastava and colleagues acknowledged that two key limitations of the study were the retrospective design and the absence of data on other survival measures, such as metastasis-free and cancer-specific survival.

“Despite these limitations, we believe the current study was able to significantly build on prior work recommending the reclassification of lymph node–positive RCC as stage IV cancer,” they concluded.

The National Cancer Institute supported the study. Some study authors disclosed relationships with pharmaceutical companies and other organizations for work performed outside of the current study. The editorial authors disclosed no conflicts of interest.

SOURCE: Srivastava A et al. Cancer. 2020 Jul 1;126(13):2991-3001.

The definition of stage IV renal cell carcinoma (RCC) should be expanded to include lymph node–positive stage III disease, according to a population-level cohort study published in Cancer.

While patients with lymph node–negative stage III disease had superior overall survival at 5 years, survival rates were similar between patients with node–positive stage III disease and stage IV disease. This supports reclassifying stage III node-positive RCC to stage IV, according to researchers.

“Prior institutional studies have indicated that, among patients with stage III disease, those with lymph node disease have worse oncologic outcomes and experience survival that is similar to that of patients with American Joint Committee on Cancer (AJCC) stage IV disease,” wrote Arnav Srivastava, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and colleagues.

The researchers used data from the National Cancer Database to identify patients with AJCC stage III or stage IV RCC who had undergone nephrectomy and lymph node dissection.

The cohort included 8,988 patients, 6,587 of whom had node–negative stage III disease, 2,218 of whom had node–positive stage III disease, and 183 of whom had stage IV metastatic disease. The researchers compared relative survival between staging groups.

The 5-year overall survival rate was 61.9% in patients with node–negative stage III RCC (95% confidence interval, 60.3%-63.4%), 22.7% in patients with node-positive stage III RCC (95% CI, 20.6%-24.9%), and 15.6% in patients with stage IV RCC (95% CI, 11.1%-23.8%).

“Patients with lymph node–positive stage III disease and those with stage IV disease were found to have overlapping 95% CIs when measuring 5-year survival; both demonstrated similar mortality,” the researchers reported. They further noted that these findings remained unchanged when patients were stratified by clear cell and non–clear cell histology.

In an accompanying editorial, Daniel D. Shapiro, MD, of the University of Texas MD Anderson Cancer Center, Houston, and E. Jason Abel, MD, of the University of Wisconsin–Madison, said the study results suggest the clinical phenotype of patients with isolated lymph node metastases is different from other stage III RCCs.

“Future editions of the AJCC staging system [should] recognize the increased risk with [lymph node–positive stage III] tumors and consider reclassification of [these] tumors as stage IV tumors so that baseline risks are more accurately measured in these rare populations,” they recommended.

Dr. Srivastava and colleagues acknowledged that two key limitations of the study were the retrospective design and the absence of data on other survival measures, such as metastasis-free and cancer-specific survival.

“Despite these limitations, we believe the current study was able to significantly build on prior work recommending the reclassification of lymph node–positive RCC as stage IV cancer,” they concluded.

The National Cancer Institute supported the study. Some study authors disclosed relationships with pharmaceutical companies and other organizations for work performed outside of the current study. The editorial authors disclosed no conflicts of interest.

SOURCE: Srivastava A et al. Cancer. 2020 Jul 1;126(13):2991-3001.

The definition of stage IV renal cell carcinoma (RCC) should be expanded to include lymph node–positive stage III disease, according to a population-level cohort study published in Cancer.

While patients with lymph node–negative stage III disease had superior overall survival at 5 years, survival rates were similar between patients with node–positive stage III disease and stage IV disease. This supports reclassifying stage III node-positive RCC to stage IV, according to researchers.

“Prior institutional studies have indicated that, among patients with stage III disease, those with lymph node disease have worse oncologic outcomes and experience survival that is similar to that of patients with American Joint Committee on Cancer (AJCC) stage IV disease,” wrote Arnav Srivastava, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and colleagues.

The researchers used data from the National Cancer Database to identify patients with AJCC stage III or stage IV RCC who had undergone nephrectomy and lymph node dissection.

The cohort included 8,988 patients, 6,587 of whom had node–negative stage III disease, 2,218 of whom had node–positive stage III disease, and 183 of whom had stage IV metastatic disease. The researchers compared relative survival between staging groups.

The 5-year overall survival rate was 61.9% in patients with node–negative stage III RCC (95% confidence interval, 60.3%-63.4%), 22.7% in patients with node-positive stage III RCC (95% CI, 20.6%-24.9%), and 15.6% in patients with stage IV RCC (95% CI, 11.1%-23.8%).

“Patients with lymph node–positive stage III disease and those with stage IV disease were found to have overlapping 95% CIs when measuring 5-year survival; both demonstrated similar mortality,” the researchers reported. They further noted that these findings remained unchanged when patients were stratified by clear cell and non–clear cell histology.

In an accompanying editorial, Daniel D. Shapiro, MD, of the University of Texas MD Anderson Cancer Center, Houston, and E. Jason Abel, MD, of the University of Wisconsin–Madison, said the study results suggest the clinical phenotype of patients with isolated lymph node metastases is different from other stage III RCCs.

“Future editions of the AJCC staging system [should] recognize the increased risk with [lymph node–positive stage III] tumors and consider reclassification of [these] tumors as stage IV tumors so that baseline risks are more accurately measured in these rare populations,” they recommended.

Dr. Srivastava and colleagues acknowledged that two key limitations of the study were the retrospective design and the absence of data on other survival measures, such as metastasis-free and cancer-specific survival.

“Despite these limitations, we believe the current study was able to significantly build on prior work recommending the reclassification of lymph node–positive RCC as stage IV cancer,” they concluded.

The National Cancer Institute supported the study. Some study authors disclosed relationships with pharmaceutical companies and other organizations for work performed outside of the current study. The editorial authors disclosed no conflicts of interest.

SOURCE: Srivastava A et al. Cancer. 2020 Jul 1;126(13):2991-3001.

A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.

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Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.

“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”

To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.

The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.

Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).

Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).

In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.

“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.

The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”

Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.

The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.

A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.

The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
 

[email protected]

SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.

A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.

Thinkstock

Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.

“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”

To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.

The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.

Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).

Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).

In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.

“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.

The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”

Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.

The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.

A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.

The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
 

[email protected]

SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.

A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.

Thinkstock

Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.

“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”

To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.

The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.

Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).

Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).

In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.

“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.

The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”

Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.

The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.

A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.

The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
 

[email protected]

SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

A version of this article originally appeared on Medscape.com.

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

A version of this article originally appeared on Medscape.com.

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

A version of this article originally appeared on Medscape.com.

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.

That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.

When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.

Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.

“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.

When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
 

Much depends on the future of telehealth

Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.

COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.

Several things need to happen to change the outlook for outpatient care, he said.

A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.

If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.

“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.

In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.

However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.

Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
 

Visit trends still down

Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.

Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”

They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.

Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.

“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.

It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
 

Telemedicine rates dropping

Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.

He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”

Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.

He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”

Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.

Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”

For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”

Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.

A version of this article originally on Medscape.com.

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.

That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.

When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.

Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.

“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.

When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
 

Much depends on the future of telehealth

Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.

COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.

Several things need to happen to change the outlook for outpatient care, he said.

A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.

If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.

“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.

In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.

However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.

Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
 

Visit trends still down

Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.

Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”

They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.

Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.

“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.

It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
 

Telemedicine rates dropping

Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.

He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”

Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.

He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”

Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.

Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”

For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”

Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.

A version of this article originally on Medscape.com.

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.

That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.

When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.

Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.

“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.

When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
 

Much depends on the future of telehealth

Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.

COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.

Several things need to happen to change the outlook for outpatient care, he said.

A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.

If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.

“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.

In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.

However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.

Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
 

Visit trends still down

Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.

Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”

They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.

Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.

“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.

It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
 

Telemedicine rates dropping

Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.

He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”

Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.

He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”

Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.

Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”

For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”

Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.

A version of this article originally on Medscape.com.

Transcatheter bariatric embolotherapy (TBE) provides sustained weight loss without serious adverse effects among obese patients, results of a pilot sham-controlled study suggest.

At 6-month follow-up, the patients receiving the intervention had lost 7.4 kg (16.3 lbs), compared with 3.0 kg (6.6 lbs) in those randomized to a sham procedure in an intention-to-treat analysis (P = .034).

Results were similar in a per-protocol analysis (9.4 kg/20.7 lbs vs. 1.9 kg/4.1 lbs; P = .0002).

Weight loss after embolotherapy was sustained over 12 months, falling 7.8 kg (17.1 lbs) from baseline in the intention-to-treat population (P = .0011) and 9.3 kg (20.5 lbs) in the per-protocol population (P = .0005).

Safety events after TBE were mild nausea or vomiting, reported Vivek Reddy, MD, Mount Sinai Hospital, New York City. Five participants had minor, asymptomatic ulcers that required no additional treatment.

“In this randomized pilot trial, we established the proof of principle that transcatheter bariatric embolotherapy of the left gastric artery is safe and it promotes clinically significant weight loss,” he concluded at PCR e-Course, the virtual meeting of the Congress of European Association of Percutaneous Cardiovascular Interventions 2020.

Although bariatric surgery is highly effective, he noted that the associated morbidity and mortality limit its use to the severely obese with a body mass index (BMI) typically over 40 kg/m².

TBE is a minimally invasive approach that uses a custom occlusion balloon microcatheter and robotic manifold to inject 300- to 500-mcm beads to the left gastric artery. Preclinical and case studies suggest it promotes weight loss by reducing ghrelin, an appetite-stimulating hormone secreted from the gastric fundus, Dr. Reddy said.

The study enrolled 44 patients (aged 21-60 years) with a BMI of 35-55, excluding those with prior bariatric surgery and a history of ulcers, type 2 diabetes, chronic aspirin or nonsteroidal inflammatory use, and active Helicobacter pylori infection.

A total of 40 patients were randomly assigned to TBE or a sham procedure, in which lidocaine was applied to the femoral area and propofol infused for 1 hour. The two groups were well matched, with a mean age of 45 vs. 46 years, weight of 110 kg vs. 119 kg, and BMI of 39 vs. 40, Dr. Reddy noted.

Embolotherapy was performed at a single center in Prague, and, on average, took 82.3 minutes and used 127 mL of contrast, 163 Gy/cm² radiation, and 4.2 mL of microspheres. A single vessel was injected in 80% of cases.

The intention-to-treat population comprised 19 TBE and 18 control subjects, and the per-protocol population comprised 15 TBE and 16 control subjects, after the exclusion of patients in whom embolotherapy was unsuccessful or incomplete or who withdrew consent.

All patients received endoscopy at baseline and 1 week, as well as an intensive 19-session lifestyle and dietary education intervention out to 6 months.

Patients who underwent TBE had significant improvement in hunger scores at 6 and 12 months, compared with baseline. Similarly, quality of life improved across all six domains, including significant gains in physical function, self-esteem, and overall quality of life at both time points, Dr. Reddy reported.

Dr. Reddy disclosed receiving research support from Endobar Solutions.

This article first appeared on Medscape.com.

Transcatheter bariatric embolotherapy (TBE) provides sustained weight loss without serious adverse effects among obese patients, results of a pilot sham-controlled study suggest.

At 6-month follow-up, the patients receiving the intervention had lost 7.4 kg (16.3 lbs), compared with 3.0 kg (6.6 lbs) in those randomized to a sham procedure in an intention-to-treat analysis (P = .034).

Results were similar in a per-protocol analysis (9.4 kg/20.7 lbs vs. 1.9 kg/4.1 lbs; P = .0002).

Weight loss after embolotherapy was sustained over 12 months, falling 7.8 kg (17.1 lbs) from baseline in the intention-to-treat population (P = .0011) and 9.3 kg (20.5 lbs) in the per-protocol population (P = .0005).

Safety events after TBE were mild nausea or vomiting, reported Vivek Reddy, MD, Mount Sinai Hospital, New York City. Five participants had minor, asymptomatic ulcers that required no additional treatment.

“In this randomized pilot trial, we established the proof of principle that transcatheter bariatric embolotherapy of the left gastric artery is safe and it promotes clinically significant weight loss,” he concluded at PCR e-Course, the virtual meeting of the Congress of European Association of Percutaneous Cardiovascular Interventions 2020.

Although bariatric surgery is highly effective, he noted that the associated morbidity and mortality limit its use to the severely obese with a body mass index (BMI) typically over 40 kg/m².

TBE is a minimally invasive approach that uses a custom occlusion balloon microcatheter and robotic manifold to inject 300- to 500-mcm beads to the left gastric artery. Preclinical and case studies suggest it promotes weight loss by reducing ghrelin, an appetite-stimulating hormone secreted from the gastric fundus, Dr. Reddy said.

The study enrolled 44 patients (aged 21-60 years) with a BMI of 35-55, excluding those with prior bariatric surgery and a history of ulcers, type 2 diabetes, chronic aspirin or nonsteroidal inflammatory use, and active Helicobacter pylori infection.

A total of 40 patients were randomly assigned to TBE or a sham procedure, in which lidocaine was applied to the femoral area and propofol infused for 1 hour. The two groups were well matched, with a mean age of 45 vs. 46 years, weight of 110 kg vs. 119 kg, and BMI of 39 vs. 40, Dr. Reddy noted.

Embolotherapy was performed at a single center in Prague, and, on average, took 82.3 minutes and used 127 mL of contrast, 163 Gy/cm² radiation, and 4.2 mL of microspheres. A single vessel was injected in 80% of cases.

The intention-to-treat population comprised 19 TBE and 18 control subjects, and the per-protocol population comprised 15 TBE and 16 control subjects, after the exclusion of patients in whom embolotherapy was unsuccessful or incomplete or who withdrew consent.

All patients received endoscopy at baseline and 1 week, as well as an intensive 19-session lifestyle and dietary education intervention out to 6 months.

Patients who underwent TBE had significant improvement in hunger scores at 6 and 12 months, compared with baseline. Similarly, quality of life improved across all six domains, including significant gains in physical function, self-esteem, and overall quality of life at both time points, Dr. Reddy reported.

Dr. Reddy disclosed receiving research support from Endobar Solutions.

This article first appeared on Medscape.com.

Transcatheter bariatric embolotherapy (TBE) provides sustained weight loss without serious adverse effects among obese patients, results of a pilot sham-controlled study suggest.

At 6-month follow-up, the patients receiving the intervention had lost 7.4 kg (16.3 lbs), compared with 3.0 kg (6.6 lbs) in those randomized to a sham procedure in an intention-to-treat analysis (P = .034).

Results were similar in a per-protocol analysis (9.4 kg/20.7 lbs vs. 1.9 kg/4.1 lbs; P = .0002).

Weight loss after embolotherapy was sustained over 12 months, falling 7.8 kg (17.1 lbs) from baseline in the intention-to-treat population (P = .0011) and 9.3 kg (20.5 lbs) in the per-protocol population (P = .0005).

Safety events after TBE were mild nausea or vomiting, reported Vivek Reddy, MD, Mount Sinai Hospital, New York City. Five participants had minor, asymptomatic ulcers that required no additional treatment.

“In this randomized pilot trial, we established the proof of principle that transcatheter bariatric embolotherapy of the left gastric artery is safe and it promotes clinically significant weight loss,” he concluded at PCR e-Course, the virtual meeting of the Congress of European Association of Percutaneous Cardiovascular Interventions 2020.

Although bariatric surgery is highly effective, he noted that the associated morbidity and mortality limit its use to the severely obese with a body mass index (BMI) typically over 40 kg/m².

TBE is a minimally invasive approach that uses a custom occlusion balloon microcatheter and robotic manifold to inject 300- to 500-mcm beads to the left gastric artery. Preclinical and case studies suggest it promotes weight loss by reducing ghrelin, an appetite-stimulating hormone secreted from the gastric fundus, Dr. Reddy said.

The study enrolled 44 patients (aged 21-60 years) with a BMI of 35-55, excluding those with prior bariatric surgery and a history of ulcers, type 2 diabetes, chronic aspirin or nonsteroidal inflammatory use, and active Helicobacter pylori infection.

A total of 40 patients were randomly assigned to TBE or a sham procedure, in which lidocaine was applied to the femoral area and propofol infused for 1 hour. The two groups were well matched, with a mean age of 45 vs. 46 years, weight of 110 kg vs. 119 kg, and BMI of 39 vs. 40, Dr. Reddy noted.

Embolotherapy was performed at a single center in Prague, and, on average, took 82.3 minutes and used 127 mL of contrast, 163 Gy/cm² radiation, and 4.2 mL of microspheres. A single vessel was injected in 80% of cases.

The intention-to-treat population comprised 19 TBE and 18 control subjects, and the per-protocol population comprised 15 TBE and 16 control subjects, after the exclusion of patients in whom embolotherapy was unsuccessful or incomplete or who withdrew consent.

All patients received endoscopy at baseline and 1 week, as well as an intensive 19-session lifestyle and dietary education intervention out to 6 months.

Patients who underwent TBE had significant improvement in hunger scores at 6 and 12 months, compared with baseline. Similarly, quality of life improved across all six domains, including significant gains in physical function, self-esteem, and overall quality of life at both time points, Dr. Reddy reported.

Dr. Reddy disclosed receiving research support from Endobar Solutions.

This article first appeared on Medscape.com.

Background: The United States Renal Data System registry estimates that approximately 30% of patients die within 1 year of initiating hemodialysis.

Dr. Lublin is a hospitalist at the University of Colorado at Denver, Aurora.

Background: The United States Renal Data System registry estimates that approximately 30% of patients die within 1 year of initiating hemodialysis.

Dr. Lublin is a hospitalist at the University of Colorado at Denver, Aurora.

Background: The United States Renal Data System registry estimates that approximately 30% of patients die within 1 year of initiating hemodialysis.

Dr. Lublin is a hospitalist at the University of Colorado at Denver, Aurora.

Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.

Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.

The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.

This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.

In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.

“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.

The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”

Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.

Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.

The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.

Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.

The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.

According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).

“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.

However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.

The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
 

Stemming the shortages

The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.

“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.

He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.

However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.

Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.

Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”

The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.

Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.

She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.

Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.

Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.

Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.

The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.

This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.

In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.

“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.

The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”

Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.

Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.

The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.

Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.

The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.

According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).

“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.

However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.

The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
 

Stemming the shortages

The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.

“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.

He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.

However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.

Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.

Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”

The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.

Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.

She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.

Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.

Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.

Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.

The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.

This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.

In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.

“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.

The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”

Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.

Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.

The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.

Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.

The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.

According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).

“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.

However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.

The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
 

Stemming the shortages

The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.

“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.

He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.

However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.

Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.

Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”

The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.

Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.

She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.

Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.

Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Older individuals had a higher risk of complications 30 days after undergoing a colonoscopy as an outpatient procedure compared with a younger group of colorectal cancer screening–eligible individuals, according to recent research published in JAMA Network Open.

Natalia Causada-Calo, MD, MSc, division of gastroenterology, at St. Michael’s Hospital, University of Toronto, and colleagues performed a retrospective cohort study of 38,069 patients in Ontario administrative databases who underwent colonoscopy between April 2008 and September 2017. The patients included were older than 50 years (mean age, 65.2 years) with a majority (73.1%) undergoing their first colonoscopy. Those with inflammatory bowel disease and hereditary colorectal cancer syndromes were excluded. Researchers divided patients into groups based on age, placing patients aged 50-74 years into a colorectal cancer–screening eligible group (30,443 patients), and individuals 75 years or older into an “older cohort” (7,627 patients). Dr. Causada-Calo and colleagues analyzed 30-day admission to hospital or emergency department, and also examined 30-day all-cause mortality and incidence of colorectal cancer.

Among individuals in the older cohort, 515 of 7,627 patients (6.8%) experienced complications after colonoscopy compared with 795 of 30,443 patients (2.6%) in the screening-eligible cohort (P less than .001). Older age was an independent risk factor for postcolonoscopy complications, with individuals older than 75 years having twofold greater odds of complications after colonoscopy (odds ratio, 2.3; 95% confidence interval, 2.0-2.6) compared with individuals aged 50-74 years.

Other independent risk factors for complications included liver disease (OR, 4.7; 95% CI, 3.5-6.5), heart failure (OR, 3.4; 95% CI, 2.5-4.6), smoking history (OR, 3.2; 95% CI, 2.4-4.3), obesity (OR, 2.3; 95% CI, 1.2-4.2), chronic kidney disease (OR, 1.8; 95% CI, 1.1-3.0), cardiac arrhythmia (OR, 1.7; 95% CI, 1.2-2.2), anemia (OR, 1.4; 95% CI, 1.2-1.7), and hypertension (OR, 1.2; 95% CI, 1.0-1.5). Individuals who had previously undergone colonoscopy had a lower risk of complications after the procedure (OR, 0.9; 95% CI, 0.7-1.0).

There was a significantly higher incidence of colorectal cancer treated with surgery in the older group (119 of 7,626; 1.6%) compared with the younger (144 of 30,443; 0.5%) group (P less than .001). Mortality from any cause was also significantly higher in the older group (20 patients; 0.2%) compared with the younger (39 patients; 0.1%) group (P less than .001).

“In accordance with our findings, the decision to perform colonoscopy should be considered carefully in older patients, particularly in the presence of comorbidities,” Dr. Causada-Calo and colleagues wrote.

Aasma Shaukat, MD, MPH, GI section chief at Minneapolis VA Health Care System and professor of medicine at University of Minnesota, said in an interview that screening colonoscopy in a population older than 75 years should be an individualized discussion with a patient who has minimal comorbidities, and the decision to move forward with a colonoscopy should be considered only if a patient’s life expectancy is at least 10 years.

“This study shows that diagnostic colonoscopy is associated with high risk of complications and quantifies the risk, to frame the discussion with the patient about going forward,” she said. “Colorectal cancers are slow growing. In individuals age 75 and older, competing health risks and risk of the colonoscopy often outweigh the small benefit they may derive. Older individuals should thus focus on other health priorities.”

Physicians should make their older patients aware that there is a risk for serious adverse events, including death, which increases after age 75. “[The] risk-benefit ratio for performing colonoscopy needs to carefully weighed,” Dr. Shaukat said. “[T]he patient should be presented with options, including the option of no screening.”

The American Cancer Society advocates “for individualized decision-making regarding screening for individuals after 75 but [does] not give any firm recommendations,” while the U.S. Preventive Services Task Force noted in its recommendations on colorectal cancer screening that the “harms are large and benefits are small” after 75 years of age, and choice to screen for colorectal cancer in that age group is an individual one, Dr. Shaukat said.

Robert A. Smith, PhD, senior vice president of cancer screening at the American Cancer Society, said in an interview that while colonoscopy is the dominant screening test for colorectal cancer, it is not known how often physicians and their older patients discuss noninvasive colorectal cancer screening methods. Noninvasive screening methods such as a high-sensitivity stool test should be a consideration even for older adults with mild chronic conditions, “especially if they have a history of screening with negative results,” he said. “[A] history of regular screening with normal test results should be a basis for considering cessation of screening after age 75, or at least transition to a test with lower risks of complications.”

Future research in this area could use a hybrid model of screening, such as using different tests among various age groups or risk groups, to see whether an invasive or noninvasive method would lower a complication rate, Dr. Smith said. “Further, we need to have a greater understanding of when individuals can confidently stop getting screened, based on their underlying risk and history of prior screening results,” he noted.

Dr. Shaukat said future studies should focus on randomized trials for individuals 75 years and older to assess the benefits and harms of screening, “[d]eveloping risk stratification tools that factor in an individual’s risk of colon cancer, their life expectancy, and guide individualized decision making to undergo screening.”

Dr. Armstrong is the chair of the National Colon Cancer Screening Network for the Canadian Partnership Against Cancer and the past president of the Canadian Association of Gastroenterology. Dr. Albashir has received honoraria and speaker fees from Janssen, and grants from AbbVie and ATGen. Dr. Shaukat and Dr. Smith report no relevant conflicts of interest.

SOURCE: Causada-Calo N et al. JAMA Netw Open. 2020;3(6):e208958.

Older individuals had a higher risk of complications 30 days after undergoing a colonoscopy as an outpatient procedure compared with a younger group of colorectal cancer screening–eligible individuals, according to recent research published in JAMA Network Open.

Natalia Causada-Calo, MD, MSc, division of gastroenterology, at St. Michael’s Hospital, University of Toronto, and colleagues performed a retrospective cohort study of 38,069 patients in Ontario administrative databases who underwent colonoscopy between April 2008 and September 2017. The patients included were older than 50 years (mean age, 65.2 years) with a majority (73.1%) undergoing their first colonoscopy. Those with inflammatory bowel disease and hereditary colorectal cancer syndromes were excluded. Researchers divided patients into groups based on age, placing patients aged 50-74 years into a colorectal cancer–screening eligible group (30,443 patients), and individuals 75 years or older into an “older cohort” (7,627 patients). Dr. Causada-Calo and colleagues analyzed 30-day admission to hospital or emergency department, and also examined 30-day all-cause mortality and incidence of colorectal cancer.

Among individuals in the older cohort, 515 of 7,627 patients (6.8%) experienced complications after colonoscopy compared with 795 of 30,443 patients (2.6%) in the screening-eligible cohort (P less than .001). Older age was an independent risk factor for postcolonoscopy complications, with individuals older than 75 years having twofold greater odds of complications after colonoscopy (odds ratio, 2.3; 95% confidence interval, 2.0-2.6) compared with individuals aged 50-74 years.

Other independent risk factors for complications included liver disease (OR, 4.7; 95% CI, 3.5-6.5), heart failure (OR, 3.4; 95% CI, 2.5-4.6), smoking history (OR, 3.2; 95% CI, 2.4-4.3), obesity (OR, 2.3; 95% CI, 1.2-4.2), chronic kidney disease (OR, 1.8; 95% CI, 1.1-3.0), cardiac arrhythmia (OR, 1.7; 95% CI, 1.2-2.2), anemia (OR, 1.4; 95% CI, 1.2-1.7), and hypertension (OR, 1.2; 95% CI, 1.0-1.5). Individuals who had previously undergone colonoscopy had a lower risk of complications after the procedure (OR, 0.9; 95% CI, 0.7-1.0).

There was a significantly higher incidence of colorectal cancer treated with surgery in the older group (119 of 7,626; 1.6%) compared with the younger (144 of 30,443; 0.5%) group (P less than .001). Mortality from any cause was also significantly higher in the older group (20 patients; 0.2%) compared with the younger (39 patients; 0.1%) group (P less than .001).

“In accordance with our findings, the decision to perform colonoscopy should be considered carefully in older patients, particularly in the presence of comorbidities,” Dr. Causada-Calo and colleagues wrote.

Aasma Shaukat, MD, MPH, GI section chief at Minneapolis VA Health Care System and professor of medicine at University of Minnesota, said in an interview that screening colonoscopy in a population older than 75 years should be an individualized discussion with a patient who has minimal comorbidities, and the decision to move forward with a colonoscopy should be considered only if a patient’s life expectancy is at least 10 years.

“This study shows that diagnostic colonoscopy is associated with high risk of complications and quantifies the risk, to frame the discussion with the patient about going forward,” she said. “Colorectal cancers are slow growing. In individuals age 75 and older, competing health risks and risk of the colonoscopy often outweigh the small benefit they may derive. Older individuals should thus focus on other health priorities.”

Physicians should make their older patients aware that there is a risk for serious adverse events, including death, which increases after age 75. “[The] risk-benefit ratio for performing colonoscopy needs to carefully weighed,” Dr. Shaukat said. “[T]he patient should be presented with options, including the option of no screening.”

The American Cancer Society advocates “for individualized decision-making regarding screening for individuals after 75 but [does] not give any firm recommendations,” while the U.S. Preventive Services Task Force noted in its recommendations on colorectal cancer screening that the “harms are large and benefits are small” after 75 years of age, and choice to screen for colorectal cancer in that age group is an individual one, Dr. Shaukat said.

Robert A. Smith, PhD, senior vice president of cancer screening at the American Cancer Society, said in an interview that while colonoscopy is the dominant screening test for colorectal cancer, it is not known how often physicians and their older patients discuss noninvasive colorectal cancer screening methods. Noninvasive screening methods such as a high-sensitivity stool test should be a consideration even for older adults with mild chronic conditions, “especially if they have a history of screening with negative results,” he said. “[A] history of regular screening with normal test results should be a basis for considering cessation of screening after age 75, or at least transition to a test with lower risks of complications.”

Future research in this area could use a hybrid model of screening, such as using different tests among various age groups or risk groups, to see whether an invasive or noninvasive method would lower a complication rate, Dr. Smith said. “Further, we need to have a greater understanding of when individuals can confidently stop getting screened, based on their underlying risk and history of prior screening results,” he noted.

Dr. Shaukat said future studies should focus on randomized trials for individuals 75 years and older to assess the benefits and harms of screening, “[d]eveloping risk stratification tools that factor in an individual’s risk of colon cancer, their life expectancy, and guide individualized decision making to undergo screening.”

Dr. Armstrong is the chair of the National Colon Cancer Screening Network for the Canadian Partnership Against Cancer and the past president of the Canadian Association of Gastroenterology. Dr. Albashir has received honoraria and speaker fees from Janssen, and grants from AbbVie and ATGen. Dr. Shaukat and Dr. Smith report no relevant conflicts of interest.

SOURCE: Causada-Calo N et al. JAMA Netw Open. 2020;3(6):e208958.

Older individuals had a higher risk of complications 30 days after undergoing a colonoscopy as an outpatient procedure compared with a younger group of colorectal cancer screening–eligible individuals, according to recent research published in JAMA Network Open.

Natalia Causada-Calo, MD, MSc, division of gastroenterology, at St. Michael’s Hospital, University of Toronto, and colleagues performed a retrospective cohort study of 38,069 patients in Ontario administrative databases who underwent colonoscopy between April 2008 and September 2017. The patients included were older than 50 years (mean age, 65.2 years) with a majority (73.1%) undergoing their first colonoscopy. Those with inflammatory bowel disease and hereditary colorectal cancer syndromes were excluded. Researchers divided patients into groups based on age, placing patients aged 50-74 years into a colorectal cancer–screening eligible group (30,443 patients), and individuals 75 years or older into an “older cohort” (7,627 patients). Dr. Causada-Calo and colleagues analyzed 30-day admission to hospital or emergency department, and also examined 30-day all-cause mortality and incidence of colorectal cancer.

Among individuals in the older cohort, 515 of 7,627 patients (6.8%) experienced complications after colonoscopy compared with 795 of 30,443 patients (2.6%) in the screening-eligible cohort (P less than .001). Older age was an independent risk factor for postcolonoscopy complications, with individuals older than 75 years having twofold greater odds of complications after colonoscopy (odds ratio, 2.3; 95% confidence interval, 2.0-2.6) compared with individuals aged 50-74 years.

Other independent risk factors for complications included liver disease (OR, 4.7; 95% CI, 3.5-6.5), heart failure (OR, 3.4; 95% CI, 2.5-4.6), smoking history (OR, 3.2; 95% CI, 2.4-4.3), obesity (OR, 2.3; 95% CI, 1.2-4.2), chronic kidney disease (OR, 1.8; 95% CI, 1.1-3.0), cardiac arrhythmia (OR, 1.7; 95% CI, 1.2-2.2), anemia (OR, 1.4; 95% CI, 1.2-1.7), and hypertension (OR, 1.2; 95% CI, 1.0-1.5). Individuals who had previously undergone colonoscopy had a lower risk of complications after the procedure (OR, 0.9; 95% CI, 0.7-1.0).

There was a significantly higher incidence of colorectal cancer treated with surgery in the older group (119 of 7,626; 1.6%) compared with the younger (144 of 30,443; 0.5%) group (P less than .001). Mortality from any cause was also significantly higher in the older group (20 patients; 0.2%) compared with the younger (39 patients; 0.1%) group (P less than .001).

“In accordance with our findings, the decision to perform colonoscopy should be considered carefully in older patients, particularly in the presence of comorbidities,” Dr. Causada-Calo and colleagues wrote.

Aasma Shaukat, MD, MPH, GI section chief at Minneapolis VA Health Care System and professor of medicine at University of Minnesota, said in an interview that screening colonoscopy in a population older than 75 years should be an individualized discussion with a patient who has minimal comorbidities, and the decision to move forward with a colonoscopy should be considered only if a patient’s life expectancy is at least 10 years.

“This study shows that diagnostic colonoscopy is associated with high risk of complications and quantifies the risk, to frame the discussion with the patient about going forward,” she said. “Colorectal cancers are slow growing. In individuals age 75 and older, competing health risks and risk of the colonoscopy often outweigh the small benefit they may derive. Older individuals should thus focus on other health priorities.”

Physicians should make their older patients aware that there is a risk for serious adverse events, including death, which increases after age 75. “[The] risk-benefit ratio for performing colonoscopy needs to carefully weighed,” Dr. Shaukat said. “[T]he patient should be presented with options, including the option of no screening.”

The American Cancer Society advocates “for individualized decision-making regarding screening for individuals after 75 but [does] not give any firm recommendations,” while the U.S. Preventive Services Task Force noted in its recommendations on colorectal cancer screening that the “harms are large and benefits are small” after 75 years of age, and choice to screen for colorectal cancer in that age group is an individual one, Dr. Shaukat said.

Robert A. Smith, PhD, senior vice president of cancer screening at the American Cancer Society, said in an interview that while colonoscopy is the dominant screening test for colorectal cancer, it is not known how often physicians and their older patients discuss noninvasive colorectal cancer screening methods. Noninvasive screening methods such as a high-sensitivity stool test should be a consideration even for older adults with mild chronic conditions, “especially if they have a history of screening with negative results,” he said. “[A] history of regular screening with normal test results should be a basis for considering cessation of screening after age 75, or at least transition to a test with lower risks of complications.”

Future research in this area could use a hybrid model of screening, such as using different tests among various age groups or risk groups, to see whether an invasive or noninvasive method would lower a complication rate, Dr. Smith said. “Further, we need to have a greater understanding of when individuals can confidently stop getting screened, based on their underlying risk and history of prior screening results,” he noted.

Dr. Shaukat said future studies should focus on randomized trials for individuals 75 years and older to assess the benefits and harms of screening, “[d]eveloping risk stratification tools that factor in an individual’s risk of colon cancer, their life expectancy, and guide individualized decision making to undergo screening.”

Dr. Armstrong is the chair of the National Colon Cancer Screening Network for the Canadian Partnership Against Cancer and the past president of the Canadian Association of Gastroenterology. Dr. Albashir has received honoraria and speaker fees from Janssen, and grants from AbbVie and ATGen. Dr. Shaukat and Dr. Smith report no relevant conflicts of interest.

SOURCE: Causada-Calo N et al. JAMA Netw Open. 2020;3(6):e208958.