Lipoprotein(a) levels can guide CV risk assessment and treatment

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Wed, 06/12/2019 - 12:17

 

Lipoprotein(a) is an independent risk factor for atherosclerotic cardiovascular disease–related events, and plasma levels of Lp(a) could help refine risk assessment and influence treatment decisions, say the authors of a scientific statement from the National Lipid Association.

Don P. Wilson, MD, of Cook Children’s Medical Center, Fort Worth, Tex., and coauthors reviewed the evidence around testing of Lp(a) in clinical practice and its use in guiding treatment for both primary and secondary prevention. Their report is in the Journal of Clinical Lipidology.

Prospective, population-based studies point to a clear link between high Lp(a) levels and high risk of myocardial infarction, coronary heart disease, coronary artery stenosis, carotid stenosis, valvular aortic stenosis, ischemic stroke, cardiovascular mortality, and all-cause mortality, the authors wrote. This association was independent of the effect of other risk factors, including LDL cholesterol.

However, existing Lp(a) assays have not been globally standardized, and there is only incomplete evidence for age, sex, or ethnicity-specific cutoff points for high risk.

The authors suggested Lp(a) levels greater than 50 mg/dL (100 nmol/L) could be considered a risk factor that justifies the initiation of statin therapy. However ,they pointed out this level corresponded to the 80th population percentile in predominantly white populations, while in African American populations the equivalent cutoff was around 150 nmol/L.



On the issue of whom to test for Lp(a) serum levels, the authors said testing could reasonably be used to refine risk assessment for atherosclerotic cardiovascular disease in adults with first-degree relatives who experienced premature atherosclerotic cardiovascular disease, those with a personal history of the disease, or in those with severe hypercholesterolemia or suspected familial hypercholesterolemia.

However, statin therapy does not decrease Lp(a) levels, and there is also evidence that patients with high Lp(a) levels may not show as much LDL-C lowering in response to statin therapy.

“There is a lack of current evidence demonstrating that lowering Lp(a), independently of LDL-C, reduces ASCVD events in individuals with established ASCVD,” the authors wrote. “It appears that large absolute reductions in Lp(a) may be needed to demonstrate a significant clinical benefit.”

Despite this, the authors argued that in primary prevention, it was reasonable to use a Lp(a) level greater than 50 mg/dL (100 nmol/L) as a “risk-enhancing factor,” and in high-risk or very-high-risk patients with elevated LDL-C, it could prompt use of more intensive therapies.

Five authors disclosed honorarium or advisory board positions with the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Wilson D et al. J Clin Lipidol. 2019 May 17. doi: 10.1016/j.jacl.2019.04.010.

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Lipoprotein(a) is an independent risk factor for atherosclerotic cardiovascular disease–related events, and plasma levels of Lp(a) could help refine risk assessment and influence treatment decisions, say the authors of a scientific statement from the National Lipid Association.

Don P. Wilson, MD, of Cook Children’s Medical Center, Fort Worth, Tex., and coauthors reviewed the evidence around testing of Lp(a) in clinical practice and its use in guiding treatment for both primary and secondary prevention. Their report is in the Journal of Clinical Lipidology.

Prospective, population-based studies point to a clear link between high Lp(a) levels and high risk of myocardial infarction, coronary heart disease, coronary artery stenosis, carotid stenosis, valvular aortic stenosis, ischemic stroke, cardiovascular mortality, and all-cause mortality, the authors wrote. This association was independent of the effect of other risk factors, including LDL cholesterol.

However, existing Lp(a) assays have not been globally standardized, and there is only incomplete evidence for age, sex, or ethnicity-specific cutoff points for high risk.

The authors suggested Lp(a) levels greater than 50 mg/dL (100 nmol/L) could be considered a risk factor that justifies the initiation of statin therapy. However ,they pointed out this level corresponded to the 80th population percentile in predominantly white populations, while in African American populations the equivalent cutoff was around 150 nmol/L.



On the issue of whom to test for Lp(a) serum levels, the authors said testing could reasonably be used to refine risk assessment for atherosclerotic cardiovascular disease in adults with first-degree relatives who experienced premature atherosclerotic cardiovascular disease, those with a personal history of the disease, or in those with severe hypercholesterolemia or suspected familial hypercholesterolemia.

However, statin therapy does not decrease Lp(a) levels, and there is also evidence that patients with high Lp(a) levels may not show as much LDL-C lowering in response to statin therapy.

“There is a lack of current evidence demonstrating that lowering Lp(a), independently of LDL-C, reduces ASCVD events in individuals with established ASCVD,” the authors wrote. “It appears that large absolute reductions in Lp(a) may be needed to demonstrate a significant clinical benefit.”

Despite this, the authors argued that in primary prevention, it was reasonable to use a Lp(a) level greater than 50 mg/dL (100 nmol/L) as a “risk-enhancing factor,” and in high-risk or very-high-risk patients with elevated LDL-C, it could prompt use of more intensive therapies.

Five authors disclosed honorarium or advisory board positions with the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Wilson D et al. J Clin Lipidol. 2019 May 17. doi: 10.1016/j.jacl.2019.04.010.

 

Lipoprotein(a) is an independent risk factor for atherosclerotic cardiovascular disease–related events, and plasma levels of Lp(a) could help refine risk assessment and influence treatment decisions, say the authors of a scientific statement from the National Lipid Association.

Don P. Wilson, MD, of Cook Children’s Medical Center, Fort Worth, Tex., and coauthors reviewed the evidence around testing of Lp(a) in clinical practice and its use in guiding treatment for both primary and secondary prevention. Their report is in the Journal of Clinical Lipidology.

Prospective, population-based studies point to a clear link between high Lp(a) levels and high risk of myocardial infarction, coronary heart disease, coronary artery stenosis, carotid stenosis, valvular aortic stenosis, ischemic stroke, cardiovascular mortality, and all-cause mortality, the authors wrote. This association was independent of the effect of other risk factors, including LDL cholesterol.

However, existing Lp(a) assays have not been globally standardized, and there is only incomplete evidence for age, sex, or ethnicity-specific cutoff points for high risk.

The authors suggested Lp(a) levels greater than 50 mg/dL (100 nmol/L) could be considered a risk factor that justifies the initiation of statin therapy. However ,they pointed out this level corresponded to the 80th population percentile in predominantly white populations, while in African American populations the equivalent cutoff was around 150 nmol/L.



On the issue of whom to test for Lp(a) serum levels, the authors said testing could reasonably be used to refine risk assessment for atherosclerotic cardiovascular disease in adults with first-degree relatives who experienced premature atherosclerotic cardiovascular disease, those with a personal history of the disease, or in those with severe hypercholesterolemia or suspected familial hypercholesterolemia.

However, statin therapy does not decrease Lp(a) levels, and there is also evidence that patients with high Lp(a) levels may not show as much LDL-C lowering in response to statin therapy.

“There is a lack of current evidence demonstrating that lowering Lp(a), independently of LDL-C, reduces ASCVD events in individuals with established ASCVD,” the authors wrote. “It appears that large absolute reductions in Lp(a) may be needed to demonstrate a significant clinical benefit.”

Despite this, the authors argued that in primary prevention, it was reasonable to use a Lp(a) level greater than 50 mg/dL (100 nmol/L) as a “risk-enhancing factor,” and in high-risk or very-high-risk patients with elevated LDL-C, it could prompt use of more intensive therapies.

Five authors disclosed honorarium or advisory board positions with the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Wilson D et al. J Clin Lipidol. 2019 May 17. doi: 10.1016/j.jacl.2019.04.010.

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For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Aug. 9-10, 2019
2019 Freston Conference: Food at the Intersection of Gut Health and Disease

GI clinicians and allied health professionals are increasingly focused on how nutrients influence GI physiology and how diet can promote sound gut health. In response to this growing body of knowledge, the 2019 James W. Freston Conference — Food at the Intersection of Gut Health and Disease, Aug. 9-10, 2019, in Chicago — will examine how nutrition management therapies can combat GI disorders such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and celiac disease and how diet supports improvement across the care continuum.
Chicago, Illinois


 

Aug. 9–11, 2019
2019 Principles of GI for the NP and PA

The Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant (NPPA) is the medical industry’s premiere course guiding and enabling nurse practitioners and physician assistants with the intricacies of identifying, treating, and managing GI disorders. Designed and taught by expert clinicians and advanced practice providers, NPPA provides the latest insights, knowledge, and research on how to improve GI patient care. Attendees will leave with stronger diagnostic and therapeutic skills, a more robust professional network, and an enhanced value for their practices.
Chicago, Illinois

Sept. 18-19, 2019; Oct. 9-10. 2019
Two-Day, In-Depth Coding Seminar by McVey Associates, Inc.

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Atlanta, GA (9/18-19); Las Vegas, NV (10/9-10)

Oct. 4, 2019
2019 AGA Partners in Value

Join GI trailblazers and leaders from AGA and DHPA to network and discuss strategies that will help your practice succeed in the changing business of health care. Leave equipped to make better decisions for the future.
Chicago, Illinois

May 2-5, 2020
Digestive Disease Week® (DDW)

Digestive Disease Week® (DDW) is the world’s leading educational forum for academicians, clinicians, researchers, students, and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery, and related fields. Whether you work in patient care, research, education, or administration, the DDW program offers something for you. Abstract submissions will be due on Dec. 1, and registration will open in January 2020.
Chicago, Illinois

 

 

AWARDS APPLICATION DEADLINES

AGA-Elsevier Pilot Research Award
This award provides $30,000 for 1 year to a recipient at any career stage performing research in gastroenterology- or hepatology-related areas.
Application Deadline: Sept. 4, 2019

AGA-Allergan Foundation Pilot Research Award in Inflammatory Bowel Disease
This award provides $30,000 for 1 year to an investigator at any career stage researching the pathophysiology and/or treatment of inflammatory bowel disease (IBD).
Application Deadline: Sept. 4, 2019

AGA-Allergan Foundation Pilot Research Award in Nonalcoholic Fatty Liver Disease
This award provides $30,000 for 1 year to an investigator at any career stage researching the pathophysiology and/or treatment of nonalcoholic fatty liver disease (NAFLD).
Application Deadline: Sept. 4, 2019

AGA-Pfizer Pilot Research Award in Inflammatory Bowel Disease
This award provides $30,000 for 1 year to recipients at any career stage researching new directions focused on improving the diagnosis and treatment of inflammatory bowel disease.
Application Deadline: Sept. 4, 2019

AGA-Rome Foundation Functional GI and Motility Disorders Pilot Research Award
This award provides $30,000 for 1 year to a recipient at any career stage performing clinical or translational research pertaining to functional GI and motility disorders.
Application Deadline: Sept. 4, 2019

AGA Research Scholar Award (RSA)
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate or equivalent) working toward an independent career in digestive disease research.
Application Deadline: Nov. 13, 2019

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application Deadline: Nov. 13, 2019

AGA-Takeda Pharmaceuticals Research Scholar Award in Inflammatory Bowel Disease
This award provides $100,000 per year for 3 years (total $300,000) to a young investigator, instructor, research associate or equivalent working toward an independent career in inflammatory bowel disease research.
Application Deadline: Nov. 13, 2019
 

AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD or equivalent fellows giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application Deadline: Feb. 26, 2020

AGA Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students, or medical residents (residents up to postgraduate year three) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW).
Application Deadline: Feb. 26, 2020

AGA-Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award supports recipients who are young (i.e., 35 years of age or younger at the time of DDW) basic, translational, or clinical investigators residing outside North America to support travel and related expenses to attend Digestive Disease Week® (DDW).
Application Deadline: Feb. 26, 2020

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For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Aug. 9-10, 2019
2019 Freston Conference: Food at the Intersection of Gut Health and Disease

GI clinicians and allied health professionals are increasingly focused on how nutrients influence GI physiology and how diet can promote sound gut health. In response to this growing body of knowledge, the 2019 James W. Freston Conference — Food at the Intersection of Gut Health and Disease, Aug. 9-10, 2019, in Chicago — will examine how nutrition management therapies can combat GI disorders such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and celiac disease and how diet supports improvement across the care continuum.
Chicago, Illinois


 

Aug. 9–11, 2019
2019 Principles of GI for the NP and PA

The Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant (NPPA) is the medical industry’s premiere course guiding and enabling nurse practitioners and physician assistants with the intricacies of identifying, treating, and managing GI disorders. Designed and taught by expert clinicians and advanced practice providers, NPPA provides the latest insights, knowledge, and research on how to improve GI patient care. Attendees will leave with stronger diagnostic and therapeutic skills, a more robust professional network, and an enhanced value for their practices.
Chicago, Illinois

Sept. 18-19, 2019; Oct. 9-10. 2019
Two-Day, In-Depth Coding Seminar by McVey Associates, Inc.

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Atlanta, GA (9/18-19); Las Vegas, NV (10/9-10)

Oct. 4, 2019
2019 AGA Partners in Value

Join GI trailblazers and leaders from AGA and DHPA to network and discuss strategies that will help your practice succeed in the changing business of health care. Leave equipped to make better decisions for the future.
Chicago, Illinois

May 2-5, 2020
Digestive Disease Week® (DDW)

Digestive Disease Week® (DDW) is the world’s leading educational forum for academicians, clinicians, researchers, students, and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery, and related fields. Whether you work in patient care, research, education, or administration, the DDW program offers something for you. Abstract submissions will be due on Dec. 1, and registration will open in January 2020.
Chicago, Illinois

 

 

AWARDS APPLICATION DEADLINES

AGA-Elsevier Pilot Research Award
This award provides $30,000 for 1 year to a recipient at any career stage performing research in gastroenterology- or hepatology-related areas.
Application Deadline: Sept. 4, 2019

AGA-Allergan Foundation Pilot Research Award in Inflammatory Bowel Disease
This award provides $30,000 for 1 year to an investigator at any career stage researching the pathophysiology and/or treatment of inflammatory bowel disease (IBD).
Application Deadline: Sept. 4, 2019

AGA-Allergan Foundation Pilot Research Award in Nonalcoholic Fatty Liver Disease
This award provides $30,000 for 1 year to an investigator at any career stage researching the pathophysiology and/or treatment of nonalcoholic fatty liver disease (NAFLD).
Application Deadline: Sept. 4, 2019

AGA-Pfizer Pilot Research Award in Inflammatory Bowel Disease
This award provides $30,000 for 1 year to recipients at any career stage researching new directions focused on improving the diagnosis and treatment of inflammatory bowel disease.
Application Deadline: Sept. 4, 2019

AGA-Rome Foundation Functional GI and Motility Disorders Pilot Research Award
This award provides $30,000 for 1 year to a recipient at any career stage performing clinical or translational research pertaining to functional GI and motility disorders.
Application Deadline: Sept. 4, 2019

AGA Research Scholar Award (RSA)
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate or equivalent) working toward an independent career in digestive disease research.
Application Deadline: Nov. 13, 2019

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application Deadline: Nov. 13, 2019

AGA-Takeda Pharmaceuticals Research Scholar Award in Inflammatory Bowel Disease
This award provides $100,000 per year for 3 years (total $300,000) to a young investigator, instructor, research associate or equivalent working toward an independent career in inflammatory bowel disease research.
Application Deadline: Nov. 13, 2019
 

AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD or equivalent fellows giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application Deadline: Feb. 26, 2020

AGA Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students, or medical residents (residents up to postgraduate year three) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW).
Application Deadline: Feb. 26, 2020

AGA-Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award supports recipients who are young (i.e., 35 years of age or younger at the time of DDW) basic, translational, or clinical investigators residing outside North America to support travel and related expenses to attend Digestive Disease Week® (DDW).
Application Deadline: Feb. 26, 2020

 

For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Aug. 9-10, 2019
2019 Freston Conference: Food at the Intersection of Gut Health and Disease

GI clinicians and allied health professionals are increasingly focused on how nutrients influence GI physiology and how diet can promote sound gut health. In response to this growing body of knowledge, the 2019 James W. Freston Conference — Food at the Intersection of Gut Health and Disease, Aug. 9-10, 2019, in Chicago — will examine how nutrition management therapies can combat GI disorders such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and celiac disease and how diet supports improvement across the care continuum.
Chicago, Illinois


 

Aug. 9–11, 2019
2019 Principles of GI for the NP and PA

The Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant (NPPA) is the medical industry’s premiere course guiding and enabling nurse practitioners and physician assistants with the intricacies of identifying, treating, and managing GI disorders. Designed and taught by expert clinicians and advanced practice providers, NPPA provides the latest insights, knowledge, and research on how to improve GI patient care. Attendees will leave with stronger diagnostic and therapeutic skills, a more robust professional network, and an enhanced value for their practices.
Chicago, Illinois

Sept. 18-19, 2019; Oct. 9-10. 2019
Two-Day, In-Depth Coding Seminar by McVey Associates, Inc.

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Atlanta, GA (9/18-19); Las Vegas, NV (10/9-10)

Oct. 4, 2019
2019 AGA Partners in Value

Join GI trailblazers and leaders from AGA and DHPA to network and discuss strategies that will help your practice succeed in the changing business of health care. Leave equipped to make better decisions for the future.
Chicago, Illinois

May 2-5, 2020
Digestive Disease Week® (DDW)

Digestive Disease Week® (DDW) is the world’s leading educational forum for academicians, clinicians, researchers, students, and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery, and related fields. Whether you work in patient care, research, education, or administration, the DDW program offers something for you. Abstract submissions will be due on Dec. 1, and registration will open in January 2020.
Chicago, Illinois

 

 

AWARDS APPLICATION DEADLINES

AGA-Elsevier Pilot Research Award
This award provides $30,000 for 1 year to a recipient at any career stage performing research in gastroenterology- or hepatology-related areas.
Application Deadline: Sept. 4, 2019

AGA-Allergan Foundation Pilot Research Award in Inflammatory Bowel Disease
This award provides $30,000 for 1 year to an investigator at any career stage researching the pathophysiology and/or treatment of inflammatory bowel disease (IBD).
Application Deadline: Sept. 4, 2019

AGA-Allergan Foundation Pilot Research Award in Nonalcoholic Fatty Liver Disease
This award provides $30,000 for 1 year to an investigator at any career stage researching the pathophysiology and/or treatment of nonalcoholic fatty liver disease (NAFLD).
Application Deadline: Sept. 4, 2019

AGA-Pfizer Pilot Research Award in Inflammatory Bowel Disease
This award provides $30,000 for 1 year to recipients at any career stage researching new directions focused on improving the diagnosis and treatment of inflammatory bowel disease.
Application Deadline: Sept. 4, 2019

AGA-Rome Foundation Functional GI and Motility Disorders Pilot Research Award
This award provides $30,000 for 1 year to a recipient at any career stage performing clinical or translational research pertaining to functional GI and motility disorders.
Application Deadline: Sept. 4, 2019

AGA Research Scholar Award (RSA)
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate or equivalent) working toward an independent career in digestive disease research.
Application Deadline: Nov. 13, 2019

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application Deadline: Nov. 13, 2019

AGA-Takeda Pharmaceuticals Research Scholar Award in Inflammatory Bowel Disease
This award provides $100,000 per year for 3 years (total $300,000) to a young investigator, instructor, research associate or equivalent working toward an independent career in inflammatory bowel disease research.
Application Deadline: Nov. 13, 2019
 

AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD or equivalent fellows giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application Deadline: Feb. 26, 2020

AGA Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students, or medical residents (residents up to postgraduate year three) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW).
Application Deadline: Feb. 26, 2020

AGA-Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award supports recipients who are young (i.e., 35 years of age or younger at the time of DDW) basic, translational, or clinical investigators residing outside North America to support travel and related expenses to attend Digestive Disease Week® (DDW).
Application Deadline: Feb. 26, 2020

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Nephrectomy may benefit select renal cancer patients based on risk factors

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Changed
Thu, 06/13/2019 - 15:47

– While cytoreductive nephrectomy is generally still inadvisable in metastatic renal cell carcinoma patients who require medical therapy, an update of the CARMENA trial suggests the procedure may provide benefit for certain patients.

Patients with only one International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factor may benefit from cytoreductive nephrectomy, said CARMENA investigator Arnaud Méjean, MD, PhD, in a presentation at the annual meeting of the American Society of Clinical Oncology.

Among patients in CARMENA treated with nephrectomy plus sunitinib, median overall survival was 31.4 months for those with just one risk factor, and 17.6 months for those with two or more (hazard ratio, 1.68; 95% confidence interval, 1.10-2.57; P = .01), suggesting the procedure was “detrimental” to perform in the presence of multiple risk factors, the investigator said.

By contrast, among patients treated with sunitinib alone, there was no significant difference in median overall survival for patients with one risk factor versus those with two or more risk factors, said Dr. Méjean, who is with the Hôpital Européen Georges-Pompidou and Paris Descartes University.

In another analysis of the data, delayed nephrectomy after initial systemic therapy was associated with long overall survival in good responders, supporting that approach as a “good therapeutic strategy,” he said.

Based on these results, Dr. Méjean told ASCO attendees he would “go back to the operating theater to operate just very selected patients.”

In a podium discussion, Alexander Kutikov, MD, FACS, said CARMENA makes it “undeniable” that up-front cytoreductive therapy should be applied to a “very select group” of patients.

While that select group may be defined as the one IMDC risk factor group, Dr. Kutkov said it is also appropriate to offer cytoreductive nephrectomy to carefully selected patients who do not need immediate systemic therapy.

“If the plan is to observe without systemic therapy, proceed with cytoreductive nephrectomy, and for everybody else, I think we take great caution in offering cytoreductive nephrectomy, because it absolutely can harm,” said Dr. Kutikov, professor and chief of urologic oncology at Fox Chase Cancer Center, Philadelphia.

The CARMENA update confirmed that, in general, cytoreductive nephrectomy should not be the standard of care, according to Dr. Méjean.

With follow-up of 61.5 months, or longer than what was previously reported for the 450-patient trial, cytoreductive nephrectomy followed by sunitinib was again found to be not superior to sunitinib alone, he said. Median overall survival was 15.6 months for the nephrectomy plus sunitinib arm versus 19.8 months for the sunitinib arm, showing that sunitinib alone was noninferior based on the statistical design of the trial (hazard ratio, 0.97; 95% CI, 0.79-1.19, with a fixed upper limit for noninferiority of 1.20).

Dr. Méjean reported disclosures related to Ipsen, Novartis, Pfizer, Bristol-Myers Squibb, Janssen, Sanofi and Roche.

SOURCE: Méjean A et al. ASCO 2019, Abstract 4508.

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– While cytoreductive nephrectomy is generally still inadvisable in metastatic renal cell carcinoma patients who require medical therapy, an update of the CARMENA trial suggests the procedure may provide benefit for certain patients.

Patients with only one International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factor may benefit from cytoreductive nephrectomy, said CARMENA investigator Arnaud Méjean, MD, PhD, in a presentation at the annual meeting of the American Society of Clinical Oncology.

Among patients in CARMENA treated with nephrectomy plus sunitinib, median overall survival was 31.4 months for those with just one risk factor, and 17.6 months for those with two or more (hazard ratio, 1.68; 95% confidence interval, 1.10-2.57; P = .01), suggesting the procedure was “detrimental” to perform in the presence of multiple risk factors, the investigator said.

By contrast, among patients treated with sunitinib alone, there was no significant difference in median overall survival for patients with one risk factor versus those with two or more risk factors, said Dr. Méjean, who is with the Hôpital Européen Georges-Pompidou and Paris Descartes University.

In another analysis of the data, delayed nephrectomy after initial systemic therapy was associated with long overall survival in good responders, supporting that approach as a “good therapeutic strategy,” he said.

Based on these results, Dr. Méjean told ASCO attendees he would “go back to the operating theater to operate just very selected patients.”

In a podium discussion, Alexander Kutikov, MD, FACS, said CARMENA makes it “undeniable” that up-front cytoreductive therapy should be applied to a “very select group” of patients.

While that select group may be defined as the one IMDC risk factor group, Dr. Kutkov said it is also appropriate to offer cytoreductive nephrectomy to carefully selected patients who do not need immediate systemic therapy.

“If the plan is to observe without systemic therapy, proceed with cytoreductive nephrectomy, and for everybody else, I think we take great caution in offering cytoreductive nephrectomy, because it absolutely can harm,” said Dr. Kutikov, professor and chief of urologic oncology at Fox Chase Cancer Center, Philadelphia.

The CARMENA update confirmed that, in general, cytoreductive nephrectomy should not be the standard of care, according to Dr. Méjean.

With follow-up of 61.5 months, or longer than what was previously reported for the 450-patient trial, cytoreductive nephrectomy followed by sunitinib was again found to be not superior to sunitinib alone, he said. Median overall survival was 15.6 months for the nephrectomy plus sunitinib arm versus 19.8 months for the sunitinib arm, showing that sunitinib alone was noninferior based on the statistical design of the trial (hazard ratio, 0.97; 95% CI, 0.79-1.19, with a fixed upper limit for noninferiority of 1.20).

Dr. Méjean reported disclosures related to Ipsen, Novartis, Pfizer, Bristol-Myers Squibb, Janssen, Sanofi and Roche.

SOURCE: Méjean A et al. ASCO 2019, Abstract 4508.

– While cytoreductive nephrectomy is generally still inadvisable in metastatic renal cell carcinoma patients who require medical therapy, an update of the CARMENA trial suggests the procedure may provide benefit for certain patients.

Patients with only one International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factor may benefit from cytoreductive nephrectomy, said CARMENA investigator Arnaud Méjean, MD, PhD, in a presentation at the annual meeting of the American Society of Clinical Oncology.

Among patients in CARMENA treated with nephrectomy plus sunitinib, median overall survival was 31.4 months for those with just one risk factor, and 17.6 months for those with two or more (hazard ratio, 1.68; 95% confidence interval, 1.10-2.57; P = .01), suggesting the procedure was “detrimental” to perform in the presence of multiple risk factors, the investigator said.

By contrast, among patients treated with sunitinib alone, there was no significant difference in median overall survival for patients with one risk factor versus those with two or more risk factors, said Dr. Méjean, who is with the Hôpital Européen Georges-Pompidou and Paris Descartes University.

In another analysis of the data, delayed nephrectomy after initial systemic therapy was associated with long overall survival in good responders, supporting that approach as a “good therapeutic strategy,” he said.

Based on these results, Dr. Méjean told ASCO attendees he would “go back to the operating theater to operate just very selected patients.”

In a podium discussion, Alexander Kutikov, MD, FACS, said CARMENA makes it “undeniable” that up-front cytoreductive therapy should be applied to a “very select group” of patients.

While that select group may be defined as the one IMDC risk factor group, Dr. Kutkov said it is also appropriate to offer cytoreductive nephrectomy to carefully selected patients who do not need immediate systemic therapy.

“If the plan is to observe without systemic therapy, proceed with cytoreductive nephrectomy, and for everybody else, I think we take great caution in offering cytoreductive nephrectomy, because it absolutely can harm,” said Dr. Kutikov, professor and chief of urologic oncology at Fox Chase Cancer Center, Philadelphia.

The CARMENA update confirmed that, in general, cytoreductive nephrectomy should not be the standard of care, according to Dr. Méjean.

With follow-up of 61.5 months, or longer than what was previously reported for the 450-patient trial, cytoreductive nephrectomy followed by sunitinib was again found to be not superior to sunitinib alone, he said. Median overall survival was 15.6 months for the nephrectomy plus sunitinib arm versus 19.8 months for the sunitinib arm, showing that sunitinib alone was noninferior based on the statistical design of the trial (hazard ratio, 0.97; 95% CI, 0.79-1.19, with a fixed upper limit for noninferiority of 1.20).

Dr. Méjean reported disclosures related to Ipsen, Novartis, Pfizer, Bristol-Myers Squibb, Janssen, Sanofi and Roche.

SOURCE: Méjean A et al. ASCO 2019, Abstract 4508.

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DOACs surpass warfarin in low-weight AFib patients

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Tue, 07/21/2020 - 14:18

– The direct-acting anticoagulants, as a class, were more effective and at least as safe as warfarin in low-weight and very-low-weight patients with atrial fibrillation in an adjusted analysis of real-world outcomes data from more than 21,000 Korean patients.

Dr, So-Ryoung Lee, cardiologist, Seoul (South Korea) National University Hospital
Mitchel L. Zoler/MDedge News
Dr. So-Ryoung Lee

The analysis also showed that the direct-acting oral anticoagulants (DOACs) had the best safety and efficacy on low-weight patients when used at the labeled dosages, with blunted efficacy and safety at dosages that either exceeded or fell short of labeled levels, So-Ryoung Lee, MD, said at the annual scientific sessions of the Heart Rhythm Society.

The overall superiority of DOACs by both efficacy and safety also generally extended to the subgroup of very-low-weight patients, those with weights of less than 50 kg. In this subgroup, which was 28% of the total population studied, the composite adverse event outcome occurred 33% less often among patients treated with a DOAC relative to patients treated with warfarin, a statistically significant difference, said Dr. Lee, a cardiologist at Seoul (South Korea) National University Hospital. Among all patients with weights of 60 kg (132 pounds) or less, the composite outcome occurred 34% less often in the DOAC-treated patients relative to the warfarin-treated patients, also a statistically significant difference.

Dr. Lee and colleagues used a Korean National Health Insurance database that included information on more than 600,000 adults with atrial fibrillation (AFib) as of January 2013. The researchers whittled this down to 21,678 patients who began for the first time treatment with an oral anticoagulant starting during or after January 2014; had no history of a stroke, intracranial hemorrhage, or gastrointestinal bleed; and weighed no more than 60 kg. This cohort included 7,575 (35%) who received warfarin treatment, and 14,103 (65%) who received a DOAC. Within the DOAC-treated group, 42% received rivaroxaban (Xarelto), 26% dabigatran (Pradaxa), 24% apixaban (Eliquis), and 8% edoxaban (Savaysa).


To account for baseline differences in demographics and comorbidities between the patients treated with a DOAC and those who received warfarin, Dr. Lee and her associates did propensity score adjustment, which resulted in similar cohorts of 6,692 patients treated with warfarin and 12,810 patients treated with a DOAC. The average age of these patients was 73 years, a third were men, and the average body mass index was just over 22 kg/m2.

The events that the researchers tallied during follow-up through December 2016 included rates of all-cause death, ischemic stroke, intracranial hemorrhage, hospitalization for GI bleeding, hospitalization for major bleeding, and the composite of these five outcomes.

In the propensity-score adjusted full cohort of all patients who weighed 60 kg or less, the rate of each of these five outcomes, as well as the composite outcome, occurred statistically significantly less often among the DOAC-treated patients than in those on warfarin. The reductions ranged from a 41% lower incidence of ischemic stroke on DOAC treatment compared with warfarin treatment, to an 18% reduced rate of hospitalization for a GI bleed, compared with warfarin-treated patients. In the subgroup of patients who weighed less than 50 kg (110 pounds), the reductions ranged from a 41% cut in ischemic stroke on a DOAC compared with warfarin to a 24% relative reduction in the rate of hospitalization for a major bleed, a difference that just reached statistical significance. The outcome of hospitalization for a GI bleed showed no significant between-group difference among very-low-weight patients, but the rates of intracranial hemorrhage and all-cause death also showed statistically significant lower rates among DOAC-treated patients.

Nearly two-thirds of the patients on a DOAC received the label-appropriate dose of the drug, but 31% received a dosage that was below the labeled level while 4% received a dosage above the labeled level. An analysis that divided the NOAC patients by the appropriateness of their treatment dosages showed that patients on the correct dosages fared best. For example, in the total cohort of patients who weighed 60 kg or less, those on the correct DOAC dosage had a 9.1% rate of the combined endpoint. Patients on a low DOAC dosage did about as well as did the patients on warfarin, with a combined event rate of 11.6% in each of these subgroups. The worst outcomes occurred among the small number of patients on an inappropriately-high DOAC dosage, with a combined event rate of 15.4%. The researchers found a similar pattern among patients who weighed less than 50 kg.

Dr. Lee had no disclosures.

SOURCE: Lee SR et al. HRS 2019, Abstract S-AB30-05.

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– The direct-acting anticoagulants, as a class, were more effective and at least as safe as warfarin in low-weight and very-low-weight patients with atrial fibrillation in an adjusted analysis of real-world outcomes data from more than 21,000 Korean patients.

Dr, So-Ryoung Lee, cardiologist, Seoul (South Korea) National University Hospital
Mitchel L. Zoler/MDedge News
Dr. So-Ryoung Lee

The analysis also showed that the direct-acting oral anticoagulants (DOACs) had the best safety and efficacy on low-weight patients when used at the labeled dosages, with blunted efficacy and safety at dosages that either exceeded or fell short of labeled levels, So-Ryoung Lee, MD, said at the annual scientific sessions of the Heart Rhythm Society.

The overall superiority of DOACs by both efficacy and safety also generally extended to the subgroup of very-low-weight patients, those with weights of less than 50 kg. In this subgroup, which was 28% of the total population studied, the composite adverse event outcome occurred 33% less often among patients treated with a DOAC relative to patients treated with warfarin, a statistically significant difference, said Dr. Lee, a cardiologist at Seoul (South Korea) National University Hospital. Among all patients with weights of 60 kg (132 pounds) or less, the composite outcome occurred 34% less often in the DOAC-treated patients relative to the warfarin-treated patients, also a statistically significant difference.

Dr. Lee and colleagues used a Korean National Health Insurance database that included information on more than 600,000 adults with atrial fibrillation (AFib) as of January 2013. The researchers whittled this down to 21,678 patients who began for the first time treatment with an oral anticoagulant starting during or after January 2014; had no history of a stroke, intracranial hemorrhage, or gastrointestinal bleed; and weighed no more than 60 kg. This cohort included 7,575 (35%) who received warfarin treatment, and 14,103 (65%) who received a DOAC. Within the DOAC-treated group, 42% received rivaroxaban (Xarelto), 26% dabigatran (Pradaxa), 24% apixaban (Eliquis), and 8% edoxaban (Savaysa).


To account for baseline differences in demographics and comorbidities between the patients treated with a DOAC and those who received warfarin, Dr. Lee and her associates did propensity score adjustment, which resulted in similar cohorts of 6,692 patients treated with warfarin and 12,810 patients treated with a DOAC. The average age of these patients was 73 years, a third were men, and the average body mass index was just over 22 kg/m2.

The events that the researchers tallied during follow-up through December 2016 included rates of all-cause death, ischemic stroke, intracranial hemorrhage, hospitalization for GI bleeding, hospitalization for major bleeding, and the composite of these five outcomes.

In the propensity-score adjusted full cohort of all patients who weighed 60 kg or less, the rate of each of these five outcomes, as well as the composite outcome, occurred statistically significantly less often among the DOAC-treated patients than in those on warfarin. The reductions ranged from a 41% lower incidence of ischemic stroke on DOAC treatment compared with warfarin treatment, to an 18% reduced rate of hospitalization for a GI bleed, compared with warfarin-treated patients. In the subgroup of patients who weighed less than 50 kg (110 pounds), the reductions ranged from a 41% cut in ischemic stroke on a DOAC compared with warfarin to a 24% relative reduction in the rate of hospitalization for a major bleed, a difference that just reached statistical significance. The outcome of hospitalization for a GI bleed showed no significant between-group difference among very-low-weight patients, but the rates of intracranial hemorrhage and all-cause death also showed statistically significant lower rates among DOAC-treated patients.

Nearly two-thirds of the patients on a DOAC received the label-appropriate dose of the drug, but 31% received a dosage that was below the labeled level while 4% received a dosage above the labeled level. An analysis that divided the NOAC patients by the appropriateness of their treatment dosages showed that patients on the correct dosages fared best. For example, in the total cohort of patients who weighed 60 kg or less, those on the correct DOAC dosage had a 9.1% rate of the combined endpoint. Patients on a low DOAC dosage did about as well as did the patients on warfarin, with a combined event rate of 11.6% in each of these subgroups. The worst outcomes occurred among the small number of patients on an inappropriately-high DOAC dosage, with a combined event rate of 15.4%. The researchers found a similar pattern among patients who weighed less than 50 kg.

Dr. Lee had no disclosures.

SOURCE: Lee SR et al. HRS 2019, Abstract S-AB30-05.

– The direct-acting anticoagulants, as a class, were more effective and at least as safe as warfarin in low-weight and very-low-weight patients with atrial fibrillation in an adjusted analysis of real-world outcomes data from more than 21,000 Korean patients.

Dr, So-Ryoung Lee, cardiologist, Seoul (South Korea) National University Hospital
Mitchel L. Zoler/MDedge News
Dr. So-Ryoung Lee

The analysis also showed that the direct-acting oral anticoagulants (DOACs) had the best safety and efficacy on low-weight patients when used at the labeled dosages, with blunted efficacy and safety at dosages that either exceeded or fell short of labeled levels, So-Ryoung Lee, MD, said at the annual scientific sessions of the Heart Rhythm Society.

The overall superiority of DOACs by both efficacy and safety also generally extended to the subgroup of very-low-weight patients, those with weights of less than 50 kg. In this subgroup, which was 28% of the total population studied, the composite adverse event outcome occurred 33% less often among patients treated with a DOAC relative to patients treated with warfarin, a statistically significant difference, said Dr. Lee, a cardiologist at Seoul (South Korea) National University Hospital. Among all patients with weights of 60 kg (132 pounds) or less, the composite outcome occurred 34% less often in the DOAC-treated patients relative to the warfarin-treated patients, also a statistically significant difference.

Dr. Lee and colleagues used a Korean National Health Insurance database that included information on more than 600,000 adults with atrial fibrillation (AFib) as of January 2013. The researchers whittled this down to 21,678 patients who began for the first time treatment with an oral anticoagulant starting during or after January 2014; had no history of a stroke, intracranial hemorrhage, or gastrointestinal bleed; and weighed no more than 60 kg. This cohort included 7,575 (35%) who received warfarin treatment, and 14,103 (65%) who received a DOAC. Within the DOAC-treated group, 42% received rivaroxaban (Xarelto), 26% dabigatran (Pradaxa), 24% apixaban (Eliquis), and 8% edoxaban (Savaysa).


To account for baseline differences in demographics and comorbidities between the patients treated with a DOAC and those who received warfarin, Dr. Lee and her associates did propensity score adjustment, which resulted in similar cohorts of 6,692 patients treated with warfarin and 12,810 patients treated with a DOAC. The average age of these patients was 73 years, a third were men, and the average body mass index was just over 22 kg/m2.

The events that the researchers tallied during follow-up through December 2016 included rates of all-cause death, ischemic stroke, intracranial hemorrhage, hospitalization for GI bleeding, hospitalization for major bleeding, and the composite of these five outcomes.

In the propensity-score adjusted full cohort of all patients who weighed 60 kg or less, the rate of each of these five outcomes, as well as the composite outcome, occurred statistically significantly less often among the DOAC-treated patients than in those on warfarin. The reductions ranged from a 41% lower incidence of ischemic stroke on DOAC treatment compared with warfarin treatment, to an 18% reduced rate of hospitalization for a GI bleed, compared with warfarin-treated patients. In the subgroup of patients who weighed less than 50 kg (110 pounds), the reductions ranged from a 41% cut in ischemic stroke on a DOAC compared with warfarin to a 24% relative reduction in the rate of hospitalization for a major bleed, a difference that just reached statistical significance. The outcome of hospitalization for a GI bleed showed no significant between-group difference among very-low-weight patients, but the rates of intracranial hemorrhage and all-cause death also showed statistically significant lower rates among DOAC-treated patients.

Nearly two-thirds of the patients on a DOAC received the label-appropriate dose of the drug, but 31% received a dosage that was below the labeled level while 4% received a dosage above the labeled level. An analysis that divided the NOAC patients by the appropriateness of their treatment dosages showed that patients on the correct dosages fared best. For example, in the total cohort of patients who weighed 60 kg or less, those on the correct DOAC dosage had a 9.1% rate of the combined endpoint. Patients on a low DOAC dosage did about as well as did the patients on warfarin, with a combined event rate of 11.6% in each of these subgroups. The worst outcomes occurred among the small number of patients on an inappropriately-high DOAC dosage, with a combined event rate of 15.4%. The researchers found a similar pattern among patients who weighed less than 50 kg.

Dr. Lee had no disclosures.

SOURCE: Lee SR et al. HRS 2019, Abstract S-AB30-05.

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More liberal criteria could greatly expand clinical trial participation

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Fri, 06/11/2021 - 10:35

– Fewer than 1 in 20 adults with cancer enroll in clinical trials, and even when cancer patients are willing to participate in a trial, they are often excluded because of comorbidities, prior therapies, or a host of other factors that could confound results.

But as a team of investigators shows in a proof-of-concept study, more generous exclusion criteria in some trials could nearly double the number of participants. Using retrospective, deidentified electronic health record data from the American Society of Clinical Oncology CancerLinQ Discovery database, R. Donald Harvey, PharmD and colleagues found that when they applied broader inclusion criteria for patients with advanced non–small cell lung cancer (NSCLC), the number of patients who would be eligible for clinical trials nearly doubled from 5,495 to 10,349.

In this video interview from the ASCO annual meeting, Dr. Harvey of the Winship Cancer Institute of Emory University in Atlanta discusses collaborations between the oncology community, federal agencies, and the pharmaceutical industry that could improve clinical trials by safely increasing sample sizes.

The study received funding from ASCO. Dr. Harvey disclosed consulting or advisory roles with and institutional research funding from multiple entities.

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– Fewer than 1 in 20 adults with cancer enroll in clinical trials, and even when cancer patients are willing to participate in a trial, they are often excluded because of comorbidities, prior therapies, or a host of other factors that could confound results.

But as a team of investigators shows in a proof-of-concept study, more generous exclusion criteria in some trials could nearly double the number of participants. Using retrospective, deidentified electronic health record data from the American Society of Clinical Oncology CancerLinQ Discovery database, R. Donald Harvey, PharmD and colleagues found that when they applied broader inclusion criteria for patients with advanced non–small cell lung cancer (NSCLC), the number of patients who would be eligible for clinical trials nearly doubled from 5,495 to 10,349.

In this video interview from the ASCO annual meeting, Dr. Harvey of the Winship Cancer Institute of Emory University in Atlanta discusses collaborations between the oncology community, federal agencies, and the pharmaceutical industry that could improve clinical trials by safely increasing sample sizes.

The study received funding from ASCO. Dr. Harvey disclosed consulting or advisory roles with and institutional research funding from multiple entities.

– Fewer than 1 in 20 adults with cancer enroll in clinical trials, and even when cancer patients are willing to participate in a trial, they are often excluded because of comorbidities, prior therapies, or a host of other factors that could confound results.

But as a team of investigators shows in a proof-of-concept study, more generous exclusion criteria in some trials could nearly double the number of participants. Using retrospective, deidentified electronic health record data from the American Society of Clinical Oncology CancerLinQ Discovery database, R. Donald Harvey, PharmD and colleagues found that when they applied broader inclusion criteria for patients with advanced non–small cell lung cancer (NSCLC), the number of patients who would be eligible for clinical trials nearly doubled from 5,495 to 10,349.

In this video interview from the ASCO annual meeting, Dr. Harvey of the Winship Cancer Institute of Emory University in Atlanta discusses collaborations between the oncology community, federal agencies, and the pharmaceutical industry that could improve clinical trials by safely increasing sample sizes.

The study received funding from ASCO. Dr. Harvey disclosed consulting or advisory roles with and institutional research funding from multiple entities.

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CDC Updates Cancer Cluster Guidelines

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Recent updates on cancer clusters haven’t been made since 2013, and the CDC plans to release new guidelines adding in current technical and scientific advantages.

In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.

But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.

The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.

“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.

The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.

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Recent updates on cancer clusters haven’t been made since 2013, and the CDC plans to release new guidelines adding in current technical and scientific advantages.
Recent updates on cancer clusters haven’t been made since 2013, and the CDC plans to release new guidelines adding in current technical and scientific advantages.

In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.

But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.

The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.

“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.

The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.

In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.

But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.

The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.

“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.

The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.

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August 2019 – ICYMI

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Gastroenterology

 

Promoting leadership by women in gastroenterology: Lessons learned and future directions. Pascua M et al. 2019 May;156(6):1548-52. doi. org/10.1053/j.gastro.2019.03.012.



How to incorporate esophageal manometry teaching in your fellowship program. Kraft C et al. 2019 June;156(8):2120-3. doi. org/10.1053/j.gastro.2019.04.024.



How to incorporate bariatric training into your fellowship program. Jirapinyo P et al. 2019 July;157(1):9-13. doi. org/10.1053/j.gastro.2019.05.034.
 

 

Clin Gastroenterol Hepatol.

Preparing for large-scale disruptions in health care delivery: Nursing strikes and beyond. Allen JI et al. 2019 July;17(8):1424-7. doi. org/10.1016/j.cgh.2019.02.001.



Optimal management of malignant polyps, from endoscopic assessment and resection to decisions about surgery. Rex DK et al. 2019 July;17(8):1428-37. doi. org/10.1016/j.cgh.2018.09.040.



Bowel cleansing strategies after suboptimal bowel preparation. Sharara AI et al. 2019 June;17(7):1239-41. doi. org/10.1016/j.cgh.2018.12.042.



Holding gastroenterologists accountable for colonoscopy through MACRA episode–based cost measure. Siddique SM et al. 2019 May;17(6):1015-8. doi. org/10.1016/j.cgh.2019.01.009.



Endoscopic mucosal resection vs endoscopic submucosal dissection for Barrett’s esophagus and colorectal neoplasia. Yang D et al. May;17(6):1019-28. doi. org/10.1016/j.cgh.2018.09.030.



Metal biliary stents in benign disease. Haseeb A et al. 2019 May;17(6):1029-32. doi. org/10.1016/j.cgh.2018.12.010.


 

Cell Mol Gastroenterol Hepatol.

Rigor, reproducibility, and responsibility: A quantum of solace. Turner JR. 2019;7(4):869-71. doi. org/10.1016/j.jcmgh.2019.03.006.

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Promoting leadership by women in gastroenterology: Lessons learned and future directions. Pascua M et al. 2019 May;156(6):1548-52. doi. org/10.1053/j.gastro.2019.03.012.



How to incorporate esophageal manometry teaching in your fellowship program. Kraft C et al. 2019 June;156(8):2120-3. doi. org/10.1053/j.gastro.2019.04.024.



How to incorporate bariatric training into your fellowship program. Jirapinyo P et al. 2019 July;157(1):9-13. doi. org/10.1053/j.gastro.2019.05.034.
 

 

Clin Gastroenterol Hepatol.

Preparing for large-scale disruptions in health care delivery: Nursing strikes and beyond. Allen JI et al. 2019 July;17(8):1424-7. doi. org/10.1016/j.cgh.2019.02.001.



Optimal management of malignant polyps, from endoscopic assessment and resection to decisions about surgery. Rex DK et al. 2019 July;17(8):1428-37. doi. org/10.1016/j.cgh.2018.09.040.



Bowel cleansing strategies after suboptimal bowel preparation. Sharara AI et al. 2019 June;17(7):1239-41. doi. org/10.1016/j.cgh.2018.12.042.



Holding gastroenterologists accountable for colonoscopy through MACRA episode–based cost measure. Siddique SM et al. 2019 May;17(6):1015-8. doi. org/10.1016/j.cgh.2019.01.009.



Endoscopic mucosal resection vs endoscopic submucosal dissection for Barrett’s esophagus and colorectal neoplasia. Yang D et al. May;17(6):1019-28. doi. org/10.1016/j.cgh.2018.09.030.



Metal biliary stents in benign disease. Haseeb A et al. 2019 May;17(6):1029-32. doi. org/10.1016/j.cgh.2018.12.010.


 

Cell Mol Gastroenterol Hepatol.

Rigor, reproducibility, and responsibility: A quantum of solace. Turner JR. 2019;7(4):869-71. doi. org/10.1016/j.jcmgh.2019.03.006.

Gastroenterology

 

Promoting leadership by women in gastroenterology: Lessons learned and future directions. Pascua M et al. 2019 May;156(6):1548-52. doi. org/10.1053/j.gastro.2019.03.012.



How to incorporate esophageal manometry teaching in your fellowship program. Kraft C et al. 2019 June;156(8):2120-3. doi. org/10.1053/j.gastro.2019.04.024.



How to incorporate bariatric training into your fellowship program. Jirapinyo P et al. 2019 July;157(1):9-13. doi. org/10.1053/j.gastro.2019.05.034.
 

 

Clin Gastroenterol Hepatol.

Preparing for large-scale disruptions in health care delivery: Nursing strikes and beyond. Allen JI et al. 2019 July;17(8):1424-7. doi. org/10.1016/j.cgh.2019.02.001.



Optimal management of malignant polyps, from endoscopic assessment and resection to decisions about surgery. Rex DK et al. 2019 July;17(8):1428-37. doi. org/10.1016/j.cgh.2018.09.040.



Bowel cleansing strategies after suboptimal bowel preparation. Sharara AI et al. 2019 June;17(7):1239-41. doi. org/10.1016/j.cgh.2018.12.042.



Holding gastroenterologists accountable for colonoscopy through MACRA episode–based cost measure. Siddique SM et al. 2019 May;17(6):1015-8. doi. org/10.1016/j.cgh.2019.01.009.



Endoscopic mucosal resection vs endoscopic submucosal dissection for Barrett’s esophagus and colorectal neoplasia. Yang D et al. May;17(6):1019-28. doi. org/10.1016/j.cgh.2018.09.030.



Metal biliary stents in benign disease. Haseeb A et al. 2019 May;17(6):1029-32. doi. org/10.1016/j.cgh.2018.12.010.


 

Cell Mol Gastroenterol Hepatol.

Rigor, reproducibility, and responsibility: A quantum of solace. Turner JR. 2019;7(4):869-71. doi. org/10.1016/j.jcmgh.2019.03.006.

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MADIT-CHIC: CRT aids patients with chemotherapy-induced cardiomyopathy

MADIT-CHIC gives us the best data we have
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– Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.

Dr. Jagmeet P. Singh chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston
Mitchel L. Zoler/MDedge News
Dr. Jagmeet P. Singh

This is the first time this therapy has been prospectively assessed in this patient population.

The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.

Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.

Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.



The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.

Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.

The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.

MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.

SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.

Body

 

No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.

Dr. Kenneth A. Ellenbogen, professor of medicine, Virginia Commonwealth University, Richmond, Va.
Mitchel L. Zoler/MDedge News
Dr. Kenneth A. Ellenbogen
This small, nonrandomized study is limited by its short-term follow-up, but it gives us the best data we have so far on this topic, and the results were striking. The response that patients had to CRT was dramatic and homogeneous in a group of patients studied for the first time: those with chemotherapy-induced cardiomyopathy (CHIC).

It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.

Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.

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No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.

Dr. Kenneth A. Ellenbogen, professor of medicine, Virginia Commonwealth University, Richmond, Va.
Mitchel L. Zoler/MDedge News
Dr. Kenneth A. Ellenbogen
This small, nonrandomized study is limited by its short-term follow-up, but it gives us the best data we have so far on this topic, and the results were striking. The response that patients had to CRT was dramatic and homogeneous in a group of patients studied for the first time: those with chemotherapy-induced cardiomyopathy (CHIC).

It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.

Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.

Body

 

No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.

Dr. Kenneth A. Ellenbogen, professor of medicine, Virginia Commonwealth University, Richmond, Va.
Mitchel L. Zoler/MDedge News
Dr. Kenneth A. Ellenbogen
This small, nonrandomized study is limited by its short-term follow-up, but it gives us the best data we have so far on this topic, and the results were striking. The response that patients had to CRT was dramatic and homogeneous in a group of patients studied for the first time: those with chemotherapy-induced cardiomyopathy (CHIC).

It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.

Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.

Title
MADIT-CHIC gives us the best data we have
MADIT-CHIC gives us the best data we have

 

– Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.

Dr. Jagmeet P. Singh chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston
Mitchel L. Zoler/MDedge News
Dr. Jagmeet P. Singh

This is the first time this therapy has been prospectively assessed in this patient population.

The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.

Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.

Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.



The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.

Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.

The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.

MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.

SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.

 

– Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.

Dr. Jagmeet P. Singh chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston
Mitchel L. Zoler/MDedge News
Dr. Jagmeet P. Singh

This is the first time this therapy has been prospectively assessed in this patient population.

The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.

Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.

Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.



The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.

Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.

The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.

MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.

SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.

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An app to help women and clinicians manage menopausal symptoms

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In North America, women experience menopause (the permanent cessation of menstruation due to loss of ovarian activity) at a median age of 51 years. They may experience symptoms of perimenopause, or the menopause transition, for several years before menstruation ceases. Menopausal symptoms include vasomotor symptoms, such as hot flushes, and vaginal symptoms, such as vaginal dryness and pain during intercourse.1

Women may have questions about treating menopausal symptoms, maintaining their health, and preventing such age-related diseases as osteoporosis and cardiovascular disease. The decision to treat menopausal symptoms is challenging for women as well as their clinicians given that recommendations have changed over the past few years.

A free app with multiple features. The North American Menopause Society (NAMS) has developed a no-cost mobile health application called MenoPro for menopausal symptom management based on the organization’s 2017 recommendations.2 The app has 2 modes: one for clinicians and one for women/patients to support shared decision making.

For clinicians, the app helps identify which patients with menopausal symptoms are candidates for pharmacologic treatment and the options for optimal therapy. The app also can be used to calculate a 10-year cardiovascular disease (heart disease and stroke) risk assessment. In addition, it contains links to a breast cancer risk assessment as well as an osteoporosis/bone fracture risk assessment tool (FRAX model calculator). Finally, MenoPro includes NAMS’s educational materials and information pages on lifestyle modifications to reduce hot flushes, contraindications and cautions to hormone therapy, pros and cons of hormonal versus nonhormonal options, a comparison of oral (pills) and transdermal (patches, gels, sprays) therapies, treatment options for vaginal dryness and pain with sexual activities, and direct links to tables with the various formulations and doses of medications.

The TABLE details the features of the MenoPro app based on a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).3 I hope that the app described here will assist you in caring for women in the menopausal transition.

References

1. American College of Obstetricians and Gynecologists. Practice bulletin no. 141: Management of menopausal symptoms. Obstet Gynecol. 2014;123:202-216.

2. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2018;25:13621387.

3. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125:1478-1483.
 

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Dr. Chen is Professor of Obstetrics, Gynecology, and Reproductive  Science and Medical Education, Vice-Chair of Ob-Gyn Education for  the Mount Sinai Health System, Icahn  School of Medicine, Mount Sinai,  New York, New York. She is an  OBG MANAGEMENT Contributing Editor.

The author reports being an advisory board member and receiving royalties from UpToDate, Inc.

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Dr. Chen is Professor of Obstetrics, Gynecology, and Reproductive  Science and Medical Education, Vice-Chair of Ob-Gyn Education for  the Mount Sinai Health System, Icahn  School of Medicine, Mount Sinai,  New York, New York. She is an  OBG MANAGEMENT Contributing Editor.

The author reports being an advisory board member and receiving royalties from UpToDate, Inc.

Author and Disclosure Information

Dr. Chen is Professor of Obstetrics, Gynecology, and Reproductive  Science and Medical Education, Vice-Chair of Ob-Gyn Education for  the Mount Sinai Health System, Icahn  School of Medicine, Mount Sinai,  New York, New York. She is an  OBG MANAGEMENT Contributing Editor.

The author reports being an advisory board member and receiving royalties from UpToDate, Inc.

Article PDF
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In North America, women experience menopause (the permanent cessation of menstruation due to loss of ovarian activity) at a median age of 51 years. They may experience symptoms of perimenopause, or the menopause transition, for several years before menstruation ceases. Menopausal symptoms include vasomotor symptoms, such as hot flushes, and vaginal symptoms, such as vaginal dryness and pain during intercourse.1

Women may have questions about treating menopausal symptoms, maintaining their health, and preventing such age-related diseases as osteoporosis and cardiovascular disease. The decision to treat menopausal symptoms is challenging for women as well as their clinicians given that recommendations have changed over the past few years.

A free app with multiple features. The North American Menopause Society (NAMS) has developed a no-cost mobile health application called MenoPro for menopausal symptom management based on the organization’s 2017 recommendations.2 The app has 2 modes: one for clinicians and one for women/patients to support shared decision making.

For clinicians, the app helps identify which patients with menopausal symptoms are candidates for pharmacologic treatment and the options for optimal therapy. The app also can be used to calculate a 10-year cardiovascular disease (heart disease and stroke) risk assessment. In addition, it contains links to a breast cancer risk assessment as well as an osteoporosis/bone fracture risk assessment tool (FRAX model calculator). Finally, MenoPro includes NAMS’s educational materials and information pages on lifestyle modifications to reduce hot flushes, contraindications and cautions to hormone therapy, pros and cons of hormonal versus nonhormonal options, a comparison of oral (pills) and transdermal (patches, gels, sprays) therapies, treatment options for vaginal dryness and pain with sexual activities, and direct links to tables with the various formulations and doses of medications.

The TABLE details the features of the MenoPro app based on a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).3 I hope that the app described here will assist you in caring for women in the menopausal transition.

In North America, women experience menopause (the permanent cessation of menstruation due to loss of ovarian activity) at a median age of 51 years. They may experience symptoms of perimenopause, or the menopause transition, for several years before menstruation ceases. Menopausal symptoms include vasomotor symptoms, such as hot flushes, and vaginal symptoms, such as vaginal dryness and pain during intercourse.1

Women may have questions about treating menopausal symptoms, maintaining their health, and preventing such age-related diseases as osteoporosis and cardiovascular disease. The decision to treat menopausal symptoms is challenging for women as well as their clinicians given that recommendations have changed over the past few years.

A free app with multiple features. The North American Menopause Society (NAMS) has developed a no-cost mobile health application called MenoPro for menopausal symptom management based on the organization’s 2017 recommendations.2 The app has 2 modes: one for clinicians and one for women/patients to support shared decision making.

For clinicians, the app helps identify which patients with menopausal symptoms are candidates for pharmacologic treatment and the options for optimal therapy. The app also can be used to calculate a 10-year cardiovascular disease (heart disease and stroke) risk assessment. In addition, it contains links to a breast cancer risk assessment as well as an osteoporosis/bone fracture risk assessment tool (FRAX model calculator). Finally, MenoPro includes NAMS’s educational materials and information pages on lifestyle modifications to reduce hot flushes, contraindications and cautions to hormone therapy, pros and cons of hormonal versus nonhormonal options, a comparison of oral (pills) and transdermal (patches, gels, sprays) therapies, treatment options for vaginal dryness and pain with sexual activities, and direct links to tables with the various formulations and doses of medications.

The TABLE details the features of the MenoPro app based on a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).3 I hope that the app described here will assist you in caring for women in the menopausal transition.

References

1. American College of Obstetricians and Gynecologists. Practice bulletin no. 141: Management of menopausal symptoms. Obstet Gynecol. 2014;123:202-216.

2. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2018;25:13621387.

3. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125:1478-1483.
 

References

1. American College of Obstetricians and Gynecologists. Practice bulletin no. 141: Management of menopausal symptoms. Obstet Gynecol. 2014;123:202-216.

2. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2018;25:13621387.

3. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125:1478-1483.
 

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Analysis: Why Alexa’s bedside manner is bad for health care

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Amazon has opened a new health care frontier: Now Alexa can be used to transmit patient data. Using this new feature – which Amazon labeled as a “skill” – a company named Livongo will allow diabetes patients – which it calls “members” – to use the device to “query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.”

Private equity and venture capital firms are in love with a legion of companies and startups touting the benefits of virtual doctors’ visits and telemedicine to revolutionize health care, investing almost $10 billion in 2018, a record for the sector. Without stepping into a gym or a clinic, a startup called Kinetxx will provide patients with virtual physical therapy, along with messaging and exercise logging. And Maven Clinic (which is not actually a physical place) offers online medical guidance and personal advice focusing on women’s health needs.

In April, at Fortune’s Brainstorm Health conference in San Diego, Bruce Broussard, CEO of health insurer Humana, said he believes technology will help patients receive help during medical crises, citing the benefits of home monitoring and the ability of doctors’ visits to be conducted by video conference.

But when I returned from Brainstorm Health, I was confronted by an alternative reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office. It was for a five-minute phone call answering a question about a possible infection.

Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced health care system.

But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to health care. Or, instead, will it be a way for the U.S. profit-driven health care system to make big bucks by outsourcing core duties – while providing a paler version of actual medical treatment?

After all, my doctors have long answered my questions and dispensed phone and email advice for free – as part of our doctor-patient relationship – though it didn’t have a cool branding moniker like telehealth. And my obstetrician’s office offered great support and advice through two difficult pregnancies – maybe they should have been paid for that valuable service. But $235 for a phone call (which works out to over $2,000 per hour)? Not even a corporate lawyer bills that.

Logic holds that some digital health tools have tremendous potential: A neurologist can view a patient by video to see if lopsided facial movements suggest a stroke. A patient with an irregular heart rhythm could send in digital tracings to see if a new prescription drug is working. But the tangible benefit of many other virtual services offered is less certain. Some people may like receiving feedback about their sleep from an Apple Watch, but I’m not sure that’s medicine.

And if virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make health care worse.

My doctor’s nurse is far better equipped to answer a question about my ongoing health problem than someone at a call center reading from a script. And, however thorough a virtual visit may be, it forsakes some of the diagnostic information that comes when you see and touch the patient.

A study published recently in Pediatrics found that children who had a telemedicine visit for an upper respiratory infection were far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work. It makes sense: A doctor can’t use a stethoscope to listen to lungs or wiggle an otoscope into a kid’s ear by video. Similarly, a virtual physical therapist can’t feel the knots in muscle or notice a fleeting wince on a patient’s face via camera.

More important, perhaps, virtual medicine means losing the support that has long been a crucial part of the profession. There are programs to provide iPads to people in home hospice for resources about grief and chatbots that purport to treat depression. Maybe people at such challenging moments need – and deserve – human contact.

Of course, companies like those mentioned are expecting to be reimbursed for the remote monitoring and virtual advice they provide. Investors, in turn, get generous payback without having to employ so many actual doctors or other health professionals. Livongo, for instance, has raised a total of $235 million in funding over six rounds. And, as of 2018, Medicare announced it would allow such digital monitoring tools to “qualify for reimbursement,” if they are “clinically endorsed.” But, ultimately, will the well-being of patients or investors decide which tools are clinically endorsed?

So far, with its new so-called skill, Alexa will be able to perform a half-dozen health-related services. In addition to diabetes coaching, it can find the earliest urgent care appointment in a given area and check the status of a prescription drug delivery.

But it will not provide many things patients desperately want, which technology should be able to readily deliver, such as a reliable price estimate for an upcoming surgery, the infection rates at the local hospital, the location of the cheapest cholesterol test nearby. And if we’re trying to bring health care into the tech-enabled 21st century, how about starting with low-hanging fruit: Does any other sector still use paper bills and faxes?

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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Amazon has opened a new health care frontier: Now Alexa can be used to transmit patient data. Using this new feature – which Amazon labeled as a “skill” – a company named Livongo will allow diabetes patients – which it calls “members” – to use the device to “query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.”

Private equity and venture capital firms are in love with a legion of companies and startups touting the benefits of virtual doctors’ visits and telemedicine to revolutionize health care, investing almost $10 billion in 2018, a record for the sector. Without stepping into a gym or a clinic, a startup called Kinetxx will provide patients with virtual physical therapy, along with messaging and exercise logging. And Maven Clinic (which is not actually a physical place) offers online medical guidance and personal advice focusing on women’s health needs.

In April, at Fortune’s Brainstorm Health conference in San Diego, Bruce Broussard, CEO of health insurer Humana, said he believes technology will help patients receive help during medical crises, citing the benefits of home monitoring and the ability of doctors’ visits to be conducted by video conference.

But when I returned from Brainstorm Health, I was confronted by an alternative reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office. It was for a five-minute phone call answering a question about a possible infection.

Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced health care system.

But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to health care. Or, instead, will it be a way for the U.S. profit-driven health care system to make big bucks by outsourcing core duties – while providing a paler version of actual medical treatment?

After all, my doctors have long answered my questions and dispensed phone and email advice for free – as part of our doctor-patient relationship – though it didn’t have a cool branding moniker like telehealth. And my obstetrician’s office offered great support and advice through two difficult pregnancies – maybe they should have been paid for that valuable service. But $235 for a phone call (which works out to over $2,000 per hour)? Not even a corporate lawyer bills that.

Logic holds that some digital health tools have tremendous potential: A neurologist can view a patient by video to see if lopsided facial movements suggest a stroke. A patient with an irregular heart rhythm could send in digital tracings to see if a new prescription drug is working. But the tangible benefit of many other virtual services offered is less certain. Some people may like receiving feedback about their sleep from an Apple Watch, but I’m not sure that’s medicine.

And if virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make health care worse.

My doctor’s nurse is far better equipped to answer a question about my ongoing health problem than someone at a call center reading from a script. And, however thorough a virtual visit may be, it forsakes some of the diagnostic information that comes when you see and touch the patient.

A study published recently in Pediatrics found that children who had a telemedicine visit for an upper respiratory infection were far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work. It makes sense: A doctor can’t use a stethoscope to listen to lungs or wiggle an otoscope into a kid’s ear by video. Similarly, a virtual physical therapist can’t feel the knots in muscle or notice a fleeting wince on a patient’s face via camera.

More important, perhaps, virtual medicine means losing the support that has long been a crucial part of the profession. There are programs to provide iPads to people in home hospice for resources about grief and chatbots that purport to treat depression. Maybe people at such challenging moments need – and deserve – human contact.

Of course, companies like those mentioned are expecting to be reimbursed for the remote monitoring and virtual advice they provide. Investors, in turn, get generous payback without having to employ so many actual doctors or other health professionals. Livongo, for instance, has raised a total of $235 million in funding over six rounds. And, as of 2018, Medicare announced it would allow such digital monitoring tools to “qualify for reimbursement,” if they are “clinically endorsed.” But, ultimately, will the well-being of patients or investors decide which tools are clinically endorsed?

So far, with its new so-called skill, Alexa will be able to perform a half-dozen health-related services. In addition to diabetes coaching, it can find the earliest urgent care appointment in a given area and check the status of a prescription drug delivery.

But it will not provide many things patients desperately want, which technology should be able to readily deliver, such as a reliable price estimate for an upcoming surgery, the infection rates at the local hospital, the location of the cheapest cholesterol test nearby. And if we’re trying to bring health care into the tech-enabled 21st century, how about starting with low-hanging fruit: Does any other sector still use paper bills and faxes?

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

 

Amazon has opened a new health care frontier: Now Alexa can be used to transmit patient data. Using this new feature – which Amazon labeled as a “skill” – a company named Livongo will allow diabetes patients – which it calls “members” – to use the device to “query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.”

Private equity and venture capital firms are in love with a legion of companies and startups touting the benefits of virtual doctors’ visits and telemedicine to revolutionize health care, investing almost $10 billion in 2018, a record for the sector. Without stepping into a gym or a clinic, a startup called Kinetxx will provide patients with virtual physical therapy, along with messaging and exercise logging. And Maven Clinic (which is not actually a physical place) offers online medical guidance and personal advice focusing on women’s health needs.

In April, at Fortune’s Brainstorm Health conference in San Diego, Bruce Broussard, CEO of health insurer Humana, said he believes technology will help patients receive help during medical crises, citing the benefits of home monitoring and the ability of doctors’ visits to be conducted by video conference.

But when I returned from Brainstorm Health, I was confronted by an alternative reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office. It was for a five-minute phone call answering a question about a possible infection.

Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced health care system.

But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to health care. Or, instead, will it be a way for the U.S. profit-driven health care system to make big bucks by outsourcing core duties – while providing a paler version of actual medical treatment?

After all, my doctors have long answered my questions and dispensed phone and email advice for free – as part of our doctor-patient relationship – though it didn’t have a cool branding moniker like telehealth. And my obstetrician’s office offered great support and advice through two difficult pregnancies – maybe they should have been paid for that valuable service. But $235 for a phone call (which works out to over $2,000 per hour)? Not even a corporate lawyer bills that.

Logic holds that some digital health tools have tremendous potential: A neurologist can view a patient by video to see if lopsided facial movements suggest a stroke. A patient with an irregular heart rhythm could send in digital tracings to see if a new prescription drug is working. But the tangible benefit of many other virtual services offered is less certain. Some people may like receiving feedback about their sleep from an Apple Watch, but I’m not sure that’s medicine.

And if virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make health care worse.

My doctor’s nurse is far better equipped to answer a question about my ongoing health problem than someone at a call center reading from a script. And, however thorough a virtual visit may be, it forsakes some of the diagnostic information that comes when you see and touch the patient.

A study published recently in Pediatrics found that children who had a telemedicine visit for an upper respiratory infection were far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work. It makes sense: A doctor can’t use a stethoscope to listen to lungs or wiggle an otoscope into a kid’s ear by video. Similarly, a virtual physical therapist can’t feel the knots in muscle or notice a fleeting wince on a patient’s face via camera.

More important, perhaps, virtual medicine means losing the support that has long been a crucial part of the profession. There are programs to provide iPads to people in home hospice for resources about grief and chatbots that purport to treat depression. Maybe people at such challenging moments need – and deserve – human contact.

Of course, companies like those mentioned are expecting to be reimbursed for the remote monitoring and virtual advice they provide. Investors, in turn, get generous payback without having to employ so many actual doctors or other health professionals. Livongo, for instance, has raised a total of $235 million in funding over six rounds. And, as of 2018, Medicare announced it would allow such digital monitoring tools to “qualify for reimbursement,” if they are “clinically endorsed.” But, ultimately, will the well-being of patients or investors decide which tools are clinically endorsed?

So far, with its new so-called skill, Alexa will be able to perform a half-dozen health-related services. In addition to diabetes coaching, it can find the earliest urgent care appointment in a given area and check the status of a prescription drug delivery.

But it will not provide many things patients desperately want, which technology should be able to readily deliver, such as a reliable price estimate for an upcoming surgery, the infection rates at the local hospital, the location of the cheapest cholesterol test nearby. And if we’re trying to bring health care into the tech-enabled 21st century, how about starting with low-hanging fruit: Does any other sector still use paper bills and faxes?

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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