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By The Numbers: Trump’s choice for FDA chief is versatile, entrenched in Pharma
President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.
Here’s a look at Dr. Gottlieb’s career, by the numbers:
188 companies
New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.
8 boards of directors
Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.
8 drug and device companies
Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.
9 recusals
In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.
The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.
7 years
Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.
Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.
33 years old
Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.
“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”
18 times before Congress
Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.
“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”
36,000 Twitter followers
More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.
72 percent
Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.
$414,000
Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.
That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.
The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.
Nearly $30,000
Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.
Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.
“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.
Here’s a look at Dr. Gottlieb’s career, by the numbers:
188 companies
New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.
8 boards of directors
Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.
8 drug and device companies
Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.
9 recusals
In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.
The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.
7 years
Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.
Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.
33 years old
Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.
“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”
18 times before Congress
Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.
“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”
36,000 Twitter followers
More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.
72 percent
Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.
$414,000
Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.
That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.
The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.
Nearly $30,000
Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.
Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.
“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor, and board member. Scott Gottlieb, MD, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.
Here’s a look at Dr. Gottlieb’s career, by the numbers:
188 companies
New Enterprise Associates, the venture capital firm in which Dr. Gottlieb is a partner, is currently or has been invested in 188 health care companies.
8 boards of directors
Dr. Gottlieb serves or has served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.
8 drug and device companies
Eight pharmaceutical companies disclosed payments to Dr. Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE, and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco, and London.
9 recusals
In a memo, Dr. Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche, and Sanofi-Aventis.
The recusals generated some headlines during the avian flu scare because Dr. Gottlieb had to recuse himself from some of the planning efforts around vaccines.
7 years
Starting in 1997, Dr. Gottlieb spent 7 years as a staff writer for BMJ, one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.
Dr. Gottlieb also spent the past 7 years as an adviser to drug maker GlaxoSmithKline’s product investment board, according to his LinkedIn page.
33 years old
Dr. Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.
“He has done a lot of thinking about how FDA should be managed – his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Dr. Gottlieb and coauthored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”
18 times before Congress
Dr. Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.
“Most people watching at the FDA would breathe a sigh of relief,” Joshua Sharfstein, MD, who served as the FDA’s principal deputy commissioner until 2011, said of Dr. Gottlieb’s impending nomination. He added that Dr. Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”
36,000 Twitter followers
More than 36,000 people follow Dr. Gottlieb on Twitter, although he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.
72 percent
Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Dr. Gottlieb to head the FDA.
$414,000
Pharmaceutical companies paid Dr. Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel, and meals.
That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco (ivacaftor). Only one other doctor received more money toward promoting the drug.
The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.
Nearly $30,000
Dr. Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.
Dr. Gottlieb contributed the most money toward Sen. Ben Sasse (R-Neb.), spending $2,600 in the primary and $2,600 again in the general election in 2013. Sen. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.
“But have you noticed how Mr. Trump uses the word ‘Reign’ – like he thinks he’s running for King?” Sen. Sasse asked in the post.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Senate confirms Verma as CMS administrator
The Senate confirmed Seema Verma as administrator of the Centers for Medicare & Medicaid Services on March 13 by a largely party line vote of 55-43.
Ms. Verma’s confirmation comes as Republicans begin their efforts to repeal and replace the Affordable Care Act. During the March 13 debate, Senate Finance Committee Chairman Orrin Hatch (R-Utah) reiterated his support for Ms. Verma, saying she will be a needed leader during the transition from the ACA.
Senate Finance Committee Ranking Member Ron Wyden (D-Ore.) continued to criticize Ms. Verma during the debate, stressing that she has presented no clear vision of her plans as the next CMS administrator.
“Ms. Verma gave the Finance Committee and the public virtually nothing to go by in terms of how she’d approach this job,” Sen. Wyden said during floor debate. “If confirmed, she’d be one of the top officials to implement Trumpcare, a bill that would raid Medicaid, slash Medicare, and kick millions of Americans off their health care... So I’m unable to support this nomination.”
A relative unknown before her nomination, Ms. Verma spent 20 years designing policy projects involving Medicaid, including HIP, the nation’s first consumer-directed Medicaid program under Indiana Governor Mitch Daniels and then-Gov. Mike Pence’s HIP 2.0 waiver proposal.
Prior to consulting, Ms. Verma served as vice president of planning for the Health and Hospital Corporation of Marion County (Ind.) and as a director with the Association of State and Territorial Health Officials in Washington.
During her confirmation hearing, senators raised concerns about Ms. Verma’s past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. But Ms. Verma argued that she never negotiated on behalf of Hewlett Packard, and that the work she conducted for the states did not overlap with work she completed for Hewlett Packard. Her company sought an ethics opinion to ensure the arrangement was not problematic, she said.
The Association for Community Affiliated Plans (ACAP) pledged to work with Ms. Verma as the Trump administration works toward changing how Medicaid is financed and administered. ACAP represents nonprofit safety net health plans in 28 states that serve patients enrolled in Medicaid, Medicare, the Children’s Health Insurance Program, marketplaces, and other publicly supported health programs.
“Flexibility is one of the great things about the Medicaid program today – this very flexibility is what has allowed the changes Ms. Verma helped to effect in Indiana,” ACAP CEO Margaret A. Murray said in a statement. “We look forward to working with Ms. Verma on pathways to refine the program while maintaining its guarantee of coverage for all eligible individuals, improving transparency and actuarial soundness in rate-setting, and assuring access to needed care and services.”
[email protected]
On Twitter @legal_med
The Senate confirmed Seema Verma as administrator of the Centers for Medicare & Medicaid Services on March 13 by a largely party line vote of 55-43.
Ms. Verma’s confirmation comes as Republicans begin their efforts to repeal and replace the Affordable Care Act. During the March 13 debate, Senate Finance Committee Chairman Orrin Hatch (R-Utah) reiterated his support for Ms. Verma, saying she will be a needed leader during the transition from the ACA.
Senate Finance Committee Ranking Member Ron Wyden (D-Ore.) continued to criticize Ms. Verma during the debate, stressing that she has presented no clear vision of her plans as the next CMS administrator.
“Ms. Verma gave the Finance Committee and the public virtually nothing to go by in terms of how she’d approach this job,” Sen. Wyden said during floor debate. “If confirmed, she’d be one of the top officials to implement Trumpcare, a bill that would raid Medicaid, slash Medicare, and kick millions of Americans off their health care... So I’m unable to support this nomination.”
A relative unknown before her nomination, Ms. Verma spent 20 years designing policy projects involving Medicaid, including HIP, the nation’s first consumer-directed Medicaid program under Indiana Governor Mitch Daniels and then-Gov. Mike Pence’s HIP 2.0 waiver proposal.
Prior to consulting, Ms. Verma served as vice president of planning for the Health and Hospital Corporation of Marion County (Ind.) and as a director with the Association of State and Territorial Health Officials in Washington.
During her confirmation hearing, senators raised concerns about Ms. Verma’s past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. But Ms. Verma argued that she never negotiated on behalf of Hewlett Packard, and that the work she conducted for the states did not overlap with work she completed for Hewlett Packard. Her company sought an ethics opinion to ensure the arrangement was not problematic, she said.
The Association for Community Affiliated Plans (ACAP) pledged to work with Ms. Verma as the Trump administration works toward changing how Medicaid is financed and administered. ACAP represents nonprofit safety net health plans in 28 states that serve patients enrolled in Medicaid, Medicare, the Children’s Health Insurance Program, marketplaces, and other publicly supported health programs.
“Flexibility is one of the great things about the Medicaid program today – this very flexibility is what has allowed the changes Ms. Verma helped to effect in Indiana,” ACAP CEO Margaret A. Murray said in a statement. “We look forward to working with Ms. Verma on pathways to refine the program while maintaining its guarantee of coverage for all eligible individuals, improving transparency and actuarial soundness in rate-setting, and assuring access to needed care and services.”
[email protected]
On Twitter @legal_med
The Senate confirmed Seema Verma as administrator of the Centers for Medicare & Medicaid Services on March 13 by a largely party line vote of 55-43.
Ms. Verma’s confirmation comes as Republicans begin their efforts to repeal and replace the Affordable Care Act. During the March 13 debate, Senate Finance Committee Chairman Orrin Hatch (R-Utah) reiterated his support for Ms. Verma, saying she will be a needed leader during the transition from the ACA.
Senate Finance Committee Ranking Member Ron Wyden (D-Ore.) continued to criticize Ms. Verma during the debate, stressing that she has presented no clear vision of her plans as the next CMS administrator.
“Ms. Verma gave the Finance Committee and the public virtually nothing to go by in terms of how she’d approach this job,” Sen. Wyden said during floor debate. “If confirmed, she’d be one of the top officials to implement Trumpcare, a bill that would raid Medicaid, slash Medicare, and kick millions of Americans off their health care... So I’m unable to support this nomination.”
A relative unknown before her nomination, Ms. Verma spent 20 years designing policy projects involving Medicaid, including HIP, the nation’s first consumer-directed Medicaid program under Indiana Governor Mitch Daniels and then-Gov. Mike Pence’s HIP 2.0 waiver proposal.
Prior to consulting, Ms. Verma served as vice president of planning for the Health and Hospital Corporation of Marion County (Ind.) and as a director with the Association of State and Territorial Health Officials in Washington.
During her confirmation hearing, senators raised concerns about Ms. Verma’s past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. But Ms. Verma argued that she never negotiated on behalf of Hewlett Packard, and that the work she conducted for the states did not overlap with work she completed for Hewlett Packard. Her company sought an ethics opinion to ensure the arrangement was not problematic, she said.
The Association for Community Affiliated Plans (ACAP) pledged to work with Ms. Verma as the Trump administration works toward changing how Medicaid is financed and administered. ACAP represents nonprofit safety net health plans in 28 states that serve patients enrolled in Medicaid, Medicare, the Children’s Health Insurance Program, marketplaces, and other publicly supported health programs.
“Flexibility is one of the great things about the Medicaid program today – this very flexibility is what has allowed the changes Ms. Verma helped to effect in Indiana,” ACAP CEO Margaret A. Murray said in a statement. “We look forward to working with Ms. Verma on pathways to refine the program while maintaining its guarantee of coverage for all eligible individuals, improving transparency and actuarial soundness in rate-setting, and assuring access to needed care and services.”
[email protected]
On Twitter @legal_med
Isolated tumor cells did not predict progression in endometrial cancer
NATIONAL HARBOR, MD. – Patients with endometrial cancer should not receive adjuvant chemotherapy or radiotherapy solely because they have isolated tumor cells in their sentinel lymph nodes, Marie Plante, MD, said during an oral presentation at the annual meeting of the Society of Gynecologic Oncology.
In a single-center prospective cohort study, about 96% of patients with endometrial cancer were alive and progression free at 3 years, a rate which resembles those reported for node-negative patients, said Dr. Plante of Laval University, Quebec City. Moreover, all 10 patients who did not receive adjuvant therapy remained alive and progression free during follow-up, she said. “Patients with isolated tumor cells carry an excellent prognosis,” she added. “Adjuvant treatment should be tailored based on uterine factors and histology and not solely on the presence of isolated tumor cells in sentinel lymph nodes.”
Pathologic ultrastaging has boosted the detection of low-volume metastases, which comprise anywhere from 35% to 63% of nodal metastases in patients with endometrial cancer. Clinicians continue to debate management when this low-volume disease consists of isolated tumor cells (ITC), defined as fewer than 200 carcinoma cells found singly or in small clusters. Finding ITC in endometrial cancer is uncommon, and few studies have examined this subgroup, Dr. Plante noted.
She and her associates evaluated 519 patients who underwent hysterectomy, salpingo-oophorectomy, lymphadenectomy, or sentinel lymph node mapping for endometrial cancer at their center between 2010 and 2015. Pathologic ultrastaging identified 31 patients with ITC (6%), of whom 11 patients received adjuvant chemotherapy, 14 received pelvic radiation therapy, and 10 underwent only brachytherapy or observation, with some patients receiving more than one treatment. Another 54 patients in the cohort had metastatic disease, including 43 patients with macrometastasis and 11 with micrometastasis.
Stage, not treatment, predicted progression-free survival (PFS), Dr. Plante emphasized. After a median follow-up period of 29 months, the estimated 3-year rate of PFS was significantly better among patients with ITC (96%), node-negative disease (88%), or micrometastasis (86%) than among those with macrometastasis (59%; P = .001), even though macrometastasis patients received significantly more chemotherapy (P = .0001).
Rates of PFS did not statistically differ between the ITC and node-negative groups, Dr. Plante noted. The single recurrence in an ITC patient involved a 7 cm carcinosarcoma that recurred despite adjuvant chemotherapy and radiation therapy. There were no recurrences among patients with endometrioid histology.
Among ITC patients who received no adjuvant treatment, half had stage IA endometrial cancer and half were stage IB, half were grade 1 and half were grade 2, all had endometrioid histology, and seven (70%) had evidence of lymphovascular space invasion, Dr. Plante said. All remained alive and progression free at follow-up.
Ultrastaging should only be performed if a sentinel lymph node is negative on initial hematoxylin and eosin stain and if there is myoinvasion, commented Nadeem R. Abu-Rustum, MD, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study. “Ultrastaging increases positive-node detection by about 8%,” he said during the scientific plenary session at the conference. “Finding positive nodes can change management, and we have to be careful not to overtreat.”
Ongoing research is examining the topography and anatomic location of ITC in sentinel lymph nodes, Dr. Abu-Rustum said. In the meantime, he advised clinicians to consider any ultrastaging result of ITC in context. “When modeling the risk of ITCs, don’t look at them in isolation. Don’t be ‘node-centric,’ ” he advised. “Look at the uterine factors and the overall bigger picture.”
Dr. Plante did not acknowledge external funding sources. Dr. Plante and Dr. Abu-Rustum reported having no conflicts of interest.
NATIONAL HARBOR, MD. – Patients with endometrial cancer should not receive adjuvant chemotherapy or radiotherapy solely because they have isolated tumor cells in their sentinel lymph nodes, Marie Plante, MD, said during an oral presentation at the annual meeting of the Society of Gynecologic Oncology.
In a single-center prospective cohort study, about 96% of patients with endometrial cancer were alive and progression free at 3 years, a rate which resembles those reported for node-negative patients, said Dr. Plante of Laval University, Quebec City. Moreover, all 10 patients who did not receive adjuvant therapy remained alive and progression free during follow-up, she said. “Patients with isolated tumor cells carry an excellent prognosis,” she added. “Adjuvant treatment should be tailored based on uterine factors and histology and not solely on the presence of isolated tumor cells in sentinel lymph nodes.”
Pathologic ultrastaging has boosted the detection of low-volume metastases, which comprise anywhere from 35% to 63% of nodal metastases in patients with endometrial cancer. Clinicians continue to debate management when this low-volume disease consists of isolated tumor cells (ITC), defined as fewer than 200 carcinoma cells found singly or in small clusters. Finding ITC in endometrial cancer is uncommon, and few studies have examined this subgroup, Dr. Plante noted.
She and her associates evaluated 519 patients who underwent hysterectomy, salpingo-oophorectomy, lymphadenectomy, or sentinel lymph node mapping for endometrial cancer at their center between 2010 and 2015. Pathologic ultrastaging identified 31 patients with ITC (6%), of whom 11 patients received adjuvant chemotherapy, 14 received pelvic radiation therapy, and 10 underwent only brachytherapy or observation, with some patients receiving more than one treatment. Another 54 patients in the cohort had metastatic disease, including 43 patients with macrometastasis and 11 with micrometastasis.
Stage, not treatment, predicted progression-free survival (PFS), Dr. Plante emphasized. After a median follow-up period of 29 months, the estimated 3-year rate of PFS was significantly better among patients with ITC (96%), node-negative disease (88%), or micrometastasis (86%) than among those with macrometastasis (59%; P = .001), even though macrometastasis patients received significantly more chemotherapy (P = .0001).
Rates of PFS did not statistically differ between the ITC and node-negative groups, Dr. Plante noted. The single recurrence in an ITC patient involved a 7 cm carcinosarcoma that recurred despite adjuvant chemotherapy and radiation therapy. There were no recurrences among patients with endometrioid histology.
Among ITC patients who received no adjuvant treatment, half had stage IA endometrial cancer and half were stage IB, half were grade 1 and half were grade 2, all had endometrioid histology, and seven (70%) had evidence of lymphovascular space invasion, Dr. Plante said. All remained alive and progression free at follow-up.
Ultrastaging should only be performed if a sentinel lymph node is negative on initial hematoxylin and eosin stain and if there is myoinvasion, commented Nadeem R. Abu-Rustum, MD, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study. “Ultrastaging increases positive-node detection by about 8%,” he said during the scientific plenary session at the conference. “Finding positive nodes can change management, and we have to be careful not to overtreat.”
Ongoing research is examining the topography and anatomic location of ITC in sentinel lymph nodes, Dr. Abu-Rustum said. In the meantime, he advised clinicians to consider any ultrastaging result of ITC in context. “When modeling the risk of ITCs, don’t look at them in isolation. Don’t be ‘node-centric,’ ” he advised. “Look at the uterine factors and the overall bigger picture.”
Dr. Plante did not acknowledge external funding sources. Dr. Plante and Dr. Abu-Rustum reported having no conflicts of interest.
NATIONAL HARBOR, MD. – Patients with endometrial cancer should not receive adjuvant chemotherapy or radiotherapy solely because they have isolated tumor cells in their sentinel lymph nodes, Marie Plante, MD, said during an oral presentation at the annual meeting of the Society of Gynecologic Oncology.
In a single-center prospective cohort study, about 96% of patients with endometrial cancer were alive and progression free at 3 years, a rate which resembles those reported for node-negative patients, said Dr. Plante of Laval University, Quebec City. Moreover, all 10 patients who did not receive adjuvant therapy remained alive and progression free during follow-up, she said. “Patients with isolated tumor cells carry an excellent prognosis,” she added. “Adjuvant treatment should be tailored based on uterine factors and histology and not solely on the presence of isolated tumor cells in sentinel lymph nodes.”
Pathologic ultrastaging has boosted the detection of low-volume metastases, which comprise anywhere from 35% to 63% of nodal metastases in patients with endometrial cancer. Clinicians continue to debate management when this low-volume disease consists of isolated tumor cells (ITC), defined as fewer than 200 carcinoma cells found singly or in small clusters. Finding ITC in endometrial cancer is uncommon, and few studies have examined this subgroup, Dr. Plante noted.
She and her associates evaluated 519 patients who underwent hysterectomy, salpingo-oophorectomy, lymphadenectomy, or sentinel lymph node mapping for endometrial cancer at their center between 2010 and 2015. Pathologic ultrastaging identified 31 patients with ITC (6%), of whom 11 patients received adjuvant chemotherapy, 14 received pelvic radiation therapy, and 10 underwent only brachytherapy or observation, with some patients receiving more than one treatment. Another 54 patients in the cohort had metastatic disease, including 43 patients with macrometastasis and 11 with micrometastasis.
Stage, not treatment, predicted progression-free survival (PFS), Dr. Plante emphasized. After a median follow-up period of 29 months, the estimated 3-year rate of PFS was significantly better among patients with ITC (96%), node-negative disease (88%), or micrometastasis (86%) than among those with macrometastasis (59%; P = .001), even though macrometastasis patients received significantly more chemotherapy (P = .0001).
Rates of PFS did not statistically differ between the ITC and node-negative groups, Dr. Plante noted. The single recurrence in an ITC patient involved a 7 cm carcinosarcoma that recurred despite adjuvant chemotherapy and radiation therapy. There were no recurrences among patients with endometrioid histology.
Among ITC patients who received no adjuvant treatment, half had stage IA endometrial cancer and half were stage IB, half were grade 1 and half were grade 2, all had endometrioid histology, and seven (70%) had evidence of lymphovascular space invasion, Dr. Plante said. All remained alive and progression free at follow-up.
Ultrastaging should only be performed if a sentinel lymph node is negative on initial hematoxylin and eosin stain and if there is myoinvasion, commented Nadeem R. Abu-Rustum, MD, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study. “Ultrastaging increases positive-node detection by about 8%,” he said during the scientific plenary session at the conference. “Finding positive nodes can change management, and we have to be careful not to overtreat.”
Ongoing research is examining the topography and anatomic location of ITC in sentinel lymph nodes, Dr. Abu-Rustum said. In the meantime, he advised clinicians to consider any ultrastaging result of ITC in context. “When modeling the risk of ITCs, don’t look at them in isolation. Don’t be ‘node-centric,’ ” he advised. “Look at the uterine factors and the overall bigger picture.”
Dr. Plante did not acknowledge external funding sources. Dr. Plante and Dr. Abu-Rustum reported having no conflicts of interest.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: For patients with endometrial cancer, isolated tumor cells in sentinel lymph nodes did not lead to disease progression and were not an indication for adjuvant treatments.
Major finding: At 3 years, the estimated rate of progression-free survival was 100% among patients who underwent only pelvic brachytherapy or observation.
Data source: A single-center prospective study of 519 patients undergoing hysterectomy, salpingo-oophorectomy, lymphadenectomy, and sentinel lymph node mapping for endometrial cancer, including 31 patients with isolated tumor cells identified in sentinel lymph nodes.
Disclosures: Dr. Plante did not report having external funding sources. Dr. Plante and Dr. Abu-Rustum had no disclosures.
More pushback from docs after CBO scores GOP health care plan
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
No benefit found for routine inpatient rehab after knee replacement
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
FROM JAMA
Key clinical point:
Major finding: There were no significant differences in the primary outcome of a 6-minute walk test at 26 weeks or in pain, function, and quality of life measures between patients randomized to inpatient or at-home rehab protocols.
Data source: A parallel, randomized controlled trial of 165 uncomplicated knee arthroplasty patients assigned to undergo either inpatient rehab for 10 days then in-home monitored rehab for 6 weeks or to a monitored 6-week home rehab 2 weeks after surgery. The study also included a third observational group of 112 patients (87 included in analysis) who underwent at-home rehab.
Disclosures: The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
VIDEO: HER2+ patients may do fine with local therapies alone
MIAMI BEACH – Unquestionably, the advent of human epidermal growth factor receptor-2 (HER2) inhibitors has dramatically improved long-term outcomes in patients with HER2-positive breast cancer.
But the benefits of therapy with the HER2-inhibitor trastuzumab (Herceptin) must be weighed against its potential for causing or exacerbating cardiomyopathy, especially when combined with anthracyclines such as doxorubicin that are associated with increased risk for late cardiotoxicity, said Sara Hurvitz, MD, director of the Breast Cancer Clinical Research Program at the David Geffen School of Medicine at UCLA in Santa Monica, Calif.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Many patients with HER2-positive disease can be safely and effectively treated with local therapy alone, but clinicians at present have no reliable way of knowing which patients are likely to have excellent outcomes without adjuvant systemic therapies or which are at high risk for recurrence and might benefit from HER2 with or without an anthracycline, leading to overtreatment of some patients out of an abundance of caution, she said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.
In a video interview, Dr. Hurvitz discussed strategies under development for identifying and evaluating biomarkers and cardiac imaging studies that could help to identify patients at highest risk for long-term cardiotoxicity, as well as alternative therapeutic regimens that eliminate the need for anthracyclines.
Dr. Hurvitz disclosed grants/research support from Amgen, Bayer, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Pfizer, Roche, Biomarin, Merrimack, OBI Pharma, Puma Biotechnology, Dignitana, Medivation, Lilly and Novartis, and travel reimbursement from Lilly, Novartis, and OBI Pharma.
MIAMI BEACH – Unquestionably, the advent of human epidermal growth factor receptor-2 (HER2) inhibitors has dramatically improved long-term outcomes in patients with HER2-positive breast cancer.
But the benefits of therapy with the HER2-inhibitor trastuzumab (Herceptin) must be weighed against its potential for causing or exacerbating cardiomyopathy, especially when combined with anthracyclines such as doxorubicin that are associated with increased risk for late cardiotoxicity, said Sara Hurvitz, MD, director of the Breast Cancer Clinical Research Program at the David Geffen School of Medicine at UCLA in Santa Monica, Calif.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Many patients with HER2-positive disease can be safely and effectively treated with local therapy alone, but clinicians at present have no reliable way of knowing which patients are likely to have excellent outcomes without adjuvant systemic therapies or which are at high risk for recurrence and might benefit from HER2 with or without an anthracycline, leading to overtreatment of some patients out of an abundance of caution, she said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.
In a video interview, Dr. Hurvitz discussed strategies under development for identifying and evaluating biomarkers and cardiac imaging studies that could help to identify patients at highest risk for long-term cardiotoxicity, as well as alternative therapeutic regimens that eliminate the need for anthracyclines.
Dr. Hurvitz disclosed grants/research support from Amgen, Bayer, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Pfizer, Roche, Biomarin, Merrimack, OBI Pharma, Puma Biotechnology, Dignitana, Medivation, Lilly and Novartis, and travel reimbursement from Lilly, Novartis, and OBI Pharma.
MIAMI BEACH – Unquestionably, the advent of human epidermal growth factor receptor-2 (HER2) inhibitors has dramatically improved long-term outcomes in patients with HER2-positive breast cancer.
But the benefits of therapy with the HER2-inhibitor trastuzumab (Herceptin) must be weighed against its potential for causing or exacerbating cardiomyopathy, especially when combined with anthracyclines such as doxorubicin that are associated with increased risk for late cardiotoxicity, said Sara Hurvitz, MD, director of the Breast Cancer Clinical Research Program at the David Geffen School of Medicine at UCLA in Santa Monica, Calif.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Many patients with HER2-positive disease can be safely and effectively treated with local therapy alone, but clinicians at present have no reliable way of knowing which patients are likely to have excellent outcomes without adjuvant systemic therapies or which are at high risk for recurrence and might benefit from HER2 with or without an anthracycline, leading to overtreatment of some patients out of an abundance of caution, she said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.
In a video interview, Dr. Hurvitz discussed strategies under development for identifying and evaluating biomarkers and cardiac imaging studies that could help to identify patients at highest risk for long-term cardiotoxicity, as well as alternative therapeutic regimens that eliminate the need for anthracyclines.
Dr. Hurvitz disclosed grants/research support from Amgen, Bayer, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Pfizer, Roche, Biomarin, Merrimack, OBI Pharma, Puma Biotechnology, Dignitana, Medivation, Lilly and Novartis, and travel reimbursement from Lilly, Novartis, and OBI Pharma.
AT MBCC
VIDEO: Breast surgeons can and do provide genetic counseling to cancer patients
MIAMI BEACH – Breast surgeons can help relieve a “medical education crisis” by advising breast cancer patients about the implications of genetic testing results. The crisis continues to worsen given the remarkable rise in precision medicine and the limited number of genetic counselors in the United States, Patrick W. Whitworth, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.
Breast surgeons are qualified to help counsel patients, and, in fact, already order more than half of breast cancer genetic sequencing, a specialist survey reveals, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, in a video interview.
At the same time, the one genotype–one phenotype paradigm for cancer genetics is rapidly shifting to testing patients for a whole panel of mutations simultaneously. Breast surgeons can partner with genetic counselors to support and expand the reach of this vital medical testing and counseling to more patients, he added.
Dr. Whitworth receives research grant support from and is a shareholder in Targeted Medical Education. He is also a shareholder in Advantage Consulting and Education.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MIAMI BEACH – Breast surgeons can help relieve a “medical education crisis” by advising breast cancer patients about the implications of genetic testing results. The crisis continues to worsen given the remarkable rise in precision medicine and the limited number of genetic counselors in the United States, Patrick W. Whitworth, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.
Breast surgeons are qualified to help counsel patients, and, in fact, already order more than half of breast cancer genetic sequencing, a specialist survey reveals, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, in a video interview.
At the same time, the one genotype–one phenotype paradigm for cancer genetics is rapidly shifting to testing patients for a whole panel of mutations simultaneously. Breast surgeons can partner with genetic counselors to support and expand the reach of this vital medical testing and counseling to more patients, he added.
Dr. Whitworth receives research grant support from and is a shareholder in Targeted Medical Education. He is also a shareholder in Advantage Consulting and Education.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MIAMI BEACH – Breast surgeons can help relieve a “medical education crisis” by advising breast cancer patients about the implications of genetic testing results. The crisis continues to worsen given the remarkable rise in precision medicine and the limited number of genetic counselors in the United States, Patrick W. Whitworth, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.
Breast surgeons are qualified to help counsel patients, and, in fact, already order more than half of breast cancer genetic sequencing, a specialist survey reveals, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, in a video interview.
At the same time, the one genotype–one phenotype paradigm for cancer genetics is rapidly shifting to testing patients for a whole panel of mutations simultaneously. Breast surgeons can partner with genetic counselors to support and expand the reach of this vital medical testing and counseling to more patients, he added.
Dr. Whitworth receives research grant support from and is a shareholder in Targeted Medical Education. He is also a shareholder in Advantage Consulting and Education.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT MBCC
GOP health plan clears first hurdle as opposition lines up
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
A key concern raised in both committee debates was the brief window between the public unveiling of the legislation and the committees’ efforts, especially the lack of financial impact analysis or “score” from the Congressional Budget Office. Democrats efforts in both committees to hold action for a CBO score were voted down on across party lines.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat in the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process.
The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid. … This has not been a transparent process. We did not go through regular order. The bill was posted less than 2 days before markup. No hearings were held, and we don’t have a CBO score,” Rep. Pallone said during committee debate.
A CBO score of the budget and coverage impacts of the Republican health care proposal could come as early as March 13.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House.
“House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
A key concern raised in both committee debates was the brief window between the public unveiling of the legislation and the committees’ efforts, especially the lack of financial impact analysis or “score” from the Congressional Budget Office. Democrats efforts in both committees to hold action for a CBO score were voted down on across party lines.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat in the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process.
The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid. … This has not been a transparent process. We did not go through regular order. The bill was posted less than 2 days before markup. No hearings were held, and we don’t have a CBO score,” Rep. Pallone said during committee debate.
A CBO score of the budget and coverage impacts of the Republican health care proposal could come as early as March 13.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House.
“House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
A key concern raised in both committee debates was the brief window between the public unveiling of the legislation and the committees’ efforts, especially the lack of financial impact analysis or “score” from the Congressional Budget Office. Democrats efforts in both committees to hold action for a CBO score were voted down on across party lines.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat in the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process.
The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid. … This has not been a transparent process. We did not go through regular order. The bill was posted less than 2 days before markup. No hearings were held, and we don’t have a CBO score,” Rep. Pallone said during committee debate.
A CBO score of the budget and coverage impacts of the Republican health care proposal could come as early as March 13.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House.
“House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
FDA approves first dedicated bifurcation device to treat coronary bifurcation lesions
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Malpractice bill would impose $250,000 damages cap
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med