Thoracic Surgery News (Archived)

VIENNA – The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.

This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.

Bruce Jancin/Frontline Medical News

CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.

Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.

The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.

The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.

The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.

Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.

There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.

Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.

“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.

He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.

“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.

Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.

Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.

[email protected]


 

VIENNA – The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.

This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.

Bruce Jancin/Frontline Medical News

CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.

Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.

The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.

The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.

The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.

Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.

There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.

Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.

“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.

He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.

“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.

Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.

Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.

[email protected]


 

VIENNA – The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.

This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.

Bruce Jancin/Frontline Medical News

CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.

Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.

The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.

The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.

The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.

Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.

There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.

Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.

“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.

He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.

“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.

Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.

Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.

[email protected]


 

WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”

This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”

This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”

This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.

[email protected]

On Twitter @mitchelzoler

A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

“The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

[email protected]

A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

“The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

[email protected]

A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

“The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

[email protected]

WASHINGTON – Acting Administrator Andy Slavitt has some advice for his successors at the CMS: Keep the Center for Medicare & Medicaid Innovation, even if you trash the Affordable Care Act.

The innovation center is vital to the success of the Quality Payment Program, the value-based payment framework set up by the Medicare Access and CHIP Reauthorization Act (MACRA), Mr. Slavitt said Dec. 1 at the National MACRA MIPS/APM Summit.

Gregory Twachtman/Frontline Medical News

Mr. Slavitt offered a few other recommendations to the next regime. First, he called on the Trump administration to ensure that the 20 million people who have obtained health care coverage under the ACA do not lose it as a key to continued delivery system reform.

“Build from a foundation of progress, do not head backwards,” Mr. Slavitt advised. “There can be no delivery system reform without building on the foundation of reaching universal coverage.”

To that end, he advised keeping other key ACA provisions, including no-cost preventive care, the elimination of annual and lifetime coverage caps, and the end of pre-existing condition exclusions.

“If we want to fix how care is delivered, so that we’re providing value, then we must ensure that Americans can afford and access quality care at every point in their lives,” he said. “If we lose even some of the coverage gains made under the ACA, or leave people in limbo, people will lose access to regular care and we will drive up long-term costs.”

He also called for more improvements in the health IT space, including a demand for affordable systems and technologies that can exchange data and support quality health care.

“MACRA is an opportunity to move the focus away from paperwork and reporting and toward paying for what works,” Mr. Slavitt said. “For a variety of reasons, EHRs became an industry before they became a useful tool. The technology community must be held accountable ... to make room for new innovators and to give clinicians more freedom and more flexibility to focus on their patients, to practice medicine, and deliver better care.”

President-elect Trump has designated Seema Verma, a health care consultant who helped design the Indiana’s ACA Medicaid expansion, to be the next CMS administrator.

[email protected]

WASHINGTON – Acting Administrator Andy Slavitt has some advice for his successors at the CMS: Keep the Center for Medicare & Medicaid Innovation, even if you trash the Affordable Care Act.

The innovation center is vital to the success of the Quality Payment Program, the value-based payment framework set up by the Medicare Access and CHIP Reauthorization Act (MACRA), Mr. Slavitt said Dec. 1 at the National MACRA MIPS/APM Summit.

Gregory Twachtman/Frontline Medical News

Mr. Slavitt offered a few other recommendations to the next regime. First, he called on the Trump administration to ensure that the 20 million people who have obtained health care coverage under the ACA do not lose it as a key to continued delivery system reform.

“Build from a foundation of progress, do not head backwards,” Mr. Slavitt advised. “There can be no delivery system reform without building on the foundation of reaching universal coverage.”

To that end, he advised keeping other key ACA provisions, including no-cost preventive care, the elimination of annual and lifetime coverage caps, and the end of pre-existing condition exclusions.

“If we want to fix how care is delivered, so that we’re providing value, then we must ensure that Americans can afford and access quality care at every point in their lives,” he said. “If we lose even some of the coverage gains made under the ACA, or leave people in limbo, people will lose access to regular care and we will drive up long-term costs.”

He also called for more improvements in the health IT space, including a demand for affordable systems and technologies that can exchange data and support quality health care.

“MACRA is an opportunity to move the focus away from paperwork and reporting and toward paying for what works,” Mr. Slavitt said. “For a variety of reasons, EHRs became an industry before they became a useful tool. The technology community must be held accountable ... to make room for new innovators and to give clinicians more freedom and more flexibility to focus on their patients, to practice medicine, and deliver better care.”

President-elect Trump has designated Seema Verma, a health care consultant who helped design the Indiana’s ACA Medicaid expansion, to be the next CMS administrator.

[email protected]

WASHINGTON – Acting Administrator Andy Slavitt has some advice for his successors at the CMS: Keep the Center for Medicare & Medicaid Innovation, even if you trash the Affordable Care Act.

The innovation center is vital to the success of the Quality Payment Program, the value-based payment framework set up by the Medicare Access and CHIP Reauthorization Act (MACRA), Mr. Slavitt said Dec. 1 at the National MACRA MIPS/APM Summit.

Gregory Twachtman/Frontline Medical News

Mr. Slavitt offered a few other recommendations to the next regime. First, he called on the Trump administration to ensure that the 20 million people who have obtained health care coverage under the ACA do not lose it as a key to continued delivery system reform.

“Build from a foundation of progress, do not head backwards,” Mr. Slavitt advised. “There can be no delivery system reform without building on the foundation of reaching universal coverage.”

To that end, he advised keeping other key ACA provisions, including no-cost preventive care, the elimination of annual and lifetime coverage caps, and the end of pre-existing condition exclusions.

“If we want to fix how care is delivered, so that we’re providing value, then we must ensure that Americans can afford and access quality care at every point in their lives,” he said. “If we lose even some of the coverage gains made under the ACA, or leave people in limbo, people will lose access to regular care and we will drive up long-term costs.”

He also called for more improvements in the health IT space, including a demand for affordable systems and technologies that can exchange data and support quality health care.

“MACRA is an opportunity to move the focus away from paperwork and reporting and toward paying for what works,” Mr. Slavitt said. “For a variety of reasons, EHRs became an industry before they became a useful tool. The technology community must be held accountable ... to make room for new innovators and to give clinicians more freedom and more flexibility to focus on their patients, to practice medicine, and deliver better care.”

President-elect Trump has designated Seema Verma, a health care consultant who helped design the Indiana’s ACA Medicaid expansion, to be the next CMS administrator.

[email protected]

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) has uncoupled spirometry results from the ABCD treatment algorithm; this move marks the organization’s first announcing of major COPD guidance since 2011.

Spirometry now stands apart from GOLD’s ABCD symptom/exacerbation risk score with its own grade, with possibilities ranging from 1 to 4. A forced expiratory volume in 1 second (FEV₁) of 80% or more of the predicted value rates a 1; the score degrades to 4 with an FEV₁ below 30%.

[email protected]

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) has uncoupled spirometry results from the ABCD treatment algorithm; this move marks the organization’s first announcing of major COPD guidance since 2011.

Spirometry now stands apart from GOLD’s ABCD symptom/exacerbation risk score with its own grade, with possibilities ranging from 1 to 4. A forced expiratory volume in 1 second (FEV₁) of 80% or more of the predicted value rates a 1; the score degrades to 4 with an FEV₁ below 30%.

[email protected]

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) has uncoupled spirometry results from the ABCD treatment algorithm; this move marks the organization’s first announcing of major COPD guidance since 2011.

Spirometry now stands apart from GOLD’s ABCD symptom/exacerbation risk score with its own grade, with possibilities ranging from 1 to 4. A forced expiratory volume in 1 second (FEV₁) of 80% or more of the predicted value rates a 1; the score degrades to 4 with an FEV₁ below 30%.

[email protected]

A counseling and shared decision-making visit improved patient knowledge of the eligibility criteria, benefits, and potential risks of lung cancer screening via a low-radiation chest CT scan.

The Center for Medicare & Medicaid Services has added the type of visit addressed in this study to Medicare’s preventive services benefits for individuals meeting certain criteria, but no previous study had looked at how the implementation of such a visit impacted a patient’s knowledge and understanding.

A counseling and shared decision-making visit improved patient knowledge of the eligibility criteria, benefits, and potential risks of lung cancer screening via a low-radiation chest CT scan.

The Center for Medicare & Medicaid Services has added the type of visit addressed in this study to Medicare’s preventive services benefits for individuals meeting certain criteria, but no previous study had looked at how the implementation of such a visit impacted a patient’s knowledge and understanding.

A counseling and shared decision-making visit improved patient knowledge of the eligibility criteria, benefits, and potential risks of lung cancer screening via a low-radiation chest CT scan.

The Center for Medicare & Medicaid Services has added the type of visit addressed in this study to Medicare’s preventive services benefits for individuals meeting certain criteria, but no previous study had looked at how the implementation of such a visit impacted a patient’s knowledge and understanding.

Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.

Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.

These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.

All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.

Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.

This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.

Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.

All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.

Dr. Udelsman and his coauthors reported having no financial disclosures.
 

Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.

Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.

These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.

All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.

Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.

This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.

Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.

All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.

Dr. Udelsman and his coauthors reported having no financial disclosures.
 

Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.

Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.

These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.

All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.

Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.

This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.

Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.

All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.

Dr. Udelsman and his coauthors reported having no financial disclosures.
 

People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.

“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.

The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).

Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.

The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.

After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.

Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.

“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”

About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.

Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.

People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.

“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.

The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).

Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.

The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.

After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.

Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.

“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”

About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.

Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.

People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.

“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.

The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).

Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.

The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.

After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.

Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.

“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”

About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.

Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.

Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).

Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.

Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.

CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.

Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.

Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.

CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.

Dr. Voron and coauthors had no financial relationships to disclose.

[email protected]

Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).

Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.

Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.

CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.

Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.

Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.

CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.

Dr. Voron and coauthors had no financial relationships to disclose.

[email protected]

Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).

Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.

Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.

CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.

Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.

Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.

CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.

Dr. Voron and coauthors had no financial relationships to disclose.

[email protected]

Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.

Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).

Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.

Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).

Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.

Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).