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The Official Newspaper of the American Association for Thoracic Surgery
Cardiac surgery symposium critiques challenging cases
“This year’s Adult Cardiac Surgery Symposium will prove to be one of the most dynamic and liveliest to date,” said course chair Vinod H. Thourani, MD, in an interview. “Each session will have dedicated time for robust panel discussion and hopefully significant participant involvement,” he said.
Dr. Thourani, of Emory University, leads an expert roster of clinicians in the AATS/STS Adult Cardiac Surgery Symposium entitled “Excellence Through Knowledge.” The all-day Sunday format allows for an in-depth exploration that can benefit clinicians with a range of perspectives. The talks will include not only examples from clinical experience, but also “will provide the audience with the most up-to-date literature on a variety of topics relevant to the practice of cardiac surgery,” Dr. Thourani said.
The topics scheduled for discussion will include the management of short-term circulatory support for acute cardiac decompensation, aortic and mitral valve surgery, coronary artery disease, and management of aorta diseases, Dr. Thourani said.
Dr. Thourani highlighted some of specific topics that he considers especially hot this year: “New Surgical and Transcatheter Therapies for Right Ventricular Failure,” by Edward G. Soltesz, MD, of the Cleveland Clinic; “TAVR for the Treatment of Aortic Stenosis: Here Comes the Tsunami!!!,” by Michael J. Mack, MD, of the Baylor Health Care System; “Indications for Concomitant Tricuspid Valve Repair,” by Gilles D. Dreyfus, MD, of the Cardio Thoracic Centre of Monaco; “Making the Heat Team a Reality in Choosing Between CABG and PCI,” by Farouc A. Jaffer, MD, of Massachusetts General Hospital; and “Root Aneurysm with Bicuspid Aortic Valve: Spare or Replace,” by Tirone E. David, MD of Toronto General Hospital.
After a break for lunch, the symposium continues with a session on “Controversies in Mitral Valve Surgery.” Topics include not only indications for concomitant tricuspid valve repair, but also determinants for mitral valve repair or replacement and a discussion of atrial fibrillation in the setting of mitral valve disease.
“We are delighted that this symposium will not only have renowned surgeons, but also cardiologists and perfusionists that truly represent a heart team approach to these complex patients,” Dr. Thourani concluded.
“This year’s Adult Cardiac Surgery Symposium will prove to be one of the most dynamic and liveliest to date,” said course chair Vinod H. Thourani, MD, in an interview. “Each session will have dedicated time for robust panel discussion and hopefully significant participant involvement,” he said.
Dr. Thourani, of Emory University, leads an expert roster of clinicians in the AATS/STS Adult Cardiac Surgery Symposium entitled “Excellence Through Knowledge.” The all-day Sunday format allows for an in-depth exploration that can benefit clinicians with a range of perspectives. The talks will include not only examples from clinical experience, but also “will provide the audience with the most up-to-date literature on a variety of topics relevant to the practice of cardiac surgery,” Dr. Thourani said.
The topics scheduled for discussion will include the management of short-term circulatory support for acute cardiac decompensation, aortic and mitral valve surgery, coronary artery disease, and management of aorta diseases, Dr. Thourani said.
Dr. Thourani highlighted some of specific topics that he considers especially hot this year: “New Surgical and Transcatheter Therapies for Right Ventricular Failure,” by Edward G. Soltesz, MD, of the Cleveland Clinic; “TAVR for the Treatment of Aortic Stenosis: Here Comes the Tsunami!!!,” by Michael J. Mack, MD, of the Baylor Health Care System; “Indications for Concomitant Tricuspid Valve Repair,” by Gilles D. Dreyfus, MD, of the Cardio Thoracic Centre of Monaco; “Making the Heat Team a Reality in Choosing Between CABG and PCI,” by Farouc A. Jaffer, MD, of Massachusetts General Hospital; and “Root Aneurysm with Bicuspid Aortic Valve: Spare or Replace,” by Tirone E. David, MD of Toronto General Hospital.
After a break for lunch, the symposium continues with a session on “Controversies in Mitral Valve Surgery.” Topics include not only indications for concomitant tricuspid valve repair, but also determinants for mitral valve repair or replacement and a discussion of atrial fibrillation in the setting of mitral valve disease.
“We are delighted that this symposium will not only have renowned surgeons, but also cardiologists and perfusionists that truly represent a heart team approach to these complex patients,” Dr. Thourani concluded.
“This year’s Adult Cardiac Surgery Symposium will prove to be one of the most dynamic and liveliest to date,” said course chair Vinod H. Thourani, MD, in an interview. “Each session will have dedicated time for robust panel discussion and hopefully significant participant involvement,” he said.
Dr. Thourani, of Emory University, leads an expert roster of clinicians in the AATS/STS Adult Cardiac Surgery Symposium entitled “Excellence Through Knowledge.” The all-day Sunday format allows for an in-depth exploration that can benefit clinicians with a range of perspectives. The talks will include not only examples from clinical experience, but also “will provide the audience with the most up-to-date literature on a variety of topics relevant to the practice of cardiac surgery,” Dr. Thourani said.
The topics scheduled for discussion will include the management of short-term circulatory support for acute cardiac decompensation, aortic and mitral valve surgery, coronary artery disease, and management of aorta diseases, Dr. Thourani said.
Dr. Thourani highlighted some of specific topics that he considers especially hot this year: “New Surgical and Transcatheter Therapies for Right Ventricular Failure,” by Edward G. Soltesz, MD, of the Cleveland Clinic; “TAVR for the Treatment of Aortic Stenosis: Here Comes the Tsunami!!!,” by Michael J. Mack, MD, of the Baylor Health Care System; “Indications for Concomitant Tricuspid Valve Repair,” by Gilles D. Dreyfus, MD, of the Cardio Thoracic Centre of Monaco; “Making the Heat Team a Reality in Choosing Between CABG and PCI,” by Farouc A. Jaffer, MD, of Massachusetts General Hospital; and “Root Aneurysm with Bicuspid Aortic Valve: Spare or Replace,” by Tirone E. David, MD of Toronto General Hospital.
After a break for lunch, the symposium continues with a session on “Controversies in Mitral Valve Surgery.” Topics include not only indications for concomitant tricuspid valve repair, but also determinants for mitral valve repair or replacement and a discussion of atrial fibrillation in the setting of mitral valve disease.
“We are delighted that this symposium will not only have renowned surgeons, but also cardiologists and perfusionists that truly represent a heart team approach to these complex patients,” Dr. Thourani concluded.
New devices improve outcomes for pediatric patients
The smallest patients get a full day’s focus in the “Congenital Heart Disease Symposium: Innovations and Controversies in the Surgical Management of Congenital Heart Disease,” session on Sunday, April 30.
“This symposium is designed for participants to get up-to-date information about cardiothoracic surgery,” said Katsuhide Maeda, MD, of Stanford University Medical Center, in an interview.
The Pumps for Kids, Infants, and Neonates (PumpKIN) trial is designed as a randomized, multicenter, two-arm study to evaluate an investigational ventricular assistance device (VAD) known as Jarvik 2015, comparing it to the EXCOR Pediatric VAD in children with heart failure. The study is designed to enroll 88 patients, 44 randomized to the Jarvik 2015 and 44 to the EXCOR.
The primary objectives of the PumpKIN trial, according to Clinicaltrials.gov description, are to determine the safety of the Jarvik 2015 based on evaluations of reported serious adverse events up to the first 180 days after implantation, and to assess benefits based on overall survival without severe neurologic impairment.
Symposium attendees can learn the latest information about outcomes as well as tips and techniques for device use in neonates and infants, Dr. Maeda said.
Some of the presentations featuring tips and techniques include “Device Innovations and Options for Biventrical Mechanical Circulatory Support,” by Mark Shepard, MD, of St. Louis Children’s Hospital; “Surgical Techniques for TAPVR,” by Christopher A. Caldarone, MD, of the Hospital for Sick Children, Toronto; and “The “Tweener” Arch - Front vs. Side,” by Charles D. Fraser, MD, of Texas Children’s Hospital.
Looking ahead, Dr. Maeda advised clinicians to keep watching the PumpKIN trial, which is set to begin in seven institutions in the United States and Canada. “This device may open a new door,” for pediatric heart surgery, he noted.
The smallest patients get a full day’s focus in the “Congenital Heart Disease Symposium: Innovations and Controversies in the Surgical Management of Congenital Heart Disease,” session on Sunday, April 30.
“This symposium is designed for participants to get up-to-date information about cardiothoracic surgery,” said Katsuhide Maeda, MD, of Stanford University Medical Center, in an interview.
The Pumps for Kids, Infants, and Neonates (PumpKIN) trial is designed as a randomized, multicenter, two-arm study to evaluate an investigational ventricular assistance device (VAD) known as Jarvik 2015, comparing it to the EXCOR Pediatric VAD in children with heart failure. The study is designed to enroll 88 patients, 44 randomized to the Jarvik 2015 and 44 to the EXCOR.
The primary objectives of the PumpKIN trial, according to Clinicaltrials.gov description, are to determine the safety of the Jarvik 2015 based on evaluations of reported serious adverse events up to the first 180 days after implantation, and to assess benefits based on overall survival without severe neurologic impairment.
Symposium attendees can learn the latest information about outcomes as well as tips and techniques for device use in neonates and infants, Dr. Maeda said.
Some of the presentations featuring tips and techniques include “Device Innovations and Options for Biventrical Mechanical Circulatory Support,” by Mark Shepard, MD, of St. Louis Children’s Hospital; “Surgical Techniques for TAPVR,” by Christopher A. Caldarone, MD, of the Hospital for Sick Children, Toronto; and “The “Tweener” Arch - Front vs. Side,” by Charles D. Fraser, MD, of Texas Children’s Hospital.
Looking ahead, Dr. Maeda advised clinicians to keep watching the PumpKIN trial, which is set to begin in seven institutions in the United States and Canada. “This device may open a new door,” for pediatric heart surgery, he noted.
The smallest patients get a full day’s focus in the “Congenital Heart Disease Symposium: Innovations and Controversies in the Surgical Management of Congenital Heart Disease,” session on Sunday, April 30.
“This symposium is designed for participants to get up-to-date information about cardiothoracic surgery,” said Katsuhide Maeda, MD, of Stanford University Medical Center, in an interview.
The Pumps for Kids, Infants, and Neonates (PumpKIN) trial is designed as a randomized, multicenter, two-arm study to evaluate an investigational ventricular assistance device (VAD) known as Jarvik 2015, comparing it to the EXCOR Pediatric VAD in children with heart failure. The study is designed to enroll 88 patients, 44 randomized to the Jarvik 2015 and 44 to the EXCOR.
The primary objectives of the PumpKIN trial, according to Clinicaltrials.gov description, are to determine the safety of the Jarvik 2015 based on evaluations of reported serious adverse events up to the first 180 days after implantation, and to assess benefits based on overall survival without severe neurologic impairment.
Symposium attendees can learn the latest information about outcomes as well as tips and techniques for device use in neonates and infants, Dr. Maeda said.
Some of the presentations featuring tips and techniques include “Device Innovations and Options for Biventrical Mechanical Circulatory Support,” by Mark Shepard, MD, of St. Louis Children’s Hospital; “Surgical Techniques for TAPVR,” by Christopher A. Caldarone, MD, of the Hospital for Sick Children, Toronto; and “The “Tweener” Arch - Front vs. Side,” by Charles D. Fraser, MD, of Texas Children’s Hospital.
Looking ahead, Dr. Maeda advised clinicians to keep watching the PumpKIN trial, which is set to begin in seven institutions in the United States and Canada. “This device may open a new door,” for pediatric heart surgery, he noted.
Multidisciplinary Teams Create Systems of Care
Experts from a variety of disciplines will come together to discuss topics related to preoperative, perioperative and postoperative care for cardiovascular surgery patients during Sunday’s full-day symposium, “Improving Systems of Care, Quality and Safety.”
“The AATS recognizes that the delivery of high-quality, patient-centered cardiovascular care is best achieved through the use of proficient multidisciplinary teams,” said course co-chair Katherine J. Hoercher, RN, FAHA, of the Cleveland Clinic. “This symposium, with its focus on interprofessional education, is an important mechanism for developing team-based care competencies that form the underpinning of high-functioning teams.”
By bringing together faculty and learners from multiple cardiovascular surgery professions, attendees can learn how effective collaboration and utilization of standardized processes can improve outcomes in systems of care, quality and safety, Ms. Hoercher said.
“The session should provide the audience with nuts-and-bolts approaches to everyday problems through a global view of the difficulties we face in consistently delivering the highest quality medical care,” added course co-chair Glenn J.R. Whitman, MD, of The Johns Hopkins Hospital.
The morning session “will address a variety of common problems that we all face in managing cardiac surgical patients,” Dr. Whitman said. “The topics are varied and include, for example, informed consent, optimizing preoperative surgical readiness, as well as specific aspects of postoperative management such as goal-directed resuscitation and approach to the cardiac arrest patient.”
Included in the morning presentations are four talks on a team approach to minimizing transfusions, including preadmission use of epoetin; preoperative evaluation and intraoperative management; perioperative management of blood preservation; and risks, recognition and management of post cardiopulmonary bypass hemorrhage.
The afternoon portion of the symposium “will continue the morning objective and focus on specific postoperative morbidities, including hyperglycemia, perioperative myocardial infarctions and strokes,” Dr. Whitman said.
The session will conclude with presentations from five nationally-renowned speakers. Douglas R. Johnston, MD, of the Cleveland Clinic, will discuss what surgical teams can learn from fighter pilots, special ops forces and other elite performers; Peter Pronovost, MD, of Johns Hopkins Medicine, and its Armstrong Institute for Patient Safety and Quality, will discuss organizational structure and process factors for improving cardiac surgery quality and safety; Don Goldmann, MD, of the Institute for Healthcare Improvement, will provide insights on the impact of the Medicare Access and CHIP Reauthorization Act (MACRA) on the delivery of cardiovascular care; David M. Shahian, MD, of Harvard Medical School, who oversees the Society of Thoracic Surgeons’ database, will talk about meaningful outcome measures in cardiac surgery; and Alex B. Haynes, MD, of Massachusetts General Hospital, will review surgical checklists and their association with decreased morbidity and mortality.
“This session should be of interest to all AATS meeting attendees as we navigate the ever-changing landscape of health care delivery,” Ms. Hoercher said. “The information presented will be something the audience can’t easily obtain elsewhere,” added Dr. Whitman.
“I hope many of the AATS meeting attendees, both surgeons and non-surgeons, will join us at what will be an excellent educational opportunity,” Ms. Hoercher said.
Experts from a variety of disciplines will come together to discuss topics related to preoperative, perioperative and postoperative care for cardiovascular surgery patients during Sunday’s full-day symposium, “Improving Systems of Care, Quality and Safety.”
“The AATS recognizes that the delivery of high-quality, patient-centered cardiovascular care is best achieved through the use of proficient multidisciplinary teams,” said course co-chair Katherine J. Hoercher, RN, FAHA, of the Cleveland Clinic. “This symposium, with its focus on interprofessional education, is an important mechanism for developing team-based care competencies that form the underpinning of high-functioning teams.”
By bringing together faculty and learners from multiple cardiovascular surgery professions, attendees can learn how effective collaboration and utilization of standardized processes can improve outcomes in systems of care, quality and safety, Ms. Hoercher said.
“The session should provide the audience with nuts-and-bolts approaches to everyday problems through a global view of the difficulties we face in consistently delivering the highest quality medical care,” added course co-chair Glenn J.R. Whitman, MD, of The Johns Hopkins Hospital.
The morning session “will address a variety of common problems that we all face in managing cardiac surgical patients,” Dr. Whitman said. “The topics are varied and include, for example, informed consent, optimizing preoperative surgical readiness, as well as specific aspects of postoperative management such as goal-directed resuscitation and approach to the cardiac arrest patient.”
Included in the morning presentations are four talks on a team approach to minimizing transfusions, including preadmission use of epoetin; preoperative evaluation and intraoperative management; perioperative management of blood preservation; and risks, recognition and management of post cardiopulmonary bypass hemorrhage.
The afternoon portion of the symposium “will continue the morning objective and focus on specific postoperative morbidities, including hyperglycemia, perioperative myocardial infarctions and strokes,” Dr. Whitman said.
The session will conclude with presentations from five nationally-renowned speakers. Douglas R. Johnston, MD, of the Cleveland Clinic, will discuss what surgical teams can learn from fighter pilots, special ops forces and other elite performers; Peter Pronovost, MD, of Johns Hopkins Medicine, and its Armstrong Institute for Patient Safety and Quality, will discuss organizational structure and process factors for improving cardiac surgery quality and safety; Don Goldmann, MD, of the Institute for Healthcare Improvement, will provide insights on the impact of the Medicare Access and CHIP Reauthorization Act (MACRA) on the delivery of cardiovascular care; David M. Shahian, MD, of Harvard Medical School, who oversees the Society of Thoracic Surgeons’ database, will talk about meaningful outcome measures in cardiac surgery; and Alex B. Haynes, MD, of Massachusetts General Hospital, will review surgical checklists and their association with decreased morbidity and mortality.
“This session should be of interest to all AATS meeting attendees as we navigate the ever-changing landscape of health care delivery,” Ms. Hoercher said. “The information presented will be something the audience can’t easily obtain elsewhere,” added Dr. Whitman.
“I hope many of the AATS meeting attendees, both surgeons and non-surgeons, will join us at what will be an excellent educational opportunity,” Ms. Hoercher said.
Experts from a variety of disciplines will come together to discuss topics related to preoperative, perioperative and postoperative care for cardiovascular surgery patients during Sunday’s full-day symposium, “Improving Systems of Care, Quality and Safety.”
“The AATS recognizes that the delivery of high-quality, patient-centered cardiovascular care is best achieved through the use of proficient multidisciplinary teams,” said course co-chair Katherine J. Hoercher, RN, FAHA, of the Cleveland Clinic. “This symposium, with its focus on interprofessional education, is an important mechanism for developing team-based care competencies that form the underpinning of high-functioning teams.”
By bringing together faculty and learners from multiple cardiovascular surgery professions, attendees can learn how effective collaboration and utilization of standardized processes can improve outcomes in systems of care, quality and safety, Ms. Hoercher said.
“The session should provide the audience with nuts-and-bolts approaches to everyday problems through a global view of the difficulties we face in consistently delivering the highest quality medical care,” added course co-chair Glenn J.R. Whitman, MD, of The Johns Hopkins Hospital.
The morning session “will address a variety of common problems that we all face in managing cardiac surgical patients,” Dr. Whitman said. “The topics are varied and include, for example, informed consent, optimizing preoperative surgical readiness, as well as specific aspects of postoperative management such as goal-directed resuscitation and approach to the cardiac arrest patient.”
Included in the morning presentations are four talks on a team approach to minimizing transfusions, including preadmission use of epoetin; preoperative evaluation and intraoperative management; perioperative management of blood preservation; and risks, recognition and management of post cardiopulmonary bypass hemorrhage.
The afternoon portion of the symposium “will continue the morning objective and focus on specific postoperative morbidities, including hyperglycemia, perioperative myocardial infarctions and strokes,” Dr. Whitman said.
The session will conclude with presentations from five nationally-renowned speakers. Douglas R. Johnston, MD, of the Cleveland Clinic, will discuss what surgical teams can learn from fighter pilots, special ops forces and other elite performers; Peter Pronovost, MD, of Johns Hopkins Medicine, and its Armstrong Institute for Patient Safety and Quality, will discuss organizational structure and process factors for improving cardiac surgery quality and safety; Don Goldmann, MD, of the Institute for Healthcare Improvement, will provide insights on the impact of the Medicare Access and CHIP Reauthorization Act (MACRA) on the delivery of cardiovascular care; David M. Shahian, MD, of Harvard Medical School, who oversees the Society of Thoracic Surgeons’ database, will talk about meaningful outcome measures in cardiac surgery; and Alex B. Haynes, MD, of Massachusetts General Hospital, will review surgical checklists and their association with decreased morbidity and mortality.
“This session should be of interest to all AATS meeting attendees as we navigate the ever-changing landscape of health care delivery,” Ms. Hoercher said. “The information presented will be something the audience can’t easily obtain elsewhere,” added Dr. Whitman.
“I hope many of the AATS meeting attendees, both surgeons and non-surgeons, will join us at what will be an excellent educational opportunity,” Ms. Hoercher said.
Beautiful Boston Welcomes AATS Members
Boston offers its visitors an unrivaled combination of American history, culture, and entertainment. Theater and performance art make an active home in the city and its environs, and there is much to do and see during the AATS Centennial meeting this year,
In entertainment venues, on Saturday, April 29, the acclaimed Alvin Ailey Dance Company will be beforming at the Wang Theater, and Sunday, April 30, the Celebrity Series of Boston will present an evening with Broadway and television star, Kristin Chenoweth at Boston Symphony Hall; and throughout the meeting, the Boston Lyric Opera will be performing Mozaert’s “The Marriage of Figaro.”
Sports fans need not be disappointed, especially baseball fans, as Fenway Park, the home of the Boston Red Sox, will be hosting the Chicago Cubs, April 28-30, and the Baltimore Orioles, May 1-4.
As every American knows, Boston has a very rich history. The Freedom Trail links 16 historically significant sites of the Revolutionary era by a red brick path and has organized walking tours. There are also popular tours of Boston breweries and a special Saturday Chocolate Walking Tour of the Back Bay.
Boston also has many world-renowned museums ranging from the Museum of Fine arts to the Museum of Science (where the delightful Butterfly Garden opens April 28), the Computer Museum, and the JFK Library and Museum. During the meeting, the Museum of Fine Arts is featuring a special ongoing exhibit of the legendary French artist, Henri Matisse. The New England Aquarium on April 28 begins a special focus on Tentacles, featuring the giant Pacific octopus and its many relations.
For more active artistic fare, the annual meeting coincides with the popular Boston ArtWeek, an award-winning festival featuring more than 150 unique and creative experiences that are participatory, interactive, or offer behind-the-scenes access to artists or the creative process. It is located at 270 Tremont Street
Photowalks Tours offers walking tours with guides of the various landmakrs and neighborhoods of Boston, allowing photo opportunites, exercise, and the chance to learn about city history and culture, including such locations as Beacon Hill and the Waterfront.
For those with a macabre sense of history, take the “Ghosts & Gravestones” tour, through Boston’s most chilling sites and haunted places. The tour is performed with the cooperation of the city’s Historic Burying Grounds Initiative, and a portion of the ticket price goes toward maintaining Boston’s historic cemeteries.
For more standard historical fare, two famous ships are available for touriing: the USS Constitution (“Old Ironsides,” the oldest commissioned warship afloat in the world), and the Boston Tea Party Ship.
For foodies, and those of us who just have to eat, the city has restaurants for every taste although seafood, of course, is the specialty cuisine. For the best in dining, visit www.bostonmagazine.com/best-restaurants-in-boston.
For more info and links to restaurants, shopping, and suggestions on things to do in the Boston area during your visit, go to www.BostonUSA.com, or www.bostoncalendar.com.
Boston offers its visitors an unrivaled combination of American history, culture, and entertainment. Theater and performance art make an active home in the city and its environs, and there is much to do and see during the AATS Centennial meeting this year,
In entertainment venues, on Saturday, April 29, the acclaimed Alvin Ailey Dance Company will be beforming at the Wang Theater, and Sunday, April 30, the Celebrity Series of Boston will present an evening with Broadway and television star, Kristin Chenoweth at Boston Symphony Hall; and throughout the meeting, the Boston Lyric Opera will be performing Mozaert’s “The Marriage of Figaro.”
Sports fans need not be disappointed, especially baseball fans, as Fenway Park, the home of the Boston Red Sox, will be hosting the Chicago Cubs, April 28-30, and the Baltimore Orioles, May 1-4.
As every American knows, Boston has a very rich history. The Freedom Trail links 16 historically significant sites of the Revolutionary era by a red brick path and has organized walking tours. There are also popular tours of Boston breweries and a special Saturday Chocolate Walking Tour of the Back Bay.
Boston also has many world-renowned museums ranging from the Museum of Fine arts to the Museum of Science (where the delightful Butterfly Garden opens April 28), the Computer Museum, and the JFK Library and Museum. During the meeting, the Museum of Fine Arts is featuring a special ongoing exhibit of the legendary French artist, Henri Matisse. The New England Aquarium on April 28 begins a special focus on Tentacles, featuring the giant Pacific octopus and its many relations.
For more active artistic fare, the annual meeting coincides with the popular Boston ArtWeek, an award-winning festival featuring more than 150 unique and creative experiences that are participatory, interactive, or offer behind-the-scenes access to artists or the creative process. It is located at 270 Tremont Street
Photowalks Tours offers walking tours with guides of the various landmakrs and neighborhoods of Boston, allowing photo opportunites, exercise, and the chance to learn about city history and culture, including such locations as Beacon Hill and the Waterfront.
For those with a macabre sense of history, take the “Ghosts & Gravestones” tour, through Boston’s most chilling sites and haunted places. The tour is performed with the cooperation of the city’s Historic Burying Grounds Initiative, and a portion of the ticket price goes toward maintaining Boston’s historic cemeteries.
For more standard historical fare, two famous ships are available for touriing: the USS Constitution (“Old Ironsides,” the oldest commissioned warship afloat in the world), and the Boston Tea Party Ship.
For foodies, and those of us who just have to eat, the city has restaurants for every taste although seafood, of course, is the specialty cuisine. For the best in dining, visit www.bostonmagazine.com/best-restaurants-in-boston.
For more info and links to restaurants, shopping, and suggestions on things to do in the Boston area during your visit, go to www.BostonUSA.com, or www.bostoncalendar.com.
Boston offers its visitors an unrivaled combination of American history, culture, and entertainment. Theater and performance art make an active home in the city and its environs, and there is much to do and see during the AATS Centennial meeting this year,
In entertainment venues, on Saturday, April 29, the acclaimed Alvin Ailey Dance Company will be beforming at the Wang Theater, and Sunday, April 30, the Celebrity Series of Boston will present an evening with Broadway and television star, Kristin Chenoweth at Boston Symphony Hall; and throughout the meeting, the Boston Lyric Opera will be performing Mozaert’s “The Marriage of Figaro.”
Sports fans need not be disappointed, especially baseball fans, as Fenway Park, the home of the Boston Red Sox, will be hosting the Chicago Cubs, April 28-30, and the Baltimore Orioles, May 1-4.
As every American knows, Boston has a very rich history. The Freedom Trail links 16 historically significant sites of the Revolutionary era by a red brick path and has organized walking tours. There are also popular tours of Boston breweries and a special Saturday Chocolate Walking Tour of the Back Bay.
Boston also has many world-renowned museums ranging from the Museum of Fine arts to the Museum of Science (where the delightful Butterfly Garden opens April 28), the Computer Museum, and the JFK Library and Museum. During the meeting, the Museum of Fine Arts is featuring a special ongoing exhibit of the legendary French artist, Henri Matisse. The New England Aquarium on April 28 begins a special focus on Tentacles, featuring the giant Pacific octopus and its many relations.
For more active artistic fare, the annual meeting coincides with the popular Boston ArtWeek, an award-winning festival featuring more than 150 unique and creative experiences that are participatory, interactive, or offer behind-the-scenes access to artists or the creative process. It is located at 270 Tremont Street
Photowalks Tours offers walking tours with guides of the various landmakrs and neighborhoods of Boston, allowing photo opportunites, exercise, and the chance to learn about city history and culture, including such locations as Beacon Hill and the Waterfront.
For those with a macabre sense of history, take the “Ghosts & Gravestones” tour, through Boston’s most chilling sites and haunted places. The tour is performed with the cooperation of the city’s Historic Burying Grounds Initiative, and a portion of the ticket price goes toward maintaining Boston’s historic cemeteries.
For more standard historical fare, two famous ships are available for touriing: the USS Constitution (“Old Ironsides,” the oldest commissioned warship afloat in the world), and the Boston Tea Party Ship.
For foodies, and those of us who just have to eat, the city has restaurants for every taste although seafood, of course, is the specialty cuisine. For the best in dining, visit www.bostonmagazine.com/best-restaurants-in-boston.
For more info and links to restaurants, shopping, and suggestions on things to do in the Boston area during your visit, go to www.BostonUSA.com, or www.bostoncalendar.com.
Legends Come to Lunch
A highlight of the Postgraduate Symposia at the AATS Centennial will be the Legends Luncheons. This year, renowned cardiothoracic surgeons, William I. Norwood, MD, Valerie W. Rusch, MD, and Magdi H. Yacoub, MD, will share their experiences at the interactive luncheons on Sunday at each of the Postgraduate Symposia. You must be registered for a Sunday Postgraduate Symposia to attend the Legend Luncheons, but you may select any luncheon to attend.
William I. Norwood, MD (Congenital Heart Surgery)
Dr. Norwood trained in cardiac surgery at the University of Minnesota as well as at Brigham and Women’s Hospital. He took a staff position at Boston Children’s Hospital in 1976. In 1981, he and his colleageues first reported the hypoplastic left heart syndrome (HLHS) procedure that bears his name. 
HLHS is congenital heart defect in which one or more of the left-sided cardiac structures are underdeveloped and unable to support the systemic circulation. Dr. Norwood’s operation, improved over the years with subsequent stages and refinements, alleviated the universally fatal condition, allowing survivors to live functional lives, even if restricted to varying degreess.
Dr. Norwood became chief of cardiac surgery at Children’s Hospital of Philadelphia, after which, he and Aldo Castaneda, MD, established a private clinic in Geneva, Switzerland in 1994. Dr. Norwood later moved to Nemours/Alfred I. duPont Hospital for Children, from which he retired from clinical practice in 2003.
Valerie W. Rusch, MD (General Thoraic Surgery)
Dr. Rusch is the Vice Chair for Clinical Research, Department of Surgery, and Miner Family Chair in Intrathoracic Cancers at Memorial Sloan Kettering Cancer Center. Dr. Rusch was a pioneer among women in cardiothoracic surgery, and was among the first women in the country to be board certified. In 2015, Dr. Rusch was elected Chair of the Board of Regents of the American College of Surgeons, one of the most prestigious positions a surgeon can attain.
Dr. Rusch specializes in the diagnosis and treatment of patients with a variety of thoracic cancers, including lung, esophageal, mediastinaal, chest wall, and pleural.
She is a national leader in clinical trials for thoracic malignancies, and has received the Thoracic Surgery Foundation for Research and Education Socrates Award. Dr. Rusch is co-author on more than 260 papers and numerous book chapters and invited texts and has received numerous teaching and patient-care excellence awards.
Magdi H. Yacoub, MD (Adult Cardiac Surgery and Transplantation)
Dr. Yacoub is Professor of Cardiothoracic Surgery at the National Heart and Lung Institute, Imperial College London, and Founder and Director of Research at the Magdi Yacoub Institute, Harefield Heart Science Centre, which focuses on tissue engineering, myocardial regeneration, stem cell biology, end stage heart failure, and transplant immunology. He is also Founder and Director of Magdi Yacoub Research Network which has created the Qatar Cardiovascular Research Center in collaboration with Qatar Foundation and Hamad Medical Corporation.
Dr. Yacoub was born in Egypt and held an assistant professorship at the University of Chicago. He was a British Heart Foundation Professor of Cardiothoracic Surgery for over 20 years, and a consultant cardiothoracic surgeon at Harefield Hospital from 1969-2001 and Royal Brompton Hospital from 1986-2001. 
Dr. Yacoub established the largest heart and lung transplantation program in the world (in the United Kingdom) where more than 2,500 transplant operations have been performed. Among his many other accomplishments, he pioneered a live-saving surgical technique for treating infants born with transposition of the great arteries.
Dr. Yacoub was knighted for his services to medicine and surgery in 1991, awarded Fellowship of the Academy of Medical Sciences in 1998 and became a Fellow of The Royal Society in 1999.
Dr. Yacoub is author or co-author on more than 1,000 articles
A highlight of the Postgraduate Symposia at the AATS Centennial will be the Legends Luncheons. This year, renowned cardiothoracic surgeons, William I. Norwood, MD, Valerie W. Rusch, MD, and Magdi H. Yacoub, MD, will share their experiences at the interactive luncheons on Sunday at each of the Postgraduate Symposia. You must be registered for a Sunday Postgraduate Symposia to attend the Legend Luncheons, but you may select any luncheon to attend.
William I. Norwood, MD (Congenital Heart Surgery)
Dr. Norwood trained in cardiac surgery at the University of Minnesota as well as at Brigham and Women’s Hospital. He took a staff position at Boston Children’s Hospital in 1976. In 1981, he and his colleageues first reported the hypoplastic left heart syndrome (HLHS) procedure that bears his name.
HLHS is congenital heart defect in which one or more of the left-sided cardiac structures are underdeveloped and unable to support the systemic circulation. Dr. Norwood’s operation, improved over the years with subsequent stages and refinements, alleviated the universally fatal condition, allowing survivors to live functional lives, even if restricted to varying degreess.
Dr. Norwood became chief of cardiac surgery at Children’s Hospital of Philadelphia, after which, he and Aldo Castaneda, MD, established a private clinic in Geneva, Switzerland in 1994. Dr. Norwood later moved to Nemours/Alfred I. duPont Hospital for Children, from which he retired from clinical practice in 2003.
Valerie W. Rusch, MD (General Thoraic Surgery)
Dr. Rusch is the Vice Chair for Clinical Research, Department of Surgery, and Miner Family Chair in Intrathoracic Cancers at Memorial Sloan Kettering Cancer Center. Dr. Rusch was a pioneer among women in cardiothoracic surgery, and was among the first women in the country to be board certified. In 2015, Dr. Rusch was elected Chair of the Board of Regents of the American College of Surgeons, one of the most prestigious positions a surgeon can attain.
Dr. Rusch specializes in the diagnosis and treatment of patients with a variety of thoracic cancers, including lung, esophageal, mediastinaal, chest wall, and pleural.
She is a national leader in clinical trials for thoracic malignancies, and has received the Thoracic Surgery Foundation for Research and Education Socrates Award. Dr. Rusch is co-author on more than 260 papers and numerous book chapters and invited texts and has received numerous teaching and patient-care excellence awards.
Magdi H. Yacoub, MD (Adult Cardiac Surgery and Transplantation)
Dr. Yacoub is Professor of Cardiothoracic Surgery at the National Heart and Lung Institute, Imperial College London, and Founder and Director of Research at the Magdi Yacoub Institute, Harefield Heart Science Centre, which focuses on tissue engineering, myocardial regeneration, stem cell biology, end stage heart failure, and transplant immunology. He is also Founder and Director of Magdi Yacoub Research Network which has created the Qatar Cardiovascular Research Center in collaboration with Qatar Foundation and Hamad Medical Corporation.
Dr. Yacoub was born in Egypt and held an assistant professorship at the University of Chicago. He was a British Heart Foundation Professor of Cardiothoracic Surgery for over 20 years, and a consultant cardiothoracic surgeon at Harefield Hospital from 1969-2001 and Royal Brompton Hospital from 1986-2001.
Dr. Yacoub established the largest heart and lung transplantation program in the world (in the United Kingdom) where more than 2,500 transplant operations have been performed. Among his many other accomplishments, he pioneered a live-saving surgical technique for treating infants born with transposition of the great arteries.
Dr. Yacoub was knighted for his services to medicine and surgery in 1991, awarded Fellowship of the Academy of Medical Sciences in 1998 and became a Fellow of The Royal Society in 1999.
Dr. Yacoub is author or co-author on more than 1,000 articles
A highlight of the Postgraduate Symposia at the AATS Centennial will be the Legends Luncheons. This year, renowned cardiothoracic surgeons, William I. Norwood, MD, Valerie W. Rusch, MD, and Magdi H. Yacoub, MD, will share their experiences at the interactive luncheons on Sunday at each of the Postgraduate Symposia. You must be registered for a Sunday Postgraduate Symposia to attend the Legend Luncheons, but you may select any luncheon to attend.
William I. Norwood, MD (Congenital Heart Surgery)
Dr. Norwood trained in cardiac surgery at the University of Minnesota as well as at Brigham and Women’s Hospital. He took a staff position at Boston Children’s Hospital in 1976. In 1981, he and his colleageues first reported the hypoplastic left heart syndrome (HLHS) procedure that bears his name.
HLHS is congenital heart defect in which one or more of the left-sided cardiac structures are underdeveloped and unable to support the systemic circulation. Dr. Norwood’s operation, improved over the years with subsequent stages and refinements, alleviated the universally fatal condition, allowing survivors to live functional lives, even if restricted to varying degreess.
Dr. Norwood became chief of cardiac surgery at Children’s Hospital of Philadelphia, after which, he and Aldo Castaneda, MD, established a private clinic in Geneva, Switzerland in 1994. Dr. Norwood later moved to Nemours/Alfred I. duPont Hospital for Children, from which he retired from clinical practice in 2003.
Valerie W. Rusch, MD (General Thoraic Surgery)
Dr. Rusch is the Vice Chair for Clinical Research, Department of Surgery, and Miner Family Chair in Intrathoracic Cancers at Memorial Sloan Kettering Cancer Center. Dr. Rusch was a pioneer among women in cardiothoracic surgery, and was among the first women in the country to be board certified. In 2015, Dr. Rusch was elected Chair of the Board of Regents of the American College of Surgeons, one of the most prestigious positions a surgeon can attain.
Dr. Rusch specializes in the diagnosis and treatment of patients with a variety of thoracic cancers, including lung, esophageal, mediastinaal, chest wall, and pleural.
She is a national leader in clinical trials for thoracic malignancies, and has received the Thoracic Surgery Foundation for Research and Education Socrates Award. Dr. Rusch is co-author on more than 260 papers and numerous book chapters and invited texts and has received numerous teaching and patient-care excellence awards.
Magdi H. Yacoub, MD (Adult Cardiac Surgery and Transplantation)
Dr. Yacoub is Professor of Cardiothoracic Surgery at the National Heart and Lung Institute, Imperial College London, and Founder and Director of Research at the Magdi Yacoub Institute, Harefield Heart Science Centre, which focuses on tissue engineering, myocardial regeneration, stem cell biology, end stage heart failure, and transplant immunology. He is also Founder and Director of Magdi Yacoub Research Network which has created the Qatar Cardiovascular Research Center in collaboration with Qatar Foundation and Hamad Medical Corporation.
Dr. Yacoub was born in Egypt and held an assistant professorship at the University of Chicago. He was a British Heart Foundation Professor of Cardiothoracic Surgery for over 20 years, and a consultant cardiothoracic surgeon at Harefield Hospital from 1969-2001 and Royal Brompton Hospital from 1986-2001.
Dr. Yacoub established the largest heart and lung transplantation program in the world (in the United Kingdom) where more than 2,500 transplant operations have been performed. Among his many other accomplishments, he pioneered a live-saving surgical technique for treating infants born with transposition of the great arteries.
Dr. Yacoub was knighted for his services to medicine and surgery in 1991, awarded Fellowship of the Academy of Medical Sciences in 1998 and became a Fellow of The Royal Society in 1999.
Dr. Yacoub is author or co-author on more than 1,000 articles
App may improve CPAP adherence
Use of a mobile app may help sleep apnea patients adhere to continuous positive airway pressure (CPAP) therapy, a small study suggests.
The app – SleepMapper (SM) – has interactive algorithms that are modeled on the same theories of behavior change that have improved adherence to CPAP when delivered in person or through telephone-linked communication, wrote Jordanna M. Hostler of Walter Reed National Military Medical Center, Bethesda, Md., and her coinvestigators (J Sleep Res. 2017;26:139-46).
“Despite our small sample size, patients in the SM group were more than three times as likely to meet Medicare criteria for [CPAP] adherence (greater than 4 hours per night for 70% of nights), a trend that just missed statistical significance (P = .06),” the researchers noted.
“The magnitude of the increase [in CPAP use] indicates likely clinical benefit,” they added.
SleepMapper allows patients to self-monitor the outcomes of positive airway pressure (PAP) therapy by providing information on their adherence, Apnea-Hypopnea Index, and mask leak. The app, which can be downloaded on a smartphone or personal computer, also includes training modules on how to use PAP. The system, owned by Phillips Respironics, will sync with Philips Respironics’ Encore Anywhere software program.
The study comprised 61 patients who had been diagnosed with obstructive sleep apnea (OSA) via overnight, in-lab polysomnography. The patients were initiating PAP for the first time at Walter Reed National Military Medical Center’s Sleep Disorders Center in Bethesda, Md., as participants in the center’s program. Such a program included group sessions with instruction on sleep hygiene and training in the use of PAP, an initial one-on-one meeting with a physician, and a follow-up appointment with a physician 4 weeks after initiating the therapy.
Thirty of the program participants included in the study used SleepMapper in addition to the center’s standard education and follow-up. The researchers analyzed 11 weeks of data for all 61 study participants.
Patients in the SleepMapper group used their PAP machines for a greater percentage of days and achieved more than 4 hours of use on more days of participation in the program, compared with patients who did not use the app. The patients using the app also showed a trend toward using PAP for more hours per night overall. Specifically, nine of the patients in the app group used their PAP machines greater than 4 hours per night for 70% of nights, versus three of the patients in the control group (P = .06). SleepMapper usage remained significantly associated with percentage of nights including greater than 4 hours of PAP use, in a multivariate linear regression analysis.
The researchers observed many similarities between patients using the app and patients in the control group, including Apnea-Hypopnea Index scores, central apnea index scores, and percentages of time spent in periodic breathing.
Some additional advantages to use of SleepMapper over simply participating in the center’s educational program are that the app provides ongoing coaching and immediate access to Apnea-Hypopnea Index and PAP use data, according to the researchers. They touted the app’s educational videos about OSA and PAP therapy and “structured motivational enhancement techniques such as feedback and goal setting, which have shown benefit when delivered by health care professionals in other studies.”
The researchers called for an additional study of the app’s usefulness in a larger group of patients.
The authors did not receive any funding or support for this study.
Feedback to patients regarding their clinical status is rarely a bad thing. I’m a big fan of tools that give patients information on their CPAP adherence and outcomes, of which several now exist, including some that are not affiliated with any particular respiratory device company, and are able to read a number of different device downloads.
In the end, the use of technology for monitoring CPAP adherence is here to stay, and the incremental cost of making it available to our patients is low. Taking the time to educate patients who are newly prescribed CPAP about interpreting their outcome data is likely to be time well spent.
Feedback to patients regarding their clinical status is rarely a bad thing. I’m a big fan of tools that give patients information on their CPAP adherence and outcomes, of which several now exist, including some that are not affiliated with any particular respiratory device company, and are able to read a number of different device downloads.
In the end, the use of technology for monitoring CPAP adherence is here to stay, and the incremental cost of making it available to our patients is low. Taking the time to educate patients who are newly prescribed CPAP about interpreting their outcome data is likely to be time well spent.
Feedback to patients regarding their clinical status is rarely a bad thing. I’m a big fan of tools that give patients information on their CPAP adherence and outcomes, of which several now exist, including some that are not affiliated with any particular respiratory device company, and are able to read a number of different device downloads.
In the end, the use of technology for monitoring CPAP adherence is here to stay, and the incremental cost of making it available to our patients is low. Taking the time to educate patients who are newly prescribed CPAP about interpreting their outcome data is likely to be time well spent.
Use of a mobile app may help sleep apnea patients adhere to continuous positive airway pressure (CPAP) therapy, a small study suggests.
The app – SleepMapper (SM) – has interactive algorithms that are modeled on the same theories of behavior change that have improved adherence to CPAP when delivered in person or through telephone-linked communication, wrote Jordanna M. Hostler of Walter Reed National Military Medical Center, Bethesda, Md., and her coinvestigators (J Sleep Res. 2017;26:139-46).
“Despite our small sample size, patients in the SM group were more than three times as likely to meet Medicare criteria for [CPAP] adherence (greater than 4 hours per night for 70% of nights), a trend that just missed statistical significance (P = .06),” the researchers noted.
“The magnitude of the increase [in CPAP use] indicates likely clinical benefit,” they added.
SleepMapper allows patients to self-monitor the outcomes of positive airway pressure (PAP) therapy by providing information on their adherence, Apnea-Hypopnea Index, and mask leak. The app, which can be downloaded on a smartphone or personal computer, also includes training modules on how to use PAP. The system, owned by Phillips Respironics, will sync with Philips Respironics’ Encore Anywhere software program.
The study comprised 61 patients who had been diagnosed with obstructive sleep apnea (OSA) via overnight, in-lab polysomnography. The patients were initiating PAP for the first time at Walter Reed National Military Medical Center’s Sleep Disorders Center in Bethesda, Md., as participants in the center’s program. Such a program included group sessions with instruction on sleep hygiene and training in the use of PAP, an initial one-on-one meeting with a physician, and a follow-up appointment with a physician 4 weeks after initiating the therapy.
Thirty of the program participants included in the study used SleepMapper in addition to the center’s standard education and follow-up. The researchers analyzed 11 weeks of data for all 61 study participants.
Patients in the SleepMapper group used their PAP machines for a greater percentage of days and achieved more than 4 hours of use on more days of participation in the program, compared with patients who did not use the app. The patients using the app also showed a trend toward using PAP for more hours per night overall. Specifically, nine of the patients in the app group used their PAP machines greater than 4 hours per night for 70% of nights, versus three of the patients in the control group (P = .06). SleepMapper usage remained significantly associated with percentage of nights including greater than 4 hours of PAP use, in a multivariate linear regression analysis.
The researchers observed many similarities between patients using the app and patients in the control group, including Apnea-Hypopnea Index scores, central apnea index scores, and percentages of time spent in periodic breathing.
Some additional advantages to use of SleepMapper over simply participating in the center’s educational program are that the app provides ongoing coaching and immediate access to Apnea-Hypopnea Index and PAP use data, according to the researchers. They touted the app’s educational videos about OSA and PAP therapy and “structured motivational enhancement techniques such as feedback and goal setting, which have shown benefit when delivered by health care professionals in other studies.”
The researchers called for an additional study of the app’s usefulness in a larger group of patients.
The authors did not receive any funding or support for this study.
Use of a mobile app may help sleep apnea patients adhere to continuous positive airway pressure (CPAP) therapy, a small study suggests.
The app – SleepMapper (SM) – has interactive algorithms that are modeled on the same theories of behavior change that have improved adherence to CPAP when delivered in person or through telephone-linked communication, wrote Jordanna M. Hostler of Walter Reed National Military Medical Center, Bethesda, Md., and her coinvestigators (J Sleep Res. 2017;26:139-46).
“Despite our small sample size, patients in the SM group were more than three times as likely to meet Medicare criteria for [CPAP] adherence (greater than 4 hours per night for 70% of nights), a trend that just missed statistical significance (P = .06),” the researchers noted.
“The magnitude of the increase [in CPAP use] indicates likely clinical benefit,” they added.
SleepMapper allows patients to self-monitor the outcomes of positive airway pressure (PAP) therapy by providing information on their adherence, Apnea-Hypopnea Index, and mask leak. The app, which can be downloaded on a smartphone or personal computer, also includes training modules on how to use PAP. The system, owned by Phillips Respironics, will sync with Philips Respironics’ Encore Anywhere software program.
The study comprised 61 patients who had been diagnosed with obstructive sleep apnea (OSA) via overnight, in-lab polysomnography. The patients were initiating PAP for the first time at Walter Reed National Military Medical Center’s Sleep Disorders Center in Bethesda, Md., as participants in the center’s program. Such a program included group sessions with instruction on sleep hygiene and training in the use of PAP, an initial one-on-one meeting with a physician, and a follow-up appointment with a physician 4 weeks after initiating the therapy.
Thirty of the program participants included in the study used SleepMapper in addition to the center’s standard education and follow-up. The researchers analyzed 11 weeks of data for all 61 study participants.
Patients in the SleepMapper group used their PAP machines for a greater percentage of days and achieved more than 4 hours of use on more days of participation in the program, compared with patients who did not use the app. The patients using the app also showed a trend toward using PAP for more hours per night overall. Specifically, nine of the patients in the app group used their PAP machines greater than 4 hours per night for 70% of nights, versus three of the patients in the control group (P = .06). SleepMapper usage remained significantly associated with percentage of nights including greater than 4 hours of PAP use, in a multivariate linear regression analysis.
The researchers observed many similarities between patients using the app and patients in the control group, including Apnea-Hypopnea Index scores, central apnea index scores, and percentages of time spent in periodic breathing.
Some additional advantages to use of SleepMapper over simply participating in the center’s educational program are that the app provides ongoing coaching and immediate access to Apnea-Hypopnea Index and PAP use data, according to the researchers. They touted the app’s educational videos about OSA and PAP therapy and “structured motivational enhancement techniques such as feedback and goal setting, which have shown benefit when delivered by health care professionals in other studies.”
The researchers called for an additional study of the app’s usefulness in a larger group of patients.
The authors did not receive any funding or support for this study.
Medicaid reform: Work-based waivers may not fly
The Trump administration may not be able to successfully implement the work requirements and other Medicaid eligibility caveats proffered by Health and Human Services Secretary Tom Price, MD, according to Jane Perkins, legal director for the National Health Law Program.
In March, Secretary Price and Seema Verma, administrator of the Centers for Medicare & Medicaid Services, wrote to state governors, letting them know that the HHS would support states’ efforts to increase employment, community engagement, and work requirements for Medicaid recipients. The letter also was supportive of aligning Medicaid benefits with private insurance via alternative benefits, cost-sharing, and premium payments.
High mandatory premiums, cost sharing, lifetime limits, and drug testing “are of concern to us,” Ms. Perkins said at an April 13 press briefing. “They really change the complexion of Medicaid and Medicaid coverage for low-income people.”
These requirements “are not typically seen in Medicaid programs,” she said.
While Section 1115 of the Social Security Act “allows states to test novel approaches to providing medical assistance” via Medicaid waivers, it does not allow the HHS or the states to “ignore congressional mandates; to cut eligibility, services, or provider payments; or to use section 1115 to save money,” according to an issue brief by Ms. Perkins.
When asked how work requirements harm people, Ms. Perkins responded that adding a work requirement to Medicaid eligibility gets things “backwards,” because a sick person needs health care before being able to return to work.
The work requirement would not save states much money, as nearly 8 in 10 adults on Medicaid are in a household that includes a worker and 59% of recipients work themselves, according to a Kaiser Family Foundation study. The adults affected by the work requirement would make up only a drop in the ocean of Medicaid spending. About two-thirds of that spending goes toward senior citizens, people with disabilities, children, and people in long term care, according to projections from the Congressional Budget Office.
The National Health Law program, which advocates for low-income Medicaid recipients, is following the waivers state-by-state with a network of lawyers who work with people with disabilities in each state.
“With this new openness to flexibility, we are certainly watching what is going on in the states,” Ms. Perkins said.
The Trump administration may not be able to successfully implement the work requirements and other Medicaid eligibility caveats proffered by Health and Human Services Secretary Tom Price, MD, according to Jane Perkins, legal director for the National Health Law Program.
In March, Secretary Price and Seema Verma, administrator of the Centers for Medicare & Medicaid Services, wrote to state governors, letting them know that the HHS would support states’ efforts to increase employment, community engagement, and work requirements for Medicaid recipients. The letter also was supportive of aligning Medicaid benefits with private insurance via alternative benefits, cost-sharing, and premium payments.
High mandatory premiums, cost sharing, lifetime limits, and drug testing “are of concern to us,” Ms. Perkins said at an April 13 press briefing. “They really change the complexion of Medicaid and Medicaid coverage for low-income people.”
These requirements “are not typically seen in Medicaid programs,” she said.
While Section 1115 of the Social Security Act “allows states to test novel approaches to providing medical assistance” via Medicaid waivers, it does not allow the HHS or the states to “ignore congressional mandates; to cut eligibility, services, or provider payments; or to use section 1115 to save money,” according to an issue brief by Ms. Perkins.
When asked how work requirements harm people, Ms. Perkins responded that adding a work requirement to Medicaid eligibility gets things “backwards,” because a sick person needs health care before being able to return to work.
The work requirement would not save states much money, as nearly 8 in 10 adults on Medicaid are in a household that includes a worker and 59% of recipients work themselves, according to a Kaiser Family Foundation study. The adults affected by the work requirement would make up only a drop in the ocean of Medicaid spending. About two-thirds of that spending goes toward senior citizens, people with disabilities, children, and people in long term care, according to projections from the Congressional Budget Office.
The National Health Law program, which advocates for low-income Medicaid recipients, is following the waivers state-by-state with a network of lawyers who work with people with disabilities in each state.
“With this new openness to flexibility, we are certainly watching what is going on in the states,” Ms. Perkins said.
The Trump administration may not be able to successfully implement the work requirements and other Medicaid eligibility caveats proffered by Health and Human Services Secretary Tom Price, MD, according to Jane Perkins, legal director for the National Health Law Program.
In March, Secretary Price and Seema Verma, administrator of the Centers for Medicare & Medicaid Services, wrote to state governors, letting them know that the HHS would support states’ efforts to increase employment, community engagement, and work requirements for Medicaid recipients. The letter also was supportive of aligning Medicaid benefits with private insurance via alternative benefits, cost-sharing, and premium payments.
High mandatory premiums, cost sharing, lifetime limits, and drug testing “are of concern to us,” Ms. Perkins said at an April 13 press briefing. “They really change the complexion of Medicaid and Medicaid coverage for low-income people.”
These requirements “are not typically seen in Medicaid programs,” she said.
While Section 1115 of the Social Security Act “allows states to test novel approaches to providing medical assistance” via Medicaid waivers, it does not allow the HHS or the states to “ignore congressional mandates; to cut eligibility, services, or provider payments; or to use section 1115 to save money,” according to an issue brief by Ms. Perkins.
When asked how work requirements harm people, Ms. Perkins responded that adding a work requirement to Medicaid eligibility gets things “backwards,” because a sick person needs health care before being able to return to work.
The work requirement would not save states much money, as nearly 8 in 10 adults on Medicaid are in a household that includes a worker and 59% of recipients work themselves, according to a Kaiser Family Foundation study. The adults affected by the work requirement would make up only a drop in the ocean of Medicaid spending. About two-thirds of that spending goes toward senior citizens, people with disabilities, children, and people in long term care, according to projections from the Congressional Budget Office.
The National Health Law program, which advocates for low-income Medicaid recipients, is following the waivers state-by-state with a network of lawyers who work with people with disabilities in each state.
“With this new openness to flexibility, we are certainly watching what is going on in the states,” Ms. Perkins said.
CMS market stabilization efforts useless without subsidies
New final regulations designed to bring stability to the individual health insurance market may not matter if the White House follows through on a threat to kill subsidies paid to insurers to help reduce deductibles and other out-of-pocket costs for low-income patients.
The final rule from the Centers for Medicare & Medicaid Services grants a number of wishes sought by the insurance industry to help bring a level of predictability and flexibility when designing plans for the individual market. Specifically, it does the following:
• Shortens the open enrollment period for the 2018 plan year to 6 weeks running from Nov. 1 to Dec. 15, so that open enrollment closely aligns with Medicare and other private insurance.
• Requires individuals to submit documentation when seeking coverage through a special enrollment period.
• Allows insurers to collect past-due premiums before issuing coverage for a future year.
• Provides more actuarial flexibility to allow for different plan designs.
• Returns network adequacy oversight to states.
The new rules are not expected to alter the existing market dynamic, according to Kelly Brantley, vice president at Avalere Health. 
“I would say the rule is nominally helpful, but it’s really unlikely to persuade anyone, particularly those insurers who are already on their way out. I don’t think this a game-changer for them,” she said in an interview.
The American Medical Association, in comments to the CMS when the rule was proposed as a draft, said that if finalized, the rule “would raise premiums, out-of-pocket costs, or both for millions of moderate-income families and would make it more difficult for eligible individuals to enroll in health coverage and access needed care.”
The potential impact of these regulatory changes could be moot if President Trump makes good on his threat to withhold cost-sharing subsidies to insurers. The subsides already are the subject of a lawsuit brought by the House of Representatives against the Obama administration; they continue to be paid while the suit makes its way through the judicial process. President Trump has threatened to cut off the subsidies in an effort to force Congressional Democrats to the negotiating table regarding the repeal and replacement of the Affordable Care Act.
“My take on this is that the [market stabilization] rule as written is not likely to shift the market, really, in terms of access,” Ms. Brantley said. “The bigger question is whether the cost-sharing reductions are going to be paid. I think that has a bigger likelihood of influencing issuer participation and robustness of the market in 2018.”
Even with the changes made by the market stabilization rule, “there is still too much instability and uncertainty in this market,” Marilyn Tavenner, president and CEO of the industry group America’s Health Insurance Plans, said in a statement. “Most urgently, health plans and the consumers they serve need to know that funding for cost-sharing reduction subsidies will continue uninterrupted.”
Ms. Tavenner noted that without the subsidies, more plans are likely to drop out of the health insurance exchanges, leading to premium increases, and “doctors and hospitals will see even greater strains on their ability to care for people.”
The AMA, in an April 12 letter to President Trump, cosigned by America’s Health Insurance Plans, the American Academy of Family Physicians, the American Hospital Association, the Federation of American Hospitals, the American Benefits Council, the Blue Cross Blue Shield Association, and the U.S. Chamber of Commerce, stated that the “most critical action to help stabilize the individual market for 2017 and 2018 is to remove uncertainty about continued funding for cost sharing reductions.”
Ms. Brantley added that if the subsides were cut, “it makes it more challenging to bring any kind of money back into the system at a later point. I think it would be hard for those cost-sharing reductions to go away at this point and then ever come back, but I do think that it’s a possibility that that could happen.”
The CMS released the final rule April 13, 2017, and it is scheduled for publication in the Federal Register on April 18, 2017.
New final regulations designed to bring stability to the individual health insurance market may not matter if the White House follows through on a threat to kill subsidies paid to insurers to help reduce deductibles and other out-of-pocket costs for low-income patients.
The final rule from the Centers for Medicare & Medicaid Services grants a number of wishes sought by the insurance industry to help bring a level of predictability and flexibility when designing plans for the individual market. Specifically, it does the following:
• Shortens the open enrollment period for the 2018 plan year to 6 weeks running from Nov. 1 to Dec. 15, so that open enrollment closely aligns with Medicare and other private insurance.
• Requires individuals to submit documentation when seeking coverage through a special enrollment period.
• Allows insurers to collect past-due premiums before issuing coverage for a future year.
• Provides more actuarial flexibility to allow for different plan designs.
• Returns network adequacy oversight to states.
The new rules are not expected to alter the existing market dynamic, according to Kelly Brantley, vice president at Avalere Health.
“I would say the rule is nominally helpful, but it’s really unlikely to persuade anyone, particularly those insurers who are already on their way out. I don’t think this a game-changer for them,” she said in an interview.
The American Medical Association, in comments to the CMS when the rule was proposed as a draft, said that if finalized, the rule “would raise premiums, out-of-pocket costs, or both for millions of moderate-income families and would make it more difficult for eligible individuals to enroll in health coverage and access needed care.”
The potential impact of these regulatory changes could be moot if President Trump makes good on his threat to withhold cost-sharing subsidies to insurers. The subsides already are the subject of a lawsuit brought by the House of Representatives against the Obama administration; they continue to be paid while the suit makes its way through the judicial process. President Trump has threatened to cut off the subsidies in an effort to force Congressional Democrats to the negotiating table regarding the repeal and replacement of the Affordable Care Act.
“My take on this is that the [market stabilization] rule as written is not likely to shift the market, really, in terms of access,” Ms. Brantley said. “The bigger question is whether the cost-sharing reductions are going to be paid. I think that has a bigger likelihood of influencing issuer participation and robustness of the market in 2018.”
Even with the changes made by the market stabilization rule, “there is still too much instability and uncertainty in this market,” Marilyn Tavenner, president and CEO of the industry group America’s Health Insurance Plans, said in a statement. “Most urgently, health plans and the consumers they serve need to know that funding for cost-sharing reduction subsidies will continue uninterrupted.”
Ms. Tavenner noted that without the subsidies, more plans are likely to drop out of the health insurance exchanges, leading to premium increases, and “doctors and hospitals will see even greater strains on their ability to care for people.”
The AMA, in an April 12 letter to President Trump, cosigned by America’s Health Insurance Plans, the American Academy of Family Physicians, the American Hospital Association, the Federation of American Hospitals, the American Benefits Council, the Blue Cross Blue Shield Association, and the U.S. Chamber of Commerce, stated that the “most critical action to help stabilize the individual market for 2017 and 2018 is to remove uncertainty about continued funding for cost sharing reductions.”
Ms. Brantley added that if the subsides were cut, “it makes it more challenging to bring any kind of money back into the system at a later point. I think it would be hard for those cost-sharing reductions to go away at this point and then ever come back, but I do think that it’s a possibility that that could happen.”
The CMS released the final rule April 13, 2017, and it is scheduled for publication in the Federal Register on April 18, 2017.
New final regulations designed to bring stability to the individual health insurance market may not matter if the White House follows through on a threat to kill subsidies paid to insurers to help reduce deductibles and other out-of-pocket costs for low-income patients.
The final rule from the Centers for Medicare & Medicaid Services grants a number of wishes sought by the insurance industry to help bring a level of predictability and flexibility when designing plans for the individual market. Specifically, it does the following:
• Shortens the open enrollment period for the 2018 plan year to 6 weeks running from Nov. 1 to Dec. 15, so that open enrollment closely aligns with Medicare and other private insurance.
• Requires individuals to submit documentation when seeking coverage through a special enrollment period.
• Allows insurers to collect past-due premiums before issuing coverage for a future year.
• Provides more actuarial flexibility to allow for different plan designs.
• Returns network adequacy oversight to states.
The new rules are not expected to alter the existing market dynamic, according to Kelly Brantley, vice president at Avalere Health.
“I would say the rule is nominally helpful, but it’s really unlikely to persuade anyone, particularly those insurers who are already on their way out. I don’t think this a game-changer for them,” she said in an interview.
The American Medical Association, in comments to the CMS when the rule was proposed as a draft, said that if finalized, the rule “would raise premiums, out-of-pocket costs, or both for millions of moderate-income families and would make it more difficult for eligible individuals to enroll in health coverage and access needed care.”
The potential impact of these regulatory changes could be moot if President Trump makes good on his threat to withhold cost-sharing subsidies to insurers. The subsides already are the subject of a lawsuit brought by the House of Representatives against the Obama administration; they continue to be paid while the suit makes its way through the judicial process. President Trump has threatened to cut off the subsidies in an effort to force Congressional Democrats to the negotiating table regarding the repeal and replacement of the Affordable Care Act.
“My take on this is that the [market stabilization] rule as written is not likely to shift the market, really, in terms of access,” Ms. Brantley said. “The bigger question is whether the cost-sharing reductions are going to be paid. I think that has a bigger likelihood of influencing issuer participation and robustness of the market in 2018.”
Even with the changes made by the market stabilization rule, “there is still too much instability and uncertainty in this market,” Marilyn Tavenner, president and CEO of the industry group America’s Health Insurance Plans, said in a statement. “Most urgently, health plans and the consumers they serve need to know that funding for cost-sharing reduction subsidies will continue uninterrupted.”
Ms. Tavenner noted that without the subsidies, more plans are likely to drop out of the health insurance exchanges, leading to premium increases, and “doctors and hospitals will see even greater strains on their ability to care for people.”
The AMA, in an April 12 letter to President Trump, cosigned by America’s Health Insurance Plans, the American Academy of Family Physicians, the American Hospital Association, the Federation of American Hospitals, the American Benefits Council, the Blue Cross Blue Shield Association, and the U.S. Chamber of Commerce, stated that the “most critical action to help stabilize the individual market for 2017 and 2018 is to remove uncertainty about continued funding for cost sharing reductions.”
Ms. Brantley added that if the subsides were cut, “it makes it more challenging to bring any kind of money back into the system at a later point. I think it would be hard for those cost-sharing reductions to go away at this point and then ever come back, but I do think that it’s a possibility that that could happen.”
The CMS released the final rule April 13, 2017, and it is scheduled for publication in the Federal Register on April 18, 2017.
It’s been a good year for heart failure research ... mostly
WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.
“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.
The good news
• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.
The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).
“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.
• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).
The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.
“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.
• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).
“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.
On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.
• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.
“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”
The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.
“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.
• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.
The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.
The bad news
• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).
• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.
Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.
“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.
• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).
“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.
• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).
“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.
• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”
Sleep apnea studies show silver lining
Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).
This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.
As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.
He reported having no financial conflicts.
WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.
“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.
The good news
• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.
The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).
“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.
• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).
The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.
“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.
• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).
“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.
On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.
• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.
“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”
The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.
“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.
• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.
The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.
The bad news
• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).
• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.
Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.
“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.
• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).
“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.
• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).
“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.
• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”
Sleep apnea studies show silver lining
Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).
This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.
As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.
He reported having no financial conflicts.
WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.
“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.
The good news
• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.
The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).
“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.
• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).
The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.
“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.
• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).
“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.
On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.
• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.
“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”
The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.
“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.
• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.
The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.
The bad news
• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).
• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.
Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.
“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.
• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).
“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.
• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).
“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.
• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”
Sleep apnea studies show silver lining
Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).
This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.
As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.
He reported having no financial conflicts.
EXPERT ANALYSIS FROM ACC 17
Routine U.S. mitral clip use found reassuring
WASHINGTON – U.S. heart teams have used the mitral valve transcatheter clip repair device for fixing leaky mitral valves exactly the way it was designed to be used once the device hit the U.S. market in 2013.
In the first review of periprocedural and 1-year outcomes of U.S. patients treated with the MitraClip repair device and entered in the national device registry, the results showed “acute effectiveness and safety of transcatheter mitral valve repair,” Paul Sorajja, MD, said at the annual meeting of the American College of Cardiology.
“We need to be keenly aware of the impact of comorbidities on the prognosis of these patients. The data show that untreated comorbidities really impact prognosis,” said Dr. Sorajja, an interventional cardiologist and director of the Center of Valve and Structural Heart Disease of the Minneapolis Heart Institute.
“The clip is for the no-option patient, meaning patients at high risk who have no surgical option. The data show that these are the patients who are being treated” in routine U.S. practice. “The data show that, even for these patients, you can still get pretty good results,” Dr. Sorajja said in an interview. “These are the first data on clip use in routine U.S. practice, and they are really reassuring. The data show that the clip is being used in the correct way, without risk creep, on patients with prohibitive surgical risk based on their STS [Society of Thoracic Surgeons] predicted mortality and frailty scores.”
The data he and his associates reviewed came from the 2,952 U.S. patients who underwent a transcatheter mitral valve clip repair following the devices premarketing approval from the Food and Drug Administration in November 2013, and through September 2015 at any of 250 U.S. sites offering the procedure.
The data on patient demographics and clinical status came from the STS/American College of Cardiology Transcatheter Valve Therapy registry, and data on 1-year outcomes came from Medicare records for 1,867 (63%) of the patients.
The mitral valve repair patients averaged 82 years old, 85% had a New York Heart Association functional class of III or IV, 93% had a mitral valve regurgitation grade of 3 or 4, half were judged frail, and their STS predicted mortality risk from mitral valve repair was about 6% and from valve replacement about 9%.
Immediately after their procedure, 93% of patients had a valve regurgitation grade of 2 or less, the periprocedural mortality rate was just under 3%, and 86% of patients were discharged home following a median length of stay of 2 days. Acute procedural success occurred in 92% of patients, Dr. Sorajja reported.
At 1 year, the mortality rate among the patients followed through their Medicare records showed that 26% of patients had died, 20% had been hospitalized at least once for heart failure, and 38% had at least one of these two outcomes. In addition, 6% underwent a repeat procedure of transcatheter mitral repair, and 2% had mitral valve replacement surgery.
Although patients who had a successful repair with a residual regurgitation grade of 0 or 1 still had a substantial mortality rate of 22% during 1-year follow-up, survival was worse in patients with higher grades of residual mitral regurgitation. One-year mortality among those with residual grade 2 regurgitation was 29%, and for those with residual grade 3 or 4 regurgitation, 1-year mortality was 49%.
Many patients also had at least one comorbidity, and when these were present, 1-year survival was significantly worse. In a multivariate model, patients on dialysis had twofold greater mortality than did those not on dialysis, patients with severe tricuspid valve regurgitation had twice the mortality of those with lesser or no tricuspid regurgitation, and patients with moderate or severe lung disease had a 50% higher mortality, compared with those with milder or no lung disease.
The study was supported in part by Abbott Vascular, the company that markets the MitraClip. Dr. Sorajja has been a consultant to and speaker on behalf of Abbott Vascular. He has also been a consultant to Integer, Lake Region Medical, and Medtronic, and a speaker on behalf of Boston Scientific.
[email protected]
On Twitter @mitchelzoler
WASHINGTON – U.S. heart teams have used the mitral valve transcatheter clip repair device for fixing leaky mitral valves exactly the way it was designed to be used once the device hit the U.S. market in 2013.
In the first review of periprocedural and 1-year outcomes of U.S. patients treated with the MitraClip repair device and entered in the national device registry, the results showed “acute effectiveness and safety of transcatheter mitral valve repair,” Paul Sorajja, MD, said at the annual meeting of the American College of Cardiology.
“We need to be keenly aware of the impact of comorbidities on the prognosis of these patients. The data show that untreated comorbidities really impact prognosis,” said Dr. Sorajja, an interventional cardiologist and director of the Center of Valve and Structural Heart Disease of the Minneapolis Heart Institute.
“The clip is for the no-option patient, meaning patients at high risk who have no surgical option. The data show that these are the patients who are being treated” in routine U.S. practice. “The data show that, even for these patients, you can still get pretty good results,” Dr. Sorajja said in an interview. “These are the first data on clip use in routine U.S. practice, and they are really reassuring. The data show that the clip is being used in the correct way, without risk creep, on patients with prohibitive surgical risk based on their STS [Society of Thoracic Surgeons] predicted mortality and frailty scores.”
The data he and his associates reviewed came from the 2,952 U.S. patients who underwent a transcatheter mitral valve clip repair following the devices premarketing approval from the Food and Drug Administration in November 2013, and through September 2015 at any of 250 U.S. sites offering the procedure.
The data on patient demographics and clinical status came from the STS/American College of Cardiology Transcatheter Valve Therapy registry, and data on 1-year outcomes came from Medicare records for 1,867 (63%) of the patients.
The mitral valve repair patients averaged 82 years old, 85% had a New York Heart Association functional class of III or IV, 93% had a mitral valve regurgitation grade of 3 or 4, half were judged frail, and their STS predicted mortality risk from mitral valve repair was about 6% and from valve replacement about 9%.
Immediately after their procedure, 93% of patients had a valve regurgitation grade of 2 or less, the periprocedural mortality rate was just under 3%, and 86% of patients were discharged home following a median length of stay of 2 days. Acute procedural success occurred in 92% of patients, Dr. Sorajja reported.
At 1 year, the mortality rate among the patients followed through their Medicare records showed that 26% of patients had died, 20% had been hospitalized at least once for heart failure, and 38% had at least one of these two outcomes. In addition, 6% underwent a repeat procedure of transcatheter mitral repair, and 2% had mitral valve replacement surgery.
Although patients who had a successful repair with a residual regurgitation grade of 0 or 1 still had a substantial mortality rate of 22% during 1-year follow-up, survival was worse in patients with higher grades of residual mitral regurgitation. One-year mortality among those with residual grade 2 regurgitation was 29%, and for those with residual grade 3 or 4 regurgitation, 1-year mortality was 49%.
Many patients also had at least one comorbidity, and when these were present, 1-year survival was significantly worse. In a multivariate model, patients on dialysis had twofold greater mortality than did those not on dialysis, patients with severe tricuspid valve regurgitation had twice the mortality of those with lesser or no tricuspid regurgitation, and patients with moderate or severe lung disease had a 50% higher mortality, compared with those with milder or no lung disease.
The study was supported in part by Abbott Vascular, the company that markets the MitraClip. Dr. Sorajja has been a consultant to and speaker on behalf of Abbott Vascular. He has also been a consultant to Integer, Lake Region Medical, and Medtronic, and a speaker on behalf of Boston Scientific.
[email protected]
On Twitter @mitchelzoler
WASHINGTON – U.S. heart teams have used the mitral valve transcatheter clip repair device for fixing leaky mitral valves exactly the way it was designed to be used once the device hit the U.S. market in 2013.
In the first review of periprocedural and 1-year outcomes of U.S. patients treated with the MitraClip repair device and entered in the national device registry, the results showed “acute effectiveness and safety of transcatheter mitral valve repair,” Paul Sorajja, MD, said at the annual meeting of the American College of Cardiology.
“We need to be keenly aware of the impact of comorbidities on the prognosis of these patients. The data show that untreated comorbidities really impact prognosis,” said Dr. Sorajja, an interventional cardiologist and director of the Center of Valve and Structural Heart Disease of the Minneapolis Heart Institute.
“The clip is for the no-option patient, meaning patients at high risk who have no surgical option. The data show that these are the patients who are being treated” in routine U.S. practice. “The data show that, even for these patients, you can still get pretty good results,” Dr. Sorajja said in an interview. “These are the first data on clip use in routine U.S. practice, and they are really reassuring. The data show that the clip is being used in the correct way, without risk creep, on patients with prohibitive surgical risk based on their STS [Society of Thoracic Surgeons] predicted mortality and frailty scores.”
The data he and his associates reviewed came from the 2,952 U.S. patients who underwent a transcatheter mitral valve clip repair following the devices premarketing approval from the Food and Drug Administration in November 2013, and through September 2015 at any of 250 U.S. sites offering the procedure.
The data on patient demographics and clinical status came from the STS/American College of Cardiology Transcatheter Valve Therapy registry, and data on 1-year outcomes came from Medicare records for 1,867 (63%) of the patients.
The mitral valve repair patients averaged 82 years old, 85% had a New York Heart Association functional class of III or IV, 93% had a mitral valve regurgitation grade of 3 or 4, half were judged frail, and their STS predicted mortality risk from mitral valve repair was about 6% and from valve replacement about 9%.
Immediately after their procedure, 93% of patients had a valve regurgitation grade of 2 or less, the periprocedural mortality rate was just under 3%, and 86% of patients were discharged home following a median length of stay of 2 days. Acute procedural success occurred in 92% of patients, Dr. Sorajja reported.
At 1 year, the mortality rate among the patients followed through their Medicare records showed that 26% of patients had died, 20% had been hospitalized at least once for heart failure, and 38% had at least one of these two outcomes. In addition, 6% underwent a repeat procedure of transcatheter mitral repair, and 2% had mitral valve replacement surgery.
Although patients who had a successful repair with a residual regurgitation grade of 0 or 1 still had a substantial mortality rate of 22% during 1-year follow-up, survival was worse in patients with higher grades of residual mitral regurgitation. One-year mortality among those with residual grade 2 regurgitation was 29%, and for those with residual grade 3 or 4 regurgitation, 1-year mortality was 49%.
Many patients also had at least one comorbidity, and when these were present, 1-year survival was significantly worse. In a multivariate model, patients on dialysis had twofold greater mortality than did those not on dialysis, patients with severe tricuspid valve regurgitation had twice the mortality of those with lesser or no tricuspid regurgitation, and patients with moderate or severe lung disease had a 50% higher mortality, compared with those with milder or no lung disease.
The study was supported in part by Abbott Vascular, the company that markets the MitraClip. Dr. Sorajja has been a consultant to and speaker on behalf of Abbott Vascular. He has also been a consultant to Integer, Lake Region Medical, and Medtronic, and a speaker on behalf of Boston Scientific.
[email protected]
On Twitter @mitchelzoler
AT ACC 17
Key clinical point:
Major finding: U.S. mitral clip patients averaged 82 years of age, their acute success rate was 92%, and 1-year mortality was 26%.
Data source: A review of 2,952 U.S. patients who underwent transcatheter mitral clip repair and entered into the STS/ACC/TVT registry through September 2015.
Disclosures: The study was supported in part by Abbott Vascular, the company that markets the MitraClip. Dr. Sorajja has been a consultant to and speaker on behalf of Abbott Vascular. He has also been a consultant to Integer, Lake Region Medical, and Medtronic, and a speaker on behalf of Boston Scientific.
