I write to share with you the Texas Heart Institute Board of Trustees’ perspective regarding the recent articles published in the Houston Chronicle and ProPublica about Baylor St. Luke’s Medical Center and the announcement by the hospital to suspend the heart transplant program while it conducts an internal review. The story has been picked up by the national news.  The articles and news coverage have generated confusion about Texas Heart Institute (THI) and its relationship with Baylor St. Luke’s Medical Center.  Indeed, several donors and friends of THI have inquired about the issues raised in the news.  The Board of Trustees wants to provide you a clear explanation of the mission and role of THI.

THI is singularly focused on cardiovascular research and education. Under the guidance of the directors of THI’s departments, THI-based research has developed devices, drug therapies, and cardiovascular care improvements that are utilized by clinical care providers around the world.  THI also trains Fellows, doctors receiving advanced training, in the art of cardiovascular care and those doctors work around the world.  THI does not provide direct patient care.  To be clear, THI does not have a role in managing the transplant program at Baylor St. Luke’s Medical Center.  Those activities and the heart transplant doctors mentioned in the news coverage are managed by the hospital and Baylor College of Medicine, their employer.

It is hard for the public to separate the roles of THI and Baylor St. Luke’s Medical Center. Indeed, Dr. Cooley (the founder of THI) and St. Luke’s Episcopal Hospital (the original name of Baylor St. Luke’s Medical Center) brought many firsts in cardiovascular care to the world including the first successful heart transplant conducted in the United States and the first implant of an artificial heart.  The use of innovations and techniques developed at THI in clinical care at the hospital have led many to believe that THI and Baylor St. Luke’s Medical Center are one and the same.  However, THI and the hospital are separate entities with different roles and this was not clearly or accurately reported in the articles.

Separately, one of the news articles raised questions about clinical research conducted by Dr. O.H. “Bud” Frazier, and in particular the study of the HeartMate II continuous-flow left ventricular assist device that was the subject of two papers published in the New England Journal of Medicine (the “Journal”), in 2007 and 2009. Dr. Frazier has a long-history of research at THI and we take seriously any allegations that THI-based research was conducted in any manner that deviates from good research practices or the rigorous protocols applicable to clinical research.  THI worked with the study sponsor, Thoratec Corporation (now Abbott), to conduct a thorough review.  The sponsor determined the results published in the Journal are undisputable and there were no breaches of research ethics and that the studies were conducted in compliance with good research practices and FDA standards.  The sponsor reported its findings to the Journal and the Journal confirmed that no action is necessary to address the assertions made by ProPublica about the studies.  We accept the sponsor’s validation of the study results and the Journal’s conclusion based upon its review of the sponsor’s analysis as full vindication of Dr. Frazier’s published research.

THI will help its colleagues at Baylor St. Luke’s Medical Center and the clinicians who admit patients there to offer the best possible solutions for the most challenging cases. Many of the news articles failed to mention that, in addition to heart transplants, numerous other types of surgeries as well as interventional and non-interventional treatment methods, many of which were developed through research and testing at THI, continue to be offered by clinicians who admit patients to Baylor St. Luke’s Medical Center and these procedures save and improve lives.

THI will continue to work at the forefront of cardiovascular science and develop new advances for cardiovascular care. On behalf of the Board of Trustees and everyone who works at THI, please know how grateful we are for your unwavering support and trust.

Sincerely,

Eric D. Wade
Chairman
, THI Board of Trustees

BOARD MEMBERS

Alfred C. Glassell, III
, Vice Chairman
Charles D. Fraser, MD
Jerome E. Granato, MD
David M. Grimes
Barbara R. Hurwitz
Anthony K. Jones
Rodney H. Margolis
S. Reed Morian
Gay Nord
Fred S. Zeidman