STS News, Winter 2012 --
Collaboration and Transformation
Michael J. Mack, MD & David R. Holmes, MD
This past year has been transformational for our Society. Much of the effort of the leadership has focused on the issues related to the introduction and then rational dispersion of transcatheter aortic valve technology into the United States. Our partner in helping guide the safe and effective introduction of this technology is the American College of Cardiology (ACC) under the visionary leadership of its President, David Holmes. As such, it is only fitting that my last letter to the STS membership as President of the Society be a joint one from Dr. Holmes and myself.
The Edwards Sapien transcatheter aortic valve received regulatory approval by the U.S. Food and Drug Administration in November 2011. STS and the ACC, in conjunction with other professional societies including AATS and the Society for Cardiac Angiography and Interventions (SCAI), have been involved in numerous activities in anticipation of this approval including publication of a Professional Society Overview of the field, as well as formulation of an Expert Consensus Document and a Training and Credentialing Criteria Document, both now in the final stages of completion and publication.
However, the truly transformative, collaborative project was the launch of the STS/ACC Transcatheter Valve Therapy (TVT) Registry on Dec. 1, 2011. This event was the product of three months of hard work, dedication, and collaboration between the STS National Database and the ACC National Cardiovascular Data Registry (NCDR) teams. This project is truly a seminal event between our two societies.
The STS/ACC TVT Registry utilizes a new data module constructed to capture relevant data elements identified by the STS and ACC teams. The module was designed to be harmonized with both STS and NCDR databases and linked to Social Security and Centers for Medicare and Medicaid Services (CMS) administrative databases. It will allow the capability of tracking risk-adjusted acute and long-term outcomes of the currently approved device, but also will facilitate evaluation of new multiple iterations of technology from multiple vendors. Furthermore, the vehicle will be in place for creation of a national “research engine” to offer the ability to track disease management and perform comparative effectiveness and cost effectiveness research. The database will be housed at the ACC facilities and access will be web-based at www.tvtregistry.org . The data analytics will be performed by the Duke Clinical Research Institute (DCRI).
The STS/ACC TVT Registry is the initial step in an unprecedented collaboration between governmental agencies, professional societies, and industry. Paramount in this collaboration is a commitment to the safe and effective introduction of new technology to the American public. The specific purpose of the TVT Registry is to capture the procedure information and outcomes of all patients receiving a transcatheter aortic valve in the United States. The ultimate goal is to build a generic platform of databases that would form the core for medical device submission for regulatory and for post approval surveillance.
The hard work of the many individuals who devoted countless hours to this ambitious project needs to be recognized and applauded. From your STS, the leadership and hard work of Fred Edwards, Director of the new STS Research Center, Fred Grover, Dave Shahian, and Cynthia Shewan were instrumental in making the registry a reality. Their combined seven decades of experience with outcomes registries was critical in this process. Other STS individuals who were key to the successful launch included Rob Wynbrandt, Dave Fullerton, Doug Mathisen, and Jeff Rich.
The database team of the ACC NCDR is as talented and dedicated as our STS team. Led by David Holmes, John Carroll, Ralph Brindis, Murat Tuzcu, and John Rumsfeld, the accumulated expertise, talent, and collaborative spirit from the ACC mirrored of that of the STS team. The ACC staff led by Jack Lewin, Kathleen Hewitt, and Tony Hermann were all key contributors in getting the registry up and running. There are numerous other individuals whose work is crucial for the success of this ambitious project. They include Eric Peterson and Rachel Dokholyan of DCRI, and David Naftal of the INTERMACS Registry for ventricular assist devices.
Collaboration with multiple other stakeholders is necessary for such an ambitious project including the FDA, CMS, and Edwards Lifesciences. The original vision for a national device registry was that of Jeff Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health. We are honored to have Dr. Shuren present the Ferguson Lecture at our Annual Meeting this year. Other key FDA contributors included Bram Zuckerman, MD, Director of the FDA’s Division of Cardiovascular Devices, and Danica Marinac-Dabic, MD, PhD, Director of the FDA’s Division of Epidemiology at the Center for Devices and Radiological Health. Key contributors from CMS included Louis Jacques, MD, Director, Coverage & Analysis Group (CAG) and CAG Division of Medical & Surgical Services Director Jyme Schafer, MD.
Acknowledgment needs to be given to the leadership at Edwards Lifesciences who have graciously agreed to blaze this new trail with us. Mike Mussallem, Chairman and CEO, Larry Wood, Vice President, Transcatheter Valve Program, and Jodi Akin, Vice President of Clinical Affairs, have provided support and commitment for this new paradigm of post-market approval device surveillance.
STS members should be proud of their Society and the investment of the hundreds of individuals who serve our societies as voluntary leaders. Without the vision and foresight of our predecessors to build our clinical databases and establish such a strong foundation, the registry would not be a reality. Their many years of work have resulted in an investment in our future that will continue to pay dividends for decades. Even further reaching is the opportunity that this registry has provided to create a strong bond and collaboration between the STS, ACC, FDA, and CMS.
The relationship between cardiac surgery and interventional cardiology has at times been a contentious one that has led on occasion to tension and distrust. The introduction of this new transformative technology has afforded our two societies a unique opportunity to work together to forge a new collaboration that truly has the best interest of our patients at heart. It is our fervent hope that each one of you can reach out in your own institutions and foster the same partnerships. It is gratifying how many new doors we can open together!