Jeffrey B. Rich, MD
STS News, Winter 2013 -- This past year has been one of ground-breaking technological advancements, extensive collaboration, and important health policy decisions. As STS President, I’ve had the opportunity to participate in numerous panels, committees, and partnerships that have driven the cardiothoracic surgery field forward and opened many doors for STS in particular. Now, as we begin a new year, I’m encouraged by the achievements that we have made and look forward to exciting developments to come.
One of our biggest successes came in May, when CMS released a National Coverage Determination for transcatheter aortic valve therapy. This capped off months of work for STS surgeon leaders and staff. The NCD was important on many levels, and firmly established the role of the heart team—including the need for a cardiac surgeon to be part of the decision-making process.
On a related note, I appeared before an FDA advisory panel in June to discuss the successful collaboration among STS, ACC, FDA, and CMS that led to the initial FDA approval and Medicare coverage of Edwards Lifesciences’ SAPIEN transcatheter heart valve. In October, FDA expanded the approved indication for the device to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
Our collaborative efforts with the ACC strengthened in 2012 with the STS/ACC TVT Registry, which has seen tremendous growth over the past year. Already, more than 150 sites have enrolled and more than 2,000 patient records have been entered. The Registry helps to enhance the monitoring of TAVR devices by serving as a repository for clinical data, and its creation has been made possible through ongoing collaborative efforts among STS, ACC, FDA, CMS, and Edwards Lifesciences. Read more about these milestones in this article.
STS is also collaborating with ACC in an application to sponsor an Investigational Device Exemption trial related to alternative access sites for TAVR. Our application was submitted in December and is pending approval.
In addition to the TAVR developments, the Society saw additional health policy achievements this year. In October, I represented STS at a White House meeting to discuss “Physician Specialists and Delivery System Transformation.” I highlighted the Society’s experience with registry-based quality improvement and payment solutions and touted the benefits of the heart team concept for improving patient care and outcomes.
Additionally, I served on the Medicare Evidence Development & Coverage Advisory Committee that convened in November to review available evidence on the use of ventricular assist devices for the management of heart failure. The Society subsequently was invited by CMS to provide input on credentialing criteria for the use of VADs, both in residency training and after surgeons enter the workforce.
Another important milestone in 2012 was the publication of results from the ASCERT and SYNTAX clinical trials, which demonstrated advantages of coronary artery bypass grafting over percutaneous coronary intervention in many patients. STS will continue to monitor the results from these studies and work to inform the public about them, especially to assist patients afflicted with multivessel coronary artery disease. ASCERT II is already under way.
The work that STS does is often enhanced by collaboration with other professional organizations, government agencies, and industry partners. During the past year, STS has strengthened its relationships with international professional societies, including the European Association for Cardio-Thoracic Surgery, the European Society of Thoracic Surgeons, and the Asian Society for Cardiovascular and Thoracic Surgery. Of particular note, several of our colleagues from Asia will present during the International Reception and Symposium at the upcoming Annual Meeting, which this year will focus on the treatment of rheumatic mitral valve disease.
This is just some of the progress that has occurred over the past year, and there’s much more to come. It has been an honor serving as your President, and I look forward to seeing many of you at the Annual Meeting in Los Angeles in just a few weeks. I hope you enjoy this issue of STS News.