December 1, 2011
Today, The Society of Thoracic Surgeons (STS) and The American College of Cardiology (ACC), launched the first-of-its-kind registry to monitor the safety and efficacy of a new minimally invasive heart therapy to treat aortic stenosis.
The STS/ACC TVT Registry was jointly developed to track real world outcomes related to transcathether aortic valve replacement therapy (TAVR). Approved by the FDA for use in the United States in November 2011, TAVR technology is now an option for elderly patients with aortic stenosis who are too sick, frail, or high risk for conventional surgical therapy.
“The TVT Registry will capture and house patient demographics, procedure details, and facility and physician information,” said Michael J. Mack, MD, FACC, and president of STS. “This standardized, evidence based data source will offer much insight into clinical practice patterns and patient outcomes. I believe this coordinated effort optimizes patient safety and ensures the appropriate use of TAVR therapy.”
Backed by the registry expertise of the STS National Database and the ACC’s National Cardiovascular Data Registry (NCDR), the TVT Registry serves as the main repository for all clinical data related to TAVR and is positioned to incorporate additional catheter-based procedures that have yet to come to market in the United States.
“The TVT Registry will provide an ideal mechanism for monitoring the use of transcatheter valve therapy,” said ACC President David R. Holmes, Jr., MD, FACC. “The Registry can provide relatively rapid feedback to individual sites and help identify trends in its usage. The Registry will also provide a rich source of data for long-term research. The ACC is pleased that through the work of the NCDR, we have been able to partner with STS in the development of this new tool and play a role in the thoughtful introduction of this therapy in the United States.”
The TVT Registry will also be linked to the Social Security Death Master File and Centers for Medicare & Medicaid Services (CMS) databases in order to track long term outcomes. Additionally, the TVT Registry will be subject to data quality checks and audits.
In order to facilitate accurate and reliable data collection, STS and ACC will sponsor several educational opportunities and events for data managers, ranging from webinars to conference calls.
Participating hospitals will receive quarterly reports comparing an institution’s procedure performance with that of the national experience. The registry measures will also look at patient risk factors to adjust for case-mix and adverse event rates.
The TVT Registry is the result of an ongoing collaboration between The Society of Thoracic Surgeons and The American College of Cardiology in support of TAVR introduction in the United States. It was also developed in collaboration with the FDA and CMS, with input from The Society for Cardiovascular Angiography and Intervention (SCAI) and The American Association for Thoracic Surgery (AATS).
For more information or for additional TVT resources please visit the TVT Registry website at www.tvtregistry.org
Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 6,300 surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. The mission of the Society is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy. Learn more at www.sts.org.
The American College of Cardiology is transforming cardiovascular care and improving heart health through continuous quality improvement, patient-centered care, payment innovation and professionalism. The College is a 39,000-member nonprofit medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at www.cardiosource.org/ACC.
Note to Editors: For more information about the STS/ACC TVT Registry, or to arrange for an interview with Dr. Mack or Dr. Holmes, contact Rachel Estrada at email@example.com or (312) 202-5865 or Stephanie Abraham at firstname.lastname@example.org or (202) 375-6296.
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