March 1, 2012 – Four leading heart organizations representing cardiologists and cardiothoracic surgeons released initial recommendations today for creating and maintaining transcatheter aortic valve replacement (TAVR) programs. The recommendations are aimed at ensuring optimal care for patients with aortic stenosis, a form of valvular heart disease, as use of the new TAVR procedure grows.
Since the Food and Drug Administration (FDA) approval of TAVR in November 2011, interest in the procedure has quickly grown among cardiologists and cardiothoracic surgeons as well as patients, prompting efforts by professional medical societies to identify institutional and physician credentialing criteria for performing the procedure. The recommendations published today represent a joint collaboration of cardiovascular specialty societies, including the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS) and The Society of Thoracic Surgeons (STS).
TAVR is a minimally invasive procedure found by the FDA to be reasonably safe and effective in the treatment of patients with severe aortic stenosis who cannot undergo surgery and have the absence of comorbidities as described in the FDA label. Prior to the availability of TAVR, these patients had few, if any, treatment options for aortic stenosis, which can lead to heart failure and death. During TAVR, physicians use a catheter to thread the replacement valve from a blood vessel in the groin to the heart’s diseased aortic valve, which is then replaced with the new valve.
“As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care,” said Carl Tommaso, M.D., chair of the document writing committee and medical director of the cardiac catheterization lab, Skokie Hospital, NorthShore HealthSystem, Chicago. “TAVR is a complex procedure that has potential to serve many patients, and it is up to us to deliver the highest standard of care available.”
Due to the complexity of the procedure and the rapid rate at which the technology is evolving, defining operator and institutional requirements is a vital step in ensuring optimal program implementation. The authors emphasize a formal collaborative effort between cardiologists and cardiothoracic surgeons as the cornerstone for establishing a successful program, noting that a program without both specialties would be fundamentally deficient. Other factors on which success is based include ensuring patient safety and demonstrated commitment to excellence by the institution and procedural volume requirements.
The recommendations classify operating requirements for those that intend to develop a TAVR program, including credentialing requirements for cardiothoracic surgeons and interventional cardiologists who intend to perform the procedure, and guidance for maintaining approval to perform TAVR. Requirements include:
- Annual heart (aortic valve) surgery and percutaneous coronary intervention (PCI) volume requirements for institutions
- Board certification and procedural requirements for both surgeons and interventional cardiologist
- Monitoring of complication rates and institutional follow up
- Participation in a national registry that will include enrollment of all patients undergoing TAVR with continued tracking of outcomes
- Commitment to a heart team concept that is led by the surgeon and interventional cardiologist and made up of a formal collaborative effort among all medical team members. In all TAVR procedures, the interventional cardiologist and surgeon must both be present during the entire procedure ensuring joint participation and optimal patient-centered care.
“Maintaining high standards and a focus on quality improvement is at the core of what we do, for the sake of patients and their safety,” said R. Morton Bolman, M.D., co-chair of the document writing committee and chief of the division of cardiac surgery at Brigham and Women’s Hospital, and professor of surgery, Harvard Medical School, Boston. “This is emphasized in the paper released today, as is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows and data accumulate.”
The full recommendations released today can be found at http://www.scai.org/asset.axd?id=f492e12c-19d9-4ff3-85c6-2540638a4d86, www.CardioSource.org/TVT, http://www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf, and www.sts.org.
The Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's patient and physician education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit www.scai.org or www.SecondsCount.org.
The American Association for Thoracic Surgery (AATS) is an international organization of over 1,100 of the Bworld’s foremost thoracic and cardiothoracic surgeons, representing 35 countries. AATS encourages and stimulates education and investigation into the areas of intrathoracic physiology, pathology and therapy. Founded in 1917 by a respected group of the last century’s earliest pioneers in the field of thoracic surgery, the AATS’ original mission was to “foster the evolution of an interest in surgery of the Thorax.” One hundred years later, the AATS continues to be the premiere association among cardiothoracic surgeons. The purpose of the Association is the continual enhancement of the ability of cardiothoracic surgeons to provide the highest level of quality patient care. To this end, the AATS encourages, promotes, and stimulates the scientific investigation and study of cardiothoracic surgery. Visit www.aats.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 40,000-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.
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.