The clinical development of percutaneous heart valve technology: A position statement of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI)

Although percutaneous devices for the repair or replacement of heart valves appear promising, they are clearly in an early stage of development. Many critical questions remain unanswered, including the durability of these devices and the potential adverse effects they may have on subsequent heart valve surgery. Therefore, one cannot justify the use of these experimental technologies in patients for whom published guideline indications do not exist or in situations of prophylactic therapy until data on safety and effectiveness are gathered from well-designed clinical trials. Study candidates should consist of symptomatic patients in whom long-term survival is already severely compromised. Such a strategy would allow the collection of mid-term device durability data while providing much needed clinically relevant safety and effectiveness data. Prospective, randomized, clinical trials provide the most reliable evidence of the effectiveness of the treatment. Without such trials, ineffective treatments (or worse, harmful treatments) may be accepted in medical practice. Our collective enthusiasm for new, less-invasive cardiovascular approaches should not divert us from the importance of evaluating these devices in the context of a controlled clinical trial environment. Success of these clinical trials ultimately depends upon a sincere commitment to collaboration between cardiology and cardiac surgery.