| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
Ann Thorac Surg 2006;82:776-780
© 2006 The Society of Thoracic Surgeons
Providence Health System, Portland, Oregon
* Address correspondence to Dr Jin, 9155 SW Barnes Rd, LL Suite 33, Portland, OR 97225 (Email: ruyun.jin{at}providence.org).
The current Food and Drug Administration (FDA) heart valve guidance document uses an objective performance criteria (OPC) methodology to evaluate the clinical performance of prosthetic heart valves. OPC are essentially historical controls, but they have turned out to be an adequate, and perhaps optimal, study design in this situation. Heart valves have a simple open-and-close mechanism, device effectiveness is easy to document, and the common complications (thromboembolism, thrombosis, bleeding, leak, and infection) are well known and easily detected. Thus, randomized clinical trials (RCTs) have not been deemed necessary for the regulatory approval of prosthetic heart valves. The OPC are derived from the average complication rates of all approved heart valves. Studies based on OPC have been shown to work well; many different valve models have gained FDA market approval based on this methodology. Although heart valve RCTs are not required by the FDA, they have been done to compare valves or treatment regimens after approval. Recently, the Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare a new Silzone sewing ring, designed to reduce infection, with the Standard sewing ring on a St. Jude Medical heart valve. This was the largest heart valve RCT ever proposed (4,400 valve patients, followed for as long as 4 years), but it was stopped prematurely because of a high leak rate associated with the Silzone valve. Examining the results showed that a much smaller, OPC-based study with 800 patient-years would have been sufficient to disclose this complication of the Silzone valve.
Related Articles
Ann. Thorac. Surg. 2006 82: 1140-1146.
Ann. Thorac. Surg. 2006 82: 773-775.
This article has been cited by other articles:
|
|
 |
|
  P. T.L. Chiam and C. E. Ruiz Percutaneous Transcatheter Aortic Valve Implantation: Assessing Results, Judging Outcomes, and Planning Trials: The Interventionalist Perspective J. Am. Coll. Cardiol. Intv., August 1, 2008; 1(4): 341 - 350. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Vahanian, O. R. Alfieri, N. Al-Attar, M. J. Antunes, J. Bax, B. Cormier, A. Cribier, P. De Jaegere, G. Fournial, A. P. Kappetein, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur. J. Cardiothorac. Surg., July 1, 2008; 34(1): 1 - 8. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Vahanian, O. Alfieri, N. Al-Attar, M. Antunes, J. Bax, B. Cormier, A. Cribier, P. De Jaegere, G. Fournial, A. P. Kappetein, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur. Heart J., June 1, 2008; 29(11): 1463 - 1470. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. F. Padera Jr. and F. J. Schoen Pathology of Cardiac Surgery Card. Surg. Adult, January 1, 2008; 3(2008): 111 - 178. [Full Text]
|
|
|
|
 |
|
 E. Chen, W. Sapirstein, C. Ahn, J. Swain, and B. Zuckerman FDA perspective on clinical trial design for cardiovascular devices. Ann. Thorac. Surg., September 1, 2006; 82(3): 773 - 775. [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| ANN THORAC SURG | ASIAN CARDIOVASC THORAC ANN | EUR J CARDIOTHORAC SURG |
| J THORAC CARDIOVASC SURG | ICVTS | ALL CTSNet JOURNALS |
