Background: A ground-breaking, US Food and Drug Administration clinical trial for the treatment of critical aortic stenosis commenced at our institution in November 2007 with our first transcatheter aortic valve repair (TAVR). This novel procedure created a new treatment option for high-risk patients with aortic stenosis. Although the pivotal trial completed enrollment in 2009, continued access was implemented by the Food and Drug Administration in response to an unprecedented demand for this new procedure by patients and physicians. This is an overview of one site's management strategy for patient referrals.
Methods: Patients underwent evaluation with a comprehensive assessment in a multidisciplinary transcatheter aortic valve clinic. All screened patients were classified as either traditional open surgical candidates or nonsurgical candidates. Major exclusions for open procedures included low Society of Thoracic Surgeons score, coronary artery disease, and other valvular disease. Major exclusions of nonsurgical candidates resulted from physician discretion or multiple comorbidities such as renal failure, significant liver or lung disease, and progressive cancer. A third group of patients was excluded because of inadequate femoral access.
Results: From November 2007 to November 2010, 681 patients were referred for evaluation, including 578 screened patients and 103 patients whose evaluation was pending. During the screening process, 82 patients died (12%). Among 343 patients who did not qualify for enrollment (50%), 108 received open surgical intervention and 235 were nonsurgical candidates; 35 of these patients underwent balloon aortic valvuloplasty. A total of 153 patients were enrolled in the TAVR trial.
Conclusions: With the availability of a novel treatment option for aortic stenosis in high-risk patients, institutions offering these alternative methods will be forced to reevaluate patient management. A careful strategy that includes multidisciplinary evaluation is crucial in order to have a successful transcatheter aortic valve program.
Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.