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Transapical Transcatheter Aortic Valve Implantation: Up to 38 Month Follow-Up in 65 Patients
Jian Ye, Anson Cheung, John G Webb, Ronald G Carere, Christopher R Thompson, Brad Munt, Robert Moss, Jean-Bernard Masson, Robert Boone, *W R Eric Jamieson, Elizabeth A Stanford, Samuel V Lichtenstein St. Paul's Hospital, University of British Columbia, Vancouver, BC, Canada
Background: Reported 2 year-survival in patients with severe aortic stenosis who were declined for conventional aortic valve replacement was 19%. This study is to evaluate mid-term clinical outcomes following transapical transcatheter aortic valve implantation (AVI). Since we reported the first case of transapical transcatheter AVI in humans in 2005 and have now completed up to 38 months follow-up on 65 patients. This is to date the longest follow-up on transapical AVI patients. Methods: Between October 2005 and December 2008, 65 patients [40 female (68.5%), 25 male (38.5%)] underwent transapical AVI with either 23 or 26 mm Edwards SAPIENTM transcatheter aortic bioprostheses through a left mini-thoracotomy. All patients had symptomatic aortic stenosis and significant co-morbidities, and were declined for conventional AVR due to unacceptable operative risks, and were also considered to be non-candidates for transfemoral AVI because of diseased and/or small ilio-femoral arteries or had failed the transfemoral approach. Clinical and echocardiographic follow-up was performed at discharge, 30 days, 6 months, and then annually thereafter. Mean follow-up time was 19.2±1.6 months, and the longest follow-up was 38 months. Results: Mean age was 80.0±1.1 years and the predicted risks for operative mortality by logistic EuroSCORE and STS risk calculator were 34.9±2.6% and 12.2±1.0%, respectively. Valves were successfully deployed and well seated in the aortic annulus in 64 patients (98% success rate). In 1 patient, a second valve was implanted at the same time. The overall 30-day mortality was 18.5% (12 events); 33.3% (5 events) in the first 15 patients (learning curve) and 14% in the remainder. Overall 1-, 2-, and 3-year-survival rates were 81.5±4.8%, 72.1±5.6%, and 65.8±6.2%, respectively. When the first 15 patients were excluded because of the significant learning curve, the 1-, 2-, and 3-year survival rates were 79.8±5.7%, 74.7±6.4%, and 68.7±7.1%, respectively. Of the patients who survived 30 days postoperatively, the 1-year survival was 88.4±4.5%. The 2-, and 3-year survival was 80.6±5.9%. There were no late valve-related complications. NYHA class decreased significantly in all patients during the follow-up. The aortic valve area and mean gradient of the aortic bioprostheses remained stable up to 38 months. Trivial to mild paravalvular leaks were common and remained unchanged during the follow-up. Conclusion: Pre-existing comorbidities are the main causes of early and late mortality. Transapical AVI improves patient status by eliminating cardiac symptoms and probably improves survival in patients who were declined for conventional AVR, compared to historical data. Valve- or cardiovascular-related late mortality or morbidity is rare.
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