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DOI: 10.1055/s-0029-1246977
6 months results of the repositionable and retrievable direct flow medical aortic valve for transfemoral aortic valve replacement
Objective: Trans-catheter aortic valve implantation (TAVI) is considered an alternative for patients at high risk for conventional surgery. The Direct Flow Medical Aortic Valve is a non-metallic tissue valve prosthesis intended to treat patients with severe aortic stenosis at high risk for surgery.
Methods: Thirty-one patients with high surgical risk scores were enrolled in the trial (Logistic EuroSCORE 28±7%, STS score 23±9%). Twenty-two patients underwent retrograde TAVI. Nine patients were excluded due to excessive calcifications or access problems. Mean pre-interventional gradient and effective orifice area (EOA) were 52±13mmHg and 0.6±0.16cm2, respectively, and 71% of patients exhibited with NYHA Functional Class III.
Results: Mean post-procedural gradient was 14.9±5.5mmHg with a mean EOA of 1.4±0.31cm2. Two patients were converted to surgery and two patients expired post-implantation: one from myocardial infarction (MI) and one from congestive heart-failure (CHF). One patient had a stroke 2 days post-procedure and three patients required a pacemaker. At 6 months the mean aortic valve gradient and EOA were 19.8mmHg and 1.30cm2, respectively. The majority of patients had no paravalvular leak (58%) and 42% had Grade 1/4 paravalvular leak, 69% exhibited with NYHA Functional Class I and 25% with NYHA Functional Class II. Three and six months survival was 87.1% and 80.6%, respectively (4/6 deaths in 31 patients).
Conclusions: Transfemoral implantation of the study valve appears safe and results are promising at 6 months. Severe leaflet and left ventricular outflow tract (LVOT) calcification impacts procedural outcome. One year follow-up will be presented at the conference.