Abstract 4434: 12 Months and Beyond: Long-Term Results of the Direct Flow Medical Repositionable and Retrievable Pericardial Valve for Percutaneous Aortic Valve Replacement
Background Percutaneous aortic valve replacement is considered an alternative for patients at high risk for open surgical repair. The Direct Flow Medical (Santa Rosa, CA) Percutaneous Aortic Valve is a non-metallic tri-leaflet bovine tissue valve that is repositionable and retrievable. The purpose of the study was to assess its safety and function up to 5 years post-implant.
Methods The study valve was implanted in 22 patients. Mean Logistic EuroSCORE was 26.9%, mean age 82.2 years. The majority of patients (71%) exhibited NYHA Functional Class III. The pre-procedural gradient and effective orifice area (EOA) were 50.5±10.8 mmHg and 0.6±0.17cm2, respectively.
Results Mean post-procedural gradient was 14.9 + 5.5 mmHg with an EOA of 1.4±0.31 cm2. Two patients were converted to surgery and two patients expired post-implant: one MI, one CHF. Eighteen implanted patients were discharged from hospital with 89% survival at 180 days (n=16). One patient died due to acute respiratory failure following pneumonia at 193 days post-implant. A second patient died of unknown cause while in rehabilitation at 142 days post-implant. More than half (58%) of patients had Grade 0 and 42% had Grade 1 paravalvular leakage at 180 days. NYHA Functional Class remained improved at 180 days with 69% of patients exhibiting with Class I, 25% with Class II and 6% with Class III. To date, nine patients have returned for 12 month follow-up and the available survival and functional class data show good results.
Conclusions Despite the high surgical risk patient profile, implantation of the study valve is safe and without hemodynamic compromise during the procedure. Complete 12 month data will be presented at AHA 2009 along with available 18 month and 2 year follow-up data.