Beyond the short-term: Clinical outcome and valve performance 2 years after transcatheter aortic valve implantation in 227 patients

Objective: Although the procedural feasibility of transcatheter aortic valve implantation has been shown by multiple groups, longer-term data are rare. We report on 2-year follow-up clinical and echocardiographic results after transcatheter aortic valve implantation in 227 patients. Methods: Patients' mean age was 81 +/- 7 years, 59% were female, mean European System for Cardiac Operative Risk Evaluation was 21% +/- 14%, mean Society of Thoracic Surgeons score was 7% +/- 5%, and access routes were transfemoral (n = 164), transapical (n = 54), axillary (n = 5), or transaortic (n = 4). A CoreValve (Medtronic Inc, Minneapolis, Minn) prosthesis was implanted in 174 patients, and a SAPIEN prosthesis (Edwards Lifesciences, Irvine, Calif) was implanted in 53 patients. Clinical and echocardiographic investigations were performed at 6 months, 1 year, and 2 years. Results: Survival was 88.5% at 30 days, 75.9% at 6 months, 74.5% at 1 year, and 64.4% at 2 years. Patients improved significantly in New York Heart Association class after 6 months (from 3.2 +/- 0.5 to 1.7 +/- 0.7, P < .001) and up to 2 years (1.9 +/- 0.7). Cumulative incidences of myocardial infarction, stroke, and life-threatening or major bleeding were 2.7%, 6.2%, and 16.2% at 2 years, respectively. The postprocedural mean transprosthetic gradient was 12 +/- 4 mm Hg for all valves and did not change up to 2 years, and the effective orifice area was 1.5 +/- 0.4 cm(2) with no change over 2 years of follow-up. Moderate or severe prosthetic regurgitation was present in 8% of patients at 2 years. In 6% of patients, the paravalvular or valvular regurgitation grade increased significantly over time. Conclusions: With excellent functional recovery of the patients, good systolic valve function, and overall low morbidity at 2 years, transcatheter aortic valve implantation may be considered the treatment of choice for aortic valve stenosis in elderly patients with an increased risk for surgery with a heart-lung machine. (J Thorac Cardiovasc Surg 2012; 143:310-7)