Three-Year Single-Center Outcomes of Transapical Aortic Valve Implantation using the Edwards Sapien 3 Valve

Aim: The Edwards Sapien 3 aortic valve prosthesis (S3) has received CE Mark approval on February 2014. To date no data has been published on 3-year outcome after transapical transcatheter aortic valve implantation (TA-TAVI). We present 3 year clinical and echocardiographic outcomes after TA-TAVI utilizing S3.

Methods: 122 high risk, elderly patients with severe aortic stenosis (AS), (ES II 10.21 ;STS 6.97% ; age 80.24 years; male 59.02%) underwent TA-TAVI for AS at our institution utilizing S3. Three-year follow-up was available in 67 out of the 122 patients between 02/2014–06/2017. All end-point-related outcomes were adjudicated according to VARC-2 definition.

Results: 31.14% were Redos. 30-days all-cause mortality was 4.09%. At 1, 2, and 3 years, all-cause mortality rates were 21.4%, 14.8, and 18.1%, respectively. Cardiac death occurred in a total of 43.75% of the patients who died. All stroke at 30 days was 1.75%. The late all-stroke was in 4.81% registered. Intraoperatively no conversion to surgery occurred. Cardiopulmonary bypass in one case was needed (0.81%). No coronary accident periprocedural was registered. 96.3% device success was achieved. PVL ≥ 2 occurred in 0.96% of patients. Late PVL ≥ 2 (within 3 years) occurred in 2 patients (1.63%). P mean at discharge ; one year and three year was 8.94 ± 5.1; 10.88 ± 5.9 and 13.6 ± 6.5 mm Hg, respectively. The rate of new pacemakers was 14.95%. Late pacemaker implantation was in 2.43% of patients necessary. Endocarditis rate within 3 years was 1.63%.

Conclusion: We observe excellent mortality and complication rate in high risk elderly patients after TA-TAVI using S3. The rate of new pacemakers remains to be improved. This results are attributable to the interaction between matured clinical learning curve and constant improvements of transcatheter heart valves. This development might justify the use of TA-TAVI in younger and patients with lower risk and makes the transapical approach very competitive.