ORIGINAL ARTICLE  CARDIAC SECTION 

The Journal of Cardiovascular Surgery 2021 December;62(6):609-17

DOI: 10.23736/S0021-9509.21.11523-X

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: English

Transapical-transcatheter aortic valve implantation using the Edwards SAPIEN 3 valve

Dritan USEINI ¹ ✉, Markus SCHLÖMICHER ¹, Blerta BELULI ², Hildegard CHRIST ³, Elias EWAIS ¹, Peter HALDENWANG ¹, Polykarpos PATSALIS ⁴, Vadim MOUSTAFINE ¹, Matthias BECHTEL ¹, Justus STRAUCH ¹

¹ Department of Cardiothoracic Surgery, Ruhr-University Hospital Bergmannsheil, Bochum, Germany; ² Department of Internal Medicine, St. Anna Hospital, Herne, Germany; ³ Institute of Medical Statistics and Computational Biology (IMSB), University Hospital of Cologne, Cologne, Germany; ⁴ Department of Cardiology and Angiology, Ruhr-University Hospital Bergmannsheil, Bochum, Germany

BACKGROUND: Scarcely any data has been published on the mid-term effect of transapical-transcatheter aortic valve implantation (TA-TAVI) using the Edwards SAPIEN 3 valve (S3; Edwards Lifesciences Corp., Irvine, CA, USA). We present mid-term clinical and echocardiographic outcomes after TA-TAVI utilizing S3.
METHODS: Between 02/2014-06/2017, 122 elderly patients with severe aortic stenosis underwent TA-TAVI utilizing S3 at our institution. We conducted clinical and echocardiographic follow-up. The mean follow-up was 15 months. All end-point-related outcomes were adjudicated according to Valve Academic Research Consortium-2 definitions.
RESULTS: The STS-score of the entire cohort was 6.26±4.6. More than one-third of the patients exhibited severe peripheral artery disease. The 30-d all-cause mortality, all-stroke rate, and myocardial infarction of the entire cohort were 4.1%, 1.6%, and 0.8% respectively. Median survival time of the entire cohort was 35 months. The cumulative mid-term myocardial infarction and stroke rate was 2.6% and 3.5%, respectively. The postoperative moderate/severe paravalvular leakage occurred in 1.6% of cases. At discharge, one-year and two-year postprocedure peak/mean gradients were 16.6±8.3/ 9±5.1 mmHg, 18±6.9/ 10±4.5 mmHg, and 22.2±5.4/ 12.8±4.6 mmHg, respectively. The rate of new pacemaker cases was 14.1%. Acute kidney injury network 2/3 appears, as an independent predictor of mortality.
CONCLUSIONS: We observed very promising early and mid-term clinical outcomes with a high degree of device success and good hemodynamic performance after TA-TAVI using the S3 in the intermediate risk patient profile.

KEY WORDS: Transcatheter aortic valve replacement; Echocardiography; Cardiovascular system