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Self-expandable or Balloon-expandable Prosthesis? A Single Center Experience on Transcatheter Aortic Valve Implantation

Valeria Gasparetto1, Massimo Napodano1, Augusto D'Onofrio2, Chiara Fraccaro1, Giuseppe Tarantini1, Paolo Buja1, Demetrio Pittarello3, Roberto Bianco2, Ermela Yzeiraj1, Marco Panfili1, Renato Razzolini1, Gino Gerosa2, Sabino Iliceto1, Giambattista Isabella1.
1Cardiology Division. Department of Cardiac, Thoracic and Vascular Sciences. University of Padova, Padova, Italy, 2Cardiac Surgery. Department of Cardiac, Thoracic and Vascular Sciences. University of Padova, Padova, Italy, 3Anesthesiology Department. University of Padova, Padova, Italy.


Objective. We assessed prosthesis performance and clinical outcome of Transcatheter Aortic Valve Implantation (TAVI) using both self-expandable and balloon-expandable devices.
Methods. We compared valve performance and outcome in a prospective registry including all patients who underwent TAVI, using the III generation CoreValve Revalving System between June 2007 and March 2009 (CRS-Medtronic, Minneapolis, Minnesota USA) and the Edwards SAPIENTM or Edwards SAPIEN-XT prosthesis between March 2009 and November 2010 (ES-Edwards Lifesciences Irvine, CA, USA). Clinical evaluation and transthoracic echocardiograms were obtained at baseline, 48 h after procedure, at 1-, 3-, 6- and 12-month follow-up and yearly thereafter. All patients in this series were eligible to 6-months follow-up.
Results. One-hundred and sixty patients underwent TAVI, 87 (54.4%) with CRS (85 transfemoral and 5 trans-subclavian), 73 (45.6%) with ES device (43 transapical and 30 transfemoral). Mean age was 80.9±6.2 years (59.4% female), logistic EuroSCORE of 21.8±12.9%. Aortic valve area was 0.78±0.21 cm2. Procedural success was 94.3% in CRS and 97.3% in ES (p=ns). Need of back-up strategies (re-dilatation, snaring or valve-in-valve) was higher in CRS (p=0.02). At 48-h echocardiogram, effective orifice area was higher in CRS (p=0.015, Table), while moderate-to-severe paravalvular leak was more frequent in CRS (p=0.012). Thirty-day mortality was 5.7% in CRS and 1.4% in ES (p=ns). AV-block requiring pacemaker were 33 (40.7%) in CRS, vs 4 (5.7%) in ES (p<0.001). At follow-up heart failure occurred in 11.7% patients, with higher rate in CRS (p<0.001). Sixteen (10.0%) patients died, 8 (5.0%) had cardiovascular death, without differences between groups. At follow-up, 92% patients were in NYHA class I or II, and no case of prosthesis failure occurred.
Conclusions. TAVI using both CRS and ES prostheses seems a safe and effective alternative to surgery, with a good prosthesis performance and low cardiovascular mortality rate at follow-up. Nevertheless PPM implantations are higher using CRS; back-up strategies to reach optimal procedural success as well as paravalvular leak occurrence seem more frequent with CRS.
Table 1. Prosthesis hemodynamic performance at follow-up
VariableCoreValve
(n = 87)
Edwards SAPIEN
(n = 73)
P intergroups
48-hFollow-up48-hFollow-up
Peak gradient, mmHg19.8±6.518.3±8.320.9±7.419.6±6.70.035
Mean Gradient, mmHg10.1±3.99.3±4.111.5 ± 4.710.10±3.70.035
Effective Orifice Area, cm22.0±0.41.8±0.351.8±0.311.7±0.310.015
Aortic Regurgitation ≥ 2, n (%)10 (11.5)14 (16.1)1 (1.4)3 (4.1)0.012

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