Clinical and Hemodynamic Outcomes of Rapid-Deployment Aortic Bioprostheses

Augusto D'Onofrio, Chiara Tessari, Giorgia Cibin, Giulia Lorenzoni, Gianni Lorenzoni, Gian Luca Martinelli, Marco Solinas, Gino Gerosa, Dario Gregori, Francesco Alamanni, Gianluca Polvani, Massimo Massetti, Marco Di Eusanio, Maurizio Merlo, Igor Vendramin, Domenico Mangino, Carmelo Mignosa, Claudio Russo, Mauro Rinaldi, Ruggero De PaulisDavide Pacini, Giampaolo Luzi, Carlo Antona, Loris Salvador, Francesco Musumeci, Daniele Maselli, Andrea Colli, Michele Portoghese, Luca Michele Portoghese, Ottavio Alfieri, Carlo Maria De Filippo

Risultato della ricerca: Contributo in rivistaArticolo in rivista

Abstract

Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients’ survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45–70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14–23 mm Hg) and 10 mmHg (IQR: 8–13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm2/m2 (IQR: 0.91–1.31 cm2/m2) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3–96.7%); 90.7% (88.3–93.1%); 86.4% (82.6–90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04–1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002–1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up.
Lingua originaleEnglish
pagine (da-a)1-9
Numero di pagine9
RivistaSeminars in Thoracic and Cardiovascular Surgery
Volume2021
DOI
Stato di pubblicazionePubblicato - 2021

Keywords

  • Aortic valve, Replacement
  • Heart valve, Bioprosthesis

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