1. Clinical and Hemodynamic Outcomes of Rapid-Deployment Aortic Bioprostheses
- Author
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Dario Gregori, Igor Vendramin, Chiara Tessari, Gino Gerosa, Claudio Russo, Carmelo Mignosa, Maurizio Merlo, Domenico Mangino, Ottavio Alfieri, Mauro Rinaldi, Carlo Maria De Filippo, Marco Di Eusanio, Marco Solinas, Davide Pacini, Francesco Alamanni, Giampaolo Luzi, Michele Portoghese, Ruggero De Paulis, Augusto D'Onofrio, Massimo Massetti, Carlo Antona, Daniele Maselli, Francesco Musumeci, Andrea Colli, Gian Luca Martinelli, Giorgia Cibin, Gianluca Polvani, Giulia Lorenzoni, and Loris Salvador
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Replacement ,Hemodynamics ,030204 cardiovascular system & hematology ,Prosthesis Design ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Aortic valve replacement ,Interquartile range ,law ,Internal medicine ,medicine ,Humans ,Aortic valve ,Settore MED/23 - CHIRURGIA CARDIACA ,Retrospective Studies ,Heart Valve Prosthesis Implantation ,Aortic valve, Replacement ,Bioprosthesis ,Body surface area ,business.industry ,EuroSCORE ,Aortic Valve Stenosis ,Heart valve, Bioprosthesis ,General Medicine ,Canadian Cardiovascular Society ,medicine.disease ,Intensive care unit ,Aortic cross-clamp ,Treatment Outcome ,030228 respiratory system ,Heart Valve Prosthesis ,Cardiology ,Surgery ,Cardiology and Cardiovascular Medicine ,business ,Heart valve - 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.
- Published
- 2022
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