TY - JOUR
T1 - Clinical and Hemodynamic Outcomes of Rapid-Deployment Aortic Bioprostheses
AU - D'Onofrio, Augusto
AU - Tessari, Chiara
AU - Cibin, Giorgia
AU - Lorenzoni, Giulia
AU - Lorenzoni, Gianni
AU - Martinelli, Gian Luca
AU - Solinas, Marco
AU - Gerosa, Gino
AU - Gregori, Dario
AU - Alamanni, Francesco
AU - Polvani, Gianluca
AU - Massetti, Massimo
AU - Eusanio, Marco Di
AU - Merlo, Maurizio
AU - Vendramin, Igor
AU - Mangino, Domenico
AU - Mignosa, Carmelo
AU - Russo, Claudio
AU - Rinaldi, Mauro
AU - De Paulis, Ruggero
AU - Pacini, Davide
AU - Luzi, Giampaolo
AU - Antona, Carlo
AU - Salvador, Loris
AU - Musumeci, Francesco
AU - Maselli, Daniele
AU - Colli, Andrea
AU - Portoghese, Michele
AU - Portoghese, Luca Michele
AU - Alfieri, Ottavio
AU - De Filippo, Carlo Maria
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Aortic valve, Replacement
KW - Heart valve, Bioprosthesis
KW - Aortic valve, Replacement
KW - Heart valve, Bioprosthesis
UR - http://hdl.handle.net/10807/199073
U2 - 10.1053/j.semtcvs.2021.04.006
DO - 10.1053/j.semtcvs.2021.04.006
M3 - Article
SN - 1043-0679
VL - 2021
SP - 1
EP - 9
JO - Seminars in Thoracic and Cardiovascular Surgery
JF - Seminars in Thoracic and Cardiovascular Surgery
ER -