المؤلفون: Lorusso, Roberto^1,2 (AUTHOR) roberto.lorussobs@gmail.com, Folliguet, Thierry³ (AUTHOR), Shrestha, Malakh⁴ (AUTHOR), Meuris, Bart⁵ (AUTHOR), Kappetein, Arie Pieter⁶ (AUTHOR), Roselli, Eric⁷ (AUTHOR), Klersy, Catherine⁸ (AUTHOR), Nozza, Michele⁹ (AUTHOR), Verhees, Luc⁹ (AUTHOR), Larracas, Cristina⁹ (AUTHOR), Goisis, Giovanni⁹ (AUTHOR), Fischlein, Theodor¹⁰ (AUTHOR)

المصدر: Thoracic & Cardiovascular Surgeon. 2020, Vol. 68 Issue 2, p114-123. 10p.

مصطلحات موضوعية: *AORTIC valve transplantation, *CORONARY artery bypass, *AORTIC stenosis, *AORTIC valve, *HEART valve prosthesis implantation, *BIOPROSTHESIS, *PERCUTANEOUS balloon valvuloplasty

مصطلحات جغرافية: LONDON (England)

مستخلص: Introduction Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. Materials and Methods PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. Discussion PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years. [ABSTRACT FROM AUTHOR]

المؤلفون: Fischlein, Theodor¹ (AUTHOR) theodor.fischlein@klinikum-nuernberg.de, Caporali, Elena^1,2,3 (AUTHOR), Folliguet, Thierry^1,4 (AUTHOR), Kappert, Utz^1,5 (AUTHOR), Meuris, Bart^1,6 (AUTHOR), Shrestha, Malakh L.^1,7 (AUTHOR), Roselli, Eric E.^1,8 (AUTHOR), Bonaros, Nikolaos^1,9 (AUTHOR), Fabre, Olivier^1,10 (AUTHOR), Corbi, Pierre^1,11 (AUTHOR), Troise, Giovanni^1,12 (AUTHOR), Andreas, Martin^1,13 (AUTHOR), Pinaud, Frederic^1,14 (AUTHOR), Pfeiffer, Steffen¹ (AUTHOR), Kueri, Sami^1,15 (AUTHOR), Tan, Erwin^1,16 (AUTHOR), Voisine, Pierre^1,17 (AUTHOR), Girdauskas, Evaldas^1,18 (AUTHOR), Rega, Filip^1,6 (AUTHOR), García-Puente, Julio^1,19 (AUTHOR)

المصدر: International Journal of Cardiology. Dec2022, Vol. 368, p56-61. 6p.

مصطلحات موضوعية: *AORTIC valve transplantation, *CARDIAC pacemakers, *RANDOMIZED controlled trials, *BIOPROSTHESIS, *ATRIAL fibrillation

مستخلص: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS). A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed. Results were compared between sutureless and stented within the two different surgical approaches. 285 patients were implanted with Perceval (67% in MS) and 293 with stented valves (65% in MS). Sutureless group showed significantly reduced surgical times both in FS and MS. In-hospital results show no differences between Perceval and stented valves in FS, while a lower incidence of new-onset of atrial fibrillation (3.7% vs 10.8%) with Perceval in MS. After 1-year, use of sutureless valve showed a significant reduction of MACCE (5.2% vs 10.8%), stroke rate (1.0% vs 5.4%), new-onset of atrial fibrillation (4.2% vs 11.4%) and re-hospitalizations (21.8 days vs 47.6 days), compared to stented valves but presented higher rate of pacemaker implantation (11% vs 1.6%). Sutureless bioprosthesis showed significantly reduced procedural times during isolated SAVR in both surgical approaches. Patients with sutureless valves and MS access showed also better 1-year outcome regarding MACCEs, stroke, re-hospitalization and new-onset atrial fibrillation, but presented a higher rate of permanent pacemaker implantation compared to patients with stented bioprosthesis. • Reduced procedural times for Perceval versus stented valves in AVR randomized trial. • Lower 1-year MACCEs rate with Perceval in ministernotomy versus stented valves. • Higher pacemaker rate with Perceval versus stented valves in ministernotomy access. • No difference between valves for pacemaker rate in full sternotomy approach. [ABSTRACT FROM AUTHOR]