Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study

Fischlein, Theodor; Meuris, Bart; Folliguet, Thierry; Hakim‐Meibodi, Kavous; Misfeld, Martín; Carrel, Thierry; Zembala, Marian; Cerutti, Elisa; Asch, Federico M.; Haverich, Axel; Zannis, Kostantinos; Pfeiffer, Steffen; Santarpino, Giuseppe; Shrestha, Malakh; Sarikouch, Samir; Gummert, Jan; Mohr, Friedrich W.; Dohmen, Pascal M.; Stalder, Mario; Roost, Eva; Filipiak‬, Krzysztof J.; Niklewski, Tomasz; Madonna, Francesco; Roques, Xavier; Flameng, Willem; Laczkovics, Axel; Bechtel, Matthias; Prat, Alain; Banfı, Carlo; Dapunt, O; Eichstaedt, Harald C.; Harringer, Wolfgang; Carstens-Fitz, Ulrike; Spyt, Tom; Wimmer-Greinecker, Jan Gerhard; Machner, Matthias; Tan, Erwin; Casselman, Filip; Yilmaz, Alaaddin; Sonker, Uday; Bleiziffer, Sabine; Oberwalder, Peter; Kocher, Alfred; Seitelberger, Rainald; Treede, Hendrik; Conradi, Lenard; Cocchieri, Riccardo; Mol, Bas A.J.M. de; Roussel, Jean‐Christian; Despins, Philippe; Jakob, Heinz; Wendt, Daniel

doi:10.1016/j.jtcvs.2020.12.109

Cited by 17 publications

(47 citation statements)

References 25 publications

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Section: Discussionmentioning

confidence: 99%

“…The use of sutureless bioprostheses has been widely reported to reduce procedure times in aortic valve replacement, both with conventional or minimally invasive approaches (6)(7)(8). Despite the extensive experience with Su-AVR (5)(6)(7)(8)12), no randomized, prospective, controlled studies have been performed comparing conventional vs. sutureless-based AVR. Based on this lack, the PERSIST-AVR trial, consisting of a prospective, randomized controlled study in patients undergoing isolated AVR or combined procedure with sutureless or stented bioprostheses, was conducted in 47 centers worldwide (10).…”

Section: Discussionmentioning

confidence: 99%

“…New prostheses have been developed to minimize the surgical risk in patients with multiple comorbidities and to reduce operating times. Sutureless prostheses have shown promising results in terms of mortality, morbidity, and hemodynamic performance (5)(6)(7). Several studies have demonstrated that sutureless valves decrease the cardiopulmonary bypass (CPB) and aortic crossclamping (ACC) times, facilitating minimally and conventional invasive cardiac surgery (5)(6)(7)(8), but no randomized controlled trials have directly compared this technology with traditional stented valves (9).…”

Section: Introductionmentioning

confidence: 99%

“…Sutureless prostheses have shown promising results in terms of mortality, morbidity, and hemodynamic performance (5)(6)(7). Several studies have demonstrated that sutureless valves decrease the cardiopulmonary bypass (CPB) and aortic crossclamping (ACC) times, facilitating minimally and conventional invasive cardiac surgery (5)(6)(7)(8), but no randomized controlled trials have directly compared this technology with traditional stented valves (9). Recently, the Perceval Sutureless Implant vs. Standard AVR (PERSIST-AVR) trial has been published with overall 1-year results demonstrating no substantial difference between sutureless vs. conventional tissue valves for isolated or combined surgical AVR (SAVR) (10,11).…”

Section: Introductionmentioning

confidence: 99%

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Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial

Fischlein

Caporali

Asch

et al. 2022

Front. Cardiovasc. Med.

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ObjectiveSutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab.MethodsPerceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance.ResultsThe site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups.ConclusionAt 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial

Fischlein

Caporali

Asch

et al. 2022

Front. Cardiovasc. Med.

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“…The 5-year follow-up presented by Fischlein and colleagues 3 adds new information on the outcomes of sutureless aortic valve bioprostheses and can permit us to make some considerations on reference points for benchmarking. First of all, the study is proof that technology in aortic valve replacement is still evolving and it is not slowed down by transcatheter aortic valve implantation (TAVI); emerging evidence of outcomes' decay of TAVI at mid-term are corroborating the viability of surgical option, and companies are still investing resources in surgical device research, despite potential future changes in indications that are not still predictable, lacking longterm evaluations.…”

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confidence: 99%

Commentary: The truth is out there

Barili

Parolari

2022

The Journal of Thoracic and Cardiovascular Surgery

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1-year outcomes of patients implanted with the Perceval sutureless valve: the Japanese post-marketing surveillance study

et al. 2023

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Sutureless offers an alternative to standard valves in surgical aortic valve replacement (SAVR). We sought to confirm the efficacy and safety of the Perceval sutureless valve in Japanese patients. Prospective observational study of 204 patients who underwent SAVR with Perceval at 19 sites in Japan between March and December 2019. The primary outcomes were 30-day mortality and postoperative complications; the secondary outcome was all-cause mortality at 1 year. Efficacy outcomes were changed in New York Heart Association (NYHA) class, pressure gradients, effective orifice area (EOA), EOA indexed to body surface area (EOAi) and severity of aortic regurgitation. Mean age was 77.7 years, 62.7% were female. Procedural success rate was 99.0%. The median cross-clamp and cardiopulmonary bypass times were 68.0 and 108 min. Perceval size S and M were implanted in 95 (46.6%) and in 76 (37.3%) of patients, respectively. The 30-day and late mortality rate were 0.5% and 4.4%, while the new permanent pacemaker implantation rate was 4.4%. Mean pressure gradient was 13.0 mmHg at discharge, reaching 11.0 mmHg at 1 year; while the mean EOA was 1.5 cm2 at discharge remaining stable up to 1 year. No moderate or severe leakages were present at discharge or at 1 year. NYHA class improved by ≥ 1 level in 55.1% of the patients at discharge and in 69.4% of the patients at 1 year. 1-year outcomes of SAVR with the Perceval sutureless valve in Japanese patients were favorable. This valve offers a promising alternative to conventional biological AVR in this Japanese population.

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Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study

Cited by 17 publications

References 25 publications

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial

Commentary: The truth is out there

1-year outcomes of patients implanted with the Perceval sutureless valve: the Japanese post-marketing surveillance study

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