Randomized controlled trial between conventional versus sutureless bioprostheses for aortic valve replacement: Impact of mini and full sternotomy access at 1-year follow-up

Fischlein, Theodor; Caporali, Elena; Folliguet, Thierry; Kappert, Utz; Meuris, Bart; Shrestha, Malakh; Roselli, Eric E.; Bonaros, Nikolaos; Fabre, Olivier; Corbi, Pierre; Troise, Giovanni; Andreas, Martin; Pinaud, Frédéric; Pfeiffer, Steffen; Kueri, Sami; Tan, Erwin; Voisine, Pierre; Girdauskas, Evaldas; Rega, Filip; García‐Puente, Julio; Lorusso, Roberto

doi:10.1016/j.ijcard.2022.08.012

Cited by 8 publications

(7 citation statements)

References 34 publications

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“…However, the shorter operative times did not translate into improved in-hospital outcomes, and rapid deployment valves were associated with higher rates of pacemaker implantation. 5,6 Several randomized controlled trials have consolidated transcatheter aortic valve replacement (TAVR) as the preferred therapeutic option in most elderly patients with severe symptomatic AS, also including low-risk patients. 7 However, sutureless valves were poorly represented in TAVR-SAVR randomized trials, 8,9 and controversial data exist comparing the outcomes associated with TAVR and Sutureless-SAVR (SU-SAVR).…”

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confidence: 99%

Midterm Outcomes Following Sutureless and Transcatheter Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

Vilalta

Alperi

Cediel

et al. 2021

Circ: Cardiovascular Interventions

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Background: Sutureless-surgical aortic valve replacement (SU-SAVR) has been proposed as a surgical alternative for treating aortic stenosis, which facilitates a minimally invasive approach. While some studies have compared the early outcomes of SU-SAVR versus transcatheter aortic valve replacement (TAVR), most data were obtained in high-risk patients and/or limited to in-hospital outcomes. This study aimed to compare in-hospital and midterm clinical outcomes following SU-SAVR and TAVR in low-risk patients with aortic stenosis. Methods: A total of 806 consecutive low-risk (EuroSCORE II <4%) patients underwent TAVR or SU-SAVR between 2011 and 2020 in 2 centers. A 1:1 propensity score matching was performed and identified 171 pairs with similar characteristics that were included in the analysis. Baseline characteristics, in-hospital and follow-up events (defined according to Valve Academic Research Consortium-2) were collected. Results: Baseline characteristics were well balanced between groups, with a median EuroSCORE II of 1.9% (1.3%–2.5%) in both SU-SAVR and TAVR groups ( P =0.85). There were no statistically significant differences regarding in-hospital mortality (SU-SAVR: 4.1%, TAVR: 1.8%, P =0.199) and stroke (SU-SAVR: 2.3%, TAVR: 2.9%, P =0.736), but SU-SAVR recipients exhibited higher rates of bleeding and new-onset atrial fibrillation, higher residual transvalvular gradients ( P <0.001), and a lower rate of pacemaker implantation ( P =0.011). After a median follow-up of 2 (1–3) years, there were no differences between groups in all-cause mortality (hazard ratio, 0.97 [95% CI, 0.52–1.82], P =0.936) and stroke (hazard ratio, 0.83 [95% CI, 0.32–2.15], P =0.708), but SU-SAVR was associated with a higher risk of heart failure hospitalization (hazard ratio, 5.38 [95% CI, 1.88–15.38], P =0.002). Conclusions: In low-risk patients with aortic stenosis, TAVR was associated with improved in-hospital outcomes (except for conduction disturbances) and valve hemodynamics, compared with SU-SAVR. Although similar mortality and stroke rates were observed at 2-year follow-up, the risk of heart failure hospitalization was higher among SU-SAVR patients. These results may contribute to reinforce TAVR over SU-SAVR for the majority of such patients.

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confidence: 99%

Midterm Outcomes Following Sutureless and Transcatheter Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

Vilalta

Alperi

Cediel

et al. 2021

Circ: Cardiovascular Interventions

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“… 21 However, this did come at the expense of an increased permanent pacemaker implantation (PPI) rate. 22 Retrospective analysis of patients undergoing SUAVR via full sternotomy versus ministernotomy indicates equivalent intraoperative time parameters, reduced hospital and intensive care unit (ICU) length of stay (LOS), as well as reduced left ventricular diastolic volume with ministernotomy. Reduced postoperative pain permitting early recovery and involvement in cardiovascular rehabilitation programs as well as reduced intraoperative myocardial handling are postulated to contribute to the observed positive cardiac remodeling with ministernotomy.…”

Section: Resultsmentioning

confidence: 99%

“… 21 In a subanalysis of the PERSIST-AVR trial comparing ministernotomy and full sternotomy approaches, SUAVR resulted in significantly lower MACCE (5.2% vs 10.8%), stroke (1.0% vs 5.4%), atrial fibrillation (4.2% vs 11.4%), and rehospitalization (21.8 vs 47.6 days) compared with SAVR when performed via ministernotomy; however, for SUAVR, this came at the expense of a higher PPI rate (11% vs 1.6%). 22 An additional subanalysis of this trial by Lorusso et al analyzed the influence of prosthesis size on PPI rates and determined that increased rates of PPI following SUAVR came only with implantation of the extra-large device. 88 The results of multiple large retrospective, propensity-matched analyses are largely consistent with these results.…”

Section: Resultsmentioning

confidence: 99%

The Perceval Sutureless Bioprosthetic Aortic Valve: Evolution of Surgical Valve Technology

Fialka,

EL-Andari,

Wang

et al. 2024

Innovations�(Phila)

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Objective: The surgical treatment of aortic stenosis continues to evolve, and sutureless aortic valve replacement (SUAVR) is an emerging technology. With the Perceval S (Corcym, London, UK) as the only true sutureless valve on the market, the objective of this review is to analyze the current literature on Perceval S. Focusing on valve design and deployment as well as applications of the technology for challenging pathology, clinical outcomes are assessed, including a comparison with transcatheter AVR (TAVR). Methods: PubMed and MEDLINE were searched by 3 authors for studies analyzing SUAVR from inception to May 19, 2023. Results: SUAVR facilitates minimally invasive surgery and offers an alternative strategy for patients with small aortic annuli. It also has a time-saving advantage for patients who require complex operations. SUAVR results in excellent long-term morbidity, mortality, durability, and hemodynamic function. In comparison with conventional surgical AVR (SAVR), SUAVR does have a greater risk of postoperative pacemaker implantation; however, increasing user experience and refinements in implantation technique have contributed to reductions in this outcome. SUAVR results in morbidity and mortality that is similar to rapid-deployment AVR. Midterm outcomes are superior to TAVR; however, further robust investigation into all of these comparisons is ultimately necessary. Conclusions: SUAVR bridges the gap in technology between SAVR and TAVR. The application of this exciting technology will undoubtedly grow in the coming years, during which additional investigation is paramount to optimize preoperative planning, valve deployment, and reintervention strategies.

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“…Transvalvular gradients are known to be of great importance in light of long-term prosthesis patency and its hemodynamic performance. The Perceval S prosthesis has shown to provide excellent hemodynamics in isolated and combined aortic valve procedures at short, mid and long term, which are comparable to conventional SAVR [ 22 , 23 , 24 , 25 , 26 ]. Similarly, in this study we also observed a satisfying hemodynamic performance of the sutureless prostheses in combined aortic and mitral valve replacement compared to the conventional surgical method.…”

Section: Discussionmentioning

confidence: 99%

Conventional Biological versus Sutureless Aortic Valve Prostheses in Combined Aortic and Mitral Valve Replacement

Szczechowicz

Rad

Amanov

et al. 2023

Life

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Background: Sutureless aortic valve prostheses have proven to provide a significant decrease in procedural, cardiopulmonary bypass and cross-clamp time, leading to a significant reduction in mortality risk in elderly high-risk cohorts. In this study, we sought to review our institutional experience on the sutureless aortic valve replacement (SU-AVR) and the concomitant mitral valve replacement (SMVR), comparing the combined conventional surgical aortic valve replacement (SAVR) with SMVR. Methods and Material: Between March 2018 and July 2022, 114 consecutive patients underwent a combined aortic and mitral valve replacement at our institution. We stratified the patients according to the operative procedures into two groups and matched them 1:2: Group 1 underwent a combined conventional SAVR and SMVR (n = 46), and Group 2 included combined SU-AVR with Perceval prosthesis and SMVR (n = 23). Results: No significant differences in the preoperative characteristics were present. SU-AVR combined with SMVR demonstrated excellent haemodynamic performance, comparable to that of SAVR plus SMVR, with median postoperative gradients over the aortic valve of 4 mmHg (IQR 3.0–4.0) in Group 1 and 4 mmHg (IQR 3.0–4.0) in Group 2 (p = 0.67). There was no significant difference in the occurrence of postoperative major adverse events such as death, stroke, myocardial infarction and kidney failure between the groups. There was also no significant difference in the permanent pacemaker implantation rate, paravalvular leakage or valve dislocation. We also could not detect any significant difference in postoperative mortality between the groups. Conclusions: SU-AVR has proven to be a reliable alternative to conventional valve prostheses in patients with multivalve disease undergoing combined aortic and mitral valve replacement, offering shorter procedural time and outstanding hemodynamic performance compared to the conventional surgical method.

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Randomized controlled trial between conventional versus sutureless bioprostheses for aortic valve replacement: Impact of mini and full sternotomy access at 1-year follow-up

Cited by 8 publications

References 34 publications

Midterm Outcomes Following Sutureless and Transcatheter Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

Midterm Outcomes Following Sutureless and Transcatheter Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

The Perceval Sutureless Bioprosthetic Aortic Valve: Evolution of Surgical Valve Technology

Conventional Biological versus Sutureless Aortic Valve Prostheses in Combined Aortic and Mitral Valve Replacement

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