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April 24, 2026SHILAP Revista de lepidopterología0 citationsOpen Access

Results from a prospective international real-world registry of sutureless aortic bioprosthesis by a minimally invasive approach

GCGiovanni ConcistrèMBMax BaghaiGSGiuseppe Santarpino

Key Result

Mini-thoracotomy for Perceval sutureless valve implantation reduced median ICU stay to 1 day compared to 2 days for mini-sternotomy, with no significant difference in late cardiovascular deaths.

Key Points

  • The research aims to evaluate the clinical and hemodynamic outcomes of aortic valve replacement with a sutureless bioprosthesis comparing two minimally invasive surgical techniques.
  • Enrolled 1,652 patients across 55 institutions from 2011 to 2021.
  • Conducted propensity score matching on preoperative covariates, analyzing a matched cohort of 261 patients for each technique.
  • Evaluated surgical outcomes including intensive care unit stays and reinterventions postoperatively.
  • Minimally invasive approaches were used in 710 patients with shorter hospital stays noted in the mini-thoracotomy group.
  • Postoperative complications included one cardiovascular death and 1.5% reinterventions in the mini-thoracotomy group.
  • Survival probability and mean pressure gradients showed no significant differences between the two surgical approaches.

Study Design

Type

Observational (n=710)

Multicenter

Yes

Structured PICO

Does aortic valve replacement via mini-thoracotomy compared to mini-sternotomy improve clinical and procedural outcomes in patients receiving a sutureless bioprosthesis?

P
Population
710 patients undergoing isolated aortic valve replacement (AVR) with Perceval sutureless bioprosthesis via minimally invasive cardiac surgery approaches (mean age 75.3, 53.9% female) from a prospective multinational registry (18 countries).
I
Intervention
Aortic valve replacement with Perceval sutureless bioprosthesis via right anterior mini-thoracotomy (MT) approach
C
Comparator
Aortic valve replacement with Perceval sutureless bioprosthesis via mini-sternotomy (MS) approach
O
Outcome
Clinical success (successful valve implantation without major adverse events by hospital discharge) and long-term survival/adverse events up to 8 yearshard clinical

Both mini-thoracotomy and mini-sternotomy approaches for sutureless aortic valve replacement are safe and effective, with mini-thoracotomy offering shorter hospital stays at the cost of longer procedural times.

Main Result

Effect estimate: OR 2.32 (95% CI 0.94-6.29)

Absolute Event Rate: 6.5% vs 2.7%

p-value: p=0.078

Limitations

  • Observational, single-arm, non-randomized study lacking a comparison with other devices
  • Absence of monitoring and adjudication for adverse events
  • Choice of surgical approach was based on surgeon preference, representing a potential source of bias
  • Echocardiographic follow-up was not systematically performed
  • In-hospital and ICU stay can be influenced by institutional practices
  • Maximum follow-up was 8 years and was more limited in the mini-sternotomy group

Abstract

Introduction The aim of this study was to report clinical and hemodynamic results from a real-world registry of aortic valve replacement (AVR) with the Perceval sutureless bioprosthesis, comparing mini-sternotomy (MS) versus mini-thoracotomy (MT) approach. Methods This prospective international registry enrolled 1,652 patients across 55 institutions between 2011 and 2021. Patients undergoing isolated AVR by minimally invasive cardiac surgery approaches were analyzed. Preoperative covariates were adjusted using 1:1 propensity score matching, reaching a final cohort of 261 patients for each approach. Results Isolated AVR via minimally invasive approaches was performed in 710 patients—406 in MS and 304 in MT. After matching, the baseline characteristics were similar between the two groups, except for the preoperative NYHA class distribution. MT was associated with shorter intensive care unit and hospital stays ( p = 0.001 and p = 0.050, respectively), but with higher cross-clamp and cardiopulmonary bypass times compared to MS (0.001). Within 30 days, one cardiovascular death occurred in the MS group, while 4 (1.5%) reinterventions were reported in the MT group. Pacemaker implantation was required in 5 (1.9%) patients in the MS group and 14 (5.4%) patients in the MT group, with no statistically significant difference. In the matched cohort, survival probability for late events showed no difference between surgical approaches. Mean pressure gradients remained stable during follow-up, with no difference between the groups. Discussion Our propensity-matched analysis demonstrates that the use of Perceval in minimally invasive approaches is associated with low perioperative complication rates. Sutureless implanted in MT has lower intensive care and in-hospital stay without significant differences in long-term clinical and echocardiographic outcomes.

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Cite This Study

Concistrè et al. (2026) conducted an observational in Aortic valve stenosis (n=710). Perceval sutureless bioprosthesis via mini-thoracotomy vs. Perceval sutureless bioprosthesis via mini-sternotomy was evaluated on Late cardiovascular death (>30 days) (OR 2.32, 95% CI 0.94-6.29, p=0.078). Mini-thoracotomy for Perceval sutureless valve implantation reduced median ICU stay to 1 day compared to 2 days for mini-sternotomy, with no significant difference in late cardiovascular deaths.

synapsesocial.com/papers/69eb07a4553a5433e34b3189https://doi.org/10.3389/fcvm.2026.1812903
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