Immediate Outcomes of Heart Valve Prostheses with a Rapid-Deployment Sutureless Cuff versus Standard Sutured Prostheses in the Correction of Degenerative Aortic Valve Failure

Q: What are the key findings of this study?

Rapid-deployment sutureless cuff prostheses showed comparable 30-day mortality (8.6% vs 7.3% and 3.3%, p=0.78) and shorter cross-clamp times (p<0.001) compared to standard sutured valves.

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Degenerative aortic valve disease (n=105). Intervention: Rapid-deployment sutureless cuff (RDSC) with mechanical or biological valve cartridges vs. Standard sutured prostheses (Medeng-2 mechanical prosthesis or UniLine biological prosthesis). Primary outcome: 30-day all-cause mortality (co-primary with 30-day prosthesis-related mortality, which was 0% across all groups) (p=0.78).

Q: What does this research mean for the field?

Rapid-deployment sutureless cuff prostheses significantly reduce cardiopulmonary bypass and aortic cross-clamp times while demonstrating early mortality and hemodynamic outcomes comparable to standard sutured prostheses in patients with degenerative aortic valve disease. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

SERGEY A. ZHURKO; Aya Osipov; Alishir  B. Gamzaev; M. L. Kalinina; M. B. Sukhovа; Emir Kurmanbek uulu; Artem A. Golubev; Лашманов Дмитрий Иванович

doi:10.21688/1681-3472-2026-3-65-77

October 21, 2026Patologiya krovoobrashcheniya i kardiokhirurgiyaOpen Access

Immediate Outcomes of Heart Valve Prostheses with a Rapid-Deployment Sutureless Cuff versus Standard Sutured Prostheses in the Correction of Degenerative Aortic Valve Failure

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Key result

Rapid-deployment sutureless valves show comparable 30-day mortality but shorter cross-clamp times vs. standard sutured prostheses.

P=0.78
n=105

Why the study?

Sutureless valves offer an alternative approach to aortic valve replacement, prompting a comparison of prostheses with a rapid-deployment sutureless cuff against standard sutured prostheses in patients with degenerative aortic valve disease.

Does surgical aortic valve replacement using a rapid-deployment sutureless cuff with mechanical or biological cartridges affect 30-day all-cause and prosthesis-related mortality and operative times compared to standard sutured mechanical (Medeng-2) or biological (UniLine) prostheses in adults with degenerative aortic valve disease?

Key Points

To compare early clinical and hemodynamic outcomes of heart valve prostheses mounted on a rapid-deployment sutureless cuff versus standard sutured prostheses in patients undergoing surgery for degenerative aortic valve disease.
Prospective, single-centre, non-randomised pilot study of 105 patients undergoing aortic valve replacement between January 2022 and March 2024.
Patients were allocated to three groups: a rapid-deployment sutureless cuff with mechanical or biological valve cartridges (n = 35), the Medeng-2 mechanical prosthesis (n = 41), and the UniLine biological prosthesis (n = 29).
Primary endpoints were all-cause and prosthesis-related mortality within 30 days; secondary endpoints included transprosthetic pressure gradients at discharge and postoperative complication rates.
Cardiopulmonary bypass and aortic cross-clamp times were significantly shorter in the rapid-deployment sutureless cuff group compared to the sutured groups (p < 0.001).
Thirty-day all-cause mortality was 8.6% (3/35) in the sutureless cuff group, 7.3% (3/41) in the Medeng-2 group, and 3.3% (1/29) in the UniLine group (p = 0.78).
Permanent pacemaker implantation rates were 8.8% in the sutureless cuff group, 0% in the Medeng-2 group, and 3.3% in the UniLine group (p = 0.18), with lower discharge mean pressure gradients observed in the sutureless cuff group than in the mechanical group.

Study Design

Type

Observational (n=105)

Blinding

Open-label

Randomization

Non-randomized

Multicenter

No

Structured PICO

Does surgical aortic valve replacement using a rapid-deployment sutureless cuff with mechanical or biological cartridges affect 30-day all-cause and prosthesis-related mortality and operative times compared to standard sutured mechanical (Medeng-2) or biological (UniLine) prostheses in adults with degenerative aortic valve disease?

P

Population

105 adults aged 18–80 years (50.5% female) with hemodynamically significant degenerative aortic valve disease undergoing aortic valve replacement, excluding infective endocarditis, concomitant ascending aorta or multivalve surgery, and hemodialysis, followed for 30 days.

I

Intervention

Surgical aortic valve replacement using a rapid-deployment sutureless cuff (RDSC / БПМ, MedEng) with Easy Fix / Easy Change mechanism implanted via supra-annular technique on 3 guiding sutures with balloon dilation of the infra-annular stent, fitted with mechanical bileaflet (MedEng-EC, n=13), full-flow mechanical (MedEng-ST, n=8), or biological (MedEng-BIO, n=14) valve cartridges (total n=35). All patients received postoperative warfarin (target INR 2.0–3.0) with early low-molecular-weight heparin bridging.

C

Comparator

Standard sutured aortic valve replacement with either the Medeng-2 mechanical bileaflet prosthesis (n=41) or the UniLine xenopericardial biological prosthesis (n=29). All groups underwent normothermic cardiopulmonary bypass with antegrade cold cardioplegia (Bretschneider solution) and received postoperative warfarin (target INR 2.0–3.0) with low-molecular-weight heparin bridging.

O

Outcome

All-cause mortality and prosthesis-related mortality (acute prosthesis thrombosis leading to sudden cardiac death or fatal arrhythmia, prosthetic endocarditis leading to sepsis and multiorgan failure, aortic root rupture with cardiac tamponade, or paravalvular regurgitation with hemodynamic instability) within 30 days.hard clinical

Main Result

Absolute Event Rate: 8.6% vs 7.3%

p-value: p=0.78

Limitations

Single-center, non-randomized pilot design with risk of selection bias
Small sample size underpowered to detect differences in rare clinical outcomes (mortality, permanent pacemaker implantation, stroke, paravalvular regurgitation)
Treatment allocation was based on clinical decision and surgeon preference rather than randomization, leading to baseline imbalances in age, LVEF, hypertension, and type 2 diabetes
Heterogeneity of cartridge types (mechanical, full-flow, biological) within the sutureless cuff group
Most procedures were performed by a single surgeon, introducing potential operator experience and learning curve effects
Short follow-up limited to the in-hospital and 30-day postoperative period
Prospective single-centre non-randomised pilot study design
No formal sample size calculation was performed due to the pilot nature of the study and ethical constraints
Limited sample size requiring pooling of different cartridge types (mechanical, full-flow, and biological) into a single RDSC group
Clinical selection differences between groups with respect to baseline age and left ventricular ejection fraction

Implication

This prospective pilot study demonstrates that a novel rapid-deployment sutureless cuff platform accepting both mechanical and biological valve cartridges significantly reduces cardiopulmonary bypass and aortic cross-clamp times compared to standard sutured prostheses, with comparable 30-day mortality and lower discharge pressure gradients than mechanical sutured valves.

Abstract

Introduction: Sutureless valves represent an alternative approach to aortic valve replacement, enabling rapid prosthesis implantation without placement of multiple interrupted sutures. Objective: To compare prostheses with a rapid-deployment sutureless cuff with standard sutured prostheses in patients with degenerative aortic valve disease. Methods: This prospective, single-centre, non-randomised pilot studyincluded 105 patients who underwent aortic valve replacement between January 2022 and March 2024. Patients were allocated to three groups: a rapid-deployment sutureless cuff with mechanical or biological valve cartridges (n = 35), the Medeng-2 mechanical prosthesis (n = 41), and the UniLine biological prosthesis (n = 29). The primary endpoints were allcause and prosthesis-related mortality within 30 days. Secondary endpoints included mean transprosthetic pressure gradients at discharge and the frequency and nature of complications. Results: The groups were comparable for most preoperative characteristics,including EuroSCORE II (p = 0.213). Statistically significant differenceswere observed in age and left ventricular ejection fraction, reflectingclinical selection rather than systematic differences in operative risk. Cardiopulmonary bypass and aortic cross-clamp times were significantlyshorter in the sutureless cuff group (p < 0.001). Thirty-day all-cause mortalitywas 8.6% (3/35) in the RDSC group, 7.3% (3/41) in the Medeng-2 group, and 3.3% (1/29) in the UniLine group (p = 0.78). Permanent pacemaker implantation rates were 8.8%, 0%, and 3.3%, respectively (p = 0.18). At discharge, mean pressure gradients were lower in the sutureless cuff group than in the mechanical prosthesis group. Conclusion: Preliminary findings from this pilot study suggest that a rapid-deployment sutureless cuff reduces operative time and provides satisfactory early haemodynamic outcomes. Further studies are required to confirm safety with respect to rare complications and to evaluate longterm outcomes. Received 18 April 2026. Revised 22 June 2026. Accepted 4 August 2026. Informed consentThe patient’s informed consent to use the records for medical purposes is obtained. FundingThe study did not have sponsorship. Conflict of interestThe authors declare no conflict of interest. Contribution of the authorsConception and study design: S.A. Zhurko, A.M. Osipov, A.B. Gamzaev, A.A. Golubev Data collection and analysis: A.M. Osipov, M.L. Kalinina, M.B. Sukhova, E. Kurmanbek uulu, D.I. Lashmanov Statistical analysis: A.M. Osipov Drafting the article: S.A. Zhurko, A.M. Osipov, A.B. Gamzaev Critical revision of the article: S.A. Zhurko, A.M. Osipov, A.B. Gamzaev Final approval of the version to be published: all authors

Discussion

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Cite This Study

ZHURKO et al. (2026) conducted an observational in Degenerative aortic valve disease (n=105). Rapid-deployment sutureless cuff (RDSC) with mechanical or biological valve cartridges vs. Standard sutured prostheses (Medeng-2 mechanical prosthesis or UniLine biological prosthesis) was evaluated on 30-day all-cause mortality (co-primary with 30-day prosthesis-related mortality, which was 0% across all groups) (p=0.78). Rapid-deployment sutureless cuff prostheses showed comparable 30-day mortality (8.6% vs 7.3% and 3.3%, p=0.78) and shorter cross-clamp times (p<0.001) compared to standard sutured valves.

synapsesocial.com/papers/6ae28e94cbadf70daf6c4375 https://doi.org/10.21688/1681-3472-2026-3-65-77

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Immediate Outcomes of Heart Valve Prostheses with a Rapid-Deployment Sutureless Cuff versus Standard Sutured Prostheses in the Correction of Degenerative Aortic Valve Failure

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Immediate Outcomes of Heart Valve Prostheses with a Rapid-Deployment Sutureless Cuff versus Standard Sutured Prostheses in the Correction of Degenerative Aortic Valve Failure

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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