Feasibility, Technical Safety, and Early Clinical Experience with an Automated Annular Suturing Device in Minimally Invasive Valve Replacement

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Minimally invasive cardiac valve surgery (mitral or aortic valve replacement) (n=43). Intervention: Automated annular suturing device (RAM). Primary outcome: Technical success (successful automated placement of all annular sutures without conversion to manual suturing or device failure) (95% CI 91.8-100.0).

Q: What does this research mean for the field?

Automated annular suturing is technically feasible and safe in minimally invasive mitral and aortic valve replacement, achieving high procedural success without paravalvular regurgitation. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Robert Balan; Parwis Massoudy; Marius Harpa; Klara Brînzaniuc; Jonah Schwarz

doi:10.3390/jcm15176870

September 4, 2026Journal of Clinical MedicineOpen Access

Feasibility, Technical Safety, and Early Clinical Experience with an Automated Annular Suturing Device in Minimally Invasive Valve Replacement

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Key result

Automated annular suturing achieves 100% technical success without device failures during minimally invasive valve replacement.

95% CI 91.8-100.0
n=43

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Why the study?

Annular suturing remains a technically demanding step in minimally invasive cardiac valve surgery, prompting evaluation of the feasibility, safety, and operational integration of an automated annular suturing device.

Does automated annular suturing using the RAM device improve technical success and safety in patients undergoing minimally invasive valve replacement?

Key Points

To evaluate the initial clinical feasibility, technical safety, and operational integration of an automated annular suturing device during institutional adoption in minimally invasive valve surgery.
Retrospectively analyzed 43 consecutive patients undergoing minimally invasive valve surgery supported by the RAM system between 2021 and 2025.
Stratified the study population into mitral valve replacement (RAM-MVR, n = 26) and aortic valve replacement (RAM-AVR, n = 17) groups.
Contextualized procedural parameters, safety metrics, and outcomes against an institutional benchmark cohort treated via percutaneous femoral cannulation (n = 182).
Technical feasibility was achieved in 100% of cases (43/43, 95% CI: 91.8–100.0%) with 0% mechanical device failures or intraoperative suture-line disruptions (0%, 95% CI: 0.0–8.2%).
Median aortic cross-clamp duration was 73.0 min (IQR 64.0–91.0) with cardiopulmonary bypass time of 114.5 min (IQR 94.8–129.5) in RAM-MVR, and 75.0 min (IQR 71.0–83.0) with cardiopulmonary bypass time of 92.0 min (IQR 86.0–108.0) in RAM-AVR.
Thirty-day mortality was 4.7% (2/43, 95% CI: 0.6–15.8%) due to non-device-related complications, and predischarge echocardiography showed zero paravalvular regurgitation (0%, 95% CI: 0.0–8.2%).

Study Design

Type

Observational (n=43)

Multicenter

No

Structured PICO

Does automated annular suturing using the RAM device improve technical success and safety in patients undergoing minimally invasive valve replacement?

P

Population

43 patients (median age 67, 39.5% female) undergoing minimally invasive mitral or aortic valve replacement, evaluated for technical feasibility of an automated suturing device.

I

Intervention

Automated annular suturing using the RAM device (RAM 5.0 and 3.5) during minimally invasive mitral or aortic valve replacement.

O

Outcome

Technical success, defined as successful automated placement of all annular sutures without conversion to manual suturing or device failure.safety

Automated annular suturing using the RAM device is technically feasible and safe in minimally invasive mitral and aortic valve replacement, achieving 100% technical success with stable operative times.

Limitations

Single-center, retrospective observational study with a small sample size
Procedures performed by a single high-volume surgeon
Non-randomized design with an unadjusted institutional benchmark cohort
Usability inferred from procedural success rather than validated human-factors frameworks
Clinical outcomes limited to the perioperative period
lack of formal comparative control group
differences in case mix and anatomical pathologies compared to benchmark cohort

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Implication

May inform workflow integration in minimally invasive valve programs; leaves open randomized confirmation of outcomes versus manual suturing.

Abstract

Background: Minimally invasive cardiac valve surgery (MIVS) provides distinct clinical advantages, yet annular suturing remains a technically demanding step. Automated annular suturing devices (RAM®) have been developed to standardize suture placement during valve replacement. This study evaluates the initial clinical feasibility, technical safety, and operational integration of automated suturing during its institutional adoption phase. Methods: We retrospectively evaluated 43 consecutive patients undergoing MIVS supported by the RAM® system (2021–2025), stratified into mitral valve replacements (RAM-MVR, n = 26) and aortic valve replacements (RAM-AVR, n = 17). Technical parameters, procedural safety metrics, and perioperative outcomes were descriptively analyzed and contextualized against our broader institutional MIVS platform using percutaneous femoral cannulation (n = 182). Results: Automated annular suturing achieved a 100% technical feasibility rate (43/43, 95% CI: 91.8–100.0%) with zero mechanical device failures or intraoperative suture-line disruptions (0%, 95% CI: 0.0–8.2%). In the RAM-MVR cohort, median cross-clamp and cardiopulmonary bypass (CPB) times were 73.0 min (IQR 64.0–91.0) and 114.5 min (IQR 94.8–129.5), respectively. In RAM-AVR, median cross-clamp time was 75.0 min (IQR 71.0–83.0). Thirty-day mortality was 4.7% (2/43, 95% CI: 0.6–15.8%), secondary to non-device-related medical complications in high-risk baseline patients. Postoperative echocardiography demonstrated no paravalvular regurgitation (0%, 95% CI: 0.0–8.2%). Conclusions: Initial institutional experience demonstrates that automated annular suturing is technically feasible and safe in minimally invasive mitral and aortic valve replacement. The system enables consistent procedural execution across valve positions. These observational data support automated suturing as a feasible alternative to manual suturing in MIVS workflows.

Discussion

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Cite This Study

Balan et al. (2026) conducted an observational in Minimally invasive cardiac valve surgery (mitral or aortic valve replacement) (n=43). Automated annular suturing device (RAM) was evaluated on Technical success (successful automated placement of all annular sutures without conversion to manual suturing or device failure) (95% CI 91.8-100.0). The automated annular suturing device achieved a 100% technical feasibility rate with zero mechanical device failures in minimally invasive valve replacement.

synapsesocial.com/papers/6a9d1ee128139818eab2203a https://doi.org/10.3390/jcm15176870

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Feasibility, Technical Safety, and Early Clinical Experience with an Automated Annular Suturing Device in Minimally Invasive Valve Replacement

Figures

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Feasibility, Technical Safety, and Early Clinical Experience with an Automated Annular Suturing Device in Minimally Invasive Valve Replacement

Figures

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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