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Sutureless Perceval S aortic valve replacement: a multicenter, prospective pilot trial.

Malakh Shrestha¹, Thierry Folliguet, Bart Meuris

¹Division of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hanover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Shrestha.Malakh.Lal@mh-hannover.de

The Journal of Heart Valve Disease

|January 27, 2010

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This pilot trial assessed the Perceval S sutureless aortic valve in high-risk patients. Results show the valve is safe and effective, potentially reducing mortality and morbidity by shortening procedure times.

Area of Science:

Cardiovascular Surgery
Medical Devices
Clinical Trials

Background:

A European, multicenter, prospective, non-randomized clinical pilot trial was conducted.
The study focused on evaluating the feasibility of the Perceval S sutureless aortic valve prosthesis.

Purpose of the Study:

To assess the feasibility, safety, and efficacy of the Perceval S sutureless aortic valve.
To evaluate clinical and echocardiographic outcomes at various follow-up intervals up to 12 months.

Main Methods:

The Perceval S valve was implanted via sternotomy with extracorporeal circulation (ECC) and aortic cross-clamping.
Suturing was not required; optimal sealing was achieved with balloon dilation.
30 high-risk patients (mean age 81 years) with aortic stenosis underwent implantation between April 2007 and February 2008.

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Main Results:

Mean aortic cross-clamp time was 34 minutes and ECC time was 59 minutes.
One in-hospital death (3.3%) and three deaths within 12 months (one valve-related).
No valve migration or dislodgement; two mild paravalvular leakages and two mild intravalvular insufficiencies were observed.

Conclusions:

The Perceval S sutureless aortic valve demonstrated safety and efficacy in high-risk patients.
Shortening aortic cross-clamp and ECC times may reduce mortality and morbidity in this patient subset.