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Clinical evaluation of the Physio annuloplasty ring
R Raffoul1, M S Uva, G Rescigno
1Unité de Chirurgie Cardiaque, Hôpital Européen de Paris La Roseraie, Aubervilliers, France.
Chest
|May 22, 1998
Summary
The Carpentier-Edwards Physio annuloplasty ring demonstrated safety and efficacy in mitral regurgitation repair. This mitral valve repair technique showed reliable, stable medium-term results with few complications.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Medical Devices
Background:
- Mitral regurgitation necessitates effective surgical repair strategies.
- Annuloplasty rings are crucial for restoring mitral valve geometry and function.
- The Carpentier-Edwards Physio ring offers selective flexibility for improved outcomes.
Purpose of the Study:
- To prospectively evaluate the safety and efficacy of the Carpentier-Edwards Physio annuloplasty ring.
- To assess the medium-term outcomes of mitral valve repair using this device.
Main Methods:
- Prospective evaluation of 190 patients with mitral regurgitation undergoing repair with the Physio ring.
- Follow-up included clinical assessment and Doppler echocardiography up to 23 months.
- Etiology of regurgitation was predominantly degenerative (74%).
Main Results:
- Hospital mortality was 2.1% (4 patients); one late death occurred.
- No late thromboembolic complications, reoperations, or endocarditis were reported.
- 99% of patients completed follow-up; 80% had no residual regurgitation at >1 year.
Conclusions:
- The Physio annuloplasty ring provides reliable and stable mitral valve repair results.
- The device is associated with a very low incidence of valve-related complications.
- Significant reduction in left ventricular end-diastolic volume index observed post-repair.