Clinical evaluation of the Physio annuloplasty ring.

STUDY OBJECTIVES: Prospective evaluation of a selectively flexible annuloplasty ring was undertaken to assess its safety and efficacy.

PATIENTS: Between December 1992 and November 1996, 190 patients with mitral regurgitation underwent mitral valve repair using an annuloplasty ring (Carpentier-Edwards Physio; Baxter-Edwards CVS Laboratories; Irvine, Calif). Ninety-four were in New York Heart Association class I or II. Etiology was degenerative in 74% of the patients.

RESULTS: Four patients died early for a hospital mortality of 2.1%, and one late death occurred. Two patients with systolic anterior motion required early valve replacement. Two transient episodes of hemiparesis occurred during the first postoperative month. There were no late thromboembolic complications, no late reoperation, and no endocarditis. Mean follow up of 23+/-13 months was complete in 99% of the patients. Seventy-seven patients (40.5%) have had Doppler echocardiography > 1 year after surgery: 61 (80%) of them have no residual regurgitation, 15 have grade 1+/4+ mitral regurgitation, while 1 has grade 2+/4+ insufficiency. Left ventricular end-diastolic volume index (mL/lm2) decreased from 107.4+/-35.5 preoperatively to 74.2+/-24.4 at last control (p<0.001).

CONCLUSION: The physio annuloplasty ring provided reliable and stable results at medium-term follow-up with a very low incidence of valve-related complications.