Midterm results of mitral valve repair with the Sculptor annuloplasty ring.
rct · Level II
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Abstract
The partly flexible Sculptor ring is more physiologic than the rigid Carpentier-Edwards ring and may improve outcome. We studied 221 consecutive patients who underwent mitral valve repair for mitral regurgitation. The Sculptor ring was randomly implanted in 30 patients (Sculptor ring group) and the Carpentier-Edwards ring in 36 patients (Carpentier-Edwards ring control group) from 1993 to 1994. Before 1993, 155 patients received the Carpentier-Edwards ring (Carpentier-Edwards ring historical group). Baseline group characteristics were similar. Thirty-day mortality in the Sculptor ring, Carpentier-Edwards ring control, and Carpentier-Edwards ring historical groups was 0.0% versus 2.8% versus 3.2% (p = 0.61), respectively. At 18 months, survival was 86% +/- 6% versus 88% +/- 7% versus 90% +/- 3% (p = 0.89), and freedom from complications was 100% +/- 0% versus 100% +/- 0% versus 98% +/- 1% (p = 0.51) for endocarditis, 90% +/- 6% versus 94% +/- 4% versus 96% +/- 2% (p = 0.47) for severe mitral regurgitation, 93% +/- 5% versus 91% +/- 5% versus 92% +/- 2% (p = 0.91) for thromboembolism, and 77% +/- 8% versus 80% +/- 7% versus 82% +/- 3% (p = 0.49) for myocardial failure, respectively. The Sculptor ring is a safe alternative to the prosthetic annuloplasty rings in current use. The benefits of its physiologic design are either clinically insignificant or undetectable with a small sample size.
Medical subject headings
- Mitral Valve
- Mitral Valve Insufficiency