A Three-Dimensional Saddle-Shaped Annuloplasty Ring for Degenerative and Functional Mitral Insufficiency

Objectives: Three-dimensional saddle-shaped annuloplasty rings have been shown to create a larger surface of leaflet coaptation in mitral valve repair (MVR) for functional (FMR) and degenerative mitral regurgitation (DMR) which may increase repair durability. This study reports for the first time long-term results after MVR for DMR and FMR with a three-dimensional saddle-shaped annuloplasty ring, which was first introduced to the market as a tool for FMR.

Methods: Between September 2009 and June 2012, a total of 369 patients with DMR (n = 326) or FMR (n = 43) underwent MVR using the Medtronic Profile 3D annuloplasty ring. Mean age was 62.3 ± 12.6 years (65.6% male). 205 patients (55.6%) underwent isolated MVR and 164 patients (44.4%) a combined procedure, such as tricuspid valve repair (n = 91), CABG (n = 54), ablation procedures (n = 35), aortic valve surgery (n = 26), and aortic surgery (n = 8). Follow-up examinations were performed in 94.9% (mean 4.9 ± 0.9 years) and echocardiographic assessment in 93.2% of patients (mean 4.3 ± 1.2 years), respectively.

Results: 30-day mortality was 1.5% (5/326) for DMR (1.5% for isolated and 1.6% for combined procedures) and 9.3% (4/43) for FMR (0% for isolated and 10.5% for combined procedures). Survival at 6.5 years was 91.8 ± 2.0% for DMR (92.7 ± 2.7% for isolated and 90.4 ± 2.8% for combined procedures) and 65.5 ± 8.0% for FMR (80.0 ± 17.9% for isolated and 62.7 ± 0.9% for combined procedures). Freedom from mitral valve related reoperation at 6.5 years was 100% for functional MR and 92.4 ± 1.6% for DMR (93.0 ± 2.0% for isolated and 91.4 ± 2.8% for combined procedures). Twenty-one patients (5.7%) required a mitral valve reoperation after an average of 1.7 ± 1.7 years (range: 2–1,694 days). Four of these reoperations were required due to endocarditis, 5 for ring dehiscence, 9 for progression of the native disease (flail leaflet), 2 for leaflet suture dehiscence, and 1 for persistent systolic anterior motion. At time of echocardiographic follow-up, one patient presented with MR > °II.

Conclusion: Repair of FMR with the three-dimensional Medtronic Profile 3D annuloplasty ring shows excellent long term results. In case of DMR the device showed no advantage. However, increased tension on the profiled ring needs very secure fixation, which may not have been obvious to all surgeons in the beginning of the experience.