Nicolas Doll1, Ventsislav Sheytanov1, Louis Labrousse2, Michael W A Chu3, Pierluigi Stefàno4, Aleš Mokrácek5, Olivier Baron6, Shuzhen Li7, Ralf Günzinger8. 1. Department of Cardiac Surgery, Sana Heart Surgery Stuttgart GmbH, Stuttgart, Germany. 2. Department of Cardiac and Vascular Surgery, University Hospital of Bordeaux, Bordeaux, France. 3. Division of Cardiac Surgery, Department of Surgery, Western University, London Health Sciences Centre, London, Ontario, Canada. 4. Department of Cardiac Surgery, Careggi University Hospital, Florence, Italy. 5. Department of Cardiac Surgery, Czech Budejovice Hospital, Budejovice, Czech Republic. 6. Department of Thoracic and Cardiovascular Surgery, North Laennec Hospital, Nantes, France. 7. Department of Biostatistics, Medtronic, Mounds View, MN, USA. 8. Department of Cardiovascular Surgery, German Heart Center Munich, Munich, Germany.
Abstract
OBJECTIVES: The Profile 3D annuloplasty ring is a complete, rigid, saddle-shaped ring indicated for reconstruction and/or remodelling of the pathological mitral valve (MV) in patients with mitral insufficiency. METHODS: This prospective, non-randomized, observational, postmarket release study characterized the patient population for which the study ring was chosen for MV repair, assessed the relief from MV dysfunction and determined the level of mitral regurgitation (MR) at follow-up (6-12 months postimplant). RESULTS: Between February 2013 and July 2015, 151 patients were enrolled at 7 centres; data were excluded for 3 patients. The mean age of the remaining 148 patients was 63.8 ± 12.3 years, and 85 patients (57.4%) were men. Ischaemic cardiomyopathy was present in 15 patients (10.1%) and dilated cardiomyopathy in 12 patients (8.1%). MR was severe in 86 of 145 patients with available data (59.3%). Implantation was successful in 141 of 147 attempted procedures. Two deaths (n = 148, 1.4%) occurred within 30 days, and 1 death (0.7%) occurred >30 days after implant. Analysis of patients with data from both visits (n = 111) demonstrated that MR was none or mild in 94.5% of patients, moderate in 3.6% and moderate to severe in 1.8% at follow-up. Nearly all (104 of 109, 95.4%) patients were in New York Heart Association Class I/II. Among patients with ischaemic cardiomyopathy or dilated cardiomyopathy preoperatively, 16 of 19 patients with available data (84.2%) had no or mild MR at follow-up. CONCLUSIONS: MV repair using the Profile 3D annuloplasty ring is a safe and effective treatment for MR. Further investigation is warranted to determine whether patients with ischaemic cardiomyopathy or dilated cardiomyopathy derive unique benefit from this saddle-shaped ring. Clinical trial registration number: www.clinicaltrials.gov, NCT01112566.
OBJECTIVES: The Profile 3D annuloplasty ring is a complete, rigid, saddle-shaped ring indicated for reconstruction and/or remodelling of the pathological mitral valve (MV) in patients with mitral insufficiency. METHODS: This prospective, non-randomized, observational, postmarket release study characterized the patient population for which the study ring was chosen for MV repair, assessed the relief from MV dysfunction and determined the level of mitral regurgitation (MR) at follow-up (6-12 months postimplant). RESULTS: Between February 2013 and July 2015, 151 patients were enrolled at 7 centres; data were excluded for 3 patients. The mean age of the remaining 148 patients was 63.8 ± 12.3 years, and 85 patients (57.4%) were men. Ischaemic cardiomyopathy was present in 15 patients (10.1%) and dilated cardiomyopathy in 12 patients (8.1%). MR was severe in 86 of 145 patients with available data (59.3%). Implantation was successful in 141 of 147 attempted procedures. Two deaths (n = 148, 1.4%) occurred within 30 days, and 1 death (0.7%) occurred >30 days after implant. Analysis of patients with data from both visits (n = 111) demonstrated that MR was none or mild in 94.5% of patients, moderate in 3.6% and moderate to severe in 1.8% at follow-up. Nearly all (104 of 109, 95.4%) patients were in New York Heart Association Class I/II. Among patients with ischaemic cardiomyopathy or dilated cardiomyopathy preoperatively, 16 of 19 patients with available data (84.2%) had no or mild MR at follow-up. CONCLUSIONS: MV repair using the Profile 3D annuloplasty ring is a safe and effective treatment for MR. Further investigation is warranted to determine whether patients with ischaemic cardiomyopathy or dilated cardiomyopathy derive unique benefit from this saddle-shaped ring. Clinical trial registration number: www.clinicaltrials.gov, NCT01112566.