Repair of Barlow Mitral Valves through the Minimally Invasive Route - Continuing Noninferiority at Five-Years in a Randomized Study vs. Median Sternotomy
Giuseppe Nasso1, Flavio Fiore1, Vito Romano1, Giuseppe Visicchio1, Emanuele Greco1, Franco Massari2, Francesco Bartolomucci3, Khalil Fattouch4, Graziano Riccioni1, Giuseppe Speziale1.
1Division of Cardiac Surgery, GVM Care & Research, Bari, Italy, 2Division of Cardiology, Altamura Hospital, Altamura, Italy, 3Division of Cardiology, “L. Bonomo” Hospital, Andria, Italy, 4Division of Cardiac Surgery, Palermo University Hospital, Palermo, Italy.
Objective. Barlow disease of the mitral valve (bileaflet prolapse with diffuse floppy tissue and annular dilatation) is a complex lesion entailing major surgical challenges to achieve adequate repair. In previous studies, the surgical approach to the mitral valve (right minithoracotomy or median sternotomy) has been reported to have limited influence over the reliability of repair. We report the five-years follow-up of a randomized study comparing alternative surgical accesses for repair of complex mitral lesion (Barlow).
Methods. A randomized study of mitral repair for Barlow disease (bileaflet prolapse) via the minimally invasive access (MI group) vs. median sternotomy (MS group), we achieved an average 5 ± 1.2 years follow-up. Artificial chordal implantation was used for both leaflets instead of leaflet resection. Follow-up consisted of echocardiography, physical exam and quality-of-life assessment (SF-36 questionnaire) at 6-months intervals.
Results. Groups included 105 (MI) and 104 (MS) patients. Operative time was significantly longer in the MI group (p=0.03), but there was no meaningful difference in cardiopulmonary bypass time (p=0.4). Mitral repair was successfully performed in 104 and 105 cases (MS and MI groups, respectively, 99% both). Mechanical ventilation time, intensive care unit and hospital stay were shorter in the MI group (p=0.002, p=0.009 and p=0.004, respectively). At the end of the follow-up, 11 patients in the MS group (10.6%) and 10 in the MI group (9.5%) displayed residual mild mitral regurgitation, while moderate/severe regurgitation and heart failure occurred in 4 patients in the MS group (3.8%) vs. 5 cases in the MI group (4.8%, p=0.7). The rate of mitral reoperation was 3.8% in both groups. The overall mortality was 2.9% in both groups. Survival free from any adverse mitral event (including moderate/severe regurgitation and mitral reoperation) was comparable among groups (p=0.84 Kaplan-Meier analysis). Analysis of SF-36 scores at the latest available follow-up evidenced comparable average outcomes for all SF-36 domains.
Conclusions. In this continuing follow-up of a randomized study over the surgical approach to repair the Barlow mitral valve, the outcomes of repair are independent on which surgical approach is employed (minithoracotomy vs. full sternotomy). Quality-of-life outcomes are comparable at 5 years.
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