Benjamin Wan1, Mohammad Rahnavardi1, David H Tian1, Kevin Phan2, Stine Munkholm-Larsen3, Paul G Bannon2, Tristan D Yan2. 1. The Systematic Review Unit, The Collaborative Research (CORE) Group, Macquarie University, Sydney, Australia; 2. The Systematic Review Unit, The Collaborative Research (CORE) Group, Macquarie University, Sydney, Australia; ; Department of Cardiothoracic Surgery, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia; 3. The Systematic Review Unit, The Collaborative Research (CORE) Group, Macquarie University, Sydney, Australia; ; Department of Cardiology, Hvidovre University Hospital, Copenhagen, Denmark.
Abstract
BACKGROUND: Mitral regurgitation (MR) is the second most common valvular heart disease after aortic stenosis. Without intervention, prognosis is poor in patients with severe symptomatic MR. While surgical repair is recommended for many patients with severe degenerative MR (DMR), as many as 49% of patients do not qualify as they are at high surgical risk. Furthermore, surgical correction for functional MR (FMR) is controversial with suboptimal outcomes and significant perioperative mortality. The percutaneous MitraClip implantation can be seen as a viable option in high surgical risk patients. The purpose of this meta-analysis is to compare the safety, clinical efficacy, and survival outcomes of MitraClip implantation with surgical correction of severe MR. METHODS: Six electronic databases were searched for original published studies from January 2000 to August 2013. Two reviewers independently appraised studies, using a standard form, and extracted data on methodology, quality criteria, and outcome measures. All data were extracted and tabulated from the relevant articles' texts, tables, and figures and checked by another reviewer. RESULTS: Overall 435 publications were identified. After applying selection criteria and removing serial publications with accumulating number of patients or increased length of follow-up, four publications with the most complete dataset were included for quality appraisal and data extraction. There was one randomized controlled trial (RCT) and three prospective observational studies. At baseline, patients in the MitraClip group were significantly older (P=0.01), had significantly lower LVEF (P=0.03) and significantly higher EuroSCORE (P<0.0001). The number of patients with post-procedure residual MR severity >2 was significantly higher in the MitraClip group compared to the surgical group (17.2% vs. 0.4%; P<0.0001). 30-day mortality was not statistically significant (1.7% vs. 3.5%; P=0.54), nor were neurological events (0.85% vs. 1.74%; P=0.43), reoperations for failed MV procedures (2% vs. 1%; P=0.56), NYHA Class III/IV (5.7% vs. 11.3; P=0.42) and mortality at 12 months (7.4% vs. 7.3%; P=0.66). CONCLUSIONS: Despite a higher risk profile in the MitraClip patients compared to surgical intervention, the clinical outcomes were similar although surgery was more effective in reducing MR in the early post procedure period. We conclude the non-inferiority of the MitraClip as a treatment option for severe, symptomatic MR in comparison to conventional valvular surgery.
BACKGROUND:Mitral regurgitation (MR) is the second most common valvular heart disease after aortic stenosis. Without intervention, prognosis is poor in patients with severe symptomatic MR. While surgical repair is recommended for many patients with severe degenerative MR (DMR), as many as 49% of patients do not qualify as they are at high surgical risk. Furthermore, surgical correction for functional MR (FMR) is controversial with suboptimal outcomes and significant perioperative mortality. The percutaneous MitraClip implantation can be seen as a viable option in high surgical risk patients. The purpose of this meta-analysis is to compare the safety, clinical efficacy, and survival outcomes of MitraClip implantation with surgical correction of severe MR. METHODS: Six electronic databases were searched for original published studies from January 2000 to August 2013. Two reviewers independently appraised studies, using a standard form, and extracted data on methodology, quality criteria, and outcome measures. All data were extracted and tabulated from the relevant articles' texts, tables, and figures and checked by another reviewer. RESULTS: Overall 435 publications were identified. After applying selection criteria and removing serial publications with accumulating number of patients or increased length of follow-up, four publications with the most complete dataset were included for quality appraisal and data extraction. There was one randomized controlled trial (RCT) and three prospective observational studies. At baseline, patients in the MitraClip group were significantly older (P=0.01), had significantly lower LVEF (P=0.03) and significantly higher EuroSCORE (P<0.0001). The number of patients with post-procedure residual MR severity >2 was significantly higher in the MitraClip group compared to the surgical group (17.2% vs. 0.4%; P<0.0001). 30-day mortality was not statistically significant (1.7% vs. 3.5%; P=0.54), nor were neurological events (0.85% vs. 1.74%; P=0.43), reoperations for failed MV procedures (2% vs. 1%; P=0.56), NYHA Class III/IV (5.7% vs. 11.3; P=0.42) and mortality at 12 months (7.4% vs. 7.3%; P=0.66). CONCLUSIONS: Despite a higher risk profile in the MitraClip patients compared to surgical intervention, the clinical outcomes were similar although surgery was more effective in reducing MR in the early post procedure period. We conclude the non-inferiority of the MitraClip as a treatment option for severe, symptomatic MR in comparison to conventional valvular surgery.
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