Outcome comparison of mitral valve surgery and MitraClip therapy in patients with severely reduced left ventricular dysfunction

Gyoten, Takayuki; Schenk, Sören; Rochor, Kristin; Herwig, V.; Harnath, Axel; Grimmig, Oliver; Just, Sören; Fritzsche, Dirk; Messroghli, Daniel

doi:10.1002/ehf2.12741

Cited by 15 publications

(15 citation statements)

References 28 publications

(41 reference statements)

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“…The rate of the failure of the MitraClip procedure in the published data ranged between 4.8% and 9.5%, and the rate of recurrent MR was 5.1%-21.5%. [14][15][16] In our study, 16 patients had residual MR (9.5%), and 27 patients had recurrent MR (16.1%). There were no significant statistical differences among both groups in preprocedural characteristics.…”

Section: Discussionsupporting

confidence: 45%

Residual versus recurrent mitral regurgitation after transcatheter mitral valve edge‐to‐edge repair

et al. 2021

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Background The number of MtraClip procedures is increasing, and consequently, the number of patients with residual or recurrent mitral regurgitation (MR). We aimed to characterize patients who had residual versus recurrent MR after MitraClip and report the outcomes of different treatment strategies. Methods From 2012 to 2020, 167 patients had MitraClip. Out of them, 16 patients (9.5%) had residual mitral regurgitation (MR), and 27 patients (16.2%) had recurrent MR. Results The median age in patients with residual MR was 67.5 (59–73) years versus 69 (61–78) years in patients with recurrent MR (p = .87). The etiology of mitral valve disease was functional in 13 patients (81.3%) and 22 patients (84.6%) in residual versus recurrent MR patients (p > .99). Cardiac resynchronization therapy‐defibrillator implantation was higher in patients with residual MR (p = .02). Survival was 93.7% at 1 year, 76.4% at 3 years versus 92.5% at 1 year, and 84.5% at 3 years in residual versus recurrent MR (p = .69). Two patients in the residual MR group had re‐clip, and three had surgery, and in the recurrent MR group, one patient had re‐clip, and two patients had surgery (p = .23). Patients who had re‐clip were older (p = .09). Surgery was associated with 100% survival at 5 years, 63% after medical therapy and the worst survival was reported in re‐clip patients (p = .007). Conclusion The outcomes of patients with residual versus recurrent mitral regurgitation after MitraClip were comparable. Survival could be improved with surgery compared with medical therapy and re‐clip.

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Section: Discussionsupporting

confidence: 45%

Residual versus recurrent mitral regurgitation after transcatheter mitral valve edge‐to‐edge repair

et al. 2021

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“…19 New evidence continues to accumulate showing the value of percutaneous mitral valve procedures. 20 Other recent reviews and advice documents have covered this field. 2122…”

Section: Discussionmentioning

confidence: 99%

“…An update advice statement has recently been published by the Heart Failure Association of the ESC 19 . New evidence continues to accumulate showing the value of percutaneous mitral valve procedures 20 . Other recent reviews and advice documents have covered this field 2122 …”

Section: Discussionmentioning

confidence: 99%

Individual patient data meta‐analysis of the effects of the CARILLON® mitral contour system

et al. 2020

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Aims Functional mitral regurgitation (MR) (FMR) is common in heart failure with reduced ejection fraction and worsens morbidity and mortality, even when mild. The CARILLON® mitral contour system (Cardiac Dimensions, Kirkland, WA, USA), a mitral annuloplasty device delivered percutaneously to the coronary sinus, is designed to reduce the mitral annular dimension by virtue of the close anatomic relationship between the coronary sinus and the posterior mitral annulus. We performed a comprehensive individual patient data meta‐analysis of all studies that used CARILLON® device vs. control that have measured mitral regurgitation severity, left ventricular (LV) remodelling, functional status, and heart failure‐related outcomes in heart failure with reduced ejection fraction patients. Methods and results The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched in July 2020. Primary outcomes of interest were measures of MR severity, LV remodelling, New York Heart Association functional class and heart failure‐related outcomes [mortality and heart failure hospitalization (HFH) during follow up]. All data were received as individual patient and individual time point data‐points. Mean differences and 95% confidence intervals (CIs) were calculated for continuous data using a fixed‐effects model. Three studies (REDUCE FMR, TITAN and TITAN II) enrolling 209 participants were identified and included. Pooled analysis showed that, compared with control, CARILLON® device significantly improved both MR volume (mean difference MD ‐9.20, 95% C.I. −16.11 to −2.29 mL, P = 0.009) and MR grade (MD ‐1.12, 95% CI −1.36 to −0.88, P < 0.00001) and this was associated with a significant reduction in LA volume, MD −7.54 mL, 95% CI −14.90 to − 0.18, P = 0.04. Significant LV reverse remodelling was also seen in terms of EDV (MD −16.53, 95% CI −28.61 to −44.4 mL, P = 0.007), and a trend in ESV (MD −8.68, 95% CI −18.69 to −1.34 mL, P = 0.09) but no significant effect on LVEF (MD 0.88, 95% CI −1.52% to 2.38%, P = 0.47), due presumably to the greater residual MR in the control patients falsely elevating the LVEF. In addition, the CARILLON® device significantly improved New York Heart Association functional Class (MD −0.22, 95% CI −0.24 to −0.16, P < 0.00001), associated with a lower rate of HFH compared with controls (45.3% vs. 64%, respectively, P = 0.04). As a sensitivity analysis we also restricted the analyses to those patients with Class 3+/4+ MR at baseline. In this cohort, the echocardiographic results were similar, and the reduction in HFH rates was even more marked (43.9% vs. 82.9%, respectively, P = 0.04). Conclusions This comprehensive meta‐analysis of individual patient data has shown that CARILLON® device provides statistically significant and clinically meaningful benefits on MR severity, LA and LV volumes, and remodelling and rates of subsequent heart failure hospitalization

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“…After an initial screening, 14 reports [Niikura 2020;Alozie 2017;Kortlandt 2018;Feldman 2015;Paranskaya 2013;Anwer 2019;Swaans 2014;Taramasso 2012;De Bonis 2015;Buzzatti 2015;Gyoten 2020;Ondrus 2016;Buzzatti 2019;Ostovar 2018] comparing MitraClip with surgical MV repair, enrolling a total of 3355 patients with severe MR, were identified and included in qualitative and quantitative analyses. Only 1 study, the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II10, was a randomized controlled trial, whereas the others were observational comparative studies (Table 1) [Niikura 2020;Alozie 2017;Kortlandt 2018;Paranskaya 2013;Anwer 2019;Swaans 2014;Taramasso 2012;De Bonis 2015;Buzzatti 2015;Gyoten 2020;Ondrus 2016;Buzzatti 2019;Ostovar 2018]. The late follow-up duration was from 180 days [Ostovar 2018] to 5 years [Feldman 2015] (Tables 1 and 2).…”

Section: Search Resultsmentioning

confidence: 99%

Comparison of Transcatheter Mitral-Valve Repair and Surgical Mitral-Valve Repair in Elderly Patients with Mitral Regurgitation

Yuan

Wei

et al. 2021

HSF

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Purpose: To summarize comparative studies of MitraClip versus surgical repair in typical, real-world elderly patients with severe mitral regurgitation (MR) and analyze the safety and effectiveness of these therapeutic options. Methods: PubMed, Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL) were searched for comparative studies of transcatheter mitral-valve repair (TMVR) versus surgical mitral-valve repair (SMVR) in elderly patients with severe MR from January 2000 to June 2020. Statistical pooling for incidence estimates was performed according to a random-effects model with generic inverse-variance weighting, computing risk estimates with 95% confidence intervals (CIs), using RevMan 5.3. Results: A total of 14 reports comparing MitraClip with SMVR, enrolling 3355 patients with severe MR, were included in this study. Mean age, Logistic EuroSCORE, and incidence of diabetes mellitus (DM) were significantly higher in the MitraClip group, except the rate of patients with New York Heart Association (NYHA) class of >II and mean value of ejection fraction (EF). The arithmetic mean of freedom from acute mobility was similar. The 2 groups had equal all-cause mortality at 30 days, but different at 1 year (14% versus 9%) and 3 years in 7 studies (37% versus 25%). The freedom from recurrent MR ≥3+ was 88% and 97.3% at 30 days, 76.0% and 90.0% at 1 year, and 79% and 95% at 3 years in the MitraClip and surgical repair group, respectively. Conclusion: Although MitraClip is safe and effective in selected high-risk patients, the surgery may be the only gold standard for “gray” patients. Further studies are needed to determine whether MitraClip should be recommended.

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Outcome comparison of mitral valve surgery and MitraClip therapy in patients with severely reduced left ventricular dysfunction

Cited by 15 publications

References 28 publications

Residual versus recurrent mitral regurgitation after transcatheter mitral valve edge‐to‐edge repair

Residual versus recurrent mitral regurgitation after transcatheter mitral valve edge‐to‐edge repair

Individual patient data meta‐analysis of the effects of the CARILLON® mitral contour system

Comparison of Transcatheter Mitral-Valve Repair and Surgical Mitral-Valve Repair in Elderly Patients with Mitral Regurgitation

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