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. 2023 May 23;329(20):1778-1788.
doi: 10.1001/jama.2023.7089.

Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation

Raj R Makkar  1 , Joanna Chikwe  1 , Tarun Chakravarty  1 , Qiudong Chen  1 , Patrick T O'Gara  2 , Marc Gillinov  3 , Michael J Mack  4 , Andrew Vekstein  5 , Dhairya Patel  1 , Amanda Lee Stebbins  5 , Annetine C Gelijns  6 , Moody Makar  1 , Deepak L Bhatt  6 , Samir Kapadia  3 , Sreekanth Vemulapalli  5 , Martin B Leon  7
Affiliations

Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation

Raj R Makkar et al. JAMA. .

Abstract

Importance: There are limited data on the outcomes of transcatheter edge-to-edge mitral valve repair for degenerative mitral regurgitation (MR) in a real-world setting.

Objective: To evaluate the outcomes of transcatheter mitral valve repair for degenerative MR.

Design, setting, and participants: Cohort study of consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent nonemergent transcatheter mitral valve repair for degenerative MR in the US from 2014 through 2022.

Exposure: Transcatheter edge-to-edge mitral valve repair with the MitraClip device (Abbott).

Main outcomes and measures: The primary end point was MR success, defined as moderate or less residual MR and a mean mitral gradient of less than 10 mm Hg. Clinical outcomes were evaluated based on the degree of residual MR (mild or less MR or moderate MR) and mitral valve gradients (≤5 mm Hg or >5 to <10 mm Hg).

Results: A total of 19 088 patients with isolated moderate to severe or severe degenerative MR who underwent transcatheter mitral valve repair were analyzed (median age, 82 years; 48% women; median Society of Thoracic Surgeons predicted risk of mortality with surgical mitral valve repair, 4.6%). MR success was achieved in 88.9% of patients. At 30 days, the incidence of death was 2.7%; stroke, 1.2%; and mitral valve reintervention, 0.97%. MR success compared with an unsuccessful procedure was associated with significantly lower mortality (14.0% vs 26.7%; adjusted hazard ratio, 0.49; 95% CI, 0.42-0.56; P < .001) and heart failure readmission (8.4% vs 16.9%; adjusted hazard ratio, 0.47; 95% CI, 0.41-0.54; P < .001) at 1 year. Among patients with MR success, the lowest mortality was observed in patients who had both mild or less residual MR and mean mitral gradients of 5 mm Hg or less compared with those with an unsuccessful procedure (11.4% vs 26.7%; adjusted hazard ratio, 0.40; 95% CI, 0.34-0.47; P < .001).

Conclusions and relevance: In this registry-based study of patients with degenerative MR undergoing transcatheter mitral valve repair, the procedure was safe and resulted in successful repair in 88.9% of patients. The lowest mortality was observed in patients with mild or less residual MR and low mitral gradients.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Makkar reported receiving research grants, speaker fees, and proctoring fees from Edwards Lifesciences, Abbott, and Medtronic. Dr Chikwe reported being the principal investigator for the PRIMARY trial. Dr Chakravarty reported being a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr Makar reported being a consultant for Abbott. Dr Bhatt reported advisory board membership for Angiowave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys; board of directors membership for Angiowave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), the Society of Cardiovascular Patient Care, and TobeSoft; being inaugural chair for the American Heart Association Quality Oversight Committee; consultancy for Broadview Ventures; data monitoring committee membership for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston Scientific, Cleveland Clinic, Contego Medical, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Novartis, the Population Health Research Institute, and Rutgers University; receiving honoraria from the American College of Cardiology, Arnold and Porter law firm (work related to Sanofi/Bristol Myers Squibb clopidogrel litigation), the Baim Institute for Clinical Research, Belvoir Publications, the Canadian Medical and Surgical Knowledge Translation Research Group, Cowen and Company, Duke Clinical Research Institute, HMP, the Journal of the American College of Cardiology, K2P, Level Ex, Medtelligence/ReachMD, MJH Life Sciences, Oakstone CME, Piper Sandler, the Population Health Research Institute, Slack Publications, Society of Cardiovascular Patient Care, WebMD, and Wiley; being deputy editor of Clinical Cardiology; being chair of the NCDR-ACTION Registry Steering Committee and the VA CART Research and Publications Committee; being named on a patent for sotagliflozin (assigned to Brigham and Women’s Hospital who assigned to Lexicon; neither Dr Bhatt nor Brigham and Women’s Hospital receive any income from this patent); receiving research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, and 89Bio; receiving royalties from Elsevier; being site co-investigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St Jude Medical, Philips, SpectraWAVE, Svelte, and Vascular Solutions; being a trustee for the American College of Cardiology; and conducting unfunded research for FlowCo and Takeda. Dr Leon reported receiving institutional clinical research support from Abbott, Edwards Lifesciences, and Medtronic and being a co–principal investigator for the PRIMARY trial. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Mitral Regurgitation and Transcatheter Mitral Valve Repair
Figure 2.
Figure 2.. MR Severity, Categories of MR Success, and Impact of Individual Categories of MR Success on Death and Heart Failure Readmission at 1 Year
Median follow-up was 359 (IQR, 55-365) days for mortality and 352 (IQR, 44-365) days for heart failure readmission. A, Mitral regurgitation (MR) success. To account for missing echocardiographic data, MR success was assessed based on the cumulative data available at all time points. A hierarchical strategy was used to account for missing echocardiographic data at 30 days; see Statistical Analysis for a description of the strategy. B, Sankey diagram for the degree of MR severity at baseline, postprocedure, discharge, and 30 days. C-D, Mortality and heart failure readmission according to categories of MR success.
Figure 3.
Figure 3.. Mortality, Heart Failure Readmission, and Mitral Valve Reintervention at 1 Year, Stratified According to Procedural Success and Surgical Risk
Median follow-up was 359 (IQR, 55-365) days for mortality, 352 (IQR, 44-365) days for heart failure readmission, and 357 (51-365) days for mitral valve reintervention. A-C, Mortality, heart failure readmission, and mitral valve reintervention at 1 year stratified according to mitral regurgitation (MR) success (defined as moderate or less residual MR and mean mitral gradient <10 mm Hg). D-F, Mortality, heart failure readmission, and mitral valve reintervention at 1 year stratified according to low (≤2%), intermediate (2%-8%), and high (>8%) surgical risk with mitral valve repair, as assessed by Society of Thoracic Surgeons predicted risk of mortality.
See this image and copyright information in PMC

References

    1. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011. doi:10.1016/S0140-6736(06)69208-8 - DOI - PubMed
    1. Iung B, Baron G, Butchart EG, et al. . A prospective survey of patients with valvular heart disease in Europe: the Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003;24(13):1231-1243. doi:10.1016/S0195-668X(03)00201-X - DOI - PubMed
    1. De Bonis M, Maisano F, La Canna G, Alfieri O. Treatment and management of mitral regurgitation. Nat Rev Cardiol. 2011;9(3):133-146. doi:10.1038/nrcardio.2011.169 - DOI - PubMed
    1. Gammie JS, Chikwe J, Badhwar V, et al. . Isolated mitral valve surgery: the Society of Thoracic Surgeons Adult Cardiac Surgery Database analysis. Ann Thorac Surg. 2018;106(3):716-727. doi:10.1016/j.athoracsur.2018.03.086 - DOI - PubMed
    1. Vassileva CM, Mishkel G, McNeely C, et al. . Long-term survival of patients undergoing mitral valve repair and replacement: a longitudinal analysis of Medicare fee-for-service beneficiaries. Circulation. 2013;127(18):1870-1876. doi:10.1161/CIRCULATIONAHA.113.002200 - DOI - PubMed

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