Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure

Background Optimizing risk stratification in patients undergoing transcatheter mitral valve repair is an ongoing challenge. The Mitral Regurgitation International Database (MIDA) score represents a user‐friendly mortality risk stratification tool that is validated on a large‐scale registry of patients with degenerative mitral regurgitation (MR). We here assessed the potential benefit of the MIDA risk score for patients with functional or degenerative MR undergoing transcatheter mitral valve repair. Methods and Results In total, 680 patients undergoing MitraClip implantation were stratified according to MIDA score tertiles into a low (0–7), intermediate (8–9), and a high (10–12) MIDA score group. MR was assessed in follow‐up echocardiograms in 416 patients at 323±169 days after transcatheter mitral valve repair. During 2‐year follow‐up, 8.2% (15/182) of patients with low, 21.3% (64/300) with intermediate, and 26.3% (52/198) with high MIDA score died (log‐rank test P <0.001). Hazard of all‐cause mortality increased by 13% (95% CI, 3%–25%) with every additional point of the MIDA score. Subanalysis of 431 patients with functional MR showed similar results. Furthermore, rates of a combined end point of mortality and hospitalization for heart failure were higher with increasing MIDA score (30% [54/182], 38% [113/300] and 48% [94/198], respectively, log‐rank test P =0.001). Frequency of residual MR ≥II at follow‐up increased with increasing MIDA score group (33%, 44%, and 59%, respectively, P <0.001). Conclusions The MIDA mortality risk score maintains its predictive utility in patients undergoing transcatheter mitral valve repair, regardless of MR cause. Moreover, it was predictive of worse event‐free survival regarding a combined end point of mortality and hospitalization for heart failure, and was associated with postprocedural residual MR ≥II and MR recurrence.

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Transcatheter Mitral Valve Repair in Patients with Heart Failure: A Meta-Analysis

Cardiology ◽

10.1159/000511412 ◽

2020 ◽

pp. 1-7

Author(s):

Ajay Vallakati ◽

Ayesha K Hasan ◽

Konstantinos Dean Boudoulas

Keyword(s):

Heart Failure ◽

Mitral Valve ◽

Mitral Valve Repair ◽

Medical Therapy ◽

Meta Analysis ◽

Pooled Analysis ◽

Valve Repair ◽

Heart Failure Patients ◽

Transcatheter Mitral Valve Repair ◽

Secondary Mr

Background: Severe secondary mitral regurgitation (MR) is associated with poor prognosis in heart failure patients with left ventricular systolic dysfunction. Few observational and randomized controlled studies demonstrated the efficacy of transcatheter mitral valve repair in heart failure patients with significant MR. A meta-analysis of published studies was performed to evaluate the role of transcatheter mitral valve repair using the MitraClip device in heart failure patients with significant secondary MR. Methods: A literature search was performed using PubMed, Cochran CENTRAL, and Embase databases using the search terms “percutaneous mitral valve repair” or “transcatheter mitral valve repair” and “heart failure.” Studies that compared medical therapy plus transcatheter mitral valve repair using MitraClip to medical therapy alone in heart failure patients with significant secondary MR were included for pooled analysis. A random-effects model with the Mantel-Haenszel method was used to analyze the data. Results: Four studies, 2 randomized controlled and 2 nonrandomized studies met the criteria for analysis. Pooled analysis included a total of 1,421 patients, of which 746 patients underwent transcatheter mitral valve repair and 675 patients received medical therapy alone. When compared to medical therapy, transcatheter mitral valve repair significantly decreased all-cause mortality (OR 0.58, 95% CI 0.37–0.91; p = 0.02). A trend toward significant reduction in rehospitalizations (OR 0.35, 95% CI 0.12–1.00; p = 0.05) was also observed. Periprocedural complications ranged from 7.5 to 12.6%. Conclusion: Evidence from pooled analysis suggests that transcatheter mitral valve repair using MitraClip on top of medical therapy, in appropriately selected symptomatic heart failure patients with significant secondary MR, provides survival benefit and may decrease hospitalizations when compared with guideline-directed medical therapy alone.

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Baseline Functional Capacity and Transcatheter Mitral Valve Repair in Heart Failure With Secondary Mitral Regurgitation

JACC Cardiovascular Interventions ◽

10.1016/j.jcin.2020.07.030 ◽

2020 ◽

Vol 13 (20) ◽

pp. 2331-2341

Author(s):

Umar I. Malik ◽

Andrew P. Ambrosy ◽

Ivy A. Ku ◽

Jacob M. Mishell ◽

Saibal Kar ◽

...

Keyword(s):

Heart Failure ◽

Mitral Valve ◽

Mitral Regurgitation ◽

Mitral Valve Repair ◽

Functional Capacity ◽

Valve Repair ◽

Transcatheter Mitral Valve Repair ◽

Secondary Mitral Regurgitation

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Health Status After Transcatheter Mitral-Valve Repair in Heart Failure and Secondary Mitral Regurgitation

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2019.02.010 ◽

2019 ◽

Vol 73 (17) ◽

pp. 2123-2132 ◽

Cited By ~ 36

Author(s):

Suzanne V. Arnold ◽

Khaja M. Chinnakondepalli ◽

John A. Spertus ◽

Elizabeth A. Magnuson ◽

Suzanne J. Baron ◽

...

Keyword(s):

Heart Failure ◽

Health Status ◽

Mitral Valve ◽

Mitral Regurgitation ◽

Mitral Valve Repair ◽

Valve Repair ◽

Transcatheter Mitral Valve Repair ◽

Secondary Mitral Regurgitation

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Association of heart failure duration with clinical outcomes after transcatheter mitral valve repair for functional mitral regurgitation

Catheterization and Cardiovascular Interventions ◽

10.1002/ccd.29390 ◽

2020 ◽

Author(s):

Atsushi Sugiura ◽

Marcel Weber ◽

Noriaki Tabata ◽

Tadahiro Goto ◽

Eberhard Grube ◽

...

Keyword(s):

Heart Failure ◽

Mitral Valve ◽

Mitral Regurgitation ◽

Clinical Outcomes ◽

Mitral Valve Repair ◽

Functional Mitral Regurgitation ◽

Valve Repair ◽

Transcatheter Mitral Valve Repair

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Clinical Trial Perspective: Cost-effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients with Heart Failure and Secondary Mitral Regurgitation. Results From the COAPT Trial

US Cardiology Review ◽

10.15420/usc.2020.01 ◽

2020 ◽

Vol 14 ◽

Cited By ~ 1

Author(s):

Suzanne J Baron

Keyword(s):

Heart Failure ◽

Cost Effectiveness ◽

Mitral Valve ◽

Mitral Regurgitation ◽

Mitral Valve Repair ◽

Medical Therapy ◽

Functional Mitral Regurgitation ◽

Valve Repair ◽

Percutaneous Therapy ◽

Secondary Mitral Regurgitation

Treatment of secondary (or functional) mitral regurgitation had traditionally been limited to optimal medical therapy because studies have failed to show a survival benefit with mitral valve surgery for this condition. However, recently the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial demonstrated a significant decrease in heart failure hospitalizations and mortality in patients with severe secondary mitral regurgitation treated with percutaneous edge-to-edge mitral valve repair (TMVr) using the MitraClip device compared with medical therapy. Based o the results of the COAPT trial, the Food and Drug Administration granted approval for MitraClip treatment of patients with severe secondary mitral regurgitation in March 2019. In an attempt to understand the economic impact of treating this patient population with TMVr using the MitraClip device, a formal cost-effectiveness analysis was performed alongside the COAPT trial. This review summarizes the methods and results of the economic substudy of the COAPT trial and discusses the value of the MitraClip device from the perspective of the US healthcare system in the treatment of patients with symptomatic heart failure and secondary mitral regurgitation.

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Contrasting Effects of Pharmacological, Procedural, and Surgical Interventions on Proportionate and Disproportionate Functional Mitral Regurgitation in Chronic Heart Failure

Circulation ◽

10.1161/circulationaha.119.039612 ◽

2019 ◽

Vol 140 (9) ◽

pp. 779-789 ◽

Cited By ~ 20

Author(s):

Milton Packer ◽

Paul A. Grayburn

Keyword(s):

Heart Failure ◽

Chronic Heart Failure ◽

Mitral Valve ◽

Mitral Regurgitation ◽

Mitral Valve Repair ◽

Cardiac Resynchronization ◽

Functional Mitral Regurgitation ◽

Valve Repair ◽

Transcatheter Mitral Valve Repair ◽

Lv Volumes

Two distinct pathways can lead to functional mitral regurgitation (MR) in patients with chronic heart failure and a reduced ejection fraction. When remodeling and enlargement of the left ventricle (LV) cause annular dilatation and tethering of the mitral valve leaflets, there is a linear relationship between LV end-diastolic volume and the effective regurgitant orifice area of the mitral valve. These patients, designated as having proportionate MR, respond favorably to treatments that lead to reversal of LV remodeling and a decrease in LV volumes (eg, neurohormonal antagonists and LV assist devices), but they may not benefit from interventions that are directed only at the mitral valve leaflets (eg, transcatheter mitral valve repair). In contrast, when ventricular dyssynchrony causes functional MR attributable to unequal contraction of the papillary muscles, the magnitude of regurgitation is greater than that predicted by LV volumes. These patients, designated as having severe but disproportionate MR, respond favorably to treatments that are directed to the mitral valve leaflets or their supporting structures (eg, cardiac resynchronization or transcatheter mitral valve repair), but they may derive little benefit from interventions that act only to reduce LV cavity size (eg, pharmacological treatments). This novel conceptual framework reflects the important interplay between LV geometry and mitral valve function in determining the clinical presentation of patients, and it allows characterization of the determinants of functional MR to guide the most appropriate therapy in the clinical setting.

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Abstract 14830: Edge-to-edge Transcatheter Mitral Valve Repair is Associated With Lower Pulmonary Artery Pressure in Cardiomems TM -monitored Patients With Heart Failure and Mitral Regurgitation

Circulation ◽

10.1161/circ.142.suppl_3.14830 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

David Shavelle ◽

J Thomas T Heywood ◽

Ajay Srivastava ◽

Rahul Agarwal ◽

Julie Prillinger ◽

...

Keyword(s):

Heart Failure ◽

Mitral Valve ◽

Mitral Regurgitation ◽

Pulmonary Artery ◽

Pulmonary Artery Pressure ◽

Mitral Valve Repair ◽

Valve Repair ◽

Additional Tool ◽

Artery Pressure ◽

Transcatheter Mitral Valve Repair

Introduction: Transcatheter mitral valve repair (TMVr) reduces heart failure (HF) hospitalizations and improves survival in patients with HF and secondary mitral regurgitation (MR), but the hemodynamics of TMVr are not well studied. Patients with a pulmonary artery pressure (PAP) monitor (CardioMEMS TM ) provide a unique opportunity to study ambulatory hemodynamics following TMVr. Methods: TMVr implants occurring July 2014 to Sept 2019 were identified from Medicare claims data and were linked to PAP data from CardioMEMS TM . Patients with CardioMEMS TM implant ≥3 mo prior to TMVr and with ≥3 mo PAP data post TMVr were included. Diastolic PAP (DPAP) and area under the curve (AUC) at 3 and 6 mo post TMVr were compared to 4 wks prior to TMVr (baseline). Analysis was repeated for those with elevated baseline DPAP, defined as ≥15 mmHg. Results: The cohort included 32 patients (74 ± 8 yrs, 66% male) with high prevalence of hypertension, ischemic heart disease, AF, and kidney disease. LVEF was available in 17 patients (32 ± 14%). Compared to baseline, DPAP was significantly lower at 3 mo (-2.1 ± 4.7 mmHg, p=0.019) and remained lower at 6 mo post TMVr (-2.5 ± 6.7 mmHg, p=0.070). AUC showed a cumulative reduction in DPAP of -129 ± 257 mmHg-days (p=0.008) at 3 mo and -438 ± 719 mmHg-days (p=0.005) at 6 mo post TMVr. Similar trends were observed for mean PAP. Sub-group analyses suggested lower DPAP after TMVr in patients with elevated baseline DPAP (3 mo Δ: -2.6 ± 4.6 mmHg, p=0.009; 6 mo Δ: -3.8 ± 6.3 mmHg, p=0.014, 3 mo AUC: -158 ± 255 mmHg-day, p=0.004; 6 mo AUC: -575 ± 721 mmHg-day, p=0.002). Conclusions: In CardioMEMS TM -monitored patients with significant MR, TMVr is associated with a clinically relevant and sustained reduction in DPAP, including patients with an elevated baseline DPAP. Although the clinical and survival benefits of TMVr are paramount, these data add to our understanding of the hemodynamic improvements of TMVr. CardioMEMS TM is an additional tool to improve filling pressures in those with HF.

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