scholarly journals 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

2020 ◽  
Vol 14 ◽  
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.

Percutaneous Mitral Valve Repair Vs. Stand-Alone Medical Therapy in Patients with Functional Mitral Regurgitation and Heart Failure

2020 ◽  
Vol 21 (1) ◽  
pp. 52-60 ◽  
Author(s):  
Tomás Benito-González ◽  
Rodrigo Estévez-Loureiro ◽  
Pedro A. Villablanca ◽  
Patrizio Armeni ◽  
Ignacio Iglesias-Gárriz ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Mitral Valve Repair ◽  
Medical Therapy ◽  
Functional Mitral Regurgitation ◽  
Valve Repair ◽  
Percutaneous Mitral Valve Repair

Secondary mitral regurgitation: pathophysiology, proportionality and prognosis

Heart ◽  
2020 ◽  
Vol 106 (10) ◽  
pp. 716-723 ◽  
Author(s):  
Omar Chehab ◽  
Ross Roberts-Thomson ◽  
Clarissa Ng Yin Ling ◽  
Michael Marber ◽  
Bernard D Prendergast ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Mitral Valve Repair ◽  
Medical Therapy ◽  
Left Ventricular ◽  
Heart Team ◽  
Valve Repair ◽  
Transcatheter Intervention ◽  
Secondary Mitral Regurgitation

Secondary mitral regurgitation (SMR) occurs as a result of multifactorial left atrioventricular dysfunction and maleficent remodelling. It is the most common and undertreated form of mitral regurgitation (MR) and is associated with a very poor prognosis. Whether SMR is a bystander reflecting the severity of the cardiomyopathy disease process has long been the subject of debate. Studies suggest that SMR is an independent driver of prognosis in patients with an intermediate heart failure (HF) phenotype and not those with advanced HF. There is also no universal agreement regarding the quantitative thresholds defining severe SMR and indeed there are challenges with echocardiographic quantification. Until recently, no surgical or transcatheter intervention for SMR had demonstrated prognostic benefit, in contrast with HF medical therapy and cardiac resynchronisation therapy. In 2018, the first two randomised controlled trials (RCTs) of edge-to-edge transcatheter mitral valve repair versus guideline-directed medical therapy in HF (Percutaneous Repair with the MitraClip Device for Severe (MITRA-FR), Transcather mitral valve repair in patients with heart failure (COAPT)) reported contrasting yet complimentary results. Unlike in MITRA-FR, COAPT demonstrated significant prognostic benefit, largely attributed to the selection of patients with disproportionately severe MR relative to their HF phenotype. Consequently, quantifying the degree of SMR in relation to left ventricular volume may be a useful discriminator in predicting the success of transcatheter intervention. The challenge going forward is the identification and validation of such parameters while in parallel maintaining a heart-team guided holistic approach.

scholarly journals Why Did COAPT Win While MITRA-FR Failed? Defining the Appropriate Patient Population for MitraClip

2019 ◽  
Vol 14 (1) ◽  
pp. 45-47 ◽  
Author(s):  
Kimberly Atianzar ◽  
Ming Zhang ◽  
Zachary Newhart ◽  
Sameer Gafoor
Keyword(s):  
Heart Failure ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Functional Mitral Regurgitation ◽  
Valve Repair ◽  
Percutaneous Therapy ◽  
Heart Failure Patients ◽  
Percutaneous Mitral Valve Repair ◽  
The World ◽  
Secondary Mitral Regurgitation

In 2018, the world of functional mitral regurgitation changed with the presentation of two trials – Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR) and Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT). The trials, which seemed to point in two different directions, raised significant questions for the field. This article looks at the differences in effective regurgitant area, guideline-directed medical therapy, patient selection, technical clues and other reasons why the trials had similar aims but very different findings.

scholarly journals Percutaneous Mitral Valve Repair for Functional Mitral Regurgitation with End-Stage Heart Failure

2015 ◽  
Vol 21 (10) ◽  
pp. S157
Author(s):  
Yukiko Mizutani ◽  
Shunsuke Kubo ◽  
Makar Moody ◽  
Mamoo Nakamura ◽  
Takahiro Shiota ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Mitral Valve Repair ◽  
Functional Mitral Regurgitation ◽  
Valve Repair ◽  
Percutaneous Mitral Valve Repair ◽  
End Stage Heart Failure ◽  
End Stage

scholarly journals Multimodality Imaging in Secondary Mitral Regurgitation

2020 ◽  
Vol 7 ◽  
Author(s):  
Harish Sharma ◽  
Boyang Liu ◽  
Hani Mahmoud-Elsayed ◽  
Saul G. Myerson ◽  
Richard P. Steeds
Keyword(s):  
Heart Failure ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Multimodality Imaging ◽  
Left Ventricular ◽  
Adverse Outcomes ◽  
Functional Mitral Regurgitation ◽  
Term Survival ◽  
Percutaneous Therapy ◽  
Secondary Mitral Regurgitation

Secondary mitral regurgitation (sMR) is characterized by left ventricular (LV) dilatation or dysfunction, resulting in failure of mitral leaflet coaptation. sMR complicates up to 35% of ischaemic cardiomyopathies (1) and 57% of dilated cardiomyopathies (2). Due to the prevalence of coronary artery disease worldwide, ischaemic cardiomyopathy is the most frequently encountered cause of sMR in clinical practice. Although mortality from cardiovascular disease has gradually fallen in Western countries, severe sMR remains an independent predictor of mortality (3) and hospitalization for heart failure (4). The presence of even mild sMR following acute MI reduces long-term survival free of major adverse events (1). Such adverse outcomes worsen as the severity of sMR increases, due to a cycle in which LV remodeling begets sMR and vice versa. Current guidelines do not recommend invasive treatment of the sMR alone as a first-line approach, due to the paucity of evidence supporting improvement in clinical outcomes. Furthermore, a lack of international consensus on the thresholds that define severe sMR has resulted in confusion amongst clinicians determining whether intervention is warranted (5, 6). The recent Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial (7) assessing the effectiveness of transcatheter mitral valve repair is the first study to demonstrate mortality benefit from correction of sMR and has reignited interest in identifying patients who would benefit from mitral valve intervention. Multimodality imaging, including echocardiography and cardiovascular magnetic resonance (CMR), plays a key role in helping to diagnose, quantify, monitor, and risk stratify patients for surgical and transcatheter mitral valve interventions.

scholarly journals Percutaneous Mitral Valve Repair versus Optimal Medical Therapy in Patients with Functional Mitral Regurgitation: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Muhammad Uzair Lodhi ◽  
Muhammad Shariq Usman ◽  
Tariq Jamal Siddiqi ◽  
Muhammad Shahzeb Khan ◽  
Muhammad Arbaz Arshad Khan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Mitral Valve Repair ◽  
Medical Therapy ◽  
Cardiovascular Mortality ◽  
Meta Analysis ◽  
Functional Mitral Regurgitation ◽  
Valve Repair ◽  
Percutaneous Mitral Valve Repair

Objectives. To compare percutaneous mitral valve repair (PMVR) with optimal medical therapy (OMT) in patients with heart failure (HF) and severe functional mitral regurgitation (FMR). Background. Many patients with HF and FMR are not suitable for surgical valve replacement and remain symptomatic despite maximal OMT. PMVR has recently emerged as an alternative solution. Methods. We performed a systematic review and a meta-analysis to address this question. Cochrane CENTRAL, MEDLINE, and Scopus were searched for randomized (RCT) and nonrandomized studies comparing PMVR with OMT in patients with HF and FMR. Primary endpoint was all-cause midterm mortality (at 1 and 2 years). Secondary endpoints were 30-day mortality and cardiovascular mortality and HF hospitalizations, at maximum follow-up. Studies including mixed cohort of degenerative and functional MR were allowed initially but were excluded in a secondary sensitivity analysis for each of the study’s end points. This meta-analysis was performed following the publication of two RCTs (MITRA-FR and COAPT). Results. Eight studies (six observational, two RCTs) comprising 3,009 patients were included in the meta-analysis. In comparison with OMT, PMVR significantly reduced 1-year mortality (RR: 0.70 [0.56, 0.87]; p=0.002; I2=47.6%), 2-year mortality (RR: 0.63 [0.55, 0.73]; p<0.001; I2=0%), and cardiovascular mortality (RR: 0.32 [0.23, 0.44]; p<0.001; I2=0%). No significant difference between PMVR+OMT and OMT was noted in HF hospitalization (HR: 0.69 [0.40, 1.20]; p=0.19; I2=85%) and 30-day mortality (RR: 1.13 [0.68, 1.87]; p=0.16; I2=0%). Conclusions. In comparison with OMT, PMVR significantly reduces 1-year mortality, 2-year mortality, and cardiovascular mortality in patients with HF and severe MR.

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

2019 ◽  
Vol 73 (17) ◽  
pp. 2123-2132 ◽  
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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