Safety, effectiveness and costs of percutaneous mitral valve repair: A real-world prospective study.

Iain Willits,Kim Keltie,Helen Cole,Mark De Belder,Julie Speller,Nicholas Linker,Andrew J Sims,Samuel G Urwin,Robert Henderson,Hannah Patrick,Helen Powell,Lee Berry,Hans-Peter Brunner-La Rocca

doi:10.1371/journal.pone.0251463

Abstract

AimsPercutaneous mitral valve leaflet repair is a treatment option for some people with severe mitral valve regurgitation for whom conventional mitral valve surgery is clinically inappropriate. This study aimed to determine the safety, efficacy, and costs of percutaneous mitral valve leaflet repair, using the MitraClip device in a UK setting.Methods and resultsThis was a prospective, single-armed registry with a follow-up of 2 years that reported a range of procedural, clinical and patient-orientated outcomes. Registry data were linked to routine data sources to allow for more comprehensive follow up concerning mortality and healthcare resource use. The registry received data for 199 mainly elective patients with mixed mitral regurgitation aetiology. A MitraClip device was implanted in 187 patients (94%), with a procedural success rate of 86%, with 8% of patients having a serious in-hospital adverse event (including 5% mortality). Percutaneous mitral valve leaflet repair reduced mitral regurgitation from 100% MR grade ≥ 3+ to 7% at discharge. There were corresponding improvements in New York Heart Association functional class, reducing from 92% (class ≥ 3) at baseline to 18% at 6 weeks. There were significant improvements in generic and disease specific quality of life indicators up to 2 years. The all-cause mortality rate was estimated to be 12.7% (95% CI 7.5 to 17.7%) at 1 year. Percutaneous mitral valve leaflet repair was associated with reduced hospital readmissions and potential cost-savings in post-procedural care.ConclusionThis study shows that percutaneous mitral valve leaflet repair using MitraClip is a relatively safe and effective treatment in patients unable to tolerate surgery and has the potential to reduce ongoing healthcare costs in the UK.

Highlights

Mitral valve regurgitation (MR) is a significant cause of morbidity and mortality in older people
MR is normally classified as degenerative (DMR, primary or structural, MR) when the valve itself deteriorates, or functional (FMR, secondary MR), when the cause is secondary to structural changes of the ventricles, as can occur following ischaemic damage, cardiomyopathy, or related diseases
Procedures were excluded (n = 57) if the reason for treatment did not include either surgical turndown, high-risk for surgery or high-risk for surgery; procedures were excluded if the reason was documented as patient preference, clinician preference, or other

Summary

Introduction

Mitral valve regurgitation (MR) is a significant cause of morbidity and mortality in older people. In the UK, it is estimated that 9.4% of the adult population have MR, with 0.5% [1] severe. MR is normally classified as degenerative (DMR, primary or structural, MR) when the valve itself deteriorates, or functional (FMR, secondary MR), when the cause is secondary to structural changes of the ventricles, as can occur following ischaemic damage, cardiomyopathy, or related diseases. Open surgery is often indicated for severe DMR [4], and less commonly for FMR [5], the risks of surgical intervention can sometimes outweigh the benefits in patients with advanced MR

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Discussion

Conclusion