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

PLoS One. 2021 May 12;16(5):e0251463. doi: 10.1371/journal.pone.0251463. eCollection 2021.

Abstract

Aims: Percutaneous 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 results: This 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.

Conclusion: This 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Female
  • Health Care Costs
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / economics
  • Heart Valve Prosthesis Implantation / methods*
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Middle Aged
  • Mitral Valve / surgery*
  • Mitral Valve Insufficiency / surgery*
  • Prospective Studies
  • Treatment Outcome

Grants and funding

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. Newcastle upon Tyne Hospitals NHS Foundation Trust, the employing institution of IW, KK, HC (for the duration of the study) and AJS, is contracted as External Assessment Centre (EAC) to the NICE Medical Technologies Evaluation Programme (MTEP) and is contracted by Academic Health Science Network North East and North Cumbria to develop methodologies and case studies relating to "evaluation in practice" in the context of using routine healthcare datasets and, where appropriate, clinical registries, to assess outcomes and adoption of novel interventions. This work was undertaken by Newcastle EAC in collaboration with NHS England. In May 2020 HC moved to a new role and is employed by the Northern Health Science Alliance Ltd., who have no past or present interest in the study.