Transcatheter mitral valve repair (TMVr) using the MitraClip in patients with cardiogenic shock (CS) and moderate-to-severe or severe mitral regurgitation (MR) improved short-term mortality and heart failure rehospitalization rates, according to a pooled patient-level analysis of previously published studies released Monday.
As transcatheter therapeutics continue to emerge, TMVr using the MitraClip has established itself as a treatment options for inoperable patients with significant MR, demonstrating a favorable safety profile in pivotal trials. Historically, patients with both CS and severe MR have a worse prognosis. TMVr using the MitraClip is increasingly being used to treat these patients, although its efficacy in this population remains unclear.
Richard G. Jung, BSc, of the University of Ottawa Heart Institute, Ontario, and co-investigators, sought to investigate the efficacy of MitraClip in these patients. They reported results from their pooled patient-level analysis of previously published patients with CS and significant MR who underwent TMVr using the MitraClip in the Jan. 11 issue of JACC: Cardiovascular Interventions.
The authors included data from 14 institutions, totaling 141 patients who underwent TMVr using the MitraClip for moderate-severe or severe MR in CS. The primary outcome of interest was inpatient mortality. Additional outcomes of interest were 90-day mortality and HF rehospitalization after dichotomizing patients by TMVr device success.
With regard to the primary outcome, the inpatient death rate was 15.6% (22 patients). At 90 days, the death rate was 15.6% (n=38) and at 1 year, the death rate 42.6% (n=55). The median length of stay was 10 days following TMVr. HF rehospitalization was required for 26 patients (18.4%) at a median of 73 days.
After patients were dichotomized according to procedural success, patients with successful TMVr saw a lower rate of inpatient death (hazard ratio [HR], 0.36; 95% confidence interval [CI]: 0.13, 0.98; p=0.04) and lower composite rate of 90-day death and HF rehospitalization (HR, 0.42; 95% CI: 0.19, 0.90; p=0.03).
Philipp Lurz, MD, PhD, and Christian Besler, MD, of the Heart Center Leipzig at University of Leipzig, Germany, wrote an accompanying editorial to the study. They began by emphasizing the challenges of managing patients with CS over the last few decades.
Despite the limited available data, they congratulated the authors on their analysis, which the editorialists said provides a more solid database of CS patients with MR receiving TMVr. The results of this study are encouraging, Lurz and Besler added, but it is too early to draw any firm conclusions from this study.
Jung RG, Simard T, Kovach C, et al. Transcatheter Mitral Valve Repair in Cardiogenic Shock and Mitral Regurgitation: A Patient-Level, Multicenter Analysis. JACC Cardiovasc Interv 2021;14:1–11.
Lurz P, Besler C. Mitral Regurgitation in Cardiogenic Shock: A Novel Target for Transcatheter Therapy? JACC Cardiovasc Interv 2021 Jan 4. (Article in press). DOI: 10.1016/j.jcin.2020.09.030