January 29, 2019—Findings from an investigation of the causes and clinical outcomes of patients who are ineligible for transcatheter mitral valve replacement (TMVR) were published online by Hiroki Niikura, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The investigators concluded that patients ineligible for TMVR and treated medically have poor outcomes. They advised that the findings and the high rate of TMVR screen failure support the need for therapy iteration and the development of alternative means of management, with the goal of improving the prognosis of these patients.

As summarized in JACC: Cardiovascular Interventions, the study was composed of 203 patients (mean age 79 ± 9 years, 48% men) who were ineligible for participation in early feasibility studies of TMVR.

The investigators reported that the ineligibility rate for TMVR was 89%. The most common reasons for TMVR exclusion were excessive frailty (15.3%), severe tricuspid regurgitation (15.3%), and previous aortic valve therapy (14.2%). Mitral anatomic exclusions were present in 15.8%, with severe annular calcification in 7.4%, and risk for left ventricular outflow tract obstruction was notably infrequent (4.4%).

Overall, 76 (37.4%) patients did not undergo subsequent commercial surgical or transcatheter mitral therapy.

Patients not eligible for TMVR and not treated commercially had high rates of cardiac death (11.8%) and death or heart failure hospitalization (22.4%) at 1 year. These rates were significantly higher than those who underwent surgery (2.4% for cardiac death, P < .001; 5.5% for heart failure hospitalization, P = .003) and remained worse after excluding patients with excessive frailty or medical futility and in multivariate modeling that adjusted for baseline differences, reported the investigator in JACC: Cardiovascular Interventions.