Abstract
Aims
The COAPT randomized trial has shown a huge benefit in the survival of patients with s heart failure and functional mitral regurgitation treated with MitraClip. However, patients in COAPT were highly selected and the clinical course in real-world patients with and without fulfilment of the trial inclusion criteria is unclear.
Methods
The present study examined the clinical outcome in consecutive patients with symptomatic moderate-to-severe or severe MR of dominant functional aetiology undergoing MitraClip therapy by the presence of the inclusion criteria of the COAPT trial (left ventricular ejection fraction >20%, left ventricular end-systolic dimension <70 mm, non-commissural primary jet, estimated pulmonary artery systolic pressure <70 mmHg, mitral valve orifice area >4 cm2, no prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure).
Results
The composite endpoint of all-cause mortality or heart failure hospitalization and the endpoint of heart failure hospitalization were analysed. Among 118 patients who underwent MitraClip implantation 61% fulfilled the inclusion criteria of COAPT. The composite endpoint was significantly less frequent (P = 0.05) in patients fulfilling the COAPT selection criteria than in those not fulfilling the criteria, with an estimated 1-year event rate of 25% vs. 49%. Heart failure hospitalization was significantly less frequent (P = 0.04) in patients fulfilling COAPT selection criteria than in those who did not, with an estimated 1-year event rate of 19% vs. 36.8%.
Conclusions
In this single centre study the outcome of patients with functional mitral regurgitation undergoing MitraClip therapy was significantly worse in patients not fulfilling COAPT inclusion criteria, indicating that these criteria might help identify futility.
MitraClip in patients with functional mitral regurgitation and advanced heart failure - Single centre experience