812 Prognostic impact of the COAPT inclusion and exclusion criteria in real-world patients with secondary mitral regurgitation undergoing MitraClip implantation

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.

Prognostic impact of right ventricular dysfunction following transcatheter mitral valve repair

Background Little is known regarding the impact of right ventricular (RV) function on clinical outcomes following MitraClip therapy. Objectives The aim of this study was to investigate the prognostic impact of RV dysfunction and its cut-off value following MitraClip therapy. Methods Consecutive 77 patients (median 79 years, 33% female) who underwent MitraClip therapy were enrolled. Clinical endpoint was defined as cardiovascular (CV) events, including cardiovascular death and rehospitalization for heart failure (HF). Results and conclusions Twenty-two (29%) patients had primary mitral regurgitation (MR). During follow-up, 5 patients died due to CV events, 8 were hospitalized for HF. On univariate Cox regression analysis, CV events were associated with eGFR (HR; 0.960, 95% CI; 0.926–0.995, p = 0.027), tricuspid annular plane systolic excursion (TAPSE, HR; 0.874, 95% CI; 0.789–0.968, p = 0.010), and significant residual MR (HR; 11.652, 95% CI; 3.257–41.691, p <0.001). On multivariate Cox regression analysis, TAPSE (HR; 0.788, 95% CI; 0.788–0.987, p = 0.029) and significant residual MR (HR; 9.373, 95% CI; 2.581–34.033, p = 0.001) were independently associated with CV events. TAPSE <11 mm was the best cut-off criteria for predicting CV events. RV function was independently associated with clinical outcomes following MitraClip therapy. TAPSE is a simple parameter for predicting CV events in patients with MR who are undergoing MitraClip therapy.

Residual mitral regurgitation impact on outcomes after mitraclip therapy: five-year follow-up from the GRASP registry

Funding Acknowledgements Type of funding sources: None. Background – Although percutaneous mitral valve repair is an attractive alternative treatment option for patients with severe mitral regurgitation (MR) at high surgical risk, residual MR is commonly observed after the procedure and little is known about its impact on outcomes after MitraClip therapy, expecially in patients with severe left ventricular (LV) impairment. Purpose – The aim of this prospective, observational study was to evaluate the impact of residual MR (MR ≤1+ vs. MR &gt;1+) on long-term outcomes of mitral valve repair with the MitraClip System in high surgical risk patients presenting with moderate-to-severe or severe MR and with severe reduction of LV ejection fraction (EF). Methods – Patients enrolled in the prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) with functional MR and EF ≤30% who were eligible at almost five-year follow-up were included in the present analysis. The primary endpoint was death at 5-year follow-up. Also echocardiographic parameters at baseline and 5-year follow-up and rehospitalization rates were assessed. Results – A total of 139 patients were included: 92 (66.2%) with post-procedural residual MR ≤1+ and 47 (33.8%) with residual MR &gt; 1+ (41 patients with residual MR 2+, 5 with residual MR 3+, 1 with residual MR 4+). Comparable clinical and echocardiographic baseline characteristics were observed between the two groups except for NYHA functional class IV and implanted pace-maker (more frequent in patients with residual MR &gt;1+) and previous myocardial infarction (more frequent in patients with residual MR ≤1+). At 5-year follow-up, no significant differences were reported in the primary endpoint (49.6% in patients with residual MR ≤ 1+ vs. 65.3% in patients with residual MR &gt; 1+, p 0.203) and in cardiac death (37.8% in patients with residual MR ≤ 1+ vs. 42.6% in patients with residual MR &gt; 1+, p 0.921). Cox regression analysis identified residual MR &gt; 1+ as an independent predictor of re-hospitalization (HR 0.51, 95% CI 0.28-0.92, p =0.026). At 5-year follow-up, a significant reduction in left ventricular end-systolic volume was observed in patients with residual MR ≤ 1+. Conclusions – At 5-year follow no significant differences in survival emerged in patients with severe LV dysfunction undergoing MitraClip therapy regardless residual MR. Nevertheless residual MR &gt; 1+ emerged as an indipendent predictor of re-hospitalization.

MitraClip therapy in patients with acute severe mitral regurgitation

Background There is a lack of data to support the optimal management of high-risk patients with acute severe mitral regurgitation (MR). The role of the MitraClip implantation in treatment of acute severe mitral regurgitation (MR) is undetermined. Methods We screened all patients who underwent MitraClip implantation at the Hadassah Medical Center between October 2015 and December 2019. We evaluated immediate, 30-day and 1-year outcomes after the procedure. We evaluated patients with severe MR due to ruptured cord because of degenerative disease and acute-on-chronic functional MR due to ischemic (after a recent myocardial infarction (MI)) or non-ischemic etiology (secondary to decompensated HF). Results From a cohort of 151 patients, who underwent MitraClip implantation in our center, we identified 35 patients (23.2%) with acute severe mitral regurgitation (4+) and decompensated refractory heart failure. Patients' mean age was 74.15 years, 66.9% - were males. One, 2, or 3 clips were implanted. Reduction of MR from 4+ to 1+ was achieved in 34 patients (66.7%). Twenty-eight patients (80%) had acute-on-chronic severe MR and refractory heart failure including 6 cases after recent MI, other 7 patients presented with heart failure and acute severe MR secondary to ruptured cord due to degenerative disease. After MitraClip implantation, reduction of MR severity was achieved in all patients. Seven patients were withdrawn from intravenous therapy and intra-aortic balloon pump 2–3 days after the procedure. Four patients died during hospitalization, three of them due to sepsis. 30-day follow-up showed improvement of NYHA functional class and a tendency toward improvement in left ventricle systolic function with signs of reverse remodeling. Nevertheless, we observed high 30-day and 1-year mortality rate (11.4 and 23.8% respectively). Conclusions MitraClip therapy could be an alternative option for treatment of patients with acute and acute-on-chronic severe MR of ischemic and non-ischemic etiology. Funding Acknowledgement Type of funding source: None