2-year outcomes for transcatheter repair in patients with functional mitral regurgitation from the CLASP study

Background: Transcatheter mitral valve repair has emerged as a favourable option in patient care for treating functional mitral regurgitation (FMR) with a need for longer term data. We herein report two-year outcomes from the FMR group of the multicentre, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system. Methods: Patients with symptomatic, clinically significant FMR ≥3+ as evaluated by the core laboratory and deemed candidates for transcatheter repair by the local heart team were eligible for the study. Follow-up was conducted at 30 days, one year, and two years with echocardiographic outcomes evaluated by the core laboratory at all timepoints and major adverse events (MAEs) evaluated by an independent clinical events committee to one year (site-reported thereafter). Results: Eighty-five FMR patients were treated with mean age 72 years, 55% male, 65% in NYHA Class III-IVa, 37% LVEF, and 100% MR grade ≥3+. Successful implantation was achieved in 96% of patients. MAEs included one cardiovascular mortality (1.2%) and one conversion tomitral valve replacement surgery (1.2%) at 30 days, and two reinterventions between 30 days and two years. Kaplan-Meier (KM) estimates for survival were 88% at one year and 72% at two years. Freedom from heart failure (HF) rehospitalization KM estimates were 81% at one year and 78% for two years. The reduction in annualized HF hospitalization rate was 81% at two years (p\u3c0.001). MR ≤1+ was achieved in 73% of patients at 30 days, 75% at one year, and 84% at two years; MR ≤2+ was achieved in 96% of patients at 30 days, 100% at one year, and 95% two years (all p\u3c0.001). Mean LVEDV of 199 mL at baseline decreased by 9 mL at 30 days (p=0.039), 29 mL at one year (p\u3c0.001), and 31 mL at two years (p\u3c0.001). NYHA class I/II was achieved in 87% of patients at 30 days, 86% at one year, and 88% at two years (all p\u3c0.001). Six-minute walk distance (6MWD) improved by 22 m at 30 days (p=0.004) and 40 m at one year (p=0.003). Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved by 16 points at 30 days and one year (all p\u3c0.001). Conclusions: In the CLASP study, the PASCAL transcatheter valve repair system demonstrated sustained favourable outcomes at two years in patients with FMR. Results showed a high survival rate of 72% and freedom from HF rehospitalization of 78% at two years. An 81% reduction in annualized HF hospitalization rate was observed. At two years, sustained MR reduction of MR ≤2+ was achieved in 95% andMR ≤1+ in 84% of patients, with evidence of left ventricular reverse remodelling. Improvements in functional status were significant and sustained at two years. The CLASP IIF randomized pivotal trial is ongoing

Depressive Symptoms in Patients with Congenital Heart Disease: Incidence and Prognostic Value of Self-Rating Depression Scales

Objective: To determine the presence of depressive symptoms in adolescent and adult patients with CHD and their impact on prognosis, using self-rating depression scales. Design: Prospective study. Setting: Outpatient clinic of a tertiary center. Patients: Sixty ambulatory adolescent and adult patients admitted at the outpatient clinic for regular evaluation. Methods: Self-rating depression questionnaires (Beck Depression Inventory [BDI] and Zung Self-Rating Depression Scale [Zung SDS]) were administered on admission. Patients were characterized as having depressive symptoms when scores on both questionnaires were above cutoff levels and were subsequently followed for 5.1 ± 1.1 years for major adverse cardiovascular events (MACEs; death or hospitalization for cardiac reasons). Results: Seventeen patients (mean age 28.9 ± 11.4 years) were characterized as having depressive symptoms. According to univariate Cox regression analysis, the presence of depressive symptoms was independently associated with adverse clinical outcome. During the follow-up period, patients with depressive symptoms had a shorter event-free survival (1559 ± 92days vs. 1077 ± 188days, P = .00215) and a twofold higher risk of getting a MACE, compared with patients without (95% CI 1.630 to 3.616, P < .05). Based on receiver operator characteristics, the BDI had a better prognostic value for future MACEs (area under curve = 0.662, 95% CI 0.5442 to 0.7792; P < .05) compared with the Zung SDS. Mean event-free survival for patients with BDI ≥ 10 was 986 ± 179 days vs. 1624 ± 83 days for patients with BDI < 10. Conclusions: The incidence of depressive symptomatology in patients with CHD is rather high and is associated with poorer prognosis. The BDI seems to independently predict adverse clinical outcome. Standardized screening tools and psychosocial interventions to improve the well being of these patients should be a priority in the overall care of this population. © 2014 Wiley Periodicals, Inc

MitraClip and left ventricular reverse remodelling: a strain imaging study

Aims: The purpose of this study is to identify echocardiography predictors of clinical response and reverse left ventricular (LV) remodelling in patients with functional mitral regurgitation (FMR) treated with MitraClip. Method and results: We retrospectively analysed 86 high surgical risk patients with severe FMR; of those, 58 were implanted a MitraClip, and 28 received medical treatment and served as controls. At baseline and at 1-year follow-up, we performed clinical and echocardiography evaluation to assess global longitudinal strain (GLS) and myocardial work [global work index (GWI), global constructive work (GCW), global wasted work (GWW), global work efficiency (GWE)]. Mitral regurgitation was significantly reduced after MitraClip implantation (3.7 ± 0.4 vs. 1.7 ± 0.8, P < 0.001), and the procedure was associated with improvement in brain natriuretic peptide levels (980 ± 1027 vs. 420 ± 338 pg/mL, P < 0.001), New York Heart Association class status (3.2 ± 0.55 vs. 2.0 ± 0.6, P < 0.001), 6-min walking test (233 ± 154 vs. 286 ± 114 m, P = 0.01) at follow-up and reduction of left ventricle end-systolic (LVESV) and left ventricle end-diastolic volumes (LVEDV) (152 ± 68 vs. 136 ± 43 mL, P = 0.004 & 219 ± 74 vs. 193 ± 66 mL, P = 0.001, respectively). MitraClip procedure was associated with improvement of LV performance and significant increase of GWI (607 ± 282 vs. 650 ± 260 mmHg%, P = 0.045) and GCW (854 ± 288 vs. 949 ± 325 mmHg%, P < 0.001). Baseline ejection fraction (EF), GLS, GWI, GCW, and effective regurgitant orifice area were the variables that were associated with reduction of LVEDV 1 year after intervention (P < 0.05 for all) and baseline GCW of the LV was the only variable associated with reduction of LVESV (P = 0.002). Receiver operating characteristic curve analysis identified that a GLS cut-off value of −8.65% (AUC 0.815, P = 0.007) was associated with a 20% reduction of the LVEDV with a sensitivity and specificity of 72% and 70%, respectively, and that a GCW cut-off value of 846 mmHg% (AUC 0.759, P = 0.007) was associated with a 10% reduction of LVESV with sensitivity and specificity 79% and 74%, respectively. Conclusions: Mitral valve repair with MitraClip has positive clinical and echocardiographic impact in patients with FMR 1 year after implantation. Preserved GLS and GCW values appear to be associated with LV reverse remodelling post intervention. © 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiolog

Percutaneous repair of moderate‐to‐severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE‐HF2 trial and comparison to COAPT and MITRA‐FR trials

© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.Aim: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. Methods and results: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. Conclusion: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.Open Access funding enabled and organized by Projekt DEALinfo:eu-repo/semantics/publishedVersio

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Mid-Term Evaluation of Valve-in-Valve and Valve-in-Ring Implantation from the VIVID Registry

Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining mid-term outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient 6510 mmHg and significant residual mitral regurgitation (MR) as 65 moderate. Results: A total of 1,079 patients (857 ViV, 222 ViR; mean age 73.5 years \ub1 12.5; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days [IQR 76 - 996 days]; median echocardiographic follow-up for patients that survived 1 year 772.5 days [IQR 510 - 1211.75 days]. Four-year Kaplan-Meier survival rate was 62.5% in ViV vs. 49.5% for ViR (p<0.001). Mean gradient across the mitral valve post-procedure was 5.7 \ub1 2.8 mmHg ( 655mmHg, 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (p=0.09). Significant residual MR was more common in ViR patients (16.6% vs. 3.1%; p<0.001) and was associated with lower survival at 4 years (35.1% vs. 61.6%; p=0.02). The rates of MVARC-defined device success were low for both procedures (39.4% total; 32.0% ViR vs. 41.3% ViV; p=0.01), mostly related to having post-procedural mean gradient 655mmHg. Correlates for residual MS were smaller true internal diameter, younger age and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (SHR 4.67; 95% CI 1.74 - 12.56; p=0.002) and significant residual MR (SHR 7.88; 95% CI 2.88 - 21.53; p<0.001) were both independently associated with repeat mitral valve replacement. Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve post-procedural hemodynamics in mitral ViV and ViR should be further explored