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

A Review of the Rationale for Additional Therapeutic Interventions to Attain Lower LDL-C When Statin Therapy Is Not Enough

Statins alone are not always adequate therapy to achieve low-density lipoprotein (LDL) goals in many patients. Many options are available either alone or in combination with statins that makes it possible to reach recommended goals in a safe and tolerable fashion for most patients. Ezetimibe and bile acid sequestrants reduce cholesterol transport to the liver and can be used in combination. Niacin is very effective at lowering LDL, beyond its ability to raise high-density lipoprotein and shift LDL particle size to a less atherogenic type. When statins cannot be tolerated at all, red yeast rice can be used if proper formulations of the product are obtained. Nutrients can also be added to the diet, including plant stanols and sterols, soy protein, almonds, and fiber, either individually or all together as a portfolio diet. A clear understanding of how each of these strategies works is essential for effective results

P1777Concordance and discordance among the recommended echocardiographic parameters for the assessment of mitral regurgitation severity

Abstract Background The EACVI and ACC/AHA guidelines recommend assessing several echocardiographic parameters when evaluating mitral regurgitant severity. In a given patient, these parameters can be discordant making the assessment of mitral regurgitation challenging. Purpose To assess the degree to which echocardiographic parameters of MR severity are concordant. Methods This analysis included 131 consecutive patients with primary mitral regurgitation enrolled in a prospective multicenter study. Nine parameters were included in this analysis (PISA –derived regurgitant volume, PISA-derived EROA, vena contracta, color Doppler jet/LA area, LA volume index, LVEDVI, peak E wave, pulmonary vein systolic flow reversal, and presence of flail leaflet). Each echocardiographic parameter was determined to represent severe or nonsevere mitral regurgitation according to the guidelines. A concordance score was calculated as: (the number of concordant parameters/9) * 100 so that a higher score reflects greater concordance. Each echocardiogram was graded as having mild, moderate, or severe mitral regurgitation using the guideline recommended integrated approach. Results The mean concordance score was 74±13% for the entire cohort. There were 4 (4%) patients with complete agreement of all parameters and 32 (25%) with agreement of 5 of the 9 parameters. There was greater discordance in patients with severe MR and eccentric jets but no difference between patients with prolapse or flail leaflets (Figure 1). Clinical predictors of discordance were vena contracta and the peak E wave. Figure 1 Conclusion In this series, there was imperfect concordance between the recommended echocardiographic parameters of MR severity in patients undergoing evaluation for mitral regurgitation. The discordance was worse with more severe mitral regurgitation and there was no ideal predictor of discordance. These findings highlight the challenges facing echocardiographers when assessing the severity of mitral regurgitation and underscore the importance of using the integrated approach recommended by professional societal guidelines. Acknowledgement/Funding None </jats:sec

A Comparative Assessment of Echocardiographic Parameters for Determining Primary Mitral Regurgitation Severity Using Magnetic Resonance Imaging as a Reference Standard.

BACKGROUND: The American Society of Echocardiography (ASE) guidelines suggest the use of several echocardiographic methods to assess mitral regurgitation severity using an integrated approach, without guidance as to the weighting of each parameter. The purpose of this multicenter prospective study was to evaluate the recommended echocardiographic parameters against a reference modality and develop and validate a weighting for each echocardiographic measure of mitral regurgitation severity. METHODS: This study included 112 patients who underwent evaluation with echocardiography and magnetic resonance imaging (MRI). Echocardiographic parameters recommended by the ASE were included and compared with MRI-derived regurgitant volume (MRI-RV). RESULTS: Echocardiographic parameters that correlated best with MRI-RV were proximal isovelocity surface area (PISA) radius (r = 0.65, P \u3c .0001), PISA-derived effective regurgitant orifice area (r = 0.65, P \u3c .0001), left ventricular end-diastolic volume (r = 0.56, P \u3c .0001), and PISA-derived regurgitant volume (r = 0.52, P \u3c .0001). In the linear regression models PISA-derived effective regurgitant orifice area, PISA-derived regurgitant volume, left ventricular end-diastolic volume, and the presence of a flail leaflet independently predicted MRI-RV. CONCLUSION: Echocardiographic parameters of mitral regurgitation as recommended by the ASE had moderate correlations with MRI-RV. The best predictors of MRI-RV were PISA-derived effective regurgitant orifice area, PISA-derived regurgitant volume, left ventricular end-diastolic volume, and the presence of a flail leaflet, suggesting that these parameters should be weighted more heavily than other echocardiographic parameters in the application of the ASE-recommended integrated approach

Six-month and one-year outcomes with the PASCAL transcatheter valve repair system for patients with mitral regurgitation from the multicentre, prospective CLASP study

Abstract Background Transcatheter mitral valve repair has emerged as a viable option for treating mitral regurgitation (MR). We report results from the multicentre, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system. Methods 109 patients with clinically significant MR deemed candidates for transcatheter repair by the local heart team were treated in the CLASP study. The study evaluated safety, performance, clinical and echocardiographic outcomes and included an independent clinical events committee and echocardiographic core lab. The primary safety endpoint was a composite MAE rate at 30 days of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications. Results Mean age was 76 years, 54% male, 57% NYHA Class III/IV, 100% MR grade ≥3+ with 62% functional, 31% degenerative, 7% mixed etiology. Successful implantation was achieved in 95% of patients. At 30 days, the MAE rate was 8.3% including one cardiovascular mortality due to cardiogenic shock as a result of severe bleeding at the contralateral arterial access site for hemodynamic monitoring further complicated by disseminated intravascular coagulation, one stroke, and one conversion to mitral valve replacement surgery. In paired analysis, 88% of patients were in NYHA Class I/II (p&amp;lt;0.001), MR grade was ≤1+ in 79% of patients and ≤2+ in 96% of patients. Significant improvements in 6MWD (+27 m, p&amp;lt;0.001) and KCCQ (+16 points, p&amp;lt;0.001) were observed. The six-month data will be available for presentation. In addition, we report one-year follow up of the first 62 patients (ITT): 93% one-year survival rate (Kaplan-Meier estimate), no stroke, no late reintervention, one late MI. In paired analysis, MR grade was ≤1+ in 82% of patients and ≤2+ in 100% of patients. 88% of patients were in NYHA Class I/II (p&amp;lt;0.001), 6MWD improved by 21 m (p=0.124) and KCCQ improved by 13 points (p&amp;lt;0.001). Conclusions This study demonstrates the PASCAL transcatheter valve repair system is safe and resulted in robust MR reduction with 100% of patients achieving MR ≤2+, and ∼ 80% MR ≤1+, sustained at one year. Results show high survival and low complication rates, and sustained improvements in functional status, exercise capacity, and quality of life at one year in patients with clinically significant, symptomatic MR. The CLASP IID/IIF pivotal trial is underway. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Edwards Lifesciences (Irvine, CA) </jats:sec