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

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

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study

OBJECTIVES: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. BACKGROUND: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. METHODS: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. RESULTS: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p \u3c 0.0001); and 85% were in New York Heart Association functional class I or II (p \u3c 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p \u3c 0.0001) and 10 (p = 0.0004) points, respectively. CONCLUSIONS: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349)

Impact of coenzyme Q-10 on parameters of cardiorespiratory fitness and muscle performance in older athletes taking statins

Many older athletes take statins, which are known to have potential for muscle toxicity. The adverse effects of statins on muscles and the influence thereof on athletic performance remain uncertain. Coenzyme Q-10 (CoQ10) may improve performance and reduce muscle toxicity in older athletes taking statins. This trial was designed to evaluate the benefits of CoQ10 administration for mitochondrial function in this population. Twenty athletes aged ≥ 50 years who were taking stable doses of statins were randomized to receive either CoQ10 (200 mg daily) or placebo for 6 weeks in a double-blind, placebo-controlled, crossover study to evaluate the impact of CoQ10 on the anaerobic threshold (AT). Several secondary endpoints, including muscle function, cardiopulmonary exercise function, and subjective feelings of fitness, were also assessed. The mean (SD) change in AT from baseline was -0.59 (1.2) mL/kg/min during placebo treatment and 2.34 (0.8) mL/kg/min during CoQ10 treatment (P = 0.116). The mean change in time to AT from baseline was significantly greater during CoQ10 treatment than during placebo treatment (40.26 s vs 0.58 s, P = 0.038). Furthermore, muscle strength as measured by leg extension repetitions (reps) increased significantly during CoQ10 treatment, with a mean (SD) increase from baseline of 1.73 (2.9) reps during placebo treatment versus 3.78 (5.0) reps during CoQ10 treatment (P = 0.031). Many other parameters also tended to improve in response to CoQ10 treatment. Treatment with CoQ10 improved AT in comparison with baseline values in 11 of 19 (58%) subjects and in comparison with placebo treatment values in 10 of 19 (53%) subjects. Treatment with CoQ10 (200 mg daily) did not significantly improve AT in older athletes taking statins. However, it did improve muscle performance as measured by time to AT and leg strength (quadriceps muscle reps). Many other measures of mitochondrial function also tended to improve during CoQ10 treatment