2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

OBJECTIVES: This study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis. BACKGROUND: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established. METHODS: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. RESULTS: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001). CONCLUSIONS: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.

Medical versus interventional management of stable angina.

Several randomized trials have been performed comparing medical management with surgery, medical management with angioplasty, and angioplasty with surgery for patients with stable angina. They were conducted in parallel with the progress of the revascularization techniques and as such, each of them reflects the prevailing practice of its time. Percutaneous revascularization and, to a lesser extent, coronary surgery have been, and it seems they will continue to be, rapidly evolving specialities. Medical management has also improved and future advances are likely to occur. One of the most remarkable advances in medical management is a new concept in metabolic approach in the treatment of angina pectoris. Despite the complexity of drawing conclusions from trials that compared approaches already outperformed in current practice, in this paper we review the relevant literature in an attempt to outline the comparative efficacy of the available treatment strategies.

Preliminary clinical experience with the repetitive administration of levosimendan in patients with end-stage heart failure.

We present our preliminary clinical experience with the initial and repetitive administration of the novel inotropic agent levosimendan in a cohort of 20 patients with end-stage heart failure who were acutely decompensated or whose symptoms were refractory to the usual pharmacological treatments thus necessitating hospitalization. Repetitive levosimendan infusions were administered to 9 patients (minimum 2, maximum 8 pulses). The effects of this therapy on the symptomatic status, vital signs, hemodynamic performance and clinical outcomes are discussed.