Application of Impella Mechanical Circulatory Support Devices in Transcatheter Aortic Valve Replacement and Balloon Aortic Valvuloplasty: A Single-Center Experience.

BACKGROUND/PURPOSE: Percutaneous valve interventions for aortic stenosis (AS) include transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV). Intraprocedural mechanical circulatory support (MCS) with Impella devices (Abiomed, Danvers, MA) is used in select high-risk patients, although data regarding its efficacy is limited. This study sought to evaluate the clinical outcomes of Impella use in patients with AS who underwent TAVR and BAV at a quaternary-care center. METHODS/MATERIALS: All patients with severe AS who underwent TAVR and BAV with Impella between 2013 and 2020 were included. Patient demographics, outcomes, complications, and 30-day mortality data was analyzed. RESULTS: Over the study period 2680 procedures were performed, 1965 TAVR and 715 BAV. 120 utilized Impella support, 26 TAVR and 94 BAV. Among TAVR Impella cases, justifications for MCS included cardiogenic shock (53.9 %), cardiac arrest (19.2 %), and coronary occlusion (15.4 %). Among BAV Impella cases, justifications for MCS included cardiogenic shock (55.3 %) and protected percutaneous coronary intervention (43.6 %). The 30-day mortality rate in TAVR Impella was 34.6 % and in BAV Impella was 28 %. BAV Impella cases involving cardiogenic shock had a higher rate of 45 %. Impella remained in-use past 24 h from the procedure in 32.2 % cases. Vascular access-related complications occurred in 4.8 % cases and bleeding complications occurred in 1.5 % cases. Conversion to open-heart surgery occurred in 0.7 % cases. CONCLUSIONS: MCS is an option for high-risk patients with severe AS who require TAVR and BAV. Despite hemodynamic support, the 30-day mortality rate remained high especially in cases where support was employed for cardiogenic shock.

Statin-Associated Muscle Symptoms Among New Statin Users Randomly Assigned to Vitamin D or Placebo.

Importance: Statin-associated muscle symptoms (SAMS) are common and may lead to discontinuation of indicated statin therapy. Observational studies suggest that vitamin D therapy is associated with reduced statin intolerance, but no randomized studies have been reported. Objective: To test whether vitamin D supplementation was associated with prevention of SAMS and a reduction of statin discontinuation. Design, Setting, and Participants: Men 50 years or older and women 55 years or older, free of cancer and cardiovascular disease, were enrolled in a randomized, placebo-controlled, double-blind clinical trial of vitamin D supplementation. Participants who initiated statin therapy after randomization were surveyed in early 2016. The data were analyzed in early 2022. Interventions: Daily cholecalciferol (2000 international units) or placebo with assessment of statin prescriptions during follow-up. Main Outcomes and Measures: Muscle pain or discomfort lasting several days (primary outcome) and discontinuation of a statin due to SAMS (secondary outcome). Results: Statins were initiated by 1033 vitamin D-assigned participants and 1050 placebo-assigned participants; mean (SD) age was 66.8 (6.2) years and 49% were women. Over 4.8 years of follow-up, SAMS were reported by 317 participants (31%) assigned vitamin D and 325 assigned placebo (31%). The adjusted odds ratio (OR) was 0.97 (95% CI, 0.80-1.18; P = .78). Statins were discontinued by 137 participants (13%) assigned to vitamin D and 133 assigned to placebo (13%) with an adjusted OR of 1.04 (95% CI, 0.80-1.35; P = .78). These results were consistent across pretreatment 25-hydroxy vitamin D levels (interaction P value = .83). Among participants with levels less than 20 ng/mL, SAMS were reported by 28 of 85 vitamin D-assigned participants (33%) and 33 of 95 placebo-assigned participants (35%). For those with levels less than 30 ng/ml, SAMS were reported by 88 of 330 vitamin-D assigned participants (27%) and 96 of 323 of placebo-assigned participants (30%). Conclusions and Relevance: Vitamin D supplementation did not prevent SAMS or reduce statin discontinuation. These results were consistent across pretreatment 25-hydroxy vitamin D levels. Trial Registration: ClinicalTrials.gov Identifier: NCT01169259.