BACKGROUND Conduction system pacing (CSP) has emerged as an alternative to biventricular pacing (BiVP). Ran-domized studies comparing both therapies are scarce and do not include left bundle branch pacing. OBJECTIVES This study aims to compare ventricular resynchronization achieved by CSP vs BiVP in patients with cardiac resynchronization therapy indication. METHODS LEVEL-AT (Left Ventricular Activation Time Shortening with Conduction System Pacing vs Biventricular Resynchronization Therapy) was a randomized, parallel, controlled, noninferiority trial. Seventy patients with cardiac resynchronization therapy indication were randomized 1:1 to BiVP or CSP, and followed up for 6 months. Crossover was allowed when primary allocation procedure failed. Primary endpoint was the change in left ventricular activation time, measured using electrocardiographic imaging. Secondary endpoints were left ventricular reverse remodeling and the combined endpoint of heart failure hospitalization or death at 6-month follow-up. RESULTS Thirty-five patients were allocated to each group. Eight (23%) patients crossed over from CSP to BiVP; 2 patients (6%) crossed over from BiVP to CSP. Electrocardiographic imaging could not be performed in 2 patients in each group. A similar decrease in left ventricular activation time was achieved by CSP and BiVP (-28 +/- 26 ms vs-21 +/- 20 ms, respectively; mean difference-6.8 ms; 95% CI: -18.3 ms to 4.6 ms; P < 0.001 for noninferiority). Both groups showed a similar change in left ventricular end-systolic volume (-37 +/- 59 mL CSP vs-30 +/- 41 mL BiVP; mean difference:-8 mL; 95% CI:-33 mL to 17 mL; P = 0.04 for noninferiority) and similar rates of mortality or heart failure hospitalizations (2.9% vs 11.4%, respectively) (P = 0.002 for noninferiority). CONCLUSIONS Similar degrees of cardiac resynchronization, ventricular reverse remodeling, and clinical outcomes were attained by CSP as compared to BiVP. CSP could be a feasible alternative to BiVP. (LEVEL-AT [Left Ventricular Activation Time Shortening With Conduction System Pacing vs Biventricular Resynchronization Therapy]; NCT04054895)
机构:
Univ Hong Kong, Queen Mary Hosp, Sch Clin Med, Dept Med,Cardiol, Hong Kong, Peoples R China
Univ Hong Kong, Queen Mary Hosp, Cardiac Hlth Heart Ctr, Dept Med,Central, Suite 1303,Cent Bldg,1 Pedder St, Hong Kong, Peoples R ChinaUniv Hong Kong, Queen Mary Hosp, Sch Clin Med, Dept Med,Cardiol, Hong Kong, Peoples R China
Lauf, Chu-Pak
Tse, Hung-Fat
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Univ Hong Kong, Queen Mary Hosp, Sch Clin Med, Dept Med,Cardiol, Hong Kong, Peoples R China
Univ Hong Kong, Shenzhen Hosp, Cardiac & Vasc Ctr, Shenzhen, Peoples R China
Ctr Stem Cell Translat Biol, Hong Kong, Peoples R ChinaUniv Hong Kong, Queen Mary Hosp, Sch Clin Med, Dept Med,Cardiol, Hong Kong, Peoples R China