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Conduction System Pacing vs Biventricular Pacing in Heart Failure and Wide QRS Patients: LEVEL-AT Trial
Margarida Pujol-Lopez1, Rafael Jiménez-Arjona2, Paz Garre2
1Institut Clínic Cardiovascular (ICCV), Hospital Clínic, Universitat de Barcelona, Catalonia, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Catalonia, Spain.
Insights
Conduction system pacing (CSP) offers similar cardiac resynchronization and reverse remodeling as biventricular pacing (BiVP). CSP is a viable alternative for patients needing cardiac resynchronization therapy.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Devices
Background:
- Conduction system pacing (CSP) is an emerging alternative to biventricular pacing (BiVP).
- Limited randomized trials exist comparing these pacing methods, particularly excluding left bundle branch pacing.
- This study addresses the need for comparative data on CSP versus BiVP.
Purpose of the Study:
- To compare the effectiveness of CSP and BiVP in achieving ventricular resynchronization.
- To evaluate left ventricular activation time, reverse remodeling, and clinical outcomes in patients receiving CSP versus BiVP.
- To determine if CSP is non-inferior to BiVP for cardiac resynchronization therapy indications.
Main Methods:
- A randomized, parallel, controlled, noninferiority trial (LEVEL-AT) was conducted.
- Seventy patients indicated for cardiac resynchronization therapy were randomized 1:1 to BiVP or CSP for 6 months.
- Primary endpoint: change in left ventricular activation time; Secondary endpoints: left ventricular reverse remodeling, heart failure hospitalization or death.
Main Results:
- Both CSP and BiVP achieved similar reductions in left ventricular activation time (mean difference -6.8 ms; P < 0.001 for noninferiority).
- Similar improvements in left ventricular end-systolic volume were observed in both groups (P = 0.04 for noninferiority).
- Rates of mortality or heart failure hospitalizations were comparable, with CSP showing a trend towards better outcomes (P = 0.002 for noninferiority).
Conclusions:
- Conduction system pacing achieves comparable cardiac resynchronization and ventricular reverse remodeling to biventricular pacing.
- CSP demonstrates feasibility as an alternative to BiVP for patients requiring cardiac resynchronization therapy.
- The LEVEL-AT trial supports CSP as a valuable option in cardiac resynchronization therapy.
Background:
Conduction system pacing (CSP) has emerged as an alternative to biventricular pacing (BiVP). Randomized 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).
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