Left Ventricular Activation Time Shortening With Conduction System Pacing vs Biventricular Resynchronization Therapy - LEVEL-AT
Contribution To Literature:
The LEVEL-AT trial showed that ventricular synchronization achieved with conduction system pacing is noninferior to conventional BiV pacing among eligible patients.
Description:
The goal of the trial was to evaluate whether conduction system pacing would be noninferior to biventricular (BiVP) pacing.
Study Design
Patients were randomized in a 1:1 fashion to either conduction system pacing (n = 35) or BiV pacing (n = 35). BiV pacing devices were implanted according to usual practice. The preferred placement of the LV lead was posterolateral or lateral. The conduction system lead was initially placed at the His-Purkinje system. After the first month of the study, the protocol was amended to allow both strategies (His bundle pacing [HBP] or left bundle branch pacing [LBBP]) to be selected according to operator discretion.
Only four of the patients allocated to conduction system pacing received HBP, while His pacing was pursued in 20% of patients allocated to conduction system pacing, with an implant success in 57% of patients. In 28 of 35 patients, LBBP was pursued with an implant success in 82%. There were eight crossovers from conduction system pacing to BiV pacing.
- Total screened: 80
- Total randomized: 70
- Duration of follow-up: 45 days
- Mean patient age: 66 years
- Percentage female: 30%
Inclusion criteria:
- Age ≥18 years
- Symptomatic patients with heart failure on optimal medical treatment with left ventricular ejection fraction (LVEF) ≤35%
- Wide QRS complex (left bundle branch block [LBBB] interval ≥130 ms or QRS ≥150 milliseconds in non-left branch block)
- Indication for cardiac resynchronization therapy (CRT) due to atrioventricular (AV) block and cardiac dysfunction
Exclusion criteria:
- Myocardial infarction
- Unstable angina
- Cardiac revascularization or valve surgery/intervention within 3 months before assessment
Other salient features/characteristics:
- LBBB: 61%
- Permanent atrial fibrillation: 8%
- LVEF: 28%
- Use of beta-blockers at baseline: 85%
Principal Findings:
The primary outcome, change in LV activation time from baseline on electrocardiographic imaging, for conduction system pacing vs. BiV pacing, was: -28 vs. -21 (p for noninferiority < 0.001; p for superiority = 0.24).
Secondary outcomes for conduction system pacing vs. BiV pacing:
- Change in QRS from baseline: -53 vs. -48 msec (p = 0.23)
- Change in LVEF at 6 months compared with baseline: 12.2% vs. 13.1% (p = 0.69)
- Heart failure hospitalization or mortality at 6 months: 1% vs. 4% (p = 0.16)
Interpretation:
The results of this trial show that ventricular synchronization achieved with conduction system pacing is noninferior to conventional BiV pacing among eligible patients. Conduction system pacing included His-bundle pacing but was primarily via LBB pacing. This approach appears promising and will need to be tested in future trials. There appears to be a high rate of crossover to BiV pacing; in the current trial, nearly 1 in 4-5 patients required crossover.
References:
Pujol-Lopez M, Jiménez-Arjona R, Garre P, et al. Conduction System Pacing vs Biventricular Pacing in Heart Failure and Wide QRS Patients: LEVEL-AT Trial. JACC Clin Electrophysiol 2022;Oct 26:[Epub ahead of print].
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Adrenergic beta-Antagonists, Arrhythmias, Cardiac, Atrial Fibrillation, Atrioventricular Block, Bundle of His, Bundle-Branch Block, Cardiac Resynchronization Therapy, Electrocardiography, Heart Failure, Pacemaker, Artificial, Stroke Volume, Ventricular Function, Left
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