His bundle pacing had more lead revisions and generator replacements than biventricular pacing, but similar risks of all-cause mortality or heart failure hospitalization (HR 0.32; P=0.147).
RCT (n=50)
1:1
Does His bundle pacing improve long-term lead performance, survival, and echocardiographic response compared to biventricular pacing in patients with symptomatic heart failure, LVEF ≤35%, and LBBB?
His-CRT provides comparable long-term echocardiographic response and clinical outcomes to BiV-CRT in heart failure patients with LBBB, though it is associated with higher rates of lead revisions and generator replacements unless low implantation thresholds are achieved.
Estimación del efecto: HR 0.32 (95% CI 0.07-1.49)
valor p: p=0.147
BACKGROUND: The His-Alternative I (A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic Heart Failure Patients With Left Bundle Branch Block) trial was the first randomized European trial to compare cardiac resynchronization therapy (CRT) delivered by His bundle pacing (His-CRT) vs CRT delivered by conventional biventricular pacing (BiV-CRT). OBJECTIVES: The goal of this study was to compare long-term lead performance, survival, and echocardiographic response between His-CRT and BiV-CRT. METHODS: A total of 50 patients with symptomatic heart failure (HF), left ventricular ejection fraction ≤35%, and left bundle branch block were randomized 1:1 to undergo His-CRT or BiV-CRT. Following crossover at implantation, 19 patients received His-CRT and 31 received BiV-CRT. The primary analyses were conducted by these groups, with 5 years of follow-up. Outcomes included the occurrence of reinterventions, an endpoint of all-cause mortality or hospitalization for HF, and echocardiographic response (≥15% reduction in left ventricular end-systolic volume compared with baseline). RESULTS: The median follow-up was 5.3 years (Q1-Q3: 4.6-5.7 years). More lead revisions (37% vs 3%; P = 0.003) and generator replacements (47% vs 10%; P = 0.005) occurred in the His-CRT group compared with the BiV-CRT group. However, no statistically significant differences in reinterventions and threshold development over time were observed between the His-CRT patients with implantation thresholds ≤2.5 V/1 millisecond and the BiV-CRT group. The risk of all-cause mortality or hospitalization for HF was similar between groups (HR: 0.32; 95% CI: 0.07-1.49; P = 0.147), and echocardiographic response was comparable between the 2 groups (89% in His-CRT and 90% in BiV-CRT; P = 1.0). CONCLUSIONS: No statistically significant difference in long-term performance was detected between His-CRT with low implantation thresholds and BiV-CRT, and echocardiographic response was comparable.
“We now have randomized data showing that [LBBAP] is a very credible CRT option, with procedural advantages in some settings and clinical outcomes that are at least broadly comparable to BiV-CRT in selected populations.”
Frandsen et al. (Wed,) conducted a rct in symptomatic heart failure (n=50). His bundle pacing (His-CRT) vs. conventional biventricular pacing (BiV-CRT) was evaluated on all-cause mortality or hospitalization for HF (HR 0.32, 95% CI 0.07-1.49, p=0.147). His bundle pacing had more lead revisions and generator replacements than biventricular pacing, but similar risks of all-cause mortality or heart failure hospitalization (HR 0.32; P=0.147).
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