Permanent His bundle pacing using a fixed curve delivery sheath significantly reduced complications compared to a deflectable curve system (4.2% vs 11.9%, P<0.001) over a median 3-year follow-up.
Cohort (n=844)
Yes
Does permanent His bundle pacing using a fixed curve sheath improve long-term electrical performance and reduce complications compared to a deflectable curve delivery system in patients with pacemaker indications?
Permanent His bundle pacing demonstrates long-term safety and stable electrical performance, with fixed curve delivery sheaths providing superior outcomes compared to deflectable systems.
Absolute Event Rate: 4.2% vs 11.9%
p-value: p=< .001
INTRODUCTION: Several single-center short-term studies have demonstrated the feasibility, safety, and positive clinical outcomes of permanent His bundle pacing (HBP). We performed a retrospective study to evaluate long-term technical and safety performances of HBP in a large population of pacemaker patients from two different centers. METHODS AND RESULTS: The analysis includes 844 patients (345 female, mean age = 75 ± 9 years) who underwent successful permanent HBP for pacemaker indications from 2004 to 2016. The main endpoints were long term electrical performances including pacing threshold, sensing, impedance, and freedom from pacing related complications. The pacing indication was AV Block in 348 (41.2%) patients, sinus node disease in 147 (17.4%), any bradycardia indication in patients with atrial fibrillation in 335 (39.7%) patients and need for cardiac resynchronization therapy in 14 (1.7%) patients. Mean pacing capture thresholds and sensed R waves were 1.6 V and 5.8 mV, respectively at implant and 2.0 V and 6.1 mV at chronic follow-up. During the median follow up of 3 years (interquartile range = 1-6 years), HBP was free of any complication in 91.6% of patients. In the first 368 patients, HBP was achieved using a deflectable curve delivery system, while in 476 using the fixed curve sheath. A significant difference was found in the thresholds (2.4 ± 1.0 V and 1.7 ± 1.1 V, P < .001, respectively) and complications (11.9% and 4.2%, P < .001, respectively) between the two groups. CONCLUSIONS: Permanent HBP was safe and effective during long-term follow-up. The fixed curved delivery sheath offered significantly better electrical parameters and reliability over time. The results of this multicenter study are consistent with recent studies.
Zanon et al. (2019) conducted a cohort in Pacemaker indications (AV block, sinus node disease, bradycardia with atrial fibrillation, need for CRT) (n=844). Permanent His bundle pacing (fixed curve sheath) vs. Deflectable curve delivery system was evaluated on Freedom from pacing related complications (p=< .001). Permanent His bundle pacing using a fixed curve delivery sheath significantly reduced complications compared to a deflectable curve system (4.2% vs 11.9%, P<0.001) over a median 3-year follow-up.