Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: LEAD-LBBP Randomized Clinical Trial.

BACKGROUND

Stylet-driven leads (SDLs) are associated with increased loss of left bundle branch capture (LLC) and lead damage during implantation in left bundle branch pacing (LBBP).

OBJECTIVES

This study examined the differences in LLC and pacing outcomes in LBBP recipients randomized to receive lumenless leads (LLLs) or SDLs.

METHODS

LEAD-LBBP (Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: The LEAD_LBBP Randomized Clinical Trial) was a multicenter, blind-adjudicated, randomized clinical trial of LBBP recipients with block randomization in a 1:1 ratio to LLL or SDL. The primary endpoint was the incidence of LLC in both groups. Secondary endpoints included acute LBBP success, acute lead damage requiring a new lead, pacing parameters, complications, and clinical outcomes (new-onset atrial fibrillation [AF], heart failure hospitalization, and all-cause mortality).

RESULTS

Of 226 patients (mean age 74.9 ± 9.6 years, 97 [44%] female), 113 were randomized to the LLL group and 113 to the SDL group. The primary endpoint of LLC at 12 months occurred in 36 (16%) patients, more frequently with SDLs compared with LLLs (22% vs 10%; P = 0.011), with a 2.7 times increased risk (HR: 2.72; 95% CI: 1.34-5.54; P = 0.006). SDLs were also associated with a lower acute LBBP success (96% LLL vs 85% SDL; P = 0.007) and a higher incidence of acute lead damage (10% SDL vs 3% LLL; P = 0.027; OR: 3.95; 95% CI: 1.07-14.58). Pacing parameters, overall complications, and clinical outcomes were comparable between the SDL and LLL groups (P > 0.05).

CONCLUSIONS

Among LBBP recipients, SDL compared with LLL resulted in a higher incidence of LLC during follow-up, lower acute LBBP procedural success, and greater acute lead damage during implantation. These findings have significant implications for lead selection in LBBP.(Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: The LEAD_LBBP Randomized Clinical Trial [LEAD-LBBP]; NCT06318130).