Prospective studies with a focus on the safety and effectiveness profile of stylet-driven left bundle branch area pacing (LBBAP) leads at both implant and chronic stages significantly contribute to a comprehensive perspective of utilizing SDL in this pacing modality. Prospectively evaluate the performance and safety of LBBA-placed Solia S leads and the related impact on the patient's quality of life (QOL) through 12 months. A multi-center, prospective, non-randomized trial enrolled patients with standard pacing indications in whom a Solia S lead was implanted in the left bundle branch area (LBBA). Adverse events and quality-of-life metrics were collected out to 12 months post implant along with threshold, sensing, and lead impedance data. For the 161 patients who experienced an SADE event or had at least 335 days of follow-up, the associated 12-month serious adverse device effect (SADE) rate was 0.02 events per subject-year [SADE-free rate of 98.1% (95% CI: 94.7%, 99.6%)]. The mean threshold was 0.98V at 0.4ms (vs. 0.84V at implant), mean sensing was 12.76mV (vs. 9.15mV at implant), and mean impedance was 521.8 ohms (vs. 670.5 ohms at implant). The mean change for the QOL physical function scale was +11.4 ± 24.0 (95% CI: 7.4, 15.4; t-value = 4.23; p < 0.001). These 12-month results utilizing the Solia S SDL demonstrate freedom from LBBAP lead-related complications, acceptable lead performance characteristics along with a significant coincident improvement in a patient's physical function.

Atrial fibrillation (AF) is the most common arrhythmia worldwide and is associated with significant morbidity and mortality. Catheter ablation of AF has been shown to result in a significant reduction in AF burden and recurrence. Pulsed field ablation (PFA) is a new modality of catheter ablation that is noninferior to its thermal ablation counterparts, coupled with a more favorable safety profile. This study seeks to compare clinical outcomes between two PFA systems: PulseSelect™ (Medtronic, Minneapolis, MN, USA) (circular catheter) and FARAPULSE™ (Boston Scientific, Marlborough, MA, USA) (pentaspline catheter). Secondary aims are to evaluate the impacts of post-ablation mapping with a high-density mapping catheter (PAHDMC) and both procedure and fluoroscopy times on recurrence. Overall, across 895 patients with a median follow-up of 12.5 months, there was a recurrence rate of 39%. PFA system, PAHDMC, and procedure time all had no effect on recurrence. To our knowledge, this is the first study to compare recurrence rates between different PFA systems. Fluoroscopy time, however, was a significant predictor of recurrence. In the pentaspline catheter group, the odds of recurrence were 60% greater for every 15 min increase in fluoroscopy time. Future studies are needed to continue comparing outcomes amongst PFA systems and assess whether PAHDMC improves outcomes in PFAs.