Patricia Tung

BACKGROUND: Pulsed field ablation (PFA) of atrial fibrillation has been rapidly adopted, partly because of safety expectations compared with thermal ablation. Comparative safety data between the 2 modalities remain limited. METHODS: We conducted a prospective registry analyzing consecutive atrial fibrillation ablations at a high-volume US academic center between 2022 and 2026. The primary end point was stroke or transient ischemic attack (TIA) within 30 days, independently adjudicated by blinded neurologists. Secondary end points included death and other procedural complications. Propensity score methods with inverse probability of treatment weighting were used to balance differences in patient characteristics. Differences in the procedural workflow of PFA versus radiofrequency ablation (RFA) were evaluated with exploratory mediation analyses. RESULTS: A total of 4221 ablation procedures (2077 RFA and 2144 PFA: 68.7% Farawave, 23.3% Sphere 9, 6.9% Varipulse, 0.7% PulseSelect) was performed by 12 operators. Patients receiving PFA and RFA had similar baseline characteristics (mean age, 67 years; 31% female; 47% persistent atrial fibrillation; 7% previous stroke/TIA), which were balanced after inverse probability of treatment weighting. Compared with RFA, PFA procedures were shorter (108 versus 144 minutes) and included more frequent posterior wall isolation (57% versus 31%). The 30-day rate of stroke/TIA was significantly higher for PFA cases (10 events; 0.47%) compared with RFA (2 events; 0.10%) in both unweighted and propensity score–weighted analyses (weighted risk difference, 0.36% [95% CI, 0.03%–0.70%]; P =0.03). Stroke/TIA events were evenly distributed throughout the study period with no clustering around the time of PFA adoption or operators (with no operator associated with ≥2 events). Exploratory mediation models were limited by the low event rates and did not identify more extensive ablation as an independent risk factor for stroke. Weighted rates of other procedural complications were low (<1%) and similar between PFA and RFA groups. CONCLUSIONS: In a high-volume, single-center registry with high clinical granularity and systematic patient follow-up, PFA was associated with a significantly higher risk of stroke/TIA at 30 days compared with RFA. These results call for enhanced postmarket surveillance and dedicated prospective evaluation as the PFA procedural volume continues to exponentially increase.

BACKGROUND: The CommandEP system v2 (Sentiar, St. Louis, MO) utilizes an augmented reality headset (Magic Leap, Plantation, FL) to display a real-time 3-dimensional electroanatomic map, catheter locations, and ablation catheter contact force data to the electrophysiologist using a hands-free interface. In the intra-PARADIGM study (Procedural Augmented Reality Assessment in a 3-Dimensional Image Guided Modality), the impact of the CommandEP system on the electrophysiologist’s ability to navigate accurately, intraprocedural communications, and system usability were studied. METHODS: CommandEP was used prospectively in patients undergoing electrophysiologist studies at 2 sites with 8 users. The electrophysiologist’s ability to navigate accurately was calculated as catheter tip displacement from the target using CommandEP versus the electroanatomic mapping system. Physician-mapper interactions were quantified and classified as high- versus low-quality communications (high quality directly impacted navigation, medical decision-making, or patient care). Usability was assessed via survey. RESULTS: A total of 102 patients completed the study with the following diagnoses: atrial fibrillation (n=78/102, 76%), atrial flutter (8/102, 8%), atrial tachycardia/supraventricular tachycardia (n=9/102, 9%), premature ventricular contraction (n=6/102, 6%), and cardiac neuroablation (1/102, 1%). The physician’s ability to navigate was more accurate when using the CommandEP system with an average distance of 2.98±2 mm versus electroanatomic mapping system 3.27±2 mm ( P =0.02); 21% of points navigated using CommandEP versus 28% of points navigated using electroanatomic mapping system were >4 mm from the target ( P =0.03). In all, 393 communications during study tasks were counted with 30 events when using CommandEP versus 363 events when using electroanatomic mapping system. Subanalysis showed no difference in accuracy pre- versus postcontact force (p=ns) and a slight reduction in both low- and high-quality communications (p=ns). Notably, 94% agreed/strongly agreed that they felt comfortable using the system, and 72% agreed/strongly agreed they would be comfortable using the CommandEP system in most/all EPS. CONCLUSIONS: The CommandEP system improved physicians’ ability to navigate accuracy, reduced the number of communications, increased the quality of communications, and had high usability.