OBJECTIVE: The purpose of this study was to evaluate the acute safety and efficacy of a custom designed 8F variable loop multielectrode mapping and PFA catheter with contact sensing.
METHODS: This acute feasibility study recruited 30 patients undergoing de novo ablation of paroxysmal or persistent atrial fibrillation (AF). The ElectroPulse Study is a first-in-human, nonrandomized, prospective study of a novel PFA system that utilizes an 8F, 10-electrode variable loop steerable mapping and ablation catheter with 2800-V biphasic bipolar waveform. All patients had pulmonary vein isolation (PVI) and posterior wall isolation (PWI) using the PFA system. The main outcomes were the acute success of PV/PWI and periprocedural serious adverse events.
RESULTS: Complete PVI/PWI was successfully achieved in all 30 patients using 59.7 ± 7.2 applications. Total procedural time was 113.6 ± 26.3 minutes, fluoroscopy time 8.0 ± 5.5 minutes, and left atrial dwell time 78.7 ± 18.6 minutes. There was no esophageal injury, phrenic nerve palsy, clinical stroke, or death. Brain magnetic resonance imaging detected 2 new but transient silent cerebral lesions. Two patients (6.7%) had vascular access complications. Although there were changes in the biomarkers for hemolysis, none of the patients experienced clinical hemolysis or related acute kidney injury.
CONCLUSION: This first-in-human study demonstrated that PFA using a novel variable loop catheter with a contact sensing system safely achieved 100% acute PVI/PWI with safety profile comparable to existing PFA systems.
OBJECTIVES: This study sought to conduct a systematic published data review and meta-analysis of RCTs comparing RM with IO follow-up.
METHODS: Electronic databases and reference lists were searched for RCTs reporting clinical outcomes in ICD patients who did or did not undergo RM. Data were extracted from 9 RCTs, including 6,469 patients, 3,496 of whom were randomized to RM and 2,973 to IO follow-up.
RESULTS: In the RCT setting, RM demonstrated clinical outcomes comparable with office follow-up in terms of all-cause mortality (odds ratio [OR]: 0.83; p = 0.285), cardiovascular mortality (OR: 0.66; p = 0.103), and hospitalization (OR: 0.83; p = 0.196). However, a reduction in all-cause mortality was noted in the 3 trials using home monitoring (OR: 0.65; p = 0.021) with daily verification of transmission. Although the odds of receiving any ICD shock were similar in RM and IO patients (OR: 1.05; p = 0.86), the odds of inappropriate shock were reduced in RM patients (OR: 0.55; p = 0.002).
CONCLUSIONS: Meta-analysis of RCTs demonstrates that RM and IO follow-up showed comparable overall outcomes related to patient safety and survival, with a potential survival benefit in RCTs using daily transmission verification. RM benefits include more rapid clinical event detection and a reduction in inappropriate shocks.