Pulsed field ablation in patients with cardiac implantable electronic devices: an ex vivo assessment of safety.

BACKGROUND: Pulse field ablation (PFA) is a novel catheter ablation technology with potential safety benefits due to its tissue selectivity. It has the potential to directly damage or interact with the functionality of cardiac implantable electronic devices (CIEDs) in the form of electromagnetic interference (EMI). The aim of our study was to assess the impact of PFA on CIEDs. METHODS: PFA lesions (45 per CIED) were applied from the Farapulse system to CIEDs (< 5 cm from the lead tip and < 15 cm from the generator). All devices were checked before and after PFA application for proper sensing and pacing functionality as well as for integrity of shock circuits in ICDs using a heart simulator. Moreover, devices were then interrogated for any spontaneous reprogramming, mode switching or other EMI effects. RESULTS: In total, 44 CIEDs were tested (16 pacemaker, 21 ICDs, 7 CRT-P/D) with 1980 PFA applications. There was no change in device settings, functionality and electrical parameters, and there was no macroscopic damage to the devices. The risk of damage to the electric components or leads on a patient-based analysis is 0/44 (95% CI 0-8%) and on a PFA pulse-based analysis is 0/1980 (95% CI 0-0.2%). Clinically relevant EMI appeared with oversensing and pacing inhibition but not tachycardia detection. CONCLUSIONS: Bipolar PFA appears safe and does not result in damage to CIEDs or leads. Clinically relevant EMI does occur, but appropriate peri-procedural programming may mitigate this. In vivo studies are needed to confirm our findings.

High-power chargers for electric vehicles: are they safe for patients with pacemakers and defibrillators?

AIMS: Battery electric vehicle (BEV) sales and use are rapidly expanding. Battery electric vehicles, along with their charging stations, are a potential source of electromagnetic interference (EMI) for patients with cardiac implantable electronic devices (CIEDs). The new 'high-power' charging stations have the potential to create strong electromagnetic fields and induce EMI in CIEDs, and their safety has not been evaluated. METHODS AND RESULTS: A total of 130 CIED patients performed 561 charges of four BEVs and a test vehicle (350 kW charge capacity) using high-power charging stations under continuous 6-lead electrocardiogram monitoring. The charging cable was placed directly over the CIED, and devices were programmed to maximize the chance of EMI detection. Cardiac implantable electronic devices were re-interrogated after patients charged all BEVs and the test vehicle for evidence of EMI. There were no incidences of EMI, specifically no over-sensing, pacing inhibition, inappropriate tachycardia detection, mode switching, or spontaneous reprogramming. The risk of EMI on a patient-based analysis is 0/130 [95% confidence interval (CI) 0%-2%], and the risk of EMI on a charge-based analysis is 0/561 (95% CI 0%-0.6%). The effective magnetic field along the charging cable was 38.65 µT and at the charging station was 77.9 µT. CONCLUSIONS: The use of electric cars with high-power chargers by patients with cardiac devices appears to be safe with no evidence of clinically relevant EMI. Reasonable caution, by minimizing the time spent in close proximity with the charging cables, is still advised as the occurrence of very rare events cannot be excluded from our results.

Deep sedation with propofol in patients undergoing left atrial ablation procedures-Is it safe?

Background: Catheter ablation for atrial fibrillation (AF) or left atrial tachycardia is well established. To avoid body movement and pain, sedative and analgesic agents are used. Objective: The aim was to investigate safety of sedation/anti-pain protocol administered by electrophysiology (EP) staff. Methods: A total of 3211 consecutive patients (61% male) undergoing left atrial ablation for paroxysmal AF (37.1%), persistent AF (35.3%) or left atrial tachycardia (27.6%) were included. Midazolam, fentanyl, and propofol were administered by EP staff. In case of respiratory depression, endotracheal intubation (eIT) or noninvasive ventilation (NIV) was implemented. Risk factors for eIT or NIV were analyzed. Results: Mean doses of propofol, midazolam, and fentanyl were 33.7 ± 16.7 mg, 3 ± 11.1 mg, and 0.16 ± 2.2 mg, respectively. Norepinephrine was administered in 396 of 3211 patients (12.3%) because of blood pressure drop (mean arterial pressure <60 mm Hg). NIV was necessary in 47 patients (1.5%) and eIT in 1 patient (0.03%). Procedure duration, high body mass index (BMI), high CHADS2-VASC2 score, high age, low glomerular filtration rate, diabetes mellitus, and low baseline oxygen saturation were associated with NIV or eIT. The only independent predictor for NIV/eIT was high BMI (>30.1 ± 9.0 kg/m2). Therefore, patients with a BMI of ≥30 had a 40% higher risk for the need of NIV/eIT during the procedure in our study. Conclusion: Sedation/anti-pain control including midazolam, propofol, and fentanyl administered by EP staff is safe, with only 1.53% requirement of NIV/eIT. High BMI (>30 kg/m2) emerged as an independent predictor for eIT/NIV.

Early arrhythmia recurrence after catheter ablation for persistent atrial fibrillation: is it predictive for late recurrence?

BACKGROUND: Early recurrence of atrial tachyarrhythmia (ERAT) is common after radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF), but its clinical significance in patients with persistent AF remains unclear. We sought to determine the predictive value of ERAT for rhythm outcome after RFCA for persistent AF. METHODS: The study included 207 consecutive patients (mean age 66.4 ± 10.7 years, male 66.2%) with persistent and long-standing persistent AF undergoing de novo pulmonary vein isolation (± atrial substrate ablation). All patients remained off antiarrhythmic drugs. ERAT was defined as any atrial arrhythmia ≥ 30 s occurring within the first 30 days. Late recurrence (LR) was determined during follow-up visits scheduled 1, 3, 6 and 12 months post-ablation using 7-day Holter ECGs. RESULTS: ERAT occurred in 143/207 (69.1%) patients as AF (60%) or atrial tachycardia (40%) and was persistent in 82% of cases. During a median follow-up of 22.2 months, LR occurred significantly more often in patients with ERAT than in patients without ERAT (92.3 vs. 43.8%, P < 0.001). The only independent predictors for LR were ERAT (OR 16.8, 95% CI 6.184-45.797, P < 0.001) and intraprocedural termination to sinus rhythm (OR 0.052, 95% CI 0.003-0.851, P = 0.038). Extending the blanking period from 30 to 90 days did not impact LR rates. CONCLUSION: ERAT following ablation of persistent AF is strongly associated with late arrhythmia recurrence, which challenges the assumption that ERAT represents merely a transient phenomenon. While limiting the blanking period to 30 days seems justified, the benefit of early re-ablations remains to be addressed in future studies.