[Lead placement in cardiac implantable electronic devices]. / Elektrodenplatzierung in der kardialen Devicetherapie.

The implantation of electrodes for cardiac implantable electronic devices (CIED) requires profound technical understanding and precise execution. The positioning of electrodes in the right ventricle and atrium has significant implications for patient safety and the effectiveness of CIED therapy. Particular focus is given to the distinction between apical and septal stimulation in ventricular positioning. Based on current data, this article provides a practice-oriented guide that leads implanters through the individual steps of electrode positioning. The implantation of electrodes for physiological stimulation (cardiac resynchronization therapy, CRT, and conduction system pacing, CSP) is not addressed in this article.

2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .

Impact of Left Atrial Posterior Wall Ablation During Pulsed-Field Ablation for Persistent Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury. OBJECTIVES: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA). METHODS: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events. RESULTS: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA2DS2-VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51). CONCLUSIONS: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months.

Balloon technologies for pulmonary vein isolation-12-month outcome and comparison of the novel radiofrequency balloon with the cryoballoon in patients with paroxysmal atrial fibrillation.

BACKGROUND: The cryoballoon (CB) has become a standard tool for pulmonary vein isolation (PVI), but the technology is limited in certain ways. A novel RF-balloon (Heliostar™, Biosense Webster, CA, USA) promises the advantages of a balloon technology in combination with 3D mapping. METHODS: To assess procedural data and outcome, all patients undergoing RF-balloon PVI were included and compared with data from consecutive patients undergoing CB PVI for paroxysmal AF. RESULTS: A total of 254 patients (63 ± 13 years, 54% male) were included: 30 patients undergoing RF-balloon and 224 patients CB PVI. Baseline parameters were comparable. Procedure duration (104.3 ± 35.3 min vs. 69.9 ± 23.1 min; p ≤ 0.001) and fluoroscopy time (16.3 ± 7.1 min vs. 11.6 ± 4.9 min; p ≤ 0.001) were longer using the RF-balloon; ablation time (43.5 ± 17.9 vs. 36.4 ± 15.6; p = 0.08) did not differ, and time-to-isolation (TTI) was shorter (18.2 ± 7.0 s vs. 62.8 ± 35.1 s; p ≤ 0.001). Second-generation RF-balloon cases showed shorter ablation time and TTI at comparable procedure duration and fluoroscopy time. One pericardial effusion occurred with the RF-balloon due to complicated transseptal access. During CB PVI in 4/224 patients (1.8%), a phrenic nerve palsy was observed. After 12 months, 78% of patients after RF-balloon and 81% of patients after CB PVI (p = 0.5) were free from atrial arrhythmias. CONCLUSION: The RF-balloon was safe and effective. Compared with the CB, TTI was shorter, but procedure durations and fluoroscopy times were longer. This can be attributed to a learning curve and the initial necessity for separate 3D map preparation. Considering the results with the second-generation RF-balloon, more experience is needed to determine the potential benefits.

[Perioperative management for cardiovascular implantable electronic devices]. / Perioperatives Management bei der Versorgung mit aktiven Rhythmusimplantaten.

Cardiovascular implantable electronic devices (CIED) are an important part of modern cardiology and careful perioperative planning of these procedures is necessary. All information relevant to the indication, the procedure, and the education of the patient must be available prior to surgery. This provides the basis for appropriate device selection. Preoperative antibiotic prophylaxis and perioperative anticoagulation management are essential to prevent infection. After surgery, postoperative monitoring, telemetric control, and device-based diagnostics are required before discharge. These processes need to be adapted to the increasing trend towards outpatient care. This review summarises perioperative management based on practical considerations.

The omnipolar mapping technology-a new mapping tool to overcome "bipolar blindness" resulting in true high-density maps.

BACKGROUND: Omnipolar mapping (OT) is a novel tool to acquire omnipolar signals for electro-anatomical mapping, displaying true voltage and real-time wavefront direction and speed independent of catheter orientation. The aim was to analyze previously performed left atrial (LA) and left ventricular (LV) maps for differences using automated OT vs. standard bipolar settings (SD) and HD wave (HDW) algorithm. METHODS: Previously obtained SD and HDW maps of the LA and LV using a 16-electrode, grid-shaped catheter were retrospectively analyzed by applying automated OT, comparing voltage, point density, pulmonary vein (PV) gaps, and LV scar area. RESULTS: In this analysis, 135 maps of 45 consecutive patients (30 treated for LA, 15 for LV arrhythmia) were included. Atrial maps revealed significantly higher point densities using OT (21471) vs. SD (6682) or HDW (12189, p < 0.001). Mean voltage was significantly higher using OT (0.75 mV) vs. SD (0.61 mV) or HDW (0.64 mV, p < 0.001). OT maps detected significantly more PV gaps per patient vs. SD (4 vs. 2), p = 0.001. In LV maps, OT revealed significantly higher point densities (25951) vs. SD (8582) and HDW (17071), p < 0.001. Mean voltage was significantly higher for OT (1.49 mV) vs. SD (1.19 mV) and HDW (1.2 mV), p < 0.001. Detected scar area was significantly smaller using OT (25.3%) vs. SD (33.9%, p < 0.001). CONCLUSION: OT mapping leads to significantly different substrate display, map density, voltage, detection of PV gaps, and scar size, compared to SD and HDW in LA and LV procedures. Successful CA might be facilitated due to true HD maps.

[Lead extraction in cardiac implantable electronic devices]. / Sondenextraktionen bei implantierbaren kardialen Devices.

Lead extraction due to infection or lead dysfunction has become more important in recent years. Patients with high risk of severe and life-threatening complications should only undergo surgery in experienced centers where appropriate personnel and equipment are available. In this review, different techniques and methods to safely and successfully perform transvenous lead extraction are summarized.

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation.

Importance: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile. Objective: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry. Design, Setting, and Participants: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF. Exposure: PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator. Main Outcomes and Measures: The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs). Results: Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19). Conclusion and Relevance: Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.

Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial.

BACKGROUND AND OBJECTIVES: Long-term oral anticoagulation (OAC) following successful catheter ablation of atrial fibrillation (AF) remains controversial. Prospective data are missing. The ODIn-AF study aimed to evaluate the effect of OAC on the incidence of silent cerebral embolic events and clinically relevant cardioembolic events in patients at intermediate to high risk for embolic events, free from AF after pulmonary vein isolation (PVI). METHODS: This prospective, randomized, multicenter, open-label, blinded endpoint interventional trial enrolled patients who were scheduled for PVI to treat paroxysmal or persistent AF. Six months after PVI, AF-free patients were randomized to receive either continued OAC with dabigatran or no OAC. The primary endpoint was the incidence of new silent micro- and macro-embolic lesions detected on brain MRI at 12 months of follow-up compared to baseline. Safety analysis included bleedings, clinically evident cardioembolic, and serious adverse events (SAE). RESULTS: Between 2015 and 2021, 200 patients were randomized into 2 study arms (on OAC: n = 99, off OAC: n = 101). There was no significant difference in the occurrence of new cerebral microlesions between the on OAC and off OAC arm [2 (2%) versus 0 (0%); P = 0.1517] after 12 months. MRI showed no new macro-embolic lesion, no clinical apparent strokes were present in both groups. SAE were more frequent in the OAC arm [on OAC n = 34 (31.8%), off OAC n = 18 (19.4%); P = 0.0460]; bleedings did not differ. CONCLUSION: Discontinuation of OAC after successful PVI was not found to be associated with an elevated risk of cerebral embolic events compared with continued OAC after a follow-up of 12 months.

Comparison of pulsed-field ablation versus very high power short duration-ablation for pulmonary vein isolation.

BACKGROUND: The newly introduced nonthermal pulsed field ablation (PFA) is a promising technology to achieve fast pulmonary vein isolation (PVI) with high acute success rates and good safety features. However, previous studies have shown that very high power short duration ablation (VHPSD) is also highly effective and fast to achieve PVI with potentially less arrhythmia recurrence compared to conventional radiofrequency ablation. Data comparing PFA to VHPSD-PVI is lacking. OBJECTIVE: This study compared procedural and outcome data for PFA-PVI to VHPSD-PVI in patients with paroxysmal or persistent atrial fibrillation (PAF/persAF). METHODS: Consecutive patients undergoing de novo PVI (PFA or VHPSD) were included in this analysis. For PFA-PVI a pentaspline 20 electrode catheter was used. For VHPSD-PVI an enhanced irrigated catheter with a power setting of 70 W/7 s (70 W/5 s at posterior wall) was employed in conjunction with electro-anatomical mapping. All procedures were performed in deep analgo-sedation. RESULTS: A total of n = 114 patients (n = 57[50%] PFA, n = 17[30%] PAF; n = 40[70%] persAF) were included in this analysis. PVI was successful in all patients. The PFA group revealed a significantly shorter procedure duration (65 ± 17 min vs. 95 ± 23 min, p < 0.01) but longer fluoroscopy time (PFA 15 ± 5 min and VHPSD 12 ± 3 min; p < 0.001). At follow-up after median 125 days (interquartile range: 109-162) n = 46 PFA (80.7%) and n = 44 VHPSD pts (77.2%) were free from atrial arrhythmia after a single procedure (p = 0.819). Two tamponades occurred in the PFA while in VHPSD two pts suffered groin bleedings. One clinically nonsignificant PV stenosis occurred in the VHPSD group. CONCLUSION: Pulsed-field ablation and VHPSD-PVI seem to be highly effective and safe to achieve PVI in the setting of PAF and persAF with comparable arrhythmia-free survival. However, procedure duration for PFA PVI is significantly shorter and therefore may be of potential benefit. Compared to PFA VHPSD-PVI might ensure information on left atrial substrate allowing to target concomitant secondary tachycardias.

Implementation and first outcomes of a novel standard operating procedure for preprocedural transoesophageal echocardiography screening in course of atrial arrhythmia ablation.

AIMS: Preprocedural transoesophageal echocardiography (TEE) screening for left atrial (LA) thrombi is the standard of care in many centres performing atrial fibrillation (AF) ablation. However, TEE imposes procedural risks for patients and is often challenging to implement in daily practice, besides causing patient discomfort. At our centre, a novel standard operating procedure (SOP) was implemented, aiming to identify patients that can be exempt from TEE screening. We aimed to assess whether this screening approach may reduce preprocedural TEEs without imposing patients of higher risks for cerebrovascular events (CVEs). METHODS AND RESULTS: Data of 1874 consecutive patients treated by catheter ablation of LA arrhythmias between 2018 and 2022 were retrospectively analysed. A cohort of 937 patients, where decision to perform TEE screening was based on a new SOP (considering rhythm at admission, CHA2DS2-VASc score, and sufficient anticoagulation), was compared to a matched cohort receiving TEE before every procedure. Number of performed TEEs and incidences of CVEs were compared. Implementation of the new SOP led to a 67% reduction in TEEs performed (old SOP: 933 vs. new SOP: 305). No significant differences between the groups were detected regarding transitory ischaemic attack (old SOP: 5 vs. new SOP: 3; P = 0.48) and stroke (no events). No solid thrombi were detected during TEE screening. CONCLUSION: The number of preprocedural screening TEEs before AF ablation procedures can be safely reduced by applying risk stratification based on rhythm at admission and CHA2DS2-VASc score, if anticoagulation was performed properly.

Comparison of pulsed field ablation and cryoballoon ablation for pulmonary vein isolation.

INTRODUCTION: Pulmonary vein isolation (PVI) remains the cornerstone in the treatment of atrial fibrillation (AF). PVI using cryoballoon (CB) technology has emerged as a standard procedure in many centers. Recently, pulsed field ablation (PFA) has been introduced and used to achieve PVI. First data show high acute and favorable long-term outcomes. So far, data comparing these new "single shot" devices are sparse. We sought to compare procedural and outcome data for first time PFA users versus CB in patients undergoing de novo PVI. Furthermore, potentially postprocedural discomfort and affection of autonomic ganglia were assessed. METHODS AND RESULTS: A retrospective analysis and comparison of all de novo PVIs with PFA and CB was performed. Furthermore, PFA PVI learning curve was evaluated. During follow-up, repeat outpatient visits and Holter electrocardiogram were performed to analyze arrhythmia-free survival. Discomfort analysis was obtained by prescribed analgesic medication within first 48 h after PVI. Potential changes in heart rate (HR) between baseline and at 3-month follow-up were evaluated. A total of 108 patients (54 PFA and 54 CB; PFA; 33 (30%) female) with paroxysmal and persistent AF were analyzed. Type of AF was comparable (Patients suffering from PAF: PFA: 16 (30%), CB: 17 (31%), p = 1.0). In 107 (99%) patients, successful PVI was achieved. Transient phrenic palsy omitted complete PVI in one CB patient. A trend for a shorter overall procedure duration was observed in the PFA group (PFA: 64.5 ± 17.5 min; CB: 73.0 ± 24.8 min; p = 0.07). Excluding LA mapping time (first 14 cases), procedure time was significantly shorter using PFA (PFA: 58.0 ± 12.5 min, CB: 73.0 ± 24.8 min, p = 0.0001). Fluoroscopy time was significantly longer for PFA (PFA: 15.3 ± 4.7 min, CB: 12.3 ± 5.3 min; p = 0.001), but significantly less contrast medium was used (PFA: 12 ± 6 mL; CB: 51 ± 29 mL, p < 0.0001). Subgroup analysis of the PFA group revealed a significant shortening of procedure duration over time (first tertile: 72.7 ± 13.5 min, second tertile: 67.3 ± 21.7 min, third tertile: 53.4 ± 9.8 min, first vs. third tertile p < 0.0001). Two cardiac tamponades occurred in the PFA group (p = 0.495), of which one was most likely related to complex transseptal puncture. In the first 48 h after PVI, the number of prescribed analgesics due to postprocedural pain was equal between both groups (PFA: 7 (13%) patients, CB: 10 (19%) patients, p = 0.598). After a FU of 273 ± 129 days, 35 of 47 patients (74%) after PFA and 36 of 50 patients (72%) after CB PVI were free of any atrial arrhythmia (HR: 0.98, p = 0.88). Only in the PFA group, a significant increase in HR 3 months after PVI was observed (pre-PVI: 61 ± 8 beats/min, post-PVI: 65 ± 9 beats/min, p = 0.008). CONCLUSION: The new PFA technology is equally effective and safe as compared to CB for complete PVI with potentially shorter procedure time and significantly less contrast medium. However, AF recurrence rates after PFA PVI seem to be comparable to CB PVI.

The infrastructure of electrophysiology centers impacts the management of cardiac tamponade-Results from a national survey.

BACKGROUND: Although electrophysiological (EP) centers have institutional standards, evidence on management of cardiac tamponade is lacking. AIM AND METHODS: A physician-based survey was conducted by sending out questionnaires to all hospitals in Germany performing EP procedures. To evaluate the infrastructure of EP centers and the impact of center volume and onsite cardiac surgery on the management of cardiac tamponade, the results of the survey were analyzed for low-volume (0-250 procedures per year), mid-volume (250-500 procedures), and high-volume (>500 procedures) centers, as well as for centers with and without onsite cardiac surgery. RESULTS: A total of 341 centers were identified and 189/341 (55%) returned data sets were analyzed. Most types of EP procedures are performed across all kinds of centers. Ablation of ventricular tachycardia (VT) is concentrated in higher volume centers and in centers with onsite cardiac surgery. None of the participating low-volume centers and only 13% of centers without onsite cardiac surgery responded to performing epicardial VT ablation. Irrespective of center volume and onsite cardiac surgery, neither body mass index nor age was reported to be an exclusion criterion for ablation procedures. Higher volume centers and centers with onsite cardiac surgery more often have dedicated EP laboratories and EP-nursing teams. Also, differences regarding periprocedural safety precautions and management of cardiac tamponade were found for low-, mid-, and high-volume centers, as well as for centers with and without onsite cardiac surgery. CONCLUSION: While center volume and onsite cardiac surgery do not impact patient selection, there are differences in ablation spectrum, infrastructure, periprocedural safety precautions, and treatment of tamponade.

First long-term outcome data for the MicraVR™ transcatheter pacing system: data from the largest prospective German cohort.

AIMS: The MicraVR™ transcatheter pacing system (TPS) has been implemented into clinical routine for several years. The primary recipients are patients in need for VVI pacing due to bradycardia in the setting of atrial fibrillation (AF). Implantation safety and acute success have been proven in controlled studies and registries. So far only few long-term real-life data on TPS exist. We report indication, procedure and outcome data from two high-volume implanting German centers. METHODS: Between 2016 and 2019, 188 (of 303) patients were included. During follow-up (FU), TPS interrogation was performed after 4 weeks and thereafter every 6 months. RESULTS: Indication for TPS implantation in 159/188 (85%) patients was permanent or intermittent AV block III° in the setting of atrial fibrillation. The mean procedure duration was 50 min [35.0-70.0]. The average acute values after system release were: thresholds: 0.5V [0.38-0.74]/0.24ms; R-wave sensing: 10.0mV [8.1-13.5]; impedance: 650 Ohm [550-783]; RV-pacing demand: 16.9% [0.9-75.9]; and battery status: 3.15 V [3.12-3.16]. During FU of 723.4 ± 597.9 days, neither pacemaker failure nor infections were reported. Long-term FU revealed: thresholds: 0.5V [0.38-0.63]/0.24 ms; sensing: 12.3mV [8.9-17.2]; impedance: 570 Ohm [488-633]; RV-pacing demand: 87.1% [29.5-98.6]; and battery status 3.02 V [3.0-3.1]. Forty-three patients died from not-device-related causes. CONCLUSION: This to date largest German long-term dataset for MicraVR™ TPS implantation revealed stable device parameter. Foremost, battery longevity seems to fulfill predicted values despite a significant increase in RV-pacing demand over time and even in patients with consecutive AV-node ablation. Of note, no infections or system failure were observed.

[Venous access routes for cardiac implantable electronic devices]. / Venöse Zugangswege in der kardialen Devicetherapie.

Various venous access routes in the region of the clavicle are available for cardiac device treatment. After many years of choosing access via the subclavian vein, current data explicitly show that lateral approaches such as preparation of the cephalic vein or puncture of the axillary vein are clearly superior in terms of probe durability and risk of complications. This article describes the preparation and performance of the various access techniques and is intended to provide a practical guide for the work in cardiac pacemaker operations. This work continues a series of articles designed for advanced training in specialized rhythmology.

Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

Pulmonary vein isolation for atrial fibrillation using true high-power short-duration vs. cryoballoon ablation.

AIMS: Pulmonary vein isolation (PVI) is achievable and effective using radiofrequency (RF) catheter (CA) or cryoballoon (CB) ablation. The newly introduced high RF-power short-duration ablation (HPSD) technique has shown promising results. Data comparing HPSD- to CB-PVI is sparse. We sought to investigate success rates and procedural differences of HPSD-PVI vs. CB-PVI in patients undergoing ablation for PAF and persAF. METHODS: Consecutive patients undergoing de novo PVI (HPSD or CB) were included. A power setting of 70W/7 s (70W/5 s at posterior wall) using a flexible tip catheter with enhanced irrigation was considered as true HPSD. Follow-up consisted of out-clinic pts visits, tele-consultation, 48-h Holter ECG, app-based telemonitoring and cardiac implanted electronic devices (CIED) interrogation. RESULTS: 721 patients (46 HPSD, 675 CB) were analyzed. In all HPSD (27 persAF [59%]) and CB patients (423 persAF [63%]), PVI was successfully achieved. Procedure duration was significantly longer for HPSD (91 ± 19 min vs. 72 ± 18 min, p < 0.01). Ablation time was similar in both groups (HPSD: 44 ± 19 min vs. CB: 40 ± 17 min; p = 0.347). No major complications occurred in HPSD. For CB-PVI, in 25 (3.7%; p = 0.296) patients, complications occurred. At a follow-up of 290 ± 135 days, arrhythmia-free survival using HPSD was non-inferior to CB-PVI in the Kaplan-Meier survival analysis (p = 0.096). CONCLUSION: PVI using HPSD is equally effective and safe to CB-PVI. This analysis revealed a similar arrhythmia-free survival after HPSD and CB with low complication rates. Procedure duration for CB was significantly shorter while LA dwell time excluding mapping was equal. Currently, a prospective trial is conducted to corroborate these findings.

Treatment of pathophysiologic propagation outside of the pulmonary veins in retreatment of atrial fibrillation patients: RECOVER AF study.

AIMS: RECOVER AF evaluated the performance of whole-chamber non-contact charge-density mapping to guide the ablation of non-pulmonary vein (PV) targets in persistent atrial fibrillation (AF) patients following either a first or second failed procedure. METHODS AND RESULTS: RECOVER AF was a prospective, non-randomized trial that enrolled patients scheduled for a first or second ablation retreatment for recurrent AF. The PVs were assessed and re-isolated if necessary. The AF maps were used to guide the ablation of non-PV targets through elimination of pathologic conduction patterns (PCPs). Primary endpoint was freedom from AF on or off antiarrhythmic drugs (AADs) at 12 months. Patients undergoing retreatment with the AcQMap System (n = 103) were 76% AF-free at 12 months [67% after single procedure (SP)] on or off AADs (80% free from AF on AADs). Patients who had only received a pulmonary vein isolation (PVI) prior to study treatment of non-PV targets with the AcQMap System were 91% AF-free at 12 months (83% SP). No major adverse events were reported. CONCLUSION: Non-contact mapping can be used to target and guide the ablation of PCPs beyond the PVs in persistent AF patients returning for a first or second retreatment with 76% freedom from AF at 12 months. The AF freedom was particularly high, 91% (43/47), for patients enrolled having only a prior de novo PVI, and freedom from all atrial arrhythmias for this cohort was 74% (35/47). These early results are encouraging and suggest that guiding individualized targeted ablation of PCPs may therefore be advantageous to target at the earliest opportunity in patients with persistent AF.

Incidence of premature battery depletion in subcutaneous cardioverter-defibrillator patients: insights from a multicenter registry.

BACKGROUND: The subcutaneous ICD established its role in the prevention of sudden cardiac death in recent years. The occurrence of premature battery depletion in a large subset of potentially affected devices has been a cause of concern. The incidence of premature battery depletion has not been studied systematically beyond manufacturer-reported data. METHODS: Retrospective data and the most recent follow-up data on S-ICD devices from fourteen centers in Europe, the US, and Canada was studied. The incidence of generator removal or failure was reported to investigate the incidence of premature S-ICD battery depletion, defined as battery failure within 60 months or less. RESULTS: Data from 1054 devices was analyzed. Premature battery depletion occurred in 3.5% of potentially affected devices over an observation period of 49 months. CONCLUSIONS: The incidence of premature battery depletion of S-ICD potentially affected by a battery advisory was around 3.5% after 4 years in this study. Premature depletion occurred exclusively in devices under advisory. This is in line with the most recently published reports from the manufacturer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04767516 .