A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.

Very high-power short-duration ablation for pulmonary vein isolation utilizing a very-close protocol-the FAST AND FURIOUS PVI study.

AIMS: The very high-power short-duration (vHP-SD) radiofrequency (RF) ablation concept of atrial fibrillation (AF) treatment by pulmonary vein isolation (PVI) aims for safer, more effective, and faster procedures. Utilizing conventional ablation, the 'close protocol' has been verified. Since lesion formation of vHP-SD ablation creates wider but shallower lesions we adapted the close protocol to an individualized and tighter 'very-close protocol' of 3-4 mm of inter-lesion distance (ILD) at the anterior and 5-6 mm at the posterior aspect of the left atrium using vHP-SD only. Here, we evaluated the safety and efficacy of vHP-SD ablation for PVI utilizing a very-close protocol in comparison with standard ablation. METHODS AND RESULTS: A total of 50 consecutive patients with symptomatic AF were treated with a very-close protocol utilizing vHP-SD (vHP-SD group). The data were compared with 50 consecutive patients treated by the ablation-index-guided strategy (control group). The mean RF time was 352 ± 81 s (vHP-SD) and 1657 ± 570 s (control, P < 0.0001), and the mean procedure duration was 59 ± 13 (vHP-SD) and 101 ± 38 (control, P < 0.0001). The first-pass isolation rate was 74% (vHP-SD) and 76% (control, P = 0.817). Severe adverse events were reported in 1 (2%, vHP-SD) and 3 (6%, control) patients (P = 0.307). A 12-month recurrence-free survival was 78% (vHP-SD) and 64% (control, P = 0.142). PVI durability assessed during redo-procedures was 75% (vHP-SD) vs. 33% (control, P < 0.001). CONCLUSIONS: PVI solely utilizing vHP-SD via a very-close protocol provides safe and effective procedures with a high rate of first-pass isolations. The procedure duration and ablation time were remarkably low. A 12-month follow-up and PVI durability are promising.

Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis.

AIMS: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures. METHODS AND RESULTS: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence. CONCLUSION: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.

Pulsed Field Ablation-Based Pulmonary Vein Isolation Using a Simplified Single-Access Single-Catheter Approach　- The Fast and Furious PFA Study.

BACKGROUND: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.Methods and Results: Consecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm. CONCLUSIONS: The combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low.

Stand-alone Focal Impulse and Rotor Modulation (FIRM) ablation versus second-generation cryoballoon pulmonary vein isolation for paroxysmal atrial fibrillation.

INTRODUCTION: Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation aiming at stable rotors has been investigated as a treatment option in patients with atrial fibrillation (AF). The objective of this study was to compare the safety and efficacy of FIRM-guided ablation with second-generation cryoballoon pulmonary vein isolation (CB2-PVI) in paroxysmal AF. METHODS: Consecutive patients (n = 22, mean age 60 ± 11 years, 59.1% of males) who were treated with a stand-alone FIRM-guided ablation were included in this retrospective single-center study. Procedural data and arrhythmia-free survival at 12 months were compared with n = 86 consecutive patients (mean age 62 ± 13 years, 62.4% of males) who received de-novo CB2-PVI. RESULTS: Median procedure duration was significantly longer in the FIRM group than in the CB2-PVI group (152 [IQR 120-176] minutes vs. 122 [110-145] minutes; p = .031). One patient (1.2%) in the CB2-PVI group and five patients (22.7%) in the FIRM group had vascular access complications. Atrial tachyarrhythmias recurred in 15 patients in the FIRM group and 11 in the CB2-PVI group. Kaplan-Meier estimation of single-procedure arrhythmia-free survival at 12 months was 25% (95% confidence interval [CI] 6%-44%) in the FIRM group and 87% (95% CI 78%-96%) in the CB2-PVI group (p < .001). Repeat ablations were performed in 14/20 (70.0%) patients in the FIRM group and in 12/85 (14.1%) in the CB2-PVI group (p < .001). CONCLUSION: De novo ablation of AF using FIRM-guided AF ablation results in shorter arrhythmia-free survival after 12 months compared to CB2-PVI and a need for repeat ablation in the majority of patients to achieve stable sinus rhythm.

Initial experience, safety, and feasibility using remote access or onsite technical support for complex ablation procedures: results of the REMOTE study.

Aims: Electroanatomical mapping (EAM) systems are essential for the treatment of cardiac arrhythmias. The EAM system is usually operated by qualified staff or field technical engineers from the control room. Novel remote support technology allows for remote access of EAM via online services. Remote access increases the flexibility of the electrophysiological lab, reduces travel time, and overcomes hospital access limitations especially during the COVID-19 pandemic. Here, we report on the feasibility and safety of EAM remote access for cardiac ablation procedures. Methods and results: Mapping and ablation were achieved by combining the EnsiteX™ EAM system and the integrated Ensite™ Connect Remote Support software, together with an integrated audiovisual solution system for remote support (Medinbox). Communication between the operator and the remote support was achieved using an incorporated internet-based common communication platform (Zoom™), headphones, and high-resolution cameras. We investigated 50 remote access-assisted consecutive electrophysiological procedures from September 2022 to February 2023 (remote group). The data were compared with matched patients (n = 50) with onsite support from the control room (control group). The median procedure time was 100 min (76, 120; remote) vs. 86 min (60, 110; control), P = 0.090. The procedural success (both groups 100%, P = 0.999) and complication rate (remote: 2%, control: 0%, P = 0.553) were comparable between the groups. Travel burden could be reduced by 11 280 km. Conclusion: Remote access for EAM was feasible and safe in this single-centre study. Procedural data were comparable to procedures with onsite support. In the future, this new solution might have a great impact on facilitating electrophysiological procedures.

Percutaneous Left Atrial Appendage Closure with the LAmbre Device Protected by a Cerebral Protection System in a 76-Year-Old Man with Persistent Left Atrial Appendage Thrombus.

BACKGROUND Despite use of optimal oral anticoagulation regimens, left atrial appendage (LAA) thrombus may develop and persist in patients with atrial fibrillation (AF). The therapeutic options in this population are limited. Percutaneous LAA closure (LAAC) is performed to reduce thrombus formation and the risk of thromboembolism. However, this approach is prohibited in patients with LAA thrombus. We report the case of a 76-year-old man with AF and persistent LAA thrombus who underwent percutaneous LAAC with the LAmbre device protected by the SENTINEL Cerebral Protection System (CPS). CASE REPORT A 76-year-old man with history of persistent AF treated with pulmonary veins and LAA isolation developed LAA thrombus resistant to different anticoagulation therapies, including apixaban and Phenprocoumon, with a target international normalized ratio (INR) of 3-3,5. Repeated follow-up transesophageal echocardiography showed a persistent LAA thrombus despite optimal INR values. Thus, we performed a percutaneous LAAC using a double-umbrella-designed appendage occluder and a CPS to minimize the risk of intraprocedural cerebral embolization. The procedure was guided by transesophageal echocardiography and fluoroscopy. No signs of systemic thromboembolism were noted, and the CPS filters showed no evidence of thrombotic material. CONCLUSIONS This report shows that the use of a CPS during percutaneous LAAC may reduce the risk of procedural cerebral embolization and could be used as an alternative therapy for patients with contraindication or lack of effectiveness of oral anticoagulation.

Diagnosis and Management of Left Ventricular Perforation During Mapping of Ventricular Tachycardia.

BACKGROUND Cardiac perforation leading to cardiac tamponade is one of the possible complications of endocardial mapping during catheter-based ablation procedures. The early diagnosis of catheter-induced perforation is critical for effective management of these patients. We hereby present the diagnosis and management of left ventricular perforation during mapping of ventricular tachycardia in a patient with left ventricular aneurysm. CASE REPORT A 70-year-old man with a history of ischemic heart disease, arterial hypertension, type 2 diabetes mellitus, and obesity was referred to our institution for the ablative treatment of recurrent, sustained monomorphic ventricular tachycardia that was resistant to medication. One particularity was the presence of a left ventricular aneurysm secondary to a non-ST segment elevation myocardial infarction, which was unusual and could increase the risk of cardiac perforation. During left ventricular mapping, several points were acquired in an apparently unusual position and the pericardial location of the mapping catheter was confirmed fluoroscopically. After setting a pericardial pigtail catheter, we successfully finished the ablation procedure using a second ablation catheter. The perforating catheter was thereafter removed by open surgery, and no significant bleeding occurred. The patient did not experience tachycardia during the follow-up period of 29 months. CONCLUSIONS Left ventricular aneurysms might increase the cardiac perforation risk during endocardial mapping in ventricular tachycardia ablation procedures. In patients with this condition, a careful manipulation of the catheters could prevent such complications. The periodic fluoroscopic assessment of the catheter's position is essential for early recognition of the perforation.