In patients with long-standing persistent (LSPer) atrial fibrillation (AF), the efficacy of catheter ablation remains limited, with long-term freedom from atrial arrhythmias typically reported at around 30% following a single procedure. Moreover, clinical evidence regarding the use of novel pulsed-field ablation (PFA) technology in this patient population is currently limited. We aimed to analyze the efficacy and safety of PFA in patients with LSPer AF compared to early-persistent AF (Eper AF). All consecutive patients undergoing persistent AF ablation with the Farapulse PFA system at 16 Italian centers with follow-up information were included. A standard protocol-directed pulmonary vein isolation (PVI) with 8 application per PV was applied with additional lesions performed at the operator’s discretion. EPer AF was defined as AF that is continuous and sustains for >7 days (but < 12 months) and requires intervention, while LSPer AF was defined as AF that is continuous for >12 months in duration. Of 434 patients, 35.5% had LSPer AF, 20.9% were female, and the mean age was 64±9 years. A more extensive lesion set than PVI was performed in 58.3% of cases, with 18.4% being redo-AF procedures. In patients with LSPer AF a 3D mapping system (45.5% vs 31.4%, p=0.005) and an intracardiac echography (33.1% vs 21.1%, p=0.009) were employed more frequently than in patients with EPer AF, while a more extensive lesion set than PVI only was used in a similar way (59.7% vs 57.5%, p=0.685). No differences were found between groups in terms of PFA deliveries outside PVs (20[14-28] vs 18[14-22], p=0.126), total number of PFA deliveries (48[32-54] vs 46[32-54], p=0.0616), skin-to-skin time (75[65-95] min vs 79[65-95] min, p=0.326) or time to PVI (19[15-24] min vs 19[12-25] min, p=0.549), whereas fluoroscopy time was longer (22[17-25] min vs 17[13-24] min, p<0.001). PVI was achieved in all patients. During a median follow-up of 309[194-384] days, 87 (20%) of patients experienced an arrhythmic recurrence after the 90-day blanking period. The proportion of patient with LSPer AF who experienced a recurrence was similar to the ones with EPer AF (20.1% for LSPer AF vs 20% for EPer AF, odd ratio=1.01, 95%CI: 0.62 to 1.65, p=0.0974); LSPer AF was not associated to recurrences (hazard ratio=1.06, 95%CI: 0.68 to 1.66, log-rank p=0.785). No major complications (including death, renal failure, oesophageal complications, PV stenosis, persistent phrenic nerve injury) were reported. In our experience, the use of the Farapulse PFA system for long-standing persistent AF demonstrated safe and effective outcomes, similar to those observed in patients with early persistent AF.
Female sex is an established, non-modifiable risk factor for adverse outcomes in atrial fibrillation (AF) patients. Left atrial appendage closure (LAAC) has been shown to be a generally safe and effective alternative to oral anticoagulation (OAC) for stroke prevention in patients with AF. However, there is limited data on sex-based outcomes with LAAC associated with catheter ablation. The OPTION trial compared the strategy of LAAC to oral anticoagulation for reducing the risk of thromboembolism in patients who had a catheter ablation for atrial fibrillation. Evaluation of outcome in women vs men was prespecified. OPTION was a randomized controlled trial enrolling catheter ablation patients. The ablation procedure could have occurred 90 to 180 days prior to or within 10 days of randomization. Groups were randomized 1:1 to either ablation+LAAC or ablation+OAC (~95% DOAC). The primary safety endpoint was 36-month non-procedural bleeding defined as International Society on Thrombosis and Haemostasis [ISTH] major bleeding or clinically relevant non-major bleeding. The primary efficacy endpoint was 36-month all-cause death, stroke, or systemic embolism. The secondary endpoint was 36-month ISTH major bleeding, including procedural bleeding. Additional endpoints included ablation and LAAC procedural characteristics, medication adherence, and arrythmia recurrence. A total of 1600 patients were randomized in OPTION (803 patients to catheter ablation+LAAC and 797 to ablation+OAC); one-third were women. The rate of the primary efficacy endpoint was similar in ablation+LAAC and ablation+OAC-treated men and women (Table). The primary safety endpoint was significantly lower in the ablation+LAAC treated men compared to ablation+OAC-treated men. The difference in ablation+LAAC vs ablation+OAC-treated women was directionally similar. At 3 years, no differences in rates of mortality, ischemic stroke, and systemic embolism were found between treatment arms in women or in men. The reduction in post-operative bleeding was higher in men as compared to women. OPTION demonstrated that LAAC reduced non-procedural bleeding compared to OAC without increasing the risk of thromboembolic events. Women exhibited higher rates of major bleeding compared to men; however, a beneficial reduction in bleeding was still observed with LAAC although conclusions may be impacted by the smaller sample size.
Subcutaneous implantable cardioverter defibrillators (S-ICDs) are preferred for younger patients who face extended lifetime risks from complications associated with traditional transvenous ICD systems. However, data on the safety and efficacy of S-ICDs in paediatric and young adult- with congenital heart disease (ACHD)- populations remain limited. This study aims to describe current European practices regarding S-ICD therapy in these population, tracking its evolution over time and associated outcomes Pediatric and ACHD patients receiving S-ICDs for primary or secondary prevention of sudden cardiac death at 12 European centers were enrolled in the multicenter, observational, retrospective, non-randomized, standard-of-care SIDECAR registry from 2010 to 2024. We analyzed baseline and procedural data, as well as acute efficacy and safety outcomes A total of 212 patients (54% with cardiomyopathies, 17% with congenital heart diseases, 14% with inherited arrhythmias, and 15% with idiopathic ventricular fibrillation), with a median age of 15 years [IQR: 13–17], BMI 21.7 ± 3.9 kg/m², underwent S-ICD implantation (57% for primary prevention). The generator was placed in an intermuscular pocket in 137 (65%) patients, and the two-incision technique was used in 186 (88%) procedures. The median procedure duration was 60 minutes [IQR: 45–91]. With increasing experience at the centers, the use of the intermuscular technique expanded from 59% in early implantations (first tertile of procedures in each center) to 73% in later ones (last tertile). Similarly, the adoption of the two-incision technique increased from 74% to 99% (P < 0.001), and procedural times significantly decreased from 66 minutes [IQR: 50–100] to 55 minutes [IQR: 43–90] (P = 0.04). Defibrillation testing was performed in 171 (81%) patients, achieving a 98% success rate at ≤65J and 100% at ≤80J, with the success rate remaining consistently high. Defibrillation testing omission remained stable at 19% across implantation cohorts (tertiles of procedures). No intraoperative complications were reported. At implantation, the median programmed conditional zone cut-off was 220 bpm [IQR: 200–220], and the shock zone cut-off was 250 bpm [IQR: 240–250]. While the conditional zone cut-off rate did not change, the shock zone cut-off increased from 240 bpm [IQR: 235–250] to 250 bpm [IQR: 240–250]. This multicenter European experience confirms that S-ICD is an effective and safe therapeutic option for paediatric and adult patients. European clinical practice in these populations has evolved, incorporating more efficient implantation techniques, which have shortened procedure times while maintaining high efficacy and safety. Long-term outcome analyses from SIDECAR registry data are ongoing.
MODULAR ATP, a multicenter, international trial, assesses a subcutaneous ICD (S-ICD) in wireless communication to a leadless pacemaker (LP) capable of pace terminating ventricular arrhythmias in addition to providing shock therapy for VT/VF. The clinical trial met 6-month safety and efficacy endpoints1, but the specific details of ventricular episodes and behavior of this novel system have not been described. Eligible patients had an ICD indication, were considered have a high risk for VT, and did not require chronic pacing. All patients were implanted with the investigational device. An independent events committee and the sponsor adjudicated arrhythmia type before and after therapy. Device therapy was re pre-specified as appropriate for persistent arrhythmia of ventricular origin, whose calculated heart rate is greater than the device-programmed conditional zone cutoff. Fine-Gray analysis was performed to identify risk of therapy delivery, accounting for mortality as a competing risk. At the time of data cutoff, 297 patients were enrolled (17.5% female, age 59±12 yrs, 57.2% primary prevention, LVEF 35±13%) and 286 patients underwent successful implantation. At a median follow-up of 15 months, 66 patients had 296 episodes: 42 patients had 105 discrete episodes (89% were VT) and 8 patients had 10 storms of VT (Figure 1). ATP-only therapy was delivered in 64% of appropriate episodes in 28 patients with a 68% ATP success rate. In 87% of appropriate episodes with ATP-only therapy, the first ATP burst terminated VT. ATP accelerated VT in 10 episodes in 7 patients. Appropriate therapy (ATP or shock) and appropriate shock rates were 12.4% and 7.5% at one year, respectively (Figure 2) Inappropriate therapy was delivered to 69 episodes in 26 subjects, yet 24/69 of these (in 10 patients) were due to overcounting of true VT whose true rate was lower than the conditional. ATP-only therapy was delivered in 14% of inappropriate episodes. Inappropriate therapy and shock rates were 8.1% and 5.9% at one year, respectively (Figure 2). Therapy was appropriately withheld in 52 episodes in 20 patients. No patient experienced lack of ATP therapy due to communication failure and no patient requested ATP or pacing therapy to be inactivated for any reason. An investigational LP, receiving ATP requests from an S-ICD via wireless communication, effectively pace-terminated VT/VF in 68% of S-ICD detected episodes. The LP appropriately withheld ATP in 43% inappropriately S-ICD sensed events. This device holds promise in refining S-ICD detected events and reducing inappropriate and appropriate S-ICD shocks.Episode Flow Chart and Classification Appropriate and Inappropriate Therapy
Background: There is sparse high-quality safety and effectiveness data for pulsed field ablation (PFA) of persistent atrial fibrillation (PerAF), where lesions beyond pulmonary vein isolation (PVI) are often placed. Additionally, no large trials have used insertable cardiac monitors (ICMs) for continuous rhythm monitoring post-ablation in PerAF patients, or after PFA in any AF population. In ADVANTAGE AF-Phase 2 , PerAF patients underwent PFA for PVI and posterior wall ablation (PWA), and in a sub-cohort, cavotricuspid isthmus (CTI) ablation for typical atrial flutter. Methods: PerAF pts underwent PVI and PWA with the pentaspline PFA catheter, and CTI with a novel focal-linear PFA catheter after IV NTG prophylaxis. Patients were followed for 1 year with continuous rhythm monitoring after ablation with ICMs to 1) emulate traditional intermittent monitoring for the primary efficacy endpoint, and 2) examine atrial arrhythmia (AA) burden and episode duration. Results: This 255-patient cohort (age 66.7±9.3, female 29%, CHA 2 DS 2 -VASc 2.4±1.4, BMI 30.9±5.3, left atrium diameter 4.3±0.6 cm) underwent PVI plus PWA (99.6%/100% acute success); a subpopulation (n=141; 55.3%) also received CTI PFA, with 98.6% achieving bidirectional block without complications (ST changes, ventricular fibrillation). CTI ablation took 8±13 minutes, using 18±6 PF applications and 4±2 mg IV NTG. The total procedure and atrial dwell times were 105±36 and 59±24 minutes, respectively. Mimicking traditional monitoring, freedom from AA was 73.4% with adverse events in 2.4%, both meeting prespecified endpoint criteria. Freedom from recurrent atrial flutter was 97.2%. Detailed analysis of the full ICM data revealed freedom from AA ≥30 seconds in 52.0%, and no episode exceeded 24 hours in 94.0% of this PerAF cohort. An AA burden >0.1% or longest episode duration >1 hour were both predictive of increased healthcare utilization. One-year procedural effectiveness was 71.6% and 70.0% using these ≤0.1% burden and <1 hour duration thresholds, respectively. Conclusions: In ADVANTAGE AF-Phase 2 , the first multicenter PerAF study of PFA with continuous rhythm monitoring: i) CTI ablation with NTG prophylaxis was safe and effective, ii) PVI + PWA was safe and effective, and iii) an AA burden <0.1% and AA episode <1 hour duration were endpoints associated with the lowest healthcare utilization.
