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.
Several studies have shown a significant association between early and late recurrence following ablation procedures for atrial fibrillation (AF). However, factors contributing to early recurrence after AF ablation, particularly with pulsed-field ablation (PFA), remain poorly understood. This study aimed to evaluate the significance of early recurrence and identify factors associated with its occurrence, with a focus on predicting late recurrence in AF patients treated with PFA. A total of 662 consecutive patients, referred for their first paroxysmal or persistent AF ablation, underwent the procedure using the FARAPULSE PFA system across 10 Italian centers were included. Early recurrence was defined as atrial arrhythmia of >30-second duration during the 3-month blanking period, and any recurrence beyond 3 months was considered as late recurrence. Of the 662 patients, 53 (8.0%) experienced early recurrence within the first 3 months of follow-up (median time to recurrence: 55[22–76] days). Specifically, 17 (32.1%) had recurrence within the first 30 days, 14 (26.4%) between 31 and 60 days, and 22 (41.5%) between 61 and 90 days post-ablation. In multivariate logistic analysis adjusted for baseline confounders, an extended lesion set beyond pulmonary vein isolation (PVI) (HR=2.91, 95% CI: 1.47–5.76, p=0.0023) and larger left atrial volume index (HR=1.03, 95% CI: 1.01–1.05, p=0.0083) were significantly associated with early arrhythmia recurrence. Over a median follow-up of 365[244–408] days, 122 (18.4%) patients experienced late recurrences (median time to recurrence: 188[133–242] days). Factors independently associated with late recurrence included age (HR=1.03, 95% CI: 1.01–1.06, p=0.0071), sleep apnea (HR=3.02, 95% CI: 1.42–6.39, p=0.0041), and early recurrence (HR=3.91, 95% CI: 2.20–6.94, p<0.0001). In patients with paroxysmal AF (n=468, 70.7%) and those undergoing PVI alone (n=512, 77.3%), early recurrences were noted in 30 (6.4%) and 31 (6.1%) cases, respectively, while late recurrences occurred in 86 (18.4%) and 88 (17.2%) cases, respectively. Early recurrence significantly increased the likelihood of late recurrence in both groups (40.0% vs. 16.9%, p<0.0001 for paroxysmal AF; 38.7% vs. 15.8%, p=0.0027 for PVI-only patients). In this cohort of AF patients undergoing PFA, an extended lesion set beyond PVI and larger left atrial volume were associated with early recurrence. Moreover, early recurrence significantly increased the risk of late recurrence, highlighting its potential as a predictive marker for long-term outcomes.
Leadless pacemakers (LP) are a promising, safe alternative to transvenous pacemakers (TVP), reducing lead and pocket related complications. LP may improve patient outcomes and comfort. A new LP system became available in 2023 in Europe; it features active fixation with helix, permitting measurement of sensing/pacing parameters before LP deployment and it is upgradable to a dual chamber LP system. Evaluate safety, longevity, electrical performances and clinical outcomes associated with LP implants in Italy. We performed a prospective evaluation of patients who received LP in Italy. Clinical and electrical data were collected at implant and follow-up. A questionnaire on the implant preferences was completed by the physicians. 141 patients (67% male, age 74±13 years) were implanted between September 2023 and September 2024 at 10 Italian sites. Pacemaker implant indications were AV-block in the 37%, atrial fibrillation with slow ventricular response in 31%, sinus node disease in the 23% and neurally-mediated syncope in 9% of the subjects. Implant was successful in all attempted cases. Final device position was mid-septum in 52 %, apical septum in the 37%, low septum in the 10%, and RVOT in the 1% of the cases. Mean skin-to-skin procedure time was 40±20 minutes. Mean fluoroscopic time was 7±3 minutes. The final device position was the first fixation site in 92% of the cases; and the first or second fixation site in 99%. No procedure or device-related complications occurred during implants. Median longevity, estimated at implant, was 21 years (interquartile range:15-23 years). At implant, mean R wave sensing was 9±4mV, mean impedance was 722±268Ohm, mean threshold was 0,7±0,3V at 0,4ms. The compression methods were figure of eight in 68%, suture closure system in 25% and simple compression in 7% of cases. Patients were ambulating after 20±6 hours; mean hospitalization time was 4±5 days. Most physicians (73%) choose to implant LP instead of TVP due to patient conditions (high risk of infection in 36%, old age in 14%, post-extraction in 12%, previous infections in 3% and other reasons in 35% of cases) and the remaining 27% choose LP as preferred standard of care. Physicians chose this LP instead of other LP available in the market for upgradability to DR in 57%, for increased battery longevity in 33% and for the possibility of extraction/repositioning in 10% of cases. In a mean follow-up of 28 days, there were no procedure or device-related complications, only one clinical event was reported (new-onset atrial fibrillation treated with anticoagulation therapy), all implanted devices performed as expected, and electrical parameters showed acceptable values. First real-world experience of a novel LP in Italy shows optimal feasibility, safety, longevity and electrical performances. Most of the physicians chose to implant this innovative LP due to the upgradability to DR system.Reasons to implant LP instead of TVP.
Increased left atrial (LA) size in atrial fibrillation (AF) is associated with AF recurrence following ablation. Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation and dilated LA. We aimed to analyze the efficacy and safety of PFA in patients with severe LA dilatation (SLAD) (≥50 ml/m2) compared to normal to moderate LA dilatation (NMLAD) (<50 ml/m2) and persistent AF. All consecutive patients undergoing AF ablation with the Farapulse system at 14 centers with complete information of left atrial volume index (LAVi) were included. Protocol-directed PVI was delivered using 2 kV with eight applications per vein. Additional lesions were performed at the operator’s discretion. 197 patients with a history of persistent AF and were included in the analysis. Of these, 74 (37.6%) had long-standing persistent AF, 47 (23.9%) were female, the mean age was 65±8 years and the mean LVEF was 54±9%. The mean LAVi was 42.8±14 ml/m2, 51 (25.9%) patients showed SLAD. A 3D mapping system was used in 70 (35.5%) of the cases, a more extensive lesion set than PVI was performed in 157 (79.7%) of cases. Patients with SLAD exhibited a lower LVEF (50±10% vs 56±8%, p=0.0001) and had a higher burden of comorbidities (structural heart disease: 23.5% vs 9.6%, p=0.016; coronary artery disease: 31.4% vs 12.3%, p=0.004; chronic kidney disease: 9.8% vs 2.1%, p=0.028). No differences between groups were found in terms of underlying AF type (long-standing AF: 37.3% vs 37.7%, p=1.00), more extensive lesion set than PVI only (82.4% vs 78.8%, p=0.688) and the use of 3D mapping system (43.1% vs 32.9%, p=0.234). No differences were also found between groups in terms of PFA deliveries outside PVs (19[14-26] vs 18[14-22], p=0.324) or total number of PFA deliveries (52[46-66] vs 49[44-57], p=0.0616), whereas skin-to-skin time (84[61-95] min vs 70[55-85] min, p=0.004) and fluoroscopy time was longer (23[15-31] min vs 17[14-23] min, p=0.001) in patients with SLAD. PVI was achieved in all patients. During a median follow-up of 358[196-402] days, 34 (17.3%) of patients experienced an arrhythmic recurrence after the 90-day blanking period. The proportion of patient with SLAD who experienced a recurrence was similar to the ones with NMLAD (15.7% for SLAD vs 17.8% for NMLAD, p=0.831); increased LA size (continuous LAVi values or LAVi ≥ 50 ml/m2) was not associated to recurrences (hazard ratio=1.09, 95%CI: 0.98 to 1.03, p=0.945 for continuous LAVi values; 0.82, 0.34 to 1.79, p=0.612 for LAVi ≥ 50 ml/m2). No major complications occurred in both groups. In our experience, the use of Farapulse PFA system for persistent AF ablation in patients with severe LA dilatation demonstrated safe and effective outcomes, mirroring a comparable pattern observed in patient with normal to moderate LA size.
