BACKGROUND:Pericardial tamponade during atrial fibrillation (AF) ablation is a life-threatening event, yet optimal rescue strategies remain uncertain. This study explored factors influencing rescue duration and long-term outcomes, focusing on the timing of protamine reversal. METHODS:Among 3544 consecutive AF ablations (March 2021-April 2025), ten patients who developed acute tamponade were retrospectively analyzed. The primary endpoint was rescue duration, defined as the time from tamponade recognition to patient departure from the electrophysiology (EP) laboratory. Secondary endpoint was a composite of recurrent tamponade, stroke, cardiac rehospitalisation, and all-cause death during follow-up. All patients received protamine and were stratified by median time to further assess its association with rescue duration. RESULTS:Protamine administration time correlated positively with rescue duration (Spearman ρ = +0.65, p = 0.043) and remained shorter in the early-use group than in the delay-use group (90 [44-130] vs. 140 [120-172.5] min, directional p = 0.048). Lower BMI correlated with longer rescue duration (Spearman ρ = -0.72, p = 0.019), and non-paroxysmal AF tended to prolong stabilization. During follow-up, patients with and without secondary endpoint events showed no significant differences in protamine timing, baseline characteristics, AF pattern, or comorbidities. CONCLUSION:Protamine reversal should be considered promptly once pericardial effusion is recognized, as earlier administration may shorten the rescue process and facilitate earlier departure from the EP laboratory without compromising long-term safety. Lower BMI and non-paroxysmal AF were associated with longer rescue durations, suggesting both patient and arrhythmia characteristics may influence rescue complexity.

BACKGROUND:Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with non-valvular atrial fibrillation (AF). AIMS:The SAFE-PROTECT trial was designed to evaluate the safety and efficacy of the AnchorMan, a novel LAA closure device, compared with the Watchman 2.5 device for patients with AF at high risk of ischaemic stroke. METHODS:SAFE-PROTECT was a multicentre, open-label, non-inferiority trial of patients with non-valvular AF at high risk of ischaemic stroke, randomised 1:1 to LAA closure with the AnchorMan or the Watchman device. The 12-month primary endpoint was clinical success (freedom from ischaemic/haemorrhagic stroke, systemic embolism, cardiovascular or unexplained death); the secondary efficacy endpoint was echocardiography-defined LAA occlusion (peridevice leak <5 mm) at 12 months. RESULTS:A total of 216 patients were randomised to either an AnchorMan (n=108) or to a Watchman (n=108) device. The AnchorMan was non-inferior to Watchman for the primary endpoint (98.1% vs 98.1%;p>0.99; difference -0.3; 95% confidence interval [CI]: -3.9 to 3.5; pnon-inferiority=0.0004) and the powered secondary efficacy endpoint of LAA closure (100% vs 100%; difference 0%; 95% CI: -3.60 to 3.50; pnon-inferiority=not applicable). The rates of all-cause death, stroke, major bleeding, and device-related complications were low and similar between groups. CONCLUSIONS:Among patients with non-valvular AF at high risk of ischaemic stroke, the AnchorMan device met its prespecified non-inferiority primary clinical success and secondary LAA occlusion endpoints compared with the Watchman 2.5 device. CLINICALTRIALS:gov: NCT04479722.

AIMS:The long-term impact of left atrial appendage occlusion (LAAO) plus ablation for atrial fibrillation remains controversial. The present study aims to compare the three-year clinical outcomes of LAAO patients with or without one-staged ablation. METHODS AND RESULTS:The RECORD study (NCT03917563) was a prospective registry conducted in 39 participating sites in China between 1 April 2019 and 31 October 2020, which consecutively enrolled 3082 patients who successfully received the WATCHMAN LAAO device. The current study compared patients who received LAAO only to patients who underwent LAAO plus ablation. A 1:1 propensity score matching was performed to attenuate confounding. The primary outcome was a composite endpoint of cardiovascular death, stroke, and systemic embolism at 3-year. 1633/2928 (55.8%) patients received LAAO only and 1295/2928 (44.2%) received LAAO plus ablation. After propensity score matching, 1016/2032 (50.0%) were in the LAAO group and 1016/2032 (50.0%) in the LAAO plus ablation group. The mean ± SD age was 68.8 ± 9.3 years, with 815 (40.1%) participants being female. The mean ± SD CHA2DS2-VASc and HAS-BLED scores at baseline were 3.9 ± 1.8 and 2.4 ± 1.1, respectively. At three-year, compared to LAAO only, LAAO plus ablation was associated with a lower risk of cardiovascular death, stroke, systemic embolism (6.9%vs.10.4%, HRPSM:0.66, 95%CI: 0.49-0.89, P = 0.007), which was driven mainly by the lower risk of cardiovascular death (3.7% vs. 7.3%, HRPSM: 0.50, 95%CI: 0.34-0.74, P = 0.001). No significant between-group differences were noted for BARC-defined bleeding. CONCLUSION:LAAO plus ablation was associated with a lower risk of a composite of cardiovascular death, stroke, and systemic embolism than LAAO only at 3-year. However, given the observational nature of the current study, the results should be considered as hypothesis-generating only.

BackgroundThe prevalence of right bundle branch block (RBBB) among patients with atrial fibrillation (AF) and its prognostic value after radiofrequency catheter ablation (RFCA) remain unclear. This study aimed to investigate the prevalence of complete RBBB (CRBBB) and incomplete RBBB (IRBBB) and to evaluate their impact on recurrence after RFCA in patients with AF.MethodsA total of 949 consecutive AF patients who underwent de novo RFCA between 2018 and 2020 were retrospectively analyzed. Patients were categorized into non-RBBB, IRBBB, and CRBBB groups. Baseline clinical characteristics were compared among groups. Kaplan–Meier analysis and Cox proportional hazards regression models were used to assess the predictive value of RBBB for recurrence.ResultsThe prevalence of CRBBB and IRBBB among AF patients was 5.3% (n = 50) and 4.4% (n = 42), respectively, and both increased with aging (p < 0.001). During a median follow-up of 790 days (interquartile range: 495–1086 days), the recurrence rates in the non-RBBB, IRBBB, and CRBBB groups were 32.2%, 23.8%, and 56.0%, respectively. Log-rank analysis revealed significant differences in sinus rhythm maintenance among the three groups (χ2 = 10.357, p = 0.006). After adjustment for confounding factors, multivariate Cox regression analysis demonstrated that CRBBB was an independent predictor of recurrence after RFCA (HR = 1.83; 95% CI: 1.04–3.23; p = 0.037), whereas IRBBB was not significantly associated with recurrence.ConclusionThe prevalence of RBBB is relatively high among AF patients undergoing RFCA and increases with aging. CRBBB may be an independent predictor of recurrence, whereas IRBBB is not associated with recurrence. The results should be proved by prospective multicenter investigation in the future.

BACKGROUND:Pulsed field ablation (PFA) is a breakthrough therapeutic modality for atrial fibrillation that employs nonthermal irreversible electroporation to selectively ablate cardiomyocytes. This preclinical study evaluated the safety and efficacy of a novel PFA system for pulmonary vein isolation (PVI). OBJECTIVES:This study aimed to assess the safety and efficacy of a preclinical used PFA system in achieving acute and durable PVI. METHODS:The PFA system-comprising two flexible circular catheters, a three-dimensional mapping system (3DMS), and a pulsed field generator-was utilized for PVI. Bipolar, biphasic waveforms were delivered in six swine using a 7-electrode circular catheter at the right superior pulmonary vein (RSPV) and a 14-electrode catheter at the common inferior pulmonary vein (CIPV). All animals underwent repeat electrophysiological mapping immediately post-procedure and at 3-month follow-up to assess lesion durability and procedural safety, followed by gross necropsy and histology. RESULTS:All targeted pulmonary veins were successfully isolated. A total of 22.7 ± 5.3 applications were delivered per animal, comprising 11.0 ± 1.9 applications using the 7-electrode catheter and 11.7 ± 4.7 applications using the 14-electrode catheter. Acute and durable PVI at 3-month follow-up was achieved in all swine. Histopathology assessment revealed 100% of transmural fibrotic lesions with a mean depth of 2.7 ± 0.6 mm at RSPV and 3.3 ± 1.4 mm at CIPV (p = 0.372) with no evidence of inflammation, or thrombus formation. No ventricular arrhythmias occurred during PFA delivery, and no periprocedural adverse events were observed. Furthermore, no collateral damage-including esophageal injury or phrenic nerve paralysis-was detected at the 3-month evaluation. CONCLUSIONS:The 3DMS integrated PFA system demonstrated excellent acute and chronic efficacy in achieving PVI, with durable lesion formation and a favorable safety profile free from collateral tissue injury.

INTRODUCTION:Atrial fibrillation (AF), with a prevalence of 1-2%, is the most common cardiac arrhythmia. AF is associated with a fivefold increased risk of cardioembolic events; approximately 20% of all strokes are caused by AF. Pulmonary vein isolation (PVI) has become the first-line treatment for AF. However, PVI cannot eliminate the residual stroke risk. Current guidelines recommend that anticoagulation be continued in this specific group of patients, regardless of the presence or absence of AF. In this large AF population post-PVI, who are considered to be in an earlier stage of AF, it is unknown whether left atrial appendage closure (LAAC) offers an alternative to direct oral anticoagulant (DOAC) therapy. METHODS AND ANALYSIS:The trial will be a prospective, randomised, multicentre non-inferiority study comparing two treatment strategies in AF patients after atrial ablation. Patients will be randomly assigned to either percutaneous LAAC (group A) or DOAC treatment (group B) in a 1:1 ratio; both sequential and concomitant planned ablation with or without LAAC are accepted. Randomisation will be conducted using web-based randomisation software. A total of 1012 participants (506 patients per group) will be enrolled. The primary effectiveness measure will be the occurrence of any of the specified events within 24 months after randomisation: stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality and all-cause mortality. ETHICS AND DISSEMINATION:The study was approved by the Ethical Review Board of Shanghai Chest Hospital, China (KS(Y)20287). Written informed consent will be obtained from all participants. The trial will follow the Declaration of Helsinki and Good Clinical Practice. Confidentiality will be maintained with anonymised, securely stored data. Findings will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER:ChiCTR2000036538.

Background We previously pioneered a negatively ionized polyethylene terephthalate membrane method (the SMART technique) with the LAMax (test) occluder to reduce platelet adhesion and promote endothelialization. Objectives This study aimed to compare the safety and efficacy of the test occluder with the Watchman 2.5 device (control) in patients with nonvalvular atrial fibrillation to reduce stroke risk. Methods Overall, 236 patients were randomly assigned (1:1) (open-label) to the test or control device for left atrial appendage occlusion (LAAO). The effectiveness endpoints included 12-month successful left atrial appendage (LAA) sealing with residual flow <= 5 mm and clinical success (composite of ischemic stroke, transient ischemic attack, and systemic embolism). Safety endpoints were also studied. A noninferiority margin of -7% was set between the devices. Results The test device was noninferior to the control device for the effectiveness endpoints of successful LAA sealing (test 93.2% vs control 89.8%; P < 0.05) and clinical success (test 93.2% vs control 89.8%; P < 0.05). The 12-month safety endpoints were similar between the 2 devices. The device-related thrombus rates for the control device at the 3- and 12-month visits were 5.7% and 4.6%, respectively; no cases of device-related thrombus occurred with the test device. Conclusions This study suggests that transcatheter LAAO using the SMART technique may effectively and safely prevent stroke in patients with nonvalvular atrial fibrillation. Although further studies with larger sample sizes are needed, this novel technique may prevent device-related thrombus formation and has high potential for application in interventional therapies. (LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke; NCT04429646) (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

The use of doxorubicin (DOX), a potent chemotherapy drug, is limited by its detrimental effects on the heart. This cardiotoxicity is primarily driven by oxidative stress and inflammation. TRIM35 plays a key role in inflammatory responses; however, its exact function in DOX-induced cardiotoxicity (DIC) remains to be fully understood. This study investigates the effects of TRIM35 on DIC and explores the underlying biological mechanisms. To assess the role of TRIM35, we reduced the expression of TRIM35 in the heart tissues of mice using an adeno-associated virus 9 (AAV9) system, delivered through tail vein injection. We then administered weekly doses of DOX (4 mg/kg) to C57BL/6 mice for 4 weeks to induce DIC. Echocardiography, histopathological assessments, and molecular techniques were employed to examine the effects and mechanisms of TRIM35 on DIC. Our research found that DOX treatment increases TRIM35 levels in the heart. By lowering TRIM35 expression, we observed an improvement in cardiac function and a decrease in myocardial damage in DOX-treated mice. Additionally, reduced TRIM35 expression lessened myocardial hypertrophy and fibrosis. It also mitigated the oxidative stress and inflammation caused by DOX. Furthermore, the down-regulation of TRIM35 expression resulted in the downregulation of TLR4 and phosphorylated P65 expression. Downregulated TRIM35 expression mitigates the oxidative stress and inflammation caused by DOX, likely through impacting the TLR4/NF-κB signaling pathway. These insights indicate that TRIM35 holds promise as a therapeutic target for managing heart damage induced by DOX.

Background:Left atrial appendage closure (LAAC) is an alternative to oral anticoagulation for stroke prevention in non-valvular atrial fibrillation (AF). Selecting the appropriate size of Watchman device is very important intra-procedure. There are several methods have been reported to measure the left atrial appendage (LAA), but each of them has its limitations. Objective:We investigated the efficacy and safety of using the novel "steel ball method" compared to using the traditional "sheath method" and TEE during procedure of LAAC with Watchman device in AF patients. Methods:Patients with atrial fibrillation who underwent LAAC with Watchman device at The First Affiliated Hospital of Ningbo University from January 2018 to December 2021 were retrospectively analyzed. A 10 mm-diameter steel ball was placed on patient's body surface at the pulmonary valve auscultation zone before procedure. The maximum LAA ostium diameter, maximum LAA depth, and 1st sheath marker band length were measured under x-ray fluoroscopy, using the delivery sheath, pigtail sheath, and steel ball as references, respectively, which we called the delivery sheath group, pigtail sheath group and steel ball group. The maximum LAA ostium diameter and maximum LAA depth were also measured by TEE. All Watchman devices were selected based on the measurement of LAA by "steel ball method". The position of Watchman device and presence of peri-device leakage (PDL) were assessed using transesophageal echocardiography (TEE) before and after the release. Results:Eventually a total of 169 patients [63.3% male, age 69 (44-87) years, 73.4% persistent or permanent AF, CHA2DS2-VASc score 4.31 ± 1.54, HAS-BLED score 2.74 ± 1.15, left atrial diameter 44.09 ± 7.55 mm] underwent Watchman device implantation successfully were enrolled. The mean maximum LAA ostium diameter measured in steel ball group (24.73 ± 3.39 mm) was significantly higher than that in delivery sheath group (20.04 ± 3.24 mm, p < 0.001) and pigtail sheath group (22.48 ± 3.74 mm, p < 0.001), while was not significantly different from the results measured by TEE (24.39 ± 4.13 mm, p = 0.176). The difference between 1st sheath marker band length measured in steel ball group and the true length (21 mm) was 0.29 ± 0.61 mm, which was significantly less than that in delivery sheath group (4.22 ± 1.42 mm) and pigtail sheath group (2.17 ± 1.90 mm) (both p < 0.001). Finally, the success rate of Watchman device implantation is 98.8%, with no serious intra-procedure complication. 2 patients (1.2%) occurred pericardial tamponade after procedure. 98.8% and 97.0% of patients had either no or slight (≤3 mm) PDL with immediate and 45 days post-procedural TEE scans, respectively. Device-related thrombosis (DRT) was detected in 1 patient (0.6%) and 2 patients (1.2%) had ischemic stroke during follow-up. Conclusions:In LAAC, the novel method using body surface steel ball as a reference scale to measure the left atrial appendage and guide the selection of Watchman device is accurate, effective, and safe. The size of Watchman device may be too small if selection is based on the measurement results with "sheath method", which can lead to unsatisfactory outcome of the procedure.

Presents corrections to the paper, Corrections to “CardioGPT: An ECG Interpretation Generation Model”.

BACKGROUND AND AIMS:Hemolysis-related renal failure after pulsed field ablation (PFA) has been described in recently published cases, we reported the incidence of bilirubin elevation after PFA utilizing a novel hexaspline PFA catheter. METHODS:PFA was performed in patients with paroxysmal atrial fibrillation using novel hexaspline PFA catheter, and serum bilirubin, hemoglobin and renal function were measured at baseline and the next day post ablation. RESULTS:A total of 94 patients were analyzed, and 30 of 94 (31.9%) patients had obvious total bilirubin elevation the next day post PFA. In the 30 patients, 26 (86.7%) patients had a predominantly indirect hyperbilirubinemia, suggesting a likely presence of PFA-induced hemolysis. The liver enzyme contents post ablation were normal in all patients and no signs of hemolytic anemia and renal function injury were detected. The impact factors associated with indrect hyperbilirubinemia were also analyzed and higher number of applications tented to produce PFA-induced hemolysis. More than 86.5 applications seem to have a better sensivity and specificity to predict hemolysis. CONCLUSION:Intravascular hemolysis can occur after utilizing novel hexaspline catheter, but the severity of hemolysis was mild and temporary. The number of applications appears to be a determining factor leading to hemolysis.

Presents corrections to the paper, Corrections to “CardioGPT: An ECG Interpretation Generation Model”.

BACKGROUND:Contact force (CF)-dependent pulse field electroporation (PFE) may generate tissue heating, affecting junctional rhythm at the triangle of Koch (ToK) in a clinical setting. PFE may also disrupt calcium homeostasis, causing calcium electroporation (CE) for some Joule heating. The impact of CF on PFE and CE for electrode temperature (ET) at the ToK has not been validated. METHODS:A CF-sensing catheter with an ET probe was positioned perpendicularly on dissected ToK from 12 swine. PFE was applied in four groups: low CF-calcium chloride (CC, 5.0 mM; LCF-CC, 2-10 g), high CF-CC (HCF-CC, 11-50 g), LCF-saline solution (SS; CF-SS, 2-10 g), and HCF-SS (11-50 g). ET changes derived from (LCF-CC minus LCF-SS) and (HCF-SS minus LCF-SS) was operationally defined as dominant CE (DCE) and PEF (DPFE) components, respectively. RESULTS:Fewer time-temperature curves with straight, abrupt surge (AS) followed by sudden descent (SD) were observed in LCF-CC versus other groups (p < 0.001). The delayed AS-maximal temperature (MT) curve is almost absent in the LCF-SS versus LCF-CC group (6.3% vs. 70.3%, p < 0.001). The highest △AS-MT was detected in HCF-CC and LCF-CC groups (4.3 ± 0.7°C vs. 4.3 ± 1.0°C, p = 0.37). △△AS-MT was larger from DCE than the DPFE effect (1.1 ± 1.0°C vs. 0.4 ± 0.4°C, p < 0.001). Although △SD-MT was similar in DCE and DPFE groups (p > 0.05), △△SD-MT (resistance to △SD-MT) was more prominent in DCE (0.2 ± 0.5 vs. -0.1 ± 0.5, p < 0.05). More extensive △SD-MT/duration was synchronously changed with short duration in LCF-CC or HCF-SS versus HCF-CC, and DCE group (p < 0.05). CONCLUSIONS:The in vitro model showed biphasic ET changes (initial rise followed by decline) correlated with CF-dependent CE and PFE. CF significantly modulated ET dynamics while maintaining safe thermal thresholds. Further studies should clarify how this biphasic pattern affects junctional rhythm generation in vivo conditions.

We previously pioneered a negatively ionized polyethylene terephthalate membrane method (the SMART technique) with the LAMax (test) occluder to reduce platelet adhesion and promote endothelialization. This study aimed to compare the safety and efficacy of the test occluder with the Watchman 2.5 device (control) in patients with nonvalvular atrial fibrillation to reduce stroke risk. Overall, 236 patients were randomly assigned (1:1) (open-label) to the test or control device for left atrial appendage occlusion (LAAO). The effectiveness endpoints included 12-month successful left atrial appendage (LAA) sealing with residual flow ≤5 mm and clinical success (composite of ischemic stroke, transient ischemic attack, and systemic embolism). Safety endpoints were also studied. A noninferiority margin of -7% was set between the devices. The test device was noninferior to the control device for the effectiveness endpoints of successful LAA sealing (test 93.2% vs control 89.8%; P < 0.05) and clinical success (test 93.2% vs control 89.8%; P < 0.05). The 12-month safety endpoints were similar between the 2 devices. The device-related thrombus rates for the control device at the 3- and 12-month visits were 5.7% and 4.6%, respectively; no cases of device-related thrombus occurred with the test device. This study suggests that transcatheter LAAO using the SMART technique may effectively and safely prevent stroke in patients with nonvalvular atrial fibrillation. Although further studies with larger sample sizes are needed, this novel technique may prevent device-related thrombus formation and has high potential for application in interventional therapies. (LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke; NCT04429646).

Background Although the method of autocalibration or calibration based on catheter diameters was proposed for fluoroscopic measurement during percutaneous left atrial appendage occlusion (LAAO), it may be imprecise and lead to mismeasurement. We sought to investigate whether the utilization of the surface steel ball calibration (SSBC) method under fluoroscopy could facilitate the fluoroscopic measurement of the post-implanted WATCHMAN device (Boston Scientific Corporation, Natick, MA, USA) in LAAO. Methods This retrospective study included 97 consecutive patients who underwent percutaneous LAAO with the WATCHMAN device. The SSBC method and sheath calibration method under fluoroscopy, and transesophageal echocardiography (TEE) were employed to measure the diameter of the post-implanted device during the LAAO procedure. The results of the three methods were then compared. Results The success rate for procedural WATCHMAN implantation was 100 %. The mean maximal diameter of the post-implanted devices was 24.7 ± 3.1 mm, 23.5 ± 3.2 mm, and 24.2 ± 3.0 mm, as measured by the SSBC method, sheath calibration method, and TEE, respectively (all p < 0.001). The relevant coefficient of correlation between the SSBC method/TEE, SSBC method/sheath calibration method, and TEE/sheath calibration method, was 0.94, 0.93, and 0.89, respectively (all p < 0.001). Conclusion The SSBC method, when employed under fluoroscopy, demonstrated a high correlation with the sheath calibration method and TEE for measurements. It may be applied to facilitate fluoroscopic measurements during percutaneous LAAO procedures.

BACKGROUND:The clinical performance of a novel nanosecond pulsed field ablation (nsPFA) system (Insight Medtech) for pulmonary vein isolation in patients with paroxysmal atrial fibrillation remains unclear. OBJECTIVES:This trial sought to evaluate the efficacy and safety of nsPFA vs ablation index (AI)-guided radiofrequency ablation (RFA) for symptomatic atrial fibrillation. METHODS:The InsightPFA trial was a prospective, multicenter, randomized controlled trial. Patients were randomly allocated in a 1:1 ratio to receive either nsPFA or ablation index (AI)-guided RFA for pulmonary vein isolation. Participants completed a standardized 12-month follow-up protocol. The primary efficacy endpoint was defined as freedom from documented atrial tachyarrhythmia recurrence without the use of class I or III antiarrhythmic drugs. The safety assessment evaluated death, stroke, transient ischemic attack, procedure- and device-related events, and other adverse outcomes in both groups. Secondary efficacy endpoints included acute procedural success and procedural evaluations. RESULTS:Among 287 patients from 13 centers in China, 141 nsPFA patients and 142 AI-guided RFA patients completed follow-up. The proportions of conscious sedation use were 89.4% in the nsPFA group and 92.4% in the AI-guided RFA group. The primary efficacy endpoint was achieved in 93 (65.5%) patients in the nsPFA group and 93 (64.1%) in the AI-guided RFA group in the full analysis set population (adjusted rate difference: 2.0%; 95% CI: -8.7% to 12.8%; P = 0.0019 for noninferiority), demonstrating that the noninferiority was met. The 12-month Kaplan-Meier treatment success rates were 66.7% and 67.4% in the nsPFA and AI-guided RFA groups, respectively (HR in the PFA group: 0.99; 95% CI: 0.66 to 1.48; P = 0.0020 for noninferiority). There was no significant difference in the incidence of procedure-related adverse events between the 2 groups. Acute procedural success rates were 100% in both groups. The nsPFA group demonstrated significantly shorter total procedure time, left atrial dwell time, and ablation time but experienced longer fluoroscopy times and higher radiation exposure doses. CONCLUSIONS:The nsPFA exhibited noninferior efficacy and comparable safety to AI-guided RFA while obviating the need for general anesthesia. Furthermore, the study revealed that this ablation technique significantly reduced both total procedure time and left atrial dwelling time. (InsightPFA Trial of the LotosPFA Catheter [InsightPFA]; NCT06014996).

Background:Pulsed field ablation (PFA), a novel non-thermal energy source, has shown favorable 1-year data on the efficacy and safety profile in the treatment of paroxysmal atrial fibrillation (PAF). We sought to compare PFA, cryoballoon ablation (CBA), and radiofrequency ablation (RFA) in PAF treatment in a 3-year follow-up period. Methods:Patients with PAF undergoing first-time catheter ablation by PFA, CBA, and RFA were retrospectively included. The procedure endpoint was pulmonary vein isolation (PVI). Patients were followed with 24 h ambulatory ECG monitoring at 1, 3, 6, and 12 months and every 6 months thereafter. The primary efficacy endpoint was freedom from any atrial tachyarrhythmia >30 s occurring after the 3-month blanking period. Results:A total of 280 PAF patients undergoing ablation with PFA (n = 65), CBA (n = 55), or RFA (n = 160) were enrolled. The mean age was 60.9 ± 8.7 years, with 55.7% male patients (n = 156). Acute PVI was achieved in all patients. Total procedural time was shortest with PFA [91.0 (85.0, 103.0) min, P < 0.001], whereas fluoroscopy time was shortest with RFA [9.0 (7.0, 10.0) min, P < 0.001]. The peri-procedural complication rate was 2.5%. The Kaplan-Meier estimated 3-year freedom from any atrial tachyarrhythmia >30 s was 76.9% with PFA, 72.7% with CBA, and 66.9% with RFA (log-rank P = 0.298). The principal finding of the study was the significantly lowest premature atrial contraction (PAC) burden in non-recurrent patients treated with PFA (0.04%) compared with CBA (0.05%) and RFA (0.11%) (P < 0.001). Conclusion:At the 3-year follow-up, arrhythmia freedom was similar in PFA, CBA, and RFA in patients with PAF. PFA and CBA contributed to significantly lower PAC burden compared with RFA in patients without recurrence.

BackgroundThe achievement of first-pass isolation (FPI) during pulmonary vein isolation (PVI) generally serves as a reliable marker of lesion quality in initial radiofrequency encirclement and predicts favorable procedural outcomes. This study sought to evaluate the impact of the FPI on the long-term clinical outcomes in persistent atrial fibrillation (PeAF) patients undergoing radiofrequency ablation.MethodsWe conducted a retrospective analysis of 346 patients with PeAF who were divided into three groups: patients with FPI in bilateral PVs (BOTH group, n = 197), those with FPI in either ipsilateral PVs (EITHER group, n = 92), and those without FPI in bilateral PVs (NEITHER group, n = 57). Achieving FPI in at least one of the two ipsilateral PVs (at least ipsilateral FPI, IFPI) was utilized as a metric for evaluation. The primary endpoint was freedom from atrial tachyarrhythmias (ATAs) lasting longer than 30s beyond the blanking period. Baseline characteristics, procedural results and long-term clinical outcomes were compared among the groups.ResultThe FPI was effectively achieved in 251 left PVs (72.5%) and 235 right PVs (67.9%). After a median follow-up of 658(402, 970) days, the NEITHER group exhibited less freedom from ATAs recurrence than the BOTH group (57.9% vs. 75.1%, P < 0.001) or the EITHER group (57.9% vs. 70.7%, P = 0.036). IFPI was an independent predictor of freedom from ATAs recurrence in PeAF patients undergoing their initial ablation (HR, 0.46; 95% CI, 0.29–0.74; P = 0.001).ConclusionAchieving FPI for PVI remained a significant association with improved ablation outcomes in PeAF patients, wherein IFPI served as an important determinant.

ABSTRACTBackgroundPulsed field ablation (PFA) is gaining recognition as a nonthermal, tissue‐specific technique for the treatment of atrial fibrillation (AF). The preclinical evaluation of the investigated novel PFA system from Insight Medtech Co. Ltd has demonstrated feasibility, safety, and 30‐day efficacy for pulmonary vein isolation (PVI) in the swine model. We are currently conducting a randomized controlled trial to compare the PFA directly with ablation‐index (AI)‐guided radiofrequency ablation (RFA) for PVI.Methods and ResultsThe InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety‐two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI‐guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9‐month follow‐up period after a 90‐day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure‐related complications, device‐related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.ConclusionsThis trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.Trial Registration: https://www.clinicaltrials.gov/study/NCT06014996; NCT06014996.