Pulmonary vein isolation using pulsed field ablation versus high-power-short-duration radiofrequency ablation in paroxysmal atrial fibrillation: efficacy, safety, and long-term follow-up. (PRIORI Study).

BACKGROUND: Pulsed field ablation (PFA) is a novel, nonthermal, cardiac tissue selective ablation modality. To date, radiofrequency (RF) guided high-power-short-duration (HPSD) ablation represents the gold standard besides cryo-ablation for pulmonary vein isolation (PVI). This single-center, retrospective study investigated the efficacy of PFA-PVI versus HPSD-RF PVI in terms of single-procedure arrhythmia-free outcome and safety in a real-world setting. METHODS: Consecutive, paroxysmal atrial fibrillation (AF) patients who underwent PVI using PFA or HPSD-RF were enrolled. In group PFA, PVI was performed using a pentaspline PFA catheter. The ablation procedure in group HPSD-RF was performed with RF-energy (45 watts, Ablation Index). RESULTS: A total of 410 patients (group PFA:201; group HPSD-RF:209) were included. There was no difference between both groups regarding age, gender and CHA2DS2-VASc-Score. Procedure time was significantly shorter in group PFA (61[44-103]min vs. 125[105-143]min; p<0.001); fluoroscopy time and dose area product were significantly higher in group PFA (16[13-20]min vs. 4[2-5]min; p<0.01 and 412[270-739]µGym2 vs. 129[58-265]µGym2; p<0.01). Overall complication rates were 2.9% in group PFA and 6.2% in group HPSD (p=0.158). There was one fatal stroke in the PFA group. The 1-year Kaplan-Meier estimated freedom from any atrial tachyarrhythmia was 85% with PFA, and 79% with HPSD-RF (log-rank p=0.160). In 56 repeat ablation procedures, PV reconnection rate was 30% after PFA and 38% after HPSD-RF (p=0.372). CONCLUSIONS: PFA and HPSD-RF were both highly efficient and effective in achieving PVI in paroxysmal AF patients. The arrhythmia-free survival is comparable. PV reconnection rate was not different.

Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients With Heart Failure.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. RESULTS: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSIONS: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients with Heart Failure: A MANIFEST-PF Sub-analysis.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: To assess the outcomes of pulsed-field ablation (PFA) in HF. METHODS: MANIFEST-PF is a multicenter patient-level registry of consecutive patients undergoing PFA for paroxysmal (PAF) or persistent AF (PerAF). In this sub-study, patients were stratified as: no history of HF (no-HF), HF with preserved EF (HFPEF; LVEF≥50%) or HF with reduced/mildly-reduced EF (HFMR/REF; LVEF<50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30s and major adverse events (MAEs), respectively. RESULTS: Of the 1,381 patients, 85% (n=1,174) were no-HF, 6.2% (n=87) were HFPEF, and 8.6% (n=120) were HFMR/REF. No-HF patients had less PerAF than patients with HF (p<0.001), with no difference between HF subtypes (p=1.00). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF than with HFPEF or HFMR/REF (79.9%, 71.3%, 67.5%, p<0.001), but similar between HFMR/REF and HFPEF (p=0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFPEF vs HFMR/REF for those with PAF (82.8%/82.4%/71.7%, p=0.09) and PerAF (73.3%, 64.2%, and 64.9%, p=0.14.MAE rates were similar between the no-HF, HFPEF and HFMR/REF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSION: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

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.

Durability of Pulmonary Vein Isolation Using Pulsed-Field Ablation: Results From the Multicenter EU-PORIA Registry.

BACKGROUND: Pulsed-field ablation (PFA) is a novel nonthermal ablation technology with high procedural safety and efficiency for pulmonary vein isolation (PVI). Premarket data showed high PVI durability during mandatory remapping studies. Data on lesion durability in real-world patients with clinically indicated redo procedures are scarce. OBJECTIVES: This study sought to report PVI durability rates in patients undergoing a clinically indicated redo procedure after an index PVI using PFA. METHODS: Patients from 7 European centers undergoing an index PVI using PFA were included the EU-PORIA (European Real-world Outcomes With Pulsed Field Ablation in Patients With Symptomatic Atrial Fibrillation) registry. In patients with subsequent left atrial redo procedures due to arrhythmia recurrence, 3-dimensional electroanatomical maps were acquired. PVI durability was assessed on a per-vein and per-patient level, and sites of reconnections and predictors of lesion durability were identified. RESULTS: Of 1,184 patients (62% paroxysmal atrial fibrillation) undergoing an index PVI using PFA, 272 (23%) had an arrhythmia recurrence. Of these, 144 (53%) underwent a left atrial redo procedure a median of 7 (Q1-Q3: 5-10) months after the first ablation. Three-dimensional electroanatomical maps identified 404 of 567 pulmonary veins (71%) with durable isolation. In 54 patients (38%), all pulmonary veins were durably isolated. Prior operator experience with cryoballoon ablation was associated with a higher PVI durability compared to operators with only point-by-point radiofrequency experience (76% vs 60%; P < 0.001). Neither the operators' cumulative experience in atrial fibrillation ablation (≤5 vs >5 years) nor the size of the PFA device used (31 mm vs 35 mm) had an impact on subsequent lesion durability (both P > 0.50). CONCLUSIONS: In 144 patients with arrhythmia recurrence after PFA PVI, durable isolation was observed in 71% of the pulmonary veins during the redo procedure, and 38% of all patients showed durable isolation of all veins.

Pulsed field ablation for atrial fibrillation - Lessons from magnetic resonance imaging.

Pulsed field ablation (PFA) is a promising technology for the treatment of atrial fibrillation (AF). Due to its unique tissue selectivity, PFA potentially bears superior characteristics as compared to established thermal energy sources in AF ablation procedures. Cardiovascular magnetic resonance imaging (CMR) using late gadolinium enhancement (LGE) is an established tool in the analysis of myocardial fibrosis representing atrial cardiomyopathy as well as ablation-induced atrial scar formation following catheter ablation with thermal energy. Mechanisms of atrial lesion formation differ between thermal ablation and electroporation and its impact on results of CMR imaging are not fully understood until now. In this review article, the potential of CMR imaging for PFA lesion assessment and available data are discussed. Further, additional needs to adopt imaging approaches to the cellular mechanisms of electroporation are considered.

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.

EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry.

AIMS: Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). The multi-centre EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multi-electrode PFA catheter. METHODS AND RESULTS: All-comer AF patients from seven high-volume centres were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality. In total, 1233 patients (61% male, mean age 66 ± 11years, 60% paroxysmal AF) were treated by 42 operators. In 169 patients (14%), additional lesions outside the PVs were performed, most commonly at the posterior wall (n = 127). Median procedure and fluoroscopy times were 58 (interquartile range: 40-87) and 14 (9-21) min, respectively, with no differences due to operator experience. Major complications occurred in 21/1233 procedures (1.7%) including pericardial tamponade (14; 1.1%) and transient ischaemic attack or stroke (n = 7; 0.6%), of which one was fatal. Prior cryoballoon users had less complication. At a median follow-up of 365 (323-386) days, the Kaplan-Meier estimate of arrhythmia-free survival was 74% (80% for paroxysmal and 66% for persistent AF). Freedom from arrhythmia was not influenced by operator experience. In 149 (12%) patients, a repeat procedure was performed due to AF recurrence and 418/584 (72%) PVs were durably isolated. CONCLUSION: The EU-PORIA registry demonstrates a high single-procedure success rate with an excellent safety profile and short procedure times in a real-world, all-comer AF patient population.

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.

Pearls and Pitfalls of Pulsed Field Ablation.

Pulsed field ablation (PFA) was recently rediscovered as an emerging treatment modality for the ablation of cardiac arrhythmias. Ultra-short high voltage pulses are leading to irreversible electroporation of cardiac cells subsequently resulting in cell death. Current literature of PFA for pulmonary vein isolation (PVI) consistently reported excellent acute and long-term efficacy along with a very low adverse event rate. The undeniable benefit of the novel ablation technique is that cardiac cells are more susceptible to electrical fields whereas surrounding structures such as the pulmonary veins, the phrenic nerve or the esophagus are not, or if at all, minimally affected, which results in a favorable safety profile that is expected to be superior to the current standard of care without compromising efficacy. Nevertheless, the exact mechanisms of electroporation are not yet entirely understood on a cellular basis and pulsed electrical field protocols of different manufactures are not comparable among one another and require their own validation for each indication. Importantly, randomized controlled trials and comparative data to current standard of care modalities, such as radiofrequency- or cryoballoon ablation, are still missing. This review focuses on the "pearls" and "pitfalls" of PFA, a technology that has the potential to become the future leading energy source for PVI and beyond.

Bronchial Safety After Pulsed Field Ablation for Paroxysmal Atrial Fibrillation.

BACKGROUND: Thermal left atrial ablation can cause bronchial damage. Pulsed field ablation (PFA) is a novel, nonthermal ablation modality for paroxysmal atrial fibrillation. We report on bronchial effects after pulmonary vein isolation using PFA for paroxysmal atrial fibrillation. METHODS: A computed tomography scan showing the respiratory tract adjacent to the left atrial was obtained. Oral anticoagulation was interrupted on procedure day. Peri-procedurally, patients received heparin with an activated clotting time goal of >350 seconds. All pulmonary veins were individually isolated with a 13F steerable sheath and a pentaspline PFA catheter using either a straight-tip or J-tip guide wire. The J-tip guide wire patients were added to test the hypothesis that the straight-tip guidewire was associated with bleeding complications. One day afterward, bronchoscopy was performed. Serial hemoglobin levels were measured during 30-day follow-up. RESULTS: In 2 series of 30 patients, PFA was performed, with all pulmonary veins acutely isolated. Clinical course was uneventful, no patient had chest discomfort, coughing, or hemoptysis. All patients underwent uncomplicated bronchoscopy, without thermal lesions or ulcers. In 12 out of 30 (40%) straight-tip guide wire patients, small amounts of old blood without active bleeding were seen in multiple segments. All hemoglobin levels remained clinically stable. At 30-day follow-up, all patients were asymptomatic. CONCLUSIONS: Pulmonary vein isolation using PFA for paroxysmal atrial fibrillation does not cause thermal lesions in the bronchial system. Use of a straight-tip, extrastiff guide wire for the over-the-wire PFA catheter can lead to asymptomatic bleeding in the bronchial system without clinical relevance at 30-day follow-up, opposite to use of a J-tip guide wire.

Multielectrode Contact Measurement Can Improve Long-Term Outcome of Pulmonary Vein Isolation Using Circular Single-Pulse Electroporation Ablation.

BACKGROUND: Irreversible electroporation (IRE) ablation is generally performed with multielectrode catheters. Electrode-tissue contact is an important predictor for the success of pulmonary vein (PV) isolation; however, contact force is difficult to measure with multielectrode ablation catheters. In a preclinical study, we assessed the feasibility of a multielectrode impedance system (MEIS) as a predictor of long-term success of PV isolation. In addition, we present the first-in-human clinical experience with MEIS. METHODS: In 10 pigs, one PV was ablated based on impedance (MEIS group), and the other PV was solely based on local electrogram information (EP group). IRE ablations were performed at 200 J. After 3 months, recurrence of conduction was assessed. Subsequently, in 30 patients undergoing PV isolation with IRE, MEIS was evaluated and MEIS contact values were compared to local electrograms. RESULTS: In the porcine study, 43 IRE applications were delivered in 19 PVs. Acutely, no reconnections were observed in either group. After 3 months, 0 versus 3 (P=0.21) PVs showed conduction recurrence in the MEIS and EP groups, respectively. Results from the clinical study showed a significant linear relation was found between mean MEIS value and bipolar dV/dt (r2=0.49, P<0.001), with a slope of 20.6 mV/s per Ohm. CONCLUSIONS: Data from the animal study suggest that MEIS values predict effective IRE applications. For the long-term success of electrical PV isolation with circular IRE applications, no significant difference in efficacy was found between ablation based on the measurement of electrode interface impedance and ablation using the classical EP approach for determining electrode-tissue contact. Experiences of the first clinical use of MEIS were promising and serve as an important basis for future research.

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).

AIMS: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.

Cerebral safety after pulsed field ablation for paroxysmal atrial fibrillation.

BACKGROUND: Pulsed field ablation (PFA) is a novel, nonthermal ablation modality that can ablate myocardial tissue with minimal effects on surrounding tissue. Preclinical data show an absence of cerebral emboli after extensive PFA. However, clinical data on silent cerebral lesions (SCLs) and/or silent cerebral events (SCEs) after PFA are lacking. OBJECTIVES: The purpose of this study was to investigate the occurrence of neurological deficits and SCL and/or SCE after PFA in paroxysmal atrial fibrillation (AF) using National Institutes of Health Stroke Scale (NIHSS) scores and magnetic resonance imaging (MRI). METHODS: In patients with symptomatic paroxysmal AF, pulmonary vein isolation (PVI) using PFA was performed. NIHSS scores were assessed before and 2 days and 30 days after PVI. One day after PVI, patients underwent cerebral 1.5-T MRI scanning using diffusion-weighted imaging and fluid-attenuated inversion recovery sequences to document the occurrence of SCL/SCE. RESULTS: PFA was performed in 30 patients (age 63 ± 10 years). No patient showed neurological deficits. All NIHSS scores showed the minimum value of 0. Cerebral MRI scans were normal in 29 of 30 patients (97%). In 1 patient (3%), a single 7-mm cerebellar lesion was observed. Forty days after the procedure, follow-up cerebral MRI scan showed complete regression of the lesion. CONCLUSION: In patients treated with PFA for symptomatic paroxysmal AF, the incidence of MRI-detected asymptomatic thromboembolic cerebral events or lesions was as low as 3%. No neurological deficits occurred in any of the patients.

First experience with pulsed field ablation as routine treatment for paroxysmal atrial fibrillation.

AIMS: Catheter ablation for atrial fibrillation (AF) using thermal energy can cause collateral damage. Pulsed field ablation (PFA) is a novel non-thermal energy source. Few small clinical studies have been published. We report on the first 'real-world' experience with pulmonary vein isolation (PVI) using PFA for paroxysmal AF (PAF). METHODS AND RESULTS: Pre- and post-ablation, phrenic nerve function was assessed. After high-density left atrial (LA) bipolar voltage mapping, all PVs were individually isolated using a 13 Fr steerable sheath and a pentaspline PFA over-the-wire catheter. After ablation, bipolar voltage mapping was repeated to assess lesion formation. In 30 PAF patients (mean 63 years; 53% female), uncomplicated PFA was performed, with all PVs acutely isolated. The median procedure time was 116 min. The median PFA catheter LA dwell time was 29 min. The median fluoroscopy time was 26 min. In one patient with roof-dependent flutter, a roof line was intentionally created. In two patients, unintentional bidirectional mitral isthmus block was created. There was no phrenic nerve or oesophageal damage. In one patient, pericardial drainage after cardiac tamponade was performed. In-hospital stay and 30-day follow-up were uneventful. After 90 days, 97% of patients were in sinus rhythm. CONCLUSION: PVI using PFA for PAF in a 'real-world' setting appears to be safe and feasible in this small patient cohort. Procedure times are homogeneous, and LA dwell time is short. Atrial ablation lines can easily be created. Unintentional ablation of atrial tissue can occur, accurate catheter alignment to the PV ostium and axis should be ensured.

The BIOMONITOR III Injectable Cardiac Monitor: Clinical Experience with a Novel Injectable Cardiac Monitor.

BACKGROUND: Injectable cardiac monitors (ICMs) are leadless subcutaneous devices for long-term monitoring of arrhythmias. The BIOTRONIK BIOMONITOR III is a novel ICM with a miniaturized profile, long sensing vector, and simplified implantation technique. METHODS: R-wave amplitude was recorded immediately after implantation, the day after implantation, and after 3 months. Follow-up was scheduled after 3 months or after an event. All data from the ICM were retrieved. The anatomical position of the ICM was determined post-implantation and after 3 months. A patient questionnaire was conducted after 3 months. RESULTS: In 36 patients (mean age 67 ± 13 years; 40% male) an ICM was inserted. Six patients were not included in the final analysis. The median time from skin cut to wound closure was 6 [IQR 5-7] minutes. Mean R-wave amplitude increased over time (0.73 ± 32 mV vs. 0.78 ± 0.38 mV vs. 0.81 ± 0.39 mV; p = ns). Three months after implantation, the ICM was in an anatomically stable position. In 14 (47%) patients, true episodes were detected. False arrhythmia alerts were detected in 13 (43%) patients. The total number of false detections was low, and the patient satisfaction rate was high. CONCLUSION: Implantation of the novel BIOMONITOR III is fast and uncomplicated; its sensing characteristics are excellent and improve over time, and patient satisfaction is high.

Characteristics and time course of acute and chronic myocardial lesion formation after electroporation ablation in the porcine model.

INTRODUCTION: Electroporation ablation creates deep and wide myocardial lesions. No data are available on time course and characteristics of acute lesion formation. METHODS: For the acute phase of myocardial lesion development, seven pigs were investigated. Single 200 J applications were delivered at four different epicardial right ventricular sites using a linear suction device, yielding a total of 28 lesions. Timing of applications was designed to yield lesions at seven time points: 0, 10, 20, 30, 40, 50, and 60 min, with four lesions per time point. After killing, lesion characteristics were histologically investigated. For the chronic phase of myocardial lesion development, tissue samples were used from previously conducted studies where tissue was obtained at 3 weeks and 3 months after electroporation ablation. RESULTS: Acute myocardial lesions induce a necrosis pattern with contraction band necrosis and interstitial edema, immediately present after electroporation ablation. No further histological changes such as hemorrhage or influx of inflammatory cells occurred in the first hour. After 3 weeks, the lesions consisted of sharply demarcated loose connective tissue that further developed to more fibrotic scar tissue after 3 months without additional changes. Within the scar tissue, arteries and nerves were unaffected. CONCLUSION: Electroporation ablation immediately induces contraction band necrosis and edema without additional tissue changes in the first hour. After 3 weeks, a sharply demarked scar has been developed that remains stable during follow-up of 3 months. This is highly relevant for clinical application of electroporation ablation in terms of the electrophysiological endpoint and waiting period after ablation.

[Pulsed field ablation : The ablation technique of the future?] / "Pulsed field ablation" : Die Ablationstechnik der Zukunft?

The ablation of cardiac arrhythmias is now standard therapy in invasive electrophysiology with a focus on atrial fibrillation due to its high prevalence. Thermal energy sources such as radiofrequency or cryoablation are the most commonly used techniques to date. Due to limitations in terms of effectiveness and safety because of possible indiscriminate tissue destruction, ablation using pulsed field ablation (PFA) can be a safe and effective alternative to thermal ablation techniques. This is a nonthermal form of energy that creates effective myocardial lesions by means of irreversible electroporation by generating short, high-energy electrical impulses. Preliminary data show high effectiveness with a low complication rate. Myocardial tissue shows a high specificity while sparing surrounding structures such as the esophagus, the phrenic nerve and surrounding vascular structures. Therefore, irreversible electroporation is a very promising technique and has the potential to become the perfect form of energy for many catheter ablations and especially for pulmonary vein isolation. In this article we provide an overview of the current status of PFA as well as an outlook on future fields of treatment.