Cryoablation of atrial fibrillation in "very severe" obese patients (BMI ≥ 40): Indications, feasibility, procedural safety and efficacy, and clinical outcome (the ICE-Obese Extreme).

BACKGROUND: Management of atrial fibrillation (AF) in very severe obese patients is challenging. Cryoballoon ablation (CBA) represents an effective rhythm control strategy. However, data in this patient group were limited. METHODS: Highly symptomatic AF patients with body mass index (BMI) ≥ 40 kg/m2 who had failed antiarrhythmic drug therapy and electrocardioversion and failure to achieve targeted body-weight-reduction underwent CBA. RESULTS: Data of 72 very severe obese AF patients (Group A) and 129 AF patients with normal BMI (Group B, BMI < 25 kg/m2) were consecutively collected. Group A had significantly younger age (60.6 ± 10.4 vs. 69.2 ± 11.2 years), higher BMI (44.3 ± 4.3 vs. 22.5 ± 1.6 kg/m2). Procedural pulmonary vein isolation (PVI) was successful in all patients (2 touch-up ablation in Group A). Compared to Group B, Group A had similar procedural (61.3 ± 22.6 vs. 57.5 ± 19 min), similar fluoroscopy time (10.1 ± 5.5 vs. 9.2 ± 4.8 min) but significantly higher radiation dose (2852 ± 2095 vs. 884 ± 732 µGym2). We observed similar rates of real-time-isolation (78.6% vs. 78.5%), single-shot-isolation (86.5% vs. 88.8%), but significantly longer time-to-sustained-isolation (53.5 ± 33 vs. 43.2 ± 25 s). There was significantly higher rate of puncture-site-complication (6.9% vs. 1.6%) in Group A. One-year clinical success in paroxysmal AF was (Group A: 69.4% vs. Group B: 80.2%; p < .001), in persistent AF was (Group A: 58.1% vs. Group B: 62.8%; p = .889). In Re-Do procedures Group A had a numerically lower PVI durability (75.0% vs. 83.6%, p = .089). CONCLUSION: For very severe obese AF patients, CBA appears feasible, leads to relatively good clinical outcome.

Initial real-world data on catheter ablation in patients with persistent atrial fibrillation using the novel lattice-tip focal pulsed-field ablation catheter.

AIMS: Technological advancements have contributed to the enhanced precision and lesion flexibility in pulsed-field ablation (PFA) by integrating a three-dimensional mapping system combined with a point-by-point ablation strategy. Data regarding the feasibility of this technology remain limited to some clinical trials. This study aims to elucidate initial real-world data on catheter ablation utilizing a lattice-tip focal PFA/radiofrequency ablation (RFA) catheter in patients with persistent atrial fibrillation (AF). METHODS AND RESULTS: Consecutive patients who underwent catheter ablation for persistent AF via the lattice-tip PFA/RFA catheter were enrolled. We evaluated acute procedural data including periprocedural data as well as the clinical follow-up within a 90-day blanking period. In total, 28 patients with persistent AF underwent AF ablation either under general anaesthesia (n = 6) or deep sedation (n = 22). In all patients, pulmonary vein isolation was successfully achieved. Additional linear ablations were conducted in 21 patients (78%) with a combination of successful anterior line (n = 13, 46%) and roof line (n = 19, 68%). The median procedural and fluoroscopic times were 97 (interquartile range, IQR: 80-114) min and 8.5 (IQR: 7.2-9.5) min, respectively. A total of 27 patients (96%) were interviewed during the follow-up within the blanking period, and early recurrent AF was documented in four patients (15%) including one case of recurrent AF during the hospital stay. Neither major nor minor procedural complication occurred. CONCLUSION: In terms of real-world data, our data confirmed AF ablation feasibility utilizing the lattice-tip focal PFA/RFA catheter in patients with persistent AF.

Ventricular tachycardia due to left ventricular metastasis: A case report.

We present the case of a 60-year-old male patient who was admitted to our hospital after experiencing a syncopal episode. First ECGs showed sinus rhythm with polymorphic premature ventricular complexes and later ventricular tachycardia with a left bundle branch block morphology were recorded. Imaging with TEE and MRI revealed a space-occupying lesion in the left ventricle, which was ultimately identified as a rare cardiac metastasis of renal cell carcinoma. Treatment was initiated with monoclonal antibodies resulting in lesion regression. This case highlights the importance of comprehensive diagnostic in patients with history of malignancy.

Early recurrences predict late therapy failure after pulsed field ablation of atrial fibrillation.

INTRODUCTION: Pulsed field ablation (PFA) is a new ablation technology for atrial fibrillation (AF). Data regarding early recurrences of atrial tachyarrhythmia (ERAT) after PFA-pulmonary vein isolation (PVI) are sparse. METHODS: Consecutive patients with symptomatic AF were enrolled to undergo PFA-PVI. A dedicated catheter delivering bipolar energy (1.9-2.0 kV) was used. Late recurrence (LR) was defined as documented AF/atrial tachycardia (AT) lasting more than 30 s after a 90-day blanking period. RESULTS: Two hundred and thirty-one patients (42% female, age 69 ± 12, 55% paroxysmal AF [PAF]) were included in this analysis. Median follow-up time was 367 days (interquartile range: 253-400). Forty-six patients (21%) experienced ERAT after a median of 23 days (46% in PAF and 54% in persistent AF [persAF]). Kaplan-Meier estimated freedom of AF/AT was 74.2% at 1 year, 81.8% for PAF, and 64.8% for persAF (p = .0079). Of patients experiencing ERAT, an LR was observed in 54%. There was no significant difference of LR between those who presented with very early ERAT (0-45 days) and those with ERAT (46-90 days) (p = .57). In multivariate analysis, ERAT (hazard ratio [HR]: 3.370; 95% confidence interval [95% CI]: 1.851-6.136; p < .001) and female sex (HR: 2.048; 95% CI: 1.114-3.768; p = .021) were the only independent predictors for LR. CONCLUSIONS: ERAT could be recorded in 21% of patients after PFA-PVI and was an independent predictor for LR. We found no difference in the rate of LRs among patients experiencing ERAT before or after 45 days.

Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: Insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) International Multicenter Registry.

AIMS: To compare outcomes of patients who underwent left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF) and contraindication to anticoagulants due to history of either gastrointestinal (GI) or intracranial (IC) bleeding. METHODS: Patients with NVAF that underwent LAAO for GI or IC bleeding from seven centers were included in this observational study. Baseline characteristics, procedural features, and follow-up data were collected, and compared between the two groups. The primary outcomes were incidence of ischemic and hemorrhagic events at 12-month. RESULTS: Six hundred twenty-eight patients were included, 57% with previous GI-bleeding, and 43% with previous IC-bleeding. Median CHA 2 DS 2-VASc score was 4 (interquartile range [IQRs]: 3-5) for both GI-bleeding and IC-bleeding patients, while GI-bleeding patients had a higher HAS-BLED score (4 [IQRs: 3-4] vs. 3 [IQRs]: 2-3]; p = 0.001). At 12-month follow-up, relative risk reduction for stroke was similar between the two groups. The GI-bleeding group had more hemorrhagic events compared to IC-bleeding group (any bleeding 8.4% vs. 3.2%; p = 0.012; major bleeding BARC 3-5: 4.3% vs. 1.8; p = 0.010). At multivariate analysis history of GI bleeding was an independent predictor of hemorrhagic events (adjusted HR: 2.39, 95% confidence interval: 1.02-5.63; p = 0.047). CONCLUSIONS: Outcomes after LAAO may be affected by the different indications for the procedure. In our study, GI-bleeding and IC-bleeding as indication to LAAO differ in their baseline characteristics. LAAO confirms its efficacy in ischemic risk reduction in both groups, while GI bleeding seems to be an independent predictor of bleeding recurrence at 12 months behind the antithrombotic regimen.

Findings from repeat ablation using high-density mapping after pulmonary vein isolation with pulsed field ablation.

AIMS: Pulsed-field ablation (PFA) can offer a novel perspective for atrial fibrillation (AF) ablation. We aimed to characterize the incidence of pulmonary vein (PV) reconnection, types of recurrent atrial tachyarrhythmia (ATa) and lesion quality after PFA-guided PV isolation (PVI). METHODS AND RESULTS: Patients undergoing second ablation for recurrent ATa following the initial PVI using the pentaspline PFA catheter were investigated. The rate of PV reconnection, the features of recurrent ATa, and the amount of isolated posterior wall (PW) surface area (ISAPW%) (ratio of the isolated- to total surface area on PW) were analyzed. RESULTS: Among 360 patients treated with PFA, 25 patients (paroxysmal AF, n = 19) with 99 PVs underwent a second procedure 6.1 ± 4.0 months after the initial procedure. The rate of PV reconnection was 9.1% (9 PVs). Patients presented with atrial tachycardia (AT) (n = 16), AF (n = 8) and typical atrial flutter (n = 1). The mechanism of all but one AT was macro-reentry. The critical isthmus was found to be linked to the initial lesion set at the left atrial (LA) PW in eight patients and linked to pre-existing substrate at the LA anterior wall in four patients. One AT had a focal origin at the septum. In three patients, AT were unmappable. Mean ISAPW% was 72.7 ± 19.0%. CONCLUSION: We revealed a remarkable low reconnection rate with a large antral lesion at the PW after pentaspline PFA catheter-guided PVI. However, macro-reentrant AT with a critical isthmus at the LAPW linked to the PVI lesion set was commonly observed.

Efficacy and safety in patients treated with a novel radiofrequency balloon: a two centres experience from the AURORA collaboration.

AIMS: A novel irrigated radiofrequency (RF) balloon (RFB) for pulmonary vein (PV) isolation (PVI) was released in selected centres. We pooled the procedural data on efficacy and safety of RFB-PVI from two high volume German centres. METHODS AND RESULTS: Consecutive patients with RFB procedures were enrolled. A 3D electroanatomical left atrial map guided the RFB navigation. Every RF delivery lasted 60 s, and duration was automatically reduced to 20 s for electrodes facing the posterior wall. Procedural data and post-procedural endoscopy data (<48 h) were analysed. Data from 140 patients were collected (57% male, 67 ± 11 years, 57% paroxysmal atrial fibrillation). There were 547 PVs identified, and 99.1% could be isolated using solely the RFB. Single-shot PVI was recorded in 330/547 (60%) PVs. Median time to isolation during the first application was 10 s (IQR 8-13). A total of 2.1 ± 1.8 applications per PV were delivered, with the left superior PV requiring more application compared to other PVs. Median procedure and fluoroscopy time were 77 min (61-99) and 13 min (10-17), respectively. Major safety events were recorded only in the first 25 cases at each centre and included 1/140(0.7%) cardiac tamponade, 1/140(0.7%) phrenic nerve palsy, and 2/140 strokes (1.4%). An oesophageal temperature rise was recorded in 81/547 (15%) PVs, and endoscopy detected oesophageal lesions in 7/85 (8%) patients undergoing endoscopy. CONCLUSION: The RFB showed a high efficacy allowing for fast PVI procedures, and 60% of PVs could be isolated at the first application. Most safety events were recorded during the learning phase. An oesophageal temperature monitoring is suggested: oesophageal lesions were detected in 8% of patients.

Prognostic value of chronic kidney disease in patients undergoing left atrial appendage occlusion.

AIMS: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thrombo-embolism (TE). CKD concomitantly predisposes towards a pro-haemorrhagic state. Our aim was to evaluate the prognostic value of CKD in patients undergoing percutaneous left atrial appendage occlusion (LAAO). METHODS AND RESULTS: A total of 2124 consecutive AF patients undergoing LAAO were categorized into CKD stage 1+2 (n = 1089), CKD stage 3 (n = 796), CKD stage 4 (n = 170), and CKD stage 5 (n = 69) based on the estimated glomerular filtration rate at baseline. The primary endpoint included cardiovascular (CV) mortality, TE, and major bleeding. The expected annual TE and major bleeding risks were estimated based on the CHA2DS2-VASc and HAS-BLED scores. A non-significant higher incidence of major peri-procedural adverse events (1.7 vs. 2.3 vs. 4.1 vs. 4.3) was observed with worsening CKD (P = 0.14). The mean follow-up period was 13 ± 7 months (2226 patient-years). In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank P-value = 0.04), CKD stage 4 (log-rank P-value = 0.01), and CKD stage 5 (log-rank P-value = 0.001). Left atrial appendage occlusion led to a TE risk reduction (RR) of 72, 66, 62, and 41% in each group. The relative RR of major bleeding was 58, 44, 51, and 52%, respectively. CONCLUSION: Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative RR in the incidence of TE and major bleeding was consistent across CKD groups.

Pulsed field ablation as first-line treatment to reduce atrial fibrillation burden documented by pacemaker.

Pulsed field ablation (PFA) using high-voltage electrical energy is a novel and powerful ablation modality. However, PFA as a first-line rhythm control in atrial fibrillation (AF) has been rarely described; whether PFA interacts with the pacemaker (PM) has been seldom reported. We reported PFA of AF in a patient with PM who needed effective rhythm control. Pulmonary vein isolation (PVI) was successfully performed without complication, and the procedure was extremely fast (skin-to-skin 25 min.) with short fluoroscopic time (3.9 min). PFA had no influence on the PM function. Six months' follow-up showed good clinical outcome and significantly decreased AF burden.

Impact of body mass index on cryoablation of atrial fibrillation: Patient characteristics, procedural data, and long-term outcomes.

INTRODUCTION: Ablation of atrial fibrillation in the context of obesity can be challenging. We sought to evaluate the role of cryoballoon pulmonary vein isolation (CB-PVI) in obese patients with symptomatic atrial fibrillation (AF). METHODS: Patients with a BMI ≥ 25 kg/m2 and symptomatic AF who underwent CB-PVI were retrospectively enrolled. Three groups were defined (G1: BMI of 25-29 kg/m2 ; G2: BMI of 30-34 kg/m2 ; G3: BMI ≥ 35 kg/m2 ). RESULTS: 600 patients were included (59% male; 66 ± 11 years old); 337, 149, and 114 were assigned to G1, G2, and G3, respectively. Acute procedural success was recorded in 99.7% of patients. Procedural and fluoroscopy time were comparable but the radiation dose was significantly higher in G3. Procedural complications were 3% in G1, 5.4% in G2, and 8.8% in G3 (p = .01). The overall freedom from AF after 1-year was 77%. G3 had a significantly worse 1-year success rate compared to G1 and G2 (G3: 66.5% vs. G1: 78.4%; p = .015 and vs. G2: 82.5%; p = .008) with reduced 1-year success in paroxysmal AF (G1: 84.0%; G2: 86.3%; and G3: 69.6%) but not in persistent AF (G1: 68.7%; G2: 77.4%; and G3: 62.1%). G3 showed similar success rates irrespective of AF form (PAF: 69.6% vs. persAF 62.1%; p = .501). CONCLUSION: Cryoballoon ablation in obese patients can be effective with an acceptable safety profile, 77% of patients were in stable SR at 1 year. Severe obese patients (BMI ≥ 35) showed reduced procedural safety and 1-year success rate. In association with life style modification, CB ablation may represent a strategy to enhance rhythm control in the context of obesity.

Unexpected large device related thrombus at 12 months follow-up after left atrial appendage closure.

An 89-year-old woman underwent left atrial appendage (LAA) closure (LAAC) in our hospital because of recurrent gastrointestinal bleedings. The first transesophageal echocardiography (TEE) follow-up at six weeks revealed a complete sealing of the LAA and no device related thrombus. In a TEE follow-up at one year after the LAA closure, a large device related thrombus (6 × 3 cm) was found. Treated with oral anticoagulation (apixaban) the thrombus showed a partial resolution one year later.

Single-sweep pulmonary vein isolation using the new third-generation laser balloon-Evolution in ablation style using endoscopic ablation system.

BACKGROUND: The endoscopic ablation system (EAS) is an established ablation device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). The novel X3 EAS is now equipped with a contiguous circumferential ablation mode (RAPID mode). AIM: To determine the feasibility of single-shot fashioned ablation using X3. METHODS: Consecutive patients who underwent AF ablation using X3 were enrolled. We assessed the acute procedural data focusing on "Single-sweep PVI" defined as successful PVI with a single RAPID mode energy application, and on "first-pass isolation" defined as successful PVI after initial circular lesion set. RESULTS: One hundred AF patients (56% male, age: 68 ± 10 years, 66% paroxysmal AF) were analyzed. A total of 379 of 383 PVs (99%) were isolated with X3. Single-sweep PVI and first-pass-isolation were achieved in 214 PVs (56%) and in 362 PVs (95%), respectively. Single-sweep PVI rates varied across PVs with higher rates at the superior PVs (61.2% vs. inferior PVs: 49.5%, p = .0239) and at PVs with maximal ostial diameter <24 mm (57.6% vs. >24 mm: 36.8%, p = .0151). The mean total procedure and fluoroscopy times were 43.0 ± 10 and 4.0 ± 2 min, respectively. In none of the patients an acute thromboembolic event (stroke or transient ischemic attack) or a pericardial effusion/tamponade occurred. A single transient phrenic nerve palsy was observed. CONCLUSION: The new X3 EAS allows for single-shot fashioned ablation in terms of single-sweep PVI in half or more of PVs. The new RAPID ablation mode leads to an improved rate of first-pass isolation associated with very short procedure times without compromising safety.

Optimizing cryoballoon pulmonary vein isolation: lessons from >1000 procedures- the Frankfurt approach.

AIMS: Cryoballoon (CB) pulmonary vein isolation (PVI) is an accepted ablation strategy for rhythm control in atrial fibrillation (AF). We describe efficacy and safety in a high volume centre with a long experience in the use of the second-generation CB (CB2). METHODS AND RESULTS: Consecutive paroxysmal AF (PAF) or persistent AF (persAF) patients undergoing CB2-PVI were enrolled. Procedural data, efficacy, and safety issues were systematically collected. The 28 mm CB2 was used in combination with an inner lumen spiral catheter, a luminal oesophageal temperature (LET) probe was used with a cut-off of 15°C, the phrenic nerve (PN) monitored during septal PVs ablation. Freeze duration was mainly set at 240 s with a bonus application in case of delayed time-to-isolation (TTI > 75 s). A total of 1017 CB2 procedures were analysed (58% male, 66 ± 12 years old, 70% with PAF). 3964 PVs were identified, 99.8% PVs isolated using solely the 28 mm CB. Mean procedure time was 69 ± 25 min, TTI during the first application was recorded in 77% of PVs after a mean of 48 ± 31 s. We recorded 0.2% cardiac tamponade, 4.8% PN injury (1.6% of PN palsy), and 19% of LET < 15°C. Among 725 patients with follow-up data, 84% with PAF and 75% with persAF were in stable SR at 1 year. Shorter freezing duration and longer TTI were procedural predictors for recurrence. CONCLUSION: Cryoballoon procedures are fast and associated with a benign safety profile. Shorter TTI and longer freeze durations are associated with sinus rhythm during follow-up.

Cryoballoon pulmonary vein isolation in treating atrial fibrillation using different freeze protocols: The "ICE-T 4 minutes vs 3 minutes" propensity-matched study (Frankfurt ICE-T 4 vs. 3).

BACKGROUND: Time-to-isolation (TTI) guided second-generation cryoballoon (CB2) ablation has been shown to be effective for pulmonary vein isolation (PVI). OBJECTIVE: The objective of this paper is to compare the safety and clinical outcome of CB2 PVI using the TTI guided 4 minutes vs 3 minutes freeze protocol. METHODS: This was a propensity-matched study based on an institutional database. Symptomatic atrial fibrillation (AF) patients who underwent CB2 PVI and systematic follow-up were consecutively included. RESULTS: A total of 573 patients were identified, of them 214 (107 matched-pairs) symptomatic AF (paroxysmal AF: 61%, persistent AF: 39%) patients (age: 67.7 ± 11.2 years) were analyzed. The baseline characteristics were comparable between the two groups. Procedural time was significantly longer in the 4 minutes group compared to 3 minutes group (67.2 ± 21.8 vs 55.9 ± 16.9 minutes, P < .0001). During a mean follow-up of 2 years, the 4 minutes group was associated with a significantly higher rate of freedom from arrhythmia recurrence compared with the 3 minutes group (66.4% vs 56.1%, P = .009), which was mainly driven by patients with persistent AF. The multivariate regression showed that the 4 minutes freeze was the independent predictor of freedom from arrhythmia recurrence. During the repeat procedure, the 4 minutes group was associated with a significantly higher rate of durable PVI. There was no difference regarding procedural adverse events between the two groups. CONCLUSION: As compared with the 3 minutes freeze, the TTI guided 4 minutes freeze is associated with a significantly higher rate of arrhythmia-free and durable PVI without compromising the safety profile, patients with persistent AF may benefit from the TTI guided 4 minutes freeze more pronouncedly.

Ablation index-guided 50 W ablation for pulmonary vein isolation in patients with atrial fibrillation: Procedural data, lesion analysis, and initial results from the FAFA AI High Power Study.

BACKGROUND: Radiofrequency high-power ablation appears to be a novel concept for atrial fibrillation (AF). The ablation index (AI) value has been associated with durability of pulmonary vein isolation (PVI). OBJECTIVES: This study aimed to report the procedural data and initial results of a combined ablation technique using AI-guided high-power (AI-HP; 50 W) ablation for PVI. METHODS: Symptomatic AF patients were consecutively enrolled and underwent wide-area contiguous circumferential PVI. Contact-force catheters were used, ablation power was set to 50 W targeting AI values (550 anterior and 400 posterior). Esophageal temperature was monitored during procedure, all patients underwent postablation esophageal endoscopy. RESULTS: PVI was achieved in all (n = 50, mean age: 68 ± 9 years, female: 60%) patients, rate of first-round PVI was 92%. A total of N = 2105 AI-guided ablation lesions were analyzed. Comparing left anterior wall vs left posterior wall and right anterior wall vs right posterior wall, mean ablation time (s) per lesion was 20.5 ± 8 vs 8.6 ± 3 and 12.2 ± 4 vs 9.3 ± 3; mean contact force (g): 17.1 ± 12 vs 25.4 ± 14 and 33.7 ± 13 vs 21.0 ± 11; mean AI: 547 ± 48 vs 445 ± 55 and 555 ± 56 vs 440 ± 47 (all P < .0001). Procedure and fluoroscopy time (minute) were 55.6 ± 6.6 and 6 ± 1.7, respectively. Only one (2%) patient had a minimal esophageal lesion. During In-hospital and 1-month follow-up no major complications such as death, stroke, tamponade, or atriaesophageal fistula (AE) occurred. Preliminary 6-month follow-up showed 48 of 50 (96%) patients were free from clinical AF/atrial tachycardia recurrence. CONCLUSION: AI-HP (50 W) ablation appears to be a feasible, safe, fast, and effective ablation technique for PVI.

Severe ST-segment elevation and AV block during pulsed-field ablation due to vasospastic angina - a novel observation.

Catheter ablation of atrial fibrillation using non-thermal electroporation represents a promising ablation modality due to its believed superior safety profile. Still, if electroporation is delivered in proximity to a coronary artery, vasospasms can occur. We report the first case of severe right coronary artery vasospasm resulting in ST-segment elevation and AV block despite a remote distance from the ablation site to the right coronary artery, indicating a different mechanism. In this case, electroporation most likely triggered a previously unknown Prinzmetal vasospastic angina in the patient, resulting in the coronary vasospasm. Thus, meticulous monitoring of ST-segment changes following PFA delivery even from regions remote to coronary arteries is required.

The impact of ultrasound-guided vascular access for catheter ablation of left atrial arrhythmias in a high-volume centre.

BACKGROUND: Vascular complications are a common occurrence during atrial fibrillation ablation. Observational studies indicate that the utilization of ultrasound (US)-guided puncture may decrease the incidence of vascular complications; however, its routine use is not established in many centres. METHODS: Patients undergoing catheter ablation for atrial fibrillation were included sequentially. All patients receiving US-guided punctures were prospectively enrolled (US group), while patients who underwent the procedure with standard puncture technique served as control group (No-US group). Periprocedural vascular complications requiring intervention within 30 days of the procedure were defined as the primary endpoint. RESULTS: A total of 599 patients (average age: 69 ± 11 years, 62.9% male) were analysed. The incidence of vascular complications was lower with the US-guided puncture than with the anatomic landmark-guided puncture (14/299 [4.7%] vs. 27/300 [9%], p = 0.036). The US-guided vascular access significantly reduced the rate of false aneurysms (3/299 [1%] vs. 12/300 [4%], p = 0.019). In addition, the occurrence of arteriovenous fistula (2/299 [0.7%] vs. 4/300 [1.3%], p = 0.686) and haematoma requiring treatment (9/299 [3%] vs. 11/300 [3.7%], p = 0.655) were also lower in the US group. US-guided puncture did not prolong the procedure time (mean procedure time: 57.48 ± 24.47 min vs. 56.09 ± 23.36 min, p = 0.478). Multivariate regression analysis identified female gender (OR 2.079, CI 95% 1.096-3.945, p = 0.025) and conventional vascular access (OR 2.079, CI 95% 1.025-3.908, p = 0.042) as predictors of vascular complications. CONCLUSIONS: The implementation of US-guided vascular access for left atrial catheter ablation resulted in a significant decrease of the overall vascular complication rate.

Pulsed Field Ablation for Atrial Fibrillation.

Catheter ablation is a widely used, effective and safe treatment for AF. Pulsed field ablation (PFA), as a novel energy source for cardiac ablation, has been shown to be tissue selective and is expected to decrease damage to non-cardiac tissue while providing high efficacy in pulmonary vein isolation. The FARAPULSE ablation system (Boston Scientific) follows the idea of single-shot ablation and is the first device approved for clinical use in Europe. Since its approval, multiple high-volume centres have performed increasing numbers of PFA procedures in patients with AF and have published their experiences. This review summarises the current clinical experience regarding the use of PFA for AF using the FARAPULSE system. It provides an overview of its efficacy and safety.

Impact of Pulsed-Field Ablation on Intrinsic Cardiac Autonomic Nervous System After Pulmonary Vein Isolation.

BACKGROUND: Although the autonomic reaction such as bradycardia is observed frequently during pulsed-field ablation (PFA)-guided pulmonary vein isolation (PVI), its mechanism and effect on the adjacent intrinsic cardiac autonomic nervous system (ICANS) are unclear. OBJECTIVES: This study aimed to reveal the clinical impact of PFA on ICANS by investigating the serum S100 increase (ΔS100), a well-known denervation relevant biomarker. METHODS: Pre- and postprocedural serum S100 analyses were systematically conducted in patients undergoing PVI using either the pentaspline PFA or cryoballoon ablation (CBA) system. ΔS100 release kinetics were compared between both technologies. Cerebral magnetic resonance imaging was conducted to eliminate the effect of central nervous system release. RESULTS: A total of 97 patients (PFA: n = 54 and CBA: n = 43) were enrolled. Overall S100 increased in both groups with a lower amount in PFA (0.035 µg/L; IQR: 0.02-0.063 µg/L) compared with CBA (0.12 µg/L; IQR: 0.09-0.17 µg/L; P < 0.0001). In cerebral magnetic resonance imaging, silent emboli were detected in 10 patients (18.5%) in PFA and 7 patients (16.3%) in CBA (P = 0.773). Even after excluding patients with cerebral emboli, ΔS100 was lower in PFA. During PFA PVI, 30 patients (56%) demonstrated transient bradycardia in 70 of 210 PVs (35%). ΔS100 was similar between patients with or without transient bradycardia. CONCLUSIONS: We report a significantly lower S100 release following PFA PVI vs CBA PVI even if silent cerebral emboli were excluded. Notably, vagal response during PFA was not associated with S100 release. These observations are in line with lower nervous tissue destruction of PFA compared with CBA.

Pulsed Field Versus Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation: Efficacy, Safety, and Long-Term Follow-Up in a 400-Patient Cohort.

BACKGROUND: The cryoballoon (CB) represents the gold standard single-shot device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Single-shot pulsed field PVI ablation (nonthermal, cardiac tissue selective) has recently entered the arena. We sought to compare procedural data and long-term outcome of both techniques. METHODS: Consecutive AF patients who underwent pulsed field ablation (PFA) and CB-based PVI were enrolled. CB PVI was performed using the second-generation 28-mm CB; PFA was performed using a 31/35-mm pentaspline catheter. Success was defined as freedom from atrial tachyarrhythmia after a 3-month blanking period. RESULTS: Four hundred patients were included (56.5% men; 60.8% paroxysmal AF; age 70 [interquartile range, 59-77] years), 200 in each group (CB and PFA), and baseline characteristics did not differ. Acute PVI was achieved in 100% of PFA and in 98% (196/200) of CB patients (P=0.123; 4 touch-up ablations). Median procedure time was significantly shorter in PFA (34.5 [29-40] minutes) versus CB (50 [45-60] minutes; P<0.001), fluoroscopy time was similar. Overall procedural complications were 6.5% in CB and 3.0% in PFA (P=0.1), driven by a higher rate of phrenic nerve palsies using CB. The 1-year success rates in paroxysmal AF (CB, 83.1%; PFA, 80.3%; P=0.724) and persistent AF (CB, 71%; PFA, 66.8%; P=0.629) were similar for both techniques. CONCLUSIONS: PFA compared with CB PVI shows a similar procedural efficacy but is associated with shorter procedure time and no phrenic nerve palsies. Importantly, 12-month clinical success rates are favorable but not different between both groups.