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.

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.

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.

A novel ablation strategy for recurrent atrial fibrillation: Fractionated signal area in the atrial muscle ablation 1-year follow-up.

INTRODUCTION: Treatment of recurrent atrial fibrillation (AF) is sometimes challenging due to non-pulmonary vein (PV) foci. Fractionated signal area in the atrial muscle (FAAM) is a valid predictor of the location of non-PV foci. FAAM ablation has the potential to decrease the recurrence rate of atrial tachyarrhythmia in patients with recurrent AF. We compared the clinical impact of FAAM ablation for recurrent AF, using 1 year follow up date. METHODS: A total of 230 consecutive patients with symptomatic recurrent AF who underwent catheter ablation specifically targeting non-PV foci as FAAM-guided ablation (n = 113) and non-FAAM-guided ablation (n = 117) were retrospectively analyzed. FAAM was assigned a parameter (peaks slider, which indicates the number of components of fractionated signals), ranging from 1 to 15, indicating the location of the FAAM (1: largest, 15: smallest). FAAM-guided ablation was performed by ablating FAAM until none inducibility of non-PV foci. On the other hand, non-FAAM-guided ablation was performed via linear ablation, complex fractionated atrial electrogram ablation, superior vena cava isolation, and focal ablation according to the location of the non-PV foci. The RHYTHMIA system was used to perform all the procedures. The primary endpoints were AF recurrence, atrial flutter, and/or atrial tachycardia. RESULTS: After a 1-year follow up, freedom from atrial tachyarrhythmia was achieved in 90.3% and 75.2% of patients in the FAAM and non-FAAM groups, respectively (hazard ratio = 0.438 [95% confidence interval: 0.243-0.788], p = .005). CONCLUSIONS: FAAM ablation showed a promising decrease in the recurrence rate of atrial tachyarrhythmia in patients with recurrent AF during a 1-year follow-up.

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.

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.

Case Series of Ventricular Tachycardia Ablation With Pulsed-Field Ablation: Pushing Technology Further (Into the Ventricle).

Three cases of ventricular tachycardia ablation with pulsed-field ablation technology performed at 2 separate centers are reported, highlighting the advantages and disadvantages of this tool inside the ventricle: its dependence on proximity rather than contact makes it useful in sites with poor stability, while the speed of application and large scope of action provided by commercially available catheters could help with ablating large diseased areas of endocardium in a fast and hemodynamically well-tolerated fashion. However, lesion depth could be insufficient for guaranteeing efficacy in preventing ventricular tachycardias originating at an epicardial site, even in the right ventricle.

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.

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.

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.

Clinical outcome for heart failure hospitalizations in patients with leadless pacemaker.

Introduction: The long-term performance of leadless pacemaker (LPM) has not been well evaluated. Methods: Between September 2017 and January 2021, 929 consecutive patients who underwent pacemaker implantation were grouped according to the types of pacemakers: LPM (LPM group, n = 368) and conventional pacemaker (PM group, n = 561). Results: The median follow-up duration was 1.7 years (interquartile range 0.8-2.6 years). Hospitalization rate for heart failure in the LPM group was 9.3%, 15.6%, and 21.6% at 1, 2, 3 years, respectively. The LPM group had a significantly higher adjusted heart failure hospitalization risk than the PM group [hazard ratio (HR) 1.70, 95% confidence interval (CI) 1.09-2.64, p = .01]. More patients with symptomatic bradycardia caused by sinus node dysfunction (SND) in the LPM group (n = 150) were admitted to the hospital for heart failure compared to those in the PM group (n = 219) (HR 2.02, 95%CI 1.04-3.90, p = .03), whereas no significant difference was observed between the two groups in the patients with bradycardia caused by atrial fibrillation (LPM group, n = 71; PM group, n = 18) or atrioventricular block (LPM group, n = 147; PM group, n = 324). Conclusions: Patients who received LPM implantation had greater hospitalization risk for heart failure, compared to those who received conventional pacemaker implantation. The increased risk was mainly attributed to patients with SND.

Predictors of lead break during transvenous lead extraction.

BACKGROUND: The incidence, predictors, and clinical impact of lead break during transvenous lead extraction (TLE) were previously unknown. METHODS: We included consecutive patients who underwent TLE between September 2013 and July 2019 at our institute. Lead break during removal was defined as lead stretching and becoming misshapen, as assessed by fluoroscopy. RESULTS: A total of 246 patients underwent TLE for 501 leads. At a patient level, complete success was achieved in 226 patients (91.9%). At a lead level, 481 leads (96.0%) were completely removed and 101 leads (20.1%) were broken during the procedure. Of 392 identified pacemaker leads, 71 (18.3%) were broken during the TLE procedure. A multivariable analysis confirmed high lead age (odds ratio [OR] 1.12, 95% confidence interval (CI) 1.07-1.17; P < .001), passive leads (OR 2.29 95% CI 1.09-4.80; P = .028), coradial leads (OR 3.45 95% CI 1.72-6.92; P < .001), and insulators made of nonpolyurethane (OR 2.38 95% CI 1.03-5.26; P = .04) as predictors of lead break. Broken leads needed longer procedure times and were associated with a higher rate of cardiac tamponade. CONCLUSIONS: Lead age, coradial bipolar leads, passive leads, and leads without polyurethane insulation were predictors of lead break and could increase the difficulty of lead extraction.

Clinical impact of eliminating nonpulmonary vein triggers of atrial fibrillation and nonpulmonary vein premature atrial contractions at initial ablation for persistent atrial fibrillation.

BACKGROUND: The role of nonpulmonary vein (PV) triggers ablation in persistent atrial fibrillation (PEAF) was suggested but it is still under debate. OBJECTIVES: We aimed to assess the effectiveness of non-PV trigger-targeted ablation for patients with PEAF. METHODS: Consecutive patients with PEAF undergoing catheter ablation (CA) between January 2015 and April 2017 were enrolled. Isoproterenol plus adenosine challenge was performed to provoke non-PV triggers. Non-PV triggers were defined as the trigger beats inducing AF (non-PV AF triggers) and/or frequent premature contractions (non-PV PACs) from other than PVs. Three groups were defined: Group 1 (n = 186) without non-PV triggers; Group 2 (n = 65) with non-PV triggers that could be completely eliminated with CA; Group 3 (n = 49) with non-PV triggers still inducible after CA. The primary endpoint was freedom from any atrial tachyarrhythmia (ATa) recurrence. RESULTS: A total of 300 patients (230 males, age 64 ± 10) were enrolled. The mean follow-up period was 27 ± 10 months. Freedom from ATa recurrence at 1 and 2 years were significantly lower in Group 3 compared to the other two groups (Group 1; 74.7%, 67.2% vs. Group 2; 75.8%, 68.3% vs. Group 3: 52.1%, 38.6%, p = .0005), irrespective of the type of non-PV triggers (non-PV AF triggers vs. non-PV PACs). On multivariate analysis, unsuccessful elimination of non-PV triggers was an independent predictor for ATa recurrence (hazard ratio = 1.80, 95% confidence interval = 1.07-2.95, p = .026). CONCLUSION: Successful non-PV triggers elimination can improve the ATa recurrence rate in PEAF ablation. ATa recurrence rate is higher, if non-PV AF triggers or even non-PV PACs remain in patients with PEAF.