Comparison between First- and Second-Generation Cryoballoon for Paroxysmal Atrial Fibrillation Ablation

Introduction. Cryoballoon (CB) ablation has emerged as a novel treatment for pulmonary vein isolation (PVI) for patients with paroxysmal atrial fibrillation (PAF). The second-generation Arctic Front Advance (ADV) was redesigned with technical modifications aiming at procedural and outcome improvements. We aimed to compare the efficacy of the two different technologies over a long-term follow-up. Methods. A total of 120 patients with PAF were enrolled. Sixty patients underwent PVI using the first-generation CB and 60 patients with the ADV catheter. All patients were evaluated over a follow-up period of 2 years. Results. There were no significant differences between the two groups of patients. Procedures performed with the first-generation CB showed longer fluoroscopy time (36.3±16.8 versus 14.2±13.5 min, resp.; p=0.00016) and longer procedure times as well (153.1±32 versus 102±24.8 min, resp.; p=0.019). The overall long-term success was significantly different between the two groups (68.3 versus 86.7%, resp.; p=0.017). No differences were found in the lesion areas of left and right PV between the two groups (resp., p=0.61 and 0.57). There were no significant differences in procedural-related complications. Conclusion. The ADV catheter compared to the first-generation balloon allows obtaining a significantly higher success rate after a single PVI procedure during the long-term follow-up. Fluoroscopy and procedural times were significantly shortened using the ADV catheter

Biomarkers of myocardial injury with different energy sources for atrial fibrillation catheter ablation

Background: Our study aims to compare acute myocardial injury biomarker rise after atrial fibrillation ablation performed with different technologies.Methods and Results: One hundred and ten patients were treated with pulmonary vein isolation with 4 different technologies: open-irrigated tip radiofrequency (RF) catheter in35 patients (Group A), cryoballoon in 35 patients (Group B), visually guided laser balloon in 20 patients (Group C), open-irrigated tip RF catheter with contact-force-sensing technology in 20 patients (Group D). Post-procedure samples of cardiac troponin I (cTnI) and creatinine kinase-MB (CK-MB) were collected at 19 ± 3 h and 43 ± 3 h after ablation. At the first postprocedural sample, cTnI and CK-MB levels were found elevated in all 110 patients with a median value of 2.11 ng/mL and 8.95 ng/mL, respectively. Group B showed cTnI levels increased (median 5.96 ng/mL) compared to other groups (median Group A: 1.72 ng/mL, Group C: 1.54 ng/mL, Group D: 2.0 ng/mL; p < 0.001). Also CK-MB levels resulted higher in cryoablation (median 26.4 ng/mL) compared to other groups (median Group A: 6.40 ng/mL, Group C: 7.15 ng/mL, Group D: 6.50 ng/mL; p < 0.001). No significant association was observed between biomarker levels and recurrences of atrial fibrillation after a mean follow-up of 369 ± 196 days.Conclusions: Highest markers for myocardial injury were observed in the cryoballoon group. It is possible that a longer delivery energy duration and other factors affecting lesion size resulted in higher amount of cardiac injury in cryoablation. The higher levels of cardiac biomarkers did not translate into a better outcome and its physiologic significance is unknown.

Comparison between First-and Second-Generation Cryoballoon for Paroxysmal Atrial Fibrillation Ablation

Introduction. Cryoballoon (CB) ablation has emerged as a novel treatment for pulmonary vein isolation (PVI) for patients with paroxysmal atrial fibrillation (PAF). The second-generation Arctic Front Advance (ADV) was redesigned with technical modifications aiming at procedural and outcome improvements. We aimed to compare the efficacy of the two different technologies over a long-term follow-up. Methods. A total of 120 patients with PAF were enrolled. Sixty patients underwent PVI using the firstgeneration CB and 60 patients with the ADV catheter. All patients were evaluated over a follow-up period of 2 years. Results. There were no significant differences between the two groups of patients. Procedures performed with the first-generation CB showed longer fluoroscopy time (36.3 ± 16.8 versus 14.2 ± 13.5 min, resp.; = 0.00016) and longer procedure times as well (153.1 ± 32 versus 102±24.8 min, resp.; = 0.019). The overall long-term success was significantly different between the two groups (68.3 versus 86.7%, resp.; = 0.017). No differences were found in the lesion areas of left and right PV between the two groups (resp., = 0.61 and 0.57). There were no significant differences in procedural-related complications. Conclusion. The ADV catheter compared to the first-generation balloon allows obtaining a significantly higher success rate after a single PVI procedure during the long-term follow-up. Fluoroscopy and procedural times were significantly shortened using the ADV catheter

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry

IntroductionThe Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting.MethodsItalian FLX registry is a retrospective, non-randomized, multicentric study across 25 investigational centers in Italy including consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and September 2021 (N = 772). The primary efficacy outcome was the technical success of the LAAO procedure (peri-device flow ≤ 5 mm) as assessed by intra-procedural imaging. The peri-procedural safety outcome was defined as the occurrence of one of the following events within 7 days after the procedure or by hospital discharge: death, stroke, transient ischemic attack, major extracranial bleeding (BARC type 3 or 5), pericardial effusion with tamponade or device embolization.ResultsA total of 772 patients were enrolled. The mean age was 76 ± 8 with a mean CHA2DS2-VASc score of 4.1 ± 1.4 and a mean HAS-BLED score of 3.7 ± 1.1. Technical success was achieved in 772 (100%) patients with the first device implanted in 760 (98.4%) patients. A peri-procedural safety outcome event occurred in 21 patients (2.7%) with major extracranial bleeding being the most common (1.7%). No device embolization occurred. At discharge 459 patients (59.4%) were treated with dual antiplatelet therapy (DAPT).ConclusionsThe Italian FLX registry represents the largest multicenter retrospective real-world study reporting periprocedural outcome of LAAO with the Watchman FLX device, resulting in a procedural success rate of 100% and a low incidence of peri-procedural major adverse events (2.7%)

Pre-procedural high serum visfatin and tumor necrosis factor-α might predict recurrent atrial fibrillation after catheter ablation

Abstract Background Many patients would require repeated ablation procedures owing to recurrent atrial fibrillation with its associated symptoms. Identifying those who are at risk of recurrent AF could assist us to develop preventive strategies and to properly select those who will benefit more from catheter ablation. Our aim is to study the role of preprocedural serum level of certain biomarkers in the prediction of AF recurrence after catheter ablation. Results The present study included 117 patients: 26 patients with persistent and 91 patients with paroxysmal AF. Blood samples for estimation of serum levels of studied cytokines were obtained prior to the procedure. Pulmonary vein isolation was performed in all patients through point-by point radiofrequency ablation guided by 3D electroanatomical mapping system. Patients were followed for 12 months for AF recurrence. Forty-one (35%) patients developed AF recurrence. Those patients were significantly older, had significantly higher BMI, lower ejection fraction, and wider maximal left atrial diameter (LAD). Serum hs-CRP, IL-6, TNF-α, visfatin, and adiponectin levels were significantly higher compared to those who did not develop AF recurrence. Correlation analysis showed positive correlations between the incidence of RAF and patients’ age, BMI, and maximum LAD and elevated cytokine levels and maximal LAD showed significant correlations with the type of AF and elevated serum TNF-α, visfatin, and adiponectin. Statistical analyses defined elevated serum levels of TNF-α, visfatin, and adiponectin as positive predictors for RAF, and automatic linear modeling analysis showed that elevated serum visfatin, TNF-α, and adiponectin can predict RAF by accuracy rates of 50%, 34%, and 16%, respectively. Conclusions RAF is most probably an outcome of the interplay between patients' clinical data, obesity, and inflammation. Pre-procedural estimation of serum levels of visfatin and TNF-α might determine patients with probability for RAF

Early Clinical Outcomes and Advantages of a Novel-Size Adjustable Second-Generation Cryoballoon: A Proof-of-Concept Study

(1) Background/Objective Balloon-guided catheter ablation (CA) has emerged as an alternative option for atrial fibrillation (AF) management. The recent introduction of a novel-size adjustable second-generation cryoballoon (CB) system offers innovations, but clinical outcomes remain unexplored. This study aims to assess the acute performance of the POLARx FIT™ CB system in AFCA. (2) Methods: Consecutive patients undergoing AF ablation with the POLARx FIT™ CB system in our center were included. The primary outcome was the rate of 31 mm balloon-size utilization, with secondary outcomes including acute pulmonary vein isolation (PVI) rate, periprocedural complications, and in-hospital AF recurrences. (3) Results: Twenty-four patients with a mean age of 59.5 years, predominantly male (87.5%), and exhibiting paroxysmal AF (91.7%) were enrolled. Procedural characteristics demonstrated a high acute success rate (100% PV isolation) with a favorable safety profile. Notably, the 31 mm CB configuration was utilized in 51% of applications, showcasing its adaptability in challenging anatomies. No major complications occurred, with two patients experiencing in-hospital self-limiting AF recurrences. (4) Conclusions: This study represents the first comprehensive assessment of the POLARx FIT™ CB system in AF ablation. While acknowledging the study’s limitations, this novel CB emerges as a promising tool, warranting further exploration in larger studies with extended follow-up periods

In vivo Lesion Index (LSI) validation in percutaneous radiofrequency catheter ablation

Lesion Index (LSI) has been developed to predict lesion efficacy during radiofrequency (RF) catheter ablation. However, its value in predicting lesions size has still to be established. The aim of our study was to assess the lesions size reproducibility for prespecified values of LSI reached during RF delivery in an in vivo beating heart