Impact of intracardiac echocardiography usage on the safety of cryoballoon atrial fibrillation ablation: Subanalysis of the prospective FREEZE cluster cohort study.

INTRODUCTION: Cryoballoon ablation (CBA) aiming at pulmonary vein isolation (PVI) became a standardized atrial fibrillation (AF) ablation procedure. Life-threatening complications like cardiac tamponade exist. Intracardiac echocardiography (ICE) usage is associated with superior safety in radiofrequency ablation. It is unclear if ICE has an impact on safety of CBA. METHODS: The FREEZE Cohort (NCT01360008) subanalysis included patients undergoing "PVI only" CBA. Patients with intraprocedural transesophageal echocardiography were excluded. Group A comprises conventional, group B ICE-guided CBA. Periprocedural results were compared. RESULTS: From 2011 to 2016, a total of 4189 patients were enrolled, and 1906 (45.5%) were included in this subanalysis, split up in two groups (A: 1066 [55.9%], B: 840 [44.1%]). Group A was younger (60.6 ± 10.8 vs. 62.4 ± 10.5 years, p < .001), with smaller left atria (41 vs. 43 mm, p < .001), and less persistent AF (23.1 vs. 38.1%, p < .001). Procedure, left atrial, and fluoroscopy times were shorter in group A as compared to group B. Dose area product was significantly higher in group A (2911 vs. 2072 cGyxcm2 , p < .001). In-hospital major adverse cerebrovascular and cardiac event rates including two deaths in group A were not different between groups (0.5% vs. 0.1%, p = .18). The rate of total procedural (10.4% vs. 5.1%, p < .001) and major complications (3.2% vs. 1.3%, p < .001) was significantly higher in group A. Cardiac tamponade occurred significantly more frequently in group A (8 [0.8%] vs. 1 [0.1%], p = .046). Independent predictors for major complications were female sex (odds ratio [OR] 2.03, p = .03) and non-ICE usage (OR 2.38, p = .02). No differences were observed for persistent phrenic nerve palsy, nor for groin complications. CONCLUSION: CBA was significantly safer and required less radiation if ICE was used, although the procedures were more complex. The risk of groin complications was not increased with ICE usage. Non-ICE usage was the only modifiable independent predictor of major complications.

Cryoballoon Ablation Strategy in Persistent Atrial Fibrillation.

Background: Cryoballoon ablation is established for pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (AF). The objective was to evaluate CBA strategy in consecutive patients with persistent AF in the initial AF ablation procedure. Material and Methods: Prospectively, patients with symptomatic persistent AF scheduled for AF ablation all underwent cryoballoon PVI. Technical enhancements, laboratory management, safety, single-procedure outcome, predictors of recurrence, and durability of PVI were evaluated. Results: From 2007 to 2020, a total of 1,140 patients with persistent AF, median age 68 years, underwent cryoballoon ablation (CBA). Median left atrial (LA) diameter was 45 mm (interquantile range, IQR, 8), and Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, prior Stroke or TIA or thromboembolism (doubled), Vascular disease, Age 65 to 74 years, Sex category (CHA2DS2-VASc) score was 3. Acute isolation was achieved in 99.6% of the pulmonary veins by CBA. Median LA time and median dose area product decreased significantly over time (p < 0.001). Major complications occurred in 17 (1.5%) patients including 2 (0.2%) stroke/transitory ischemic attack (TIA), 1 (0.1%) tamponade, relevant groin complications, 1 (0.1%) significant ASD, and 4 (0.4%) persistent phrenic nerve palsy (PNP). Transient PNP occurred in 66 (5.5%) patients. No atrio-esophageal fistula was documented. Five deaths (0.4%), unrelated to the procedure, occurred very late during follow-up. After initial CBA, arrhythmia recurrences occurred in 46.6% of the patients. Freedom from atrial arrhythmias at 1-, and 2-year was 81.8 and 61.7%, respectively. Independent predictors of recurrence were LA diameter, female sex, and use of the first cryoballoon generation. Repeat ablations due to recurrences were performed in 268 (23.5%) of the 1,140 patients. No pulmonary vein (PV) reconduction was found in 49.6% of the patients and 73.5% of PVs. This rate increased to 66.4% of the patients and 88% of PVs if an advanced cryoballoon was used in the first AF ablation procedure. Conclusion: Cryoballoon ablation for symptomatic persistent AF is a reasonable strategy in the initial AF ablation procedure.

Cardiac computed tomography angiography-derived analysis of left atrial appendage morphology and left atrial dimensions for the prediction of atrial fibrillation recurrence after pulmonary vein isolation.

BACKGROUND: Left atrial appendage (LAA) is a potential source of atrial fibrillation (AF) triggers. HYPOTHESIS: LAA morphology and dimensions are associated with AF recurrence after pulmonary vein isolation (PVI). METHODS: From cardiac computed tomography angiography (CCTA), left atrial (LA), pulmonary vein (PV), and LAA anatomy were assessed in cryoballoon ablation (CBA) patients. RESULTS: Among 1103 patients undergoing second-generation CBA, 725 (65.7%) received CCTA with 473 (42.9%) qualifying for detailed LAA analysis (66.3 ± 9.5 years). Symptomatic AF reoccurred in 166 (35.1%) patients during a median follow-up of 19 months. Independent predictors of recurrence were LA volume, female sex, and mitral regurgitation ≥°II. LAA volume and AF-type were dependent predictors of recurrence due to their strong correlations with LA volume. LA volumes ≥122.7 ml (sensitivity 0.53, specificity 0.69, area under the curve [AUC] 0.63) and LAA volumes ≥11.25 ml (sensitivity 0.39, specificity 0.79, AUC 0.59) were associated with recurrence. LA volume was significantly smaller in females. LAA volumes showed no sex-specific difference. LAA morphology, classified as windsock (51.4%), chicken-wing (20.7%), cactus (12.5%), and cauliflower-type (15.2%), did not predict successful PVI (log-rank; p = 0.596). CONCLUSIONS: LAA volume was strongly correlated to LA volume and was a dependent predictor of recurrence after CBA. Main independent predictors were LA volume, female sex, and mitral regurgitation ≥°II. Gender differences in LA volumes were observed. Individual LAA morphology was not associated with AF recurrence after cryo-PVI. Our results indicate that preprocedural CCTA might be a useful imaging modality to evaluate ablation strategies for patients with recurrences despite successful PVI.

Impact of age on the outcome of cryoballoon ablation as the primary approach in the interventional treatment of atrial fibrillation: Insights from a large all-comer study.

INTRODUCTION: The objective was to analyze the impact of patient age on clinical characteristics, procedural results, safety, and outcome of cryoballoon ablation (CBA) as the primary approach in the interventional treatment of symptomatic atrial fibrillation (AF). METHODS AND RESULTS: The single-center prospective observational study investigated consecutive patients who underwent initial left atrial ablation for symptomatic paroxysmal (PAF) or persistent AF (persAF). Age groups (A-F) of less than 40, 40-49, 50-59, 60-69, 70-79 and more than or equal to 80 years were evaluated. Follow-up (FU) included ECG, Holter monitoring and assessment of AF-symptoms. From 2012 to 2016, a total of 786 patients (64 ± 11 years, range 21-85) underwent CBA. With advancing age, more cardiovascular comorbidities and larger LA diameter were observed, more females were included (each p < .001). PAF (57%) and persAF (43%, p = .320) were equally distributed over all age groups. Age was neither related to procedural parameters, nor to the complication rate (3.9%, p = .233). Median FU was 38 months. Two non-procedure related noncardiac deaths occurred late during FU. Freedom from arrhythmia was independent of age at 18 months (p = .210) but decreased for patients more than or equal to 70 years at 24 months (p = .02). At 36 months, freedom from arrhythmia was 66%-74% (groups A-D), 54% (E) and 49% (F), respectively (p = .002). LA diameter and persAF were independent predictors, whereas age was a dependent predictor of recurrence. CONCLUSION: CBA as the primary approach in the initial ablation procedure is safe and highly effective in the young, middle aged, and elderly population. LA diameter and persAF, but not ageing, were independent predictors for arrhythmia recurrence.

Catheter Ablation in Complex Atrial Arrhythmias: Pilot Study Evaluating a 3D Wide-Band Dielectric Imaging System.

BACKGROUND: Cryoballoon ablation (CBA) for pulmonary vein isolation (PVI) is a standard in atrial fibrillation (AF) ablation but might not be enough in complex atrial arrhythmias (AA). An open three-dimensional wide-band dielectric imaging system (3D-WBDIS) has been introduced to guide CBA. MATERIAL AND METHODS: Pilot study evaluating feasibility and safety of 3D-WBDIS in combination with CBA and optional radiofrequency ablation (RFA) in patients with complex AA defined as (1) history of persistent AF, (2) additional atrial tachycardia/flutter, or (3) previous left atrial ablation. RESULTS: Prospectively, seventeen patients, 68.9 ± 12.2 years of age, with complex AA were enrolled. In 70 pulmonary veins (PV), balloon positioning maneuvers (n = 129) were guided additionally by the occlusion tool (1.84/PV). Compared to angiography, its sensitivity and specificity was 94.5, and 85%, respectively. CBA-PVI was achieved in 100% of PVs including variants. In 68 maps, the median number of mapping points was 251.0 (interquartile range (IQR) 298.0) with a median map volume of 52.8 (IQR 83.9) mL. Following CBA, six additional arrhythmias (two right and two left atrial flutter, one left atrial appendage tachycardia, and one atrioventricular nodal reentry tachycardia) were identified and successfully ablated by means of RFA in five patients (29.4%). Left atrial and fluoroscopy times were 88 (IQR 40) and 20 (IQR 10) minutes, respectively. Dose area product was 1,100 (IQR 1252) cGyxcm2. Freedom from AA after 6 months follow-up time and 90 days blanking period was documented in 10/17 (59%) patients, and 8/17 (47%) without a blanking period. No major complication was observed. CONCLUSION: The combined use of CBA with optional RFA guided by a novel 3D-WBDIS is feasible and safe in patients suffering from complex AA. The occlusion tool shows high sensitivity and specificity for assessment of the balloon occlusion. Additional arrhythmias were successfully mapped and ablated. Short-term outcome is promising, and subsequent prospective, larger outcome studies are necessary to confirm our observations.

Benefit of ultra-high-density mapping-guided radiofrequency reablation in pulmonary vein isolation non-responders after initial cryoballoon procedure.

AIMS: Symptomatic atrial arrhythmias despite complete pulmonary vein isolation (PVI) are common. The purpose was to evaluate ultra-high-density multi-electrode electroanatomical mapping-guided radiofrequency ablation (RFA) in PVI non-responders. METHODS AND RESULTS: Ultra-high-density multi-electrode electroanatomical mapping-guided RFA in consecutive symptomatic atrial fibrillation (AF) patients after initial cryoballoon PVI was performed. Patients were included if all pulmonary veins (PVs) were still isolated. Radiofrequency targets were atrial tachycardia (AT), extra-PV trigger, and/or substrate. Procedural results and outcome were evaluated. Of 95 patients, 67 (70.5%) with complete PVI were included (70 years, CHA2DS2Vasc 2.9, left atrium 45 mm, persistent AF 45%, AT 45%). The median time to reablation was 26 months. One hundred and seven maps (1.6/patient) and 11.890 ± 9.018 electrograms were acquired in 33 ± 12 min. Twenty-eight percent of the left atrial (LA) wall showed pathological voltage signals, predominantly at the anterior (37%) and septal wall (26%). Atrial tachycardia (49 left, 4 right) were ablated in 35 patients (52%), extra-PV trigger in two patients (3%). One atrioventricular nodal re-entry tachycardia and seven right atrial isthmus ablation (10%) were performed. In 32 patients (48%), no AT was present and substrate-based ablation was performed. Mean LA area ablated was 7 ± 6 cm2 (7%). No major complication occurred. The mean follow-up time was 772 ± 317 days. Freedom from atrial arrhythmia recurrence off antiarrhythmic drugs was 49% at 12 months. CONCLUSION: Pulmonary vein isolation non-responders are older, mainly suffering from complex atrial arrhythmias. Left atrial substrate is predominantly located at the anterior and septal wall. Ultra-high-density multi-electrode electroanatomical mapping-guided RFA is safe and effective. At 1 year, 5 out of 10 patients were in stable sinus rhythm off antiarrhythmic drugs.

The fourth cryoballoon generation with a shorter tip to facilitate real-time pulmonary vein potential recording: Feasibility and safety results.

INTRODUCTION: Time-to-isolation (TTI) guided ablation protocols have been developed to ensure durable pulmonary vein isolation (PVI) in cryoballoon ablation (CBA). The aim was to determine the feasibility and safety of the fourth generation cryoballoon (CBG4) with a shortened tip. METHODS AND RESULTS: Consecutive patients scheduled for initial atrial fibrillation (AF) ablation were prospectively included. PVI with the 28 mm CBG4 and the latest 20 mm spiral-mapping catheter (SMC) was performed. A total of 302 pulmonary veins (PVs) in 76 patients (64.8 ± 10.4 years, paroxysmal AF 49%) were treated with 617 applications. Left atrium (LA) time, fluoroscopy time, and dose-area product were 65.5 ± 19.2 minutes, 14.6 ± 5.6 minutes, and 1094 (738; 2097) cGy·cm2 , respectively. PVI in cryoballoon technique was achieved in 302 of 302 (100%) PVs. TTI was determined in 256 (84.8%) of PVs. The mean TTI was 45.3 ± 26.4 seconds. Single-shot isolation was achieved in 247 (82%) PVs. In 6 of 302 (2.0%) PV the SMC was changed to a stiff wire to isolate the PV because of instability, and in 17 of 302 (5.6%) of PVs, the 23 mm CB was used to isolate. No radiofrequency touch-up applications were applied. The mean nadir balloon temperature was -44.8°C ± 6.6°C. Balloon dislodgement during positioning occurred in 3 of 617 (0.5%) applications without complications. One PN palsy occurred which resolved until discharge. One patient suffered from the inflammatory syndrome. CONCLUSION: The CBG4 with a shorter distal tip seems to be safe and effective, and allows determining the TTI in 84.8% of PVs. In case of balloon instability, the exchange of the SMC to a stiff wire or, in small PV, the 23 mm cryoballoon facilitate PVI.