Cryoballoon Ablation For Atrial Fibrillation Research Articles

Persistent iatrogenic atrial septal defect after cryoballoon ablation for atrial fibrillation

Aims: Pulmonary vein isolation (PVI) by cryoballoon ablation (CB) technology is effective and safe treatment option for atrial fibrillation (AF). CB is performed by large diameter, 15Fr (4.95mm) transseptal sheath that may lead to creation of iatrogenic atrial septal defect (iASD). The objective of this study was to assess the incidence of iASD in patients who had undergone CB. Methods: Patients with AF having undergone Arctic Front® CB ablation and a subsequent transesophageal echocardiography (TEE) examination during post-ablation follow up period were consecutively enrolled. During all CB procedures, 15Fr transseptal sheath (Flex Cath, Medtronic, Minneapolis, MN) was utilized via single transseptal puncture (TsP). Results: Twenty-eight patients (15 females, mean age 55.8+15.5) with paroxysmal (n=24) or persistent (n=4) AF formed study group. iASD was present 11 (39.3%) of them after mean follow-up time of 17.3+6.2 months. The procedural time is significantly longer in patient with iASD (119.0+8.8 minutes, p=0.01). No patients died or suffered from any clinically significant cerebral ischemic event. There was no sign of increase in systolic pulmonary arterial pressure (sPAP). Conclusion: iASD after CB was found to be present in 39.3% of patient during a mean follow-up time of 17.3+6.2 months. The prolonged CB procedural time was the only factor that predicted iASD in our study. No adverse clinic events that might be related to iASD was observed during follow-up period.

Meta-analysis of pulsed-field ablation versus cryoablation for atrial fibrillation.

The available data on the treatment strategy of pulsed field ablation (PFA) for patients with atrial fibrillation (AF) is limited. This study aims to provide a comparative analysis of the efficacy, safety, and procedural efficiency between PFA and cryoballoon ablation (CBA) for AF. We conducted a comprehensive search of the EMBASE, PubMed, Cochrane Library, and ClinicalTrials.gov databases to identify trials comparing PFA with CBA for AF from their inception until December 2023. The odds ratio (OR) and mean difference (MD), along with a 95% confidence interval (CI), were utilized as measures of treatment effect. The analysis included 15 eligible trials with a total enrollment of 1880 patients. No significant differences were found in recurrent atrial arrhythmia (OR 0.83, 95% CI 0.64, 1.07) or periprocedural complications (OR 0.78, 95% CI 0.46, 1.30) between the two ablation techniques examined in this study. However, the PFA technique demonstrated a significantly shorter procedure time (MD -7.17, 95% CI -13.60, -0.73), but a longer fluoroscopy time (MD 2.53, 95% CI 0.87, 4.19). Similarly, PFA was found to be significantly associated with a decreased incidence of phrenic nerve palsy (OR 0.20, 95% CI 0.07, 0.59), but an increased incidence of cardiac tamponade (OR 4.07, 95% CI 1.15, 14.39). Moreover, there was a significantly higher release of troponin with PFA compared to CBA (MD 470.28, 95% CI 18.89, 921.67), while the increase in S100 protein and heart rate was significantly lower with PFA than with CBA (MD -64.41, 95% CI -105.46, -17.36), (MD -8.76, 95% CI -15.12, -2.40). The utilization of PFA provides a safer, time-saving, and tissue-specific procedure compared to CBA, while maintaining comparable success rates. This has the potential to enhance procedural efficiency and optimize resource utilization in clinical practice. These findings underscore the feasibility and promise of PFA as an alternative technique for PVI in patients with AF.

Integrated dilator-needle transseptal crossing device in atrial fibrillation cryoballoon ablation procedures.

In cryoballoon ablation (CBA) procedures, transseptal access (TSA) is generally achieved using a standard sheath and needle system that is exchanged for the cryoballoon delivery sheath and dilator over a long wire. Sheath exchange has been related with air embolic events. Recently, an integrated dilator-needle system assembled to the cryoballoon sheath was introduced. We aimed to evaluate the efficacy and safety of an integrated TSA tool compared with the traditional approach in atrial fibrillation CBA procedures. Patients scheduled for CBA procedures were randomized 1:1 to traditional TSA (t-TSA) or integrated TSA (i-TSA). TSA time was defined as time from superior vena cava to LA insertion of the cryoballoon delivery sheath, after sheath exchange (t-TSA) or directly (i-TSA). Ninety-seven patients (76 males, mean age 59 ± 10 years) were randomized, 48 patients underwent t-TSA, and 49 i-TSA. Mean TSA time was 5 min 59 s ± 5 min 36 s in the t-TSA group and 2 min 59 s ± 2 min 14 s in the i-TSA group (p < .001). Total fluoroscopy time, skin-to-skin procedure time, and LA dwell time were respectively 15 ± 6, 69 ± 16, and 44 ± 12 min in the t-TSA group and 13 ± 6, 65 ± 15, and 43 ± 11 min in the i-TSA group (p = ns). No clinically significant acute complications related to TSA were noted in both cohorts. This is the first randomized study comparing both TSA approaches. TSA in CBA procedures using this integrated tool enables a safe andefficient workflow, reducing TSA time and avoiding sheath exchange.

Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry

Background. Pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CBA) is a well-established and widely adopted method for the treatment of patients with atrial fibrillation (AF) to prevent recurrences of AF. CBA adoption in South Africa (SA) and outcome data in SA patients are limited.Objectives. To evaluate real-world usage, safety and effectiveness of CBA in SA. Methods. In this sub-analysis of the Cryo Global Registry, 81 participants with paroxysmal AF (PAF) and persistent AF (PsAF) were enrolled between 2017 and 2021 across two private SA hospitals. Baseline characteristics, procedural characteristics, 12-month safety, effectiveness (atrial arrhythmia recurrence), healthcare utilisation (repeat ablation and all-cause hospitalisation), quality of life (QoL; measured by EQ-5D-3L) and predefined symptoms were reported on. Results. Participants in the SA cohort were a mean (standard deviation) of 60 (12) years old, 19 (23.5%) were female, and 48 (59.3%) presented with PAF. The overall presence of baseline comorbidities in the SA cohort was relatively low compared with the entire Cryo Global Registry cohort. The acute PVI success rate was high (98.8%). Two serious procedure-related adverse events occurred in 2 (2.5%) participants in the SA cohort. Freedom from arrhythmia recurrence was 97.4% (95% confidence interval (CI) 83.2 - 99.6%) in PAF and 78.4% (95% CI 58.1 - 89.7%) in persistent AF (p=0.035). Kaplan-Meier estimates for freedom from repeat ablations and all-cause hospitalisations were 97.0% (95% CI 88.4 - 99.2%) and 98.5% (95% CI 90.0 - 99.8%), respectively. Participants reported significant improvement in EQ-5D-3L index score and symptoms from baseline (0.90 (0.11)) - 12 months (0.97 (0.07), p&lt;0.001). Conclusion. CBA standard-of-care procedures in SA resulted in a high clinical freedom from arrhythmia recurrence, with a low risk of safety events within 12 months post ablation. In addition, participants experienced an improvement in QoL and high freedom from healthcare utilisation at 12 months. The obtained results will be important for guiding clinical decisions around CBA in SA.

One-year outcomes of wide antral cryoballoon ablation guided by high-density mapping vs. conventional cryoballoon ablation for atrial fibrillation: a propensity score-matched study.

Pulmonary vein isolation with wide antral ablation leads to better clinical outcomes for the treatment of atrial fibrillation, but the isolation lesion is invisible in conventional cryoballoon ablation. In this study, we aim to investigate the efficacy of the wide pulmonary vein isolation technique that includes the intervenous carina region, guided by high-density mapping, compared with pulmonary vein isolation alone without the mapping system. We conducted a propensity score-matched comparison of 74 patients who underwent a wide cryoballoon ablation guided by high-density mapping (mapping group) and 74 controls who underwent conventional cryoballoon ablation in the same period (no-mapping group). The primary outcome was a clinical recurrence of documented atrial arrhythmias for >30 s during the 1-year follow-up. Of 74 patients in the mapping group, residual local potential in the pulmonary vein antrum was found in 30 (40.5%) patients, and additional cryothermal applications were performed to achieve a wide pulmonary vein isolation. Compared with the no-mapping group, the use of the mapping system in the mapping group was associated with a longer fluoroscopic time (26.97 ± 8.07 min vs. 23.76 ± 8.36 min, P = 0.023) and greater fluoroscopic exposure [339 (IQR181-586) mGy vs. 224 (IQR133-409) mGy, P = 0.012]. However, no significant differences between the two groups were found in terms of procedural duration and left atrial dwell time (104.10 ± 18.76 min vs. 102.45 ± 21.01 min, P = 0.619; 83.52 ± 17.01 min vs. 79.59 ± 17.96 min, P = 0.177). The rate of 12-month freedom from clinical atrial arrhythmia recurrence was 85.1% in the mapping group and 70.3% in the no-mapping group (log-rank P = 0.029). Voltage and pulmonary vein potential mapping after cryoballoon pulmonary vein isolation can identify residual potential in the pulmonary vein antrum, and additional cryoablation guided by mapping leads to improved freedom from atrial arrhythmias compared with conventional pulmonary vein isolation without the mapping system. ChiCTR2200064383.

Pulsed field versus cryoballoon ablation for atrial fibrillation: areal-world observational study on procedural outcomes and efficacy.

Atrial fibrillation often necessitates catheter ablation when antiarrhythmic drug therapy fails. Single-shot technologies using thermal energy, such as cryoballoon ablation, are commonly used, but pulsed field ablation (PFA), an innovative non-thermal ablation technique, is apotential alternative. This retrospective observational study aimed to compare the safety and efficacy of cryoballoon ablation and PFA in patients undergoing their first pulmonary vein isolation (PVI) procedure for atrial fibrillation treatment. We utilised real-world data from patients who underwent PVI using cryoballoon ablation or PFA. The primary outcome encompassed procedural complications, including phrenic nerve palsy, cardiac tamponade, thromboembolic complications, bleeding complications and mortality. Secondary outcomes were procedural characteristics including procedure duration, length of hospital admission, and re-do ablation rates within 6months. Atotal of 1714 procedures were analysed: 1241 in the cryoballoon group and 473 in the PFA group. Gender distribution (p = 0.03) and estimated glomerular filtration rate (p = 0.01) differed significantly. With regard to the primary outcome, the cryoballoon group demonstrated ahigher incidence of phrenic nerve palsy compared with the PFA group (15 vs0; p = 0.02). The procedure duration was shorter in the PFA group, even after adjusting for baseline characteristics (95.0 vs 74.0 min; p < 0.001). After adjustment for baseline characteristics, admission duration differed between the groups as well (p = 0.04). The study results supported the safety and efficacy of PFA over cryoballoon ablation for PVI, highlighting advantages such as shorter procedure duration and absence of phrenic nerve palsy.

An Economic Evaluation of a Streamlined Day-Case Atrial Fibrillation Ablation Protocol and Conventional Cryoballoon Ablation versus Antiarrhythmic Drugs in a UK Paroxysmal Atrial Fibrillation Population.

Symptom control for atrial fibrillation can be achieved by catheter ablation or drug therapy. We assessed the cost effectiveness of a novel streamlined atrial fibrillation cryoballoon ablation protocol (AVATAR) compared with optimised antiarrhythmic drug (AAD) therapy and a conventional catheter ablation protocol, from a UK National Health Service (NHS) perspective. Data from the AVATAR study were assessed to determine the cost effectiveness of the three protocols in a two-step process. In the first stage, statistical analysis of clinical efficacy outcomes was conducted considering either a three-way comparison (AVATAR vs. conventional ablation vs. optimised AAD therapies) or a two-way comparison (pooled ablation protocol data vs. optimised AAD therapies). In the second stage, models assessed the cost effectiveness of the protocols. Costs and some of the clinical inputs in the models were derived from within-trial cost analysis and published literature. The remaining inputs were derived from clinical experts. No significant differences between the ablation protocols were found for any of the clinical outcomes used in the model. Results of a within-trial cost analysis show that AVATAR is cost-saving (£1279 per patient) compared with the conventional ablation protocol. When compared with optimised AAD therapies, AVATAR (pooled conventional and AVATAR ablation protocols efficacy) was found to be more costly while offering improved clinical benefits. Over a lifetime time horizon, the incremental cost-effectiveness ratio of AVATAR was estimated as £21,046 per quality-adjusted life-year gained (95% credible interval £7086-£71,718). The AVATAR streamlined protocol is likely to be a cost-effective option versus both conventional ablation and optimised AAD therapy in the UK NHS healthcare setting.

Left Main Coronary Artery Spasm During Cryoballoon Ablation for Atrial Fibrillation: A Case Report and Literature Review

Left Main Coronary Artery Spasm During Cryoballoon Ablation for Atrial Fibrillation: A Case Report and Literature Review

The efficacy and safety of cryoballoon atrial fibrillation ablation in patients with heart failure: A systematic review and meta-analysis

IntroductionWhile atrial fibrillation (AF) ablation has proven beneficial for heart failure (HF) patients, most reports were performed with radiofrequency ablation. We aimed to evaluate the efficacy and safety of cryoballoon AF ablation in patients with HFrEF. MethodWe comprehensively searched the databases of MEDLINE, EMBASE, and Cochrane database from inception to December 2022. Studies that reported the outcomes of freedom from atrial arrhythmia, complications, NYHA functional class (NYHA FC), and left ventricular ejection fraction (LVEF) after Cryoballoon AF ablation in HF patients were included. Data from each study were combined with a random-effects model. ResultA total of 9 studies observational studies with 1414 HF patients were included. Five studies had only HF with reduced ejection fraction (HFrEF), 1 study with HF with preserved ejection fraction (HFpEF), and others with mixed HF types. Freedom from AA in HFrEF at 12 months was 64% (95% CI 56–71%, I2 58%). There was a significant improvement of LVEF in these patients with a standard mean difference of 13% (95% CI 8.6–17.5%, I2 99% P < 0.001. The complication rate in HFrEF group was 6% (95% CI 4–10%, I2 0%). The risk of recurrence of atrial arrhythmia was not significantly different between HF and no HF patients (RR 1.34, 95% CI 0.8–2.23, I2 76%). ConclusionCryoballoon AF ablation is effective in HFrEF patients comparable to radiofrequency ablation. The complication rate was low.

Incidence of cryoballoon expansion dislodgement during pulmonary vein isolation-An underappreciated frequent cause of incomplete isolation.

Cryoballoon ablation for atrial fibrillation (AF) requires adequate contact between the pulmonary vein (PV) antrum and cryoballoon. The surge of intraballoon pressure during the initial phase of ablation may change the balloon's shape and compliance, resulting in balloon dislodgement and loss of PV occlusion. Without continuous monitoring, this phenomenon is often undetected but can be associated with incomplete PV isolation (PVI). Primary cryoablation of AF was performed in 15 patients. PV occlusion status pre- and post-freezing were analyzed with intracardiac echocardiography (ICE) and dielectric imaging-based occlusion tool (DIOT) to calculate the incidence of expansion dislodgement of cryoballoon. A total of 105 cryoablation applications were performed on 57 veins, including three common ostiums of left pulmonary veins. In the evaluation of PV occlusion, both modalities reported consistent results in 86.7% of the assessments. Despite complete PV occlusion before ablation, peri-balloon leak after initiation of freezing was detected by ICE in 5/22 (22.7%) applications and by DIOT in 8/25 (32%) applications. Incidence of expansion dislodgement of the cryoballoon was detected in one-fourth to one-third of cryoablation applications depending on the imaging modality used, which was clinically frequent and significant.

Feasibility study of cryoballoon ablation for atrial fibrillation with KODEX-EPD: a single center experience

To evaluate the feasibility of cryoballoon (CB) ablation of atrial fibrillation (AF) under the guidance of a new three-dimensional (3D) mapping system KODEX-EPD. 40 patients scheduled for CB ablation of AF in the first affiliated Hospital of Xinjiang Medical University from August 2021 to July 2022 were randomly divided into two groups: KODEX-EPD 3D mapping system guidance group (KODEX group, n = 20) and conventional two-dimensional perspective group (standard group, n = 20). The ablation time, operation time, fluoroscopy time, fluoroscopy dose, contrast agent dosage and follow-up data were compared between the two groups. Besides, the feasibility and accuracy of the dielectric sensing system in evaluating pulmonary vein (PV) occlusion in patients with AF during CB ablation were verified. All pulmonary veins were being isolated. The ablation time (36.40 ± 6.72 min vs 35.15 ± 6.29 min, P > 0.05) and the operation time (64.20 ± 11.82 min vs 66.00 ± 13.18 min, P > 0.05) were not statistically different in the two groups. The standard group has longer fluoroscopy time, dose and contrast medium dosage. There were significant differences in fluoroscopy time (532.30 ± 72.83 s vs 676.25 ± 269.33 s, P < 0.05), fluoroscopy dose (110.00 ± 28.64 mGy vs 144.68 ± 66.66 mGy, P < 0.05), and contrast medium dosage (71.90 ± 5.97 ml vs 76.05 ± 5.93 ml, P < 0.05) between the two groups. The learning curves of the first 5 patients and the last 15 patients in the KODEX group were compared. There was no statistical difference in the ablation time (36.80 ± 8.56 min vs 36.27 ± 6.34 min, P > 0.05) or the operation time (69.00 ± 5.00 min vs 62.60 ± 13.10 min, P > 0.05); however, compared to the first 5 patients, fluoroscopy time (587.40 ± 38.34 s vs 513.93 ± 73.02 s, P < 0.05), fluoroscopy dose (147.85 ± 35.19 mGy vs 97.39 ± 8.80 mGy, P < 0.05) and contrast medium dosage (79.60 ± 1.14 ml vs 69.33 ± 4.45 ml, P < 0.05) were significantly decreased. Using pulmonary venography as the gold standard, the sensitivity, specificity of the completely occlusion in KODEX group was 93.6% (95% CI 85–97.6%) and 69.6% (95% CI 54–81.8%); and the sensitivity, specificity of the small leak in KODEX group was 93.1% (95% CI 82.4–97.8%) and 82.0% (95% CI 65.9–91.9%). During an average follow-up of (9.90 ± 1.06) months, there was no statistical difference in arrhythmia recurrence and antiarrhythmic drugs taking after CB ablation between the two groups (P > 0.05). Using the KODEX-EPD system, the CB ablation procedure can correctly evaluate the PV occlusion, and significantly reduce fluoroscopy exposure and contrast medium without significantly increasing the operation time.

Association of typical atrial flutter and cavotricuspid isthmus ablation on clinical recurrence after cryoballoon ablation for atrial fibrillation.

Typical atrial flutter commonly occurs in patients with atrial fibrillation (AF). Limited information exists regarding the effects of concurrent atrial flutter on the long-term outcomes of rhythm control. This study investigated the association between concurrent typical atrial flutter and cavotricuspid isthmus (CTI) ablation and the recurrence of atrial arrhythmia. The data were obtained from a multicenter registry of cryoballoon ablation for AF (n = 2,689). Patients who were screened for typical atrial flutter were included in the analysis (n = 1,907). All the patients with typical atrial flutter underwent CTI ablation. The primary endpoint was the late recurrence of atrial arrhythmia, including AF, atrial flutter, and atrial tachycardia. Among the 1,907 patients, typical atrial flutter was detected in 493 patients (25.9%). Patients with concurrent atrial flutter had a lower incidence of persistent AF and a smaller size of the left atrium. Patients with atrial flutter had a significantly lower recurrence rate of atrial arrhythmia (19.7% vs. 29.9%, p < 0.001). In patients with atrial flutter, the recurrence rate of atrial tachycardia or atrial flutter was more frequent (7.3% vs. 4.7%, p = 0.028), but the recurrence rate of AF was significantly lower (17.0% vs. 29.4%, p < 0.001). Atrial flutter has been identified as an independent predictor of the primary endpoint (adjusted hazard ratio, 0.704; 95% confidence interval, 0.548-0.906; p = 0.006). Typical atrial flutter in patients with AF may serve as a positive marker of the recurrence of atrial arrhythmia, and performing CTI ablation in this population is associated with a reduced likelihood of AF recurrence. Performing routine screening and ablation procedures for coexisting atrial flutter may improve the clinical outcomes of AF.

Cryoballoon ablation of atrial fibrillation in octogenarians: one year outcomes from the cryo global registry

Abstract Background Limited information is available on the safety and efficacy of cryoballoon ablation (CBA) in elderly patients with atrial fibrillation (AF). Moreover, global utilization of CBA in this population (≥ 80 years old) has not been reported. This study’s objectives were to determine the use, efficacy, and safety of CBA to treat octogenarians suffering from AF. Methods In this sub-analysis of the Cryo Global Registry, 12-month outcomes of treating AF via CBA in octogenarians were compared to patients &lt; 80 years old. Efficacy was evaluated as time to a ≥ 30 s atrial arrhythmia (AA) recurrence. Healthcare utilization was determined via repeat ablations and hospitalizations. Improvement upon disease burden was evaluated through patient reporting of symptoms and the EQ-5D-3L quality of life (QoL) survey. Results The octogenarian cohort (n = 101) had a higher prevalence of females (51.5% vs 35.7%) and CHA2DS2-VASc scores (4.2 ± 1.3 vs 2.0 ± 1.5) compared to the control cohort (n = 1573, both p &lt; 0.01). Even when adjusting for baseline characteristics and antiarrhythmic drug usage, freedom from AA recurrence at 12 months (80.6% vs 78.9%, HRadj:0.97 [95% CI:0.59–1.58], p = 0.90) was comparable between octogenarians and control, respectively. Similar serious adverse event rates were observed between octogenarians (5.0%) and control (3.2%, p = 0.38). The groups did not differ in healthcare utilization nor reduction of AF-related symptoms from baseline to follow-up, but both experienced an improvement in QoL at 12 months. Conclusions Despite more age-related comorbidities, CBA is a safe and effective treatment for AF in octogenarians, with efficacy and adverse events rates akin to ablations performed in younger patients. Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT02752737 Graphical Abstract

Long-term efficacy and safety of cryoballoon ablation of atrial fibrillation: A systematic review and meta-analysis.

This meta-analysis evaluated long-term efficacy and safety of cryoballoon ablation (CB) of atrial fibrillation (AF). PubMed, Cochrane Library, and Web of Science were searched until July 31, 2023, for published works investigating efficacy and safety of CB of AF in which mean/median follow-up time was not less than 36 months. Safety was assessed by adverse events. Efficacy was assessed by AF recurrence, defined as any atrial arrhythmias lasting more than 30 s. A total of 19 clinical studies were included. After an average of 58.1 months of follow-up, the overall AF recurrence rate was about 37%. The predictors of recurrence were duration of AF (HR 1.00; 95% CI [1.00 ∼ 1.01]), early recurrence of atrial fibrillation (HR 3.96; 95%CI [1.12 ∼ 14.02]), left atrial diameter (HR 1.04; 95%CI [1.02 ∼ 1.06]), and persistent AF (HR1.47; 95% CI [1.19 ∼ 1.82]). In terms of safety, the incidence of transient phrenic paralysis (PNP) was the highest, about 3%; followed by vascular complications (about 2%); pseudoaneurysm, permanent PNP, and all-cause death was (about 1%); and pericardial effusion and stroke / TIA was very low. CB is associated with low rates of severe complications and reasonable success rates.

Effect of early cryoballoon ablation on atrial fibrillation recurrence - a nationwide register study

Abstract Introduction Cryoballoon ablation seems a viable first-line therapy in atrial fibrillation (AF) patients and outperforms antiarrhythmic drugs (AAD) regarding sinus rhythm maintenance. Despite this, guidelines in general recommend AAD use before ablation for AF, delaying a potential ablation. Therefore, data regarding the impact of the timing of cryoballoon ablation on AF recurrence in large, unselected cohorts is highly warranted. Purpose To examine AF recurrence after AF cryoballoon ablation by time from AF diagnosis to AF ablation. Methods From nationwide registers, we included all AF patients above 18 years who underwent first-time cryoballoon ablation from January 2010 to December 2018. The AF patients were stratified by ablation timing: Early ablation (&amp;lt; 1 year after AF diagnosis) and late ablation (≥1 year after AF diagnosis). The primary endpoint was recurrent AF, defined as a composite endpoint of AF hospitalization, claimed prescriptions of AAD, re-ablation or electrical cardioversions. The cumulative incidence of recurrent AF at 5-year follow-up after a blanking period of 90 days was estimated using the Aalen-Johansen estimator, taking the competing risk of death into account. The relative rates of recurrent AF were examined using cox models adjusted for sex, age, procedure-year, left atrial size, body mass index, AF-type (paroxysmal or persistent), hypertension, heart failure, ischemic heart disease, and chronic obstructive pulmonary disease. Results The study cohort consisted of 677 patients, 204 in the early ablation group and 473 in the late ablation group. Median age increased from 59 in the early ablation group to 65 in the late ablation group. In the early ablation group 71% had paroxysmal AF compared to 66% in the late ablation group. Use of amiodarone and Class 1C antiarrhythmic medication were higher in the late ablation group. The 5-year cumulative incidence of recurrent AF was 41% and 51% in the early and late ablation groups. The Hazard ratio (HR) and 95% confidence interval (95% CI) were 1.44 and (CI 1.10-1.89) in the late ablation group compared to the early ablation group (Figure 1). For paroxysmal AF the 5-year cumulative incidence of recurrent AF was 41% and 49% in the early and late ablation groups with a HR of 1.32 (CI 0.95-1.84) in the late ablation group compared to the early ablation group. For persistent AF the 5-year cumulative incidence of recurrent AF was 39% and 59% in the early and late ablation groups with a HR of 1.74 (CI 1.05-2.87) in the late ablation group compared to the early ablation group (Figure 2). Conclusion In this nationwide register study examining recurrent AF after cryoballoon ablation, we found lower recurrence rates when early ablation was performed. Based on this, early cryoballoon ablation could potentially provide considerable benefits and improve outcomes after ablation, indicating that cryoballoon ablation as first-line therapy might be ideal.Figure 1Figure 2

Abstract 14224: Cryoballoon Ablation of Atrial Fibrillation in Octogenarian

Introduction: While the safety and efficacy of AF ablation using radiofrequency (RF) have been demonstrated in the very elderly, data on the application of cryoballoon ablation in this population is limited. Hypothesis: Cryoballoon ablation of AF in the very elderly is feasible and safe. Methods: Consecutive patients who was 80 years or older and underwent de novo cryoablation of AF from June 2015 to September 2021 were included. All procedures were performed under general anesthesia and with ICE guidance. Following single transseptal puncture, a 28 Cryoballoon was used for all cases; procedural endpoint was isolation of all PVs. Extra-PV ablation including CTI, linear ablation or substrate modification was performed when deemed necessary. At the end of procedure, figure-of-8 suture was applied at the groin(s) to achieve hemostasis which was removed after 4-hour bed resting if no bleeding. Results: 70 patients were included mean age of whom was 83 (median 82, range 80-94). Baseline demographics and clinical characteristics of the patients were summarized in Table 1 . PVI was achieved in all but one patient in one PV, this vein was isolated by RF touch-up ablation. CTI ablation was performed in 26 cases but none of the patients required additional ablation. No major complication including tamponade, stroke/TIA, heart failure/fluid overload, phrenic nerve injury or death was associated to the procedure. Iliac vein bleeding developed in one case (1.43%) which required transfusion and stent placement. 11 (15.7%) patients were discharged at the same day of procedure. Overall, all patients were discharged from hospital within 25.2 hours after the procedure. Of 45 patients who completed12-month follow-up, 22 (48.9%) remained in sinus rhythm. 10 patients were reported deceased during follow-up. Conclusions: Cryoablation of AF in the very elderly is a feasible and safe procedure. Most patients can be discharged within one day or even on the same day of procedure.

Abstract 14252: Redefining the Blanking Period After Cryoballoon Ablation for Atrial Fibrillation: From Korean Cryoballoon Ablation Registry

Background: Early recurrence (ER) of atrial arrhythmia in blanking period (&lt;3 months) after radiofrequency ablation for atrial fibrillation (AF) has been considered as benign episode. Recently, there were controversies of long-term outcome of ER in radiofrequency ablation. the evidences of long-term impact of ER in cryoballoon ablation was still lacking. Hypothesis: There would be a significant impact of ER in patients with cryoballoon ablation on late recurrence of atrial tachyarrhythmia. Thus, this study sought to evaluate long-term outcome according to presence and timing (&lt;1 month, 1-2 months, 2-3 months) of ER after cryoballoon ablation. Methods: Using the data from a multicenter registry of cryoballoon ablation for AF in Korea between May 01, 2018, and June 30, 2022, we identified 2,654 eligible patients. The primary outcome was late recurrence of atrial tachyarrhythmia including atrial fibrillation, atrial flutter, or atrial tachycardia longer than 30 seconds, excluding a blanking period of 3 months. A multivariable Cox proportional hazard model was performed to evaluate the impact of ER for late recurrence of AF. Results: Among 2,654 patients, 763 (28.7%) patients experienced ER of atrial arrhythmia after cryoballoon ablation. During mean follow-up periods (21.2 ± 10.3 months) after 3-month blanking period, 874 (32.9%) patients developed late recurrence of atrial arrhythmia. The 1-year freedom from late recurrence were 85.5% in patients without ER, 44.1% in those with ER &lt;1 month, 32.4% in those with ER of 2-3 month, and 39.0% in those of ER with 2-3 month, respectively ( p = 0.0001). In multivariable Cox proportional hazard model, ER was significantly associated with late recurrence (hazard ratio: 3.98; 95% confidence intervals: 3.47-4.57) ( p = 0.001). Conclusion: Anytime ER after cryoballoon ablation is a significant predictor of late recurrence of atrial arrhythmia.

Cryoballoon ablation for atrial fibrillation in patients with heart failure and reduced left ventricular ejection fraction: A systematic review and meta-analysis.

The coexistence of atrial fibrillation (AF) with heart failure (HF) is prevalent, leading to severe complications. This review aimed to investigate the success rate and efficacy of cryoballoon ablation (CBA) by measuring the improvement in the New York Heart Association (NYHA) classification and the effect on the left ventricular systolic function in patients with AF accompanied by heart failure with reduced ejection fraction (HFrEF). Electronic databases search included PubMed, Web of Science, and Scopus in January 2023. Outcomes addressed the following: left ventricular ejection fraction (LVEF) improvement, AF recurrence, NYHA classification improvement, and mortality. STATA 17.0 software was used for data analysis. The effect size for the studies was a standard mean difference (SMD) with a 95% confidence interval (CI) for outcomes. Proportion analysis with 95% CI was used for freedom from early AF and AF after 2 years and all-cause death. We included six studies, including 1699 HF patients with 365 HFrEF patients. The SMD of postoperative LVEF compared to preoperative LVEF in HFrEF was 0.99 ([95% CI: 0.60, 1.39], p = .00), and for NYHA was -1.12 ([95% CI: -1.36, -0.87], p = .00). The analysis results in HFrEF patients for freedom from AF after 1 year was 65% ([95% CI: 0.55, 0.75], and after 2 years was 39% ([95% CI: 0.10, 0.67]). Proportional analysis was conducted for all-cause death, resulting in 3% mortality ([95% CI: -0.01, 0.07]). Cryoablation of AF accompanied by HFrEF appeared safe as it reduced AF recurrence and enhanced clinical outcomes.

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

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. 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. 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. 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.

Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry

BackgroundCryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized.MethodsPatients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up.ResultsA total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection.ConclusionsDespite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02752737Graphical