Cryoballoon Ablation For Atrial Fibrillation Research Articles

Comparative effectiveness of pulsed field ablation and cryoballoon ablation for atrial fibrillation: a systematic review and meta-analysis

Abstract Background Cryoballoon ablation (CBA) is a well-established technique for treating atrial fibrillation (AF), with a low complication rate related to cryoenergy-induced lesions. Pulsed Field Ablation (PFA) has emerged as a non-thermal alternative, with promising potential to further reduce complications. Purpose We aim to conduct a systematic review and meta-analysis comparing the efficacy and safety of PFA versus CBA in patients with AF. Methods We conducted a systematic search across PubMed, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials (RCTs) or observational studies published between 2013 and 2024 that compared PFA and CBA ablation techniques in patients with AF. Statistical analysis was carried out utilizing RevMan 5.1.7. Heterogeneity was assessed with I² statistics; p-values inferior to 0.05 and I²>25% were considered as significant heterogeneity. Results A total of 840 studies were screened in the initial search, and 26 studies were selected for full-text review based on inclusion criteria. Out of these, 8 observational studies involving 3,113 patients were included. Among these, 1,088 (34.9%) underwent PFA, while 2,025 (65.0%) underwent CBA. Periprocedural complications were significantly lower in patients who underwent PFA compared with the CBA group (RR 0.46; 95% CI 0.29 to 0.74; p=0.001; I²=1%; Fig. 1A). Furthermore, there was a significant reduction in procedure time in the PFA group (MD -8.21 min; 95% CI -13.74 to -2.69; p=0.004; I²=96%; Fig. 1B). However, no statistically significant difference was observed among groups regarding fluoroscopy time (MD 1.63 min; 95% CI -0.22 to 3.48; p=0.08; I²=92%; Fig. 2A), or recurrence of atrial arrhythmias after the blanking period (RR 0.84; 95% CI 0.68 to 1.04; p=0.12; I²=6%; Fig. 2B). Additionally, a subgroup analysis involving only propensity score-matched cohorts was conducted but didn’t show any statistical difference for any outcomes evaluated. Conclusion In this systematic review and meta-analysis, PFA was associated with a lower risk of periprocedural complications and a shorter procedure duration, compared to CBA in patients with AF. Additionally, it didn’t show a potential for reducing the recurrence of atrial arrhythmias, and the data regarding fluoroscopy time were inconclusive.Primary outcomesSecondary outcomes

Comparison of procedural analgosedation in patients undergoing pulsed field ablation or cryoballoon ablation for atrial fibrillation

Abstract Background Pulsed field ablation (PFA) has emerged as a novel technology that is increasingly applied for the catheter ablation (CA) of atrial fibrillation (AF) with similar efficacy to established, thermal energy sources. Data solely focussing on analgosedation compared to established single-shot modalities, such as cryoballoon (CB) ablation are scarce. Aim The aim of this study was to assess differences of analgosedation requirement, procedural cardiopulmonary stability, and analgosedation-associated complications between PFA and CB ablation. Methods This study was a retrospective single-centre comparison of analgosedation in patients with paroxysmal, persistent, and long-standing persistent AF undergoing pulmonary vein isolation (PVI) with either PFA or CB from March 2021 until April 2022. The primary study endpoints were the requirements of analgosedation medications (propofol, midazolam and sufentanyl), cardiorespiratory stability measured as decreases in oxygen saturation and systolic blood pressure and analgosedation-associated complications. Secondary endpoints were acute procedural success, procedure time and overall complication rates. Results A total of 100 patients were included {PFA n=50, CB n=50, mean age 66 ± 10.6, 61% male patients, 65% paroxysmal AF). The body weight – and procedure time-adjusted requirement of all analgosedation medications was significantly higher in the PFA group compared to CB {Propofol 0.14 ± 0.04 mg/kg/min in PFA versus 0.11 ± 0.04 mg/kg/min in CB (p=0.001); midazolam 0.00086 ± 0.0004 mg/kg/min in PFA versus 0.00063 ± 0.0003 mg/kg/min in CB (p=0.002) and sufentanyl 0.0013 ± 0.0007 µg/kg/min in PFA versus 0.0008 ± 0.0004 µg/kg/min in CB (p<0.0001)}. Procedural cardiorespiratory stability did not differ between groups (maximum blood pressure decrease PFA 53.4 ± 20.9 mmHg, CB 50.3 ± 18.6 mmHg, P=0.28 and maximum decrease in oxygen saturation: PFA group 4.8 ± 5.3 %, CB group 3.5 ± 2.6 %, P=0.12). Analgosedation-associated complications did not differ between both groups (PFA n=1/50 mild aspiration pneumonia, CB n=0/50, p=0.99). There was no significant difference in acute procedural success (100% n=50/50 in both groups, p>0.99), non-analgosedation associated complications (PFA: n=2/50, 4%, CB: n=1/50, 2%, p=0.99) and procedure times (PFA 75 ± 31, CB 84 ± 32 mins, p=0.18) between groups. Conclusions Pulsed field ablation is associated with higher sedation and especially analgesia requirement compared to cryoballoon ablation, however, the safety of analgosedation does not differ significantly to cryoballoon ablation.

Comparison of complications during catheter ablation of atrial fibrillation between radiofrequency and cryoballoon ablation: insights from a nation-wide claims-based database

Abstract Background Few large-scale, real-world studies have compared the safety of radiofrequency (RF) catheter ablations (CA) with that of cryoballoon ablations of atrial fibrillation (AF), especially in east Asian countries. Methods This retrospective, cross-sectional study used a nationwide administrative claims database, to compare complication-incidence rates between patients who underwent RFCA and cryoballoon ablation of AF. We used data from Medical Data Vision Co., Ltd, that is derived from the health claims, Diagnosis Procedure Combination (DPC) system, and flat-fee payment system in Japan. We first extracted hospitalization records with CA with diagnosis of AF. Exclusion criteria were 1) records with diagnoses of atrial flutter or atrial tachycardia, 2) patients aged <20 years old, 3) CA of AF performed other than RFCA or cryoballoon, 4) records with insufficient clinical data, and 5) patients who were prescribed both direct oral coagulants and warfarin. Complications were defined using the following ICD-10 diagnosis codes: major bleeding (I31.9, I97.1, J98.5, J048, J0021); thromboembolism (H342, I24, I269, I740, I741, I744, I748, I749, K550, K868, N280, or T790); ischemic stroke (G45, or I63); cardiac tamponade (I31.9, I97.1, or J98.5); and vascular access complications (hematoma: S701, S801, T140 or T810; and/or pseudoaneurysms: I72.4). Logistic regression analyses were performed to estimate odds ratios and 95% confidence intervals (CI) for major bleeding, systemic thromboembolism, ischemic stroke, and cardiac tamponade. Results Among the 32,797,540 records between June 2011 and August 2020 from 426 hospitals, 41,347 records who underwent CA of AF (Median 68 [60–74] years old, 30.2 % women) were included in the study. A total of 36,729 RFCA (88.8%) and 4,618 cryoballoon ablation (11.2%) cases were included in the cohort. Major bleeding, systemic thromboembolism, ischemic stroke, cardiac tamponade, and vascular access complications occurred in 194 (0.5%), 193 (0.5%), 116 (0.3%), 414 (1.0%) and 115 (0.3%) patients, respectively. As a result of logistic regression analysis, when cryoballoon ablation was used as a reference, RFCA was associated with higher risk of cardiac tamponade (OR 1.54, 95% CI 1.09–2.25, P = 0.02), while it was not associated with higher or lower risk of other complications (major bleeding OR [95% CI ]1.21 [0.77–2.04]; thromboembolism 1.74 [1.03–3.22]; ischemic stroke 1.88 [0.94–4.47]; vascular access complication; 1.00 [0.58–1.87]). Conclusion Compared to cryoballoon ablations, RFCA was associated with higher risk of cardiac tamponade, using nationwide administrative claims database.

Problematic vascular access during cryoballoon ablation of atrial fibrillation in a patient with a history of prostate cancer treatment – a case study

Atrial fibrillation (AF) is the most common supraventricular tachyarrhythmia in the population and occurs more often in older people. We present a case study of a 59-year-old male with paroxysmal atrial fibrillation who underwent a radical prostatectomy and radiotherapy. His planned cryoablation was complicated by difficulties accessing the femoral vein. Finally, we performed an effective cryoballoon ablation using the left common femoral vein. Patients after extensive abdominal surgery may pose a challenge for the operator, but vascular access on the opposite side may resolve the problem.

Thirty-day mortality risk in patients following radiofrequency and cryoballoon ablation for atrial fibrillation across the entire nation of Poland: An 8-year analysis from the National Health Fund of Poland.

Atrial fibrillation (AF) is the most common sustained arrhythmia, and catheter ablation (CA) is a primary therapeutic option. However, the 30-day all-cause mortality risk associated with CA for AF may be underestimated due to selection bias. Our study aimed to assess 30-day mortality in an unselected cohort of patients. Data from the National Health Fund-Poland covered over 99% of nationwide radiofrequency ablation (RF) or cryoballoon ablation for AF, with 100% recorded deaths. The study included consecutive CA procedures in adult patients between 2012 and 2019. Thirty-day mortality rates were calculated for each age group. A total of 31 214 CAs for AF were performed on 26 767 patients (34.8% female). Forty-four percent of patients had hypertension, 31.2% had coronary artery disease, 14.4% had heart failure, 11% had diabetes mellitus, 5.6% had malignant neoplasms, 2.7% had a previous myocardial infarction, 2.5% had a previous stroke, and 2.2% had kidney disease. Thirty-two deaths (0.1%) occurred within 30 days, with the highest mortality in the oldest age group (>80 years). Statistical analysis revealed higher incidences of kidney disease (p < 0.001) and heart failure (p = 0.001) in patients who died within 30 days. Mortality risk did not significantly differ between cryoballoon and RF ablation, as well as first and subsequent ablation for AF. The risk of death within 7 days postablation for AF was 1 in 2750 procedures, while the risk of death on the same day postablation was 1 in 6250 procedures. The 30-day mortality rate in a large, unselected AF ablation cohort, covering 99% of procedures in the country, is low except for the oldest patients. This factor should be taken into consideration when offering CA for AF.

The use of Intracardiac Echocardiography in Catheter Ablation of Atrial Fibrillation.

Intracardiac echocardiography (ICE) provides real-time, fluoroless imaging of cardiac structures, allowing optimal catheter positioning and energy delivery during ablation procedures. This review summarizes the use of ICE in catheter ablation of atrial fibrillation (AF). Growing evidence suggests that the use of ICE improves procedural safety and facilitates radiofrequency and cryoballoon AF ablation. ICE-guided catheter ablation is associated with reduced procedural duration and fluoroscopy use. Recent studies have examined the role of ICE in guiding novel ablation techniques, such as pulsed field ablation. Finally, the use of ICE allows for early detection and timely management of potentially serious procedural complications. Intracardiac echocardiography offers significant advantages during AF ablation procedures and its use should be encouraged to improve procedural safety and efficacy.

Comprehensive analysis of recurrence factors in cryoballoon AF ablation: integrating clinical, biomarkers, and echocardiographic parameters.

Atrial fibrillation (AF) poses substantial challenges in cardiovascular diseases, impacting patient health and economic burdens. Understanding the mechanical effects of AF on the left atrium (LA) and assessing the influence of treatment modalities on LA functions are critical. This study aims to assess the efficacy of echocardiographic and biochemical parameters in predicting AF recurrence following second generation cryoballoon ablation (CB-2). Ninety-two patients with symptomatic AF, treated with CB-2 at Istanbul University-Cerrahpaşa, Faculty of Medicine, Department of Cardiology, were prospectively examined from January 2021 to July 2023. The study endeavors to develop a predictive model for AF recurrence, investigating the relationship between echocardiographic measurements and serum biomarkers with recurrence. The follow-up duration for echocardiographic assessments and biochemical analyses was systematically documented. The study revealed a significant enhancement in LA mechanical functions during echocardiographic follow-ups three months post-procedure. Specifically, LA strain parameters emerged as significant predictors of recurrence (LAsr: 95%CI 1.004-1.246, p = 0.047; LAsct: 95%CI 1.040-1.750, p = 0.024). Biochemical analyses demonstrated a correlation between elevated PRO-BNP levels and an increased risk of recurrence (95%CI 1.000-1.003, p = 0.012). Moreover, specific biomarkers such as MYBPHL, which demonstrated increased levels post-procedure, were deemed indicative of atrial damage, suggesting potential additional atrial substrate modification beyond PVI. Consequently, improvements in LA function post-cryoballoon ablation and biochemical markers have surfaced as potential indicators for predicting AF recurrence. This study elucidates the effectiveness of CB-2 in treating AF and its impact on LA functions. Notably, LA strain measurements and PRO-BNP levels have emerged as reliable indicators for predicting recurrence. Beyond clinical implications, our research establishes a foundation for a deeper understanding of the role of CB-2 in AF management and factors associated with recurrence.

Meta-analysis of high-power short-duration versus cryoballoon ablation for atrial fibrillation.

The existing literature regarding the treatment strategy for high-power short-duration (HPSD) ablation in patients diagnosed with atrial fibrillation (AF) is currently insufficient. The objective of this study is to perform a comparative analysis evaluating the effectiveness, safety, and procedural efficiency of HPSD versus cryoballoon ablation (CBA) for AF. A comprehensive search was conducted in PubMed, EMBASE, Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov databases to identify trials comparing HPSD with CBA for AF from their inception until December 25, 2023. Treatment effect measures were expressed as odds ratio (OR), mean difference (MD), accompanied by a 95% confidence interval (CI). The analysis comprised six eligible trials involving a total enrollment of 2481 patients. No statistically significant disparities were observed in recurrent atrial arrhythmia (OR 0.90; 95% CI, 0.71-1.16) or total complications (OR 0.65; 95% CI, 0.38-1.12) between the two ablation techniques examined in this study. However, HPSD technique exhibited a significantly prolonged procedure time (MD 27.42; 95% CI, 19.03 to 35.81). Conversely, no significant differences were observed between the two modalities in terms of total fluoroscopy duration (MD -4.37; 95% CI -10.70 to 1.96) and ablation time (MD 7.95; 95% CI -3.97 to 19.88). Furthermore, HPSD demonstrated significantly higher odds of extrapulmonary vein (PV) trigger ablation compared to CBA (OR 18.86; 95% CI, 5.12-69.49). The subgroup analyses revealed that CBA continued to exhibit superior procedure time (except for the paroxysmal AF subgroup: [MD 29.52; 95% CI -4.25 to 63.60]), while no significant differences in safety and efficacy (except for the HPSD ≥ 70W subgroup: [OR 0.44, 95% CI 0.20-0.97]) outcomes were still observed. Among patients undergoing ablation therapy for AF, both HPSD and CBA demonstrate comparable efficacy and safety profiles; however, HPSD is associated with longer procedural time and higher rates of extra-PV trigger ablation.

Feasibility and safety of cryoballoon ablation for atrial fibrillation and closing patent foramen ovale without implantation：A pilot study

BackgroundPatent foramen ovale (PFO) affects 20%–34% of adults and is associated with strokes and other disorders. The conventional treatment of PFO-related strokes is a closure procedure. The metal device is associated with some adverse events. ObjectiveOur aim was to investigate the efficacy and safety of PFO closure using cryoablation without implantation in patients with atrial fibrillation (AF) who underwent pulmonary vein isolation (PVI). MethodsWe divided the 22 patients with both PFO and AF who underwent PVI via cryoablation into 2 groups: standard PVI + atrial septal (AS) cryoablation group (group 1, n = 11) and standard PVI group (group 2, n = 11). The guidewire accesses the left atrium through the PFO without AS puncture during the procedure. Standard PVI via cryoablation was performed. The cryoballoon was retracted to the right atrium and inflated against the AS post-PVI. Patients in group 1 had cryoablation for 120–150 seconds, whereas patients in group 2 received sham ablation. The co-primary end points were the PFO closure rate and a composite of AF recurrence and stroke/transient ischemic attack (TIA) events. ResultsThere were no differences in procedure-related adverse events between the 2 groups. Neither group had an ischemic stroke report at 1-year follow-up. The PFO closure rate at 6 months in group 1 was significantly higher than that in group 2 (7 [63.6%] vs 1 [9.1%]; P = .002). AF recurrence post ablation was comparable in both groups at 3 months (3 [27.3%] vs 1 [9.1%]; P = .269), 6 months (0 vs 0), and 12 months (2 [18.2%%] vs 1 [9.1%]; P = .534) of follow-up. ConclusionCryoablation is a safe and effective approach to close PFO in patients with AF undergoing PVI in a single procedure.

Intra-procedural three-dimensional rotational angiography in cryoballoon ablation of atrial fibrillation - results from a randomised clinical trial

Abstract Introduction There are a variety of approaches for pre-procedural imaging to facilitate atrial fibrillation (AF) ablation. Intra-procedural three-dimensional rotational angiography (3DRA) is the least employed method and it can be advantageous regarding efficiency and procedural logistics (1). There is an open question whether LA imaging could improve safety and outcomes of cryoballoon (CB) ablation. Purpose The aim of this study is to evaluate possible benefits of 3DRA for procedural success, safety and long-term outcomes of CB ablation. Methods We designed a single-centre unblinded randomised clinical trial and recruited 134 patients (64.2% male, 59.0±11.6 years) with paroxysmal (93.3%) and early-persistent AF. Patients were randomised to no imaging or 3DRA which was performed intra-procedurally after trans-septal puncture. Angiographic images were segmented and overlaid to the fluoroscopy screen to guide the ablation procedure. Patients were scheduled for follow-up visits and twenty-four hour ECG recordings at 3, 6 and 12 months, and every 6 months thereafter. Results Of all the patients recruited, 66 (49.3%) were randomised to 3DRA and angiography was successfully performed in all but one patient (1.5%). Procedure time was significantly longer when 3DRA was performed (86.7±27.8 min compared to 67.2±22.1 in non-3DRA group, p&amp;lt;0.001). Total radiation dose (447.4±485.0 vs. 133.9±166.2 mGy, p&amp;lt;0.001) and contrast administration (131.8±28.3 vs. 40.8±26.5 ml, p&amp;lt;0.001) were significantly higher in the 3DRA group (Table 1). In patients who received no imaging one pulmonary vein (PV) couldn’t be isolated in 2 patients while this occurred in 3 patients in the 3DRA group (OR 1.57, 95% CI 0.25-9.72). Only minor complications were reported in both groups. Five patients developed large haematoma (4 in the 3DRA group vs. 1 in the control group). In each group there were 3 incidents of impending or transient phrenic nerve palsy. During 12 months of follow-up, 88.2% of patients in the control group and 81.8% in the 3DRA group were free of atrial fibrillation (OR 1.67, 95% CI 0.63-4.38). Two patients from the control group developed atrial flutter and were treated by ablation. In total, 10 patients underwent redo procedures (7 in the control and 3 in the 3DRA group respectively) and PV reconnections were detected in 9 cases. Conclusion 3DRA is a safe and efficient intra-procedural imaging method to guide CB ablation of AF. However, it significantly increases procedure duration, total radiation dose and contrast expenditure. In our trial it did not have any impact on the acute success rate of PV isolation or freedom from atrial fibrillation during 12-month follow-up.

Effectiveness of cryoballoon ablation for atrial fibrillation in patients with left common pulmonary vein variant: insights from a national multicenter catheter ablation registry

Abstract Background Pulmonary vein isolation (PVI) is the most effective therapy to achieve rhythm control in atrial fibrillation (AF). Yet, data regarding the safety and effectiveness of this procedure in left common pulmonary vein (LCPV) variant is limited. Purpose To explore the effectiveness of cryoballoon AF ablation in patients with LCPV variant. Methods A prospective cohort, based on a multicenter registry that included patients who underwent PVI during the years 2019-2021. The study end points were acute isolation success of the pulmonary veins (PVs), AF recurrence and the need for a repeat ablation procedure at 12 months. Results Seventy-four patients with LCPV variant and 822 patients with standard four pulmonary veins (PVs) were included in the study cohort. The acute isolation success rates of the left pulmonary veins were significantly lower in the LCPV variants compared to the standard 2 left PVs; 95.9% versus 98.9% respectively (P=0.03). The acute isolation success rates of the right pulmonary veins were not different among patients with LCPV versus standard anatomy; 98.6% versus 98.5% respectively (P=0.9). The rates of AF recurrence at 12 months were numerically higher in the LCPV variant compared to the standard anatomy group; 17.6% versus 11.1% respectively, but did not reach statistical significance (P=0.09) (Figure 1). The rates of repeat ablation did not differ between the study groups; 8.1% versus 6.2% respectively (P=0.51) (Figure 2). Conclusion In our study cohort, the acute isolation success rate of the LCPV was significantly lower compared to standard two left PVs, this finding emphasizes the challenge of isolating LCPV variants using cryoballoon PVI. However, in spite of the lower isolation success rates in the LCPV variants, the clinical effectiveness to prevent AF recurrences was preserved.Figure 1Figure 2

Cryoballoon ablation for atrial fibrillation in young adults: a propensity-score matching comparison with an older cohort

Abstract Background Cryoballoon ablation (CB-A) has proven to be a valid technology for achieving pulmonary vein isolation (PVI) in patients affected by symptomatic atrial fibrillation (AF). Data regarding CB-A in young adults are still scarce and mainly derived from studies performed without balancing comorbidities and echocardiographic parameters between the groups. The present study aimed to focus on the outcomes and complications of CB-A PVI in young adults (&amp;lt; 50 years) compared to a propensity score-matched population of older individuals, seeking also to understand the true role of "age" as potential risk factor for arrhythmia recurrences. Methods and results We retrospectively enrolled 172 consecutive patients aged &amp;lt; 50 years who underwent PVI employing the second-generation cryoballoon (CB-2). A 1:1 propensity score matching comparison with an older cohort of patients was performed and 290 patients (145 subjects aged &amp;lt; 50 years vs. 145 patients aged ≥ 50 years) were then selected. The mean age was 43.3 ± 4.9 years in the younger group and 64.7 ± 8.7 years in the control group (p &amp;lt; 0.001). After an overall median follow-up of 18 [12 - 29] months, the Kaplan-Meier curves showed a similar rate of freedom from arrhythmia relapses between the younger and the older cohorts (85.5% vs. 77.2% respectively, log-rank p = 0.31). The rate of major complications was low (2.8 %) and did not significantly differ between the groups, being 2.1% for the younger cohort and 3.5% for the older group (p = 0.50). Vascular complications and phrenic nerve palsy appeared to be the most common procedure-related adverse events, occurring in 8 (2.8%) patients. Arrhythmia recurrences during blanking period (ERAF) was found to be the only independent predictor of late AT/AF relapses. Conclusions Our propensity-score model demonstrates that CB-A PVI is equally safe and effective in young adults as it is in older individuals. Furthermore, our findings suggest that "age" itself does not appear to play a significant role in predicting recurrences after CB-A PVI. This result underscores the importance of controlling the modifiable risk factors (comorbidities) and emphasizes the value of early AF diagnosis and intervention.Survival Curve

Catheter ablation of atrial fibrillation shows pulmonary vein dependent effect on the signal-averaged P-wave morphology

Abstract Background and Aims Cryoballoon ablation of atrial fibrillation alters a significant amount of vital myocardium that contributes to its electrical activity. However, the impact of pulmonary vein isolation (PVI) on P-wave morphology is unclear. The aim of this investigation was to quantify whether the contribution of the left or right pulmonary veins (PVs) is greater using means of signal-averaged P-wave analysis. Methods Unfiltered high-resolution (2000 samples/second) ECGs were obtained for 5 minutes both pre- and post-isolation of the left and right PVs, with 12 standard and 10 additional leads (x01-x10). Additional lead positions were determined in prior studies for optimal detection of atrial electrical activity not captured by standard leads. Signal-averaged ECGs were computed and analyzed using bespoke software in Matlab. Statistical significance was assessed using a two-tailed paired t-test. A total of 69 participants were screened for the study. For the analysis, 64 participants with sinus rhythm in all ECG recordings were eligible. Results Significant postablation changes for various ECG parameters across different lead combinations were found (Table 1). On average, after ablation of the left pulmonary veins (LPVs), there was a reduction in P-wave terminal force (3.07±2.05 mV*ms vs. 2.84±1.88 mV*ms, p = 0.044), P-wave complexity (2.02±0.64 vs. 1.90±0.57, p = 0.047), and sample entropy (0.210±0.039 au vs. 0.197±0.031 au, p &amp;lt; 0.001), whereas P-wave duration (148.24 ms vs. 153.23 ms, p &amp;lt; 0.001) and PQ time (200.41 ms vs. 205.43 ms, p &amp;lt; 0.001) prolonged. However, after ablation of the right pulmonary veins (RPVs), sample entropy decreased (0.196±0.031 au vs. 0.190 ±0.027 au, p = 0.049) and amplitude increased (0.087±0.024 mV vs. 0.091±0.024 mV, p = 0.002). Conclusion PVI in atrial fibrillation has a significant effect on signal-averaged P-wave. These effects are more pronounced after ablation of the LPVs than the RPVs. Parameters such as PWTF, PWC and SaE demonstrate potential to assess the effect of catheter ablation and may serve as a potential indicator for a successful procedural outcome.

Effectiveness of a novel integrated dilator-needle transseptal crossing device in atrial fibrillation cryoballoon ablation procedures

Abstract Background In cryoballoon ablation (CBA) procedures, left atrial (LA) access 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 in CBA procedures. A novel integrated dilator-needle system, that can be combined with the cryoballoon delivery sheath allowing direct LA transseptal access, was recently introduced. Figure. Objective The purpose of this study is to evaluate the efficacy and safety of this new integrated transseptal access tool compared with the traditional approach in CBA procedures. Methods In this prospective single-center study, consecutive patients who underwent AF CBA procedures were randomly assigned 1:1 to undergo traditional transseptal access (t-TSA) or integrated transseptal access (i-TSA). Patients with foramen ovale or interatrial communication, detected on transesophageal echocardiogram prior to the procedure, were excluded. Transseptal access 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). Results We evaluated 82 patients (63 males, mean age 59 ± 10 years) indicated to CBA of atrial fibrillation, 42 patients underwent t-TSA and 40 i-TSA. The baseline characteristics of the study population were comparable between groups. Table. Mean CBS transseptal access time was 5 min 6 sec ± 2 min 5 sec in the t-TSA group and 3 min 5 sec ± 2 min 23 sec in the i-TSA group, P &amp;lt; 0.001. Challenging interatrial septa were noted in 3 patients: 1 in t-TSA (1 aneurysmal/elastic) and 2 in i-TSA group (1 lipomatous hypertrophy, and 1 abnormally thickened/fibrotic). No acute complications related to transseptal access were noted in both cohorts. The CBA procedure time and fluoroscopy time were lower in the i-TSA group. Table. There were 1 temporary phrenic nerve injury and 1 vascular complication, both in the t-TSA group. Importantly, no signs of clinical air embolism were noted in both groups. Conclusion This is the first randomized study comparing the traditional approach and the use of a new integrated dilator-needle system. Transseptal crossing in CBA procedures using this integrated tool enables a safe and more efficient workflow, reducing time for transseptal access and avoiding sheath exchange.FigureTable

Micro-Costing Analysis for the Treatment of Atrial Fibrillation: An Economic Evaluation of the First Italian Experience of Same-Day Discharge Protocol for Cryoballoon Atrial Fibrillation Ablation.

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia, and its prevalence is expected to increase further due to the aging population, increasing prevalence of risk factors, improving detection methods, and broadening of catheter ablation indications. Along with limited healthcare resources and bed availability, these reasons led to the development of a same-day discharge (SDD) protocol. The aim of this study was to evaluate the health and economic impact of a routine adoption of same-day discharge after cryoballoon AF ablation. Methods: Consecutive patients with symptomatic and drug-refractory AF scheduled for first-time AF ablation were screened, and if deemed suitable, the SDD protocol was proposed and, if accepted, enrolled in the protocol. Results: A total of 324 patients were screened, and 118 were considered eligible for the SDD pathway. Fifty-two patients accepted the SDD pathway and were included in this study. The analysis showed that the variation in resource consumption associated with cryoablation in SDD is equal to EUR 739.85/patient. The analysis showed that the main cost driver for ordinary hospitalization was represented by the hospital stay, which was calculated to be 36% of the total cost. In total, there was a cost reduction of EUR 38.472 thanks to optimized AF patient management from the standard recovery setting to SDD. Conclusions: SDD after cryoballoon ablation of AF is feasible in selected patients with a standardized protocol.

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.