Pulmonary Vein Isolation In Patients Research Articles

Usefulness of empiric superior vena cava isolation in paroxysmal atrial fibrillation ablation: a meta-analysis of randomized clinical trials.

The long-term success rate of pulmonary vein isolation (PVI) is suboptimal due to the presence of non-pulmonary vein (PV) foci that can trigger atrial fibrillation (AF) in up to 11%. Among non-PV triggers, the superior vena cava (SVC) is a major site of origin of ectopic beats initiating AF. To compare data from randomized controlled trials (RCTs) assessing PVI + empiric SVC isolation (SVCI) versus PVI alone in terms of AF recurrence, procedure-related complications, and fluoroscopic and procedural times. A search of online scientific libraries (from inception to April 1, 2024) was performed. Four RCTs were considered eligible for the meta-analysis totaling 600 patients of whom 287 receiving PVI + SVCI and 313 receiving PVI alone. In the overall population, SVCI + PVI was associated with a non-significant reduction of AF recurrence at follow-up (0.66 [0.43;1.00], p = 0.05, I2 0%). In patients with paroxysmal AF (PAF), a significant reduction of AF recurrence was related to SVCI + PVI (11.7%) as compared to PVI alone (19.9%) (0.54 [0.32;0.92], p = 0.02, I2 0%). No statistical differences were found among the groups in terms of fluoroscopic (3.31 [- 0.8;7.41], p = 0.11, I2 = 91%), procedural times (5.69 [- 9.78;21.16], p = 0.47, I2 = 81%), and complications (1.06 [0.33;3.44], p = 0.92, I2 = 0%). The addition of SVCI to PVI in patients in PAF is associated with a significant lower rate of AF recurrence at follow-up, without increasing complication rates and procedural and fluoroscopy times.

Efficacy of renal denervation as an adjunct to pulmonary vein isolation for atrial fibrillation treatment: a systematic review and meta-analysis.

Catheter ablation, consisting of pulmonary vein isolation (PVI), is the most effective treatment modality for the management of symptomatic patients with atrial fibrillation (AF). Unfortunately, this procedure has a considerable relapse rate, ranging from 15 to 50% depending on AF type and other patient factors. Hypertension (HTN) is associated with a higher risk of developing AF and can also be managed with a catheter-based procedure-renal denervation (RDN). This meta-analysis aimed to compare the effect of PVI with and without RDN in hypertensive patients with AF. OVID MEDLINE and Embase were searched on 1 February 2023 and trials that reported the effects of RDN on AF recurrence in hypertensive patients were included. A total of 637 patients across 8 randomised controlled trials were included. The results from the pooled analysis showed that when compared with PVI alone, RDN added to PVI: (1) Lowered AF recurrence [RR 0.67 (0.53, 0.85), P = 0.001, I 2 = 23%, NNT = 5.9 patients]; (2) Reduced both systolic blood pressure and diastolic blood pressure, with medium effect size, as reflected by standardised mean differences of 0.5 (P = 0.02, I 2 = 80%) and 0.43 (P = 0.006, I 2 = 60%), respectively; and (3) was not associated with a decrease in estimated glomerular filtration rate (+7.19 mL/min/1.73 m2, P = 0.15, I 2 = 89%). Adding RDN to PVI in patients with AF and resistant HTN was associated with a reduction of blood pressure levels and AF recurrence. Consideration to RDN should be given as an adjunctive treatment for patients with AF and resistant HTN.

Low-Voltage Area Ablation in Addition to Pulmonary Vein Isolation in Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis.

Background: Low-voltage area (LVA) ablation, in addition to pulmonary vein isolation (PVI), has been proposed as a new strategy in patients with atrial fibrillation (AF), but clinical trials have shown conflicting results. We performed a systematic review and meta-analysis to assess the impact of LVA ablation in patient undergoing AF ablation (PROSPERO-registered CRD42024537696). Methods: Randomized clinical trials investigating the role of LVA ablation in addition to PVI in patients with AF were searched on PubMed, Embase, and the Cochrane Library from inception to 22 April 2024. Primary outcome was atrial arrhythmia recurrence after the first AF ablation procedure. Secondary endpoints included procedure time, fluoroscopy time, and procedure-related complication rate. Sensitivity analysis including only patients with LVA demonstration at mapping and multiple subgroups analyses were also performed. Results: 1547 patients from 7 studies were included. LVA ablation in addition to PVI reduced atrial arrhythmia recurrence (odds ratio [OR] 0.65, 95% confidence interval [CI] 0.52-0.81, p < 0.001) with a number needed to treat to prevent recurrence of 10. No difference in procedure time (mean difference [MD] -5.32 min, 95% CI -19.01-8.46 min, p = 0.45), fluoroscopy time (MD -1.10 min, 95% CI -2.48-0.28 min, p = 0.12) and complication rate (OR 0.81, 95% CI 0.40-1.61, p = 0.54) was observed. Consistent results were demonstrated when considering only patients with LVA during mapping and in prespecified subgroups for AF type (paroxysmal vs. persistent), multicentric vs. monocentric trial, and ablation strategy in control group. Conclusions: In patients with AF, ablation of LVAs in addition to PVI reduces atrial arrhythmia recurrence without a significant increase in procedure time, fluoroscopy time, or complication rate.

Voltage-guided pulmonary vein isolation for atrial fibrillation

BackgroundBipolar voltage amplitude is capable of helping determine the ideal lesion size index (LSI) setting during radiofrequency ablation for atrial fibrillation (AF). ObjectiveWe aimed to determine whether voltage-guided pulmonary vein isolation (PVI) is noninferior to conventional LSI-guided PVI in patients with nonvalvular AF. MethodsThis was a multicenter randomized trial conducted during a period of 12 months. The primary efficacy end points of the study were AF recurrence, atrial flutter, and atrial tachycardia, and the noninferiority margin was set at a hazard ratio of 1.4. The primary safety end point was a composite of procedure-related complications. ResultsA total of 370 patients underwent randomization; 189 and 181 were assigned to the voltage (underwent voltage-guided PVI) and control (underwent conventional LSI-guided PVI) groups, respectively. The primary efficacy end point occurred in 22 patients (12.0%) in the voltage group and 23 patients (12.9%) in the control group (1-year Kaplan-Meier event-free rate estimates, 88.0% and 87.1%, respectively; hazard ratio, 1.00; 95% confidence interval, 0.80–1.25). The primary safety end points were 4.8% in the voltage group and 6.6% in the control group (P = .2791). PVI time was significantly shorter in the voltage group (35.7 ± 14.5 minutes vs 39.7 ± 14.7 minutes; P < .001). ConclusionVoltage-guided PVI was noninferior to conventional LSI-guided PVI with respect to efficacy in the treatment of patients with AF, and its use significantly reduced procedure time.UMIN Clinical Trials Registry: UMIN000042325

Initial experience with zero-fluoroscopy pulmonary vein isolation in patients with atrial fibrillation: single-center observational trial

Pulmonary vein isolation (PVI) stands as a widely practiced cardiac ablation procedure on a global scale, conventionally guided by fluoroscopy. The concurrent application of electroanatomical mapping systems (EAMS) and intracardiac echocardiography offers a means to curtail radiation exposure. This study aimed to compare procedural outcomes between conventional and our initial zero-fluoroscopy cases in patients with paroxysmal or persistent atrial fibrillation (AF), undergoing point-by-point PVI. Our prospective observational study included 100 consecutive patients with AF who underwent point-by-point radiofrequency PVI. The standard technique was used in the first 50 cases (Standard group), while the fluoroless technique was used in the subsequent 50 patients (Zero group). The zero-fluoroscopy approach exhibited significantly shorter procedural time (59.6 ± 10.7 min vs. 74.6 ± 13.2 min, p < 0.0001), attributed to a reduced access time (17 [16; 20] min vs. 31 [23; 34.5] min, p < 0.001). Comparable results were found for the number of RF applications, total ablation energy, and left atrial dwelling time. In the Zero group, all procedures were achieved without fluoroscopy, resulting in significantly lower fluoroscopy time (0 [0; 0] sec vs. 132 [100; 160] sec, p < 0.0001) and dose (0 [0; 0] mGy vs. 4.8 [4.1; 8.2] mGy, p < 0.0001). The acute success rate was 100%, with no major complications. Zero-fluoroscopy PVI is feasible, safe, and associated with shorter procedure times compared to the standard approach, even in cases without prior experience in zero-fluoroscopy PVI.

Safety and feasibility of pulmonary vein isolation utilizing pulsed field ablation in patients with symptomatic atrial fibrillation and implanted Watchman devices.

Pulsed field ablation (PFA) is a novel method of non-thermal cardiac ablation for atrial fibrillation (AF). Its use on patients with pre-existing Watchman devices has not been studied. Pulmonary vein isolation (PVI) utilizing PFA was performed in 7 patients with symptomatic AF and implanted Watchman devices. All cases were conducted at a single academic center. Successful PVI in patients with Watchman devices implanted at a median time of 534days prior to the index ablation procedure (IQR 365days) was achieved in all cases. No major adverse events (intraprocedural CVA, post-procedural CVA, major or minor bleeding events, device embolization, or cardiac tamponade) were observed. In 6 of 7 patients, a low-dose direct oral anticoagulant (DOAC) strategy was implemented post-PFA. We present the first reported case series of PFA in patients with AF and implanted Watchman devices. This study highlights the safety and feasibility of the FARAPULSE PFA system in this patient population.

Relationship between sodium-glucose cotransporter 2 inhibitors and atrial fibrillation recurrence after pulmonary vein isolation in patients with type 2 diabetes and persistent atrial fibrillation.

The impact of sodium-glucose cotransporter 2 (SGLT2) inhibitors on the postoperative recurrence of atrial fibrillation (AF) in patients with persistent AF undergoing an initial radiofrequency ablation is not yet established. The objective of this study is to assess the impact of SGLT2 inhibitors on the recurrence of AF after radiofrequency ablation in patients with type 2 diabetes complicated persistent AF. A total of 182 patients with type 2 diabetes and persistent AF, who underwent their first radiofrequency ablation for AF at our center, were enrolled and divided into two groups: the SGLT2 inhibitor group and the non-SGLT2 inhibitor group. The main outcome of the follow-up was the postoperative recurrence of AF. A total of 49 participants experienced AF recurrence. The use of SGLT2 inhibitors in patients with type 2 diabetes who underwent AF ablation was associated with a significantly lower risk of AF recurrence (adjusted hazard ratio: 0.65; 95% confidence interval: 0.28-0.83; p < .01). The use of SGLT2 inhibitors is associated with a decreased risk of arrhythmia recurrence after AF ablation in patients with type 2 diabetes complicated with persistent AF.

Adjunctive left atrial posterior wall isolation for atrial fibrillation: An updated systematic review and meta-analysis.

Posterior left atrial wall isolation (PWI) plus traditional pulmonary vein isolation (PVI) has been proposed as a promising intervention to decrease atrial fibrillation (AF) recurrence. We aim to investigate the efficacy and safety of adding PWI to the traditional PVI in patients with AF. A systematic review and meta-analysis was conducted using synthesizing randomized controlled trials (RCTs) retrieved by systematically searching PubMed, Web of Science, SCOPUS, EMBASE, and Cochrane through June 14, 2023. We used Stata version 17 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD), with a 95% confidence interval (CI) (PROSPERO ID: CRD42023446227). We included 11 RCTs with a total number of 1534 patients. Combined ablation with PWI + PVI was not associated with any significant difference over PVI only regarding the recurrence of clinical AF (RR: 0.86 with 95% CI [0.70-1.06]), all atrial arrhythmia (RR: 0.93 with 95% CI [0.82-1.07]), nonatrial fibrillation arrhythmia (RR: 1.22 with 95% CI [0.97-1.53]), early AF (RR: 0.89 with 95% CI [0.62-1.27]), and antiarrhythmic drugs at discharge (RR: 0.83 with 95% CI [0.67-1.04]). However, it was associated with increased total ablation duration (minutes) (MD: 12.58 with 95% CI [6.80-18.37]) and total procedure duration (minutes) (MD: 16.77 with 95% CI [9.63-23.91]), without any significant difference regarding adverse events (RR: 1.05 with 95% CI [0.63-1.74]). While the pooled data from PWI + PVI using point-by-point radiofrequency did not suggest a benefit in the recurrence of various atrial arrhythmias compared to PVI alone, PWI+PVI using direct posterior wall ablation, especially with cryoballoon, demonstrated a significant reduction in recurrence of AF/atrial arrhythmias. Also, PWI + PVI significantly increased the ablation and total procedure durations.

Comparing outcomes after pulmonary vein isolation in patients with systolic and diastolic heart failure

The benefit of pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF) is well established; its efficacy in patients with heart failure preserved ejection fraction (HFpEF) is less clear. The objective of the study was to compare AF and heart failure (HF) rehospitalizations after PVI in patients with HFpEF vs HFrEF. The IBM MarketScan Database was used to identify patients undergoing PVI for AF. Patients were categorized by HF status: absence of HF, presence of HFrEF, or presence of HFpEF. Primary outcomes were HF and arrhythmia hospitalizations after PVI. A total of 32,524 patients were analyzed: 27,900 with no HF (86%), 2948 with HFrEF (9%), and 1676 with HFpEF (5%). Compared with those with no HF, both patients with HFrEF and HFpEF were more likely to be hospitalized for HF (hazard ratio [HR] 7.27; P < .01 for HFrEF and HR 9.46; P < .01 for HFpEF) and for AF (HR 1.17; P < .01 for HFrEF and HR 1.74; P < .01 for HFpEF) after PVI. In matched analysis, 23% of patients with HFrEF and 24% patients with HFpEF demonstrated a reduction in HF hospitalizations (P = .31) and approximately one-third demonstrated decreased arrhythmia rehospitalizations (P = .57) in the 6 months after PVI. Compared with those with HFrEF in longer-term follow-up (>1 year), patients with HFpEF were more likely to have HF (HR1.30; P < .01) and arrhythmia (HR 1.19; P < .01) rehospitalizations. Reductions in HF and arrhythmia hospitalizations are observed early after PVI across all patients with HF, but patients with HFpEF demonstrate higher HF rehospitalization and arrhythmia recurrence in longer-term follow-up than do patients with HFrEF.

The Value of Adjunctive Left Atrial Posterior Wall Isolation on Clinical Outcomes in Atrial Fibrillation Patients: A Systematic Review and Meta-Analysis.

Although pulmonary vein isolation (PVI) remains the mainstream way of atrial fibrillation (AF) ablation. The left atrial posterior wall (LAPW) may contributes to the development of AF as an arrhythmogenic substrate. The efficacy of additional left atrial posterior wall isolation (LAPWI) beyond PVI is in AF patients remains undefined. This study explored the influence of posterior wall isolation (PWI) on clinical outcomes in AF patients. PubMed, EMBASE, and Cochrane Library databases were searched for studies comparing the outcomes of AF with and without PWI. The efficacy outcomes were recurrence of all atrial arrhythmia (AA), atrial fibrillation (AF), and atrial flutter (AFL)/atrial tachycardia (AT). The safety outcomes were mainly focused on procedural adverse events. A total of 16 studies (7 randomized controlled trials (RCTs), 3 prospective studies and 6 retrospective analyses) with 3340 AF patients were enrolled (1550 patients in PVI with PWI group and 1790 in PVI alone group). 12 studies included persistent atrial fibrillation patients, 3 studies with paroxysmal AF patients and 1 study with paroxysmal AF and persistent AF concurrently. Mean follow-up period was 16.56 months. In AF patients, adjunctive PWI obviously reduced the recurrence of all atrial arrhythmias (risk ratio (RR) 0.78 [95% CI 0.64-0.95], = 79%, p = 0.01) and the recurrence of AF (RR 0.68 [95% CI 0.53-0.88], = 75%, p = 0.004); Meanwhile, additional PWI left no impact substantially on lower recurrence of AFL/AT (RR 1.23 [95% CI 0.94-1.60], = 49%, p = 0.12). The results seemed to be no significant differences in occurrence rate of procedural complications between the PVI only and PWI+PVI (RR 1.19 [95% CI 0.80-1.79], = 0%, p = 0.39). In subgroup analyses, the benefit of adjunctive PWI compared with PVI only was more distinct in persistent AF group and cryoballoon ablation group. Notably, adjunctive PWI with radiofrequency ablation may induce a slight increase of recurrent AFL/AT compared with PVI only (RR 1.56 [95% CI 1.02-2.39], = 30%, p = 0.04). Compared with PVI alone, additional PWI to PVI appeared to be associated with decreased recurrence of AF and atrial arrhythmias without an increased occurrence of procedural complications, especially in persistent AF patients. Cryoballoon ablation seemed more suitable for PWI compared with radiofrequency ablation. More RCTs are needed to verify the conclusion.

Body mass index and pulmonary vein isolation: real-world data on outcomes and quality of life.

Increasing numbers of overweight and obese patients undergo pulmonary vein isolation (PVI), despite the association between higher body mass index (BMI) and adverse PVI outcomes. Evidence on complications and quality of life in different bodyweight groups is limited. This study aims to clarify the impact of BMI on repeat ablations, periprocedural complications, and changes in quality of life. This multi-centre study analysed prospectively collected data from 15 ablation centres, covering all first-time PVI patients in the Netherlands from 2015 to 2021. Patients were categorized by BMI: normal weight (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), and obesity (≥30 kg/m2). Quality of life was assessed using the Atrial Fibrillation Effect on QualiTy-of-life questionnaire at baseline and 1-year post-PVI. Among 20 725 patients, 30% were of normal weight, 47% overweight, and 23% obese. Within the first year after PVI, obese patients had a higher incidence of repeat ablations than normal-weighing and overweight patients (17.8 vs. 15.6 and 16.1%, P < 0.05). Obesity was independently associated with repeat ablations (odds ratio 1.15; 95% confidence interval 1.01-1.31, P = 0.03). This association remained apparent after 3 years. Complication rates were 3.8% in normal weight, 3.0% in overweight, and 4.6% in obese, with weight class not being an independent predictor. Quality of life improved in all weight groups post-PVI but remained lowest in obese patients. Obesity is independently associated with a higher rate of repeat ablations. Pulmonary vein isolation is equally safe in all weight classes. Despite lower quality of life among obese individuals, substantial improvements occur for all weight groups after PVI.

Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation (SINGLE SHOT CHAMPION): Study protocol for a randomized controlled trial

IntroductionSingle-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel pulsed-field ablation (PFA) device (FARAPULSE, Boston Scientific) has been introduced with the aim to improve procedural safety and efficacy. ObjectiveThis study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF. MethodsSINGLE SHOT CHAMPION is a multicentre, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor (ICM) is performed in all patients. ResultsThe primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the ICM within 91 and 365 days post-ablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity Troponin on day 1 post-ablation, (2) analysis of post-ablation 3D electro-anatomical mapping (first 25 patients per study group), (3) AF burden, and (4) quality of life changes ConclusionSINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.

Pulmonary vein isolation combined with a new protocol of linear ablation to treat persistent atrial fibrillation: a prospective cohort with 1 year follow-up

Abstract Background The clinical value of ablation strategies beyond pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (perFA) is not clearly established and the optimal strategy to cure perFA remains a challenge due to the high recurrence rate after PVI alone (up to 50% of patients during 1-year follow-up). Purpose To determine the additional therapeutic value of a new design of linear ablation in the left atrium (LA) added to PVI in patients with perFA. Methods In this prospective study consecutive patients with perFA were included and underwent PVI combined with a predefined homogeneous protocol of linear ablation in the LA: anterolateral line from the mitral annulus to the left superior pulmonary vein around the left atrial appendage, anteroseptal line and posterior wall isolation. Patients were followed during 12 months after ablation with daily 30 s single-lead ECG obtained with mobile applications. The main endpoint was the incidence of recurrences, defined as any documented, sustained (&amp;gt;30 s) episodes of atrial arrhythmia that occurred after a 3 months blanking period. Antiarrhythmic drugs were avoided after the blanking period. Results 59 patients were included (61 [IQR 53-69] years old, 76% male sex). Acutely successful PVI was achieved in all patients and the linear ablation protocol was performed in 52 (89,7%) patients. The linea ablation protocol was not completed in 6 patients due to the following reasons: repetitive AF triggering from the same PV in 2 patients, induction and successful focal ablation of left atrial flutter in 1 patient, respiratory failure in 1 patient with severe obstructive lung disease and excessively prolonged procedure time in 2 patients. 58 patients completed the 12 months follow-up period and 1 patient was lost due to end-stage heart failure. The survival free of atrial arrhythmia recurrences was 69.1% [95%CI 55.1-79.5] (Figure). No patient had recurrences of perAF (&amp;gt;7 days continuous AF). 9 (53%) patients had at least 1 episode of self-limited paroxysmal AF. In these patients the average paroxysmal AF burden during the follow-up was 24 hours/year [IQR 9-24 hours/year]. In another 8 (47%) patients the recurrent arrhythmia was atypical left atrial flutter exclusively The incidence of procedure-related complications was 6,9%: 1 pericardial bleeding, 1 acute pulmonary edema, 1 splenic infarction and 1 stroke); no patient died during the study period. Conclusions A combined strategy of PVI plus the specific linear ablation protocol used in this study is associated with a low rate of atrial arrhythmia recurrences and total absence of persistent AF after ablation. A randomized multicenter clinical trial is ongoing to validate these results.Ablation strategy.Kaplan-Meier curve: recurrences

Treatmen of atrial fibrillation with cryoballoon pulmonary vein isolation - results of a 5-year follow-up

Abstract Background Atrial fibrillation is the most common arrhythmia in the general population and cryoballoon ablation is gradually becoming a first-line treatment. However, data regarding long-term outcomes after this procedure are still lacking. Aim The goal was to show the results of a long-term follow-up following the cryoballoon pulmonary vein isolation in patients with atrial fibrillation (AF). Methods A total of 126 patients were included in the study of which 77.0% had paroxysmal atrial fibrillation (PAF). Successful treatment outcome was defined as AF recurrence-free survival with stabile sinus rhythm during 5 years after the procedure. A treatment failure was defined as symptomatic AF recurrence with ECG verification (12 lead ECG or AF lasting &amp;gt;30s by Holter EKG). The patients on antiarrhythmic therapy and those who underwent a redo pulmonary vein isolation procedure were also included. Results Following cryoballoon pulmonary vein isolation in a 5-year period 52.4% of patients were in stable sinus rhythm without AF recurrence. With redo pulmonary vein procedures a total of 61.9% of patients were without AF recurrence. Together with antiarrhythmic drugs 57.9% of patients were in sinus rhythm without AF recurrence in a 5-year period. With redo pulmonary vein isolation and antiarrhythmic drugs a total of 73.8% of patients were without AF recurrence. There was a statistically significant difference regarding AF recurrence between patients who underwent redo pulmonary vein isolation and those who did not (p=0.006). In patients with PAF, 62.9% remained without AF recurrence, and 79.4% underwent a redo procedure. In patients with persistent atrial fibrillation (PersAF), 41.4% were without AF recurrence, and 55.1% underwent a redo procedure. The difference between PAF and PersAF was statistically significant (p=0.009). Conclusion Data from our center show good long-term results of cryoballoon pulmonary vein isolation in patients with atrial fibrillation. The procedure is especially successful in patients with PAF.1 The use of redo procedures is justified as it increases the long-term success rate.

Prevalence of diabetes mellitus diminished the efficacy of additional ablation following pulmonary vein isolation: a sub-analysis of the EARNEST-PVI trial

Abstract Introduction Diabetes mellitus (DM) is a well-known cause of atrial remodeling in patients with atrial fibrillation (AF). Although additional left atrial ablation following pulmonary vein isolation (PVI) is a strategy to modify AF substrate, its efficacy has not been well elucidated in patients with DM. We hypothesized that the efficacy of additional ablation was different in patients with DM and in those without. Purpose The purpose of this study was to investigate the efficacy of additional ablation following PVI in patients with or without DM. Methods The EARNEST-PVI was a multicenter, prospective, randomized controlled trial. In this sub-analysis, 493 consecutive patients of persistent AF (age, 65 ± 9 years; female, 120 [24%] patients) who underwent the initial radiofrequency catheter ablation were analyzed. Patients were randomized to be treated with PVI only (PVI-alone) or PVI plus linear and/or complex fractionated atrial electrogram ablation (PVI-plus). Primary outcome measure was defined as AF recurrence during the 12 months follow-up periods. Results In total, 84 (17%) patients had DM. Primary outcome occurred in 120 (24%) patients. In patients without DM, freedom from AF recurrence was significantly higher in PVI-plus group than in PVI-alone group (80.0% versus 71.1%, p=0.03) (Figure 1A). Conversely, in patients with DM, freedom from AF recurrence was similar between PVI-plus group and PVI-alone group (75.4% versus 72.9%, p=0.70) (Figure 1B). Conclusion Additional ablation following PVI reduced AF recurrence after radiofrequency catheter ablation only in patients without DM.Figure 1

Feasibility and procedural safety of the pentaspline pulsed field ablation catheter for atrial lesions beyond pulmonary vein isolation

Abstract Background The pentaspline multi-electrode pulsed-field ablation (PFA) catheter is widely used for the ablation of atrial fibrillation (AF). Given the favorable safety profile of PFA, lesions beyond pulmonary vein isolation (PVI) are increasingly performed. Purpose We aimed to assess the feasibility and safety of PFA beyond PVI with the pentaspline PFA catheter. Methods We retrospectively studied all patients who underwent PFA for atrial arrhythmias in our center between January and October 2023. Procedural characteristics and complications were compared between patients undergoing only PVI (PVI-only group) and those receiving extra-venous applications (extra-PVI group). Results We analysed 202 PFA cases. Indications for ablation included paroxysmal AF (34.7%), persistent AF (57.4%), long-standing persistent AF (5.9%) and atypical atrial flutter (2%). Redo procedures accounted for 18.8% of the total cases. PFA beyond PVI was performed in 142 (70.3%) patients. Patients in the extra-PVI group had a higher incidence of persistent AF (76.8% vs 11.7%, p&amp;lt;0.001), a higher BMI (29±5 vs 26±5 kg/m2, p=0.001) and a more dilated left atrium (LAVI: 73±24 vs 52±20 ml/m2, p&amp;lt;0.001, Table 1). PFA in this group consisted of PVI (98.6%), posterior wall isolation (PWI) (93%), mitral isthmus (MI) ablation (56.3%), a roof line (2.1%), ablation of dispersion electrograms (10.6%) and cavotricuspid isthmus (CTI) ablation (0.7%). In 22 (15.5%) patients, additional CTI ablation with radiofrequency (RF) was performed, while alcohol ablation of the vein of Marshall and RF ablation in the coronary sinus were required in 9 (6.3%) and 2 (1.4%) patients, respectively, to achieve MI block. Compared to the PVI-only group, PFA beyond PVI required a mean of 43 additional applications, a longer procedural (84±29 vs 65±22 min, p&amp;lt;0.001) and fluoroscopy time (25±10 vs 18±6 min, p&amp;lt;0.001) and had a higher fluoroscopy dose (24±35 vs 16.4±28.5 Gy.cm2, p=0.001). A three-dimensional electroanatomic map was used in 12% of cases. Acute success rates were 99% for PVI and PWI, 89% for MI ablation and 100% for roof lines and CTI ablation. Overall complication rates were similar in both groups (16.2% vs 13.3%, p=0.68, Table 2). One cardiac tamponade was observed in the extra-PVI group (0.7%) compared to 4 in the PVI-only group (6.7%, p=0.03). Among the latter, 2 incidents occurred during PVI in patients with long-standing persistent AF, precluding further extra-venous ablation. A small pericardial effusion (without hemodynamic compromise) and/or pericarditis were seen in 9.2% of patients in the extra-PVI group compared to 6.7% in the PVI-only group (p=0.78). No deaths occurred in either group. Conclusions Ablation beyond PVI with the pentaspline PFA catheter is feasible with high success rates and no apparent increase in procedural complications. However, it increases procedural duration and fluoroscopy. Notably, the majority of cardiac tamponades in this cohort occurred during PVI.

Validation of the Castle HTx data in a real world scenario

Abstract Background Pulmonary vein isolation (PVI) is recommended in patients with symptomatic atrial fibrillation (AF) and reduced left ventricular ejection fraction (LVEF). Recently the Castle HTx (CHTx) trial showed a significant mortality reduction in end stage heart failure patients undergoing PVI in addition to optimized medical therapy (OMT) compared to OMT only. Aim Objective of this analysis is to validate results of Castle HTx study in a real world scenario. Methods All patients between September 2021 und September 2023 referred for PVI at our center with symptomatic AF und LVEF ≤35% were included in this retrospective analysis at the University Hospital Cologne. Results A total of 119 PVI in patients with LVEF≤35% were successfully performed (mean age 63.3±10.1 years, 96 patients (81%) male, 43 (36%) paroxysmal AF, 76 (64%) persistent AF) matching inclusion criteria used in CHTx. Cryo-PVI was used in 50 (42%), RF-PVI in 60 (50%) and PFA in 9 (8%) patients. Complete follow-up (FU) with a mean of 549.6±430.2 days was obtained in 108 patients, comparable to CHtx (540 days). During FU 11 patients (10%) died from any cause (CHTx 8 patients (8%)), 2 patients (2%) received a left ventricular assist device (CHTx 1 patient (1%)) and no patient had urgent heart transplantation (CHTx 1 patient (1%)). For 30 patients (28%) recurrence of AF was detected and 72% remained in sinus rhythm. In 6 patients (5%) post-procedural complications occurred: 5 inguinal hematoma, 1 decompensation. During FU LVEF was statistically significantly improved (EF initial 26.9±6.5%, EF FU (n=80) 37.1±12.8%, p&amp;lt;0.001) (CHTx EF initial 29.0±6.4%, EF FU (n=92) 37.2±9.1%). Conclusion The findings of the Castle HTx patients have been validated in a real-world setting. PVI for rhythm control in end stage heart failure patients is safe and highly effective. Our patient cohort, matched to the Castle HTx ablation group, showed freedom from AF rate of 72% after mean FU time of 550 days. Furthermore, LVEF was improved significantly in our cohort echoing the results from CHTx.

One year of atrial fibrillation ablation using pulsed-field pentaspline catheter - learning curves based on a single centre experience

Abstract Introduction Pulsed-field ablation (PFA) represents a novel nonthermal strategy for ablation of atrial fibrillation (AF). As the technology has recently emerged in routine clinical praxis, only limited data on learning curves exist so far. Hereby, we present data from our centre regarding learning curves after the first year of using PFA. Methods The ablation procedure was performed under deep sedation or general anaesthesia in patients with paroxysmal or persistent AF. No 3D mapping system was used, procedures were guided by fluoroscopy and intracardiac echocardiography. For ablation itself, a pantaspline over-the-wire catheter with a steerable sheath was used. The following parameters were analysed over the course of time: procedure time, left atrial (LA) catheter dwelling time, total fluoroscopy time, and complications. Patients who received pulmonary vein isolation (PVI) alone and those with another additive set of lesions (PVI+) were analysed separately. Procedural parameters of the first and the last 20 patients of each group were compared for statistical significance. Results A total number of consecutive 159 patients (mean age 63.20 ± 10.51 years, 69.40 % males) were included in the analysis (PVI N = 73 (45.91 %), PVI+ N = 83 (54.09 %)). Procedures were performed by 3 certified electrophysiology specialists usually in random teams of 2 operators. The mean procedure time was 62.59 ± 23.09 min (PVI 59.64 ± 27.27; PVI+ 65.09 ± 18.64 min, P = 0.15). Over time, there was a non-significant decrease in PVI group (60.30 ± 17.44 vs. 52.75 ± 16.33 min, P = 0.16), but no difference in PVI+ cohort (67.85 ± 13.31 vs. 67.65 ± 28.88 min, P = 0.97). The mean LA catheter dwelling time was 39.84 ± 13.52 min (PVI 35.04 ± 10.20 min; PVI+ 44.33 ± 14.72 min, P &amp;lt;0.001). Non-significant shortening of the LA dwelling time was observed in PVI patients (36.56 ± 8.0 vs. 33.37 ± 9.58 min, P = 0.29). In contrast, the LA dwelling time in the PVI+ group became non-significantly longer (42.93 ± 10.62 vs. 48.56 ± 22.28 min, P = 0.39). The mean fluoroscopy time was 9.28 ± 3.66 min (PVI 8.65 ± 3.04; PVI+ 9.80 ± 4.05 min, P = 0.043). Importantly, fluoroscopy time decreased significantly in both groups over time (PVI: 10.63 ± 3.51 vs. 6.95 ± 2.45 min, P &amp;lt;0.001; PVI+: 12.82 ± 4.99 vs. 9.13 ± 4.16 min, P = 0.017). Regarding complications, we observed one pulmonary oedema requiring orotracheal intubation and mechanical ventilation in the early period. Other complications were related to the femoral puncture site. Conclusion Over the course of time with the new PFA technology, we observed a significant decrease in total fluoroscopy time. However, the change in total procedure and LA dwelling time did not reach statistical significance.

Strategies for recurrent atrial fibrillation in patients despite durable pulmonary vein isolation

Abstract Background Pulmonary vein isolation (PVI) is the cornerstone in treatment of atrial fibrillation (AF). Despite initially successful PVI patients experience recurrence of AF mostly due to reconnection of pulmonary veins (PVs). However, a certain number of patients presents with recurrent AF despite durable PVI. The optimal ablation strategy for these patients has yet to be discerned. Aim The aim of this study was to compare outcomes for different ablation strategies for recurrent AF despite persistent PVI. Methods All redo procedures for recurrence of AF from 01/2016 – 6/2022 at our center were analyzed. Only patients with proven durable PVI (entrance/exit block and high density (HD) mapping) were included. Patients were excluded, if re-PVI or right atrial ablation was necessary. In all procedures (HD) 3-D mapping and radiofrequency ablation were performed. Ablation strategy was at operators’ discretion. A 12-month follow up (FU) was obtained. Results A total of 405 left-atrial procedures for the recurrence of AF were analyzed. In 85 (21.0%) procedures all PVs were still isolated. Of these 30 patients (35.3 %) were female and 70 patients (82.4 %) suffered from persistent AF. In 49 patients (57.6 %) LA scar was detectable (85.7 % persAF). The ablation strategies consisted of: roof line (n=9; 10.6 %), left atrial anterior line (n=8, 9.4 %), roof line and left atrial anterior line (n=8, 9.4%), roof line and left atrial inferior line (n=18, 21.2 %), box lesion (n=6, 7.1 %), other left atrial ablation lines (n=20, 23.5 %) and substrate modification (CFAE and substrate encirclement) (n=16, 18.8 %). In patients with PAF (n=15), 3 patients received a roof line (20.0 %), 3 patients received the latter and left atrial inferior line (20.0 %), 5 patients received other left atrial ablation lines (33.3 %) and 4 patients received substrate modification (CFAE and substrate encirclement) (26.7 %). After a mean follow up of 401 +/- 125 days 55.3 % (n=47) of patients were free from any atrial arrhythmia (roof line 77.8 +/- 15 %, left atrial anterior line 87.5 +/- 13 %, roof line and left atrial anterior line 37.5 +/- 18 %, roof line and left atrial inferior line 50 +/- 12 %, box lesion 83.3 +/- 17 %, other left atrial ablation lines 45.0 +/- 11 %, substrate modification (CFAE and substrate encirclement) 43.8 +/- 13 %, p=0.122), 35.3 % (n=30) showed recurrence of AF (p=0.287) and 9.4 % (n=8) showed atrial tachycardia (AT) (p=0.693). None of the ablation strategies led to a significantly superior outcome. Conclusion In patients suffering from recurrence of AF despite durable pulmonary vein isolation different substrate modification strategies did not show any superiority for one or the other. Despite the necessity of additional ablation beyond PVI the optimal ablation strategy needs to be yet determined to improve outcome for redo procedures.

An enhanced and objective approach to advancing the classification system for left atrial appendage morphology in atrial fibrillation

Abstract The left atrial appendage (LAA) is an important part of the heart that can contribute to the formation of blood clots and the development of arrhythmias. Managing the LAA is crucial in clinical practice. Besides oral anticoagulation, one approach is LAA occlusion, which can reduce the risk of blood clots in selected patients. Another approach is LAA ablation, which has been proposed in addition to pulmonary vein isolation (PVI) and might improve the success of treating atrial fibrillation (AF). Different types of LAA morphology have been identified, and these differences can affect the choice of treatment and strategies for individual patients. To refine current classification system, a new approach has been proposed. The study utilized an observational single-center trial with blinded retrospective analysis of cardiac computed tomography angiography (CCTA) images from cryoballoon PVI patients. Statistical analysis included baseline characteristics and left atrium/LAA measurements. An LAA bounding box was introduced to enhance the current classification system, particularly focusing on distinguishing "chicken-wing" and "windsock," as well as "cauliflower" and "cactus" morphologies. From 2012 to 2016 a total of 1.103 patients underwent second generation cryoballoon PVI. Prior to PVI, CCTA was available for 725 (65.7%) patients with sufficient quality for measuring in 473 (65.2%). Mean age was 66.3±9.5 years; Paroxysmal AF was present in 277 (58.6%) participants. The distribution of LAA morphological types was as follows: "windsock" 51%, "chicken-wing" 20%, "cauliflower" 15%, and "cactus" 13%. Inter-rater reliability, assessed using Cohen's Kappa with Landis and Koch criteria, demonstrated substantial agreement (Kappa = 0.69; p&amp;lt;0.001). "Chicken-wing" morphology had the largest LAA volume at 9.9 (7.9; 12.8) mL, followed by "windsock" morphology with an LAA volume of 9.7 (7.7; 13.1) mL. "Cactus" and "cauliflower" morphologies had considerably smaller LAA volumes, measuring 5.4 (4.6; 7.5) mL and 5.6 (4.4; 7.6) mL, respectively. Bounding box parameters were utilized to distinguish between "windsock" and "chicken-wing" as well as "cauliflower" and "cactus" morphologies. "Windsock" had a maximal LAA depth of 44.3±7.1 mm, while "chicken-wing" measured 40.1±8.6 mm (p&amp;lt;0.001). The sinus values for the bounding box were 0.40±0.06 for "windsock" and 0.44±0.08 for "chicken-wing" (p&amp;lt;0.001). For "cauliflower," the LAA depth averaged 30.42±5.0 mm, whereas for "cactus," it measured 33.4±4.3 mm (p&amp;lt;0.001). The mean sinus of the bounding box was 0.48±0.08 for "cauliflower" and 0.44±0.07 for "cactus" (p&amp;lt;0.05). The utilization of novel bounding box parameters has the potential to aid in the differentiation between different LAA morphologies, such as 'chicken-wing' and 'windsock', as well as 'cactus' and 'cauliflower', especially in cases where the current classification system may not provide clear distinctions.