Catheter Ablation in End-Stage Heart Failure with Atrial Fibrillation.

BACKGROUND: The role of catheter ablation in patients with symptomatic atrial fibrillation and end-stage heart failure is unknown. METHODS: We conducted a single-center, open-label trial in Germany that involved patients with symptomatic atrial fibrillation and end-stage heart failure who were referred for heart transplantation evaluation. Patients were assigned to receive catheter ablation and guideline-directed medical therapy or medical therapy alone. The primary end point was a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation. RESULTS: A total of 97 patients were assigned to the ablation group and 97 to the medical-therapy group. The trial was stopped for efficacy by the data and safety monitoring board 1 year after randomization was completed. Catheter ablation was performed in 81 of 97 patients (84%) in the ablation group and in 16 of 97 patients (16%) in the medical-therapy group. After a median follow-up of 18.0 months (interquartile range, 14.6 to 22.6), a primary end-point event had occurred in 8 patients (8%) in the ablation group and in 29 patients (30%) in the medical-therapy group (hazard ratio, 0.24; 95% confidence interval [CI], 0.11 to 0.52; P<0.001). Death from any cause occurred in 6 patients (6%) in the ablation group and in 19 patients (20%) in the medical-therapy group (hazard ratio, 0.29; 95% CI, 0.12 to 0.72). Procedure-related complications occurred in 3 patients in the ablation group and in 1 patient in the medical-therapy group. CONCLUSIONS: Among patients with atrial fibrillation and end-stage heart failure, the combination of catheter ablation and guideline-directed medical therapy was associated with a lower likelihood of a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation than medical therapy alone. (Funded by Else Kröner-Fresenius-Stiftung; CASTLE-HTx ClinicalTrials.gov number, NCT04649801.).

Atrial fibrillation ablation workflow optimization facilitated by high-power short-duration ablation and high-resolution mapping.

AIMS: Pulmonary vein isolation (PVI) for catheter ablation of atrial fibrillation (AF) is a time-demanding procedure. High-power short-duration (HPSD) ablation protocols and high-density mapping catheters have recently been introduced to clinical practice. We investigated the impact of high-density mapping and HPSD ablation protocols on procedural timing, efficacy, and safety by comparing different standardized set-ups. METHODS AND RESULTS: Three electrophysiology (EP) laboratory set-ups were analysed: (i) circular catheter for mapping and HPSD ablation with 30/35 W guided by an ablation index (AI); (ii) pentaspline catheter for mapping an HPSD ablation with 50 W guided by an AI; and (iii) pentaspline catheter for mapping and HPSD ablation with 90 W over 4 s using a novel ablation catheter. All patients underwent PVI without additional left atrial ablation strategies. Procedural data and operating intervals in the EP laboratory were systematically analysed. Three hundred seven patients were analysed (30/35 W AI: n = 102, 50 W AI: n = 102, 90 W/4 s: n = 103). Skin-to-skin times [105.3 ± 22.7 (30/35 W AI) vs. 81.4 ± 21.3 (50 W AI) vs. 69.5 ± 12.2 (90 W/4 s) min, P ≤ 0.001] and total laboratory times (132.8 ± 42.1 vs. 107.4 ± 25.7 vs. 95.2 ± 14.0 min, P < 0.001) significantly differed among the study groups. Laboratory interval analysis revealed significant shortening of mapping and ablation times. Arrhythmia-free survival after 12 months was not different among the study groups (log-rank P = 0.96). CONCLUSION: The integration of high-density mapping and HPSD protocols into an institutional AF ablation process resulted in reduced procedure times without compromising safety or efficacy.

Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

Left atrial appendage closure in end-stage renal disease and hemodialysis: Data from a German multicenter registry.

BACKGROUND: Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild-to-moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end-stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials. OBJECTIVES: The objective of this study is to evaluate safety and efficacy of LAAC in patients with ESRD. METHODS: Patients undergoing LAAC were collected in a German multicenter real-world observational registry. A composite endpoint consisting of the occurrence of ischemic stroke/transient ischemic attack, systemic embolism, and/or major clinical bleeding was assessed. Patients with ESRD were compared with propensity score-matched patients without severe CKD. ESRD was defined as a glomerular filtration rate < 15 ml/min/1.73 m2 or chronic hemodialysis treatment. RESULTS: A total of 604 patients were analyzed, including 57 with ESRD and 57 propensity-matched patients. Overall, 596 endocardial and 8 epicardial LAAC procedures were performed. Frequency of major complications was 7.0% (42/604 patients) in the overall cohort, 8.8% (5/57 patients) in patients with ESRD, and 10.5% (6/57 patients) in matched controls (p = 0.75). The estimated event-free survival of the combined endpoint after 500 days was 90.7 ± 4.5% in patients with ESRD and 90.2 ± 5.5% in matched controls (p = 0.33). CONCLUSIONS: LAAC had comparable procedural safety and clinical efficacy in patients with ESRD and patients without severe CKD.

Practical guidance to reduce radiation exposure in electrophysiology applying ultra low-dose protocols: a European Heart Rhythm Association review.

Interventional electrophysiology offers a great variety of treatment options to patients suffering from symptomatic cardiac arrhythmia. Catheter ablation of supraventricular and ventricular tachycardia has globally evolved a cornerstone in modern arrhythmia management. Complex interventional electrophysiological procedures engaging multiple ablation tools have been developed over the past decades. Fluoroscopy enabled interventional electrophysiologist throughout the years to gain profound knowledge on intracardiac anatomy and catheter movement inside the cardiac cavities and hence develop specific ablation approaches. However, the application of X-ray technologies imposes serious health risks to patients and operators. To reduce the use of fluoroscopy during interventional electrophysiological procedures to the possibly lowest degree and to establish an optimal protection of patients and operators in cases of fluoroscopy is the main goal of modern radiation management. The present manuscript gives an overview of possible strategies of fluoroscopy reduction and specific radiation protection strategies.

Magnetic resonance assessment of left atrial scar formation following a novel very high-power short-duration workflow for atrial fibrillation ablation.

AIMS: Atrial fibrillation (AF) ablation protocols using energy delivery with very high power and short duration (vHPSD) have been introduced to improve lesion formation. This study reports procedural data of vHPSD ablation in AF patients and analyses characteristics of ablation-induced left atrial (LA) scar formation from cardiac magnetic resonance imaging (MRI). METHODS AND RESULTS: Sixty consecutive patients undergoing index pulmonary vein isolation following our institutional Q4U-AF workflow were prospectively enrolled. Ablation was conducted using a contact force sensing catheter allowing for vHPSD ablation using a temperature-controlled ablation mode. Thirty patients underwent cardiac late gadolinium enhancement MRI of the LA 3 months after ablation to assess LA scar. Mean procedural duration was 66.5 ± 14.8 min. Mean ablation time was 4.7 ± 0.9 min with a mean number of 69.9 ± 14.2 applications. First-pass isolation was achieved in 51 patients (85%) for the right pulmonary veins (RPVs), in 37 patients (61.7%) for the left pulmonary veins (LPVs), and in 34 patients (56.7%) for both pulmonary veins (PVs). Magnetic resonance imaging at 3 months post-ablation demonstrated a mean scar width of 14.4 ± 2.6 mm around RPVs and 11.9 ± 1.9 mm at LPVs (P > 0.05). Complete PV encirclement was observed in 76.7% for RPVs, in 76.7% for LPVs, and in 66.7% for both PV pairs. During a mean follow-up of 4.7 ± 1.4 months, arrhythmia recurrence was observed in 3.3% of the patients. CONCLUSION: Pulmonary vein isolation following a novel vHPSD workflow resulted in short procedure duration and high acute and mid-term efficacy. Magnetic resonance imaging demonstrated durable and transmural PV lesions with homogeneous and contiguous scar formation.

EASY-WPW: a novel ECG-algorithm for easy and reliable localization of manifest accessory pathways in children and adults.

AIMS: Accessory pathway (AP) ablation is a standard procedure for the treatment of Wolff-Parkinson-White syndrome (WPW). Twelve-lead electrocardiogram (ECG)-based delta wave analysis is essential for predicting ablation sites. Previous algorithms have shown to be complex, time-consuming, and unprecise. We aimed to retrospectively develop and prospectively validate a new, simple ECG-based algorithm considering the patients' heart axis allowing for exact localization of APs in patients undergoing ablation for WPW. METHODS AND RESULTS: Our multicentre study included 211 patients undergoing ablation of a single manifest AP due to WPW between 2013 and 2021. The algorithm was developed retrospectively and validated prospectively by comparing its efficacy to two established ones (Pambrun and Arruda). All patients (32 ± 19 years old, 47% female) underwent successful pathway ablation. Prediction of AP-localization was correct in 197 patients (93%) (sensitivity 92%, specificity 99%, PPV 96%, and NPV 99%). Our algorithm was particularly useful in correctly localizing antero-septal/-lateral (sensitivity and specificity 100%) and posteroseptal (sensitivity 98%, specificity 92%) AP in proximity to the tricuspid valve. The accuracy of EASY-WPW was superior compared to the Pambrun (93% vs. 84%, P = 0.003*) and the Arruda algorithm (94% vs. 75%, P < 0.001*). A subgroup analysis of children (n = 58, 12 ± 4 years old, 55% female) revealed superiority to the Arruda algorithm (P < 0.001*). The reproducibility of our algorithm was excellent (Ï°>0.8; P < 0.001*). CONCLUSION: The novel EASY-WPW algorithm provides reliable and accurate pre-interventional ablation site determination in WPW patients. Only two steps are necessary to locate left-sided AP, and three steps to determine right-sided AP.

Pulsed field ablation for atrial fibrillation - Lessons from magnetic resonance imaging.

Pulsed field ablation (PFA) is a promising technology for the treatment of atrial fibrillation (AF). Due to its unique tissue selectivity, PFA potentially bears superior characteristics as compared to established thermal energy sources in AF ablation procedures. Cardiovascular magnetic resonance imaging (CMR) using late gadolinium enhancement (LGE) is an established tool in the analysis of myocardial fibrosis representing atrial cardiomyopathy as well as ablation-induced atrial scar formation following catheter ablation with thermal energy. Mechanisms of atrial lesion formation differ between thermal ablation and electroporation and its impact on results of CMR imaging are not fully understood until now. In this review article, the potential of CMR imaging for PFA lesion assessment and available data are discussed. Further, additional needs to adopt imaging approaches to the cellular mechanisms of electroporation are considered.

Lesion formation following pulsed field ablation for pulmonary vein and posterior wall isolation.

BACKGROUND: Pulsed field ablation (PFA) results in unique lesion formation, but there is lack of in-vivo validation in terms of scar formation following atrial fibrillation (AF) ablation. OBJECTIVE: We aimed to access atrial lesion formation based on late gadolinium enhancement (LGE) cardiovascular magnetic resonance imaging (CMR) following PFA for pulmonary vein (PV) and posterior wall isolation (PWI). METHODS: AF ablation was performed in 10 patients using a 31 mm pentaspline PFA catheter. After pulmonary vein isolation (PVI; n = 8 PFA-applications/ PV; n = 4 in basket and n = 4 in flower configuration), another eight applications in flower configuration were conducted for concomitant PWI. Patients underwent LGE CMR 3 months after ablation aiming for quantification of left atrial (LA) scar. RESULTS: Acute procedural success was achieved in all patients. Mean procedure duration was 62 ± 7 min. and mean LA dwell time of the PFA catheter was 13 ± 2 min. Mean post ablation total LA scar burden was 8.1 ± 2.1% and mean scar width was 12.8 ± 2.1 mm. At the posterior LA, 22.6 ± 2.2% of the anatomical segment resulted in chronic scar tissue, concentrated at the PW. Postablation CMR found no evidence for PV stenosis or collateral damage of adjacent structures. At 7 months of follow-up, 9/10 patients (90%) were free from arrhythmia recurrence. CONCLUSION: PFA for AF resulted in durable and transmural atrial scar tissue at the PVs and PW. LGE CMR found a very homogeneous and contiguous lesion pattern with no signs for collateral damage.

Mechanisms of late arrhythmia recurrence after initially successful pulmonary vein isolation in patients with atrial fibrillation.

BACKGROUND: Catheter ablation is an effective treatment for atrial fibrillation (AF,) but arrhythmia recurrence occurs in a relevant number of patients. Mechanisms of late occurring arrhythmias after ablation procedures are not fully understood. We analyzed electrophysiological mechanisms of early and late arrhythmia recurrences in patients who underwent radiofrequency-based catheter ablation of AF. METHODS AND RESULTS: Consecutive patients who underwent repeat ablation procedures after initial pulmonary vein isolation (PVI) for symptomatic arrhythmia recurrence were analyzed. A total of 110 consecutive patients who underwent catheter ablation for paroxysmal (79%) or persistent AF (21%) were included. Forty-seven patients suffered from early arrhythmia recurrence (group #1: 3-24 months), 29 patients from mid-term arrhythmia recurrences (group #2: 2-5 years), and 34 patients from late arrhythmia recurrences (group #3: > 5 years). Electrical PV reconnection was found in 98% in group #1, 72% in group #2 and 56% in group #3 (p < .001). Mode of arrhythmia recurrence was organized tachycardia in 25%, 28%, and 65% of patients in groups #1, #2, and #3 (p = .001), respectively. Patients with late arrhythmia recurrence had more pronounced left atrial low voltage as compared to patients with early arrhythmia recurrence based on two published scoring system. CONCLUSION: Electrical PV reconnection was found in the majority of patients with early AF recurrence after PVI. In patients with late arrhythmia recurrences this mechanism may play an inferior role, with many patients presenting without PV reconnection, but with LA structural alterations. Thus, early and late occurring arrhythmia recurrence after catheter ablation may be the same symptom of different diseases.

The individual relationship between atrial fibrillation sources from CARTOFINDER mapping and atrial cardiomyopathy: The catch me if you can trial.

BACKGROUND: Targeting individual sources identified during atrial fibrillation (AF) has been used as an ablation strategy with varying results. OBJECTIVE: Aim of this study was to evaluate the relationship between regions of interest (ROIs) from CARTOFINDER (CF) mapping and atrial cardiomyopathy from late gadolinium enhancement (LGE) cardiovascular magnetic resonance imaging (CMR). METHODS: Twenty consecutive patients underwent index catheter ablation for persistent AF (PERS AF). Pre-processed LGE CMR images were merged with the results from CF mapping to visualize harboring regions for focal and rotational activities. Atrial cardiomyopathy was classified based on the four Utah stages. RESULTS: Procedural success was achieved in all patients (n = 20, 100%). LGE CMR revealed an intermediate amount of 21.41% ± 6.32% for LA fibrosis. ROIs were identified in all patients (mean no ROIs per patient n = 416.45 ± 204.57). A tendency towards a positive correlation between the total amount of atrial cardiomyopathy and the total number of ROIs per patient (regression coefficient, ß = 10.86, p = .15) was observed. The degree of fibrosis and the presence of ROIs per segment showed no consistent spatial correlation (posterior: ß = 0.36, p-value (p) = .24; anterior: ß = -0.08, p = .54; lateral: ß = 0.31, p = 39; septal: ß = -0.12; p = .66; right PVs: ß = 0.34, p = .27; left PVs: ß = 0.07, p = .79; LAA: ß = -0.91, p = .12). 12 months AF-free survival was 70% (n = 14) after ablation. CONCLUSION: The presence of ROIs from CF mapping was not directly associated with the extent and location of fibrosis. Further studies evaluating the relationship between focal and rotational activity and atrial cardiomyopathy are mandatory.

First clinical experience using a novel automated mapping algorithm for mapping of ventricular arrhythmias.

A new automated vector-based mapping algorithm (AMA) for 3-dimensional (3D) mapping has been introduced. The aim of this study was to present our experience using AMA to recognize additional catheter ablation targets in patients with ventricular arrhythmias (VA). A total of 16 patients (ICM; ischemic cardiomyopathy, n = 6; NICM; non-ischemic cardiomyopathy n = 10) suffering from VA underwent catheter ablation. Following bipolar voltage mapping, AMA was utilized to reveal zones of decelerated conduction velocity vectors (CVV) and this information was superimposed onto the 3D reconstructions and compared with the presence of scar. Mapping time was 28.1 ± 10 min for the endocardial reconstruction of the left ventricle (LV) and 17 ± 5.4 min for the epicardium (n = 6 patients). The mean area of LV low voltage was 13.9 ± 15% (endocardial) and 11.9 ± 5.7% (epicardial). Decelerating CVV zones were revealed in all patients (mean conduction velocity threshold of 39.3 ± 13%). Sustained VA have been terminated through ablation and substrate modification was performed in all patients. Correlation between the presence of CVV deceleration zones and areas of abnormal low voltage from bipolar mapping was revealed in only 37.5% of patients, but there was good correlation between scar from unipolar voltage mapping and the presence of CCV deceleration zones (94%; p = 0.008). The novel AMA may improve the understanding of individual VA substrates due to the visualization of decelerated CVV zones and their correlation with abnormal low voltage predominantly from unipolar mapping.

Direct comparison of two 50 W high power short duration approaches-Temperature- versus ablation index-guided radiofrequency ablation for atrial fibrillation.

INTRODUCTION: Approaches applying higher energy levels for shorter periods (high power short duration, HPSD) to improve lesion formation for atrial fibrillation (AF) ablation have been introduced. This single-center study aimed to compare the efficacy, safety, and lesion formation using the novel DiamondTemp (DT) catheter or an ablation index (AI)-guided HPSD ablation protocol using a force-sensing catheter with surround-flow irrigation. METHODS: One hundred thirteen consecutive patients undergoing radiofrequency-guided catheter ablation (RFCA) for AF were included. Forty-five patients treated with the DT catheter (50 W, 9 s), were compared to 68 consecutive patients undergoing AI-guided ablation (AI anterior 550; AI posterior 400) adherent to a 50 W HPSD protocol. Procedural data and AF recurrence were evaluated. RESULTS: Acute procedural success was achieved in all patients (n = 113, 100%). DT-guided AF ablation was associated with a longer mean procedure duration (99.10 ± 28.30 min vs. 78.24 ± 25.55, p < .001) and more RF applications (75.24 ± 30.76 min vs. 61.27 ± 14.06, p = .019). RF duration (792.13 ± 311.23 s vs. 1035.54 ± 287.24 s, p < .001) and fluoroscopy dose (183.81 ± 178.13 vs. 295.80 ± 247.54 yGym2 , p = .013) were lower in the DT group. AI-guided HPSD was associated with a higher AF-free survival rate without reaching statistical significance (p = .088). Especially patients with PERS AF (p = .009) as well as patients with additional atrial arrhythmia substrate (p = .002) benefited from an AI-guided ablation strategy. CONCLUSION: Temperature- and AI- controlled HPSD RFCA using 50 W was safe and effective. AI-guided HPSD ablation seems to be associated with shorter procedure durations and fewer RF applications. Particularly in advanced AF, freedom from AF-recurrence may be improved using an AI-guided HPSD approach.

AV-node isolation as an alternative to AV-node ablation in patients undergoing pace & ablate strategy.

INTRODUCTION: Atrioventricular (AV)-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation (AF). We hypothesized that isolation of the AV nodal isolation (AVNI) is associated with a more frequent preservation of an adequate escape rhythm compared to AVNA. METHODS: This retrospective study included 20 patients with therapy-refractory AF being treated with AVNI and 40 historical AVNA-controls. In AVNI the AV-node region was mapped using a 3D mapping system. Ablation was performed around the previously mapped HIS-cloud regions isolating the atrium from the AV-node. In the AVNI group, ablation was performed with irrigated tip ablation catheter in all cases. The two approaches were compared regarding rate of escape rhythm, delta QRS, and procedural data. RESULTS: The number of patients with adequate escape rhythm in AVNI was significantly superior to AVNA immediately postoperative (90% vs. 40%, p < 0.01) and during follow-up (77% vs. 36%, p < 0.05). The median change in QRS width was 0 ms in AVNI versus +26 ms in AVNA (p < 0.01). Thirty percent new bundle branch blocks in AVNA were observed compared to 0% in AVNI (p < 0.01). In the AVNI group, fluoroscopy time and total dose area product were significantly lower (p < 0.01). CONCLUSION: The present study suggests that AV-node isolation using 3D navigation mapping system is a feasible and effective alternative to conventional AVNA. The precise application of radiofrequency lesions preserves a stable AV-junctional rhythm.

Repeat catheter ablation in patients with atrial arrhythmia recurrence despite durable pulmonary vein isolation.

INTRODUCTION: Arrhythmia recurrence after pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) is common and often linked to pulmonary vein reconnection. In patients with arrhythmia recurrences despite durable PVI the optimal ablation approach is unclear. The purpose of the present study was to analyze efficacy of extended ablation maneuvers in these patients and predictors of procedural success. METHODS: Consecutive patients with durable PVI undergoing repeat ablation procedures were prospectively enrolled. Patients underwent substrate modification with creation of linear lesions and/or mechanism-specific atrial tachycardia (AT) ablation. Three dimensional-mapping images were analyzed for the presence of left atrial (LA) low-voltage areas according to published scoring systems. RESULTS: Seventy-four patients were analyzed. Mode of recurrence after durable PVI was AF in 27 patients (36.5%) and AT in 47 patients (63.5%). Linear lesion ablation was performed in 60 patients (81.1%). Twenty-four patients (32.4%) were treated for focal AT mechanisms. Mean follow-up was 565 ± 342 days. Estimated arrhythmia-free survival after 24 months was significantly higher in patients with AT than in patients with AF as mode of recurrence after durable PVI (42.9 ± 8.2% vs. 24.7 ± 8.5%, p = .023) and in patients without compared to patients with marked LA low-voltage areas (40.5 ± 9.2% vs. 22.8 ± 8.5%, p = .041). The mode of recurrence after durable PVI was the only independent predictor of further arrhythmia recurrence after repeat ablation. CONCLUSION: Arrhythmia-free survival following repeat ablation procedures in patients with durable PVI highly depends on mode of arrhythmia recurrence and the presence of LA low-voltage areas.

Stand-alone Focal Impulse and Rotor Modulation (FIRM) ablation versus second-generation cryoballoon pulmonary vein isolation for paroxysmal atrial fibrillation.

INTRODUCTION: Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation aiming at stable rotors has been investigated as a treatment option in patients with atrial fibrillation (AF). The objective of this study was to compare the safety and efficacy of FIRM-guided ablation with second-generation cryoballoon pulmonary vein isolation (CB2-PVI) in paroxysmal AF. METHODS: Consecutive patients (n = 22, mean age 60 ± 11 years, 59.1% of males) who were treated with a stand-alone FIRM-guided ablation were included in this retrospective single-center study. Procedural data and arrhythmia-free survival at 12 months were compared with n = 86 consecutive patients (mean age 62 ± 13 years, 62.4% of males) who received de-novo CB2-PVI. RESULTS: Median procedure duration was significantly longer in the FIRM group than in the CB2-PVI group (152 [IQR 120-176] minutes vs. 122 [110-145] minutes; p = .031). One patient (1.2%) in the CB2-PVI group and five patients (22.7%) in the FIRM group had vascular access complications. Atrial tachyarrhythmias recurred in 15 patients in the FIRM group and 11 in the CB2-PVI group. Kaplan-Meier estimation of single-procedure arrhythmia-free survival at 12 months was 25% (95% confidence interval [CI] 6%-44%) in the FIRM group and 87% (95% CI 78%-96%) in the CB2-PVI group (p < .001). Repeat ablations were performed in 14/20 (70.0%) patients in the FIRM group and in 12/85 (14.1%) in the CB2-PVI group (p < .001). CONCLUSION: De novo ablation of AF using FIRM-guided AF ablation results in shorter arrhythmia-free survival after 12 months compared to CB2-PVI and a need for repeat ablation in the majority of patients to achieve stable sinus rhythm.

A frozen decade: Ten years outcome of atrial fibrillation ablation using a single shot device for pulmonary vein isolation.

AIMS: Cryoballoon-guided pulmonary vein isolation (CB-PVI) for symptomatic atrial fibrillation (AF) has become an established treatment option with encouraging results in terms of safety and efficacy. Data reporting on long-term data beyond a follow-up (FU) period of 5 years is scarce. This prospective study aimed to evaluate very long-term outcome after CB-PVI for AF. METHODS: Data from consecutive patients treated with CB-PVI for symptomatic and drug refractory AF between 2005 and 2012 were analyzed. Patients with a FU of ≥9 years after index CB-PVI were included. All patients were continuously followed-up in our outpatient clinic. Arrhythmia recurrence was defined as AF or atrial tachycardia (AT) lasting >30 s beyond a 3-month blanking period. RESULTS: A total of 385 patients (71% male) were included. Mean age was 58 ± 10 years and paroxysmal AF was present in 93% of patients. Mean FU duration was 124 ± 24 months. At the end of the observational period, 73% of all patients were in stable sinus rhythm after a mean of 2 ± 0.8 ablation procedures. Patients with AF/AT recurrence were older (60 ± 8 vs. 57 ± 10 years; p = .019), had a higher CHA2 DS2 -Vasc Score (2.47 ± 1.46 vs. 1.98 ± 1.50; p = .01) and presented with a larger left atrium (LA)-diameter (43 ± 5.6 vs. 40 ± 5.1 mm; p = .002). The LA-diameter was also a significant predictor for AF/AT recurrence after CB-PVI (odds ratio: 0.939, 95% confidence interval: [0.886, 0.992], p = .03). CONCLUSIONS: CB-PVI as index procedure for AF ablation resulted in favorable long-term outcome in symptomatic AF. CB-PVI might be recommended as interventional therapy in patients with lower LA remodeling.

Two competing cryoballoon technologies for single shot pulmonary vein isolation: first experiences with the novel system.

Following its introduction into clinical practice, the cryoballoon (CB) has proved to be an alternative for pulmonary vein isolation (PVI) in patients with paroxysmal and persistent atrial fibrillation (AF). In comparison with the standard radiofrequency procedure, the CB method results in a shorter procedure time and learning curve as well as a higher degree of reproducibility. A new cryoballoon (NCB) was recently introduced on the market. In this review, we addressed the following questions: Is the new system technically similar to the previous one? Is there a difference in terms of periprocedural parameters? Are acute success and complication rates similar? Is the learning curve different?

First clinical experience using a visualized sheath for atrial fibrillation ablation.

INTRODUCTION: Recently, a novel steerable sheath allowing its real-time visualization within a 3D-mapping system was introduced to facilitate atrial fibrillation (AF) ablation. AIM: This study aimed to assess safety and efficacy of AF ablation using the visualized sheath and to compare its performance with a matched control group of patients who received ablation with conventional and non-visualized sheaths. METHODS: The study included consecutive patients between 09/2019 and 02/2021 who underwent routine AF ablation using the visualized sheath. Patients were regularly followed-up in our outpatient's clinic. Arrhythmia recurrence was defined as any atrial fibrillation (AF)/ atrial tachycardia (AT) episode lasting > 30 s after a blanking period of 3 months. RESULTS: A total number of 100 patients undergoing ablation using the visualized sheath were compared to a group of 99 matched patients. No major complications were observed. Total procedure duration (108 ± 22 min vs. 112 ± 12 min; p = 0.045), fluoroscopy time (7 ± 3 min vs. 10 ± 5 min; p < 0.001) and -dose (507 ± 501 cGy*cm2 vs. 783 ± 433 cGy*cm2 ; p < 0.001) were significantly lower using the visualized sheath. The benefit in terms of procedure duration was mainly driven by a shortened left atrial dwell time (73 ± 13 min vs. 79 ± 12 min; p = 0.001). During a mean follow-up of 12 months, the overall procedural success was 85% in the visualized sheath group versus 83% in the control group (p = 0.948). CONCLUSION: AF ablation using the novel visualized sheath is safe and effective and leads to a measurable decrease of procedure duration and radiation exposure. The integration of the novel sheath might help to further improve safety and efficacy of AF ablation.

Experience and procedural efficacy of pulmonary vein isolation using the fourth and second generation cryoballoon: The shorter, the better?

BACKGROUND: The second-generation cryoballoon (CB2) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The novel fourth-generation cryoballoon (CB4) incorporates a 40% shorter distal tip. This design change may translate into an increased rate of PVI real-time signal recording, facilitating an individualized ablation strategy using the time to effect (TTE). METHODS AND RESULTS: Three hundred consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled. The first 150 consecutive patients underwent CB2 based PVI (CB2 group) and the last 150 consecutive patients were treated with the CB4 (CB4 group). A total of 594/594 (100%, CB4) and 589/594 (99.2%, CB2) pulmonary veins (PVs) were successfully isolated utilizing the CB4 and CB2, respectively (p = .283). The real-time PVI visualization rate was 47% (CB4) and 39% (CB2; p = .005) and the mean freeze cycle duration 200 ± 90 s (CB4) and 228 ± 110 s (CB2; p < .001), respectively. The total procedure time did not differ between the groups (CB4: 64 ± 32 min) and (CB2: 62 ± 29 min, p = .370). No differences in periprocedural complications were detected. CONCLUSIONS: A higher rate of real-time electrical PV recordings are seen using the CB4 as compared to CB2, which may facilitate an individualized ablation strategy using the TTE.