Occupational radiation exposure of electrophysiology staff with reproductive potential and during pregnancy: an EHRA survey.

AIMS: Electrophysiology (EP) is a growing field in cardiology, with an increasing involvement of young people. Nevertheless, concerns about radiation exposure and its impact on reproduction and pregnancy may discourage the choice of an EP career. The study is aimed at investigating the level of awareness and main sources of concern about the effects of radiation on reproductive potential and pregnancy, exploring the safety measures adopted in different EP labs, and verifying the adherence to the current guidelines. METHODS AND RESULTS: An online survey was conducted using the European Heart Rhythm Association (EHRA) infrastructure from April to June 2022. A total of 252 EP personnel (42% women) participated, from 50 countries and different professional roles. Most participants expressed concerns regarding the effects of radiation on reproductive capacity (67.1%) and offspring diseases (68.2%). Only 37.9% of participants were aware of the EHRA 2017 consensus document about occupational radiation exposure. Most participants (80.9%) considered that occupational radiation during pregnancy is not safe. EP female staff were not allowed to work in the EP lab during pregnancy in 48.1% of cases. Zero-fluoroscopy was the preferred choice to continue working in the EP lab during pregnancy. CONCLUSION: EP staff, including both men and women, have concerns about the effects of radiation on reproductive capacity. Despite the recommendations issued by international bodies, implementation of the policies regarding pregnancy and occupational radiation exposure is heterogeneous. Zero-fluoroscopy is the preferred approach to ensure safety during pregnancy in the EP lab.

Diagnostic and therapeutic pathways for the malignant left atrial appendage: European Heart Rhythm Association physician survey.

AIMS: Patients with atrial fibrillation who despite taking oral anti-coagulant therapy (OAT) suffer a stroke or systemic embolism (SSE) without vascular cause or who develop left atrial appendage (LAA) thrombus (LAAT) should be considered as having malignant LAA. The optimal treatment strategy to reduce SSE risk in such patients is unknown. The aim of the study is to investigate the diagnostic and therapeutic pathways for malignant LAA practiced in European cardiac centres. METHODS AND RESULTS: An 18-item online questionnaire on malignant LAA was disseminated by the European Heart Rhythm Association (EHRA) Scientific Initiatives Committee. A total of 196 physicians participated in the survey. There seems to be high confidence in transoesophageal echocardiography (TEE) imaging, considering LAAT diagnosis. Switching to another direct oral anti-coagulant (DOAC) is the preferred initial step for the treatment of malignant LAA followed by a switch to vitamin K antagonist (VKA), low-molecular-weight heparin, or continued/optimized DOAC dosage, whereas LAA closure is the last option. Left atrial appendage closure is a viable option in patients with embolic stroke despite OAT and no evidence of thrombus at TEE (empty LAA) after comprehensive diagnostic measures to exclude other sources of embolism. CONCLUSION: This EHRA survey provides a snapshot of the contemporary management of patients diagnosed with malignant LAA. Currently, the majority of patients are treated on an outpatient basis with either shifting from VKA to DOAC or from one DOAC to another. Left atrial appendage closure in this population seems to be reserved for patients with higher bleeding risk or complications of malignant LAA, such as stroke.

Overweight and aging increase the risk of atrial fibrillation after cardiac surgery independently of left atrial size and left ventricular ejection fraction.

BACKGROUND: Body mass index (BMI), age, left atrium (LA) dimension and left ventricular ejection fraction (LVEF) have been linked to post-operative atrial fibrillation (POAF) after cardiac surgery. The aim of this study was to better define the role of these risk factors. METHODS: This retrospective cohort study evaluated 249 patients (without prior atrial dysrhythmia) undergoing cardiac or aortic surgery. Prior to surgery, the following data were collected: age, BMI, LA diameter, LA area, LVEF, thyroid stimulating hormone (TSH), creatinine and the presence of arterial hypertension (AH) and diabetes. Intraoperative data such as operation time, total clamp time, cardiopulmonary bypass time, and presence of pericardial/pleural effusion were also collected. Only patients without pre- and post-surgery prophylactic anti-arrhythmic therapy were included. RESULTS: Patients with (N = 127, 51%) and without POAF (N = 122, 49%) were compared. No difference was observed for sex, LA diameter, LA area, LVEF, TSH, diabetes and use of ACE inhibitors or statins prior to intervention. Moreover, no difference was observed in terms of operation time, total clamp time, cardiopulmonary bypass time, and presence of pericardial/pleural effusion. However, patients with POAF were older (70.6 ± 10.7 vs. 60.4 ± 16.4 years, p = 0.001), had higher BMI (26.8 ± 4.5 vs. 24.9 ± 3.6 kg/m2, p = 0.001), higher baseline creatinine (1.06 ± 0.91 vs. 0.88 ± 0.32 mg/dL, p = 0.038) and a higher frequency of arterial hypertension (73.2% vs. 50%, p = 0.001) and Bentall procedure (24.4% vs. 9.8%, p = 0.023). Multivariate analysis showed that the only independent predictors of POAF were age (OR = 1.05, 95%CI 1.02-1.07, p = 0.001) and BMI (OR = 1.11 95%CI 1.03-1.2,p = 0.006). CONCLUSIONS: These findings suggest that advanced age and a higher BMI are strong risk factors for POAF in patients without previous AF even in the presence of comparable LA dimensions and LVEF.

Cryoballoon pulmonary vein isolation in treating atrial fibrillation using different freeze protocols: The "ICE-T 4 minutes vs 3 minutes" propensity-matched study (Frankfurt ICE-T 4 vs. 3).

BACKGROUND: Time-to-isolation (TTI) guided second-generation cryoballoon (CB2) ablation has been shown to be effective for pulmonary vein isolation (PVI). OBJECTIVE: The objective of this paper is to compare the safety and clinical outcome of CB2 PVI using the TTI guided 4 minutes vs 3 minutes freeze protocol. METHODS: This was a propensity-matched study based on an institutional database. Symptomatic atrial fibrillation (AF) patients who underwent CB2 PVI and systematic follow-up were consecutively included. RESULTS: A total of 573 patients were identified, of them 214 (107 matched-pairs) symptomatic AF (paroxysmal AF: 61%, persistent AF: 39%) patients (age: 67.7 ± 11.2 years) were analyzed. The baseline characteristics were comparable between the two groups. Procedural time was significantly longer in the 4 minutes group compared to 3 minutes group (67.2 ± 21.8 vs 55.9 ± 16.9 minutes, P < .0001). During a mean follow-up of 2 years, the 4 minutes group was associated with a significantly higher rate of freedom from arrhythmia recurrence compared with the 3 minutes group (66.4% vs 56.1%, P = .009), which was mainly driven by patients with persistent AF. The multivariate regression showed that the 4 minutes freeze was the independent predictor of freedom from arrhythmia recurrence. During the repeat procedure, the 4 minutes group was associated with a significantly higher rate of durable PVI. There was no difference regarding procedural adverse events between the two groups. CONCLUSION: As compared with the 3 minutes freeze, the TTI guided 4 minutes freeze is associated with a significantly higher rate of arrhythmia-free and durable PVI without compromising the safety profile, patients with persistent AF may benefit from the TTI guided 4 minutes freeze more pronouncedly.

Incidence and pattern of conduction gaps after pulmonary vein isolation with the endoscopic ablation system.

PURPOSE: Durable pulmonary vein isolation (PVI) is the goal of atrial fibrillation (AF) ablation. The endoscopic ablation system (EAS) is associated with a high rate of persistent PVI. The aim of this study was to analyze the incidence and pattern of conduction gaps in patients with arrhythmia recurrence after an EAS-guided PVI. METHODS: Repeat ablations after an EAS-guided PVI were analyzed. After PV angiograms, PV reconnection was assessed. Radiofrequency ablation was delivered at the earliest pulmonary vein (PV) activation site (gap) with the goal of PV re-isolation. First, the incidence of reconnected PVs per patient was assessed. Second, the gap pattern according to the individual PV quadrant was analyzed. RESULTS: Fifty-nine out of 373 (16%) patients underwent a second procedure after index EAS. PV reconnection was observed in 71/230 (31%) PVs without statistically significant differences between individual PVs. A higher incidence of gaps was found for right PVs (49 vs. 27; p 0.0006). The carina between the superior and inferior PV presented a low incidence of gaps (18 vs. 56, p < 0.0001). Gaps were also predominant at the AS segment of the RSPV (11 gaps). No predictors of reconnection were found, except the higher total amount of application in the reconnected right inferior PV (26.03 ± 1.30 vs. 32.04 ± 2.89; p 0.0396). CONCLUSION: EAS-guided PVI results in a 72% durable PVI rate in patients with AF recurrences without difference between individual PVs. More of the gap was found in the right PVs especially in the anterosuperior segment of the RSPV.

Impact of Cryoballoon Freeze Duration on Long-Term Durability of Pulmonary Vein Isolation: ICE Re-Map Study.

OBJECTIVES: This study sought to evaluate the durability of pulmonary vein isolation (PVI) after 2 different freeze durations by using time-to-effect guided (ICE-T) second generation cryoballoon (CB2) ablation strategy in patients with atrial fibrillation (AF) undergoing repeat procedure. BACKGROUND: CB2 represents a powerful technology for PVI. Recently, the ICE-T CB2 ablation strategy targeting a 240-s single freeze demonstrated fast and efficient PVI. To further optimize safety and efficacy, a shortened 3-min freeze duration has been suggested, but PVI durability remains unclear. METHODS: Between May 1, 2013 and December 31, 2017, all CB2 ablations followed the ICE-T concept (target freeze: 240 s or 180 s). Patients undergoing a second procedure for arrhythmia recurrence were analyzed. Two groups were defined based on the index freeze duration (group A: 240 s vs. group B: 180 s). In all repeat procedures a 3-dimensional left-atrial map was obtained. Durability of PVI and localization of conduction gaps were compared. RESULTS: Of 788 total patients, 106 (13%) underwent a second procedure (group A: 80 of 604 vs. group B: 26 of 184) after a mean of 377 days. There was no difference regarding PV occlusion and time-to-isolation in the index procedure between the 2 groups. No major complications occurred. During the second procedure, significantly more patients demonstrated durable isolation of all PV in group A (61% vs. 35%; p = 0.02) along with a significantly increased rate of PVI durability (88% vs. 69%, per vein; p < 0.001). Left-sided PV did significantly benefit from 240-s freeze (reconnection left superior PV: 6% vs. 27%; p = 0.004, left inferior PV: 14% vs. 39%; p = 0.006). CONCLUSIONS: The ICE-T ablation strategy is associated with a high rate of durable PVI in patients with arrhythmia recurrence. Target freeze duration of 240 s versus 180 s is associated with significantly increased lesion durability, particularly at left-sided PV, without increasing complications.

Durability of cryoballoon left atrial appendage isolation: Acute and invasive remapping electrophysiological findings.

BACKGROUND: The left atrial appendage (LAA) has been identified as a potential source of atrial fibrillation (AF) and has been described as the "fifth" pulmonary vein (PV). We report our initial experience in LAA isolation (LAAI) using the cryoballoon (CB) and data on durability of CB-LAAI. METHODS: Patients treated with a CB-LAAI were retrospectively identified. Six weeks after electrical LAAI, patients were scheduled for staged percutaneous LAA closure. During the second procedure, a subset of patients underwent invasive remapping of the LAA. RESULTS: A total of 32 patients (21 males, 68 ± 10 years old) were treated with CB-LAAI. Acute LAAI was achieved in 29 of 32 (91%) patients: single-shot LAAI was observed in 18 of 32 (56%) patients. Acute procedural sustained LAAI was related with a significantly shorter time to LAAI (sustained LAAI: 84 ± 50 s vs nonsustained LAAI: 166 ± 76 s, P = 0.004). Mean procedure and fluoroscopy time were 61 ± 29 and 8 ± 6 min, respectively. One left-sided phrenic nerve palsy occurred. In 25 of 32 (78%) patients, a second procedure for percutaneous LAA closure device implantation was performed. In 22 patients, persistency of LAAI was tested: durable LAAI was documented in 16/22 patients (73%). CONCLUSION: In the present report, CB LAA isolation followed by staged LAA closure appeared to be safe and feasible but more data are required. Time to LAAI played a role in predicting acute sustained LAAI rate. CB LAA ablation leads to 73% of durable LAA isolation.

Analysis of procedural data of pulmonary vein isolation for atrial fibrillation with the second-generation laser balloon.

BACKGROUND: The procedural data of pulmonary vein (PV) isolation (PVI) for patients with atrial fibrillation using the second-generation laser balloon (LB2), which became available recently, remains unclear and were evaluated. METHODS: Thirty consecutive patients (116 PVs) underwent PVI using LB2 (LB2 group) and were matched to 30 patients (116 PVs) treated with the first-generation laser balloon (LB1 group). The left atrial isolated surface area (ISA) (ratio of the total isolated antral surface area excluding PV to the total isolated antral surface area including the posterior wall) was also measured after LB2 PVI. RESULTS: PVI was achieved in 103/116 (89%) PVs and 108/116 (93%) PVs in the LB2 and LB1 groups, respectively, after the initial circular ablation (P = 0.360) and in 115/116 (99%) PVs and 116/116 (100%) PVs in the LB2 and LB1 groups, respectively, at the end of the procedure (P = 1.000). PV occlusion grade, categorized by the degree of PV occlusion, was significantly better in the LB2 group than in the LB1 group (P < 0.001). Zero rotational maneuver was applicable in 23/116 (20%) PVs and 8/116 (7%) in the LB2 and LB1 groups, respectively (P = 0.007). There was no significant difference in the procedural time, fluoroscopic time, or complications. The mean ISA after LB2 PVI was 53 ± 14%. The application number was the only independent predictor of successful PVI after initial circular LB2 ablation (adjusted odds ratio 0.860; 95% confidence interval 0.764-0.968; P = 0.013). CONCLUSION: LB2 displays favorable PV occlusion characteristics and enables more zero rotational maneuvers.

HEartLight guided - PUre Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate: HEURECA Study.

BACKGROUND: It remains unclear whether left atrial low-voltage area (LALVA) affects atrial tachyarrhythmia recurrence after laser balloon pulmonary vein isolation (PVI) for atrial fibrillation (AF). We prospectively evaluated the outcome of laser balloon PVI in patients with and without LALVA (≤ 0.5 mV) together with surface/intracardiac electrophysiological criteria. METHODS: One hundred consecutive paroxysmal/persistent AF patients underwent laser balloon PVI. The relative extent of LALVA (extent of LALVA/left atrial surface area × 100 [%]: rLALVA), total p-wave duration in lead II (PWD), and time interval from the beginning of p-wave to the local activation in left atrial appendage (TTLAA) were assessed. Patients were divided into patients with LALVA (group A: 23 patients) and those without LALVA (group B: 77 patients). The primary endpoint was freedom from atrial tachyarrhythmia after the blanking periods. RESULTS: Complete PVI was achieved in 99/100 (99%) patients. PWD and TTLAA were longer in group A (both, P < 0.001). During 12 months' follow-up, survival free from atrial tachyarrhythmia recurrence was lower in group A (12/23 [52%] patients vs 67/77 [87%] patients, P < 0.001). Multivariate analysis identified rLALVA as the only independent predictor of atrial tachyarrhythmia recurrence. rLALVA correlated with PWD and TTLAA (r = 0.41, P < 0.001 and r = 0.60, P < 0.001, respectively). Receiver operating characteristic curve for rLALVA revealed PWD of 122 ms and TTLAA of 92 ms as the optimal cut-off value. CONCLUSION: LALVA was associated with poorer outcome after laser balloon PVI. Patients may be identified by longer PWD and TTLAA.

Compound motor action potential guided 240 seconds plus bonus freeze for safe and durable left atrial appendage isolation in patients with recurrent persistent atrial fibrillation: How to isolate the appendage with cryoballoon (the CMAP guided ICE-B protocol).

INTRODUCTION: Pulmonary vein isolation (PVI) is the cornerstone ablation strategy for treatment of atrial fibrillation (AF). Ablation outside the PVs is sometimes needed particularly in persistent or longstanding AF. This study reported left atrial appendage isolation (LAAI) using cryoballoon (CB) focusing on technical data and short-term clinical follow-up. METHODS AND RESULTS: Patients with recurrent persistent AF after multiple AF procedures were enrolled. LAAI was performed using the second generation CB guided by compound motor action potential (CMAP) and 240 seconds plus bonus freeze (ICE-B) protocol. Ten patients were included, median age was 69.5 (56-73) years, CHA2 DS 2 -VASc score was 3 (1.8-4), LA diameter was 44 (38.8-46.5) mm. All patients had a mean of three AF procedures before the LAAI procedure. All patients were under successful CMAP guidance. During the CB LAAI procedure, the median time to LAA isolation was 100 (76-270) seconds, minimal freeze temperature was -50 (-57 to -47)°C. A "pull-down (or pull-away)" CB maneuver was performed in all patients. Median fluoroscopic time was 4.8 (3.4-6.8) minutes and acute LAAI success rate was 100%. No phrenic nerve injury or other major complications were observed. At 6-week follow-up, remapping of the LAA showed durable isolation of all PVs (100%), all patients were scheduled for LAA occlusion. Six-month follow-up showed that 80% of patients were free from AF/AT recurrence. CONCLUSION: CMAP plus ICE-B guided LAAI using cryo-technology appears feasible and safe, results in durable LAAI, and shows promising clinical results in patients with recurrent persistent AF.

Low Risk of Pulmonary Vein Stenosis After Contemporary Atrial Fibrillation Ablation　- Lessons From Repeat Procedures After Radiofrequency Current, Cryoballoon, and Laser Balloon.

BACKGROUND: The incidence of pulmonary vein stenosis (PVS) after AF ablation following contemporary procedures remains unclear. We compared the incidence of PVS/narrowing (PVS/N) after PV isolation (PVI) for (1) 3-D mapping-guided wide-area encircling irrigated radiofrequency current (RFC) ablation; (2) first-third-generation big cryoballoon (CB1-3) ablation; and (3) laser balloon (LB) ablation.Methods and Results:All patients undergoing a second procedure between January 2012 and November 2016 were subgrouped according to index ablation (PVI): RFC; CB; or LB. PVS/N was classified using PV diameter ratio (second/index procedure) on selective PV angiogram performed before ablation: mild, 25-49%; moderate, 50-74%; or severe, ≥75%. A total of 344 patients (1,362 PV) were analyzed (RFC, n=211; 840 PV; CB1, n=21; 82 PV; CB2,3, n=64; 250 PV; LB, n=48; 190 PV). In the LB group, 45 patients (94%) were treated with dose ≥8.5 W. Second procedures were performed on average 14.9±14.1 months after the index procedure. Mild PVS/N was observed in 18.4%, 9.5% and 3.6% of PV in the LB, RFC and CB groups, respectively (P<0.01). Moderate PVS was recognized in 2 PV (0.1%; RFC, LB). Severe PVS was never observed, and no PV intervention/surgery was required. CONCLUSIONS: The risk for significant PVS is low after RFC/CB. The incidence of mild PVS/N was highest after standard-dose LB ablation and lowest after high-dose CB ablation.

Atrial fibrillation ablation using cryoballoon technology: Recent advances and practical techniques.

Atrial fibrillation (AF) affects 1-2% of the population, and its prevalence is estimated to double in the next 50 years as the population ages. AF results in impaired patients' life quality, deteriorated cardiac function, and even increased mortality. Antiarrhythmic drugs frequently fail to restore sinus rhythm. Catheter ablation is a valuable treatment approach for AF, even as a first-line therapy strategy in selected patients. Effective electrical pulmonary vein isolation (PVI) is the cornerstone of all AF ablation strategies. Use of radiofrequency (RF) catheter in combination of a three-dimensional electroanatomical mapping system is the most established ablation approach. However, catheter ablation of AF is challenging even sometimes for experienced operators. To facilitate catheter ablation of AF without compromising the durability of the pulmonary vein isolation, "single shot" ablation devices have been developed; of them, cryoballoon ablation, is by far the most widely investigated. In this report, we review the current knowledge of AF and discuss the recent evidence in catheter ablation of AF, particularly cryoballoon ablation. Moreover, we review relevant data from the literature as well as our own experience and summarize the key procedural practical techniques in PVI using cryoballoon technology, aiming to shorten the learning curve of the ablation technique and to contribute further to reduction of the disease burden.

Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study.

BACKGROUND: Pulmonary vein isolation is the cornerstone of ablation for persistent atrial fibrillation (AF). The role of balloon catheters in this patient population remains ill defined. We sought to compare efficacy and safety of the laser balloon (LB) with wide-area circumferential pulmonary vein isolation using irrigated radiofrequency current (RF) ablation and 3-dimensional mapping. METHODS AND RESULTS: In 6 European centers, patients with persistent AF were prospectively randomized. Follow-up included 3-day Holter ECG recordings and office visits at 3, 6, and 12 months. The primary efficacy end point was freedom from AF between 90 and 365 days after a single ablation. The primary safety end point was the incidence of any periprocedural complications. Of 152 enrolled patients, 134 (n=68 LB and 66 RF; 63% men; mean age, 66+10 years) with persistent AF (median AF history, 14 months; Q1-Q3, 7-36 months) underwent pulmonary vein isolation and completed the entire follow-up. Baseline parameters were similar in both groups. Procedure and fluoroscopy times were similar in both groups (135±38 and 14±9 minutes (LB) versus 128±51 and 11±9 minutes). The primary efficacy end point was met by 71.2% versus 69.3%, in the LB and RF groups, respectively (P=0.40). In the LB group, stroke (n=1), a false aneurysm (n=1), and phrenic nerve palsy (n=1) were observed. In the RF group, 2 patients developed a false aneurysm, and 1 patient needed surgical repair. CONCLUSIONS: An LB-guided strategy was associated with similar efficacy as wide-area circumferential pulmonary vein isolation using irrigated RF in patients with persistent AF. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.org. Unique identifier: NCT01863472.

Complications in Catheter Ablation of Atrial Fibrillation in 3,000 Consecutive Procedures: Balloon Versus Radiofrequency Current Ablation.

OBJECTIVES: The aim of this study was to identify predictors of cardiac tamponade (CT) during atrial fibrillation (AF) ablation using different technologies and strategies. BACKGROUND: The major cause of death during catheter ablation of AF is related to CT. The risk for CT may be linked to different procedural steps (transseptal puncture, catheter manipulation during left atrial and pulmonary vein mapping and ablation). METHODS: All AF ablation procedures undertaken from May 2010 to July 2015 at a single center were included. Two ablation groups were defined: group A, radiofrequency current, and group B, balloon. Group A was divided into groups A1 (pulmonary vein isolation [PVI] only) and A2 (PVI plus additional ablation). In group A, 2 transseptal punctures were performed, followed by wide-area circumferential point-by-point PVI (group A1) within a 3-dimensional left atrial map and complex fractionated atrial electrograms and/or linear lesions (group A2). In group B, 1 transseptal puncture by balloon-based PVI (cryoballoon, laser balloon). All episodes of CT were analyzed. RESULTS: In total, 3,000 AF ablation procedures were performed, 2,125 in group A (group A1, n = 1,559; group A2, n = 566) and 875 in group B (cryoballoon, n = 589; laser balloon, n = 286). The rate of CT was 1.1% (32 of 3,000) and was significantly lower in group B than in group A: 0.1% (1 of 875) versus 1.5% (31 of 2,125) (p = 0.001). The reduced CT risk remained if PVI only (group B vs. group A1) was compared: 0.8% (13 of 1,559) versus 0.1% (1 of 875) (p = 0.024). The greatest CT risk was seen in group A2: 3.2% (18 of 566). Radiofrequency current ablation beyond PVI was a predictor of CT. CONCLUSIONS: The risk for CT in patients undergoing AF ablation at a single high-volume center was decreased with the use of balloon catheters. Extensive radiofrequency current ablation beyond PVI leads to an increased perforation risk.

What Is the Acute Antral Lesion Size After Pulmonary Vein Isolation Using Different Balloon Ablation Technologies?

BACKGROUND: Clinical outcome after pulmonary vein isolation (PVI) may be linked to both durability of PVI and the antral lesion size. Data on balloon-guided technologies are scarce. We investigated the size of the isolated surface area (ISA) acutely after PVI achieved by cryoballoon (CB) or laser balloon (LB), both using voltage mapping.Methods and Results:In 40 patients (73% male, mean age 66±9 years), a bipolar voltage map before and after PVI in sinus rhythm was acquired to delineate the isolated antral surface area (IASA, contiguous area of low voltage <0.5 mV) and the ISA (relative size of the low-voltage area in relation to the whole antral surface area including the posterior wall). IASA (CB: 57±14 cm2vs. LB: 42±15 cm2; P=0.002) as well as ISA (65±8% vs. 54±10%; P=0.001) were significantly larger in the CB than in the LB group. No periprocedural complications occurred. During a mean follow-up of 326±142 days, 4/20 and 5/20 patients experienced an AF/AT recurrence in the CB and LB groups, respectively. No differences in clinical outcome were observed between patients with a large (≥55%) or small (<55%) ISA. CONCLUSIONS: Balloon-guided PVI is associated with antral lesion formation. CB-guided PVI is associated with the largest ISA as compared with LB procedures. ISA size did not correlate with clinical outcome after a single procedure in the present study population.

Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial.

BACKGROUND: The ideal energy dosing remains unclear in second-generation cryoballoon (CB) pulmonary vein isolation (PVI). We aimed to investigate the effect of an individualized dosing strategy based on time to PVI (TTI). OBJECTIVE: The purpose of this study was to prospectively investigate the safety and efficacy of individualized PVI using the second-generation CB guided by real-time pulmonary vein recordings. METHODS: Two groups were prospectively randomized: ICE-T group: if TTI <75 seconds, then no bonus freeze; and control group: acute PVI followed by 1 empiric bonus freeze. Freeze duration was set to 240 seconds. The primary end point was single procedure sinus rhythm after 12 months (blanking period 3 months). Secondary end points included procedural data, complications, and biomarker release. RESULTS: In total, 100 patients with paroxysmal atrial fibrillation were randomized. The primary end point was not different (88% vs 82%). Procedure and fluoroscopy times were significantly shorter in the ICE-T group (70 ± 20 minutes vs 89 ± 21 minutes; P < .001 and 10.6 ± 3.9 minutes vs 12.7 ± 5.5 minutes; P = .03). More complications occurred in the control group (n = 9 vs n = 3) (persistent phrenic nerve injury: n = 1 vs n = 0; transient phrenic nerve injury: n = 5 vs n = 2; esophageal lesions: n = 3 vs n = 1). Postablation troponin T levels were not different (ICE-T group vs control group: 1035 ± 402 ng/L vs 1219 ± 509 ng/L; P = .099), whereas a significantly lower lactic acid dehydrogenase release was observed in the ICE-T group (259 ± 47 U/L vs 282 ± 57 U/L; P = .038). Multivariate analysis identified a mean TTI of >43 seconds as the only independent predictor of recurrent atrial tachyarrhythmia. CONCLUSION: The individualized CB PVI strategy allows faster atrial fibrillation ablation without affecting the favorable clinical outcome. A short TTI appears to predict freedom from recurrent atrial tachyarrhythmia.

Procedural characteristics of pulmonary vein isolation using the novel third-generation cryoballoon.

AIM: A novel third-generation cryoballoon (CB3) to perform pulmonary vein isolation (PVI) has recently been released, featuring a shortened distal balloon tip when compared with the second-generation (CB2), possibly allowing for enhanced intra-ablation pulmonary vein (PV) signal mapping. We aimed to investigate procedural efficacy and safety of the CB3 as compared to the CB2. METHODS AND RESULTS: We studied 472 consecutive patients who underwent CB-PVI for paroxysmal or persistent atrial fibrillation (CB3: 49 patients; CB2: 423 patients). Detailed procedural data and in-hospital complications were registered in a prospective database. Complete PVI using the CB only was achieved in 98% of patients in each group. Single-freeze PVI was observed in 84/88% (CB2/CB3, P = n.s.) of the PVs. Time-to-PVI (TPVI) was 49 ± 32 (CB2) and 45 ± 27 s (CB3) (P = n.s.). Time-to-PVI determination rate was higher in the CB3 group (89.5 vs. 82.6%, P = 0.016). Signal noise due to ice formation on mapping electrodes occurred after 70 ± 46 s using CB3 and did not interfere with TPVI determination. Exchange of the spiral mapping catheter with a guide wire was more frequently required in the CB3 group (8.2 vs. 0.7% patients, P < 0.001). Balloon dislodgement during hockey stick manoeuvres occurred in 6.1% patients of the CB3 group only (P = 0.001). Complication rates were not different between the groups. CONCLUSION: The CB3 offers a higher TPVI determination rate, facilitating dosing schemes based on TPVI, with equally high single-freeze efficacy compared with the CB2. The shortened distal tip of the CB3 requires adaptation of standard catheter manoeuvers to avoid balloon dislodgement.

Visually guided pulmonary vein isolation in patients with persistent atrial fibrillation.

AIMS: The role of balloon catheters in patients with persistent forms of atrial fibrillation (AF) remains ill defined. We therefore sought to assess the safety and efficacy of a laser balloon (LB)-guided pulmonary vein isolation (PVI) in consecutive all-comers with persistent AF. METHODS AND RESULTS: All patients undergoing an LB-guided PVI procedure for persistent AF between January 2011 and December 2012 were matched to patients undergoing circumferential PVI using irrigated radiofrequency (RF) current ablation for date of procedure, age, gender, AF duration, left atrial (LA) size, and left ventricular ejection fraction. The primary endpoint was freedom from AF between 90 and 365 days post-ablation after a single procedure. Eighty patients (mean age 66 ± 9; 71% male) with a median (Q1-Q3) AF episode duration of 2 (1-3) months underwent successful PVI in the two groups. The primary endpoint of 1-year single procedure AF/atrial tachycardia (AT) recurrences was reached by 11/40 (27.5%) patients in the LB group and in 9/40 (22.5%) patients in the RF group (P = 0.87). During a mean follow-up of 517 ± 170 days, 13 (32.5%) and 16 (40%) patients in the LB and RF groups, respectively, experienced AF/AT recurrences (P = 0.64). Procedural complications occurred in one patient in the LB group and in six patients in the RF group. CONCLUSION: A subset of patients with drug-refractory persistent AF of short duration benefit from pure PVI without additional substrate modification. A LB-based strategy showed similar outcomes as an irrigated RF-guided circumferential PVI and may be considered an alternative option for the index ablation.