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Introduction: Catheter ablation of atrial fibrillation (AF) is frequently studied in randomized trials, observational and registry studies. The aim of this expert opinion is to provide guidance for clinicians and industry regarding the development of future clinical studies on catheter ablation of AF, implement lessons learned from previous studies, and promote a higher degree of consistency across studies. Background: Studies on catheter ablation of AF may benefit from well‐described definitions of endpoints and consistent methodology and documentation of outcomes related to efficacy, safety and cost‐effectiveness. The availably of new, innovative technologies warrants further consideration about their application and impact on study design and the choice of endpoints. Moreover, recent insights gained from AF ablation studies suggest a reconsideration of some methodological aspects. Methods: A panel of clinical experts on catheter ablation of AF and designing and conducting clinical studies developed an expert opinion on the design and endpoints for studies on catheter ablation of AF. Discussions within the expert panel with the aim to reach consensus on predefined topics were based on outcomes reported in the literature and experiences from recent clinical trials. Results: A comprehensive set of recommendations is presented. Key elements include the documentation of clinical AF, medication during the study, repeated ablations and their effect on endpoint assessments, postablation blanking and the choice of rhythm‐related and other endpoints. Conclusion: This expert opinion provides guidance and promotes consistency regarding design of AF catheter ablation studies and identified aspects requiring further research to optimize study design and methodology. Recent insights from studies on catheter ablation of atrial fibrillation (AF) and the availability of new innovative technologies warrant reconsideration of methodological aspects related to study design and the choice and assessment of endpoints. This expert opinion, developed by clinical experts on catheter ablation of AF provides a comprehensive set of recommendations related to these methodological aspects. The aim of this expert opinion is to provide guidance for clinicians and industry regarding the development of clinical studies, implement lessons learned from previous studies, and promote a higher degree of consistency across studies. [ABSTRACT FROM AUTHOR]

Introduction: Cryoballoon ablation (CBA) aiming at pulmonary vein isolation (PVI) became a standardized atrial fibrillation (AF) ablation procedure. Life‐threatening complications like cardiac tamponade exist. Intracardiac echocardiography (ICE) usage is associated with superior safety in radiofrequency ablation. It is unclear if ICE has an impact on safety of CBA. Methods: The FREEZE Cohort (NCT01360008) subanalysis included patients undergoing "PVI only" CBA. Patients with intraprocedural transesophageal echocardiography were excluded. Group A comprises conventional, group B ICE‐guided CBA. Periprocedural results were compared. Results: From 2011 to 2016, a total of 4189 patients were enrolled, and 1906 (45.5%) were included in this subanalysis, split up in two groups (A: 1066 [55.9%], B: 840 [44.1%]). Group A was younger (60.6 ± 10.8 vs. 62.4 ± 10.5 years, p <.001), with smaller left atria (41 vs. 43 mm, p <.001), and less persistent AF (23.1 vs. 38.1%, p <.001). Procedure, left atrial, and fluoroscopy times were shorter in group A as compared to group B. Dose area product was significantly higher in group A (2911 vs. 2072 cGyxcm2, p <.001). In‐hospital major adverse cerebrovascular and cardiac event rates including two deaths in group A were not different between groups (0.5% vs. 0.1%, p =.18). The rate of total procedural (10.4% vs. 5.1%, p <.001) and major complications (3.2% vs. 1.3%, p <.001) was significantly higher in group A. Cardiac tamponade occurred significantly more frequently in group A (8 [0.8%] vs. 1 [0.1%], p =.046). Independent predictors for major complications were female sex (odds ratio [OR] 2.03, p =.03) and non‐ICE usage (OR 2.38, p =.02). No differences were observed for persistent phrenic nerve palsy, nor for groin complications. Conclusion: CBA was significantly safer and required less radiation if ICE was used, although the procedures were more complex. The risk of groin complications was not increased with ICE usage. Non‐ICE usage was the only modifiable independent predictor of major complications. [ABSTRACT FROM AUTHOR]

Pulmonary vein stenosis (PVS) after radiofrequency energy‐mediated percutaneous pulmonary vein isolation as a treatment option for atrial fibrillation is a serious complication and the prevalence in historical reports varies between 0% and 42%. Symptoms of PVS are nonspecific and can include general symptoms such as dyspnea, cough, recurrent pneumonia, and chest pain. Pathophysiologically it increases the postcapillary pressure in the pulmonary circuit and may result in pulmonary hypertension (PH). Misdiagnosis and delayed treatment are common. We here report a case of a 59‐year‐old female with a history of pulmonary vein ablation followed by progressive dyspnea (New York Heart Association IV), right heart failure, CPR, and the need for extracorporeal membrane oxygenation (ECMO). Further treatment strategy includes pulmonary vein dilatation and stenting of both the left superior pulmonary vein and left inferior pulmonary vein, as well as balloon dilatation of RIPV under temporary ECMO support. Symptomatic, severe PVS is a rare complication after catheter ablation of atrial fibrillation. PVS can result in life‐ threatening complications such as PH with acute right heart failure. Early diagnosis is crucial but challenging. Mechanical cardiopulmonary support by veno‐arterial ECMO for bridging to angioplasty could be a lifesaving option. [ABSTRACT FROM AUTHOR]

Introduction: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. Methods and Results: The REDUCE‐TE Pilot was a prospective multicenter, single‐arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold‐tip, externally irrigated ablation catheter. After ablation, cerebral diffusion‐weighted MRI and a postablation follow‐up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2DS 2‐VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3‐16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow‐up. Conclusions: Ablation of AF using a novel gold‐tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function. [ABSTRACT FROM AUTHOR]

Introduction: We analyzed the procedural experience and clinical outcome after pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) gained over 5 years using the second‐generation cryoballoon (CB‐Adv). Methods and Results: For this retrospective study, we enrolled 281 patients undergoing PVI at our institution between 2012 and 2016. The analyzed period was divided into 5 calendar years. Follow‐up data, including Holter electrocardiography recordings, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. The median procedure and fluoroscopy times over the years were 90 (72 of 114) and 15 (11 of 21) minutes, respectively. A continuous decline in complication rates and fluoroscopy and procedure times was observed in each subsequent year. During mid‐term follow‐up (33 [25 of 48] months), 178 (63.3%) patients were AF, atrial flutter, or atrial tachycardia free. Multivariate analysis revealed left atrial area (hazard ratio [HR] = 1.05; P < 0.001), female sex (HR = 2.53; P < 0.001), and common ostium (HR = 1.93; P < 0.001) as significant predictors of outcome. The overall 1‐year success rate was 76.2%. A gradual decrease in the 1‐year success rate (from 90.5% in 2012 to 67.9% in 2016) was mainly related to a steady increase of left atrial area in the entire cohort with successive years of the study. Conclusions: PVI using CB‐Adv in patients with persistent AF is accompanied by a learning curve and facilitates a satisfactory outcome, followed by the proper selection of patients. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: We aimed to compare arrhythmia recurrence rates after second‐generation cryoballoon (CB‐Adv) ablation and radiofrequency (RF) ablation in patients with symptomatic persistent atrial fibrillation (AF) and left atrial (LA) enlargement. Methods and results: Persistent AF patients with LA enlargement were compared using a propensity‐score‐matching algorithm, and 111 patients treated with CB‐Adv ablation and 111 patients treated with RF ablation were selected. The primary endpoint was the first documented >30‐second arrhythmia recurrence after a 3‐month blanking period. Median LA area was comparable between the RF and CB‐Adv groups (24.2 vs. 24.0 cm2, P = 0.49). In addition to pulmonary vein isolation, roof lines (RLs) with bidirectional conduction block were created in 48 patients in the CB‐Adv group and 49 patients in the RF group. Midterm outcome after single procedure is characterized by arrhythmia recurrences in 47 patients in the RF group and 32 patients in the CB‐Adv group (P = 0.20). There were no differences in the number of AF recurrences in the two groups (38 vs. 32, P = 0.66), but there were more instances of LA tachycardia (LAT) in the RF group than in the CB‐Adv group (11 vs. 0, P < 0.01). LAT recurrence in RF patients was associated with RL creation (9 with vs. 2 without, P < 0.01). Among patients in whom a RL was created, arrhythmia‐free survival was lower in the RF group than in the CB‐Adv group (44.9% vs. 79.2%, P < 0.01). Conclusions: Arrhythmia recurrence rates in the two groups during midterm follow‐up were comparable. RL creation during CB‐Adv ablation resulted in acceptable outcomes. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Data on long‐term outcomes of cryoballoon (CB) ablation for treatment of persistent atrial fibrillation (AF) are sparse. Here, we report the first 3‐year follow‐up results and predictors of success for catheter ablation using the second‐generation CB in patients with persistent AF. Methods and results: For this prospective observational study, we enrolled 101 patients ablated with the second‐generation CB at our institution. The endpoint was the first documented recurrence (> 30 seconds) of AF, atrial flutter, or atrial tachycardia after a 3‐month blanking period. Follow‐up data were collected during outpatient clinic visits and included Holter‐ECG recordings. The impact of several variables on recurrence was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. After a median follow‐up of 37 (31 of 42) months, recurrence was documented in 30 patients (29.7%). The median procedure and fluoroscopy times were 120 (102 of 147) and 20 (16 of 27) minutes, respectively. Phrenic nerve palsy occurred in 2.0% of the patients. Among the 30 patients who experienced recurrence, 16 underwent repeat ablation in radiofrequency technique. Cox regression analysis showed that left atrial area > 21 cm2 and AF history duration > 2 years independently predicted recurrence. Conclusions: Sinus rhythm was maintained in a substantial proportion of patients even 3 years after CB ablation. Patients with a nonenlarged left atrium and short AF history had the best outcome. [ABSTRACT FROM AUTHOR]

Introduction This observational study was designed to analyze the safety and feasibility of percutaneous skin closure using a purse-string suture and compare it with the use of a compression bandage after pulmonary vein isolation. Methods and results A total of 407 patients undergoing pulmonary vein isolation (217 with radiofrequency and 190 with cryoballoon ablation) were treated with either purse-string sutures or compression bandages. The purse-string suture was applied after ablation before withdrawal of the sheaths. Patients were on bed rest for 6 hours prior to suture removal, which was accomplished 18-24 h after ablation. The compression bandage was applied after sheath withdrawal and was removed after 12 hours of bed rest. We analyzed the occurrence of any vascular or thromboembolic complication as well as hospital costs and hospital stay length after ablation. The incidence of vascular complications after compression bandage was higher than after purse-string suture in the cryoballoon and radiofrequency group (P < 0.05, respectively). The hospital costs were lower and hospital stay was shorter in both radiofrequency (4.921 ± 3.145 vs. 5.802 ± 4.006 Euro; 2.34 ± 1.32 vs. 2.98 ± 1.57 days, P < 0.05) and cryoballoon groups (4.705 ± 3.091 vs. 5.661 ± 3.563 Euro; 2.14 ± 1.37 vs. 2.61 ± 1.55 days, P < 0.05) in patients treated with a purse-string suture. Conclusions Percutaneous skin closure with a purse-string suture has the clinical impact to reduce vascular complications, hospital costs, and hospital stay length after pulmonary vein isolation. [ABSTRACT FROM AUTHOR]

Rapid Mapping and Ablation Using a Novel Platform Introduction A noninvasive 3D mapping technique (ECVUE™, CardioInsight Inc., Cleveland) maps the origin and mechanisms of various arrhythmias without catheterizing the heart. Methods Thirty-three patients (3 centers, mean 45.0 ± 14.6 years,) with symptomatic premature ventricular complexes (24 PVCs), focal atrial tachycardias (2 ATs), and manifest accessory pathways (7 WPW syndromes) were prospectively explored using 3D, noninvasive bedside electrocardiomapping. The location of origin of the focal arrhythmia was first determined using noninvasive mapping. Subsequently, a stimulus artifact was delivered at this site to confirm and evaluate the precise location of the mapped focal origin. The procedural parameters and clinical efficacy were studied. Results Ablation was successful in 32/33 (97%) patients (PVCs: 13 right, 10 left, 1 septal; WPW: 3 left, 3 right; ATs: 2 left) without complications. The time from catheterization to permanent arrhythmia elimination/termination, RF duration, skin-to-skin procedural duration, and fluoroscopic exposure were median 16, 3.98, 71, and 11.9 minutes (for n = 29), respectively. At mean 24.7 ± 3.7 months of follow-up, 31 patients remain arrhythmia-free after a single procedure. One patient (right WPW syndrome) required repeat ablation 1 month later. One patient had recurrence of PVCs and is now deceased. The cumulative radiation (CT scan and fluoroscopy) exposure was median 7.57 mSv. Conclusion ECVUETM is a noninvasive tool allowing rapid preprocedural localization of focal arrhythmia and enables the electrophysiologist with highly specific information to direct RF delivery at the source of the arrhythmia with minimal intracardiac mapping. [ABSTRACT FROM AUTHOR]

Aims In this observational study, we examine the significance of the left atrial (LA) surface area and compare the clinical usage of the Arctic Front Advance (CBA) versus Arctic Front (CB) cryoballoon with the intent to investigate the impact of each in terms of long-term freedom from atrial fibrillation (AF) for patients with nonvalvular AF. Methods Pulmonary vein isolation (PVI) was performed while using a cryoballoon ablation catheter in conjunction with an intraluminal circular diagnostic mapping catheter, Achieve. The consecutive patients ablated with CBA were matched with patients previously ablated with CB, using propensity score matching. The primary endpoint of this observational single-center retrospective study was the first observation of electrocardiogram-documented recurrence of atrial arrhythmias lasting >30 seconds. Results The patient demographic data were similar in the CBA- and CB-group (N = 188 patients each group). In all patients in the CBA-group and in 95% of the patients in the CB group, acute procedural PVI of all veins was achieved with the single usage of a 28-mm cryoballoon. The one-year freedom from atrial arrhythmias was significantly better in the CBA- versus the CB-group of patients, 90% versus 64%, respectively. During 15-month clinical follow-up in CBA group, patients with LA area above 23 cm2 were more likely to experience recurrence of AF (23%) than patients with LA area below 23 cm2 (7%). Conclusions Comparing one-year outcomes, the CBA is superior to the CB with regards to maintenance of normal sinus rhythm. When using the CBA catheter, an enlarged LA is associated with a higher recurrence of arrhythmia. [ABSTRACT FROM AUTHOR]

Background Catheter ablation (CA) of atrial fibrillation (AF) is now established therapeutic option. Multiple procedures (MPs) are often needed to achieve the satisfactory outcome. The aim of the study was to assess the outcome after MPs in AF patients categorized to risk-score groups. Methods We followed a cohort of consecutive 911 (69% male; median 59 years) patients with AF (58% paroxysmal) who had CAAF performed. ALARMEC (Atrial fibrillation type, Left Atrium size, Renal insufficiency, MEtabolic syndrome, cardiomyopathy) risk score was calculated for each patient. The end point was maintenance of sinus rhythm at the follow-up of 60 months. Results We performed 1,199 CAAF procedures. One, two, and three procedures were performed in 663 (73%), 208 (23%), and 40 (4%) patients, respectively. Outcome after the first procedure (56%) was improved with MPs (76%). MPs > 2 were performed in 1%, 3%, 5%, 6%, and 10% patients with ALARMEC score of 0, 1, 2, 3, and 4, respectively. MPs were successful in 89%, 86%, 81%, 65%, and 43% of patients with ALARMEC score of 0, 1, 2, 3, and 4, respectively. Outcome in 174 (19%) patients on antiarrhythmic drugs (AADs) was 85%, 68%, 75%, 44%, and 39% in ALARMEC score: 0, 1, 2, 3, and 4, respectively. Outcome in 737 (81%) patients without AAD was 90%, 85%, 80%, 77%, and 69% in ALARMEC score of 0, 1, 2, 3, and 4, respectively. Conclusion The moderate success rate after index procedure of CAAF can be further improved with multiple ones and AAD. [ABSTRACT FROM AUTHOR]

German Ablation Registry-Different Energy Sources in AF Ablation Background Catheter ablation is used extensively with curative intention in atrial fibrillation. Radiofrequency ablation has long been a standard of care, while cryoballoon technology has emerged as a feasible approach with promising results. Prospective multicenter registry data referring to both ablation technologies in AF ablation therapy are lacking. Methods Between January 2007 and August 2011, a total of 3,775 consecutive patients with symptomatic paroxysmal AF who underwent PV ablation in their respective centers were enrolled. The cohort was divided into 2 groups according to the ablation energy source used: cryoballoon ablation (group 1, n = 905 [24.0%], median age 63 years, 64.3% men) and RF ablation (group 2, n = 2870 [76.0%], median age 63 years, 62.7% men). Comorbidities and baseline clinical characteristics were similar in both groups. Results Acute success rate was similar in both groups (97.5% in cryo vs 97.6% in RF; P = 0.81). Procedure times were similar, ablation and fluoroscopy times were higher in cryoballoon when compared to RF ablation. Overall complication rate was similar in cryo- (4.6%) and RF-ablation (4.6%; P = 1.0). Phrenic nerve palsy was more often in cryo versus RF ablation (2.1% in cryo vs 0.0% in RF; P < 0.001). Other complications were more common in RF compared to cryoablation (4.6% in RF vs 2.7% in cryo; P < 0.05). Conclusion RF ablation is the most widespread ablation method in Germany, but use of cryoballoon increased significantly. Procedure times were similar, but ablation and fluoroscopy times were longer in cryoballoon ablation. No significant differences were found in terms of acute success and overall complication rate. [ABSTRACT FROM AUTHOR]

Background: The goal of this study was to analyze impact of metabolic syndrome (MetS) and impaired renal function on long-term follow-up after catheter ablation of atrial fibrillation (AF). Methods and Results: A total of 702 consecutive patients with AF (age = 58 year, history of AF = 5 year, male = 478, paroxysmal atrial fibrillation = 416, coronary artery disease = 62, hypertension = 487) considered for catheter ablation were enrolled in the study. The MetS was diagnosed at admission in 276 patients. The renal function was estimated by glomerular filtration rate (eGFR). Pulmonary vein isolation (PVI) was performed either with cryoballoon technique (n = 260) or circumferential PVI (n = 442) with a 3.5-mm irrigated tip catheter. A 7-day-Holter electrocardiogram was performed at each follow-up visit. Any episode of documented AF after an initial 3-month blanking period was considered as clinical endpoint. Out of 702 patients, 370 (52.7%) were free of AF recurrences at median follow-up of 15 six interquartile range (12.7-42.3) months. The patients with MetS had significantly lower success rate than those without (128/276 (46.4%) vs 242/426 (56.8%), P = 0.006). Among 103 patients with eGFR < 68 mL/min only 35 (34%) were free of recurrences compared with 335/599 (55.9%) in patients with GFR ≥ 68 mL/min (P = 0.001). Both parameters were revealed in multivariate analysis to be independent predictors for outcome after catheter ablation. Conclusion: The results of our study clearly demonstrated that outcome after 1st catheter ablation of AF is poor in patients with MetS and/or impaired renal function. This observation has a potential clinical impact for the follow up management of these patients. (PACE 2012;1-12) [ABSTRACT FROM AUTHOR]

Aims: The data on anti-arrhythmic effect of renin-angiotensin-aldesteron system blockers (RASB) in patients with atrial fibrillation (AF) are controversially discussed. The goal of this analysis was to identify cohort of patients with AF and hypertension, who may have benefit from RASB therapy after pulmonary vein isolation (PVI). Methods: A total of 284 patients with AF and hypertension (paroxysmal AF [PAF]= 218, male = 185, age = 61 years, left ventricular ejection fraction = 60%, coronary artery disease = 42) considered for PVI were included. The patients with PAF were stratified according to time spent in AF (AF burden) within 3 months prior to admission ( 500 hours). Further patients were divided into two groups: (1) low-burden AF; (2) high-burden AF (PAF and persistent AF). In 195 patients, RASB therapy was administered. A 7-day continuous Holter electrocardiogram was performed after discharge, every 3 months thereafter and by symptoms. Results: Preventive effect of RASB was revealed in whole group (112 out of 195 [57%] vs 36 out of 89 [40%]; P = 0.025) and was more pronounced in patients with low-burden AF (79 out of 112 [71%] receiving RASB vs 27 out of 55 [49%] being on other drugs; P = 0.013). However, efficiency of RASB failed in patients with high-burden AF (33 out of 83 on RASB [40%] vs nine out of 34 on other drugs [27%]; P = 0.328). Conclusions: Our data suggest that RASB appears to protect against AF recurrences after PVI in patients with low-burden paroxysmal AF. These results should be tested in a prospective study. (PACE 2010; 33:1101–1111) [ABSTRACT FROM AUTHOR]

Background: Delayed interatrial conduction, manifested on the electrocardiogram as a P wave ≥110 ms (interatrial block, IAB), is highly prevalent and associated with atrial fibrillation (AF). It is correlated with P-terminal force (Ptf; product of the duration and amplitude of the negative terminal phase of the P wave in lead V1). Our purpose was to describe the modifications of the P-wave duration and Ptf after pulmonary vein antrum isolation (PVAI) in patients with paroxysmal AF. Methods: PVAI was performed in 45 patients with paroxysmal AF, either with the cryoballoon technique (n = 15) or radiofrequency ablation (n = 30). Electrocardiograms were recorded before PVAI, 3 and 6 months after ablation. Results: From the sample (median age 60 [53; 66] years; female 40%), median P-wave duration was 122 [114; 134] ms before PVAI and 116 [106; 124] ms at 3-month follow-up (P < 0.001). IAB was observed in 42 patients (93.3%) before ablation and in 31 patients (68.9%) at 3-month follow-up. Median Ptf was 0.047 [0.020; 0.068] before ablation and 0.013 [0.004; 0.025] at 3-month follow-up (P < 0.001). Twenty-six patients (57.8%) had a Ptf > 0.04 mV x ms before ablation and only one (2.2%) at 3-month follow-up. P-wave duration and Ptf were not significantly modified between 3- and 6-month follow-up. Conclusion: The terminal part of the P wave is modified after PVAI, perhaps due to the loss of pulmonary vein antrum signals. P-wave duration and Ptf must be carefully interpreted after such a procedure. The prognostic value of these modifications should be evaluated. (PACE 2010; 784–789) [ABSTRACT FROM AUTHOR]

Introduction: Severe pulmonary vein stenosis (PVS) after catheter ablation of atrial fibrillation (AF) is a well-recognized complication with a further reported incidence of 1.3%. The preferred therapy for symptomatic PVS is pulmonary vein (PV) angioplasty, but this treatment modality is followed by restenosis in 44–70%. Whether there is additional long-term benefit from PVS stenting is uncertain. The aim of this study was the evaluation of the long-term success after PV stenting of severe stenosis. Methods and Results: Ten patients (pts) with 13 PVS were prospectively evaluated. PV stenting was performed with Palmaz Genesis stents. Magnetic resonance imaging (MRI), lung perfusion scans, and CT-scans were performed before, directly after, and every 12 months thereafter. Primary endpoint of the study was the occurrence of restenosis after PV stenting. After a median follow-up of 47.7 (IQRs 25/75 47.2–48.5) months, the primary endpoint was achieved in 3 out of 13 PVs (23% of the treated PVs). We observed two in-stent restenosis 2 and 4 years after PV stenting. These pts experienced onset of dyspnea some weeks before. After an additional balloon angioplasty, the in-stent restenosis was resolved. In one asymptomatic patient, we observed an occlusion of the PV stent 13 months poststenting. Normalization of lung perfusion was noted 4 years after PV stenting versus directly poststenting in all pts without in-stent restenosis (n = 7). Conclusion: PVS stenting with stent sizes ≥10 mm seems to be an adequate therapy modality for treatment of severe acquired PVS. Late in-stent restenosis after PVS stenting can occur. The normalization of the initially disturbed lung perfusion scan is possible and remains stable, even 4 years after PVS stenting. [ABSTRACT FROM AUTHOR]

Introduction: Cryoablation is successful in the treatment of common atrial flutter. Long-term clinical success is mainly dependent on persistence of bidirectional conduction block (BCB) in the inferior cavotricuspid isthmus (CTI). Only few data on persistence of BCB post cryoablation with the reported technique are available. This prospective study aimed to test efficacy of cryo energy and persistence of BCB in the CTI 1 month post cryoablation. Methods: Cryoablation of the CTI was performed in 50 consecutive patients (64 ± 12 years, 40 males) with symptomatic common atrial flutter using a novel 9 Fr 8-mm-tip catheter. BCB in the CTI 30 minutes following the final cryoapplication was the ablation endpoint. Thirty days post ablation, persistence of BCB was controlled by repeat electrophysiological study (EPS). Results: In all patients BCB was achieved with a mean of 9 (IQR 7–17.5) cryo applications and a mean cryo time of 2,378 seconds (IQR 1,680–3,474 seconds). In 5 of 50 patients, common atrial flutter recurred within 1 month post cryoablation. In 30 of 32 recurrence-free patients, persistence of BCB was verified. In 2 patients, resumption of isthmus conduction was detectable. Including relapses, 81.1% of patients (30/37) showed persistence of BCB. No patients reported pain during cryoapplication. No procedural complications were observed. Conclusions: Cryoablation of the CTI using a large-tip catheter is feasible and safe in the treatment of common atrial flutter. Acute and short-term success rates are comparable to those reported for radiofrequency (RF) ablation. Besides short-term clinical success, the persistence of BCB demonstrates efficacy of the cryoablation technique. [ABSTRACT FROM AUTHOR]

Background: The definition of symptomatic improvement after pulmonary vein isolation (PVI) is controversial. We assessed primarily the usefulness and predictive accuracy (PA) of AF (atrial fibrillation) burden (AFB) within the first 3 months after the procedure as an early predictor for curative success as well as reduction of symptoms. Methods: We studied 100 pts (62 men, mean age: 54 ± 9 years, LVEF: 57 ± 9%, paroxysmal AF, 85, persistent AF, 15) who underwent PVI. RF ablation was used in 63 patients. The combination of cryoablation and RF (Hybrid therapy) was used in the remaining 37 patients, in 19 patients of whom additionally linear lesions were performed. All patients were followed up 3 months after PVI (the blanking period) and every 3 months thereafter. The significance of early recurrence of AF (ERAF) was separately analyzed for RF and for hybrid therapy arm. Quality of life (QoL) was assessed using the physical composite summary score (PCS) and mental composite summary score (MCS). AFB was dichotomized at: 0, 0.5, 1, 6, 12, and 24 hours. Results: ANOVA revealed significant differences between PCS at baseline and after PVI in patients without recurrence and with those with postablation AFB <12 hours. There was no difference between PCS in patients with AFB ≥12 hours within a 3 months interval and PCS at baseline. ERAF occurred in 35% of patients (16 patients, AFB ≥12 hours). Symptomatic ERAF occurred in 29 patients (17 patients AFB ≥12 hours). After the blanking period, documented AF recurrence was found in 50 patients (17 patients, AFB ≥12 hour). Symptomatic late recurrence was found in 47 patients (31 patients with AFB ≥12 hours). Absence of ERAF was revealed to be predictive for long-term success and symptomatic ERAF was found to be predictive for symptomatic AF recurrence (P <0.0001). Conclusion: AF recurrence with AFB ≥12 hours within 3 months is associated with a missed improvement of QoL. Symptomatic ERAF predicts recurrence independently of therapy. [ABSTRACT FROM AUTHOR]

Introduction: Pulmonary vein stenosis (PVS) is a potential complication of pulmonary vein isolation (PVI) using radiofrequency energy. The aim of our study was the evaluation of the severity and long-term outcome of primary angioplasty and angioplasty with pulmonary vein stenting for PVS. Methods and Results: Twelve patients with 15 PVS (greater than 70% stenosis) were prospectively evaluated. Primary dilation of the stenosis was performed because of clinical symptoms (10 patients) and/or the lung perfusion scans showed a significant perfusion defect (11 patients). Magnetic resonance imaging and lung perfusion scans performed before, directly after, during 3-month, and 6-month follow-up. In the stenting group additional multislice CT-scans directly after, during 6-month, and 12-month follow-up were performed. Within 2 months after primary balloon angioplasty, the PV size parameters were significantly reduced (P < 0.001) with recurrence of PVS in 11 of 15 PVs (73%). Pulmonary vein stenting in 8 patients and 11 PVs resulted in no vein stenosis during 12-month follow-up. Normalization of lung perfusion was noted in 8 of 12 patients. We observed 2 patients with hemoptysis during PV dilation, as severe complications with potential life-threatening character. Conclusion: PVS stenting seems to be superior to balloon angioplasty and effective at least over a period of 12 months in treating acquired PVS after pulmonary vein isolation. [ABSTRACT FROM AUTHOR]

Cryocatheter Ablation of Ventricular Tachycardia. Introduction:Cryocatheter techniques have been successfully applied to treat supraventricular tachycardia but there are no reports on their value in treating ventricular tachycardia (VT). We present our initial experience with cryocatheter ablation of right ventricular outflow tract (RVOT) tachycardia.Methods and Results:Cryocatheter ablation was attempted in 14 patients (13 females, age 45.9± 12.7 years) who were highly symptomatic due to frequent monomorphic ventricular extrasystole (VES) or nonsustained VT originating within the RVOT. A 9-Fr, 8-mm-tip cryocatheter was used for both mapping and ablation. Cryoablation was started after localizing the arrhythmic focus by pace and activation mapping. Ablation success, defined by complete disappearance of target VES/VT acutely and during a follow-up of 9.3± 1.4 weeks, was achieved in 13 of 14 patients. Ablation was successful with local activation times of 35± 4 ms, 5.8± 3.3 applications, 18.8± 7.5 minutes total cryo time, 9.4± 4.2 minutes fluoroscopy time, and 66.9± 26.1 minutes total procedure time, the latter two measures showing a reduction with number of patients treated. Three patients reported slight pain related to local pressure of the catheter on the RVOT wall. No pain was described related to delivery of cryothermal energy.Conclusions:Initial experience shows that focal VES/VT originating in the RVOT can be successfully treated using cryocatheter ablation. Acute and short term success rates, fluoroscopy times, and duration of procedure are comparable to conventional ablation techniques. A major advantage seems to be the virtual absence of ablation related pain.(J Cardiovasc Electrophysiol, Vol. 16, pp. 1-4, April 2005) [ABSTRACT FROM AUTHOR]

BERKOWITSCH, A.,et al.: A Decrease in Pulmonary Vein Diameter After Radiofrequency Ablation Predicts the Development of Severe Stenosis. A decrease in ostial pulmonary vein (PV) diameter was observed in patients on the day after radiofrequency ablation of atrial fibrillation (AF). This study examined whether a relative reduction in PV diameter on day 1 (RRPVD1) after the procedure predicts the late development of severe PV stenosis (PVS). The study included 104 consecutive patients (mean age= 55 years, range 46–61, 34 women) with drug refractory AF. Pulmonary vein diameter was measured using MR angiography (MRA) on the day before and on day 1 after the ablation procedure. The MRA was repeated every 3 months after the procedure. Severe PVS was defined as a>70% diameter reduction from the initial ostial diameter. The cut-off of RRPVD1 was prespecified as 25% decrease in initial diameter. The data are presented as medians and interquartile range. A total of 357 PV were treated. The RRPVD1 was 0.0% (0.0–11.1%). Severe PVS was found in 18 PV during a follow-up of 12 months (range 6–13). The log-rank analysis confirmed a strong association between a RRPVD1≥25% and the development of PVS (hazard ratio: 7.1; 95% confidence interval 3.8–13.5, P<0.0001). By multivariate Cox regression model, after adjustment of procedure variables, RRPVD1 was the strongest predictor of development of severe PVS. RRPVD1≥25% was a strong independent predictor of development of severe PVS.(PACE 2005; 28:S83–S85) [ABSTRACT FROM AUTHOR]