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Frankfurt am Main, Germany

Furnkranz A.,Cardioangiologisches Centrum Bethanien | Brugada J.,University of Barcelona | Albenque J.-P.,University Paul Sabatier | Tondo C.,University of Milan | And 4 more authors.
Journal of Cardiovascular Electrophysiology

Rationale and Design of Fire and Ice Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia imposing substantial morbidity and mortality. Catheter-based pulmonary vein isolation (PVI) using radiofrequency current (RFC) has become a standard treatment for drug-resistant and symptomatic paroxysmal AF (PAF). In recent years, the cryoballoon-based technique is increasingly used as a promising alternative with a short learning curve. Methods The FIRE AND ICE trial is a prospective, randomized, controlled, open, blinded outcome assessment, noninferiority trial comparing cryoballoon-, and RFC-based PVI. Patients with drug-resistant PAF will be randomized in a 1:1 matrix in multiple European centers. The primary hypothesis is that cryoballoon ablation is not inferior to RFC ablation using 3-dimensional mapping with respect to clinical efficacy. The primary endpoint is defined as the time to first documented clinical failure, including: (1) recurrence of AF; (2) atrial flutter or atrial tachycardia; (3) prescription of class I or III antiarrhythmic drugs; or (4) re-ablation, whichever comes first, following a blanking period of 3 months after the index ablation procedure. The primary safety endpoint is a composite of death, stroke/transient ischemic attack, cardiac arrhythmias (apart from AF recurrence) causally related to the therapeutic intervention, and procedure-related serious adverse events. Conclusion The FIRE AND ICE trial compares 2 different technologies to perform catheter ablation of PAF with respect to efficacy and safety. It aims at providing objective data to guide selection and usage of ablation catheters in the treatment of AF. © 2014 Wiley Periodicals, Inc. Source

Kuck K.-H.,Asklepios Klinik St. Georg | Brugada J.,University of Barcelona | Furnkranz A.,Cardioangiologisches Centrum Bethanien | Metzner A.,Asklepios Klinik St. Georg | And 8 more authors.
New England Journal of Medicine

BACKGROUND: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology. METHODS: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events. RESULTS: A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for noninferiority). The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; hazard ratio, 0.78; 95% CI, 0.52 to 1.18; P = 0.24). CONCLUSIONS: In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. Copyright © 2016 Massachusetts Medical Society. Source

Puricel S.,University of Fribourg | Cuculi F.,Luzerner Kantonsspital | Weissner M.,University Hospital Mainz | Weissner M.,German Center for Cardiac and Vascular Research | And 10 more authors.
Journal of the American College of Cardiology

Background Recent reports suggest an elevated incidence of bioresorbable vascular scaffold (BVS) thrombosis (scaffold thrombosis [ScT]). Objectives This study investigated occurrence rates, clinical and angiographic characteristics, and possible mechanisms of ScT in all-comer patients undergoing BVS implantation at 2 German and 2 Swiss hospitals. Methods A total of 1,305 consecutive patients (mean age 64 years, 78% male) who received 1,870 BVS (mean 1.4 ± 0.8 BVS/patient) were enrolled. Clinical/procedural characteristics, mortality, and ScT data at 485 days (range 312 to 652 days) were examined. Results ScT occurred in 42 patients. The incidence of probable and definite ScT was 1.8% at 30 days and 3.0% at 12 months, without differences among centers (p = 0.60). A total of 22 (52%) ScTs presented as ST-segment elevation myocardial infarction and 6 (17%) as sudden cardiac death. In multivariable analysis, ostial lesions (p = 0.049) and impaired left ventricular ejection fraction (p = 0.019) were independently associated with ScT. Nine (21%) of the ScTs occurred in patients who had suspended dual antiplatelet therapy, in 6 cases prematurely. Lower post-procedural minimum lumen and reference vessel diameters were hallmarks of ScT (all p < 0.0001). The risk of ScT appeared to rapidly increase for post-procedural minimum lumen diameters below 2.4 mm (for the 2.5- to 3.0-mm BVS) and 2.8 mm (for the 3.5-mm BVS). When a BVS-specific implantation strategy was implemented, 12-month ScT rates fell from 3.3% to 1.0%, an effect that remained significant when adjusted for multivariable propensity score (p = 0.012; hazard ratio: 0.19; 95% confidence interval: 0.05 to 0.70). Conclusions The 12-month incidence of ScT reached 3% and could be significantly reduced when an optimized implantation strategy was employed. (retrospective multicentric registry and Mainz Intracoronary Database. © 2016 American College of Cardiology Foundation. Source

Furnkranz A.,Cardioangiologisches Centrum Bethanien | Bordignon S.,Cardioangiologisches Centrum Bethanien | Schmidt B.,Cardioangiologisches Centrum Bethanien | Bohmig M.,Medizinische Klinik I | And 6 more authors.
Heart Rhythm

BACKGROUND: The novel second-generation cryoballoon (CB) facilitates pulmonary vein isolation (PVI) by improved surface cooling. The impact of this redesign on collateral damage is unknown. OBJECTIVE: To investigate the incidence of esophageal lesions after PVI using the second-generation CB and the role of luminal esophageal temperature (LET) measurement as a predictor of lesion formation. METHODS: Thirty-two consecutive patients underwent PVI using the second-generation 28 mm CB. Target application time was 2 × 240 seconds. Ninety-two percent of the PVs were isolated after 1 cryoenergy application. Complete PVI was achieved in all patients. LET with 3 thermocouples was continuously measured during cryoenergy application. Freezing was interrupted only if weakening/loss of phrenic nerve function or low LET (<5°C) was observed. RESULTS: The lowest measured LET was -12°C (despite cryoappli-cation interruption). Postprocedural gastroesophagoscopy was performed after 1-3 days in all patients and showed lesions in 6 of 32 (19%) patients. A minimum LET of ≤12°C predicted esophageal lesions with 100% sensitivity and 92% specificity (area under the receiver-operator characteristic curve 0.97; 95% CI 0.93-1.02; P = .001). Persistent phrenic nerve palsy occurred in 2 (6%) patients during ablation at the right inferior pulmonary vein. Repeat gastroesophagoscopy confirmed healing of lesions after 16 ± 14 days. CONCLUSIONS: Second-generation 28 mm CB PVI is associated with significant esophageal cooling, resulting in lesion formation in 19% of the patients. LET measurement accurately predicts lesion formation and may enhance the safety of the novel device. © 2013 Heart Rhythm Society. All rights reserved. Source

Metzner A.,Asklepios Klinik St. Georg | Wissner E.,Asklepios Klinik St. Georg | Schmidt B.,Cardioangiologisches Centrum Bethanien | Chun J.,Cardioangiologisches Centrum Bethanien | And 4 more authors.
Journal of Cardiovascular Electrophysiology

Clinical Outcome After Endoscopic PVI. Introduction: The acute and long-term outcome of pulmonary vein isolation (PVI) using an endoscopic ablation system (EAS) has only been reported in single-center studies. The current prospective, multicenter study assessed the acute and 1-year outcome following PVI using the EAS. Methods and Results: Seventy-two patients (34 female, mean age 58 ± 10 years) with a history (5 ± 6 years) of drug-refractory paroxysmal atrial fibrillation (AF) were included. Endoscopic PVI was performed in all patients. Follow-up was based on regular telephone interviews, Holter ECG, and transtelephonic ECG recordings. Recurrence was defined as a symptomatic and/or documented AF episode >30 seconds following a blanking period of 3 months. In 72 patients, a total of 281 pulmonary veins (PVs) were targeted and 277/281 (98.6%) PVs were isolated successfully using only the EAS. PV stenosis, thrombembolic events, pericardial effusion, pericardial tamponade, and phrenic nerve palsy occurred in 0 of 72, 0 of 72, 3 of 72 (4.2%), 4 of 72 (5.6%), and in 1 of 72 (1.4%) patients, respectively. Sixty-seven of 72 (93.1%) patients completed a follow-up of 365 days and 42 of 67 (62.7%) patients remained in stable sinus rhythm after a single procedure. A total of 13 of 25 (52%) patients suffering from AF recurrence consented to repeat PVI using conventional radiofrequency energy 221 ± 121 days after the index procedure. LA to PV reconduction was found in 30 of 45 (67%) previously isolated PVs. Conclusions: A very high rate of acute electrical PVI is achieved using exclusively the EAS. The 1-year single-procedure success rate in patients with paroxysmal AF is comparable to conventional PVI. PV reconduction is the major determinant for AF recurrence. © 2012 Wiley Periodicals, Inc. Source

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