10 results on '"Luik, Armin"'
Search Results
2. Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience.
- Author
-
Yap SC, Anic A, Breskovic T, Haas A, Bhagwandien RE, Jurisic Z, Szili-Torok T, and Luik A
- Subjects
- Boston, Humans, Prospective Studies, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Catheter Ablation, Cryosurgery adverse effects, Pulmonary Veins diagnostic imaging, Pulmonary Veins surgery
- Abstract
Introduction: Recently a novel cryoballoon system (POLARx, Boston Scientific) became available for the treatment of atrial fibrillation. This cryoballoon is comparable with Arctic Front Advance Pro (AFA-Pro, Medtronic), however, it maintains a constant balloon pressure. We compared the procedural efficacy and biophysical characteristics of both systems., Methods: One hundred and ten consecutive patients who underwent first-time cryoballoon ablation (POLARx: n = 57; AFA-Pro: n = 53) were included in this prospective cohort study., Results: Acute isolation was achieved in 99.8% of all pulmonary veins (POLARx: 99.5% vs. AFA-Pro: 100%, p = 1.00). Total procedure time (81 vs. 67 min, p < .001) and balloon in body time (51 vs. 35 min, p < .001) were longer with POLARx. After a learning curve, these times were similar. Cryoablation with POLARx was associated with shorter time to balloon temperature -30°C (27 vs. 31 s, p < .001) and -40°C (32 vs. 54 s, p < .001), lower balloon nadir temperature (-55°C vs. -47°C, p < .001), and longer thawing time till 0°C (16 vs. 9 s, p < .001). There were no differences in time-to-isolation (TTI; POLARx: 45 s vs. AFA-Pro 43 s, p = .441), however, POLARx was associated with a lower balloon temperature at TTI (-46°C vs. -37°C, p < .001). Factors associated with acute isolation differed between groups. The incidence of phrenic nerve palsy was comparable (POLARx: 3.5% vs. AFA-Pro: 3.7%)., Conclusion: The novel cryoballoon is comparable to AFA-Pro and requires only a short learning curve to get used to the slightly different handling. It was associated with faster cooling rates and lower balloon temperatures but TTI was similar to AFA-Pro., (© 2021 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)
- Published
- 2021
- Full Text
- View/download PDF
3. Sex-specific efficacy and safety of cryoballoon versus radiofrequency ablation for atrial fibrillation: An individual patient data meta-analysis.
- Author
-
du Fay de Lavallaz J, Badertscher P, Kobori A, Kuck KH, Brugada J, Boveda S, Providência R, Khoueiry Z, Luik A, Squara F, Kosmidou I, Davtyan KV, Elvan A, Perez-Castellano N, Hunter RJ, Schilling R, Knecht S, Kojodjojo P, Wasserlauf J, Oral H, Matta M, Jain S, Anselmino M, and Kühne M
- Subjects
- Atrial Fibrillation physiopathology, Humans, Recurrence, Sex Factors, Treatment Outcome, Atrial Fibrillation surgery, Catheter Ablation methods, Cryosurgery methods, Heart Conduction System physiopathology, Pulmonary Veins surgery
- Abstract
Background: Atrial fibrillation (AF) is a growing health burden, and pulmonary vein isolation (PVI) using cryoballoon (CB) or radiofrequency (RF) represents an attractive therapeutic option. Sex-specific differences in the epidemiology, pathophysiology, and clinical presentation of AF and PVI are recognized., Objective: We aimed at comparing the efficacy, safety, and procedural characteristics of CB and RF in women and men undergoing a first PVI procedure., Methods: We searched for randomized controlled trials and prospective observational studies comparing CB and RF ablation with at least 1 year of follow-up. After merging individual patient data from 18 data sets, we investigated the sex-specific (procedure failure defined as recurrence of atrial arrhythmia, reablation, and reinitiation of antiarrhythmic medication), safety (periprocedural complications), and procedural characteristics of CB vs RF using Kaplan-Meier and multilevel models., Results: From the 18 studies, 4840 men and 1979 women were analyzed. An analysis stratified by sex correcting for several covariates showed a better efficacy of CB in men (hazard ratio for recurrence 0.88; 95% confidence interval 0.78-0.98, P = .02) but not in women (hazard ratio 0.98; 95% confidence interval 0.83-1.16; P = .82). For women and men, the energy source had no influence on the occurrence of at least 1 complication. For both sexes, the procedure time was significantly shorter with CB (-22.5 minutes for women and -27.1 minutes for men)., Conclusion: CB is associated with less long-term failures in men. A better understanding of AF-causal sex-specific mechanisms and refinements in CB technologies could lead to higher success rates in women., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
- Full Text
- View/download PDF
4. Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes.
- Author
-
Luik A, Kunzmann K, Hörmann P, Schmidt K, Radzewitz A, Bramlage P, Schenk T, Schymik G, Merkel M, Kieser M, and Schmitt C
- Subjects
- Aged, Atrial Fibrillation diagnosis, Atrial Fibrillation physiopathology, Catheter Ablation adverse effects, Disease-Free Survival, Female, Germany, Humans, Male, Middle Aged, Prospective Studies, Pulmonary Veins physiopathology, Recurrence, Time Factors, Treatment Outcome, Atrial Fibrillation surgery, Catheter Ablation methods, Cryosurgery adverse effects, Cryosurgery instrumentation, Pulmonary Veins surgery, Therapeutic Irrigation adverse effects
- Abstract
Background: Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF., Methods: FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications., Results: Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group., Conclusion: The data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure., Trial Registration: ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.
- Published
- 2017
- Full Text
- View/download PDF
5. Cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: an updated meta-analysis of randomized and observational studies.
- Author
-
Buiatti A, von Olshausen G, Barthel P, Schneider S, Luik A, Kaess B, Laugwitz KL, and Hoppmann P
- Subjects
- Atrial Fibrillation diagnosis, Atrial Fibrillation physiopathology, Chi-Square Distribution, Cryosurgery adverse effects, Equipment Design, Female, Humans, Male, Middle Aged, Observational Studies as Topic, Odds Ratio, Pulmonary Veins physiopathology, Randomized Controlled Trials as Topic, Recurrence, Risk Factors, Time Factors, Treatment Outcome, Atrial Fibrillation surgery, Cardiac Catheters, Catheter Ablation adverse effects, Cryosurgery instrumentation, Pulmonary Veins surgery
- Abstract
Aims: Radiofrequency (RF) ablation represents a standard of care for pulmonary vein isolation in patients with drug-refractory paroxysmal atrial fibrillation (AF). In this setting, cryoballoon (CB) ablation has emerged as alternative therapy. However, the efficacy and safety of CB vs. RF ablation in patients with paroxysmal AF remain a matter of debate., Methods and Results: We searched electronic scientific databases for studies of CB vs. RF ablation in patients with paroxysmal AF. Aggregate data were pooled to perform a meta-analysis. The primary efficacy and safety outcomes were the recurrence of any atrial arrhythmia and procedure-related complications, respectively. A total of 6473 participants from 10 studies (CB, n = 2232 vs. RF, n = 4241) were studied. After a median follow-up of 16 months, the risk of any atrial arrhythmia recurrence (risk ratio, RR 95% confidence interval [95% CI] = 1.01 [0.90-1.14], P = 0.83) and procedure-related complications (RR [95% CI] = 0.92 [0.66-1.28], P = 0.61) were comparable between CB vs. RF ablation. Cryoballoon ablation led to a higher risk of persistent phrenic nerve palsy (RR [95% CI] = 13.60 [3.87-47.81], P < 0.01) and a lower risk of cardiac tamponade (RR [95% CI] = 0.48 [0.25-0.89], P = 0.02) compared with RF ablation. There was a trend of statistically significant interaction between the type of CB and the duration of ablation (P for interaction = 0.09)., Conclusion: In patients with paroxysmal AF, ablation therapy with CB is associated with efficacy and safety comparable to that of RF. Second-generation CB catheters seem to reduce procedure duration. Further studies are warranted to disclose the impact of second-generation CB catheters compared with RF for ablation of paroxysmal AF., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)
- Published
- 2017
- Full Text
- View/download PDF
6. Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study.
- Author
-
Luik A, Radzewitz A, Kieser M, Walter M, Bramlage P, Hörmann P, Schmidt K, Horn N, Brinkmeier-Theofanopoulou M, Kunzmann K, Riexinger T, Schymik G, Merkel M, and Schmitt C
- Subjects
- Adrenergic beta-Antagonists therapeutic use, Aged, Anticoagulants adverse effects, Anticoagulants therapeutic use, Atrial Fibrillation drug therapy, Atrial Fibrillation epidemiology, Cardiovascular Diseases epidemiology, Catheter Ablation adverse effects, Catheter Ablation instrumentation, Combined Modality Therapy, Comorbidity, Cryosurgery adverse effects, Cryosurgery instrumentation, Diabetes Mellitus epidemiology, Electrocardiography, Ambulatory, Female, Humans, Imaging, Three-Dimensional, Intraoperative Complications epidemiology, Intraoperative Complications etiology, Male, Middle Aged, Pericardial Effusion epidemiology, Pericardial Effusion etiology, Phrenic Nerve injuries, Postoperative Hemorrhage chemically induced, Prospective Studies, Risk Assessment, Sample Size, Thrombophilia drug therapy, Thrombophilia etiology, Treatment Outcome, Atrial Fibrillation surgery, Catheter Ablation methods, Cryosurgery methods, Pulmonary Veins surgery
- Abstract
Background: There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation., Methods and Results: In a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; P=0.933). For the intention-to-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, -0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, -0.097 to 0.116; P=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; P=0.002)., Conclusion: This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00774566., (© 2015 The Authors.)
- Published
- 2015
- Full Text
- View/download PDF
7. Cryoablation versus radiofrequency energy for the ablation of atrioventricular nodal reentrant tachycardia (the CYRANO Study): results from a large multicenter prospective randomized trial.
- Author
-
Deisenhofer I, Zrenner B, Yin YH, Pitschner HF, Kuniss M, Grossmann G, Stiller S, Luik A, Veltmann C, Frank J, Linner J, Estner HL, Pflaumer A, Wu J, von Bary C, Ucer E, Reents T, Tzeis S, Fichtner S, Kathan S, Karch MR, Jilek C, Ammar S, Kolb C, Liu ZC, Haller B, Schmitt C, and Hessling G
- Subjects
- Adult, Aged, Atrioventricular Block epidemiology, China, Endpoint Determination, Europe, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Prospective Studies, Risk Factors, Tachycardia, Atrioventricular Nodal Reentry mortality, Treatment Outcome, Catheter Ablation methods, Cryosurgery methods, Tachycardia, Atrioventricular Nodal Reentry surgery
- Abstract
Background: Cryoablation has emerged as an alternative to radiofrequency catheter ablation (RFCA) for the treatment of atrioventricular (AV) nodal reentrant tachycardia (AVNRT). The purpose of this prospective randomized study was to test whether cryoablation is as effective as RFCA during both short-term and long-term follow-up with a lower risk of permanent AV block., Methods and Results: A total of 509 patients underwent slow pathway cryoablation (n=251) or RFCA (n=258). The primary end point was immediate ablation failure, permanent AV block, and AVNRT recurrence during a 6-month follow-up. Secondary end points included procedural parameters, device functionality, and pain perception. Significantly more patients in the cryoablation group than the RFCA group reached the primary end point (12.6% versus 6.3%; P=0.018). Whereas immediate ablation success (96.8% versus 98.4%) and occurrence of permanent AV block (0% versus 0.4%) did not differ, AVNRT recurrence was significantly more frequent in the cryoablation group (9.4% versus 4.4%; P=0.029). In the cryoablation group, procedure duration was longer (138±54 versus 123±48 minutes; P=0.0012) and more device problems occurred (13 versus 2 patients; P=0.033). Pain perception was lower in the cryoablation group (P<0.001)., Conclusions: Cryoablation for AVNRT is as effective as RFCA over the short term but is associated with a higher recurrence rate at the 6-month follow-up. The risk of permanent AV block does not differ significantly between cryoablation and RFCA. The potential benefits of cryoenergy relative to ablation safety and pain perception are counterbalanced by longer procedure times, more device problems, and a high recurrence rate., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00196222.
- Published
- 2010
- Full Text
- View/download PDF
8. Rationale and design of the FreezeAF trial: a randomized controlled noninferiority trial comparing isolation of the pulmonary veins with the cryoballoon catheter versus open irrigated radiofrequency ablation in patients with paroxysmal atrial fibrillation.
- Author
-
Luik A, Merkel M, Hoeren D, Riexinger T, Kieser M, and Schmitt C
- Subjects
- Adolescent, Adult, Aged, Female, Humans, Male, Middle Aged, Treatment Outcome, Atrial Fibrillation surgery, Catheter Ablation, Cryosurgery, Pulmonary Veins surgery
- Abstract
Background: Atrial fibrillation is the most commonly encountered clinical arrhythmia, and there are an increasing number of patients with paroxysmal atrial fibrillation treated by catheter ablation. The criterion standard is the isolation of the pulmonary veins (PVs) using radiofrequency (RF) energy in combination with an open irrigated tip catheter. The procedure remains technically challenging with a significant number of complications. So far, no randomized comparisons between the outcome of cryoballoon versus RF ablation are available., Study Design: The object of this randomized clinical trial is to compare the efficacy of isolating the PVs with either the cryoballoon or the open irrigated tip RF catheter. Two hundred forty-four patients with paroxysmal atrial fibrillation will be randomized for either RF or cryoballoon. With both techniques, PV isolation will be performed. Primary end point of the study is freedom from atrial fibrillation without antiarrhythmic drugs and without persistent complications at 6 and 12 months. Clinical success will be evaluated using Holter electrocardiogram and event recordings for at least 7 days. Within 6 months, no redo procedure is performed; and a redo after 6 months is performed with the previously used energy source. Secondary end points include the mid- and long-term clinical success, procedural data, and cost-effectiveness., Conclusion: The FreezeAF trial will examine for the first time in a randomized trial whether PV isolation with the cryoballoon is not relevantly inferior to open irrigated RF ablation in patients with paroxysmal atrial fibrillation during follow-up. It will additionally directly compare acute procedural success and safety of the procedures., (Copyright 2010 Mosby, Inc. All rights reserved.)
- Published
- 2010
- Full Text
- View/download PDF
9. Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study.
- Author
-
Martin, Claire A., Tilz, Roland R. R., Anic, Ante, Defaye, Pascal, Luik, Armin, de Asmundis, Carlo, Champ‐Rigot, Laure, Iacopino, Saverio, Sommer, Philipp, Albrecht, Elizabeth M., Raybuck, Jonathan D., Richards, Elizabeth, Cielen, Nele, and Yap, Sing‐Chien
- Subjects
ATRIAL fibrillation treatment ,CLINICAL trials ,CRYOSURGERY ,CATHETER ablation ,TREATMENT effectiveness ,PULMONARY veins ,DATA analysis software ,LONGITUDINAL method - Abstract
Introduction: Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the safety and effectiveness of the POLARxTM cryoballoon for PVI to treat paroxysmal AF. Methods: POLAR ICE, a prospective, non‐randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers. Procedural characteristics, such as time to isolation, cryoablations per pulmonary vein (PV), balloon nadir temperature, and occlusion grade were recorded. PVI was confirmed with entrance block testing. Results: Data on 372 de novo PVI procedures (n = 2190 ablations) were collected. Complete PVI was achieved in 96.8% of PVs. Procedure and fluoroscopy times were 68.2 ± 24.6 and 15.6 ± 9.6 min, respectively. Left atrial dwell time was 46.6 ± 18.3 min. Grade 3 or 4 occlusion was achieved in 98.2% of PVs reported and 71.2% of PVs isolation required only a single cryoablation. Of 2190 cryoapplications, 83% had a duration of at least 120 s; nadir temperature of these ablations averaged −56.3 ± 6.5°C. There were 6 phrenic nerve palsy events, 2 of which resolved within 3 months of the procedure. Conclusion: This real‐world usage data on a novel cryoballoon suggests this device is effective, safe, and relatively fast in centers with cryoballoon experience. These data are comparable to prior POLARx reports and in keeping with reported data on other cryoballoons. Future studies should examine the long‐term outcomes and the relationship between biophysical parameters and outcomes for this novel cryoballoon. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
10. Cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: an updated meta-analysis of randomized and observational studies.
- Author
-
Buiatti, Alessandra, von Olshausen, Gesa, Barthel, Petra, Schneider, Simon, Luik, Armin, Kaess, Bernhard, Laugwitz, Karl-Ludwig, and Hoppmann, Petra
- Subjects
ATRIAL fibrillation diagnosis ,ATRIAL fibrillation ,CATHETER ablation ,CHI-squared test ,CLINICAL trials ,COMPARATIVE studies ,CRYOSURGERY ,RESEARCH methodology ,MEDICAL cooperation ,META-analysis ,PULMONARY veins ,RESEARCH ,TIME ,SYSTEMATIC reviews ,DISEASE relapse ,PRODUCT design ,EVALUATION research ,TREATMENT effectiveness ,VASCULAR catheters ,ODDS ratio ,EQUIPMENT & supplies ,SURGERY - Abstract
Aims: Radiofrequency (RF) ablation represents a standard of care for pulmonary vein isolation in patients with drug-refractory paroxysmal atrial fibrillation (AF). In this setting, cryoballoon (CB) ablation has emerged as alternative therapy. However, the efficacy and safety of CB vs. RF ablation in patients with paroxysmal AF remain a matter of debate.Methods and Results: We searched electronic scientific databases for studies of CB vs. RF ablation in patients with paroxysmal AF. Aggregate data were pooled to perform a meta-analysis. The primary efficacy and safety outcomes were the recurrence of any atrial arrhythmia and procedure-related complications, respectively. A total of 6473 participants from 10 studies (CB, n = 2232 vs. RF, n = 4241) were studied. After a median follow-up of 16 months, the risk of any atrial arrhythmia recurrence (risk ratio, RR 95% confidence interval [95% CI] = 1.01 [0.90-1.14], P = 0.83) and procedure-related complications (RR [95% CI] = 0.92 [0.66-1.28], P = 0.61) were comparable between CB vs. RF ablation. Cryoballoon ablation led to a higher risk of persistent phrenic nerve palsy (RR [95% CI] = 13.60 [3.87-47.81], P < 0.01) and a lower risk of cardiac tamponade (RR [95% CI] = 0.48 [0.25-0.89], P = 0.02) compared with RF ablation. There was a trend of statistically significant interaction between the type of CB and the duration of ablation (P for interaction = 0.09).Conclusion: In patients with paroxysmal AF, ablation therapy with CB is associated with efficacy and safety comparable to that of RF. Second-generation CB catheters seem to reduce procedure duration. Further studies are warranted to disclose the impact of second-generation CB catheters compared with RF for ablation of paroxysmal AF. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.