scholarly journals How Close Are We toward an Optimal Balance in Safety and Efficacy in Catheter Ablation of Atrial Fibrillation? Lessons from the CLOSE Protocol

2021 ◽  
Vol 10 (18) ◽  
pp. 4268
Author(s):  
Michelle Lycke ◽  
Louisa O’Neill ◽  
Kris Gillis ◽  
Jean-Yves Wielandts ◽  
Jean-Benoit Le Polain De Waroux ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Prospective Study ◽  
High Power ◽  
Pulmonary Veins ◽  
Anterior Wall ◽  
Cryoballoon Ablation ◽  
Single Center ◽  
Safety And Efficacy ◽  
Rf Applications

Catheter ablation for atrial fibrillation (AF) is a common treatment strategy in patients with drug-resistant, symptomatic AF. In patients with paroxysmal and short-standing persistent AF, pulmonary vein isolation (PVI) is often enough to prevent recurrence of atrial tachyarrhythmia (ATA). Point-by-point encircling of the PVs with radiofrequency (RF) applications, together with cryoballoon ablation, have been the mainstay strategies for the last 10 to 20 years. Each of these strategies, however, suffers from the delicate balance between preventing PV reconnection, on the one hand (toward more energy), and preventing (mainly esophageal) complications (toward less energy), on the other. The CLOSE protocol was developed as an RF ablation strategy that would result in the safe creation of durable isolation leading to improved outcomes. Basically, the aim of the protocol is to enclose the pulmonary veins with stable, contiguous (intertag distance, ITD ≤ 6 mm) and optimized lesions (35 Watts, W, RF applications up to ablation index targets of ≥400 and ≥550 at the posterior and anterior wall). In this review, we describe the background of the CLOSE protocol and the studies from the St Jan Bruges research group on procedural performance, efficacy, and safety of the CLOSE protocol in (a) single-center prospective PILOT study (CLOSE-PILOT), (b) a single-center prospective study with continuous rhythm monitoring (CLOSE to CURE), (c) a database of systematic esophageal endoscopic studies, (d) a multicenter prospective study (VISTAX), and (e) the CLOSE database (comprising > 400 patients). We also discuss the results of the randomized POWER-AF study comparing conventional CLOSE to high power CLOSE (up to 50 W). Finally, we discuss the performance, safety, and efficacy of the CLOSE protocol in light of the emerging changes in the field of catheter ablation being ultra-short high-power ablation and electroporation.

scholarly journals Safety and efficacy of cryoballoon-ablation for atrial fibrillation performed at local hospitals: results of the german register on cryoballoon-ablation in local hospitals (REGIONAL)

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
J Michaelsen ◽  
U Parade ◽  
H Bauerle ◽  
K-D Winter ◽  
U Rauschenbach ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Phrenic Nerve ◽  
Nerve Palsy ◽  
Pulmonary Veins ◽  
Hospital Death ◽  
Cryoballoon Ablation ◽  
Complication Rates ◽  
Community Hospitals ◽  
Phrenic Nerve Palsy ◽  
Safety And Efficacy

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf REGIONAL Background Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) has become an established procedure for the treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI at community hospitals with low to moderate case numbers is unknown. Aim To determine safety and efficacy of PVI using CBA performed at community hospitals with limited annual case numbers. Methods 1004 PVI performed consecutively between 01/2019 and 09/2020 at 20 community hospitals (each <100 PVI using CBA/year) for symptomatic paroxysmal AF (n = 563) or persistentAF (n= 441) were included in this registry. CBA was performed considering local standards. Procedural data, efficacy and complications were determined. Results Mean number of PVI using CBA/year was 59 ± 26. Mean procedure time was 90.1 ± 31.6 min and mean fluoroscopy time was 19.2 ± 11.4 min. Isolation of all pulmonary veins could be achieved in 97.9% of patients, early termination of CBA due to phrenic nerve palsy was the most frequent reason for incomplete isolation. There was no in-hospital death. 2 patients (0.2%) suffered a clinical stroke. Pericardial effusion occurred in 6 patients (0.6%), 2 of them (0.2%) required pericardial drainage. Vascular complications occurred in 24 patients (2.4%), in 2 of these patients (0.2%) vascular surgery was required. In 48 patients (4.8 %) phrenic nerve palsy was noticed which persisted up to hospital discharge in 6 patients (0.6%). Conclusions PVI for paroxysmal or persistent AF using CBA can be performed at community hospitals with high efficacy and low complication rates despite low to moderate annual procedure numbers.

Abstract 256: Cardiac CT in Ablation of Atrial Fibrillation

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Ala Mohsen ◽  
Nicole Worden ◽  
Manju Bengaluru Jayanna ◽  
Michael Giudici
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Ct Scan ◽  
Radiation Exposure ◽  
Cardiac Ct ◽  
Pulmonary Veins ◽  
Cryoballoon Ablation ◽  
Atrial Fibrillation Recurrence ◽  
Significant Difference ◽  
The Impact

Background: This study aims to determine the impact of pre-procedural cardiac computerized tomography (CT) on procedural efficacy, clinical outcome and complications in patients who undergo radiofrequency or cryo-therapy catheter ablation to eliminate atrial fibrillation (AF). Methods: In this retrospective review, Radiofrequency or Cryoballoon ablation was done on 50 consecutive patients with atrial fibrillation with mean age of 63 (Min 47-Max 86) with paroxysmal (8 2 %) or persistent (18%) AF. Twenty-five patients underwent cryoablation and twenty-five patients underwent Radiofrequency ablation to isolate the pulmonary veins. Procedural and clinical outcomes were compared among patients who underwent catheter ablation with and without pre procedural Cardiac CT. Results: Out of 50 consecutive patients between 01/2014 and 08/2014 there were 26 patients who had a pre-procedural CT scan and 24 patients who did not undergo a pre-procedural CT scan. The mean duration of the procedure (303 ± 93 vs. 271 ± 43 min, P = 0.244) and fluoroscopy time (53 ± 25 vs. 43 ± 17 min, P = 0.086) was similar among patients who did and did not have pre-procedural cardiac CT. The occurrence of complications such as bleeding, pericardial tamponade, pneumothorax, infection and embolic events were also similar in both groups. Repeat ablation was performed in 4 (15%) and 7 (29%) of the patients who did and did not have cardiac CT, respectively (P = 0.249). At 3 months, 5 (19%) and 2(8%) of the patients who did and did not have pre-procedural cardiac CT had atrial fibrillation recurrence (P =0.323). At 12 months, 6 (23%) and 4 (17%) of the patients who did and did not have pre-procedural cardiac CT had atrial fibrillation recurrence (P = 0.467). There was statistically significant difference in Radiation exposure (1805 [IQR 998-2397] vs. 1195 [IQR 738-1363] P=0.0323) between patients who did and did not get pre-procedural cardiac CT, which did not include the radiation added by performing the CT itself. Conclusions: Pre-procedural structural anatomy obtained by cardiac CT scan before catheter ablation for atrial fibrillation in a center where operators used both Radiofrequency and Cryoablation does not appear to have a significant effect on AF recurrence at 3 months or 1 year. The procedural radiation exposure was significantly less in the group that did not have pre-procedure cardiac CT.

Role of inducibility and its dynamic change in the outcome of catheter ablation of atrial fibrillation: a single center prospective study

2020 ◽  
Vol 31 (3) ◽  
pp. 705-711
Author(s):  
Angeliki Darma ◽  
Sait S. Daneschnejad ◽  
Thomas Gaspar ◽  
Yan Huo ◽  
Ulrike Wetzel ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Prospective Study ◽  
Dynamic Change ◽  
Single Center

Beating Heart Direct Left Atrial Access Balloon Cryoablation: Safety and Efficacy of Pulmonary Vein Isolation in an Ovine Model

2007 ◽  
Vol 2 (4) ◽  
pp. 188-191
Author(s):  
James S. Gammie ◽  
G Kwame Yankey ◽  
Timothy Nolan ◽  
Z. Jon Wu ◽  
Timm Dickfeld ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrium ◽  
Pulmonary Vein ◽  
Left Atrial ◽  
Pulmonary Veins ◽  
Beating Heart ◽  
Direct Access ◽  
Large Animal ◽  
Cryoballoon Ablation ◽  
Safety And Efficacy

Objective Clinical experience with endocardial cryoablation for the surgical treatment of atrial fibrillation has demonstrated safety and efficacy. Direct access to the left atrium via a thoracoscopic or pericardial approach with a balloon-tipped cryoablation catheter might facilitate endocardial cryoablation on the beating heart. We investigated the ability of a novel cryoballoon to produce endocardial pulmonary vein ostial cryolesions on the beating heart in a large-animal model. Methods Six sheep underwent small left thoracotomy. A 10.5F catheter with a 23-mm cryoballoon was inserted directly into the left atrium under fluoroscopic and intracardiac echo (ICE) guidance. Cryoablation of the pulmonary vein ostia was performed. Animals were killed at 14 days. Pulmonary venous electrical isolation was assessed immediately before the animals were killed. Results All animals survived balloon cryoablation with no periprocedural complications. Balloon occlusion was well tolerated hemodynamically, with minimal change in blood pressure (–4 ± 6 mm Hg systolic BP) and no change in heart rate. ICE demonstrated an absence of intracardiac air or ice embolization during ablation. Mean balloon temperature was −67 ± 8°C. All animals were neurologically intact after the procedure. Five of 6 (83%) veins exhibited circumferential exit block. Phrenic nerve function was intact in all animals. On gross inspection, all lesions were circumferential and continuous without evidence of endocardial thrombus. Pathology confirmed circumferential transmurality in all treated veins. Conclusions Direct left atrial access cryoballoon ablation was effective for isolating pulmonary veins. This technology may be an important component of a minimally invasive beating heart CryoMaze procedure for the treatment of atrial fibrillation.

scholarly journals Safety and outcome of cryoballoon ablation versus radiofrequency catheter ablation of the pulmonary veins in patients with paroxysmal atrial fibrillation

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
O H M A Riad ◽  
T Wong ◽  
A N Ali ◽  
M T Ibrahim ◽  
M A Abdelhamid ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Radiofrequency Ablation ◽  
Catheter Ablation ◽  
Pulmonary Vein ◽  
Paroxysmal Atrial Fibrillation ◽  
Pulmonary Veins ◽  
Cryoballoon Ablation ◽  
The Mean

Abstract Background Pulmonary vein isolation (PVI) has become the mainstay of catheter ablation of atrial fibrillation (AF). There are two commonly used methods to isolate the pulmonary veins, either point-by-point delivery of circumferential lesion sets around ipsilateral pulmonary veins using radiofrequency energy, or the application of the cryoballoon to the pulmonary vein antrum with occlusion of the vein ostium. The cryoballoon has proven to be a reliable alternative to radiofrequency ablation in acute and long-term freedom from AF. We describe our results using both modalities. Aim and Objectives to compare the safety and efficacy of cryoballoon (CB) ablation and radiofrequency (RF) ablation in treatment of paroxysmal atrial fibrillation. Patients and Methods Forty-four consecutive patients having paroxysmal AF underwent PVI using the second generation cryoballoon were compared to a retrospective cohort of 69 patients who had radiofrequency induced PVI, either by conventional RF catheter (n = 32), or a contact-force sensing-catheter (n = 37). The study took place at Ain Shams university hospitals and Royal Brompton & Harefield NHS trust. Patient data, procedural data and follow up data- at 3, 6 and 12 months- were collected and analysed. Recurrence was defined as documented AF or atrial arrhythmias with duration exceeding 30 seconds, either by 12 lead ECG or an ambulatory monitoring device. Results A total of 113 patients were studied. The mean age was 53.84 ± 15.01 for the CB group and 55.78 ± 14.84 for the RF group and females representing 40.9% vs 34.8% respectively. The mean procedural times in minutes were significantly less in the CB group (94.37 ± 39.32 vs 184.57 ± 88.19, p < 0.0001), while the median fluoroscopy times were similar [30 (11.04 - 40) vs 37.25 (14.2 - 70), p = 0.172]. Procedural complications were comparable between the two groups (p = 0.06) with 1 patient (2.3%) having long term phrenic nerve paresis. At 1 year follow up, after an initial 90-day blanking period, recurrence rate of CB was similar to RF (27.3% vs 30.4% respectively, p = 0.719), the Kaplan Meier estimates of AF- free survival for a period of 1 year were comparable between both groups (log rank test, p = 0.606). Conclusion Cryoballoon is a feasible method for pulmonary vein isolation with similar success rates to radiofrequency ablation. Cryoballoon ablation is safe with shorter duration of the procedure.

scholarly journals CRYOABLATION IN ATRIAL FIBRILLATION: RATIONALE OF THE NATIONAL PROSPECTIVE REGISTRY AND PRELIMINARY RESULTS

2018 ◽  
pp. 21-25
Author(s):  
E. N. Mikhailov ◽  
T. A. Lyubimtseva ◽  
K. V. Davtyan ◽  
A. G. Topchian ◽  
E. S. Tarasyuk ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Pulmonary Veins ◽  
National Study ◽  
Cryoballoon Ablation ◽  
Ablation Procedure ◽  
Safety And Efficacy ◽  
Informational System ◽  
Real Clinical Practice

Aim. Current registry is the continued national study on cryoablation in atrial fibrillation (AF). The aim of the project is assessment of safety and efficacy of cryoballoon ablation of pulmonary veins from AF treatment in real clinical practice prospective observation.Material and methods. The project has been developed for prospective inclusion of the data to guarded automatic informational system, on clinical data of patients, ablation parameters, repeat ablation and results of 12-month follow-up. To participate in the project in January of 2017, the representatives of 33 in-patient facilities were invited, that routinely perform the procedure.Results. Twenty five institutions confirmed their participation, and by December of 2017, the database was completed by specialists from 13 clinics: information on the ablation procedure and outcomes is included for 451 patient. The enrollment is ongoing with estimated end by January 2019; prospective follow-up to be completed by January 2020.Conclusion. Prospective registry of AF cryoablation is important for gathering of experience and common analysis of the procedures throughout the country. Detailed analysis will make it to reveal predictors of efficacy and methods for procedural risk decrease.

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