scholarly journals Results and Implications of the FIRE AND ICE Trial

2016 ◽  
Vol 02 (02) ◽  
pp. 55
Author(s):  
Karl-Heinz Kuck ◽  
Michael Schlüter ◽  
◽  
Keyword(s):  
Atrial Fibrillation ◽  
Radiofrequency Ablation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Gold Standard ◽  
Cryoballoon Ablation ◽  
Clinical Failure

Whilst radiofrequency ablation is widely considered the “gold standard” for pulmonary-vein isolation, cryoballoon ablation is considered easier to perform. The aim of the randomised, multicentre FIRE AND ICE trial was to demonstrate, in patients with paroxysmal atrial fibrillation, the non-inferiority of cryoballoon ablation with respect to the time to a first documented clinical failure within 1 year outside a 90-day “blanking period” after the index ablation. This editorial gives an overview of the trial and its findings.

P2846Focal impulse and rotor modulation ablation versus pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation (FIRMAP AF study)

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Tilz ◽  
C L Lenz ◽  
P S Sommer ◽  
N Sawan ◽  
R Meyer-Saraei ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Gold Standard ◽  
Artery Aneurysm ◽  
Rf Ablation ◽  
Af Ablation ◽  
Number Of Patients

Abstract Background Based on the assumption of trigger elimination, pulmonary vein isolation (PVI) currently presents the gold standard of atrial fibrillation (AF) ablation. Recently, rapidly spinning rotors or focal impulse formation has been raised as a crucial sustaining mechanism of AF. Ablation of these rotors may potentially obviate the need for trigger elimination with PVI. Purpose This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation only with the gold standard of pulmonary vein isolation (PVI) in patients with paroxysmal AF. Methods This was a post-market, prospective, single-blinded, randomized, multi-center trial. Patients were enrolled at three centers and equally (1:1) randomized between those undergoing conventional RF ablation with PVI (PVI group) vs. those treated with FIRM-guided RF ablation without PVI (FIRM group). Data was collected at enrollment, procedure, and at 7-day, 3-month, 6-month, and 12-month follow-up visits. The study was closed early by the sponsor. At the time of study closure, any pending follow-up visits were waived. Results From February 2016 until February 2018, a total of 51 (out of a planned 170) patients (mean age 63±10.6 years, 57% male) were enrolled and randomized. Four patients withdrew from the study prior to treatment, resulting in 23 patients allocated to the FIRM group and 24 in the PVI group. Only 13 patients in the FIRM group and 11 patients in the PVI group completed the 12-month follow-up. Statistical analysis was not completed given the small number of patients. Single-procedure effectiveness (freedom from AF/atrial tachycardia recurrence after blanking period) was 52.9% (9/17) in the FIRM group and 85.7% (12/14) in the PVI group at 6 months; and 31.3% (5/16) in the FIRM group and 80% (8/10) in the PVI group at 12 months. Repeat procedures were performed in 45.8% (11/24) patients in the FIRM group and 7.4% (2/27) in the PVI group. The acute safety endpoint [freedom from procedure-related serious adverse events (SAE)] was achieved in 87% (20/23) of FIRM group patients and 100% (24/24) of PVI group patients. Procedure related SAEs occurred in three patients in the FIRM group: 1 femoral artery aneurysm and 2 injection site hematomas. No additional procedure-related SAEs were reported >7 days post-procedure. Conclusions These partial study effectiveness results reinforce the importance of PVI in paroxysmal atrial fibrillation patients and suggest that FIRM-guided ablation alone (without PVI) is not an effective strategy for treatment of paroxysmal AF in most patients. Further study is needed to understand the effectiveness of adding FIRM-guided ablation as an adjunct to PVI in this patient group. Acknowledgement/Funding Abbot

scholarly journals Procedural Patterns and Safety of Atrial Fibrillation Ablation

2020 ◽  
Vol 13 (9) ◽  
Author(s):  
Zak Loring ◽  
DaJuanicia N. Holmes ◽  
Roland A. Matsouaka ◽  
Anne B. Curtis ◽  
John D. Day ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Radiofrequency Ablation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Contact Force ◽  
De Novo ◽  
Class I ◽  
Cryoballoon Ablation ◽  
Af Ablation ◽  
Life Threatening

Background: Catheter ablation is an increasingly used treatment for symptomatic atrial fibrillation (AF). However, there are limited prospective, nationwide data on patient selection and procedural characteristics. This study describes patient characteristics, techniques, treatment patterns, and safety outcomes of patients undergoing AF ablation. Methods: A total of 3139 patients undergoing AF ablation between 2016 and 2018 in the Get With The Guidelines-Atrial Fibrillation registry from 24 US centers were included. Patient demographics, medical history, procedural details, and complications were abstracted. Differences between paroxysmal and patients with persistent AF were compared using Pearson χ 2 and Wilcoxon rank-sum tests. Results: Patients undergoing AF ablation were predominantly male (63.9%) and White (93.2%) with a median age of 65. Hypertension was the most common comorbidity (67.6%), and patients with persistent AF had more comorbidities than patients with paroxysmal AF. Drug refractory, paroxysmal AF was the most common ablation indication (class I, 53.6%) followed by drug refractory, persistent AF (class I, 41.8%). Radiofrequency ablation with contact force sensing was the most common ablation modality (70.5%); 23.7% of patients underwent cryoballoon ablation. Pulmonary vein isolation was performed in 94.6% of de novo ablations; the most common adjunctive lesions included left atrial roof or posterior/inferior lines, and cavotricuspid isthmus ablation. Complications were uncommon (5.1%) and were life-threatening in 0.7% of cases. Conclusions: More than 98% of AF ablations among participating sites are performed for class I or class IIA indications. Contact force-guided radiofrequency ablation is the dominant technique and pulmonary vein isolation the principal lesion set. In-hospital complications are uncommon and rarely life-threatening.

Efficacy of pulmonary vein isolation by cryoballoon ablation in patients with paroxysmal atrial fibrillation

Heart Rhythm ◽  
2008 ◽  
Vol 5 (6) ◽  
pp. 802-806 ◽  
Author(s):  
Gunnar Klein ◽  
Hanno Oswald ◽  
Ajmal Gardiwal ◽  
Ulrich Lüsebrink ◽  
Christoph Lissel ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Cryoballoon Ablation

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.

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