scholarly journals Clinical success of cryoballoon pulmonary vein isolation in patients with atrial fibrillation

2019 ◽  
Vol 7 (4S) ◽  
pp. 6-14
Author(s):  
T. Y. Chichkova ◽  
S. E. Mamchur ◽  
E. A. Khomenko
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Direct Current ◽  
Clinical Success ◽  
Persistent Atrial Fibrillation ◽  
Cryoballoon Ablation ◽  
Clinical Effects ◽  
Rf Ablation

Aim. To estimate the clinical success of cryoballoon pulmonary vein isolation (PVI).Methods.230 patients (males: 49.6%, mean age 57 (53; 62) with symptomatic paroxysmal and persistent atrial fibrillation (AF) resistant to antiarrhythmic therapy were included in a single-center prospective study. The patients were randomized into 2 groups to undergo either cryoballoon ablation (n = 122) or radiofrequency (RF) (n = 108) ablation. Both groups were comparable in baseline parameters. The follow-up period was 12 months. Clinical outcomes were estimated with the use of a three-stage scale. The rates of cardiovascular rehospitalizations, direct-current cardioversions and repeated ablations during were estimated within the follow-up. The quality of life (QoL) in the cryoablation group was measured using the AFEQT scale.Results.77% (n = 94) of patients in the cryoballoon ablation group and 71.3% (n = 77) of patients in the RF group (р = 0.71) demonstrated reported the optimal clinical effects. Both groups, cryo ablation and RF ablation, had similar rates of cardiovascular hospitalizations (23.8 vs 28.7%, OR 0.8, 95% CI 0.4–1.4; р = 0.39), direct-current cardioversions (12.3 vs 17.6%, OR 0.7, 95% CI 0.3–1.4; р = 0.26) and repeated ablations (9.8–11.1%, OR 0.9, 95% CI 0.4–2.0; р = 0.75). The patients treated with cryoballoon as opposed to RF ablation had significantly more successful usage of “pill-in-pocket” strategy – 14.8 vs 6.5% (OR 2.5, 95% CI 1.01–6.2; р = 0.04). Significant improvements of the QoL parameters with strong size effect have been found in the cryoablation group, i.e. global score (GS) increased by 8.9±6.9 (95% CI 6.6–10.1; dCohen 1.2; р<0.001), symptoms (S) – by 8.3±7.9 (95% CI 4.2–8.8; dCohen 1.5; р<0.001), daily activities (DA) – by 10.0±6.9 (95% CI = 6.4–10.6; dCohen 0.9; р<0.001), treatment concerns (TC) – by 5.5±6.0 (95% CI 6.3–9.2; dCohen 1.2; р<0.001) and treatment satisfaction (TS) – by 5.5±6.0 (95% CI 5.4–9.8; dCohen 0.9; р<0.001).Conclusion.The both catheter-based technologies had comparable clinical success. Cryoablation was characterized by improvement in all QoL parameters based on the AFEQT score.

scholarly journals Impact of body mass index on atrial fibrillation ablation using cryoballoon: procedural data and clinical outcomes

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Urbanek ◽  
S Chen ◽  
S Bordignon ◽  
N Tsianakas ◽  
F Bologna ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Body Mass Index ◽  
Pulmonary Vein ◽  
Body Mass ◽  
Pulmonary Vein Isolation ◽  
Clinical Success ◽  
Cryoballoon Ablation ◽  
Group 3 ◽  
The Impact

Abstract Background The impact of body mass index (BMI) on atrial fibrillation (AF) ablation using cryoballoon (CB) has been seldom reported. Purpose To evaluate the impact of BMI on procedural data as well as the clinical efficacy and safety character of using CB. Methods Symptomatic AF patients (paroxysmal / persistent AF) with BMI ≥25 who underwent CB based pulmonary vein isolation (PVI) were enrolled. CB PVI was performed using the second generation CB (CB 2, 28mm), with 4min based freeze protocol and bonus freeze delivery in case of time-to-isolation (TTI) &gt;75 sec. All procedures were performed under conscious sedation. Procedural endpoint was electrical pulmonary vein isolation. Clinical success was defined as no recurrence of AF/atrial tachycardia (AT). Results Data from 600 consecutive patients were collected. Three groups defined: BMI 25–29 (Group 1, G1 n=337); BMI 30–34 (Group 2, G2 n=149); BMI ≥35 (Group 3, G3 n=114). Patients in Group 3 were younger (G1: 67±11 y; G2: 68±10y G3 62±11y; p&lt;0,001) and presented bigger LA (G1 39,5±4,9 mm; G2: 41,6±5,5; G3 42,4±5,1; p&lt;0,001). Most of the patients presented with PAF (G1: 59,3% G2: 57,7% G3: 54,4%). Among 2342 Targeted PVs, 2332 (99,6%) were isolated using solely the CB (G2: one procedure was abolished due to failed aortic puncture during transseptal access; G3: one PVI was not completed due to PNP; 6 touch up RF ablation in G1 and 2 in G3). Procedure time (G1:58,45 min; G2: 60,44 min; G3 63,19 min) and fluoroscopy time (G1: 9,3 min; G2: 9,5 G3: 10,6 min) were comparable among the groups. PN Injury was the main recorded complication: 20/600 (2,6%) patients with a transient PN palsy (PNP) and 6/600 (1%) with a persistent PNP. No sedation related complication was recorded. Follow up survival curve analysis after one year revealed a favorable follow up in G1 (78,4%) and G2 (82,5%) compared to G3 (66,5%) (G1 Vs G3 p: 0,002 G2 vs G3 p=0,008, G1 vs G2 p=0,47). The influence of BMI on the follow up was confirmed in the subgroup of patients with paroxysmal AF but not in patients presenting persistent AF. Conclusions Cryoballoon ablation in obese patients is feasible and associated with a relatively low complication rate. BMI plays a role in predicting recurrences especially in patients presenting with paroxysmal AF. Funding Acknowledgement Type of funding source: None

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

P1913Implantable Loop Recorder Detected Pattern of Atrial Fibrillation Recurrence Following Cryoballoon Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Musat ◽  
N Milstein ◽  
R Shaw ◽  
A Bhatt ◽  
M Preminger ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Persistent Atrial Fibrillation ◽  
Limited Data ◽  
Loop Recorder ◽  
Long Term Follow Up ◽  
Af Recurrence

Abstract Background Cryoballoon (CB) pulmonary vein isolation (PVI) is increasingly being used in patients (pts) with persistent atrial fibrillation (AF). However, there are limited data about the pattern of atrial fibrillation (AF) recurrence in these pts. Objective To assess, using an implantable loop recorder (ILR), the patterns of AF recurrence following CB PVI in pts with persistent atrial fibrillation. Methods We enrolled consecutive pts with persistent AF ablation undergoing their first CB ablation. Other cavotricuspid isthmus ablation when indicated, no other ablation was performed. A Reveal LINQ ILR (Medtronic) was implanted <3 months following ablation; all pts had a minimum of 1-year follow-up. The recurrence of any atrial arrhythmia was determined and adjudicated; 4 distinct AF patterns were characterized (Figure). Results We studied 64 pts (66±9 years; 50 [78%] male; CHA2DS2-VASc 2.6±1.9) with persistent AF; 52 (81%) pts were on an antiarrhythmic drug (AAD) peri-ablation. During 803±361 days of follow-up, 33 (52%) pts had their 1st AF recurrence 91–365 days post-ablation and another 17 (27%) pts had their 1st AF recurrence >365 days post-ablation. No AF was seen in 14 (31%) pts. Most pts (33 of 50, 66%) with AF recurrence presented with 1 of 3 distinct patterns of paroxysmal AF (Figure), which ranged from 22 min to 124 hours. In 2/3 of these pts, all AF recurrences lasted <24 hours. Only 17 (34%) pts recurred with persistent AF. Conclusion Following single CB PVI, most pts with persistent AF remained free of persistent AF during long-term follow-up. Most pts with recurrent AF have 1 of 3 distinct patterns with episodes commonly last <24 hours. These data suggest that CB PVI ablation may halt AF progression in pts initially presenting with persistent AF.

Abstract 19348: Efficacy of Cryoballoon Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Emily Guhl ◽  
Donald Siddoway ◽  
Evan Adelstein ◽  
Samir Saba ◽  
Andrew Voigt ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Persistent Atrial Fibrillation ◽  
Free Survival ◽  
Kaplan Meier ◽  
Initial Strategy ◽  
Free Rate ◽  
Af Recurrence

Introduction: Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency PVI for the treatment of paroxysmal atrial fibrillation (AF). The optimal ablation strategy for patients with persistent AF is unclear, as data on Cryoballoon PVI alone are limited. Methods: We analyzed a prospective registry of consecutive patients with persistent AF who underwent Cryoballoon PVI at a single center between 2011 and 2014. Patients were assessed for AF recurrence (including any atrial arrhythmia) after a 3 month blanking period at 6 months, 1 year, 2 years, and as needed for symptoms post PVI. Recurrence was based on typical symptoms or ECG/ event monitor evidence of AF. Kaplan-Meier analysis was used to estimate AF-free survival. Results: The 69 patients who underwent Cryoballoon PVI were aged 59 ± 8 years, 86% male, 54% HTN, had a CHADS2-VASC score 1.6 ± 1.2, and had a LA dimension 4.5 ± 0.6 cm. The AF recurrence-free rate at 1-year post-procedure was 59%. Overall, AF-free survival was 50% at the mean follow-up of 607 days. In comparing patients with persistent AF duration <1 year vs. >1 year, there was a trend toward greater AF recurrence-free rates in the <1 year group (66% vs 55%, p=0.09) Conclusions: Cryoballoon PVI appears to be an effective initial strategy in treating persistent AF, with an AF recurrence-free rate of 59% at 1 year.

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