Safety and Efficacy of Cryoballoon Based Pulmonary Vein Isolation in Patients with Atrial Fibrillation and a History of Cancer

Introduction: A growing body of evidence suggests a strong association between atrial fibrillation (AF) and cancer. A relevant number of patients with a present or former malignant disease with highly symptomatic drug-refractory AF are in need of interventional therapy. Data on the safety and efficacy of catheter ablation in these patients are sparse. The present study aims to analyze the safety and efficacy of cryoballoon-based pulmonary vein isolation (CB-PVI) for symptomatic AF in patients with past or present cancer disease. Methods and Results: Consecutive patients undergoing CB-PVI for symptomatic AF at University Hospital Lübeck, Germany between July 2015 and January 2019 were included in this study. Propensity-score based matching was performed to identify comparable patients with and without cancer disease and further analyze clinical characteristics, periprocedural complications and arrhythmia-free survival. A total of 70 patients with a history of cancer undergoing CB-PVI were matched to 70 patients without a history of cancer. The frequency of complications was similar between patients with and without a history of cancer (p = 0.11), with four phrenic nerve palsies occurring in patients with a history of cancer (5.6% of the cohort) vs. one phrenic nerve palsy in patients without cancer (p = 0.36). Arrhythmia free survival after 12 months did not differ significantly in patients with and without a history of cancer (67.1 ± 5.8% vs. 77.8% ± 5.1%, p = 0.16). Conclusion: This study indicates that CB-PVI for symptomatic AF is equally safe and effective in patients with and without a history of cancer and cancer treatment.

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B-AB21-02 VOLTAGE MAP GUIDED ANTRAL PULMONARY VEIN ISOLATION WITH OCCLUSIVE AND NON-OCCLUSIVE CRYOBALLOON APPLICATIONS IS SUPERIOR IN ACHIEVING 1-YEAR ATRIAL FIBRILLATION FREE SURVIVAL

Heart Rhythm ◽

10.1016/j.hrthm.2021.06.118 ◽

2021 ◽

Vol 18 (8) ◽

pp. S40

Author(s):

Gourg A. Atteya ◽

Kristie Coleman ◽

Amarbir Bhullar ◽

Parth Makker ◽

Moussa Saleh ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Free Survival

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

European Heart Journal ◽

10.1093/eurheartj/ehz748.1156 ◽

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

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Additional Low‐Voltage‐Area Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the Randomized Controlled VOLCANO Trial

Journal of the American Heart Association ◽

10.1161/jaha.120.015927 ◽

2020 ◽

Vol 9 (13) ◽

Author(s):

Masaharu Masuda ◽

Mitsutoshi Asai ◽

Osamu Iida ◽

Shin Okamoto ◽

Takayuki Ishihara ◽

...

Keyword(s):

Atrial Fibrillation ◽

Survival Rate ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Paroxysmal Atrial Fibrillation ◽

Low Voltage ◽

Strong Predictor ◽

Recurrence Free Survival ◽

Free Survival ◽

Group B

Background The efficacy of low‐voltage‐area ( LVA ) ablation has not been well determined. This study aimed to investigate the efficacy of LVA ablation in addition to pulmonary vein isolation on rhythm outcomes in patients with paroxysmal atrial fibrillation ( AF ). Methods and Results VOLCANO (Catheter Ablation Targeting Low‐Voltage Areas After Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation Patients) trial included paroxysmal AF patients undergoing initial AF ablation. Of 398 patients in whom a left atrial voltage map was obtained after pulmonary vein isolation, 336 (85%) had no LVA (group A). The remaining 62 (15%) patients with LVA s were randomly allocated to undergo LVA ablation (group B, n=30) or not (group C, n=32) in a 1:1 fashion. Primary end point was 1‐year AF ‐recurrence‐free survival rate. No adverse events related to LVA ablation occurred. Procedural (124±40 versus 95±33 minutes, P =0.003) and fluoroscopic times (29±11 versus 24±8 minutes, P =0.034) were longer in group B than group C. Patients with LVA s demonstrated lower AF ‐recurrence‐free survival rates (88%) than those without LVA (B, 57%, P <0.0001; C, 53%, P <0.0001). However, LVA ablation in addition to pulmonary vein isolation did not impact AF ‐recurrence‐free survival rate (group B versus C, P =0.67). Conclusions The presence of LVA was a strong predictor of AF recurrence after pulmonary vein isolation in patients with paroxysmal AF . However, LVA ablation had no beneficial impact on 1‐year rhythm outcomes. Registration URL: https://www.umin.ac.jp/ctr ; Unique identifier: UMIN000023403.

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

Circulation ◽

10.1161/circ.132.suppl_3.19348 ◽

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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Abstract 2756: Prevention of Atrial Fibrillation Recurrence after Radiofrequency Catheter Procedure of Pulmonary Vein Isolation by Corticosteroids

Circulation ◽

10.1161/circ.118.suppl_18.s_772-b ◽

2008 ◽

Vol 118 (suppl_18) ◽

Author(s):

Takashi Koyama ◽

Yukio Sekiguchi ◽

Hiroshi Tada ◽

Takanori Arimoto ◽

Hiro Yamasaki ◽

...

Keyword(s):

Atrial Fibrillation ◽

Placebo Group ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Therapeutic Option ◽

Artery Bypass ◽

Underlying Mechanism ◽

Control Group ◽

Number Of Patients ◽

Af Recurrence

Background: Catheter based radiofrequency pulmonary vein isolation (PVI) has been shown to be an effective therapeutic option for controlling drug-refractory atrial fibrillation (AF); however, the recurrence of AF has become one of the major problems after procedure. Although the underlying mechanism of the AF recurrence is not well evaluated, previous reports indicated that inflammatory process could be associated with the onset of AF and the use of intravenous hydrocortisone reduced the incidence of AF after coronary artery bypass surgery. We therefore prospectively evaluated the efficacy of the hydrocortisone for the prevention of AF recurrence. Methods and Results: This study included consecutive 150 patients with drug-refractory paroxysmal AF. Patients were randomized to receive either hydrocortisone or matching placebos as follows: intravenous hydrocortisone (dose of 2mg/kg) was used in the day of operation, and oral hydrocortisone was administered (dose of 0.6mg/kg/day) for 3 days after PVI. Patients with non-PV-foci AF were excluded in this study (Control group; 4 patients, Hydrocortisone group; 6 patients). Various biophysical data were closely investigated between control group (n=71) and hydrocortisone group (n=69). Rate of total AF recurrence and immediate AF recurrence (recurrence of AF within 3 days after PVI) was significantly lower in hydrocortisone group than placebo group (total AF recurrence; 27.0% vs 46.1%, immediate AF recurrence; 6.7% vs 29.5%, p<0.01). Number of patients who underwent second PVI (8.3% vs 23.1%, p<0.01), rise of body temperature after the procedure (0.675°C vs 1.633°C, p=0.005), any sign of pericariditis (0% vs 6.4%, p<0.01), high sensitive CRP level after the procedure (1.17mg/dl vs 2.09mg/dl, P=0.015) and the number of patients using antiarrhythmics (classIb, classIII) after the procedure (classIb; 0% vs 6.4%, classIII; 6.7% vs 26.9%, p<0.01) were also significantly lower in hydrocortisone group than in placebo group. Conclusion: Transient use of hydrocortisone immediately after PVI can be one of the therapeutic options for the prevention of acute AF recurrence after PVI to avoid second procedure and/or the additional antiarrhythmic drug therapy.

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Abstract 2161: Left Atrium Reverse Remodeling After Pulmonary Vein Isolation. Will It Be a Predictor for Non-recurrence of Atrial Fibrillation?

Circulation ◽

10.1161/circ.118.suppl_18.s_678-c ◽

2008 ◽

Vol 118 (suppl_18) ◽

Author(s):

kiyotake Ishikawa ◽

Yukihiko Yoshida ◽

Sumio Morita ◽

Kenji Furusawa ◽

Noriyoshi Kanemura ◽

...

Keyword(s):

Atrial Fibrillation ◽

Catheter Ablation ◽

Left Atrium ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Reverse Remodeling ◽

Transverse Diameter ◽

Before And After ◽

History Of ◽

Af Recurrence

Background: Left atrium (LA) dilation plays an important role in development and persistence of atrial fibrillation (AF). Some cases show structural reverse remodeling of LA after catheter ablation of AF. The aim of this study was to assess the clinical significance of LA reverse remodeling. Method and Results: Echocardiographic data before and after ablation was obtained in 173 cases who underwent pulmonary vein isolation from January 2006 to April 2008 (74.0% men, 61.0±11 years old; paroxysmal AF 114, persistent AF 34, permanent AF 25). Mean atrial diameter before ablation was 39.0±6.1mm (paroxysmal 37.7±5.6mm, persistent 40.7±5.3mm, and permanent 43.0±6.8mm) and LA reverse remodeling was defined as 10% decrement of LA transverse diameter. Half of the cases were taking anti-arrhythmic drugs after ablation, and AF recurrence occurred in 16.8% (29/173) during mean follow up period of 8.5±6.3 months. Reverse remodeling of LA was seen in 34.1% (59/173) and AF recurrence rate in this group was 11.9% (7/59), whereas 19.3% (22/114) without reverse remodeling (P=0.29). However, limited in patients with LA diameter over 40mm (44.5%; 77/173), 3.2% (1/31) of AF recurrence was seen in those with reverse remodeling, while 21.7% (10/46) without reverse remodeling (P=0.04). LA reverse remodeling was observed significantly frequent in patients without history of hypertension(41.5% without hypertension vs 25.6% with hypertension, P=0.036). Conclusion: LA reverse remodeling after catheter ablation of AF in dilated LA patient is a simple and useful predictor for non-recurrence of AF. Hypertension could be a disturbance for LA reverse remodeling.

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