PERMANENT RIGHT PHRENIC NERVE PARALYSIS FOLLOWING CATHETER RADIOFREQUENCY (RF) ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION (PAF)

CHEST Journal ◽  
2005 ◽  
Vol 128 (4) ◽  
pp. 276S ◽  
Author(s):  
Long X. Le ◽  
Patricia J. Sime
Keyword(s):  
Atrial Fibrillation ◽  
Paroxysmal Atrial Fibrillation ◽  
Phrenic Nerve ◽  
Rf Ablation ◽  
Nerve Paralysis ◽  
Phrenic Nerve Paralysis

scholarly journals Direct Comparison Between Second-Generation Cryoballoon Ablation Versus Contact Force-Sensing Radiofrequency Ablation in Paroxysmal Atrial Fibrillation Patients: A Systematic Review and Meta-Analysis Study

2021 ◽  
Author(s):  
Yoga Waranugraha ◽  
Ardian Rizal ◽  
Yoga Yuniadi
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Paroxysmal Atrial Fibrillation ◽  
Phrenic Nerve ◽  
Meta Analysis ◽  
Force Sensing ◽  
Rf Ablation ◽  
Nerve Paralysis ◽  
Analysis Study ◽  
Phrenic Nerve Paralysis

Abstract Background Pulmonary vein isolation (PVI) is the main ablation approach for paroxysmal atrial fibrillation (AF). The superiority of the second-generation cryoballoon (2G-CB) ablation over contact force-sensing radiofrequency (CF-RF) ablation is unclear. Therefore, we sought to investigate the superiority of 2G-CB ablation over CF-RF ablation in paroxysmal AF patients. Methods A systematic review and meta-analysis study was conducted. We included 12 studies involving 1419 patients. The overall effects were quantified using pooled odds ratio (OR) or mean difference (MD) for categorical or continuous variables. Results Freedom from atrial tachyarrhythmias (ATAs) (OR = 0.88; 95% confidence interval [CI] = 0.68 to 1.15; p = 0.35), freedom from AF (OR = 0.93; 95% CI = 0.64 to 1.34; p = 0.7), and acute PVI (OR = 1.00; 95% CI = 1.00 to 1.00; p = 0.99) between 2G-CB ablation and CF-RF ablation were not different. The 2G-CB ablation took shorter procedure time (MD = -18.78 minutes; 95% CI = -27.72 to -9.85 minutes; p < 0.01) and relative similar fluoroscopy time (MD = 2.66 minutes; 95% CI = -0.52 to 5.83 minutes; p = 0.10). Phrenic nerve paralysis was higher in 2G-CB ablation group (OR = 7.25; 95% CI = 2.37 to 22.16; p = < 0.005). Conclusion The 2G-CB ablation was not superior to CF-RF ablation in paroxysmal AF in terms of acute PVI, freedom from ATAs, and freedom from AF. The 2G-CB ablation procedure can be performed faster than CF-RF ablation, although correlated with a higher phrenic nerve paralysis.

Phrenic nerve paralysis during cryoballoon ablation for atrial fibrillation: A comparison between the first- and second-generation balloon

Heart Rhythm ◽  
2013 ◽  
Vol 10 (9) ◽  
pp. 1318-1324 ◽  
Author(s):  
Ruben Casado-Arroyo ◽  
Gian-Battista Chierchia ◽  
Giulio Conte ◽  
Moisés Levinstein ◽  
Juan Sieira ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Phrenic Nerve ◽  
Second Generation ◽  
Cryoballoon Ablation ◽  
Nerve Paralysis ◽  
Phrenic Nerve Paralysis ◽  
First And Second Generation

scholarly journals Acute safety and performance outcomes from the inspIRE trial using a novel pulsed field ablation system for the treatment of paroxysmal atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T De Potter ◽  
V Reddy ◽  
P Neuzil ◽  
G Rackauskas ◽  
A Anic ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Paroxysmal Atrial Fibrillation ◽  
Performance Outcomes ◽  
Ablation Procedure ◽  
Multi Centre Study ◽  
Nerve Paralysis ◽  
Pulsed Field ◽  
Phrenic Nerve Paralysis ◽  
Mapping System

Abstract Background/Introduction The inspIRE clinical trial was designed to assess the safety and efficacy of a fully integrated biphasic pulsed field ablation (PFA) system comprised of a multi-channel generator, variable decapolar irrigated loop circular catheter, and mapping system (Figure A) for the treatment of paroxysmal atrial fibrillation (PAF). Purpose Using this novel PFA system in a multicentre clinical trial, we present the initial feasibility of electrical pulmonary vein isolation (PVI), procedural performance, and acute safety results. Methods inspIRE is a prospective, non-randomized, multi-centre study, planned to enrol up to 550 patients. PVI is performed with the novel, variable loop circular catheter, compatible mapping system and generator. Acute procedural effectiveness (entrance block in all clinically targeted PVs post adenosine/isoproterenol challenge) and the incidence of primary adverse events (PAEs) were assessed. PAEs are defined as the occurrence of cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack, permanent phrenic nerve paralysis, pulmonary edema, pericarditis, and any major vascular access complications within 7 days of the ablation procedure. Additionally, any incidence of procedure or device related death, atrio-esophageal fistula, or PV stenosis (related to the ablation procedure or study catheter) within the 12M follow-up period is classified as a PAE. Results A total of 35 PAF subjects (age 59.7±10.7 years, 54.3% male) were treated across 5 European sites by 6 operators. Acute procedural success was achieved in 100% of study subjects (Figure B) with zero incidence of PAEs. Mean total procedure time was 82.9±19.9 minutes with 27.0±11.9 minutes of PFA from first to last application. Average fluoroscopy use was 10.6±6.8 minutes and LA dwell time was 45.6±15.3 minutes. Conclusion Initial results of the inspIRE trial demonstrate the acute safety and effectiveness of the new integrated IRE circular catheter, mapping system and generator for PVI in PAF patients. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): inspIRE is a company-sponsored study funded by Biosense Webster, Inc. Figure 1. (A) PFA System; (B) PVI Voltage Map

P1862Phrenic nerve damage after atrial fibrillation ablation using second generation cryoballoon

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Yorgun ◽  
M Oksul ◽  
Y Z Sener ◽  
U Canpolat ◽  
B Evranos ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Phrenic Nerve ◽  
Rare Complication ◽  
Nerve Damage ◽  
Safe Alternative ◽  
Nerve Paralysis ◽  
Phrenic Nerve Paralysis ◽  
Study Characteristics ◽  
Technological Developments

Abstract Background Cryoballoon (CB) ablation is a safe alternative to radiofrequency ablation in the treatment of atrial fibrillation (AF). However, phrenic nerve damage (PND) is a bothersome complication of the procedure. Purpose In this study, we aimed to establish the incidence of PND during CB and define the characteristics of affected patients. Methods In this retrospective analysis, all patients with AF that underwent CB ablation between 2013 and 2018 were included into the study. Characteristics and outcomes of patients complicated with PND were evaluated. PND was detected by palpation of diaphragma contractions or observation of reduced diaphragma motility by fluoroscopy during the procedure. Results Totally 653 patients were included in the study. PND was detected in 3.5% (23/653) of the patients. Median age of the patients with PNP was 56 (25–78) years and 10 patients (43.4%) were male. The most common ablation site related with PND was right superior pulmonary vein (RSPV) (18 patients, 78%). Transient PND was observed in 16 patients (69%) of the patients which resolved within 24 hours after the procedure. In the remaining 5 patients (21%) diaphragmatic contraction was recovered at the 6th month control visit. In 2 patients (10%), phrenic nerve paralysis was still present >1 year visit. Table 1. Baseline characteristics of patients with PND Age (years), median (min–max) 56 (25–78) Gender, n (male %) 10 (43.4%) Hypertension, n (%) 9 (39.1%) LA (mm), (mean ± sd) 38.5±5.8 EF (%), (mean ± sd) 60.8±6.5 Structrual heart disease, n (%) 3 (0.13%) – HCMP 2 (0.087%) – DCMP 1 (0.043%) DCMP: Dilated cardiomyopathy; HCMP: Hypertrophic cardiomyopathy; EF: Ejection fraction; LA: Left atrium; PND: Phrenic nerve damage. Conclusion PND is not a rare complication of CB ablation despite all the preventive maneuvers during the procedure and technological developments. However, most of the PND recovered during the follow-up.

scholarly journals Phrenic Nerve Damage After Atrial Fibrillation Ablation Using Second Generation Cryoballoon

Acta Medica ◽  
2019 ◽  
Vol 50 (1) ◽  
pp. 14-19
Author(s):  
Hikmet YORGUN ◽  
Yusuf Ziya ŞENER ◽  
Metin OKŞUL ◽  
Uğur CANPOLAT ◽  
Banu EVRANOS ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Phrenic Nerve ◽  
Rare Complication ◽  
Nerve Damage ◽  
Safe Alternative ◽  
Nerve Paralysis ◽  
Phrenic Nerve Paralysis ◽  
Study Characteristics ◽  
Technological Developments

Abstract Objective: Cryoballoon (CB) ablation is a safe alternative to radiofrequency ablation in the treatment of atrial fibrillation (AF). However, phrenic nerve damage (PND) is a bothersome complication of the procedure. In this study, we aimed to establish the incidence of PND during CB and define the characteristics of affected patients. Material & Methods:  In this retrospective analysis, all patients with AF that underwent CB ablation between 2013 and 2018 were included into the study. Characteristics and outcomes of patients complicated with  PND were evaluated. PNP was detected by palpation of diaphragma contractions or observation of reduced diaphragma motility by fluoroscopy during the procedure. Results: Totally 653 patients were included in the study. PND was detected in 3.5% (23/653) of the patients. Median age of the patients with PNP was 56 (25-78) years and 10 patients (43.4 %) were male. The most common ablation site related with PND was RSPV (18 patients, 78%). Transient PND was observed in 16 patients (69%) of the patients which resolved within 24 hours after the procedure. In the remaining 5 patients (21%) diaphragmatic contraction was recovered at the 6th month control visit. In 2 patients (10%), phrenic nerve paralysis was still present >1 year visit Conclusion: PND is not a rare complication of CB ablation despite all the preventive maneuvers during the procedure and technological developments. However, most of the PND recovered during the follow-up.

Abstract P65: Outpatient Atrial Fibrillation Ablation on Therapeutic Warfarin - Safety, Efficacy, and Cost Savings

2011 ◽  
Vol 4 (suppl_1) ◽  
Author(s):  
Michael C Giudici ◽  
Deborah L Paul ◽  
Caroline Sloane ◽  
Gisela Press ◽  
Ashley Petersen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cost Savings ◽  
Nerve Paralysis ◽  
Phrenic Nerve Paralysis ◽  
Outpatient Unit ◽  
Heparin Administration ◽  
Same Day Discharge ◽  
Procedural Time ◽  
Hospital Stays ◽  
Mean Time

Introduction: Catheter ablation for atrial fibrillation (PVI) is being performed with increasing frequency. This time and labor-intensive procedure is under increasing scrutiny as we look for means to decrease costs of delivering care. Performing these procedures on therapeutic warfarin could shorten hospital stays, eliminate costly low-molecular weight heparin (LMW) use, and decrease procedural heparin administration which could reduce hemorrhage from access sites. Methods: Over a six-year period, 180 patients, 138 M/42 F, mean age 43 yr (18-77 yr), underwent PVI for persistent - 99 pts., and paroxysmal - 81 pts. atrial fibrillation. Mean INR was 2.2 (1.5 - 4.2). Procedures were performed with standard radiofrequency (RF) catheters - 132, Cryoablation - 27, and Ablation Frontiers RF - 21. Procedural time, fluoroscopy time, hospital stays, outcomes, and complications were tracked. Results: 127 of 180 pts. were discharged the day of procedure (OP) from the outpatient unit, 51 pts. stayed one night post-procedure (IP), 2 patients stayed 4 days, one for pulmonary treatment and one for CVA. Mean procedural length was 3.3 hours, mean fluoro time was 52 min. Mean time from hospital admit to discharge was 17.3 hr. Mean time from procedure end to discharge was 11.0 hr. 77% of pts. were free from AF on follow-up on no meds or “pill-in-the-pocket”. 6 complications occurred - 1 phrenic nerve paralysis (resolved), 2 CVAs (one was 72 hrs post PVI), 1 perforation/tamponade, 1 groin bleed requiring evacuation, 1 PV stenosis. There was no difference in outcome for patients discharged OP vs IP. Cost savings by continuing warfarin were LMW = $205/dose X 6 doses - $1230/pt. Cost savings by same day discharge = $1330/day. Conclusions: PVI can be safely performed as an outpatient procedure on therapeutic warfarin with good clinical outcomes. Significant cost savings can be realized from OP PVI from reduced staff, medication, and facilities utilization.

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

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