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

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

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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

10.21203/rs.3.rs-654073/v1 ◽

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.

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

CHEST Journal ◽

10.1378/chest.128.4_meetingabstracts.276s-a ◽

2005 ◽

Vol 128 (4) ◽

pp. 276S ◽

Cited By ~ 2

Author(s):

Long X. Le ◽

Patricia J. Sime

Keyword(s):

Atrial Fibrillation ◽

Paroxysmal Atrial Fibrillation ◽

Phrenic Nerve ◽

Rf Ablation ◽

Nerve Paralysis ◽

Phrenic Nerve Paralysis

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Faculty Opinions recommendation of Autonomic denervation added to pulmonary vein isolation for paroxysmal atrial fibrillation: a randomized clinical trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718085390.793483917 ◽

2013 ◽

Author(s):

Jan Amlie

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Paroxysmal Atrial Fibrillation ◽

Autonomic Denervation

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Pulsed Field Ablation of Paroxysmal Atrial Fibrillation

JACC: Clinical Electrophysiology ◽

10.1016/j.jacep.2021.02.014 ◽

2021 ◽

Author(s):

Vivek Y. Reddy ◽

Srinivas R. Dukkipati ◽

Petr Neuzil ◽

Ante Anic ◽

Jan Petru ◽

...

Keyword(s):

Atrial Fibrillation ◽

Paroxysmal Atrial Fibrillation ◽

Pulsed Field

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Magnesium Sulfate versus Placebo for Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial

Academic Emergency Medicine ◽

10.1111/j.1553-2712.2009.00360.x ◽

2009 ◽

Vol 16 (4) ◽

pp. 295-300 ◽

Cited By ~ 14

Author(s):

Kevin Chu ◽

Rhona Evans ◽

Gregory Emerson ◽

Jaimi Greenslade ◽

Anthony Brown

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Magnesium Sulfate ◽

Randomized Clinical Trial ◽

Paroxysmal Atrial Fibrillation

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

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.4.suppl_1.ap65 ◽

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.

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