Acute Safety of an Open‐Irrigated Ablation Catheter with 56‐Hole Porous Tip for Radiofrequency Ablation of Paroxysmal Atrial Fibrillation: Analysis from 2 Observational Registry Studies

Abstract

Acute Safety from 2 AF Ablation RegistriesIntroductionThis report presents safety data on the use of a new open-irrigation radiofrequency ablation (RFA) catheter with a 56-hole porous tip in 742 patients enrolled in 2 US prospective, multicenter observational registry studies representing real-world use of the catheter.MethodsThis analysis is comprised of patients who underwent RFA of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (AF). Acute adverse events (AEs) were collected and categorized by seriousness, timing, and relatedness, with 7 days of follow-up data in one study and at least 120 days of data from a 1-year follow-up in the other. Acute serious adverse events (SAEs) that were identified as potentially related to the device and/or procedure were adjudicated by an independent safety committee.ResultsA total of 30 patients (4.0%) in the combined studies experienced an acute SAE related to the device and/or procedure, which was similar in the subset of patients age 65 and over (4.2%). These SAEs included 1.2% cardiac tamponade/perforation, 0.7% pericarditis, 0.5% pulmonary events, and 0.8% vascular access complications. No myocardial infarction, stroke, transient ischemic attack, or atrioesophageal fistulas within 7 days postprocedure were reported. In the study with extended follow-up, 1 pulmonary vein stenosis and 1 esophageal injury were seen beyond 7 days postprocedure (0.2% each). There were no device or procedure related deaths.ConclusionResults from 2 large observational studies demonstrated that a new porous tip RFA catheter was safe for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF, including treatment of older patients (≥65 years).

Healthcare Utilization and Quality of Life Improvement after Ablation for Paroxysmal AF in Younger and Older Patients

“…The benefits of catheter ablation in the elderly population are increasingly being reported . In a study of patients undergoing ablation at Johns Hopkins Hospital, Hoyt et al.…”

“…In particular, the elderly patients may be healthier than average AF patients their age, potentially representing the most robust of this elderly population. Nevertheless, several studies have shown that of the elderly who do present for ablation, outcomes are favorable when compared with the younger population . In addition, “real‐world” studies such as this provide valuable complementary information and insights to data derived from randomized controlled trials due to fewer inclusion and exclusion criteria and a broader range of participating clinical sites.…”

“…All of the IUAF procedures and some of the SFAF procedures also included use of the SoundStar ® Catheter for 3D intracardiac echocardiography. Ablation methodology was at the discretion of the operators with minimal recommendations, as reported previously for these trials …”

Safety and Clinical Outcomes of Catheter Ablation of Atrial Fibrillation in Patients With Chronic Kidney Disease

“…Congestive heart failure has been increasingly recognized as an acute sequela after AF ablation and may be due to fluid overload in the setting of a noncompliant atrium, poor left atrial function, or diastolic dysfunction . A reduction in fluid delivery with use of low‐volume irrigated‐tip catheters may have promise in reducing HF complications associated with volume overload, as would tools or techniques that can reduce overall procedure time . On the other hand, impaired renal function is itself a risk factor for both HF and HF hospitalization and higher hospitalization rates could reflect the higher prevalence of HF in the CKD group at baseline, or at least the propensity to retain fluid.…”

Characterization of a stepwise approach in cavotricuspid isthmus ablation for typical atrial flutter: A randomized study comparing three catheters

“…For the last years, a novel diffuse‐irrigation system consistent on a porous‐tip has been available for clinical use (ThemoCool SF © ; Biosense Webster Inc., Diamond Bar, CA, USA). Previous randomized studies have displayed an appropriate profile in terms of safety and efficacy on pulmonary vein isolation . However, no data are available for the use of these catheter in the ablation of the CTI.…”