Comparing rates of atrioesophageal fistula with contact force-sensing and non-contact force-sensing catheters: analysis of post-market safety surveillance data.

PURPOSE: There is limited data on the specific incidence of serious adverse events, such as atrioesophageal fistula (AEF), associated with either contact force (CF) or non-CF ablation catheters. Since the actual number of procedures performed with each type of catheter is unknown, making direct comparisons is difficult. The purpose of this study was to assess the incidence of AEF associated with the use of CF and non-CF catheters. Additionally, we aimed to understand the workflow present in confirmed AEF cases voluntarily provided by physicians. METHODS: The number of AEFs for 2014-2017 associated with each type of catheter was extracted from an ablation device manufacturer's complaint database. Proprietary device sales data, a proxy for the total number of procedures, were used as the denominator to calculate the incidence rates. Additional survey and workflow data were systematically reviewed. RESULTS: Both CF and non-CF ablation catheters have comparably low incidence of AEF (0.006 ± 0.003% and 0.005 ± 0.003%, respectively, p = 0.69). CF catheters are the catheter of choice for left atrium (LA) procedures which pose the greatest risk for AEF injury. Retrospective analysis of seven AEF cases demonstrated that high power and force and long RF duration were delivered on the posterior wall of the left atrium in all cases. CONCLUSIONS: CF and non-CF ablation catheters were found to have similar AEF incidence, despite CF catheters being the catheter of choice for LA procedures. More investigation is needed to understand the range of parameters which may create risk for AEF.

Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy Delivery: Short-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE).

BACKGROUND: Balloon catheters facilitate pulmonary vein (PV) isolation, but current technology is limited by either a single ablative element, potentially leading to over-ablation of thin and under-ablation of thick tissue, or prolonged procedure times. Visualized by electroanatomical mapping, a novel compliant radiofrequency balloon catheter with 10 irrigated, flexible electrodes can simultaneously and independently deliver energy. Herein, we evaluated the feasibility, safety, and short-term efficacy of this radiofrequency balloon in a multicenter, single-arm, first-in-human study. METHODS: Paroxysmal atrial fibrillation patients underwent PV isolation with the radiofrequency balloon delivered over-the-wire with a deflectable 13.5F sheath. Radiofrequency energy is delivered simultaneously from all electrodes-up to 30 s posteriorly and 60 s anteriorly. Esophageal temperature was monitored in all patients; the esophagus was also mechanically deviated in 10 patients. RESULTS: At 4 sites, 39 patients were treated by 9 operators. The radiofrequency balloon isolated all targeted PVs (152/152), 79.6% with a single application. Electrical reconnection occurred in only 7/150 PVs (4.7%) on adenosine/isoproterenol challenge. Mean procedure, balloon dwell, and fluoroscopy times were 101.6, 40.5, and 17.4 min, respectively. Esophagogastroduodenoscopy revealed asymptomatic esophageal erythema in 5 patients. Phrenic nerve palsy occurred in a patient in whom phrenic pacing was inadvertently omitted. At 3 months, imaging revealed no PV stenosis, and early atrial arrhythmia recurrence occurred in only 10/39 (25.6%) patients. CONCLUSIONS: The compliant radiofrequency balloon can directionally tailor energy delivery for efficient, effective, and reasonably safe acute PV isolation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: ISRCTN 11764506.