Comparing rates of atrioesophageal fistula with contact force-sensing and non-contact force-sensing catheters: analysis
- PDF / 363,057 Bytes
- 7 Pages / 595.276 x 790.866 pts Page_size
- 29 Downloads / 224 Views
Comparing rates of atrioesophageal fistula with contact force-sensing and non-contact force-sensing catheters: analysis of post-market safety surveillance data Hugh Calkins 1 & Andrea Natale 2 & Tara Gomez 3 & Alex Etlin 3 & Moe Bishara 3 Received: 22 August 2019 / Accepted: 27 October 2019 # The Author(s) 2019
Abstract 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. Keywords Atrial fibrillation (Afib) . Atrioesophageal fistula (AEF) . Contact force . Radiofrequency (RF) ablation . THERMOCOOL SMARTTOUCH® . CARTO® 3
1 1 Background During radiofrequency (RF) ablation of cardiac arrhythmias, stable catheter-tissue contact is an important factor for making contiguous transmural lesions and is a strong predictor of 12month procedural success [1–3]. For that reason, contact force (CF)-sensing catheters are widely used as part of a strategy for the treatment of arrhythmias [4, 5]. Atrial fibrillation ablation procedures involve delivering RF on the posterior wall of the left atrium, often in close proximity to the esophagus. The * Moe Bishara [email protected] 1
Johns Hopkins Medical Institutions, 600 N. Wolfe Street, Sheikh Zayed Tower 7125R, Baltimore, MD, USA
2
Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, 3000 N. I-35, Suite 720, Austin, TX 78705, USA
3
Biosense Webster Inc., 33 Technology Dr, Irvine, CA 92618, USA
associated risk of atrioesophageal fistula (AEF) is a rare but potentially lethal consequence of RF ablation [4, 6, 7]. The THERMOCOOL SMARTTOUCH® catheter is a C
Data Loading...
