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

2019 ◽  
Vol 59 (1) ◽  
pp. 49-55 ◽  
Author(s):  
Hugh Calkins ◽  
Andrea Natale ◽  
Tara Gomez ◽  
Alex Etlin ◽  
Moe Bishara
Keyword(s):  
Left Atrium ◽  
Contact Force ◽  
Posterior Wall ◽  
Incidence Rates ◽  
Force Sensing ◽  
Limited Data ◽  
Serious Adverse Events ◽  
Atrioesophageal Fistula ◽  
Post Market ◽  
Low Incidence

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.

scholarly journals The role of local impedance drop in the acute lesion efficacy during pulmonary vein isolation performed with a new contact force sensing catheter—A pilot study

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257050
Author(s):  
Nándor Szegedi ◽  
Zoltán Salló ◽  
Péter Perge ◽  
Katalin Piros ◽  
Vivien Klaudia Nagy ◽  
...  
Keyword(s):  
Pilot Study ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Contact Force ◽  
Posterior Wall ◽  
Anterior Wall ◽  
Force Sensing ◽  
Lesion Formation ◽  
Force Time

Introduction Our pilot study aimed to evaluate the role of local impedance drop in lesion formation during pulmonary vein isolation with a novel contact force sensing ablation catheter that records local impedance as well and to find a local impedance cut-off value that predicts successful lesion formation. Materials and methods After completing point-by-point radiofrequency pulmonary vein isolation, the success of the applications was evaluated by pacing along the ablation line at 10 mA, 2 ms pulse width. Lesions were considered successful if loss of local capture was achieved. Results Out of 645 applications, 561 were successful and 84 were unsuccessful. Compared to the unsuccessful ablation points, the successful applications were shorter (p = 0.0429) and had a larger local impedance drop (p<0.0001). There was no difference between successful and unsuccessful applications in terms of mean contact force (p = 0.8571), force-time integral (p = 0.0699) and contact force range (p = 0.0519). The optimal cut-point for the local impedance drop indicating successful lesion formation was 21.80 Ohms on the anterior wall [AUC = 0.80 (0.75–0.86), p<0.0001], and 18.30 Ohms on the posterior wall [AUC = 0.77 (0.72–0.83), p<0.0001]. A local impedance drop larger than 21.80 Ohms on the anterior wall and 18.30 Ohms on the posterior wall was associated with an increased probability of effective lesion creation [OR = 11.21, 95%CI 4.22–29.81, p<0.0001; and OR = 7.91, 95%CI 3.77–16.57, p<0.0001, respectively]. Conclusion The measurement of the local impedance may predict optimal lesion formation. A local impedance drop > 21.80 Ohms on the anterior wall and > 18.30 Ohms on the posterior wall significantly increases the probability of creating a successful lesion.

scholarly journals Low Incidence of Esophageal Lesions After Pulmonary Vein Isolation Using Contact-Force Sensing Catheter Without Esophageal Temperature Probe

2017 ◽  
Vol 58 (6) ◽  
pp. 880-884 ◽  
Author(s):  
Christian Blockhaus ◽  
Patrick Müller ◽  
Stephan vom Dahl ◽  
Silke Leonhardt ◽  
Dieter Häussinger ◽  
...  
Keyword(s):  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Contact Force ◽  
Force Sensing ◽  
Esophageal Temperature ◽  
Temperature Probe ◽  
Low Incidence

High-power, short-duration atrial fibrillation ablations using contact force sensing catheters: Outcomes and predictors of success including posterior wall isolation

Heart Rhythm ◽  
2020 ◽  
Vol 17 (8) ◽  
pp. 1223-1231 ◽  
Author(s):  
Roger A. Winkle ◽  
R. Hardwin Mead ◽  
Gregory Engel ◽  
Melissa H. Kong ◽  
Jonathan Salcedo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Short Duration ◽  
Contact Force ◽  
High Power ◽  
Posterior Wall ◽  
Force Sensing ◽  
Predictors Of Success

Risk of atrioesophageal fistula formation with contact force–sensing catheters

Heart Rhythm ◽  
2017 ◽  
Vol 14 (9) ◽  
pp. 1328-1333 ◽  
Author(s):  
Eric Black-Maier ◽  
Sean D. Pokorney ◽  
Adam S. Barnett ◽  
Emily P. Zeitler ◽  
Albert Y. Sun ◽  
...  
Keyword(s):  
Contact Force ◽  
Fistula Formation ◽  
Force Sensing ◽  
Atrioesophageal Fistula

TBE in Italy

2020 ◽  
Keyword(s):  
Surveillance System ◽  
Ad Hoc ◽  
National Level ◽  
Case Series ◽  
Incidence Rates ◽  
Mountainous Regions ◽  
North East ◽  
The North ◽  
Tick Borne Encephalitis ◽  
Low Incidence

Italy is considered a low-incidence country for tick-borne encephalitis (TBE) in Europe.1 Areas at higher risk for TBE in Italy are geographically clustered in the forested and mountainous regions and provinces in the north east part of the country, as suggested by TBE case series published over the last decade.2-5 A national enhanced surveillance system for TBE has been established since 2017.6 Before this, information on the occurrence of TBE cases at the national level in Italy was lacking. Both incidence rates and the geographical distribution of the disease were mostly inferred from endemic areas where surveillance was already in place, ad hoc studies and international literature.1

scholarly journals Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology

2020 ◽  
Vol 2 (1) ◽  
pp. e000058
Author(s):  
Joseph G Akar ◽  
James P Hummel ◽  
Xiaoxi Yao ◽  
Lindsey Sangaralingham ◽  
Sanket Dhruva ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Acute Care ◽  
Contact Force ◽  
Emergency Department Visits ◽  
Atrial Fibrillation Ablation ◽  
Esophageal Injury ◽  
Force Sensing ◽  
Complication Rates ◽  
Af Ablation ◽  
Complications And Mortality

ObjectivesContact force-sensing catheters allow real-time catheter-tissue contact force monitoring during atrial fibrillation. These catheters were rapidly adopted into clinical practice following market introduction in 2014, but concerns have been raised regarding collateral damage such as esophageal injury. We sought to examine whether the introduction of force-sensing catheters was associated with a change in short-term and intermediate-term acute care use, complications and mortality following atrial fibrillation ablation.DesignRetrospective cohort analysis. We used inverse probability treatment weight matching to account for the differences in baseline characteristics between groups.SettingWe examined patients included in the OptumLabs Data Warehouse who underwent ablation for atrial fibrillation before (2011–2013) and after (2015–2017) the market introduction of contact force-sensing catheters.Main outcome measuresWe examined 30-day and 90-day rates of all-cause acute care use, including hospitalizations and emergency department visits, as well as death and hospitalization for catheter-related complications, including atrioesophageal fistula, pericarditis, cardiac tamponade/perforation and stroke/transient ischemic attack.ResultsOur sample included 3470 and 5772 patients who underwent atrial fibrillation (AF) ablation before and after market introduction of contact force-sensing catheters, respectively. Complication rates were low and did not differ between the two periods (p>0.10 for each outcome). The 30-day and 90-day mortality was 0.1% and 0.3%, respectively after market introduction and unchanged from prior to 2014. The 90-day rates of all-cause acute care use decreased, from 27.0% in 2011–2013 to 23.9% in 2015–2017 (p<0.001).ConclusionsAF ablation-related catheter complications and mortality are low and there has been no significant change following the introduction of force-sensing catheters.

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