Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: real-world experience from a prospective, multicentre observational cohort registry

Abstract Background Although pulmonary vein isolation (PVI) is considered the standard approach of atrial fibrillation ablation worldwide, procedural practice during the ablation varies by geographical region. Using the same magnetic sensor enabled contact force-sensing ablation catheter for the treatment of de novo paroxysmal atrial fibrillation, a comparison of procedural detail between Europe and U.S operators can provide insights into geographic specific clinical practices. Purpose To characterize and compare procedural differences during paroxysmal atrial fibrillation ablation performed with a magnetic sensor enabled contact force-sensing catheter across European and U.S. centers. Methods Procedural data were prospectively collected in clinical cases performed with a new magnetic sensor enabled, contact force ablation catheter within the first 6 months of use at participating centers in Europe and the U.S. Procedure time, PVI time, PVI confirmation method, fluoroscopy usage and lesion delivery parameters were analyzed based on geographies. Results A total of 131 cases across 35 centers in 11 European countries, and 95 cases across 26 U.S. centers were analyzed. Target geometry was created with the ablation catheter in 94 out of 131 (71.8%) European cases, while only 5 out of 95 U.S. cases (5.3%) reported the use of the ablation catheter for model creation. Although a steerable sheath (64.1% and 67.3%) was commonly used with the ablation catheter in both geographies, difference in the utilization of bidirectional contact force catheter (52.7% and 90.5%) and the automated lesion marking module (76.3% and 81.1%) were observed in European and U.S. cases, respectively. The use of adenosine or isoproterenol to confirm PVI was reported in 25% and 64% of the European and U.S. cases. Average waiting periods were 18.2 minutes and 26.5 minutes from reported European and U.S. cases. Total procedural time, mapping time, and fluoroscopy time were similar between European and U.S. cases. (Table). First pass PVI were 66.4% and 72.6% for European and U.S. cases, respectively. Conclusion Total procedural time and RF time were similar between European and U.S. cases during de novo paroxysmal atrial fibrillation ablation using the same ablation catheter. Differences in workflow including the use of a mapping catheter for geometry creation and waiting period were observed between the two geographies. Summary of procedural details De novo PAF N Procedural time(min) Mapping time (min) PVI time (min) Total RF time (min) Fluoro time( min) Europe 131 144.0 ± 56.9 16.6 ± 17.1 69.8 ± 35.0 33.2 ± 15.6 11.6 ± 10.1 U.S. 95 137.6 ± 64.8 18.1 ± 23.5 58.8 ± 31.5 32.3 ± 22.2 12.0 ± 15.8

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P981Comparison of automark utilization and lesion metric target during paroxysmal atrial fibrillation ablation with a contact force-sensing ablation catheter: European and U.S. multicenter Experiences

EP Europace ◽

10.1093/europace/euaa162.004 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

H Ramanna ◽

J L Lloret ◽

F Zahwe ◽

C Porterfield ◽

S Trines ◽

...

Keyword(s):

Atrial Fibrillation ◽

Contact Force ◽

Paroxysmal Atrial Fibrillation ◽

Magnetic Sensor ◽

Atrial Fibrillation Ablation ◽

Force Sensing ◽

Ablation Catheter ◽

Energy Delivery ◽

Target Values ◽

The U.S

Abstract Background Accurate delivery of transmural lesion is associated with improved durability of pulmonary vein isolation and reduced reconduction. Lesion quality depends on multiple parameters such as radiofrequency power, tissue-catheter contact, duration of energy application, and catheter tip temperature. Consequently, energy delivery parameters vary based on individual operators’ preferences and procedural needs. Purpose To characterize and compare the utilization of automated lesion marking feature and lesion delivery parameters used during paroxysmal atrial fibrillation ablation performed with a magnetic sensor enabled contact force-sensing catheter across European and U.S. centers. Methods Procedural data were prospectively collected in clinical cases performed with a new magnetic sensor enabled, contact force ablation catheter within the first 6 months of use at participating centers in Europe and the U.S. Use of bidirectional CF catheters, steerable sheaths, automated lesion marking software and associated lesion delivery parameters during paroxysmal atrial fibrillation ablation were evaluated. Results A total of 149 cases across 37 centers in 11 European countries, and 112 cases across 31 U.S. centers were analyzed. A bidirectional contact force catheter (56.4% and 90.2%), a steerable sheath (65.8% and 69.6%), and the automated lesion marking module (77.9% and 90.2%) were used in most European and U.S. cases, respectively. The most commonly reported energy delivery parameters were: lesion index (LSI), Force-Time Integral (FTI), and time from European cases; LSI, average force, and FTI for U.S. cases (Table). Target LSI values were recorded for 126 cases in Europe and 34 in the U.S, ranging from 3 to 6. In anterior/roof segments, most common LSI target values for anterior/roof and posterior/inferior segments were 6 (42.9%) and 5 (51.2%) in Europe, and 5.5 (44.1%) and 5 (54.5%) in the U.S. PVI was confirmed with an average of 20.3 minutes waiting period (69.1%) for European cases and exit block (57.1%) in U.S. cases. First pass PVI were 67.1% and 74.4% for European and U.S. cases, respectively. Conclusion Energy delivery parameters and PVI confirmation method varied considerably by geography during paroxysmal atrial fibrillation ablation using the magnetic sensor enabled, contact force ablation catheter. Further study on efficacy implication on these differences in practice should be examined. Energy delivery parameters used Paroxysmal AF N LSI FTI Time Imp Drop Avg Force Other N/A Europe 149 44.0 % 13.4 % 7.0 % 6.0 % 2.4 % 1.0 % 26.2 % U.S. 112 31.2% 17.9 % 6.2 % 8.0 % 23.2 % 11.7 % 1.8 % Energy delivery parameters used in paroxysmal AF ablation in Europe and U.S.

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

BMJ Surgery, Interventions, & Health Technologies ◽

10.1136/bmjsit-2020-000058 ◽

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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