TY - JOUR
T1 - Safety and Effectiveness of a Catheter with Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
AU - Dhruva, Sanket S.
AU - Zhang, Shumin
AU - Chen, Jiajing
AU - Noseworthy, Peter A.
AU - Doshi, Amit A.
AU - Agboola, Kolade M.
AU - Herrin, Jeph
AU - Jiang, Guoqian
AU - Yu, Yue
AU - Cafri, Guy
AU - Collison Farr, Kimberly
AU - Ervin, Keondae R.
AU - Ross, Joseph S.
AU - Coplan, Paul M.
AU - Drozda, Joseph P.
N1 - Funding Information:
Funding/Support: This project was supported by a research grant from the MDIC as part of the NEST Coordinating Center, an initiative funded by grant 1U01FD006292-01 from the FDA.
Funding Information:
Administrative, technical, or material support: Zhang, Noseworthy, Doshi, Collison Farr, Ervin, Coplan, Drozda. Supervision: Zhang, Doshi, Coplan, Drozda. Conflict of Interest Disclosures: Dr Dhruva reported receiving grants from the Medical Device Innovation Consortium (MDIC) during the conduct of the study and research funding from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), US Food and Drug Administration (FDA), Greenwall Foundation, Arnold Ventures, National Institute for Health Care Management, and Department of Veterans Affairs. Dr Zhang reported being an employee of Johnson & Johnson and receiving restricted share units from Johnson & Johnson. The manufacturer of the ThermoCool catheters is Biosense Webster, which is part of the Johnson & Johnson Family of Companies. Dr Chen reported receiving grants from MDIC during the conduct of the study. Dr Cafri reported receiving salary support from Johnson & Johnson during the conduct of the study and outside the submitted work. Ms Collison Farr reported receiving grants from MDIC during the conduct of the study. Dr Ross reported receiving grants from MDIC during the conduct of the study and grants from the FDA, Johnson & Johnson, Agency for Health Care Research and Quality, NIH/NHLBI, and Laura and John Arnold Foundation outside the submitted work. Dr Ross is an expert witness at the request of relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. Dr Coplan reported being an employee of Johnson & Johnson in the Office of the Chief Medical Officer, Department of Epidemiology and Real World Data Sciences. Dr Drozda reported receiving grants from MDIC during the conduct of the study and having a nondependent son who is an employee of Boston Scientific Corporation. No other disclosures were reported.
Publisher Copyright:
© 2022 American Medical Association. All rights reserved.
PY - 2022/8/17
Y1 - 2022/8/17
N2 - Importance: The ThermoCool SmartTouch catheter (ablation catheter with contact force and 6-hole irrigation [CF-I6]) is approved by the US Food and Drug Administration (FDA) for paroxysmal atrial fibrillation (AF) ablation and used in routine clinical practice for persistent AF ablation, although clinical outcomes for this indication are unknown. There is a need to understand whether data from routine clinical practice can be used to conduct regulatory-grade evaluations and support label expansions. Objective: To use health system data to compare the safety and effectiveness of the CF-I6 catheter for persistent AF ablation with the ThermoCool SmartTouch SurroundFlow catheter (ablation catheter with contact force and 56-hole irrigation [CF-I56]), which is approved by the FDA for this indication. Design, Setting, and Participants: This retrospective, comparative-effectiveness cohort study included patients undergoing catheter ablation for persistent AF at Mercy Health or Mayo Clinic from January 1, 2014, to April 30, 2021, with up to a 1-year follow-up using electronic health record data. Exposures: Use of the CF-I6 or CF-I56 catheter. Main Outcomes and Measures: The primary safety outcome was a composite of death, thromboembolic events, and procedural complications within 7 to 90 days. The exploratory effectiveness outcome was a composite of AF-related hospitalization events after a 90-day blanking period. Propensity score weighting was used to balance baseline covariates. Risk differences were estimated between catheter groups and averaged across the 2 health care systems, testing for noninferiority of the CF-I6 vs the CF-I56 catheter with respect to the safety outcome using 2-sided 90% CIs. Results: Overall, 1450 patients (1034 [71.3%] male; 1397 [96.3%] White) underwent catheter ablation for persistent AF, including 949 at Mercy Health (186 CF-I6 and 763 CF-I56; mean [SD] age, 64.9 [9.2] years) and 501 at Mayo Clinic (337 CF-I6 and 164 CF-I56; mean [SD] age, 63.7 [9.5] years). A total of 798 (55.0%) had been treated with class I or III antiarrhythmic drugs before ablation. The safety outcome (CF-I6 - CF-I56) was similar at both Mercy Health (1.3%; 90% CI, -2.1% to 4.6%) and Mayo Clinic (-3.8%; 90% CI, -11.4% to 3.7%); the mean difference was noninferior, with a mean of 0.5% (90% CI, -2.6% to 3.5%; P <.001). The effectiveness was similar at 12 months between the 2 catheter groups (mean risk difference, -1.8%; 90% CI, -7.3% to 3.7%). Conclusions and Relevance: In this cohort study, the CF-I6 catheter met the prespecified noninferiority safety criterion for persistent AF ablation compared with the CF-I56 catheter, and effectiveness was similar. This study demonstrates the ability of electronic health care system data to enable safety and effectiveness evaluations of medical devices..
AB - Importance: The ThermoCool SmartTouch catheter (ablation catheter with contact force and 6-hole irrigation [CF-I6]) is approved by the US Food and Drug Administration (FDA) for paroxysmal atrial fibrillation (AF) ablation and used in routine clinical practice for persistent AF ablation, although clinical outcomes for this indication are unknown. There is a need to understand whether data from routine clinical practice can be used to conduct regulatory-grade evaluations and support label expansions. Objective: To use health system data to compare the safety and effectiveness of the CF-I6 catheter for persistent AF ablation with the ThermoCool SmartTouch SurroundFlow catheter (ablation catheter with contact force and 56-hole irrigation [CF-I56]), which is approved by the FDA for this indication. Design, Setting, and Participants: This retrospective, comparative-effectiveness cohort study included patients undergoing catheter ablation for persistent AF at Mercy Health or Mayo Clinic from January 1, 2014, to April 30, 2021, with up to a 1-year follow-up using electronic health record data. Exposures: Use of the CF-I6 or CF-I56 catheter. Main Outcomes and Measures: The primary safety outcome was a composite of death, thromboembolic events, and procedural complications within 7 to 90 days. The exploratory effectiveness outcome was a composite of AF-related hospitalization events after a 90-day blanking period. Propensity score weighting was used to balance baseline covariates. Risk differences were estimated between catheter groups and averaged across the 2 health care systems, testing for noninferiority of the CF-I6 vs the CF-I56 catheter with respect to the safety outcome using 2-sided 90% CIs. Results: Overall, 1450 patients (1034 [71.3%] male; 1397 [96.3%] White) underwent catheter ablation for persistent AF, including 949 at Mercy Health (186 CF-I6 and 763 CF-I56; mean [SD] age, 64.9 [9.2] years) and 501 at Mayo Clinic (337 CF-I6 and 164 CF-I56; mean [SD] age, 63.7 [9.5] years). A total of 798 (55.0%) had been treated with class I or III antiarrhythmic drugs before ablation. The safety outcome (CF-I6 - CF-I56) was similar at both Mercy Health (1.3%; 90% CI, -2.1% to 4.6%) and Mayo Clinic (-3.8%; 90% CI, -11.4% to 3.7%); the mean difference was noninferior, with a mean of 0.5% (90% CI, -2.6% to 3.5%; P <.001). The effectiveness was similar at 12 months between the 2 catheter groups (mean risk difference, -1.8%; 90% CI, -7.3% to 3.7%). Conclusions and Relevance: In this cohort study, the CF-I6 catheter met the prespecified noninferiority safety criterion for persistent AF ablation compared with the CF-I56 catheter, and effectiveness was similar. This study demonstrates the ability of electronic health care system data to enable safety and effectiveness evaluations of medical devices..
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U2 - 10.1001/jamanetworkopen.2022.27134
DO - 10.1001/jamanetworkopen.2022.27134
M3 - Article
C2 - 35976649
AN - SCOPUS:85136909706
SN - 2574-3805
VL - 5
SP - E2227134
JO - JAMA Network Open
JF - JAMA Network Open
IS - 8
ER -