TY - JOUR
T1 - Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure
AU - Dukkipati, Srinivas R.
AU - Holmes, David R.
AU - Doshi, Shephal K.
AU - Kar, Saibal
AU - Singh, Sheldon M.
AU - Gibson, Douglas
AU - Price, Matthew J.
AU - Natale, Andrea
AU - Mansour, Moussa
AU - Sievert, Horst
AU - Houle, Vicki M.
AU - Allocco, Dominic J.
AU - Reddy, Vivek Y.
N1 - Funding Information:
The PROTECT-AF, PREVAIL, and CAP2 studies were funded by Boston Scientific. Dr Dukkipati has received a research grant from Biosense Webster; and has equity in Manual Surgical Sciences and Farapulse (acquired by Boston Scientific). Dr Holmes is a member of the advisory board (unpaid) for Boston Scientific. Dr Doshi has received research and grand support from Abbott; has served as a consultant for and received research and grant support from Boston Scientific; and has served as a consultant for and received research support from Conformal. Dr Kar has served as a consultant and co–principal investigator of PINNACLE FLX and CHAMPION-AF for Abbott and Boston Scientific; has served as a consultant and principal investigator of EXPAND Registry and the REPAIR MR trial for Abbott; and has served as a consultant for WL Gore, Medtronic, and Laminar. Dr Gibson has served as a consultant for Boston Scientific, Abbott, Biosense-Webster, and Acutus. Dr Price has received consulting honoraria, speaker’s fees, and proctoring fees from Abbott Vascular and Boston Scientific; has received consulting honoraria and speaker’s fees from AstraZeneca and Medtronic; and has received consulting honoraria from WL Gore and Baylis Medical. Dr Natale has served as a consultant and advisory board member for Boston Scientific. Dr Mansour has served as a consultant for Biosense-Webster, Abbott, Medtronic, Boston Scientific, and Philips; and has equity/stock options in NewPace and Affera. Dr Sievert has served as a consultant for 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, Celonova, Contego, Coramaze, Croivalve, CVRx, Dinova, Edwards, Endobar, Endologix, Endomatic, Hangzhou Nuomao Medtech, Holistick Medical, Intershunt, Intervene, K2, Laminar, Lifetech, Magenta, Maquet Getinge Group, Medtronic, Metavention, Mitralix, Mokita, NXT Biomedical, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed, and Whiteswell. Dr Houle is a full-time employee of and has stock in Boston Scientific. Dr Allocco is a full-time employee of and has stock in Boston Scientific. Dr Reddy has served as a consultant (unpaid) for Boston Scientific; and has served as a consultant for and/or has equity in (not related to this work) Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, Biosense-Webster, BioTel Heart, Biotronik, Cardiac Implants, CardiaCare, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, CoreMap, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse (acquired by Boston Scientific), Fire1, Gore & Associates, HRT, Impulse Dynamics, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Manual Surgical Sciences, Medlumics, Medtronic, Middlepeak, Newpace, Nuvera, Philips, Pulse Biosciences, Restore Medical, Sirona Medical, Surecor, Valcare, and Vizaramed. Dr Singh has reported that he has no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2022
PY - 2022/8/2
Y1 - 2022/8/2
N2 - Background: In the U.S. Food and Drug Administration (FDA) clinical trials of left atrial appendage (LAA) closure, a postimplantation peridevice leak (PDL) of ≤5 mm (PDL≤5) was accepted as sufficient LAA “closure.” However, the clinical consequences of these PDLs on subsequent thromboembolism are poorly characterized. Objectives: We sought to assess the impact of PDL≤5 on clinical outcomes after implantation of the Watchman device. Methods: Using combined data from the FDA studies PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy), and CAP2 (Continued Access to PREVAIL), we assessed patients with successful device implantation for PDL by means of protocol-mandated transesophageal echocardiograms (TEEs) at 45 days and 1 year. Five-year outcomes were assessed as a function of the absence or presence of PDL≤5. Results: The cohort included 1,054 patients: mean age 74 ± 8.3 years, 65% male, and CHA2DS2-VASc 4.1 ± 1.4. TEE imaging at 45 days revealed 634 patients (60.2%) without and 404 (38.3%) with PDL≤5, and 1-year TEE revealed 704 patients (71.6%) without and 272 (27.7%) with PDL≤5. The presence of PDL≤5 at 1 year, but not at 45 days, was associated with an increased 5-year risk of ischemic stroke or systemic embolism (adjusted HR: 1.94; 95% CI: 1.15-3.29; P = 0.014), largely driven by an increase in nondisabling stroke (HR: 1.97; 95% CI: 1.03-3.78; P = 0.04), while disabling or fatal stroke rates were similar (HR: 0.69; 95% CI: 0.19-2.46; P = 0.56). PDL≤5 was not associated with an increased risk of cardiovascular or unexplained death (HR: 1.20; P = 0.45) or all-cause death (HR: 0.87; P = 0.42). Conclusions: PDL≤5 at 1 year after percutaneous LAA closure with the Watchman device are associated with increased thromboembolism, driven by increased nondisabling stroke, but similar mortality.
AB - Background: In the U.S. Food and Drug Administration (FDA) clinical trials of left atrial appendage (LAA) closure, a postimplantation peridevice leak (PDL) of ≤5 mm (PDL≤5) was accepted as sufficient LAA “closure.” However, the clinical consequences of these PDLs on subsequent thromboembolism are poorly characterized. Objectives: We sought to assess the impact of PDL≤5 on clinical outcomes after implantation of the Watchman device. Methods: Using combined data from the FDA studies PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy), and CAP2 (Continued Access to PREVAIL), we assessed patients with successful device implantation for PDL by means of protocol-mandated transesophageal echocardiograms (TEEs) at 45 days and 1 year. Five-year outcomes were assessed as a function of the absence or presence of PDL≤5. Results: The cohort included 1,054 patients: mean age 74 ± 8.3 years, 65% male, and CHA2DS2-VASc 4.1 ± 1.4. TEE imaging at 45 days revealed 634 patients (60.2%) without and 404 (38.3%) with PDL≤5, and 1-year TEE revealed 704 patients (71.6%) without and 272 (27.7%) with PDL≤5. The presence of PDL≤5 at 1 year, but not at 45 days, was associated with an increased 5-year risk of ischemic stroke or systemic embolism (adjusted HR: 1.94; 95% CI: 1.15-3.29; P = 0.014), largely driven by an increase in nondisabling stroke (HR: 1.97; 95% CI: 1.03-3.78; P = 0.04), while disabling or fatal stroke rates were similar (HR: 0.69; 95% CI: 0.19-2.46; P = 0.56). PDL≤5 was not associated with an increased risk of cardiovascular or unexplained death (HR: 1.20; P = 0.45) or all-cause death (HR: 0.87; P = 0.42). Conclusions: PDL≤5 at 1 year after percutaneous LAA closure with the Watchman device are associated with increased thromboembolism, driven by increased nondisabling stroke, but similar mortality.
KW - left atrial appendage closure
KW - peridevice leaks
KW - stroke
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U2 - 10.1016/j.jacc.2022.04.062
DO - 10.1016/j.jacc.2022.04.062
M3 - Article
C2 - 35902169
AN - SCOPUS:85134232658
SN - 0735-1097
VL - 80
SP - 469
EP - 483
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 5
ER -