Jacc. Cardiovascular Imaging
Published by Elsevier on behalf of the American College of Cardiology Foundation
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Necessity of 45-Day Transesophageal Echocardiography After the WATCHMAN Procedure Amid the COVID-19 Pandemic
Volume: 13, Issue: 11
DOI 10.1016/j.jcmg.2020.05.015
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Tan, Depta, Baibhav, and Bhatt: Necessity of 45-Day Transesophageal Echocardiography After the WATCHMAN Procedure Amid the COVID-19 Pandemic

Amidst the coronavirus disease-2019 (COVID-19) outbreak, elective aerosolizing procedures such as transesophageal echocardiography (TEE) should be deferred as the procedure provokes coughing and gagging, which can cause aerosolization of the virus (1). The American Society of Echocardiography recommends applying personal protective equipment when performing TEE in symptomatic patients with suspected/confirmed COVID-19. The risks and benefits of TEE should be considered for both symptomatic and asymptomatic COVID-19 patients (1).

In atrial fibrillation patients undergoing left atrial appendage closure (LAAC), TEE is typically performed at 45 days to assess peri-device flow <5 mm and an absence of device-related thrombus (DRT) before oral anticoagulation (OAC) is discontinued. We sought to investigate whether a 45-day TEE is absolutely necessary for patients who underwent LAAC amid the COVID-19 pandemic (2).

We retrospectively studied 200 patients who underwent a successful WATCHMAN procedure in a tertiary hospital (from June 2016 to June 2019). Upon discharge, patients were maintained on OAC and aspirin. We aimed to assess TEE measured peri-device flow at the time of implantation and at 45 days. Institutional review board approval was obtained. The mean age was 75.9 ± 8.3 years, and 42.9% of patients were women. The mean CHA2DS2-VASc and HAS-BLED scores were 4.8 ± 1.6 and 2.9 ± 0.9, respectively. Patients were discharged more frequently on direct oral anticoagulants (DOACs) (77.5%) as opposed to warfarin (22.0%). At the time of the WATCHMAN procedure, 189 of 200 patients (94.5%) had an absence of peri-device flow, and 11 of 200 (5.5%) had peri-device flow 1 to 5 mm.

Among 189 patients without peri-device flow during the procedure, 180 underwent TEE at 45 days; where 126 of 180 patients (70.0%) had an absence of peri-device flow, 53 of 180 (29.4%) had flow 1 to 5 mm, and 1 of 180 (0.6%) had significant peri-device flow >5 mm (Figure 1 ). Among 11 patients with peri-device flow 1 to 5 mm at the time of the procedure, 9 underwent TEE at 45 days; where 4 of 9 patients (44.4%) had an absence of peri-device flow, 5 of 9 (55.6%) had flow 1 to 5 mm, and 0 of 9 (0%) had peri-device flow >5 mm. No patients had DRT on 45-day TEE.

Peri-Device Flow During the Procedure and at 45 Days
Figure 1
Peri-Device Flow During the Procedure and at 45 DaysAmong 189 patients who underwent 45-day transesophageal echocardiography, only 1 patient had peri-device flow >5 mm.

In the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) trial, peri-device flow >3 mm was observed in 13% and 12% of patients on 45-day and 1-year TEE, respectively. However, the more recent EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) study showed that significant peri-device flow >5 mm occurred only in 1% of patients on 1-year TEE. In our study, 1 patient (0.5%) developed significant peri-device flow on 45-day TEE, and none had DRT.

For WATCHMAN programs that deviate from standard warfarin regimen post-LAAC, DRT is more common with single/dual antiplatelet therapy than OAC (warfarin and DOACs) (3). The rates of DRT were similar in patients receiving DOAC (0.9%) compared with warfarin (0.5%) in a retrospective multicenter study (4). Thus, a 45-day assessment may be more relevant in patients receiving single/dual antiplatelet therapy post-LAAC. Additionally, it calls into question the current practice of assessing DRT while on OAC at 45 days. It may be more reasonable to assess for DRT after discontinuation of OAC. This specific question requires further investigation.

In this retrospective analysis, we showed that the incidence of significant peri-device flow and DRT at 45 days is very low. Thus, a 45-day TEE post-WATCHMAN implantation may not be necessary for all patients, and OAC may be safely discontinued at 45 days without a TEE. Currently, the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry requires documentation of device closure and absence of DRT at 45 days post-LAAC. Computed tomography is a reasonable alternative to TEE for device surveillance (5). In our opinion (not supported by the present study), the rationale for foregoing a 45-day TEE should also extend to the baseline TEE before LAAC. Use of computed tomography may be considered. Amid the COVID-19 pandemic, deferring 45-day TEE post-WATCHMAN implantation has the potential to minimize use of personal protective equipment and reduce preventable risks of viral transmission. Prospective trials are warranted to see whether this practice should be reconsidered even after the pandemic subsides (2).

References

1 

    Kirkpatrick J.N., Mitchell C., Taub C., Kort S., Hung J., Swaminathan M.. ASE statement on protection of patients and echocardiography service providers during the 2019 novel coronavirus outbreak. J Am Coll Cardiol 75: 2020. , pp.3078-3084

2 

    Wang X., Bhatt D.L.. COVID-19: an unintended force for medical revolution?. J Invasive Cardiol 32: 2020. , pp.E81-E82

3 

    Søndergaard L., Wong Y.H., Reddy V.Y.. Propensity-matched comparison of oral anticoagulation versus antiplatelet therapy after left atrial appendage closure with WATCHMAN. J Am Coll Cardiol Intv 12: 2019. , pp.1055-1063

4 

    Enomoto Y., Gadiyaram V.K., Gianni C.. Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the Watchman device. Heart Rhythm 14: 2017. , pp.19-24

5 

    Qamar S.R., Jalal S., Nicolaou S., Tsang M., Gilhofer T., Saw J.. Comparison of cardiac computed tomography angiography and transoesophageal echocardiography for device surveillance after left atrial appendage closure. EuroIntervention 15: 2019. , pp.663-670

Notes

Dr. Depta has been a consultant and on advisory boards for Edwards Lifesciences LLC, Boston Scientific, and WL Gore & Associates. Dr. Bhatt has been on advisory boards for Cardax, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; has been a member of the Board of Directors for Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; has been Chair of the American Heart Association Quality Oversight Committee; is on Data Monitoring Committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Medtelligence/ReachMD (CME steering committees), Level Ex, MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national coleader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); has received grants from Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); is Site Co-Investigator for Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; is a Trustee of the American College of Cardiology; and is involved in unfunded Research with FlowCo, Merck, Novo Nordisk, and Takeda. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Imagingauthor instructions page.
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