Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec;9(12):2587-2599.
doi: 10.1016/j.jacep.2023.08.004. Epub 2023 Oct 11.

Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S

Enrico G Ferro  1 , Mohamad Alkhouli  2 , Devi G Nair  3 , Samir R Kapadia  4 , Jonathan C Hsu  5 , Douglas N Gibson  6 , James V Freeman  7 , Matthew J Price  6 , Kristine Roy  8 , Dominic J Allocco  8 , Robert W Yeh  1 , Jonathan P Piccini  9
Affiliations

Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S

Enrico G Ferro et al. JACC Clin Electrophysiol. 2023 Dec.

Abstract

Background: Intraprocedural imaging is critical for device delivery in transcatheter left atrial appendage occlusion (LAAO). Although pivotal trials of LAAO devices were conducted using transesophageal echocardiography (TEE), intracardiac echocardiography (ICE) is an emerging imaging modality.

Objectives: This study compared outcomes after ICE- and TEE-guided Watchman FLX implantation in the SURPASS (SURveillance Post Approval AnalySiS Plan) nationwide LAAO registry.

Methods: Baseline characteristics were compared using chi-square and t-tests. Outcomes were reported in unadjusted and adjusted comparisons via propensity weighting.

Results: Between August 2020 and September 2021, LAAO was attempted in 39,759 patients at 698 sites, including 2,272 cases (5.7%) with ICE and 31,835 (80.0%) with TEE. ICE and TEE patients had similar baseline characteristics and mean procedural times (ICE 82 minutes vs TEE 78 minutes). ICE patients were less likely to receive general anesthesia (54% vs 98%, P < 0.01). Successful device implantation (98.3% vs 97.6%) and complete seal rates at 45 days were similar (n = 25,280; 83% vs 82%). Most adverse event rates were similar; unadjusted mortality rates at 45 days were 1.1% for ICE vs 0.8% for TEE (P = 0.14), and 1.0% vs 0.7% (P = 0.27) in adjusted analyses. Even after adjustment, pericardial effusion rates requiring intervention were significantly higher with ICE at 45 days (1.0% vs 0.5%; P = 0.02). This rate decreased as operators performed more ICE-guided procedures, although 82% of operators had performed <10 ICE-guided procedures overall.

Conclusions: In the largest comparison to date, ICE use was infrequent. ICE and TEE both achieved high rates of complete LAAO. ICE was associated with significantly higher rates of pericardial effusion requiring intervention.

Keywords: atrial fibrillation; intracardiac echocardiography; left atrial appendage occlusion; pericardial effusion; peridevice leak; transesophageal echocardiography.

PubMed Disclaimer

Conflict of interest statement

Funding Support and Author Disclosures The SURPASS analysis was funded by the Boston Scientific Corporation. The views expressed here represent those of the authors, and do not necessarily represent the official views of the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr Piccini is supported by R01AG074185 from the National Institutes of Aging. Dr Hsu has received honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Janssen Pharmaceuticals, Bristol-Myers Squibb, Pfizer, Sanofi, Zoll Medical, iRhythm, Acutus Medical, Galvanize Therapeutics, and Biosense-Webster; research grants from Biotronik and Biosense-Webster; and has equity interest in Vektor Medical. Dr Freeman has received research funding from the NIH/NHLBI and the American College of Cardiology National Cardiovascular Data Registry; consulting/advisory board fees from Medtronic, Boston Scientific, Biosense Webster, and PaceMate; and equity in PaceMate. Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; consulting honoraria from W. L. Gore & Associates, Baylis Medical, Biotronik, and Philips; consulting honoraria and speaker fees from Medtronic; consulting honoraria from Biosense Webster and Shockwave; and has equity in Indian Wells, Inc. Drs Allocco and Roy are full-time employees and stockholders of Boston Scientific. Dr Yeh has received research funding and consulting fees from Abbott Vascular, Boston Scientific, and Medtronic; and research funding from Bard, Cook, and Philips. Dr Piccini has received grants for clinical research from Abbott, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, iRhythm, and Philips; and serves as a consultant to Abbott, Abbvie, ARCA biopharma, Bayer, Boston Scientific, Bristol Myers Squibb (Myokardia), Element Science, Itamar Medical, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, ReCor, Sanofi, Philips, and Up-to-Date. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1.
Figure 1.. Utilization Histograms for ICE and TEE, by Operator and by Site.
ICE, intracardiac echocardiography; TEE, transesophageal echocardiography.
Figure 2.
Figure 2.. Monthly Trends in ICE and TEE Utilization.
ICE, intracardiac echocardiography; TEE, transesophageal echocardiography.
Figure 3.
Figure 3.. Volume-Outcome Relationship in ICE-Guided Cases.
ICE, intracardiac echocardiography; min, minutes; mL, milliliters.
See this image and copyright information in PMC

Comment in

References

    1. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1–14. doi: 10.1016/j.jacc.2021.10.023 - DOI - PubMed
    1. Munir MB, Khan MZ, Darden D, et al. Contemporary procedural trends of Watchman percutaneous left atrial appendage occlusion in the United States. J Cardiovasc Electrophysiol. Jan 2021;32(1):83–92. doi: 10.1111/jce.14804 - DOI - PMC - PubMed
    1. Freeman JV, Varosy P, Price MJ, et al. The NCDR Left Atrial Appendage Occlusion Registry. J Am Coll Cardiol. Apr 7 2020;75(13):1503–1518. doi: 10.1016/j.jacc.2019.12.040 - DOI - PMC - PubMed
    1. Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. Aug 15 2009;374(9689):534–42. doi: 10.1016/s0140-6736(09)61343-x - DOI - PubMed
    1. Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. Jul 8 2014;64(1):1–12. doi: 10.1016/j.jacc.2014.04.029 - DOI - PubMed

Publication types

MeSH terms