Elsevier

International Journal of Cardiology

Volume 324, 1 February 2021, Pages 72-77
International Journal of Cardiology

Comparison of fluoroscopy and transesophageal echocardiogram for intra-procedure device surveillance assessment during implantation of Watchman

https://doi.org/10.1016/j.ijcard.2020.08.070Get rights and content

Highlights

  • For experienced operators in large volume centers, LAAO performed with fluoroscopic guidance under local anesthesia is feasible and safe.

  • However, our findings suggest that there is a trend in favor of TEE for a greater safety of the procedure, allowing to achieve a more complete seal of the appendage.

  • LAA implantation using fluoroscopy-alone approach could be proposed for patients with strong contra-indications for general anesthesia and/or transesophageal echocardiography.

Abstract

Objectives

To evaluate intraprocedural assessments using transesophageal echocardiography (TEE) and fluoroscopy during left atrial appendage occlusion (LAAO) with the WATCHMAN device.

Method

A total of 208 patients with non-valvular atrial fibrillation (AF) undergoing LAAO were included in this study[101 standard procedures (retrospective cohort) and 107 with fluoroscopy-alone approach (prospective cohort). Individual device position, anchoring, compression and peri-device leak (PDL) were successively analyzed based on TEE and fluoroscopy in the retrospective cohort to summarize detailed fluoroscopic assessments for prospective application. Clinical outcomes were assessed between two cohorts.

Results

For retrospective cohort, TEE and fluoroscopy agreed on device position and anchoring. Compression upon fluoroscopy was well correlated with 2D-TEE (r = 0.908) and the difference in overall detection of PDL was not statistically significant between two imaging modalities (p = 0.304). For the prospective cohort with fluoroscopy-guidance alone, implantation success was similar to that of the retrospective cohort (98.13% vs 100%, p = 0.498). The incidence rate of major clinical adverse events was relatively higher in prospective cohort during hospitalization and follow-up but did not reach significant difference (5.61% vs 1.98%; 0.99% vs 0.93%, p > 0.05). Moreover, the prospective group presented with shorter procedural duration, shorter in-hospital stay and lower total hospitalization cost than retrospective group.

Conclusion

LAAO performed by experienced operators in large volume centers is feasible under fluoroscopy guidance. However, there is still a trend in favor of TEE for greater procedural safety and more complete LAA seal. We suggest that this minimalist approach could be proposed in cases with contraindication to general anesthesia and/or TEE.

Introduction

Atrial fibrillation (AF) has been shown to increase individual embolic strokes risk by five-fold, mainly because of thrombus formation in the left atrial appendage (LAA) [[1], [2], [3]]. Left atrial appendage occlusion (LAAO), nowadays universally performed for stroke prevention in non-valvular AF patients, is recommended according to 2019 AHA/ACC guidelines (IIb) especially for those at high risk of stroke with contraindications for long-term oral anticoagulation [4].

To ensure successful device implantation in LAAO, evaluation of intra-procedural device surveillance is important. Occluder stability is largely associated with desirable position and anchoring while adequate device compression and accurate measurements of peri-device leak can further help assess implant outcomes. TEE accompanied by fluoroscopy is nowadays the recommended conventional imaging modality to guide and assess LAAO [[5], [6], [7], [8]]. On the other hand, the use of TEE throughout the procedure requires a dedicated anesthetic team and is limited by gastrointestinal disease, stomatology disease and risks of esophageal injury, which leads to increasing procedural burden and complexity. In the present study, we systematically compared fluoroscopic assessment of device position, stability and residual leak to the established TEE-based approach. Furthermore, the feasibility and safety of intra-procedural guidance with fluoroscopy alone was tentatively explored in clinical practice.

Section snippets

Methods

A total of 208 consecutive patients who were referred to Zhongshan Hospital, Fudan University for LAAO using the WATCHMAN™ device (Boston Scientific, Marlborough, MA, USA) were studied. All patients had non-valvular AF at high-risk for stroke (CHA2DS2 ≥ 2) and relative or absolute contraindications for long-term oral anticoagulation (OAC). The study included both retrospective and prospective analysis. In 101 patients, LAAO procedure was performed under general anesthesia guided by TEE and

Results

This study enrolled 101 patients (59 male, mean age of 68.16 ± 7.82) in the retrospective cohort and 107 patients (70 male, mean age of 66.28 ± 10.03) in the prospective group. Baseline characteristics of the retrospective and prospective cohorts are described in Table 1 and no statistically significant differences in gender, age, incidence of hypertension, diabetes, stroke and major bleeding were found. The CHA2DS2-VASc and HAS-BLED scores were also similar between two cohorts (3.74 ± 1.38 vs

Discussion

In our study comparing the utility of TEE and fluoroscopy for intra-procedural device surveillance, fluoroscopy was comparable for assessing device position, stability and detecting residual leakage. The derived fluoroscopic assessment was applied in a prospective study in which LAAO procedure was performed with fluoroscopy-only guidance. Perioperative and follow-up clinical outcomes in the prospective cohorts further confirmed the feasibility and safety of fluoroscopy alone during LAAO in a

Conclusion

LAAO performed by experienced operators in large volume centers is feasible under fluoroscopy guidance. However, there is a trend in favor of TEE for a greater safety of the procedure, allowing to achieve a more complete seal of the appendage. This minimalistic approach could be proposed among patients with strong contra-indications for general anesthesia and/or transesophageal echocardiography.

Funding

This work was supported by the National Natural Science Foundation of China [grant numbers 81771837], Shanghai Committee of Science and Technology [grant numbers 17411962400].

Declaration of Competing Interest

The authors declare that they have no conflict of interest.

References (25)

  • A.S. Go et al.

    Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and risk factors in atrial fibrillation (ATRIA) study

    JAMA

    (2001)
  • European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery et al.

    Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC)

    Eur. Heart J.

    (2010)
  • Cited by (15)

    • Impact of Echocardiographic Guidance on Safety and Efficacy of Left Atrial Appendage Closure: An Observational Study

      2021, JACC: Cardiovascular Interventions
      Citation Excerpt :

      The LAA device was successfully implanted in 96% of the patients in both groups, with similarly low complication rates. Zhang et al (17) recently reported the results of a single-center study including 208 LAACs, of which 107 were guided by fluoroscopy and 101 by TEE. The rates of in-hospital complications favored, numerically, the TEE group but did not differ significantly.

    • TEE versus ICE for LAAO: Is ICE just as nice?

      2024, Journal of Cardiovascular Electrophysiology
    View all citing articles on Scopus
    1

    Contribute equally to the work.

    View full text