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

Zhang, Xiaochun; Jin, Qinchun; Kong, Dehong; Chen, Shasha; Chen, Dandan; Hou, Cody R.; Zhang, Lei; Pan, Cuizhen; Zhou, Daxin; Ge, Junbo

doi:10.1016/j.ijcard.2020.08.070

Cited by 20 publications

(42 citation statements)

References 24 publications

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“…They reported the optimistic results with a 100% implantation success rate (31/31), 0 events of peri‐procedural complications, no significant peri‐device leakage (>5 mm), no DRT, 0 events of ischemic stroke during 3–45 months follow‐up. In the present study, the procedure time, fluoroscopy time, total radiation dose, contrast medium dose, percentage of fluoroscopic peri‐device leakage is similar to the previous reports of the variable devices implanted under procedural fluoroscopic guidance only 6,16,17 or the LAmbre device implantation guided by TEE 26 . The cost for each patient, about 58,000 yuan (8900 USD) in our institution, was less than the previous report 17 .…”

Section: Discussionsupporting

confidence: 86%

“…In the present study, the procedure time, fluoroscopy time, total radiation dose, contrast medium dose, percentage of fluoroscopic peri‐device leakage is similar to the previous reports of the variable devices implanted under procedural fluoroscopic guidance only 6,16,17 or the LAmbre device implantation guided by TEE 26 . The cost for each patient, about 58,000 yuan (8900 USD) in our institution, was less than the previous report 17 . The favorable procedural characteristics could be owed to the operators’ experience and skill in radiofrequency ablation for operators.…”

Section: Discussionsupporting

confidence: 86%

“…The implantation success rate was generally over 96.0% with procedural guidance of TEE or ICE or fluoroscopy only for Watchman, WATCHMAN FLX, Amplatzer, and LAmbre device 7,9,16,17,26–29 . The device success was comparable for both occluders in the present study.…”

Section: Discussionsupporting

confidence: 51%

“…For the Watchman device, Zhang et al 17 . conducted a single‐center non‐randomized comparison study of the fluoroscopy‐alone and TEE‐guided Watchman device implantation.…”

Section: Discussionmentioning

confidence: 99%

“…Patients treated with the use of ICE and under local anesthesia need to spend 60,000 yuan with about 80% covered by Medicare and the additional expenditure, that is, the price of ICE 20,000 yuan, with about 50% covered by Medicare. To relieve the medical cost and minimize the procedure of LAAO, some studies have reported the approach of the procedural fluoroscopic guidance only and its feasibility and safety for LAmbre 16 or Watchman (Boston Scientific Corporation, USA) device 17 . In the present study, we investigated the feasibility and safety of LAAO guided with fluoroscopy only, without GA, using LAmbre and Watchman device; the complications and follow‐up outcomes were also assessed.…”

Section: Introductionmentioning

confidence: 97%

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Feasibility and safety of left atrial appendage occlusion guided by procedural fluoroscopy only: A pilot study

Wang

Rong

Zhang

et al. 2021

Pacing Clinical Electrophis

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Background Left atrial appendage occlusion (LAAO) is usually performed via the guidance of procedural transesophageal echocardiography (TEE) companied by general anesthesia (GA). Objective To investigate the feasibility and safety of LAAO guided by procedural fluoroscopy only. Methods The patients eligible for LAAO were enrolled into the current study and received implantation of either Watchman device or LAmbre device. The procedure was carried out with procedural fluoroscopy only and no companied GA; the position, shape, and leakage of the device were assessed by contrast angiography. TEE was performed after 3‐month follow‐up to evaluate the thrombosis, and leakage of device. Results Ninety‐seven patients with atrial fibrillation (AF) with either Watchman device (n = 49) or LAmbre device (n = 48) were consecutively enrolled. Watchman device group was of lower CHA2DS2‐VASc and HAS‐BLED scores compared with LAmbre device groups (p < .05); the two groups had similar distributions of other baseline characteristics (p > .05), including procedural success rate (98.0% vs. 97.9%), mean procedure time, mean fluoroscopy time, total radiation dose, contrast medium dose, percentage of peri‐device leakage. Pericardial effusions requiring intervention occurred in two of the Watchman group. TEE follow‐up found no patient with residual leakage ≥5 mm at 3 months and no device related thrombosis (DRT). During the 22.0 ± 11.1 months follow‐up, two patients experienced ischemic stroke. Conclusions LAAO with the procedural imaging of fluoroscopy only exhibited the promising results of efficacy and safety. A prospective randomized multicenter study would be required to verify the observations in this study.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 51%

“…For the Watchman device, Zhang et al 17 . conducted a single‐center non‐randomized comparison study of the fluoroscopy‐alone and TEE‐guided Watchman device implantation.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

See 3 more Smart Citations

Feasibility and safety of left atrial appendage occlusion guided by procedural fluoroscopy only: A pilot study

Wang

Rong

Zhang

et al. 2021

Pacing Clinical Electrophis

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A preliminary study of minimal left atrial appendage occlusion using Watchman under the guidance of fluoroscopy

Ruan,

Li,

Jin

et al. 2023

Cathet Cardio Intervent

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BackgroundLeft atrial appendage occlusion (LAAO) has been considered an alternative treatment to prevent embolic stroke in patients with nonvalvular atrial fibrillation (NVAF). However, it carries a risk of general anesthesia or esophageal injury if guided by transesophageal echocardiography (TEE).AimsWe aimed to investigate the feasibility and safety of minimal LAAO (MLAAO) using Watchman under fluoroscopy guidance alone in patients with NVAF.MethodsA total of 249 consecutive patients with NVAF who underwent LAAO using the WATCHMAN device were divided into two groups: the Standard LAAO (SLAAO) group and the MLAAO group. Procedural characteristics and follow‐up results were compared between the two groups.ResultsThere was no statistically significant difference in the rate of successful device implantation (p > 0.05). Fluoroscopy time, radiation exposure dose, and contrast medium usage in the MLAAO group were higher than those in the SLAAO group (p < 0.001). The procedure time and hospitalization duration were significantly lower in the MLAAO group than those in the SLAAO group (p < 0.001). The occluder compression ratio, measured with fluoroscopy, was lower than that measured with TEE (17.63 ± 3.75% vs. 21.69 ± 4.26%, p < 0.001). Significant differences were observed between the SLAAO group and the MLAAO group (p < 0.05) in terms of oropharyngeal/esophageal injury, hypotension, and dysphagia. At 3 months after LAAO, the MLAAO group had a higher incidence of residual flow within 1−5 mm compared to the SLAAO group, although the difference was not statistically significant.ConclusionMLAAO guided by fluoroscopy, instead of TEE, without general anesthesia simplifies the operational process and may be considered safe, effective, and feasible, especially for individuals who are unable to tolerate or unwilling to undergo TEE or general anesthesia.

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Long‐term outcomes after echocardiography versus fluoroscopy‐guided left atrial appendage closure: Is there still a role for a simplified approach?

Gilhofer,

Schweiger,

Gehler

et al. 2024

Cathet Cardio Intervent

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BackgroundLeft atrial appendage closure (LAAC) represents an alternative to oral anticoagulation for stroke prevention in patients with non‐valvular atrial fibrillation (AF). While transoesophageal echocardiography is the current standard for guiding LAAC procedures, several centers have employed fluoroscopic guidance alone. However, data on long‐term outcomes are lacking.MethodsA total of 536 patients with AF undergoing LAAC and with available data on long‐term follow‐up were included in the retrospective, single‐center analysis. Outcomes of patients undergoing fluoroscopy‐guided LAAC were compared with those undergoing echocardiography guided LAAC. Time‐dependent analysis was performed with the Kaplan–Meier method.ResultsA total of 234 (44%) and 302 (56%) patients were treated with echocardiography and fluoroscopy guidance, respectively. Baseline characteristics did not differ between the two groups. Procedural success rates were high in both groups (97% of fluoroscopy vs. 98% of echocardiography guided procedures; p = 0.92) and rates of relevant peri‐device leaks (p = 0.50) and device‐related thrombus formation (p = 0.22) did not differ between groups. Median clinical follow‐up time was 48 (IQR 19–73) months. Rates of all‐cause mortality (p = 0.15, HR 0.83, CI 0.64–1.07) and stroke (p = 0.076, HR 2.23, CI 0.90–5.54) were comparable among groups.ConclusionLAAC with fluoroscopy guidance alone is equally safe and leads to similar clinical outcome compared to LAAC with additional echocardiography guidance.

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

Cited by 20 publications

References 24 publications

Feasibility and safety of left atrial appendage occlusion guided by procedural fluoroscopy only: A pilot study

Feasibility and safety of left atrial appendage occlusion guided by procedural fluoroscopy only: A pilot study

A preliminary study of minimal left atrial appendage occlusion using Watchman under the guidance of fluoroscopy

Long‐term outcomes after echocardiography versus fluoroscopy‐guided left atrial appendage closure: Is there still a role for a simplified approach?

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