What does this research mean for the field?

Peri-device leak was observed in only 7.7% of patients after WATCHMAN implantation, with 1.8% having leaks ≤3.0mm and 5.9% having leaks >3.0mm. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This research aims to evaluate the incidence of peri-device leak following WATCHMAN device implantation using computed tomography.

February 8, 2026

Peri-device leak post WATCHMAN implantation in the real world: lessons from computed tomography imaging at follow-up from a prospective multicenter high-volume operator registry in the US

Resultado clave

CT follow-up after WATCHMAN implant showed peri-device leak in only 7.7% of patients, with 45.1% showing no contrast in the left atrial appendage.

Puntos clave

This research aims to evaluate the incidence of peri-device leak following WATCHMAN device implantation using computed tomography.
Prospective multicenter registry of patients scheduled for WATCHMAN FLX or WATCHMAN FLX Pro implant.
Follow-up imaging done utilizing gated contrast computed tomography.
Assessment of procedural success, complications, and rates of leak and thrombus through core lab adjudication.
No contrast was observed in the left atrial appendage in 45.1% of patients.
Peri-device leak was identified in only 7.7% of patients on CT imaging.
Minor leaks (<3.0mm) occurred in 1.8% and larger leaks (>3.0mm) in 5.9% of patients.

PICO estructurado

What is the rate of peri-device leak detected by computed tomography imaging at follow-up after WATCHMAN implantation in real-world practice?

Población

676 patients scheduled to undergo implantation with a WATCHMAN FLX or WATCHMAN FLX Pro device in a prospective multicenter high-volume operator registry in the US.

Intervención

WATCHMAN FLX or WATCHMAN FLX Pro device implantation followed by gated contrast computed tomography (CT) imaging

Resultado

Procedural success, procedural complications, leak and thrombus rates as adjudicated by a central imaging core labsurrogate

Follow-up CT imaging after WATCHMAN implantation demonstrates that true peri-device leak is uncommon (7.7%), suggesting that contrast seen in the left atrial appendage mostly represents benign trans-fabric flow.

Resultado numérico

Tasa de eventos absoluta: 0% vs 0%

Resumen

Abstract Background The FDA approved the WATCHMAN device in March 2015 with the caveat follow-up transesophageal echo (TEE) at 45 days and 1 year post implant to assess peri-device leak (PDL) and device-related thrombus formation (DRT) as an important step before interruption of anticoagulation. However, our understanding of these PDLs is mostly derived from TEE. Gated contrast CT recently emerged as a non-invasive alternative to TEE to follow-up post WATHMAN implanted patients. Current experience with CT is limited to small series and case reports. Methods Patients were eligible for enrollment in this prospective registry if they were scheduled to undergo implantation with a WATCHMAN FLX or WATCHMAN FLX Pro device. Enrolled patients were implanted with a WATCHMAN device and followed per local standard of care without interference from the central core lab or study leadership. There were no pre-specified endpoints, but analyses include procedural success, procedural complications, leak and thrombus rates as adjudicated by a central imaging core lab. Incomplete seal of the LAA by CT comprises both PDLs, uncovered lobes, as well as micro-flow through the device fabric. Results At follow-up, no contrast was observed in the left atrial appendage in 45.1% (305/676) of patients (Figure 1). However, PDL was seen in only 7.7% (52/676) of patients on CT. PDL 3.0mm was observed in1.8% (12/676) of patients and PDL 3.0mm was observed in 5.9% (40/676) of patients (Graph 1). Conclusion Despite concerns that the high sensitivity of CT angiography may lead to "overcalling" device leak due to a combination of PDL and trans-fabric flow, in the largest series of core lab adjudicated CTs post WATCHMAN implant to date, contrast seen in the LAA represents mostly fabric flow and PDL remains uncommon in the majority of patients. The use of CT and TEE for follow-up in individual patients should be explored to future studies.

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Cite This Study

Saliba et al. (Sat,) reported a other. CT follow-up after WATCHMAN implant showed peri-device leak in only 7.7% of patients, with 45.1% showing no contrast in the left atrial appendage.

synapsesocial.com/papers/698828cb0fc35cd7a884888a https://doi.org/https://doi.org/10.1093/eurheartj/ehaf784.210

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