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Updated: Aug 20, 2026
Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure
Published on: February 8, 2022
Thrombosis after septal closure device placement: a review of the current literature
Jonathan M Sherman1, Donald J Hagler, Frank Cetta
1Division of Pediatric Cardiology, Mayo Clinic College of Medicine and Mayo Clinic Foundation, Rochester, MN 55905, USA.
Insights
Transcatheter septal occlusion devices can develop thrombus, a rare complication affecting all device types. Early echocardiographic surveillance and thorough coagulation evaluation before placement are recommended to manage this risk.
Area of Science:
- Cardiovascular Interventions
- Medical Device Thrombosis
- Interventional Cardiology
Background:
- Thrombus formation is a known complication of transcatheter septal occlusion devices.
- Existing reports are primarily single-institution case studies with variable pre-placement screening and post-deployment anticoagulation protocols.
Purpose of the Study:
- To synthesize current data on device thrombosis associated with transcatheter septal occlusion devices.
- To evaluate the incidence, timing, and management of thrombosis across different device types.
Main Methods:
- A systematic literature search of the Medline database was conducted from 1980 to 2004.
- Seventeen articles reporting 54 unique cases of device thrombosis were analyzed.
Main Results:
- Thrombosis occurred on eight different transcatheter septal occlusion device types, with all commercially available devices having reported cases.
- Thrombosis was diagnosed a mean of 5 months post-deployment; coagulation status prior to placement was often unreported or normal.
- Warfarin therapy was effective in resolving thrombosis in most treated patients.
Conclusions:
- Septal occlusion device thrombosis is a rare but recognized complication affecting all device types.
- Early echocardiographic surveillance (within 3 months) is crucial for detecting device thrombosis.
- Comprehensive coagulation assessment before transcatheter device implantation is imperative.
Abstract:
Thrombus formation has been described for all types of commercially available transcatheter septal occlusion devices. Most reports have been single-institution case studies. Screening for hypercoagulable conditions prior to device placement and anticoagulation after device deployment has been variable. The objective of this study was to synthesize the current experience with device thrombosis; the Medline database from 1980 until 2004 was searched. Seventeen articles identified 54 unique patients with device thrombosis. Thrombus developed on eight different types of transcatheter devices. All commercially available devices had at least one reported case of thrombosis. Patient mean age was 44.2 +/- 9.8 years. Thrombosis was diagnosed at a mean of 5 months after device deployment. Prior to device placement, 12 patients had normal coagulation evaluations and 5 had coagulopathies. For 37 patients, no mention was made in the report of coagulation studies. Prior to device thrombosis, 26 patients received aspirin and clopidogrel, 15 patients received aspirin alone, 8 received warfarin, 2 heparin alone, 1 aspirin and warfarin. One patient with hemophilia A received no anticoagulation and in one case treatment prior to thrombosis was not reported. After device thrombosis, 35 patients were treated with warfarin with thrombus resolution, 2 had successful lytic therapy, 1 was treated with heparin alone. Sixteen patients had surgical explantation of the device. Septal occlusion device thrombosis is rare. All types of commercially available devices have been associated with thrombosis. All patients should have early (< or = 3 months) echocardiographic surveillance for device thrombosis. Thorough coagulation evaluation is imperative prior to transcatheter device placement.
