Thrombosis after septal closure device placement: a review of the current literature.

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. (c) 2004 Wiley-Liss, Inc.