Key result
Amplatzer devices linked to 0% thrombus incidence versus other intra-atrial shunt closure devices.
Why the study?
Detailed post-procedure information about thrombotic material on different devices for transcatheter closure was missing.
Does the type of closure device affect the incidence of thrombus formation in patients undergoing transcatheter closure of intra-atrial shunts?
Observational (n=1,000)
Does the type of closure device affect the incidence of thrombus formation in patients undergoing transcatheter closure of intra-atrial shunts?
Thrombus formation on intra-atrial shunt closure devices is generally low (2.0%) and usually resolves with anticoagulation, but the incidence varies significantly depending on the specific device used.
Answers are grounded in this paper and cite their sources.
Amplatzer linked to lower thrombus risk after intra-atrial shunt closure; leaves open device selection pending randomized confirmation.
OBJECTIVES: The purpose of this study was to investigate the incidence, morphology, and clinical course of thrombus formation after catheter closure of intra-atrial shunts. BACKGROUND: Post-procedure detailed information about thrombotic material on different devices for transcatheter closure is missing. METHOD: A total of 1,000 consecutive patients were investigated after patent foramen ovale (PFO) (n = 593) or atrial septal defect (ASD) (n = 407) closure. Transesophageal echocardiography (TEE) was scheduled after four weeks and six months. Additional TEEs were performed as clinically indicated. RESULTS: Thrombus formation in the left atrium (n = 11), right atrium (n = 6), or both (n = 3) was found in 5 of the 407 (1.2%) ASD patients and in 15 of the 593 (2.5%) PFO patients (p = NS). The thrombus was diagnosed in 14 of 20 patients after four weeks and in 6 of 20 patients later on. The incidence was: 7.1% in the CardioSEAL device (NMT Medical, Boston, Massachusetts); 5.7% in the StarFLEX device (NMT Medical); 6.6% in the PFO-Star device (Applied Biometrics Inc., Burnsville, Minnesota); 3.6% in the ASDOS device (Dr. Ing, Osypka Corp., Grenzach-Wyhlen, Germany); 0.8% in the Helex device (W.L. Gore and Associates, Flagstaff, Arizona); and 0% in the Amplatzer device (AGA Medical Corp., Golden Valley, Minnesota). The difference between the Amplatzer device on one hand and the CardioSEAL device, the StarFLEX device, and the PFO-Star device on the other hand was significant (p < 0.05). A pre-thrombotic disorder as a possible cause of the thrombus was found in two PFO patients. Post-procedure atrial fibrillation (n = 4) and persistent atrial septal aneurysm (n = 4) had been found as significant predictors for thrombus formation (p < 0.05). In 17 of the 20 patients, the thrombus resolved under anticoagulation therapy with heparin or warfarin. In three patients, the thrombus was removed surgically. CONCLUSIONS: The incidence of thrombus formation on closure devices is low. The thrombus usually resolves under anticoagulation therapy.
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Krumsdorf et al. (2004) conducted an observational in Patent foramen ovale (PFO) or atrial septal defect (ASD) (n=1,000). Catheter closure devices was evaluated on Thrombus formation. Thrombus formation after catheter closure of intra-atrial shunts occurred in 20 of 1000 patients, with the Amplatzer device showing a significantly lower incidence (0%) than other devices (p<0.05).
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