title: Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Krumsdorf
authors.forename: Stefan
authors.initials: S
authors.lastname: Ostermayer
authors.forename: Kai
authors.initials: K
authors.lastname: Billinger
authors.forename: Thomas
authors.initials: T
authors.lastname: Trepels
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Zadan
authors.forename: Kathrin
authors.initials: K
authors.lastname: Horvath
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D006328:Cardiac Catheterization / Q000379:methods; D017548:Echocardiography, Transesophageal; D004868:Equipment Failure; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000628:therapy*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D019736:Prostheses and Implants / Q000009:adverse effects*; D013927:Thrombosis / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000453:epidemiology* / Q000209:etiology*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants