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J Am Coll Cardiol, 2004; 43:302-309, doi:10.1016/j.jacc.2003.10.030
© 2004 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients

Ulrike Krumsdorf, MD*, Stefan Ostermayer, MD*, Kai Billinger, MD*, Thomas Trepels, MD*, Elisabeth Zadan, MD*, Kathrin Horvath, MD* and Horst Sievert, MD, PhD*,*

* Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany

Manuscript received May 2, 2003; revised manuscript received October 13, 2003, accepted October 27, 2003.

* Reprint requests and correspondence: Prof. Dr. med. Horst Sievert, Cardiovascular Center Frankfurt, Sankt Katharinen, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany.
horst.sievert{at}dgn.de

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.

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.

Abbreviations and Acronyms
  AF = atrial fibrillation
  ASA = atrial septal aneurysm
  ASD = atrial septal defect
  PFO = patent foramen ovale
  TEE = transesophageal echocardiographic/echocardiography
  TIA = transient ischemic attack
  TTE = transthoracic echocardiographic/echocardiography




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