Copyright © 2005, The European Society of Cardiology
Thrombus formation on an atrial septal defect closure device: A case report and review of the literature
aDepartment of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
bDepartment of Cardiac and Thoracic Surgery, Hannover Medical School, Hannover, Germany
Received 19 July 2005; received in revised form 13 October 2005; accepted after revision 31 October 2005.
* Corresponding author. Tel.: +49 511 532 3818; fax: +49 511 532 3357. divchev.dimitar{at}mh-hannover.de
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Abstract |
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We report on a case of a mobile left atrial thrombus formation on an atrial septal defect occluder system (28mm StarFLEX®-Occluder) despite 6 months of postprocedural anticoagulation with phenprocoumon and platelet antiaggregation with aspirin in a 69-year-old woman. The closure was performed because of a significant left to right atrial shunt (Qp/Qs 1.8) with enlargement of the right atrial and ventricular cavities and impairment of right ventricular function in the presence of persistent atrial fibrillation and chronic heart failure (NYHA II–III). The 6-month follow up by transoesophageal echocardiography (TEE) revealed the floating thrombus located at the left atrial side of the occluder.
Keywords: TEE; transoesophageal echocardiography; ASD; atrial septal defect; PFO; patent foramen ovale; ASA; atrial septal aneurysm; INR; international normalized ratio
We are presenting this case in context with a review of the current literature focussing on predictors of thrombus formation on transcatheter ASD-closure devices.
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Case presentation |
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A 69-year-old woman was admitted for transcatheter closure of an atrial septal defect (ASD).
The patient showed symptoms of chronic heart failure (NYHA II–III) and had a medical history of systemic hypertension for 19years and received oral anticoagulation with phenprocoumon due to atrial fibrillation for 1year. There were no episodes of systemic embolism or deep vein thrombosis in the past.
Echocardiography and cardiac catheterisation revealed an ASD leading to a significant left to right atrial shunt (Qp/Qs 1.8) with enlargement of the right atrial and ventricular cavities and impairment of right ventricular function. The patient underwent a TEE-guided transcatheter closure of the atrial septal defect under local anaesthesia using a 28mm StarFLEX®-Occluder without residual shunt. The medication with phenprocuomon had been stopped 5days prior to closure device implantation and changed to anticoagulation with intravenous heparin before and in the first days after ASD closure. Phenprocoumon was started again with a target INR of 2.5 and aspirin 100mg per day was added.
The patient came back for a scheduled follow-up after 6months. She did not report any complications during the period after closure device implantation to follow-up except episodes of epistaxis. Therefore aspirin 100mg per day had been stopped by her general physician after 5months. There was a reduction of heart failure symptoms (NYHA I–II). According to the weekly blood samples, the anticoagulation with phenprocoumon was strictly managed during the 6months with INR values ranging between 2.0 and 3.0.
TEE after 6months showed a floating echogenic structure connected to the left atrial part of the well positioned StarFLEX®-Occluder without any additional atrial or ventricular thrombi and absence of spontaneous echo contrast (Fig. 1). There was no residual shunt on colour Doppler imaging. The patient was checked for a possible coagulation disorder although congenital or acquired hypercoagulation seemed rather improbable. The check up was performed without testing resistance to activated Protein C and Protein S deficiency because of ongoing therapy with phenprocoumon, and with heparin under continuing atrial fibrillation.
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The patient was referred for surgery and underwent a successful explantation of the device together with the thrombotic apposition and a closure of the atrial septal defect using a pericardial patch (Fig. 2).
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Comment on the current literature |
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Transcatheter closure of different congenital atrial septal defects leading to paradoxical embolism or intracardiac shunt has become an effective and less invasive alternative to surgery. Appropriate anticoagulation after transcatheter device placement is discussed controversially especially in cases without history of systemic embolism. Patients without thromboembolism or neurologic events typically receive antiplatelet therapy for several months until the endothelialisation of the blood exposed parts has been completed. For patients with a history of stroke or atrial fibrillation, there are no established guidelines for postprocedural anticoagulation. Most of the patients receive warfarin, antiplatelet therapy, or different combinations.
In our department, patients undergoing a transcatheter device placement with a StarFLEX®-Occluder due to an ASD with significant shunt as well as paradoxical embolism in cases of PFO receive anticoagulation with phenprocoumon (target INR 2.5) together with antiplatelet therapy with aspirin 100mg per day for 6months in order to avoid postprocedural device associated thrombus formation.
Device associated atrial thrombi after transcatheter ASD- or PFO-closure are reported complications (Table 1), but the true incidence may be underestimated and there are no randomised trials assessing independent predictors of device associated thrombi. There are no investigations comparing patients receiving a transcatheter closure with similar pre- and postprocedural risk factors for thromboembolism or different closure devices under the same anticoagulation regimen.
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In a study, La Rosée et al.6 analysed 102 consecutive patients treated for an ASD or PFO with the Amplatzer®, ASDOS® or PFO-Star® device. They saw 11 (11.2%) device associated thrombi in the early (2–3days) TEE-follow-up (two ASDOS®-ASD, five ASDOS®-PFO, three PFO-STAR® and one Amplatzer®-ASD device). Phenprocoumon was used in the first 20 ASDOS®-treated patients and the other patients received a combination of aspirin together with either ticlopidine 500mg or clopidogrel 75mg per day for 6months. The patients treated with the Amplatzer® device received aspirin 100mg per day for 12months and the PFO-Star® patients had a regimen with aspirin 100mg/day for 12months together with clopidogrel 75mg for 3months. The majority of thrombi resolved after 6months of anticoagulation and there was only one detectable thrombus after 1year. There were no independent predictors of thrombus in this trial.
Krumsdorf et al.7 reported 1000 consecutive patients, 593 of them with PFO and 407 with an ASD. There were 20 device associated thrombi during the 4-week (n=14) or 6-month (n=6) follow up by TEE. Nine different closure devices were used. The thrombi occurred more often in patients with the CardioSEAL® (7.1%) or the StarFLEX® (5.7%) device compared to the Amplatzer® device (p<0.05). There was a trend toward device associated thrombi in patients with persisting or new onset atrial fibrillation after the procedure (n=4; 6.2 vs. 20%; p<0.05) as well as in patients with persisting atrial septal aneurysm (ASA) despite effective transcatheter closure (n=4; 1.3 vs. 20%, p<0.01). It should be mentioned that the patients underwent platelet antiaggregation with aspirin and clopidogrel and most of the thrombi (17/20) disappeared after anticoagulation with either heparin or warfarin alone or under their combined therapy. Three of the thrombi had to be surgically explanted together with the device after persistence under anticoagulation.
A similar trend towards the type of closure device used as a possible independent predictor of thrombus formation was revealed by Anzai et al.8 in a study with 66 consecutive patients treated for PFO or ASD with the Amplatzer® or CardioSEAL® closure system. Five thrombi were found on CardioSEAL® devices (p=0.02), none on the other system. Only one device was surgically removed, the other thrombi resolved under anticoagulation. ASA or atrial fibrillation were not identified as independent predictors of thrombus formation in this study.
In summary, there are only two studies trying to discriminate predictors of device associated thrombus formation after transcatheter closure. The trend towards persisting ASA as well as atrial fibrillation as possible independent risk factors or a preference for the CardioSEAL® or the later developed StarFLEX® occluder system in comparison with the Amlatzer device should be discussed very carefully; there are no randomised trials offering a randomly assigned patient collective with similar risk factors under the same or different anticoagulation regimens.
Cetta et al.9 focused on a patient after transcatheter closure of a PFO with the CardioSEAL® closure device. A large left atrial thrombus formation occurred despite accurate warfarin therapy in the absence of arrhythmias or coagulation disorders.
In comparison, our case demonstrates an unexpected thrombus occurrence despite effective combined anticoagulation and platelet antiaggregation.
The optimal anticoagulation for transcatheter closure of atrial septal defects at increased thrombotic risk is not known. In the presence of atrial fibrillation and/or enlarged cavities, routine TEE follow-up of the patients is suggested. TEE follow up should be performed after 6months in cases without additional prothrombotic risk factors. An early TEE follow up after 4weeks could be useful in the presence of increased thrombotic risk.
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References |
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TopAbstractCase presentationComment on the current...References |
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- Sievert H., Babic U.U., Hausdorf G., Schneider M., Hopp H.W., Pfeiffer D., et al. Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS device (a multi-institutional European trial). Am J Cardiol (1998) 82:1405–1413.[CrossRef][Web of Science][Medline]
- La Rosee K., Deutsch H.J., Schnabel P., Schneider C.A., Burkhard-Meier C., Hopp H.W. Thrombus formation after transcatheter closure of atrial septal defect. Am J Cardiol (1999) 84:356–359.[CrossRef][Web of Science][Medline]
- Franke A., Kuhl H.P., Muhler E.G., Nussbaum J., Visser L., Lepper W., et al. Frequency of occluder-related atrial thrombi despite different prophylactic therapy after transcatheter closure of a patent foramen ovale. Eur Heart J (2000) 21:25. (abstr).
- Sievert H., Horvath K., Zadan E., Krumsdorf U., Fach A., Merle H., et al. Patent foramen ovale closure in patients with transient ischemia attack/stroke. J Interven Cardiol (2001) 14:261–266.[Medline]
- Krumsdorf U., Keppeler P., Horvath K., Zadan E., Schrader R., Sievert H. Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices. J Interv Cardiol (2001) 14:49–55.[Medline]
- La Rosée K., Krause D., Becker M., Beuckelmann D.J., Deutsch H.J., Hopp H.W. Transcatheter closure of atrial septal defect in adults: practicability and safety of four different occluder systems used in 102 patients. Dtsch Med Wochenschr (2001) 126:1030–1036.[CrossRef][Medline]
- Krumsdorf U., Ostermayer S., Billinger K., Trepels T., Zadan E., Horvath K., et al. Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1000 consecutive patients. J Am Coll Cardiol (2004) 43(2):302–309.
[Abstract/Free Full Text] - Anzai H., Child J., Natterson B., Krivokapich J., Fishbein M.C., Chan V.K., et al. Incidence of thrombus formation on the CardioSeal and the Amplatzer interatrial closure devices. Am J Cardiol (2004) 93:426–431.[CrossRef][Web of Science][Medline]
- Cetta F., Arruda M.J., Graham L.C. Large left atrial thrombus formation despite warfarin therapy after device closure of a patent foramen ovale. Catheter Cardiovasc Interv (2003) 59(2):396–398.[CrossRef][Web of Science][Medline]
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