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© 2003 European Association of Cardio-Thoracic Surgery
Recurrent thromboembolic events after percutaneous device closure of patent foramen ovale
a Department of Cardiothoracic Surgery, Martin-Luther-University Halle-Wittenberg, Ernst-Grube-Strasse 40, 06097 Halle/Saale, Germany
* Corresponding author. Tel.: +49-345-557-2079; fax: +49-345-557-2711 Received June 13, 2002; received in revised form December 5, 2002; accepted December 9, 2002
We report on a 34-year-old male with recurrent transient ischemic attacks 1 year after transcatheter closure of a patent foramen ovale. Echocardiography demonstrated thrombus attached to the device, although the patient had been anticoagulated with phenprocoumon. There was no residual shunt. Computed tomography and transcranial Doppler ultrasonography showed no evidence of a new stroke. The thrombosed device was removed under cardiopulmonary bypass and the defect was closed with a pericardial patch. The patient was discharged home and has been well for almost 2 years. At this time, there is no evidence for any new neurological events.
Key Words: Paradoxical embolism; Patent foramen ovale; Transcatheter closure; Device thrombus; Embolization; Surgery
1.1. History, physical examination, and diagnosis A 34-year-old male was admitted to our hospital because of at least five recent transient ischemic attacks, which included paresthesias and numbness of the fingers of his right hand and the right half of his tongue. Four years earlier, the patient had first experienced similar symptoms. At that time, echocardiography had revealed a 12 mm patent foramen ovale (PFO) with a 33% left-to-right shunt fraction, but no true anatomical septal defect. There was only mild tricuspid and pulmonary valve regurgitation. Since the symptoms we thought to be the result of paradoxical emboli, the PFO was closed with a 23 mm CardioSEAL occluder device (NMT Medical Inc., Boston, MA, USA) 1 year prior to this admission. The patient was subsequently anticoagulated with phenprocoumon and 300 mg acetyl salicylic acid (ASA) qid. The current symptoms lasted for approximately 15 min and were associated with concomitant aphasia which persisted for more than 1 h. In addition, the patient complained of bifrontal headaches persisting for about 7 days after onset of the other symptoms. On admission, the patient had no neurological findings and the physical examination revealed no significant abnormalities. A recent extensive cardiac and neurological evaluation at the referring hospital had not revealed device thrombosis. During the current work-up, echocardiography demonstrated thrombi in both right and left atrium as well as thrombi attached to the device. A residual shunt as a possible reason for the recurrent thromboembolic events [1] was ruled out in several echocardiographic examinations and cardiac catheterization. Cerebral computed tomography and magnetic resonance imaging ruled out a new stroke. Carotid Doppler ultrasonography showed no stenoses. Protein C, S and antithrombin III levels were normal. A thorough hematological assessment could not demonstrate coagulation disorders and there was no evidence of systemic vascular disease. 1.2. Treatment and outcome Because of the recurrent neurological episodes, we decided to surgically remove the thrombosed occluder device (Figs. 1 and 2) and to close the resulting 25x35 mm defect with a bovine pericardial patch. The postoperative course was uneventful and the patient was discharged home on the 16th postoperative day. To date, almost 2 years after the operation, he has remained free of neurological symptoms. Regular cardiac follow-ups showed neither valvular and ventricular dysfunction nor leakage around the inserted patch. The patient feels well and continued to work. Phenprocoumon was initially continued because of intermittent postoperative atrial flutter and fibrillation and to prevent re-thrombosis. After stable sinus rhythm was established by electrical cardioversion, oral anticoagulation was stopped 3 months postoperatively.
Recurrent thromboembolic events are more frequent in patients who had a patent foramen ovale associated with paradoxical embolism [2,3]. To date, the most appropriate strategy to prevent further cerebrovascular events after interventional and surgical procedures is still unknown. Although transcatheter closure was proven to be a feasible therapy for selected patients with paradoxical embolization, more studies are needed to identify patients most likely to benefit from this intervention and to determine the long-term risks. The annual risk of recurrent stroke or transient neurological events following device placement was 3.2% in a study by Hung et al. [4]. Windecker [1] reported a 2.5% annual risk for transient ischemic attacks (TIA) and a 0.9% risk for peripheral emboli. This patient's initial symptoms prior to device insertion are characteristic for cerebrovascular thromboembolic events such as transient ischemic attacks. In the absence of any other identifiable cause of systemic emboli, the patient was presumed to have had paradoxical emboli. While coughing, sneezing or straining to move one's bowels, and during other Valsalva maneuvers, right atrial pressure exceeds left atrial pressure and emboli can cross a patent foramen ovale. The patient's neurological events after device implantation are more difficult to explain. Device related problems may cause rather frequent neurological events within the 1st year after implantation, but several other possible reasons including coagulation disorders or inadequate anticoagulation due to lacking compliance must also be considered. One study reported early CardioSEAL occluder device thrombosis in 1 of 11 patients [5]. Our patient's postprocedural International normalised ratio (INR) had been adjusted to 2.53.0 and laboratory findings revealed normal levels of antithrombin III, protein C, and S, without evidence of coagulation disorders and systemic vascular disease. Carotid artery disease was also ruled out. The decision for surgical intervention was primarily based on the fact that transient ischemic attacks recurred despite adequate anticoagulation and administration of a platelet inhibitor (ASA). Although the risk for stroke remains unclear after percutaneous PFO closure and although no reliable prospective data about the long-term benefits of surgical therapy are available, we believe that the surgical benefits clearly outweigh the possible and undeterminable long-term risks resulting from cerebral embolization particularly in young patients like ours. According to Mattila et al., surgical atrial septal defect closure can be recommended even in older patients (>50 years) [6], and the authors of a German study state that at present, surgical closure is the treatment of choice for secondary prevention of paradoxical embolism [7]. Devices are often deeply embedded in the septal tissues. Removal of a thrombosed occluder device may therefore be challenging and can often be accomplished only by excision of the device together with the septum. The resulting septal defect is usually large and will inevitably require patch closure. Residual shunts are best avoided by securing the patch with two running continuous sutures [8]. Although the incidence of atrial fibrillation, and less commonly atrial flutter, is a hallmark in the course of patients with atrial septal defects, a variety of arrhythmias may complicate the postoperative course. Using magnetic resonance imaging and Doppler ultrasonography, Devuyst et al. demonstrated in 30 patients that surgical closure of a PFO (without anticoagulation) effectively prevents recurrent neurological events [9]. The authors did not observe any cerebrovascular events after a mean follow-up period of 2 years.
ICVTS on-line discussion Author: Dr. Antonio Corno, CHUV, Cardiac Surgery, 46 rue du Bugnon, CH-1011 Lausanne, Switzerland Date: 23-Jan-2003 06:55 Message: It is interesting to observe that all the Authors of this case report are surgeons, or at least they all work in a surgical Department. Would it be possible to share with the readers their opinion on the indication for interventional cardiology device closure of patent foramen ovale in a patient with previous ischemic episode? Do the Authors agree with the indication? What is their policy in these patients? > In the case, they agreed with the indication, after this episode did they review their indications? Response Author: Mr. Claudius Diez, Martin Luther University Halle, Cardiothoracic Surgery, Ernst-Grube-Str. 40, Halle/Saale, 06114, Germany Date: 25-Feb-2003 12:56 Message: Indeed, all authors work in the surgical department. The indication to close the PFO with an occluder device despite recurrent ischemic events was primarily based on the pediatric cardiologists decision without our consultation. The patient did not want to undergo a surgical procedure at the time and instead was offered "only" an interventional procedure. Whether or not to close a PFO in adults with an occluder with previous ischemic events is still controversially discussed. There are no guidelines available. There are only few reports that describe similar cases. From our surgical point of view we clearly prefer the PFO closure in a surgical manner because, as we stated in the article, the long-term risks of embolizastion and further ischemic events after device closure are still uncertain. Especially young adults may benefit from that approach. Two studies mentioned in the article also are in favour of the surgical approach. The question if we still share the indication for the occluder device is difficult to answer. We think that Center experience with device closure is an important factor as well as the surgical experience. The decision whether or not to close a PFO with an occluder should be made individually based on discussions from both cardiological and surgical staff. In this case we cannot rule out lacking compliance with the anticoagulation regimen and hence the device thrombosis. doi:10.1016/S1569-9293(02)00118-4
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