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Ann Thorac Surg 2002;73:64-68
© 2002 The Society of Thoracic Surgeons

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Original article: cardiovascular

Fontan’s operation: is aspirin enough? Is coumadin too much?

^a Sections of Cardiothoracic Surgery and Cardiology, St. Christopher’s Hospital for Children, Philadelphia, Pennsylvania, USA
^b Department of Surgery, Deborah Heart and Lung Center, Browns Mills, New Jersey, USA

* Address reprint requests to Dr Jacobs, Section of Cardiothoracic Surgery, St. Christopher’s Hospital for Children, Erie Ave at Front St, Philadelphia, PA 19134, USA

Presented at the Thirty-seventh Annual Meeting of The Society of Thoracic Surgeons, New Orleans, LA, Jan 29–31, 2001.

	Abstract

Top Footnotes Abstract Introduction Patients and methods Results Comment Discussion References

 
Background. Thromboembolism after Fontan’s operation is attributed to low flow states, stasis in venous pathways, right to left shunts, blind cul-de-sacs, prosthetic materials, atrial arrhythmias, and hypercoagulable states. We assessed the efficacy of a strategy to reduce thromboembolic events including aspirin anticoagulation.

Methods. From January 1996 through December 2000, 72 patients underwent Fontan procedures. Management included (1) avoidance of direct caval cannulation and central venous lines, (2) inotropic support for 48 to 72 hours to optimize cardiac output, (3) aortopulmonary anastomosis or suture closure of patent pulmonary valves, and (4) administration of aspirin (81 mg per day) beginning on postoperative day one. No other anticoagulation strategies were used. Surveillance included intraoperative and postoperative transesophageal echo, transthoracic echo at discharge, at first reevaluation, and at 6 month intervals, and catheterization 1 year after surgery.

Results. There were no early or late deaths. Follow-up was completed with 2,882 patient-months and a mean of 40 months. There were no documented thromboembolic events; however, all suspicious occurrences were investigated by echo and brain imaging. There were no hemorrhagic events or aspirin-related complications.

Conclusions. Low dose aspirin can be used safely in young patients with Fontan connections. At intermediate follow-up, the strategies described appear effective in preventing thromboembolic complications. Routine use of more aggressive anticoagulation regimens seems unwarranted.

	Introduction

Top Footnotes Abstract Introduction Patients and methods Results Comment Discussion References

 
Thromboembolic events account for significant morbidity and mortality after Fontan procedures. Almost since its introduction in 1971, the Fontan procedure and its subsequent modifications have been the focus of numerous case reports describing occurrences of central venous, intracardiac and pulmonary artery thrombosis [1–9], and systemic thromboemboli to the central nervous system or coronary circulation [10–13]. Several retrospective series have reported the incidence of thromboembolic events after Fontan operations ranging from 3% to 20% [14–17]. Others have reviewed the incidence and circumstances of stroke after the Fontan operation [18, 19]. The time course of these thromboembolic events ranged from the first 24 hours after the operation to as late as 16 years postoperatively. Efforts have been made to characterize abnormalities of coagulation that are associated with the post-Fontan circulation [20–22], but they are hampered in part by lack of age specific controls [23]. While there is general agreement that ligation of the main pulmonary artery leaving a blind pouch or cul-de-sac distal to the pulmonary valve is a worrisome substrate for the occurrence of thromboembolism [24, 25] almost every other assertion with regard to thromboembolic events after Fontan’s operation is the subject of controversy. Specifically, there is little agreement as to the efficacy of various forms of anticoagulant therapy that are recommended or used in hopes of reducing the morbidity and mortality from thromboembolic events after Fontan operations [11].

In 1998, Monagle and associates [26] reviewed the literature on thromboembolic complications after Fontan procedures. They concluded that much of the extant data was anecdotal, and suggested that multicenter randomized controlled trials comparing prophylactic antiplatelet and anticoagulation therapies could provide important information to guide the management of patients who undergo Fontan procedures. In the absence of such randomized trials, we offer our retrospective evaluation of the results of a scheme of Fontan patient management, including aspirin therapy, that has been applied consistently in our practice for more than 5 years.

	Patients and methods

Top Footnotes Abstract Introduction Patients and methods Results Comment Discussion References

 
This is a retrospective survey of the outcomes of 72 consecutive Fontan operations by one surgical team at two institutions. All operations were "completion Fontan operations," as every patient had previously undergone either a hemi-Fontan procedure or a bidirectional Glenn anastomosis. No patient was receiving any anticoagulant medications prior to the Fontan procedure. In 65 patients, total cavopulmonary connection was accomplished by means of the lateral atrial tunnel technique, using a gusset of polytetrafluoroethylene (PTFE) (IMPRA Inc, Tempe, AZ). In each patient, three separate fenestrations were created in the PTFE gusset using a 2.5-mm aortic punch. In 7 patients, total cavopulmonary connection was accomplished using an extracardiac tube graft of PTFE with a single fenestration (4 of 7 patients). In every instance where amalgamation of the proximal main pulmonary artery with the aorta (Norwood or Damus-Kaye-Stansel procedure connection) had not been accomplished as part of prior palliation, the main pulmonary artery was transected and the pulmonary valve and proximal pulmonary artery stump were oversewn directly in two layers.

Several additional features of the operative plans were intended to reduce the likelihood of thromboembolism. No central venous lines were placed. Bypass was started with a dilute blood prime using a single venous cannula in the right atrium with a pump return to the ascending aorta. No direct caval cannulations were used, and no tourniquets were placed around the inferior or superior vena cava. Total cavopulmonary connection was accomplished as described [27] during a period of hypothermic circulatory arrest. After rewarming, infusions of Dopamine or Dobutamine, or both were started at 2 to 7 mcg/kg per minute, ventilation was increased, and bypass was discontinued. For purposes of hemodynamic monitoring and infusions, two 18-gauge polyvinyl catheters were inserted through the right atrial cannulation site with the tips situated in the pulmonary venous portion of the right atrium. They were exteriorized through the chest wall. No catheters were placed in the venous pathway or the pulmonary arteries. Following reversal of heparin with protamine (6 to 10 mg/kg with a goal of achieving the patient’s baseline activated clotting time), fresh whole blood (less than 48 hours old, citrated) was administered to replenish intravascular volume and restore adequate coagulation. No patient received aprotinin, epsilon amino caproic acid, or platelet concentrates. A single anterior mediastinal chest tube was placed, and primary sternal closure was achieved in routine fashion. Patients were extubated in the intensive care unit as they emerged from anesthesia if hemodynamics were stable and bleeding was minimal. Postoperative pleural fluid collections were drained using 7 French polyvinyl catheters placed using the Seldinger technique. Aspirin was administered at a dose of 81 mg by mouth daily, beginning on the first postoperative day. To optimize cardiac output, inotropic support was continued at gradually diminished doses for a minimum of 48 hours.

Each patient underwent transesophageal echocardiography at the time of separation from cardiopulmonary bypass or within a few hours of admission to the intensive care unit. Transthoracic echocardiography was then performed prior to discharge, at the first outpatient reevaluation, and thereafter at 6-month intervals. Complete hemodynamic assessments by heart catheterization and angiography were performed 1 year after surgery. In addition to the routine postoperative surveillance, any suspicious events possibly thought to be the consequence of thromboembolism were investigated by transthoracic ± transesophageal echocardiography and by imaging studies of the brain (computed tomographic scan ± magnetic resonance imaging). In addition to this surveillance protocol, current information with regard to each patient was obtained by means of a telephone survey and a mailed questionnaire from October 2000 through December 2000. Follow-up was considered current if contact was successfully achieved with a parent and the patient’s primary cardiologist.

	Results

Top Footnotes Abstract Introduction Patients and methods Results Comment Discussion References

 
From January 1996 through December 2000, 72 consecutive patients underwent completion Fontan operations as described. Diagnoses are shown in Table 1. Sixty-two patients underwent prior hemi-Fontan operations and 10 patients underwent prior bidirectional Glenn anastomosis. Ages of the patients ranged from 1.5 to 15 years (median, 25 months); all patients were less than 5 years old, except 1 patient who was 15 years old. Fontan procedures included 65 patients by lateral atrial tunnel and 7 patients by extracardiac conduit. The duration of hypothermic circulatory arrest ranged from 15 to 39 minutes, with a mean of 21 minutes. The duration of cardiopulmonary bypass (excluding circulatory arrest) ranged from 35 to 65 minutes with a mean of 43 minutes.

The telephone survey and questionnaire resulted in contact with a parent or surrogate of every patient, and with the primary cardiologist of all except 2 patients. As there is current data on all patients, this constitutes 2,882 patient-months of follow-up, with an average duration of follow-up of 40 months. Sixty-nine of 72 patients remain on daily aspirin, and 1 patient is on aspirin (81 mg) every other day. Two patients no longer take aspirin on a regular basis. In most instances the surveillance recommendations were observed at the discretion of their primary cardiologist, although several patients (after more than 2 years post-Fontan operations) now have echocardiograms every year rather than every 6 months. Catheterization with cardiac angiography was performed about 1 year after Fontan operations on 54 patients.

There were no early postoperative deaths and no late deaths. There have been no hemorrhagic events or aspirin-related complications. No patient has taken warfarin or other nonaspirin anticoagulant. There have been no documented thromboembolic events. Two suspicious events were investigated, and thromboembolism was ruled out. A 4-year-old girl with complex transposition of the great arteries experienced self-limited seizures during a febrile illness 2 years after the completion Fontan procedure. Echocardiography showed no evidence of thrombus or thromboembolism and no evidence of right to left shunt. The brain computed tomographic scan was normal. A subsequent magnetic resonance image showed no evidence of thromboembolic phenomena. A 4-year-old boy with single left ventricle had a 4-hour loss of consciousness followed by seizures after a fall with closed head trauma. An emergent brain computed tomographic scan was done and was found to be normal. Echocardiography showed no evidence of thrombus or thromboembolism and no evidence of right to left shunt. Subsequent brain magnetic resonance imaging showed small hemangiomas and no evidence of infarction.

	Comment

Top Footnotes Abstract Introduction Patients and methods Results Comment Discussion References

 
Ultimate reduction of the morbidity and mortality associated with Fontan’s operation requires a strategy to minimize thromboembolic complications. Some detailed information is available concerning the status of the coagulation system after Fontan’s operation. Decrease in the levels of protein C and protein S have been described by numerous authors [20–22], although the relevance of these values to patient age has been questioned [23]. Decreased levels of antithrombin III and increased levels of factor VIII are also described [21, 22]. These alterations suggest the possibility of a procoagulant state. Also reported however, is a relative decrease in levels of factor VII, which, if moderate in degree should predispose to bleeding, not coagulation. This together with the fact that protein C is a natural anticoagulant synthesized in the liver as a vitamin K dependent protein, suggests a complex interaction between procoagulant and anticoagulant factors in Fontan patients. No authors have demonstrated a clear relation between the presence of coagulation factor abnormalities and the clinical and hemodynamic condition of the patients. Furthermore, Jahangiri and colleagues [28] ruled out regional differences in coagulation abnormalities in patients late after the Fontan operation. Thus the available information concerning the state of the coagulation system in Fontan patients suggests a complex field of physiologic variables, some potentially predisposing to thrombotic events, and some potentially predisposing to a hypocoagulable state.

In our patients, the consistent use of low dose aspirin after Fontan operations is based in part upon experimental work by Pearl and colleagues [29] that demonstrated aspirin delayed but did not prevent the spontaneous closure of fenestrations in a PTFE atrial septal substitute in a canine experimental model. Importantly, they showed that closure was accomplished primarily through the ingrowth of fibrous tissue, and not as a result of thrombosis. Unlike warfarin, the regular administration of low-dose aspirin to children extracts very little in the way of cost, inconvenience, adverse side effects, or the need for monitoring.

We do not attribute the absence of clinically evident thromboembolic complications in our series to the use of aspirin alone. The operations as described are designed to minimize the potential for distortion and disruption of smooth endothelial surfaces in the venous pathways. The avoidance of direct caval cannulation requires the use of brief periods of hypothermic circulatory arrest. As pointed out by Mosca and colleagues [30], this strategy not only avoids caval distortion, but also obviates the need for dissection around the superior and inferior vena cava. This potentially reduces problems from bleeding and from phrenic nerve injury. Avoidance of central venous catheters is based on the observation that these frequently serve as the nidus for initiation of platelet and fibrin thrombi. The use of only transthoracic atrial lines permits continuous monitoring of cardiac filling pressures during the early postoperative period, without the additional presence of foreign bodies in the cavopulmonary pathway. In no patient was the removal of these lines after the initiation of aspirin therapy associated with significant blood loss. The routine use of inotropic agents during the first 48 to 72 hours is intended to optimize cardiac output during this crucial period, although most patients could be successfully separated from cardiopulmonary bypass without pharmacologic support. The use of small percutaneous catheters to drain pleural fluid collections facilitates early mobilization because these do not need to be attached to continuous drainage systems but may alternatively be aspirated using a syringe and stopcock system.

The potential contribution of baffle fenestration and persistent right to left shunts to the incidence of thromboembolic complications is a matter of speculation. We are convinced that the early postoperative state of Fontan patients is improved by baffle fenestration, resulting in less difficulty optimizing cardiac output and less morbidity from effusions. We choose in most instances to create a lateral atrial tunnel with multiple small fenestrations, and we have demonstrated that these fenestrations undergo spontaneous closure, usually within 1 year [31]. This strategy confers the early postoperative benefits of fenestration while limiting the duration of the persistence of right-to-left shunting. This strategy also eliminates the need for subsequent use of catheter delivered intracardiac devices to accomplish fenestration closure. The use of such devices may increase the overall risk of thromboembolic complications.

We do not take issue with those who suggest that multiinstitutional randomized controlled trials would be the most scientific method to arrive at recommendations for anticoagulation therapy after Fontan operations. Nor do we suggest that routine administration of low-dose aspirin will entirely eradicate these important morbid complications. We are however, significantly encouraged by the 5-year experience reported here in this study. Of course the study is limited by its retrospective nature and lack of a control group. The consistent young ages of the patient population leave the questions open regarding the impact of such a strategy on older patients and on these patients as they age and undergo normal maturational changes of the coagulation system. Furthermore, we acknowledge that more sensitive, though more invasive means of investigation might possibly have revealed clinically silent thrombi in our patients. Clearly, the possibility exists that patients may experience small pulmonary emboli that are not clinically apparent, and that they may in fact lyse spontaneously without specific therapy. Fyfe and colleagues [16] have shown that transesophageal echocardiography is more sensitive than transthoracic echocardiography as a tool to detect thrombi in Fontan pathways. Intravascular ultrasound still may be more sensitive. However, in the absence of adverse clinical outcomes because of thromboembolic complications, the surveillance we recommend and use seems efficacious.

We infer from our experience that low-dose aspirin can be used safely in young patients with these types of Fontan connections. At intermediate follow-up the strategies described appear effective in preventing thromboembolic complications. Routine use of more aggressive anticoagulation regimens seem unwarranted.

	Footnotes

Top Footnotes Abstract Introduction Patients and methods Results Comment Discussion References

 
This article has been selected for the open discussion forum on the CTSNet Web site: http://www.ctsnet.org/doc/5499

	Discussion

Top Footnotes Abstract Introduction Patients and methods Results Comment Discussion References

 
DR CARL BACKER (Chicago, IL): Congratulations, Marshall, that’s really a beautiful series. Seventy Fontans with no mortality is outstanding.

What I would like to ask you is based on your review of the literature and the information from your own patients. I was impressed with that fact that you presented that two-thirds of the thromboembolic events reported in the literature occurred in the first year after the Fontan operation. Based on that very significant analysis, and your own analysis, what do you think about a strategy of keeping Fontan patients on Coumadin therapy for the first year following the Fontan and then converting them to aspirin therapy following that?

DR JACOBS: Actually, that is a very good question. The review of the literature, as I mentioned, goes back to 1978. A lot of these early case reports involved thrombosis of a conduit between the right atrial appendage and the left pulmonary artery in patients with prior Glenn anastomosis, or thrombosis in hugely enlarged right atria following atriopulmonary anastomoses. So I think that the merit of an anticoagulant strategy is really related to the technique by which the operation is done. And certainly I would not want to suggest that the routine use of aspirin would be adequate for all Fontan patients with all types of connections, particularly those that we have largely abandoned because of the technical complications associated with them.

However, I would have thought that even with a small series like this, that if aspirin anticoagulation was inadequate to prevent thromboembolic complications during the first year, that this experience would have shown us some evidence of that with an adverse clinical outcome, and we didn’t see any.

DR BACKER: My other point you made, that is, it is important not to extend this analysis to the patients that have had prior atriopulmonary connections where there may be a higher incidence of thromboembolic events.

My last question is what do you tell families when they ask you "What is the incidence of Reye’s syndrome, keeping a child on aspirin for many years?" Or is that a thing of the past? Thank you.

DR JACOBS: Yes, that’s a very good question. Reye’s syndrome is one of those things that saturated the pediatric and infectious disease medical literature, I think in the late 1970s and early 1980s, and has all but disappeared. And I’m not sure whether it’s all but disappeared because of anything intelligent or therapeutic that we’re doing. Nonetheless, we do communicate with these patients’ general pediatricians and recommend that the aspirin therapy be interrupted in the course of a viral syndrome, or with exposure to varicella. I don’t think that the interruption of aspirin therapy results in any kind of rebound phenomenon, or any kind of prothrombotic state, and it is known that the period of time during which the aspirin is discontinued is probably shorter than the period of time that platelet dysfunction from the effect of salicylates persists. Nonetheless, we do make that recommendation because of the association with Reye’s syndrome.

	References

Top Footnotes Abstract Introduction Patients and methods Results Comment Discussion References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Marshall L. Jacobs Kamal K. Pourmoghadam Angelo T. Reyes John W. Moore Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Jacobs, M. L. Articles by Moore, J. W. Search for Related Content PubMed PubMed Citation Articles by Jacobs, M. L. Articles by Moore, J. W. Related Collections Congenital - cyanotic