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Section of Cardiothoracic Surgery, Indiana University School of Medicine, Indianapolis, Indiana
Accepted for publication October 21, 2009.
* Address correspondence to Dr Brown, Section of Cardiothoracic Surgery, Indiana University School of Medicine, 545 Barnhill Dr, EH 215, Indianapolis, IN 46202-5123 (Email: jobrown{at}iupui.edu).
Presented at the Fifty-fifth Annual Meeting of the Southern Thoracic Surgical Association, Austin, TX, Nov 5–8, 2008.
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Abstract |
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Methods: Between 1992 and 2008, 220 of 280 patients (median age, 2.5 years; range, 1 to 45) with a wide range of underlying diagnoses underwent a fenestrated or nonfenestrated LTF operation at our institution. Current follow-up information was available for 215 patients (98%; mean follow-up, 6.7 ± 3.9 years). Risk factor analysis included patient-related and procedure-related variables, with death, failure (takedown or transplantation), and bradyarrhythmia or tachyarrhythmia as outcome variables.
Results: There was 1 early death, 10 late deaths, 3 takedown operations, and 1 heart transplantation. Kaplan-Meier estimated survival was 96% at 5 years and 95% at 10 and 15 years, and freedom from failure was 94% at 5 years and 93% at 10 years. Freedom from new supraventricular tachyarrhythmia was 98% at 5 years and 95% at 10 years; freedom from new bradyarrhythmia was 97% at 5 years and 96% at 10 years. Six patients have protein-losing enteropathy, and 2 of 6 have had Fontan takedown. Multivariable risk factors for development of supraventricular tachyarrhythmia included atrioventricular valve abnormalities (p = 0.02), and preoperative bradyarrhythmia (p = 0.01). Risk factors for bradyarrhythmia included the need for early postoperative pacing (p = 0.001). None of the patient-related variables significantly influenced survival.
Conclusions: The LTF operation results in excellent midterm outcome even when used in patients with complex anatomy. The incidence of postoperative atrial tachyarrhythmia is low and depends largely on the underlying cardiac morphology and incidence of preoperative arrhythmia. The good midterm outcome after a LTF operation should serve as a basis for comparison with other surgical alternatives to complete the Fontan circulation.
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Introduction |
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Introduced in 1987 [4–6], the LTF involves placement of an intra-atrial Gore-Tex or pericardial baffle. Although excellent midterm and long-term results of the LTF have been documented, potential risks includes atrial distension, postoperative arrhythmias, and the need for cardiopulmonary bypass with ischemic arrest or ventricular fibrillation to construct the intra-atrial baffle [2, 8, 9]. The ECF, introduced in 1990 [7], has several potential advantages, including the preservation of normal atrial pressure for the entire atrium, the absence of extensive intraatrial suture lines, possible avoidance of cardiopulmonary bypass (assuming no intracardiac repairs are needed), and the feasibility of early or late fenestration without the use of the extracorporeal bypass. However, this procedure has potential disadvantages related to using the extracardiac prosthetic tube, including the lack of growth potential, the delay of completing the Fontan to an older patient age, potential conduit stenosis secondary to intimal peel, and an increased risk of thromboembolism with the need for urgent reoperation [8].
The choice of completion Fontan technique is often based on surgeon or center experience. Our enthusiasm for the LTF is based on our experience with the hemi-Fontan over the bidirectional superior caval pulmonary connection as the second-stage palliation. The hemi-Fontan creates a large cavopulmonary connection that facilitates augmentation of the branch pulmonary arteries if needed and simplifies completion of the inferior vena cava to pulmonary artery pathway at the time of the completion Fontan.
The purpose of this manuscript is to review our experience employing a strategy to complete the Fontan circulation using a LTF pathway and compare our results with those recently published with one or both techniques.
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Patients and Methods |
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Preoperative and hospital course data were collected from medical records. The most recent follow-up information was obtained from Clarian Heath clinic database and our pediatric cardiology database. The primary malformation was hypoplastic left heart syndrome in 65, tricuspid atresia in 54, double-inlet left ventricle in 48, unbalanced atrioventricular septal defect in 22, and other complex cardiac defects in the remaining 31 patients (Table 1). Patients with double-outlet right ventricle underwent a univentricular repair because of hypoplasia of one ventricle, straddling atrioventricular valve, or multiple ventricular septal defects. Concomitant procedures are presented in Table 2. Twenty-six patients (12%) had an associated diagnosis of isomerism/heterotaxy syndrome; 22 patients (11%) had bilateral superior vena cavae, and 3 patients had only left superior vena cava.
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Thirty-six patients (16%) did not have previous staged palliation (they receive a single-stage hemi-Fontan and LTF), but 184 (84%) had previous cavopulmonary pulmonary anastomosis: hemi-Fontan (n = 155), right hemi-Fontan plus left bidirectional Glenn (n = 19), bidirectional Glenn only (n = 7), and left hemi-Fontan only (n = 3).
Surgical Technique
Our current surgical technique for LTF employs median sternotomy, cardiopulmonary bypass, with bicaval cannulation and mild hypothermia (28° to 30°C). Aortic cross-clamping was always used; myocardial protection was by cold, intermittent dose, antegrade blood cardioplegia. Ventricular fibrillation or circulatory arrest was not used in any patient. The only group (not discussed here) who did not have aortic cross-clamping was the heterotaxy group who received ECF.
All but 7 patients underwent a primary superior caval pulmonary connection and hemi-Fontan anastomosis (Fig 1). The procedure was constructed by sewing the cranial end of the divided superior vena cava to the superior aspect of the right pulmonary artery. The caudal end of the superior vena cava was sewn to the underside of the distal right pulmonary artery (Fontan connection). The superior vena cava–right atrial orifice was closed within the right atrium by using a circular patch of 0.6 mm Gore-Tex (W. L. Gore & Assoc, Flagstaff, AZ) polytetrafluoroethylene (PTFE). If a left superior vena cava was present, it was routinely anastomosed to the left pulmonary artery. All patients underwent modified ultrafiltration after separation from CPB. At the time of sternal closure, a pleural drainage tube was placed on the right and in the mediastinum and was removed when the daily drainage was less than 2 mL/kg.
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Statistical Analysis
The SPSS statistical program for Windows version 10 (SPSS, Chicago, IL) was used to perform data analysis. Data are expressed as mean ± SD and range. The Kaplan-Meier product limit method and Cox proportional hazards regression methods were used for actuarial survival analysis and analysis of freedom from arrhythmias. Potential risk factors in these analyses included sex, age (less than 1 month, 1 month to 1 year, 1 year to 18 years, more than 18 years), fenestration or nonfenestration, size of fenestration, concomitant surgical procedures, era (before and after 2000), isolated versus complex intracardiac anomalies, presence of isomerism/heterotaxy syndrome, nonstage LCT group, mean preoperative pulmonary artery pressure, oxygen saturation, ejection fraction, preoperative and postoperative arrhythmias, the need for preoperative or postoperative pacing, prolonged chest tube drainage (longer than 4 days), associated cardiac anomalies, morphology of the single ventricle, atrioventricular valve insufficiency, and chromosomal syndrome. All p values of 0.05 or less were considered significant. Early mortality was defined as death in the hospital or within 30 days of discharge. All other deaths were considered late.
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Results |
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There have been 10 late deaths (from 2 months to 12 years; median, 1.5). The etiology was low cardiac output (n = 4), arrhythmia (n = 2), pneumonia (n = 1), respiratory failure (n = 1), multiorgan failure (n = 1), and severe hepatic necrosis secondary to adenovirus (n = 1). Kaplan-Meier estimated survival was 96% at 5 years and 95% at 10 and 15 years (Fig 3). There were no significant correlations in any of the outcome variables for the survival.
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Protein-losing enteropathy was observed in 6 patients (3%). One patient underwent a successful LTF takedown with conversion hemi-Fontan. A second patient underwent successful heart transplantation 3 years after LTF. The third patient underwent successful refenestration of Fontan baffle 1 year after completion Fontan. Three other patients who had PLE (1, 4, and 6 years after a Fontan operation) are under good control and in relative remission. Overall, freedom from PLE is 97% at 15 years.
No patient required reexploration for postoperative bleeding. Prolonged pleural effusions requiring extended chest tube drainage (longer than 4 days) developed in 17 patients (8%). One patient had hemiparesis secondary to right middle cerebral artery embolism at 3 weeks postoperatively.
Reoperations
Seven patients (7 of 219; 3%) have required reoperation. One patient underwent a supravalvular ridge resection with Dacron (C. R. Bard, Haverhill, PA) patch aortoplasty 2 years postoperatively, and a second patient with increased cyanosis underwent ligation of a left superior vena cava. The third patient required refenestration secondary to PLE (see Morbidity section). Four patients (2%) underwent surgical closure of fenestration at 1 to 3 years after LTF, and 20 patients (9%) underwent device closure of their fenestration at a mean 3.1 ± 2.6 years postoperatively. Freedom from reoperation was 94%, 90%, and 88% at 5, 10, and 15 years, respectively.
Thromboembolism
Thromboembolic events occurred in 6 patients (including 2 patients with gene mutation contributing to a hypercoagulability state, 2 with patent fenestration greater than 2.5 cm and 4 without fenestration. None of these patients had atrial arrhythmias. Interestingly, we observed a significant increase in the frequency of thromboembolic events among patients receiving a LTF without fenestration (fenestration, 2 of 201 [1%] versus no fenestration, 4 of 18 [22%]; p < 0.01).
Follow-Up
Of the 219 hospital survivors, 4 patients were lost to follow-up. Follow-up was 98% complete and averaged 6.7 ± 3.9 years. At last follow-up, the mean New York Heart Association (NYHA) functional class of the survivors was 1.7 ± 0.5: 201 patients (96%) were in NYHA class I/II and 8 patients in class III.
Arrhythmias
Six patients had preoperative atrial rhythm disturbances that persisted after LTF: 4 patients with junctional rhythm and 2 patients with complete heart block required a permanent pacemaker early after LTF (within 2 months postoperatively). Of the remaining 209 patients, 191 (91%) were in sinus rhythm during their postoperative course, but 18 patients had late postoperative atrial rhythm disturbances. The postoperative arrhythmias that occurred in those 18 patients (9%) included supraventricular tachyarrhythmia (n = 13), and severe sinus bradyarrhythmia with junctional escape rhythm (n = 5). Nine of those patients (4.5%; 4 with atrial flutter, 4 with bradycardia, and 1 with tachycardia) required a permanent pacemaker. The remaining 9 patients are currently receiving antiarrhythmic medication.
Freedom from new supraventricular tachyarrhythmia was 98%, 95%, and 93% at 5, 10, and 15 years respectively; freedom from new bradyarrhythmia was 98% at 5 years and 97% at 10 and 15 years (Fig 4). Multivariable risk factors for development of supraventricular tachyarrhythmia included atrioventricular valve abnormalities (p = 0.02), and preoperative bradyarrhythmia (p = 0.01). Risk factors for bradyarrhythmia included early postoperative pacing (p = 0.001).
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Comment |
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Mortality after the Fontan operation has improved significantly over the past several years. Mortality rates with the classic atrial pulmonary connection approximated 15% to 25%, but currently the LTF or ECF can be performed with an early mortality of 2% to 5% [2, 3, 8, 9, 11, 12]. Risk factors for Fontan failure or death include pulmonary artery stenosis or distortion, elevated pulmonary artery pressure or resistance, ventricular dysfunction, systemic atrioventricular valve regurgitation, prolonged cardiopulmonary bypass or cross-clamp time and postoperative arrhythmias [8, 13–15]. At present, the type of total caval pulmonary connection employed (LTF or ECF) does not affect early or late mortality or long-term outcome (Table 3). The use of a fenestration and the presence of arterial-to-pulmonary collaterals, however, can affect perioperative and long-term morbidity. [13, 14, 16]. In most series, the LTF and ECF have similar survival rates [8, 9, 11, 17] (Table 3). Combined early and late mortality after the LTF in the current series is 5% and compares favorably with other contemporary reports [8, 13, 15]. Three patients in the current cohort required takedown of their total pulmonary connection, and only 1 patient underwent heart transplantation. We did not observe risk factors for mortality by univariate and multivariable analysis.
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Atrial dysrhythmias and poor functional outcome have been major concerns during follow-up after the Fontan operation. The construction of a bidirectional cavopulmonary shunt or the hemi-Fontan procedure may precipitate atrial rhythm disturbances, inherent to the surgical technique employed in these operations [2, 8, 11, 17, 18]. The mean annual incidence of new dysrhythmias in Fontan patients is 5% per year (range, 4% to 15%) [2, 8]. These rhythm disturbances may include bradyarrhythmia and supraventricular tachycardia. The frequency of dysrhythmias at follow-up after the ECF or LTF is variable. In a series of 107 primary Fontan connections, Azakie and colleagues [8] found the LTF patients had a significantly higher incidence of postoperative sinus node dysfunction, supraventricular tachycardia, and need for temporary postoperative pacing than the ECF cohort did (45% versus 15%). Multivariate analysis identified the LTF connection as an independent predictor of atrial arrhythmias in the acute postoperative and intermediate follow-up periods. Lee and colleagues [9] demonstrated a similar frequency of dysrhythmias at follow up: 22% in LTF patients versus 11% in ECF patients (p < 0.001).
Conversely, Kumar and associates [2] identified the ECF as a risk factor for sinus node dysfunction in a series of 33 patients. Similar results have been observed by others [11, 17]. Ovroutski and colleagues [19], employing 24-hour Holter monitoring, documented a higher degree of sinus rhythm in ECF patients and a greater frequency of pacemaker implantation for sinus node dysfunction in LTF patients. One potential reason for these differences may be the approach taken to Fontan staging. In our series, and others [2, 11, 17], LTF patients were staged with a prior hemi-Fontan procedure, whereas ECF patients had a bidirectional Glenn shunt. Azakie and colleagues [8] reported that the patients were staged with a bidirectional Glenn for all but 1 patient. In our series, the hemi-Fontan procedure establishes a connection between the cranial and caudal end of the divided superior vena cava to the right pulmonary artery [20]. No incision crosses the superior vena cava–right atrial junction, and no incision is placed in the dome of the right atrium, which has the potential of sacrificing the blood supply to the sinus node. Our technique of the hemi-Fontan involves surgery away from the region of the sinus node, and the subsequent LTF procedure can be carried out without incisions, suturing, or redissection in the region of the node and its blood supply [20]. In contrast, the LTF after a previous bidirectional Glenn requires anastomosis of the superior aspect of the right atrium to the pulmonary arteries. This involves dissection, an incision, and suturing in the vicinity of the sinus node and its blood supply, which may be obscured by scarring and absence of the superior cavoatrial junction as a landmark. These considerations may have contributed to the contrasting rates of early sinus node dysfunction among LTF patients in our report versus the series of Azakie and colleagues [8].
Other reports also support a relationship between Fontan staging and sinus node dysfunction. Cohen and associates [21] analyzed early sinus node dysfunction and found that LTF and ECF groups had an equal incidence of sinus node dysfunction (13%) at hospital discharge. Manning and coworkers [18] also examined early sinus node dysfunction in patients undergoing a staged Fontan procedure. Among 60 patients with LTF procedures staged with a previous bidirectional Glenn, sinus node dysfunction was observed in 56% [18]. Thus, early sinus node dysfunction appears to be more frequent with a bidirectional Glenn–LTF rather than a hemi-Fontan–LTF or bidirectional Glenn–ECF operation. Early sinus node dysfunction may carry long-term implications, as it predicts late sinus node dysfunction [21], which in turn is associated with late supraventricular tachycardia [21, 22].
There were relatively few thromboembolic events in this series (3%). It has been our policy to give anticoagulation therapy to all Fontan patients early after the LTF. Patients in whom the fenestration remains patent remain on a regimen of Coumadin and low-dose aspirin indefinitely. For all other patients, aspirin is used indefinitely. This policy, however, did not give absolute protection to our patients, as the majority of those who experience thromboembolic events were receiveing anticoagulation therapy at the time of this event.
The pathogenesis of PLE remains poorly understood [23, 24]. Feldt and colleagues [24] found several factors associated with the late development of PLE in Fontan patients, including nondominant left ventricle, elevated preoperative end-diastolic pressure, prolonged cardiopulmonary bypass time, and hospital stay beyond 15 days. These authors did not specifically evaluate the duration and volume of postoperative chylous effusions, but they speculated that an association may exist. In this study, we did not observe any significant risk factors for PLE.
In conclusion, we continue to prefer the LCT Fontan for the third-stage palliation in functional single-ventricle patients with suitable anatomy, and it can generally be accomplished at a younger age than an ECF can. The ECF is our procedure of choice for completion Fontan in the heterotaxy subgroup or patients who had a bidirectional Glenn at another institution before coming to us for completion Fontan. Based on computational fluid dynamic modeling, the hemi-Fontan procedure followed by the LCT Fontan minimizes energy losses and optimizes the distribution of inferior vena cava flow into both lungs [12, 25]. The use of autologous tissue for the majority of the reconstruction may allow for growth potential and reduce the theoretical risk of thromboembolism. With the exception of a specific indication for Coumadin for fenestrated patients, in this cohort our patients are managed with low-dose aspirin alone, with few documented cases of thromboembolism. As for postoperative atrial dysrhythmias, using the techniques we have described and avoiding incisions across the atriocaval junction and the region of the sinus node blood supply may explain our relatively low incidence of this vexing postoperative complication.
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Discussion |
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Because I came in late, I missed your description of your technique for performing the hemi-Fontan, and I suspect that the reason that you like the hemi-Fontan relates to the fact that you are having such excellent results with the completion Fontan using the lateral tunnel technique. Are there any other factors that make the hemi-Fontan your technique of choice at the second stage?
DR BROWN: I think it is because of the low incidence of atrial arrhythmias that we have seen. We try to use a no-touch technique for the crista terminalis, the atriocaval junction, and the blood supply to the SA node. That is a no man's land for us. You can't disturb those tissues, in our mind, and expect that the patient is going to be remain in sinus rhythm. There will be some arrhythmia's regardless of what you do, but I think if you avoid disturbing the anatomy in these regions you are more likely to maintain sinus rhythm long term.
DR AUSTIN: The other thing is that there are some patients, most typically patients with heterotaxy syndrome, where the anatomy is such that the pathway from the inferior vena cava (IVC), or if there is no IVC, from the hepatic veins, up to the pulmonary artery is not a straightforward one with an intra-atrial technique. I also noted in the manuscript that you did do some extracardiac Fontans. I wondered if any of those cases used the extracardiac conduit because of anatomy or do you feel confident that in every case no matter how complex the venous drainage that you can construct an intra-atrial tunnel?
DR BROWN: No. During this same period there were 28 extracardiac Fontans because of heterotaxy and other complex lesions. There weren't enough patients in this subset to make a meaningful comparison with the lateral tunnel Fontans. And there were an additional 32 patients very early in this experience that had classic Fontans, but, again, the numbers weren't great enough to make a meaningful comparison.
DR AUSTIN: Well, thank you, John. I thought this was thought provoking for me and certainly made me reconsider an operation that I haven't performed in a while. I think the technical points that you bring out have much to do with your success and should be noted by those who continue to use the lateral tunnel and those who may want to return to it.
DR BROWN: Thank you.
DR J. WILLIAM GAYNOR (Philadelphia, PA): Thanks, John. I really enjoyed that. We use both lateral tunnel and extracardiac and we see very similar results and very little difference between the two techniques and intermediate-term outcomes. We used echocardiography to identify sites of thrombus. In the lateral tunnel, with a fairly high incidence, we saw thrombus on the pulmonary venous side of the baffle, which may relate to the risk of stroke. We didn't see this in the extracardiac Fontan patients. Did you evaluate your patients with echocardiography, to determine how many patients have thrombus on the pulmonary venous side? We don't use anticoagulation, so that may cause some differences.
DR BROWN: In those 6 patients who had neurologic deficits, we were never able to find the source. The echocardiograms at the time of onset of symptoms did not show anything and so we could not identify the source.
DR JAMES S. TWEDDELL (Milwaukee, WI): That was a great presentation, terrific series. In one of your beginning slides you conjecture that the lateral tunnel Fontan allows for growth, and I wonder if that really true has anyone demonstrated that the lateral tunnel Fontan does in fact grow appropriately as the patient grows. I am not certain that that strip of lateral atrium is really viable and it may not grow. Certainly we wouldn't be surprised if we patched the pulmonary artery with a piece of GoreTex and it became stenotic some years later. I don't think that would be a shock to anybody. Are you going to look at growth of the lateral tunnel in your ongoing follow-up?
DR BROWN: Just to make it clear, the prosthetic part of the lateral caval tunnel is a 2-cm wide by 5- to 7-cm long patch of Gore-Tex. Three fourths to 80% of the lateral caval tunnel is native issue. So it is only a narrow strip that has the fenestration in it that is prosthetic. We have not seen any late stenoses or gradients across the lateral caval tunnel in any of the patients thus far.
DR EDWARD L. BOVE (Ann Arbor, MI): John, I enjoyed your paper very much and, as an advocate of the lateral tunnel, it is easy for me to come up and agree. I wanted to make a couple of points, and one relates to what Jim Tweddell just said. We now have over 20-year follow-up on the lateral tunnel procedure and have not seen obstruction, even though these operations are generally done at 18 months of age. Our oldest hypoplastic left heart syndrome survivor is now 22 years of age. Although it is only one case, I have a patient in whom I performed an extracardiac conduit many years ago because there was no other way to make a connection from the IVC. That patient outgrew the conduit, which had to be replaced, so I share your thoughts although I admit that the evidence is weak.
The other thing not mentioned, which I believe is important, are the benefits of the hemi-Fontan procedure. I noticed you divide the cava and suture both ends to the pulmonary artery. In a computer flow modeling study that we did sometime back, we found that the only way that we could get the computer to model the circulation such that you have minimal energy losses and evenly distributed flow to each lung was by keeping the caval offset in an anterior-posterior orientation. This is what the hemi-Fontan allows you to do very well. This is an excellent staging procedure to the lateral tunnel. When we modeled the Fontan by dividing both vena cavae with or without an extracardiac conduit, the caval offset is side to side, which means you will get most of the caval flow to whatever side you offset.
The final comment I would make is we have not used Coumadin in any of our patients and really have not seen much incidence at all of thrombus. We only use aspirin and that has worked remarkably well. Thank you. It was a great series.
DR BROWN: Thank you, Ed. It is tough to argue with your results. I am aware of your computer modeling. Again, we have sort of focused on not disturbing the blood supply and the anatomy at this atriocaval junction. And it seems in those few patients that we have late studies on utilizing our technique of lateral tunnel Fontan, we have seen the expected distribution in pulmonary blood flow, with about 60% to the right, 40% to the left. So we haven't seen any lack or maldistribution of blood flow to either lung as a result from doing the completion Fontan our way.
DR ANDREW C. FIORE (St. Louis, MO): John, my question involves 2 patients with PLE. In one case, you enlarged the lateral tunnel fenestration and in another case you took down the lateral tunnel Fontan and converted them presumably to a hemi-Fontan. What was the outcome for the PLE in each of these patients?
DR BROWN: Yes, in both instances. Only 1 patient went on to transplantation who we enlarged the fenestration and PLE persisted, and that patient was just not doing well and we transplanted. There is 1 transplant patient in the series and that was a patient who didn't respond well to the enlargement of the fenestration, and I think that is the same patient who had the takedown but still had poor ventricular function and eventually ended up being transplanted.
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