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J Thorac Cardiovasc Surg 2003;125:1252-1259
© 2003 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

The modified Fontan procedure: Early and late results in 132 adult patients

From the Division of Cardiovascular Surgery,^a Section of Pediatric Cardiology,^b Division of Cardiovascular Diseases,^c and Division of Biostatistics,^d Mayo Clinic and Mayo Foundation, Rochester, Minn.

Received for publication June 6, 2002. Revisions received Nov 12, 2002. Accepted for publication Nov 25, 2002. Address for reprints: Joseph A. Dearani, MD, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 (E-mail: jdearani{at}mayo.edu).

	Abstract

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
Objective: The modified Fontan procedure, usually performed in children, is used for the treatment of anomalies with a single functional ventricle. We reviewed our experience with the modified Fontan procedure performed in the adult patient.
Methods: Between October 1973 and May 2001, the modified Fontan procedure was performed on 132 adult patients (74 men, 58 women). Median age was 23 years (range, 18 to 53 years). Diagnoses included tricuspid atresia in 34 patients (26%), double-inlet left ventricle in 48 (36%), and complex lesions in 50 (38%). The majority of patients (89%) had at least one prior palliative procedure; the most common procedures were Blalock-Taussig shunt in 85 patients and Glenn anastomosis in 31.
Results: Operations included an atriopulmonary connection in 74 patients, lateral tunnel in 27, intra-atrial conduit in 14, right atrium-to-right ventricle in 9, extra-cardiac conduit in 3, and other in 5. Overall early mortality was 8.3%. Mortality was 6.5% for operations performed after 1980. This is comparable to the mortality of the modified Fontan procedure performed in children during the same time interval at our institution. All 7 of the early deaths since 1980 occurred in the complex lesion group. Morbidity included prolonged pleural effusion in 36 patients, atrial arrhythmias in 25, reoperation for bleeding in 13, permanent pacemaker in 8, and stroke in 2. Mean follow-up was 9.1 years with a maximum of 21.2 years. Actuarial survival for early survivors was 89% (84,95), 75% (67,84), and 68% (58,79) at 5, 10, and 15 years, respectively. Freedom from late reoperation was 89% (83,95), 85% (78,93), and 80% (70,91) at 5, 10 and 15 years, respectively. The majority (90%) of present survivors were New York Heart Association class I or II at follow-up.
Conclusions: In properly selected adult patients with functional single ventricle, the modified Fontan procedure can be performed with early mortality similar to younger patients. Early mortality is more likely with complex lesions. The majority of late survivors have a good quality of life.

	Introduction

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
In 1971 Fontan and Baudet first described successful clinical bypass of the right ventricle, with separation of the pulmonary and systemic circulations, in a patient with tricuspid atresia. ¹ The technique described in this initial report included a classic Glenn anastomosis, a pulmonary homograft valve inserted at the inferior vena cava-right atrial junction, and an aortic valved homograft from the right atrial appendage to the main pulmonary artery. Independently, Kreutzer and colleagues described right ventricle bypass in a patient with tricuspid atresia in which the pulmonary annulus and valve were detached from the right ventricular outflow tract and connected to the right atrial appendage. ² Since these initial reports, the operative technique has gone through many technical modifications and has been applied to patients with a variety of functional single-ventricle diagnoses. Since 1973, we have performed several modifications of the Fontan procedure (MFP) in patients with tricuspid atresia, double-inlet left ventricle, and other forms of complex functional single ventricle. Historically, the operation has been performed predominantly in children. The purpose of this study was to examine the clinical course and outcome of all adult patients who had an MFP performed at the Mayo Clinic.

	Patients and methods

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
MFP was performed in 957 patients from October 31, 1973, to April 24, 2001, at the Mayo Clinic in Rochester, Minnesota. One hundred thirty-two of these patients (14%) were 18 years of age or older. Medical records of these 132 adult patients were reviewed for patient demographics, preoperative symptoms, operative procedure, pre- and postoperative hemodynamics, early and late morbidity, and survival. Adult patients undergoing revision of a previous MFP were excluded from this study.

Seventy-four patients (56%) were men and 58 (44%) were women. Median age at time of the MFP was 23 years (range, 18 to 53 years). The majority of patients (85%) were in New York Heart Association (NYHA) functional class III or IV preoperatively. Fifty patients (38%) were on preoperative digoxin, 20 (15%) were on diuretic therapy, and 15 (11%) were on an antiarrhythmic agent.

Diagnoses were divided into three groups as seen in Table 1. All of the patients in the complex lesion group had a functional single ventricle or two ventricles unsuitable for ventricular septation. The subset of patients with double-outlet right ventricle included asplenia and polysplenia syndromes, hypoplastic or straddling atrioventricular valves, and crisscross hearts, all of which had anomalies that precluded a two-ventricle repair.

The follow-up status of the patients was determined principally by review of the patient records, written questionnaires, or telephone interviews when necessary. Data reviewed included functional status, any hospitalizations, cardiovascular events, and reoperations. Death certificates, physician notes, and hospital notes were reviewed in the event of a death.

Early mortality was defined as death occurring within 30 days of operation or at any time during the operative hospitalization. Survival statistics were performed using the Kaplan-Meier method with the day of operation as the starting point. ³ Ninety-five percent confidence intervals were calculated for each survival estimate. Survival curves were compared using the log-rank test. Factors that affected survival were analyzed with the Cox proportional hazards model. ⁴ Continuous risk factors were dichotomized using roughly the median or third quartile as a cut point. P values less than .05 were considered statistically significant.

	Results

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
All operations were performed through a median sternotomy utilizing cardiopulmonary bypass. The median cardiopulmonary bypass time was 138 minutes (range, 66 to 339 minutes). Aortic crossclamping was utilized in 121 patients (92%) for a median time of 70 minutes (range, 6 to 194 minutes). Circulatory arrest with deep hypothermia was used in 14 patients (11%). Available preoperative and postoperative hemodynamic measurements are reported in Table 3. The modifications of the Fontan procedure performed are shown in Table 4. Associated cardiac procedures performed at the time of the MFP, other than takedown of shunts, atrial septal defect closures, and main pulmonary artery closures, are listed in Table 5. Only 2 patients had an atrial fenestration.

View larger version (10K): [in this window] [in a new window]   Fig. 1. Kaplan-Meier curve for survival excluding early mortality. n = number of patients at risk.

View larger version (11K): [in this window] [in a new window]   Fig. 2. Kaplan-Meier curves for survival, excluding early mortality, divided into diagnoses: tricuspid atresia (solid line), double-inlet left ventricle (dotted line), and complex (dashed line). There was no statistically significant difference in the 15-year survival between the groups. n = number of patients at risk.

View larger version (10K): [in this window] [in a new window]   Fig. 3. Curve showing freedom from late reoperation in early survivors. n = number of patients at risk.

	Discussion

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
Definitive palliation for anomalies with a single functional ventricle, or two ventricles with anatomy that precludes ventricular septation, has been successfully accomplished by separation of the pulmonary and systemic circulations. ^1,2 Many modifications of the original procedures have been made. Although the majority of the literature describes the outcome of children undergoing an MFP, adult patients may present with no or unsatisfactorily palliated single-ventricle physiology. We have previously reported our results with a small number of adult MFP patients from our early experience. ^5,6 This report examines the late results of all adult patients who underwent MFP at our institution over a 28-year period.

Our philosophy regarding patient selection has evolved over the past 3 decades. Early in our experience, we recognized that the criteria for operability suggested by Choussat and Fontan were too strict and excluded patients who could potentially be helped with an MFP. ⁷ Accordingly, we liberalized our criteria for selected patients. ^8,9 The previously recommended upper limit of age (15 years) was exceeded in all patients in this review. The anatomical and cardiac rhythm criteria of operability such as normal drainage of the venae cavae, normal volume of the right atrium, no mitral insufficiency, and sinus rhythm were also exceeded in many patients. In addition, hemodynamic criteria regarding ventricular function and mean pulmonary artery pressure were exceeded in approximately half of the patients, as shown in Table 3 (mean ventricular ejection fraction was 55%, and mean pulmonary artery pressure was 15 mm Hg).

Most patients (85%) were in NYHA functional class III or IV, and the vast majority were experiencing progressive decrease in exercise tolerance and quality of life. Objective progressive decline in ventricular function, decline in arterial oxygen saturation, or increase in atrioventricular valve regurgitation were other factors that were considered. Selected deteriorating patients who were recognized to be at significantly increased risk for operation and for whom no other surgical options were available were offered operation if it was thought there was a reasonable chance for their survival and improvement, and some such patients had excellent late results. However, it is still often difficult to determine with confidence which adult patients who exceed accepted criteria for operability might be benefited by an MFP and which should not be offered operation. Elevated pulmonary arteriolar resistance and severe systolic and diastolic ventricular dysfunction have been found to be the most important contraindications to the MFP. ^8,9 In general, the indications and criteria employed for adults in this series were the same as for children at our institution.

Early mortality was 8.3% for the entire group of 132 patients. Over half of the early deaths were due to cardiac causes. The early mortality declined after 1980 to 6.5%. Similar early mortality rates ranging from 5% to 13% have been reported in adult MFP patients. ^10-12 Of note is that the mortality of our adult series is comparable to mortality of the MFP performed in children at our institution as well as other institutions. ^13-16 Mair and coworkers reported an early mortality of 9% in a cohort of patients, the majority of whom (88%) were 19 years old or younger. ¹³ All 7 of the early deaths since 1980 in the present study occurred in patients with complex anatomy; there was no early mortality in adult patients with double-inlet left ventricle (n = 36) or tricuspid atresia (n = 25). Overall in this study, there has been only 1 early death in all 34 patients (2.9%) with a diagnosis of tricuspid atresia.

Important postoperative morbidity occurred in 63% of the patients. The most common was chest tube drainage longer than 14 days, occurring in 30%. We and others have reported similar postoperative pleural effusion rates in children and adults. ^11,17 Many of our patients were operated on prior to the introduction of the fenestration concept. Nevertheless, we apply the fenestration selectively for patients with findings that the attending cardiologist and surgeon anticipate will increase the probability for postoperative morbidity or mortality, especially if hemodynamics are borderline at the conclusion of the MFP. If a fenestration is performed in an adult patient, warfarin anticoagulation is usually recommended. The long-term risks associated with chronic right-to-left shunting, thrombus formation, and potential paradoxical embolism have been the major concerns associated with fenestration, especially in adult patients. ¹⁷ In addition, there is the decrease in exercise tolerance, and consequently quality of life, in fenestrated patients with arterial desaturation.

The second most common postoperative morbidity was atrial arrhythmias, occurring in 21% of the patients. This is consistent with other mixed-aged cohorts showing a 10% to 20% incidence of atrial arrhythmias in the postoperative period. ^18-20 Of note is that 16 of the 25 patients who experienced atrial arrhythmias had an atriopulmonary connection without lateral tunnel. Newer MFP modifications such as the extracardiac conduit MFP, which has fewer atrial suture lines as well as decreased atrial wall tension, may reduce the incidence of this postoperative arrhythmias. However, extracardiac conduits in the pulmonary ventricle-to-pulmonary artery position are known to have a high incidence of late complications, especially stenosis. The late results of the extracardiac MFP remain to be determined.

The development of late atrial arrhythmias continues to be a significant problem following the MFP. One third of our patients at late follow-up had been or were being treated for atrial arrhythmias. Veldtman and colleagues and Gates and coworkers reported late atrial arrhythmias in 46% and 37%, respectively in adult patients undergoing the MFP. ^10,11 Late follow-up on large numbers of patients will be necessary to demonstrate which of the many MFP modifications will give the lowest incidence of this important complication. ²⁰

Four patients had late cerebrovascular accidents, none of whom were on warfarin. Anticoagulation after an MFP continues to be a topic of controversy. ²¹ In general, we tend to anticoagulate most adult patients, particularly those with a fenestration or those with a history of arrhythmias, intracardiac thrombus, slow circulation, and venous varices. In the asymptomatic young adult patient, we may substitute aspirin.

Late survival, excluding early mortality, was 89%, 75%, and 68% at 5, 10, and 15 years, respectively. These results are similar to the 61 adult patient series by Veldtman and colleagues in which survival rates of 76%, 72%, and 67% were reported at 5, 10, and 15 years, respectively. ¹⁰ These results are also similar to results of series primarily comprised by pediatric patients as reported by our institution and others. ^8,22 Risk factors for late mortality included preoperative mean pulmonary artery pressures greater than 15 mm Hg, age greater or equal to 30 years, and male gender. Hemodynamic risk factors in this series were similar to those patients of all ages undergoing the MFP. ^9,23

From the standpoint of symptoms, a marked improvement was noted in most of these adult patients postoperatively. Prior to the MFP, 85% of patients were in NYHA functional class III or IV. At long-term follow-up, 90% of survivors were NYHA class I or II. Other series have shown similar results. ^10,11

In conclusion, the MFP can be performed with low early mortality in properly selected adult patients with functional single ventricle. Early mortality is more likely with complex lesions. Late survival is good and similar to results reported in children. The majority of late survivors enjoy a good quality of life.

	Appendix: Discussion

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
Dr T. Spray (Philadelphia, Pa). I compliment the authors of this excellent paper on their presentation of a large series of adult patients who underwent Fontan reconstruction for variations of single-ventricle anatomy over a 28-year period in a single institution. The authors have shown very nicely that the Fontan operation can be performed in adult patients with excellent outcomes and improvement in functional status, with mortality and complication rates that are only slightly higher than those seen in the pediatric population. Obviously, patient selection has much to do with the excellent outcomes presented and therefore I have several questions for the authors.

Patients who came to the Fontan completion in this series had class 3 or class 4 symptoms. I assume that most patients had symptoms primarily related to progressive cyanosis rather than heart failure. There have been some centers that have recommended leaving patients with a Glenn anastomosis and not proceeding to a Fontan completion operation, especially in adults.

Your data would suggest that these patients eventually become cyanotic enough to require a Fontan completion. Could you comment on your institutional philosophy regarding the timing of and indications for the completion operation in adult patients?

It is particularly interesting to note that in the series presented, the majority of patients underwent atrial pulmonary operations and relatively fewer adults had the lateral tunnel modification. Only 3 patients in the series underwent an extracardiac completion operation, even though this approach has been preferred in many centers for as long as 10 years and would seem to be ideally suited for those patients who had a previous Glenn anastomosis. Could you comment on why the extracardiac approach has not been used more commonly in your patient population? Is the lateral tunnel technique still the preferred operation at the Mayo Clinic?

Prolonged pleural effusions greater than 2 weeks in duration were noted in about 30% of the adult population that you presented. Fenestration of the Fontan baffle, however, was only utilized in 2 patients in the series, and yet if cyanosis was the primary indication for operation, a fenestration would still have permitted improvement in oxygen saturation postoperatively and would likely have limited the duration and severity of postoperative effusions.

In your manuscript, which you kindly provided for me prior to this discussion, it was noted that fenestration was used in patients with mild elevation in pulmonary resistance or mildly decreased ejection fraction. Could you elaborate more on what is considered mild elevation of pulmonary resistance or a decrease in ventricular function, considering that the significant majority of your patients had a functional single left ventricle? Would patients with right ventricular morphology have different indications for the complete Fontan operation in your institution in adulthood, and would fenestrations be more commonly used in that patient population?

I also thought it was interesting to note the incidence of arrhythmias both early and late postoperatively in your experience, and I wonder whether you would use antiarrhythmic operations at the time of completion Fontan more routinely now after having this experience?

Dr Burkhart. Thank you, Dr Spray. With regard to our philosophy concerning the timing of and indications for completion of the modified Fontan operation in adult patients, the principal indication was progressive decrease in exercise tolerance and quality of life. Most patients (85%) were in NYHA functional class III or IV. Objective progressive decline in ventricular function, decline in arterial oxygen saturation, or increase in atrioventricular valve regurgitation were other factors that were considered. Selected deteriorating patients who were recognized to be at increased risk for operation and for whom no other surgical options were available were offered operation if it was thought there was a reasonable chance for their survival and improvement, and some such patients had excellent late results. However, we often still find it difficult to determine with confidence which adult patients who exceed accepted criteria for operability might be benefited by a modified Fontan procedure and which should not be offered operation. Elevated pulmonary arteriolar resistance and severe systolic and diastolic ventricular dysfunction have been found to be the most important contraindications to the modified Fontan procedure. In general, the indications and criteria employed for adults in this series were the same as for children at our institution.

With regard to which modifications of the Fontan procedure we have used, your observation is correct that the majority of patients at the beginning of our experience had an atriopulmonary connection without a lateral tunnel. Subsequently, both total cavopulmonary connections and atriopulmonary connections with lateral tunnel were in vogue, as well as a few intracardiac and extracardiac conduits. The latter modifications are still being performed, depending on the cardiac anatomy and the individual surgeon's preference (there is no institutional philosophy in this regard). We do have some reservations regarding the late fate of extracardiac venous conduits, based on our experience that extracardiac conduits in the pulmonary ventricle-to-pulmonary artery position are known to have a high incidence of late complications, especially stenosis.

With regard to the role of atrial fenestrations, many of our patients in this series were operated on prior to the introduction of the fenestration concept. However, we remain relatively conservative in the use of fenestrations, and do not employ them routinely with the hope they will avoid prolonged pleural effusions. Fenestrations are applied selectively for patients with findings which the attending cardiologist and surgeon anticipate will increase the probability for postoperative morbidity or mortality, especially if hemodynamics are borderline at the conclusion of the modified Fontan procedure. If a fenestration is performed in an adult patient, warfarin anticoagulation is usually recommended. The long-term risks associated with chronic right-to-left shunting, thrombus formation, and potential paradoxical embolism have been of concern. In addition, there is a decrease in exercise tolerance, and consequently quality of life, in fenestrated patients with arterial desaturation.

With regard to the incidence of early and late atrial arrhythmias, newer modifications such as the extracardiac conduit modified Fontan procedure, which has fewer atrial suture lines as well as decreased atrial wall tension, may reduce the incidence of postoperative arrhythmias. Use of a lateral tunnel baffle in which suture lines avoid the crista terminalis may also reduce the incidence of atrial arrhythmias. Late follow-up on large numbers of patients will be necessary to demonstrate which of the many Fontan procedure modifications will give the lowest incidence of this important complication. Many different types of late atrial arrhythmias have been noted in these patients, and the type of any surgical antiarrhythmic operation performed depends on the specific type and mechanism of the arrhythmia. Additionally, any surgical blocking lines or lines created by cryothermia or radiofrequency have the potential for creating new re-entry arrhythmias. Accordingly, we do not favor any prophylactic antiarrhythmic procedures at the time of completion Fontan.

Dr D. Drinkwater (Nashville, Tenn). I very much enjoyed this wonderful series spanning the decades, and I just have a couple of questions. One is: Why in this series did you not have any Potts or Waterston patients, or did I just miss that in your presentation? It seemed as though most or all of your patients had modified Glenn or Blalock-Taussig shunts. The majority of our adult single-ventricle patients, unfortunately, have come to us with virtually discontinuous pulmonary arteries due to previous Potts or Waterston shunts. Another large group of patients are those with prior classic Glenn shunt and divergent pulmonary arteries. How did you unifocalize them? Did you use homograft or pericardial material? Do you have any tricks that you could offer to us besides the extracardiac, which seems to lend itself to this challenging group? I look forward to reading your manuscript. Again, I very much enjoyed your paper. Thank you.

Dr Burkhart. Thank you, Dr Drinkwater. Although the vast majority of prior palliative procedures were the Blalock-Taussig shunt and the Glenn shunt, there were also a number of patients who previously had a central shunt. The Waterston shunt had been performed in 19 patients and the Potts shunt had been performed in 16 patients. Dr Puga can make additional comments about tricks that we have learned in the operating room for patients who had discontinuous pulmonary arteries.

Dr Puga. I will just comment on the techniques. Very rarely did we operate on patients with nonconfluent pulmonary arteries, but when it happens, we prefer to use a bifurcated pulmonary homograft to reconstruct the pulmonary arterial confluence.

	Footnotes

 
Read at the Eighty-second Annual Meeting of The Association for Thoracic Surgery, Washington, DC, May 5-8, 2002.

	References

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 

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16. Gaynor JW, Bridges ND, Cohen MI, et al. Predictors of outcome after the Fontan operation: is hypoplastic left heart syndrome still a risk factor? J Thorac Cardiovasc Surg. 2002;123:237-45.[Abstract/Free Full Text]
    
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