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Ann Thorac Surg 2000;70:568-574
© 2000 The Society of Thoracic Surgeons

Original articles: cardiovascular

Interventions associated with minimal Fontan mortality

Glen S. Van Arsdell, MDa, Brian W. McCrindle, MDb, Kathleen D. Einarson, BScNa, Kyong-Jin Lee, MDb, Elizabeth Oag, BScNa, Christopher A. Caldarone, MDa, William G. Williams, MDa

a Divisions of Division of Cardiovascular Surgery, The Hospital for Sick Children and the University of Toronto, Toronto, Ontario, Canada
b Division of Cardiology, The Hospital for Sick Children and the University of Toronto, Toronto, Ontario, Canada

Address reprint requests to Dr Van Arsdell, Division of Cardiovascular Surgery, The Hospital for Sick Children, 555 University Ave, Toronto, ON M5G 1X8, Canada
e-mail: glen.vanarsdell{at}sickkids.on.ca


   Abstract
Top
 Abstract
Introduction
 Material and methods
 Results
 Comment
 References
 
Background. The operative mortality rate for the first 400 Fontan procedures at this institution was 15% but declined to 4% for the next 100 procedures.

Methods. The cases of 100 consecutive patients receiving the Fontan procedure and associated with this change in mortality rate were reviewed to determine associations.

Results. The mortality rate in the first and second 50 patients was 16% and 0%, respectively. There were no differences in age, number of risk factors, diagnosis, or operating surgeon between the two groups. Patients in the lower-mortality era were significantly more likely to have had a cavopulmonary anastomosis before a Fontan procedure (90% versus 70%) and to have an extracardiac Fontan procedure (38% versus 8%), shorter cross-clamp (45 ± 24 minutes versus 58 ± 22 minutes) and cardiopulmonary bypass times (121 ± 42 minutes versus 141 ± 45 minutes), magnesium-rich cardioplegia (100% versus 39%), hemoconcentration after bypass (67% versus 4%), and institution of pharmacologic support in the operating room.

Conclusions. Patient characteristics and risk factors were similar in the two groups. However, several interventions that were increasingly utilized in the lower-mortality era, including the extracardiac Fontan procedure and modified ultrafiltration after bypass, are associated with lower mortality. Each one had the potential to improve postoperative myocardial function.


   Introduction
Top
 Abstract
 Introduction
Material and methods
 Results
 Comment
 References
 
Since the inception of the Fontan procedure for tricuspid atresia [1], the indications for this therapy have been extended to encompass nearly all forms of single-ventricle physiology [2, 3]. The evolution of the procedure and the progress in short-term results have been enhanced by comprehensive analysis of successes and failures [2–8]. Risk factor modification, increased understanding of perioperative physiology, and improving surgical techniques [9–12] have led to a decline in reported postoperative mortality. Early-era mortality rates in large series ranged from 17% to 31% [7, 8, 13]; in the 1990s, mortality rates in large series have been reported to be as low as 4.5% to 7% [4, 6, 8, 13, 14].

As surgical techniques have improved, the timing of interventions has altered. Treatment algorithms originally driven by symptomatic need have more recently been driven by planned interventions based on the morphologic substrate. To define reasons for the decline in mortality more closely, a single-institution review comparing interventions and outcomes between different surgical eras was performed. These data may be useful in identifying treatment algorithms that are beneficial to patient outcomes.


   Material and methods
Top
 Abstract
 Introduction
 Material and methods
Results
 Comment
 References
 
A database search at the Division of Cardiovascular Surgery, The Hospital for Sick Children, Toronto, was performed to determine consecutive Fontan series. From 1977 through March 1997, 500 Fontan procedures were performed. The data were plotted against hospital mortality or 30-day mortality (whichever was greater) to create a cumulative mortality summation graph [15], which is shown in Figure 1. The mortality rate in the first 400 procedures was 15%, but it declined to 4% for the next 100 procedures. This change in mortality rate is represented by an inflection point in the slope of the graph in 1993. The cases of 50 consecutive patients on either side of this inflection point were reviewed (100 consecutive patients in one of two groups: the higher-mortality era and the lower-mortality era). Data were collected from hospital, surgical, and cardiology records. Repeat analysis of cardiac catheterizations to obtain missing McGoon and Nakata indices was performed. The first 50 children were operated on between January 1992 and October 1993 inclusive and the second 50, between November 1993 and November 1995.



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  		Fig 1. Cumulative summation of patient mortality after Fontan procedure. There were 67 deaths among 500 patients, a mortality rate of 13.4%. The arrow points to an inflection point in the slope of the mortality curve.

 
Clinical variables
Variables were divided into three broad categories: morphologic and physiologic substrate at the time of the Fontan procedure, operative and perioperative interventions, and outcomes.

Data analysis
Data are described as frequencies, medians with ranges, and means ± one standard deviation. Where data were missing, the number of values present is given. Differences in characteristics and outcomes between the two groups were tested using Fisher’s exact tests, {chi}2 and Mantel-Haenszel {chi}2 tests, Kruskal-Wallis analysis of variance, and t tests, as appropriate. Risk factors for mortality were sought initially with Fisher’s exact tests, {chi}2 tests, Kruskal-Wallis analysis of variance, and t tests. Significant variables were further tested in multiple logistic regression analysis. Differences in outcomes related to use of the extracardiac Fontan connection were also tested with Fisher’s exact tests, {chi}2 tests, Kruskal-Wallis analysis of variance, and t tests. The level of significance was set at a p value of less than 0.05.


   Results
Top
 Abstract
 Introduction
 Material and methods
 Results
Comment
 References
 
Patient characteristics
Except for the number of patients with a previous cavopulmonary anastomosis (Table 1), preoperative demographic, physiologic, and anatomic data were equivalent between the higher- and lower-mortality patient groups (Table 2; see Table 1). More patients in the lower-mortality era had had a previous cavopulmonary shunt.


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  		Table 1. Morphologic and Physiologic Substrate at Time of Fontan Operationa,b

 

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  		Table 2. Preoperative Cardiac Catheterization Dataa

 
Operative and perioperative interventions
In the lower-mortality group, more patients had the following: an extracardiac Fontan procedure, magnesium-rich cardioplegia, modified ultrafiltration after cardiopulmonary bypass, and either no aortic cross-clamping or only one period of cross-clamping short enough to administer a single dose of cardioplegia (Table 3). Total cardiopulmonary bypass times were shorter in the lower-mortality group. Patients in this group also were more likely to have had inotropic and vasodilative support instituted in the operating room. Vasodilation was used more frequently after 6 hours in the intensive care unit, and the median number of ventilator days was less in the lower-mortality group. These differences represent an institutional shift in treatment methods.


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  		Table 3. Operative and Perioperative Interventionsa,b

 
Outcomes
Children having operation in the higher-mortality era had an increased incidence of low cardiac output syndrome, were more likely to have had an early postoperative catheterization, and had a longer median interval before chest tube removal (Table 4; see Table 3). The lower-mortality group had shorter median stays postoperatively in the intensive care unit and the hospital. There were no significant differences in postoperative physiologic measurements between the two groups (Table 5). The mortality rate for the entire group was 8%. The mortality rate in the first group of 50 patients was 16% compared with 0% in the second group.


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  		Table 4. Outcomesa

 

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  		Table 5. Postoperative Physiologic Measurementsa

 
Comparison between survivors and nonsurvivors
Surgical complications occurred less frequently in survivors than in nonsurvivors: clinically significant bleeding (4 of 88 [5%] versus 4 of 12 [33%]; p = 0.007); reoperation for bleeding (4 of 91 [4%] versus 4 of 9 [44%]; p = 0.002); cardiac tamponade (5 of 96 [5%] versus 3 of 4 [75%]; p = 0.002); clinically noted ascites (3 of 85 [4%] versus 5 of 15 [33%]; p = 0.002); and low cardiac output syndrome (0 of 89 [0%] versus 8 of 11 [73%]; p < 0.001). Survivors also had fewer early postoperative catheterizations (1 of 83 [1%] versus 7 of 17 [41%]; p < 0.001) and a lower incidence of Fontan takedowns (6 of 97 [6%] versus 2 of 3 [67%]; p = 0.02). Survivors were more likely to have had a shorter cardiopulmonary bypass time (128 ± 42 minutes [n = 92] versus 166 ± 62 minutes [n = 8]; p = 0.03) and higher oxygen saturation levels (95% ± 5% [n = 86] versus 92% ± 8% [n = 8]; p = 0.03) in the operating room after the procedure.

Independent predictors of survival
Significant variables associated with survival were entered in a multiple logistic regression analysis. The only variable that entered significantly in the model was a shorter cardiopulmonary bypass time. After this variable entered the model, no other variable had a significant independent association with survival.

Extracardiac Fontan procedure
Survival of children who underwent the extracardiac Fontan operation did not differ significantly from survival of those who had other types of procedures (mortality 0 of 23 [0%] versus 8 of 77 [10%]; p = 0.2). The median aortic cross-clamp time (34 minutes [range, 12 to 79 minutes] versus 51 minutes [range, 15 to 130 minutes]; p = 0.02), left atrial pressure on arrival to the intensive care unit (6 mm Hg [range, 2 to 10 mm Hg] versus 7 mm Hg [range, 4 to 14 mm Hg]; p = 0.02), ventilator days (1 day [range, < 1 to 6 days] versus 2 days [range, < 1 to 99 days]; p < 0.05), and days in intensive care (3 days [range, 1 to 7 days] versus 4 days [range, 1 to 103 days]; p < 0.05,) however, were less in those children having an extracardiac Fontan.


   Comment
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
References
 
This study was done to determine if there were any differences in patient population and treatment modalities between the higher- and lower-mortality eras. No significant differences were demonstrated in risk factors or other patient characteristics except the presence of a previous cavopulmonary anastomosis. This indicates that the diminished mortality was a result of altered treatment algorithms, differing interventions, or unmeasured factors.

Analysis of the incidence of low cardiac output syndrome demonstrated a decreased occurrence in the low-mortality group. There were interventional differences between the two groups that could account for improved cardiac output.

Interventional differences
Cavopulmonary anastomosis
More patients in the lower-mortality era had received a cavopulmonary anastomosis before the Fontan procedure (90% versus 70%). It has previously been shown that a cavopulmonary anastomosis allows regression of myocardial hypertrophy [16]. Although there was no measurable difference in wall mass to end-diastolic volume between the two groups, an unmeasured improvement in compliance is possible. Better diastolic filling would improve cardiac output.

Magnesium-enriched cardioplegia
Studies have demonstrated superior recovery of the ischemic myocardium when magnesium is added to the cardioplegic solution [17]. The optimal concentration has been suggested to be 10 to 16 mmol/L of cardioplegic infusate [17, 18]. All patients in our lower-mortality group having ischemic arrest received magnesium-enriched cardioplegia, a significantly greater number than in the higher-mortality group. The presence of magnesium in the blood cardioplegic solution may have improved myocardial preservation.

Modified ultrafiltration
There are several potential benefits to modified ultrafiltration after cardiopulmonary bypass. When it is used, randomized clinical and experimental trials have shown an improvement in left-ventricular diastolic compliance and preload-recruitable stroke work index [19, 20]. It also decreases myocardial edema. Improvement in diastolic compliance may be critical in marginal candidates for the Fontan procedure.

In a prospective, randomized clinical trial, Naik and colleagues [21] found that patients who underwent modified ultrafiltration had less blood loss and fewer transfusion requirements than controls. These two factors may contribute to reduced mortality. Excessive bleeding is a risk factor for death in our report.

Endothelin-1 levels were reduced by modified ultrafiltration in a randomized clinical trial [22]. Endothelin-1 is a potent pulmonary vasoconstrictor. There may also be an improvement in pulmonary vascular resistance related to modified ultrafiltration after bypass.

Pharmacologic support
Institution of inotropic and vasodilative support at the time of separation from cardiopulmonary bypass became an institutional policy for children receiving the Fontan procedure. It has the potential benefit of eclipsing a postoperative reduction in cardiac function and the delay inherent to recognition and treatment. This phenomenon is demonstrated by the fact that the higher-mortality group of patients had received less inotropic support on arrival at the intensive care unit but had reached an equivalent dose to the lower-mortality group 6 hours later.

Spontaneous respiration
Shekerdemian and associates [23] demonstrated improved cardiac output with negative-pressure ventilation compared with conventional positive-pressure modalities. To benefit from this physiologic effect, a concerted effort was made to extubate patients early during the lower-mortality era. Several patients were extubated within the first few hours after operation.

Extracardiac Fontan and cardiopulmonary bypass time
A shorter cardiopulmonary bypass time was a predictor of survival in the present report as well as others [5]. More extracardiac Fontan procedures were performed in the lower-mortality group of patients. However, even though this procedure required shorter cross-clamp and total cardiopulmonary bypass times, the procedure itself was not an independent predictor of survival.

Extracardiac Fontan and arrhythmias
In the immediate recovery phase after a Fontan procedure, the extracardiac arrangement has the potential advantage of decreased atrial arrhythmias because of less atrial suturing [24, 25] and a lower intraatrial pressure. There was not, however, a significant difference in early postoperative arrhythmias between children having an extracardiac Fontan procedure and those who did not.

Fenestration
In a multivariate analysis of 500 children receiving a Fontan procedure, Gentles and coworkers [13] demonstrated that fenestration is associated with lower mortality. In contrast, fenestration was not associated with a lower mortality in our analysis. Fenestration also did not affect the duration of chest tube insertion. Nevertheless, fenestration is a significant component of treatment at The Hospital for Sick Children, Toronto. Failure to demonstrate significant improvement may be related to sample size, era, or a weak physiologic effect. What the present data do indicate is that outcome improvement at this institution cannot be attributed to fenestration alone.

Study limitations
The primary limitation of this study relates to the failure to determine which of the many interventions were causally related to the decrease in mortality. Multiple interventions were introduced over the study period, and the small number of deaths did not allow meaningful multivariate analysis of that outcome. Nevertheless, it appears that multiple interventional differences have accounted for an improved operative survival in an equivalent group of patients.

Conclusions
Patient characteristics and risk factors were similar in the two groups respective higher- and lower-mortality eras. Several interventions that were employed in the latter period including more extracardiac Fontan procedures and modified ultrafiltration after bypass were associated with a lower mortality. Each interventional change had the potential to improve postoperative myocardial function, which may account for the diminished occurrence of low cardiac output syndrome and mortality.


   Acknowledgments
 
We thank Drs George A. Trusler, John G. Coles, Ivan M. Rebeyka, and Michael D. Black for their contribution of patients to this series. Dr Robert M. Freedom also thoughtfully reviewed the manuscript.

This study was prepared with the assistance of Editorial Services, The Hospital for Sick Children, Toronto, ON, Canada.


   References
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

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Accepted for publication February 14, 2000.


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