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Ann Thorac Surg 2000;69:1900-1906
© 2000 The Society of Thoracic Surgeons

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Original articles: Cardiovascular

Univentricular repair: is routine fenestration justified?

^a Cardiothoracic Sciences Centre, All India Institute of Medical Sciences, New Delhi, India

Address reprint requests to Dr Airan, Department of Cardiothoracic & Vascular Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India
e-mail: bairan{at}medinst.ernet.in

	Abstract

Top Abstract Introduction Patients and methods Results Comment Appendix References

 
Background. A decade after the introduction of baffle fenestration, the outcome of Fontan-type repair for hearts with a functional single ventricle finally looks promising. Our study was designed to assess the impact of fenestration on the outcome of univentricular repairs.

Methods. From January 1988 to December 1997, 348 patients (104 with tricuspid atresia and 244 with other morphological diagnoses) underwent univentricular repair at our institute. Since 1994, routine fenestration of the atrial baffle was performed in all patients (n = 126).

Results. The overall Fontan failure rate was 14% (50 of 348) and included 45 early deaths and five Fontan take downs. Absence of fenestration was the only and highly significant predictor of Fontan failure (risk ratio [RR] 3.3, 95% confidence interval [CI] 1.49 to 7.31, p = 0.002). Significant pleural effusion was seen in 27% of patients. Absence of fenestration of the atrial baffle (RR 3.97, 95% CI 2.17 to 7.26, p < 0.001) and aortic cross-clamp time more than 60 minutes (RR 2.15, 95% CI 1.3 to 3.5, p = 0.002) were found to be significant risk factors. The follow-up ranged from 6 to 120 months (mean 46.0 ± 18.0 months). There were 12 late deaths and 5 patients were lost to follow-up. Actuarial survival (Kaplan Meier) at 90 months was 81% ± 4%. Two hundred and fifty-eight patients (90%) were in New York Heart Association class I at their last follow-up visit. Oxygen saturation in the fenestrated group ranged from 85% to 94% (mean 89%). Thirty patients (26%) had spontaneous closure of the fenestration over a mean period of 34 months, and there has been no incidence of late systemic thromboembolism. In no instance has there been a need to close the fenestration.

Conclusions. Elective fenestration of the intraatrial baffle is associated with decreased Fontan failure rate and decreased occurrence of significant postoperative pleural effusions. Routine elective fenestration of the atrial baffle may, therefore, be justified in all univentricular repairs.

	Introduction

Top Abstract Introduction Patients and methods Results Comment Appendix References

 
Over the last 27 years, since Fontan and Baudet [1] first described their technique for univentricular repair in 1971, various modifications have been introduced in the Fontan circuitry. Fenestration of the atrial baffle was proposed in 1988 [2] on the basis that it allows a protective right-to-left shunt at the atrial level to overcome the period of low cardiac output in the early postoperative period at the expense of mild to moderate desaturation [3–5]. In this center, we converted from a policy of no fenestration to routine fenestration in 1994 after results with fenestration demonstrated an improvement in outcome [6]. This study is an extension of the previous one [6], as we are now in a position to draw more definite conclusions based on a larger sample size and longer duration of follow-up.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment Appendix References

 
Three hundred and forty-eight patients who have undergone univentricular repair for various morphological diagnoses (Table 1) at our institute from January 1988 to December 1997 form the study population. The group included 261 male and 87 female patients. The patients who had undergone extracardiac Fontan procedure were not included in this study, as those cases were performed on a beating heart without any cardiac arrest.

To decide about performing a single-stage procedure, pulmonary artery size (McGoon ratio) was estimated angiographically in all the patients. A localized pulmonary artery narrowing producing a reduction in diameter equal to or greater than 50% of the diameter of the adjacent pulmonary artery before its branching was an indication for a pulmonary arterioplasty. This finding generally was against a one-stage Fontan type repair. Since 1994 (n = 138), we also estimate pulmonary artery size in the operating room by sizing the pulmonary artery with Hegar’s dilators and comparing it with the expected value for that age and body surface area [7, 8]. The final decision was based on the intraoperative measurement of pulmonary artery size. Pulmonary arteries with Z value less than zero were considered as "small," and if Z value was less than -2, a univentricular repair was not performed.

Atrioventricular valve regurgitation was judged as none, mild, moderate, or severe by echocardiographic or cineangiographic evaluation. Moderate and severe regurgitation was considered significant. Similarly, ventricular function was also assessed by echocardiography/cineangiography. An ejection fraction less than 45% was designated as suboptimal.

The type of surgical modification used was directed by the underlying cardiac anatomy before 1994 and included atriopulmonary connection (n = 113) or total cavopulmonary connection (n = 104). Subsequently, it was entirely the total cavopulmonary connection (n = 131). All patients operated upon after January 1994 had elective fenestration of the intraatrial baffle. Fenestration was done using a 4- or 5-mm coronary punch in the baffle. Cardiopulmonary bypass and myocardial preservation techniques were essentially the same over the entire study period.

Assesment of operative outcome
Outcome variables assessed were Fontan failure and postoperative pleural effusions. Fontan failure included all patients who died within 30 days of operation as well as those who survived Fontan takedown. Hemodynamic Fontan failure was defined as persistent low cardiac output after a univentricular repair with need to maintain central venous pressure higher than 18 mm Hg or inordinately high fluid requirement to maintain systemic arterial pressure [6].

Any pleural effusion that lasted for more than 10 days after operation came under the category "significant." If there was any recurrence of effusion after the removal of chest tubes, it was also included in the list of significant pleural effusions.

Since 1994, low-dose oral anticoagulation was given for a period of 6 months in all the patients undergoing univentricular repair. This was followed by antiplatelet therapy. The patient’s clinical course (survival, symptomatic class, need for cardiac medications, occurrence of late complications) after hospital discharge were monitored. Echocardiographic studies were performed as routine follow-up protocol.

A group of patients, presenting for follow-up between July 1997 and September 1998, underwent 24-hour ambulatory electrocardiographic monitoring (Holter study) using an H-12 Holter unit (Mortara Instruments, Inc, Milwaukee, WI). Recording was analyzed on a standard Mortara Holter analyzer by a senior consultant in cardiac electrophysiology.

Statistical analysis
All data were analyzed with BMDP statistical software (Biomedical Data Processing Statistical Software, Inc, Los Angeles, CA). Continuous and interval-related data were expressed as the mean ± standard deviation. Numeric data were analyzed with unpaired Student’s t test. Categorical variables were analyzed with ² analysis. A multiple logistic regression model was used to identify independent risk factors (Appendix) for Fontan failure and occurrence of significant pleural effusion. Selection of independent variables was a forward stepwise method with a critical probability value of 0.15 for variable inclusion and exclusion. A p value of less than 0.05 was considered significant in the final model. Analysis of time-related survival was performed using the Kaplan-Meier method.

	Results

Top Abstract Introduction Patients and methods Results Comment Appendix References

 
A total of 348 patients were operated on. Various procedures performed are shown in Table 3. A 4- or 5-mm fenestration was performed in 126 patients. Associated TAPVC repair was performed in 9 patients and subaortic resection was done in 1.

Late outcome
There were 12 (3.4%) late deaths. One of the patients died of severe hemoptysis in spite of repeated coil embolization of aortopulmonary collaterals, 2 died of sepsis after recurrent pleural effusion, 1 died of infected thrombus on the right and left side of the intraatrial baffle, 3 died of pneumonia, 1 of protein-losing enteropathy, 1 of anorexia nervosa, 1 of acute pancreatitis after exploratory laparotomy, and 2 during reoperation for baffle leak.

Of the survivors, 287 patients have been followed up for periods ranging from 6 to 120 months (mean 46 ± 18.0 months). Actuarial survival was 81% ± 4% at 90 months (Fig 1). Two hundred and fifty-eight patients (90%) were in New York Heart Association class I at their last follow-up visit.

View larger version (19K): [in this window] [in a new window]   Fig 1. Actuarial survival curve of patients undergoing univentricular repair.

Oxygen saturations ranged from 85% to 94% (mean 89%) in patients having functioning fenestrations at a mean follow-up period of 34 months. Thirty of these (26%) had spontaneous closure of their fenestration as demonstrated by lack of any right-to-left shunt by contrast echocardiography, and in no patient has there been any incidence of cerebrovascular accidents. None of the patients with fenestration has been taken up for closure of the fenestration, either surgically or by catheter.

	Comment

Top Abstract Introduction Patients and methods Results Comment Appendix References

 
Improvement in results of univentricular repair at this center dates to the introduction of routine fenestration of the baffle in 1994. Another factor was abandonment of atriopulmonary connection. Hence, the bias of the date of operation cannot be removed from the analysis of outcome. However, the univentricular repairs have been performed long before 1994 at our center, and thus, the learning curve does not seem to be responsible for the improved results.

This study included patients who underwent the Fontan operation according to the modified criteria of selection (discussion of Sharma and associates [6]), and our policy was strict with reference to pulmonary artery size, pulmonary artery distortion, and ventricular function. Pulmonary artery entry was the exception at preoperative cardiac catheterization because most of the patients had severe pulmonary stenosis and were deeply cyanosed. Preoperative pulmonary artery pressure was not available in most patients and was measured directly during operation in these. Calculation of pulmonary vascular resistance was routinely not available for all patients.

Age less than 4 years and more than 15 years, as reported by Fontan and others [9–11] as a significant risk factor for early mortality, was not in accordance with our observation, which showed no significant impact of age on operative outcome. The same finding has also been noted by others [12–14], and patients under 4 years of age can be safely offered the fenestrated Fontan option when they do not violate other selection criteria.

While analyzing the risk factors for Fontan failure, it was observed that absence of fenestration was the only significant factor, and introduction of elective routine fenestration reduced the Fontan failure rate significantly. Aortic cross-clamp time more than 60 minutes and absence of fenestration were risk factor for postoperative pleural effusion. Elective fenestration, though it reduces the pleural effusion rate significantly, is not protective enough if aortic clamp time exceeds 60 minutes.

Successful outcome of Fontan procedure is dependent on the pulmonary vascular resistance and pulmonary artery size [15]. Though sizing the pulmonary artery by calculating the McGoon ratio from preoperative angiography had no significant impact on either early mortality or effusions, we believe that the sizing of pulmonary arteries by Hegar’s dilator intraoperatively is more informative about the decision making for a one-stage Fontan. This may be explained by the observation that the pulmonary artery size determined by angiography in patients with decreased pulmonary blood flow is an underestimate of true pulmonary artery size (ie, measured intraoperatively).

Arrhythmias have been reported as a sequel to Fontan operation due to the distention of the atrium, and secondary to multiple suture lines [16]. Supraventricular arrhythmias reduced from 20% to 8% with introduction of fenestration, which may signify reduced distension of exposed atrial wall. However, the mean follow-up duration in the fenestrated group (26 ± 12 months) was much less than that in the nonfenestrated group (63 ± 19 months), and thus, the difference in incidence of arrhythmias may also be attributed to the duration of follow-up. Higher incidence of supraventricular tachyarrhythmias in patients with nonfenestrated Fontan may also be attributed to a greater proportion of patients having atriopulmonary connection.

Atrial thrombosis resulting in thromboembolism has been reported after Fontan operation [17]. Atrial thrombosis occured in 1 of our patients who had undergone fenestrated repair and contributed to his demise. Despite its presence, fenestration did not contribute to occurrence of systemic thromboembolism.

Staging the Fontan procedure has been established to have a good outcome in spite of the presence of a number of risk factors [5, 18]. There was no Fontan failure or early mortality in this group, while the effusion rate was similar (21% vs 27% of the series) to the single-stage univentricular repairs. This is a significant observation because these patients had more risk factors for Fontan operation as compared with the group undergoing one-stage repair, but still had a favorable outcome. The small number, however, makes any derivations highly speculative.

Follow-up of patients has shown excellent results with respect to New York Heart Association functional class (90% in class I). Thirty patients (26%) had spontaneous closure of a 4-mm fenestration over a mean period of 34 months, and oxygen saturation of 85% to 94% postoperatively in these patients raises a question regarding the need for closure of the fenestration. The fact that in none of our patients did we think it necessary to close the fenestration subsequently infers the recommendation of routine fenestration of atrial baffle with no need for subsequent closure.

Conclusions
Fenestration of the atrial baffle is associated with reduced Fontan failure rate and decreased occurrence of pleural effusion. Subsequent closure of the fenestration is usually not required. Ischemic time more than 60 minutes continues to be a risk factor for postoperative effusion despite fenestration.

	Acknowledgments

 
We thank Rajvir Singh, MSc(Stat) for statistical analysis of the work.

	Footnotes

 
This article has been selected for the discussion forum on the STS Web site: http://www.sts.org/section/atsdiscussion/

	Appendix

Top Abstract Introduction Patients and methods Results Comment Appendix References

 

List of variables

Preoperative variables Age Morphology Previous systemic pulmonary artery shunt Previous pulmonary artery band Previous bidirectional Glenn Pulmonary artery size (McGoon ratio) Pulmonary artery stenosis Systemic ventricular dysfunction Systemic atrioventricular valve dysfunction Subaortic stenosis Total anomalous pulmonary venous drainage Pulmonary artery pressure Left ventricular end diastolic pressure Operative variables Year of operation (1993 and before vs 1994 and after) CPB time Aortic cross-clamp time Simultaneous pulmonary artery reconstruction Additional procedure Type of connection (total cavopulmonary connection vs others) Fenestration of atrial partition Surgeon identity

	References

Top Abstract Introduction Patients and methods Results Comment Appendix References

 

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4. Bridges N.D., Mayer J.E., Lock J.E., et al. Effect of fenestration on outcome of modified Fontan repair. Circulation 1992;86:1762-1769.[Abstract/Free Full Text]
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This Article Abstract Full Text (PDF) Online Discussion 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): Anil Bhan Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Airan, B. Articles by Venugopal, P. Search for Related Content PubMed PubMed Citation Articles by Airan, B. Articles by Venugopal, P.