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Ann Thorac Surg 2002;74:133-138
© 2002 The Society of Thoracic Surgeons

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Original article: cardiovascular

Total correction of tetralogy of fallot in the first year of life: late results

^a Department of Cardiothoracic Surgery, Oregon Health and Science University, Portland, Oregon, USA

Accepted for publication March 18, 2002.

* Address reprint requests to Dr Cobanoglu, 01944 SW Palatine Hill Rd, Portland, OR, USA 97219

	Abstract

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Background. Correction of tetralogy of Fallot in patients less than 1 year of age offers the advantage of a more normal development; but in the majority of cases exposes the patient to the possibly of a higher mortality with one-stage primary repair, and to the long-term effects of a transannular patch, which is often necessary.

Methods. A retrospective review of total correction of tetralogy of Fallot performed in 63 consecutive patients at less than 1 year of age was made. Risk factors for operative mortality and functional status at follow-up were analyzed. Follow-up was obtained from clinic appointments and telephone questionnaires.

Results. The operative mortality was 6%, with three late deaths. Aortic cross-clamp time more than 60 minutes (p = 0.023), cardiopulmonary bypass time more than 90 minutes (p = 0.016), and frequent preoperative respiratory tract infection symptoms (p = 0.008) affected operative survival; whereas age less than 3.0 months or weight less than 6.0 kg did not. Mean follow-up is 11.6 years (± 0.6 years, standard error). Actuarial survival is 89% (± 4%) and freedom from reoperation is 96% (± 4%) at up to 20 years after correction. Eighty-seven percent of patients have normal echocardiographic right ventricular function. Only 4 patients have greater than moderate pulmonary regurgitation by echocardiography. Three of these four patients are asymptomatic. At more than 15 years postoperatively, 88% of patients have good-to-excellent functional status.

Conclusions. Early correction of tetralogy of Fallot at less than 1 year of age can have a low operative mortality and provide excellent asymptomatic long-term survival.

	Introduction

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More than four decades have passed since C. Walton Lillehei and his associates [1] performed the first surgical correction of tetralogy of Fallot (TOF). Current evidence supports early repair of TOF to minimize the adverse effects of hypoxia, prevent organ damage, reduce ventricular arrhythmias, and optimize functional and cardiac outcomes [2–8]. Since the early 1980s, a system of centralized pediatric clinics, and a single surgeon seeing the patient early in life, gave us the opportunity to perform total correction of TOF in patients less than 1 year of age. The purpose of this review is to identify risk factors for early mortality and decreased functional status, and to investigate the long-term outcomes and efficacy of total correction of TOF in the first year of life.

	Material and methods

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Patients
Between January 1, 1981, and July 1, 1995, 63 consecutive patients, less than 12 months of age, with TOF underwent intracardiac correction at The Oregon Health and Science University. Enrollment was halted in 1995 to allow evaluation of results more than 5 years after operation. Age at total correction was 6.5 ± 0.4 months (range, 1 day to 11.2 months) (Fig 1). Weight was 6.6 ± 0.2 kg (range, 2.8 to 10.2 kg) (Fig 2). Forty patients (63%) were males and 23 patients were females (37%). All available clinical and laboratory reports were reviewed. Twenty patients had been treated for two or more separate incidents of respiratory tract infection symptoms, by either their primary physician or pediatric cardiologist, and were defined as having frequent respiratory tract infection symptoms. Other findings were recorded if noted in the patients’ preoperative clinic notes (Table 1). Nine patients required inotropic support, one patient ß-adrenergic blockade, one patient inotropic support and mechanical ventilation, and one patient ß-adrenergic blockade and mechanical ventilation before total correction. Fifty-three patients were scheduled for elective repair, 8 for urgent repair, completed the day after diagnosis, and 2 for emergent repair performed the day of diagnosis.

View larger version (11K): [in this window] [in a new window]   Fig 1. Age distribution of patients at the time of total correction of tetralogy of Fallot.

View larger version (11K): [in this window] [in a new window]   Fig 2. Weight distribution of patients at the time of total correction of tetralogy of Fallot.

Operative procedure
The heart was exposed through a median sternotomy, a patch of pericardium was removed for right ventricular outflow tract reconstruction, and previously placed shunts were closed and divided. Conventional nonpulsatile bypass with a membrane oxygenator was used. Bicaval venous cannulation and systemic hypothermia (18° to 20°C) was used. In 10 patients a brief period of total circulatory arrest was used to promote visualization during VSD closure. Intermittent doses of cold blood potassium cardioplegia and topical cooling were used for myocardial protection. Septal temperature probes monitored the heart between 10° and 18°C at all times. A vertical right ventriculotomy was used to expose the right ventricular outflow tract and to repair the ventricular septal defect in 98% of the patients. Infundibulectomy was completed without excessive resection in the area of the crista supraventricularis. The VSD was closed with a double velour Dacron patch using simple, interrupted, 5-0 silk sutures. The right ventricular outflow tract or pulmonary artery were enlarged with autologous pericardium in 94% of the patients. A transannular patch was used in 53 patients (84%). In cases of right or left pulmonary artery stenosis, the patch was carried beyond the point of obstruction. After 1985, all pericardial patches were treated with glutaraldehyde solution before implantation. All identified atrial septal defects, including a patent foramen ovale present in 32 of 63 patients, were closed. The patent ductus arteriosus was ligated in 6 patients. The single case of discrete subaortic stenosis was corrected using a transaortic resection.

Follow-up
Postoperative inquiry was initiated and completed in December 2001. Two patients were lost to follow-up within the first year after total correction. Information obtained during the last clinic visit of these 2 patients is included in the following results. The calculation of actuarial survival includes all early deaths and the patients lost to follow-up. Current data were mostly available from routine periodic postoperative visits, or checkups with one of the pediatric cardiologists at the University Hospital during late 2001. All data were updated through written or telephone communications with patients, relatives, or current physicians in December 2001. Specific attention was given to questions and examinations delineating symptoms, growth and development, functional capacity, and medications at the time of interview. Two-dimensional and continuous wave Doppler echocardiographic results were used to quantitate ventricular ejection fraction, tricuspid and pulmonary regurgitation, and right ventricular outflow tract obstruction.

Statistical methods
The Statistical Package for the Social Sciences program (SPSS Inc, Chicago, IL), was used to evaluate all data. A survival curve was constructed according to the actuarial method [9]. Fisher’s two-tailed exact test was used to test risk factors for operative deaths and New York Heart Association functional classes worse than I. A p value less than 0.05 was considered statistically significant.

	Results

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Four patients died either in the hospital or within 30 days of the operation, yielding an operative mortality of 6%. After an urgently scheduled correction, 1 patient immediately experienced a low cardiac output state with biventricular failure and died 12 hours after repair. Another patient became bradycardic 32 hours after repair, later developed ventricular fibrillation, and ultimately expired with right ventricular failure 42 hours after operation. The third patient developed bradycardia and asystole 18 hours after correction, and eventually expired from multiorgan failure 17 days after operation. The fourth patient acquired a postoperative respiratory syncytial virus infection, later pseudomonas bronchopneumonia, respiratory failure, and sepsis, with death 31 days after repair. Autopsies performed in all patients revealed all repairs to be intact.

Mean cardiopulmonary bypass time was 73.5 ± 5.2 minutes. The mean aortic cross-clamp time was 59.7 ± 2.4 minutes. In 10 patients, a period of total circulatory arrest was used, with a mean of arrest time of 17.6 ± 11.2 minutes.

Factors affecting operative survival were analyzed. Bypass time more than 90 minutes (p = 0.016), aortic cross-clamp time more than 60 minutes (p = 0.023), and preoperative frequent respiratory tract infection symptoms (p = 0.008) affected operative survival. Previous palliative procedures, operative urgency, use of a transannular patch, age less than 3.0 months, and weight less than 6.0 kg at the time of operation did not adversely affect operative mortality (Table 3).

Three late deaths occurred. The first death, related to neglect by the parents, resulted from pneumonia and sepsis 35 days after hospital discharge. The second late death occurred 6 months after repair and also resulted from pneumonia and sepsis. The third late death occurred 6 months after repair, when the patient suffered an esophageal perforation during dilation of a stricture, leading to sepsis. Actuarial survival, inclusive of operative mortality, demonstrates 89% ± 4% alive at 5, 10, and 15 years after total correction (Fig 3). The late deaths did not appear to be related to the TOF correction.

View larger version (8K): [in this window] [in a new window]   Fig 3. Actuarial percent survival of patients after total correction of tetralogy of Fallot.

The mean follow-up time for hospital survivors was 11.6 ± 0.6 years. More than 70% of the survivors have been observed for more than 10 years, and 30% for more than 15 years. Total follow-up is 699 patient-years. At the time of the last clinic visit, only 9 patients were below the 5th percentile for growth in height and 12 patients were below the 5th percentile for weight.

Currently 51 (90%) patients require no cardiac medication, 4 patients (7%) require digoxin, 2 patients (3%) are taking digoxin and lasix, and 1 patient is on atenolol for paroxysmal supraventricular tachycardia.

Functional tolerance was categorized by follow-up interval (Fig 4). Eighty-two percent of patients are considered to have no functional limitation. At more than 10 years of follow-up, 4 patients (11%) were considered to have mild impairment of their functional tolerance. No one at this interval had moderate or severe impairment of functional status. Preoperative frequent respiratory tract infection symptoms were associated with a New York Heart Association functional class worse than I (p = 0.01). Aortic cross-clamp time more than 60 minutes, cardiopulmonary bypass time more than 90 minutes, age at operation less than 3.0 months, weight at operation less than 6.0 kg, preoperative palliative procedure, use of a transannular patch, and the need for urgent or emergent operation were not associated with a New York Heart Association functional class worse than I (Table 4).

View larger version (15K): [in this window] [in a new window]   Fig 4. New York Heart Association functional class, by follow-up interval, of survivors of total correction of tetralogy of Fallot.

Twenty-four-hour Holter monitor tests were obtained for 19 patients. All patients were in normal sinus rhythm. Sixteen patients had rare or occasional premature ventricular contractions, 1 patient had an occasional sinus pause, and 1 patient, an occasional premature atrial contraction.

	Comment

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Despite total correction of TOF being a common cardiac surgical procedure for more than 40 years, some controversy still exists regarding the optimal treatment method in the first year of life. Some groups advocated routine two-staged procedures for TOF, with a shunt for symptomatic patients during infancy, and total correction within 1.5 years of palliation [10]. Other investigators propose selective staged management with initial shunting, particularly in patients with less than ideal anatomy [11, 12]. However, patients undergoing staged treatment of TOF, using a palliative shunt and subsequent total correction, accrue the risk of two operative procedures and the potential complications of right-to-left intracardiac shunting, compromised ventricular function, and fibrosis with ongoing hypoxemia and myocardial ischemia [13–15]. Rather than routinely submitting patients to two operations some centers, including ours, have undertaken early total correction of TOF in all patients with acceptable anatomy [3, 5, 6]. Although long-term data after early total correction in the recent era is increasing, functional outcome related to method of repair is limited.

Early in this series, we were concerned about pulmonary artery size less than 3 mm. However, our current policy has been to proceed with primary repair in infancy, even if the pulmonary arteries are smaller than 3 mm, regardless of the age or weight of these patients. We believe that, although small, these arteries are quite distensible, and will enlarge to accommodate adequate flow after operation. If initial palliation is deemed necessary, we proceed with complete repair at 6 to 12 months of age. Our surgical strategy has been to relieve the right ventricular outflow obstruction as completely as possible, without leaving significant regurgitation. We have been liberal in using a transannular patch to accomplish these goals. We routinely use a right ventriculotomy. This approach facilitates closure of the malalignment VSD often seen with TOF, and also expedites a thorough examination and resection of the infundibular muscle bundles. Residual VSD has been nonexistent during the follow-up of this series, and this is attributed to the excellent exposure obtained with a ventriculotomy.

Immediate concerns of early repair include the possibility of high mortality and complication rates in these young, small, and possibly more fragile infants [12]. In our series, age at operation less than 3 months or weight at operation less than 6 kg, did not have an effect on operative or long-term mortality. Another concern relates to the higher incidence of transannular patching, which has been associated with a risk of early death, and could lead to more severe pulmonary regurgitation and right ventricular dysfunction [8, 12, 16]. In our series of patients, use of a transannular patch did not have an effect on operative mortality or long-term functional status.

Our mortality rate of 6% for total correction compares very favorably with the mortality of just an initial shunt operation for this congenital defect [17, 18]. In addition, awaiting final correction after palliation has its own attrition rate. Seven percent of 141 palliated infants in the review by Vobecky and colleagues [10] died after palliation, but before complete repair. Hospital mortality for early total correction of TOF ranges from 0% to 5% in more recent series, which our results approximate [3–8, 18]. It is important to note that many of these series are comprised of patients operated on in the 1990s [3, 4, 6, 7]. A series detailed by Knott-Craig and associates [18] demonstrated that overall mortality was significantly lower for TOF patients corrected since 1990, as compared to those corrected before 1990. More than two-thirds of the corrections in our series were performed before 1991. One finding was that operative mortality was significantly higher with longer cardiopulmonary bypass and aortic cross-clamp times. The higher mortality with longer cases, possibly related to more complex anatomy or difficulty of repair, is not unique to this condition and is seen with other cardiac operations. Postoperative problems or complications were minimal in this series.

The 10- and 15-year survival rates of 89%, inclusive of early deaths, compare favorably to reports of patients corrected in infancy and also at relatively older ages [3, 5, 7, 10, 12, 18–20]. Older age at repair has been correlated with increased long-term mortality [19, 21] Repair in infancy may improve long-term survival compared to repair at more than 1 year of age. In our series, the late deaths occurred within 1 year after discharge. The cause of death in each patient was noncardiac, and illustrates the risks of comorbid illnesses in these patients.

Arrhythmias have not caused any late deaths. This agrees with reports associating a lower incidence of ventricular arrhythmias, late events, and sudden deaths with early repair [16, 20]. In the Stanford series by Zhao and colleagues [20], 29% of late deaths were either known or suspected to be due to ventricular arrhythmias. In the series by Deanfield and associates [15], a subset of patients with less than 11 years of follow-up, demonstrated that more than 20% of patients repaired at 8 to 15 years of age and 80% of patients repaired at more than 16 years of age, had greater than or equal to grade two ventricular arrhythmias. Our mean follow-up of 11.6 years allows some comparison to this subset of Deanfield’s patients, and demonstrates a lower rate of ventricular arrhythmias, with repair in infancy. It is possible that the need for extensive resection in the heavily trabeculated and hypertrophic infundibulum of older patients leaves more myocardial fibrosis. Chronic hypoxic injury before total correction may also affect the myocardium inflicting a vulnerability to ventricular arrhythmias [21–23]. Both these changes could serve as substrates for induction of ventricular ectopy.

In this series, 96% of patients were free from a reoperation at up to 20 years. One patient had reoperation to revise the pericardial patch used in the right ventricular outflow tract. This aneurysm occurred early in the series, before our routine use of glutaraldehyde to process the pericardium. Glutaraldehyde stabilizes the collagen bonds, yielding tougher pericardial tissue. The treated tissue may diminish this complication.

No patient required reoperation for right ventricular dysfunction secondary to pulmonary regurgitation. Some groups have reported the need for reoperation for pulmonary valve replacement after repair of TOF [5, 16, 23, 24]. In these reports, most patients had an associated lesion that increased the preload or afterload of the right ventricle, such as residual right ventricular outflow tract stenosis, pulmonary hypertension, or tricuspid insufficiency. The incidence and severity of pulmonary and tricuspid regurgitation are similar to other series [5, 6, 20, 25]. In our experience, isolated pulmonary insufficiency in patients after TOF repair has been very well tolerated.

In our patients, manifestations of decreased functional tolerance during late follow-up were related to frequent preoperative respiratory tract infection symptoms. These symptoms may or may not be caused by infectious agents. Rather, they most likely serve as a marker for impaired pulmonary function. The worsened pulmonary status may negatively impact the patient’s myocardial oxygenation leading to a greater incidence of adverse operative cardiac events and early deaths. Long-term effects of diminished pulmonary function would also decrease cardiac function and exercise tolerance. Further study investigating the relationship of respiratory tract infection symptoms with impaired pulmonary function, and this function’s impact on outcomes after repair of TOF, may be interesting to pursue.

The patients in our series have fared well during late follow-up. Only a small number of patients have lagged behind normal growth curves. Only 7 patients require cardiac medications on a chronic basis. At up to 20 years of follow-up, 88% of patients are in New York Heart Association functional class I, and no patient has significant limitation or disability. Such gratifying results have been reported by other researchers [4, 5, 13, 19, 20]. The great majority of surviving patients have remained completely asymptomatic, the quality of life has been good, and they have led normal or almost normal lifestyles.

This 20-year experience with total correction of TOF in infants confirms the rewards of this cardiac operation. Primary correction is safe in these young infants. Overall long-term survival and exercise tolerance are excellent. Physical growth and development are satisfactory. Serious consideration should be given to early primary correction in all patients with TOF less than 1 year of age, unless a very unfavorable anatomic configuration necessitates palliation.

	Acknowledgments

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
We thank Jonathan Fields, MS, for his assistance in applying the SPSS program to our data.

	References

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1. Lillehei C.W., Cohen M., Warden H.E., et al. Direct vision intracardiac surgical correction of the tetralogy of Fallot, pentalogy of Fallot, and pulmonary atresia defects. Report of first ten cases. Ann Thorac Surg 1955;142:418-445.
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