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Ann Thorac Surg 2004;77:1717-1726
© 2004 The Society of Thoracic Surgeons

Original articles: cardiovascular

Repair of complete atrioventricular septal defects in patients weighing less than 5 kg

Edvin Prifti, MD, PhDa,b, Massimo Bonacchi, MDb*, Massimo Bernabei, MDa, Adrian Crucean, MDa, Bruno Murzi, MDa, Fabio Bartolozzi, MDc,d, Vincenzo Stefano Luisi, MDa, Marzia Leacche, MDb, Nadia S. Nathan, Vittorio Vanini, MDa

a Division of Pediatric Cardiac Surgery, G. Pasquinucci Hospital, Massa, Italy
b Division of Cardiac Surgery, Cattedra di Cardiochirurgia, Policlinico Careggi, Florence, Italy
c Cardiothoracic Department at St. James Hospital, Dublin, Ireland
d Brigham and Women's Hospital, Harvard University, Boston, Massachusetts, USA

Accepted for publication June 19, 2003.

* Address reprint requests to Dr Bonacchi, Cattedra di Cardiochirurgia, University Hospital of Florence "Careggi," Viale Morgagni, 85, 50134 Firenze, Italy.
e-mail: edvinprifti{at}hotmail.com


   Abstract
Top
 Abstract
Introduction
 Material and methods
 Results
 Comment
 References
 
BACKGROUND: The aim of this study was to evaluate the impact of weight less than 5 kg at operation on mortality and morbidity in patients with atrioventricular septal defect (AVSDc) undergoing total correction.

METHODS: Between January 1990 and December 2002, 190 consecutive patients with AVSDc underwent total biventricular correction. They were divided into two groups: group I (n = 64 patients weighing < 5 kg) and group II (n = 126 patients weighing > 5 kg). Associated major cardiac malformations were found in 49 (25.8%) patients. Associated left atrioventricular valve (LAVV) malformations were found in 35 (18.4%) patients. The mean follow-up time was 4.1 ± 2.9 years (range 2 months–10.7 years).

RESULTS: The in-hospital mortality in group I was 7.8% (5 patients) versus 8.7% (11 patients) in group II (p = 0.95). Major associated cardiac malformations (p < 0.001) and pulmonary hypertension (p = 0.006) were found to be strong predictors for poor postoperative survival. At discharge the mean LAVVR grade in group I was 1.45 ± 1.2 versus 1.2 ± 1 in group II (p = 0.13). The actuarial overall survival rates at 1, 3, 5, and 7 years were 96.5%, 92.5%, 91.5%, and 89% respectively and the actuarial overall reoperation free survival rates at 1, 3, 5, and 7 years were 95%, 87%, 84%, and 73%. Twenty-three patients underwent reoperation due to severe left atrioventricular valve regurgitation (LAVVR). Strong predictors for overall reoperation free survival were the operation year before 1995 (p < 0.001), postoperative LAVVR greater than or equal to 2 (p = 0.006), major associated cardiac malformations (p = 0.00034), associated LAVV malformations (p = 0.0044), and non or partial LAVV cleft closure (p = 0.012). The actuarial survival rates between patients weighing less than 5 kg versus patients weighing more than 5 kg were similar (p = 0.51); instead the overall reoperation free survival was significantly lower in patients weighing less than 5 kg (p = 0.022) according to the log-rank test. Weight less than 5 kg (p = 0.023, ß = –0.6) was one of the predictors for reoperation due to severe LAVVR in this series.

CONCLUSIONS: We may conclude that in the current era repair of AVSDc can be carried out successfully in patients less than 5 kg, however, weight less than 5 kg at initial complete repair seems to be a predictor for late reoperation due to LAVVR. Suture separation at the cleft site or between the leaflets of the newly created mitral valve and the patch remain the main causes of postoperative LAVVR in patients weighing less than 5 kg.


   Introduction
Top
 Abstract
 Introduction
Material and methods
 Results
 Comment
 References
 
The complete atrioventricular septal defect (AVSDc) includes a group of malformations related to abnormal development of the endocardial cushions sharing common morphologic features. Since the first successful repair of AVSDc by Lillehei and associates [1] surgical treatment of this malformation has steadily improved and the age at repair has gradually decreased. The single patch technique consisting in a single autologous pericardial patch was firstly described by Maloney and associates [2] in 1962. In 1976 Trusler and colleagues [3] introduced the two-patch technique with a prosthetic patch for the ventricular septal defect (VSD). Left atrioventricular valve (LAVVR) remains an important cause of postoperative morbidity after AVSDc with an reoperation rate between 6%–15% [4–14]. Very few studies have been focused on the relationship between the age at repair and early and late outcomes [8, 14]. Most surgeons would prefer to correct the AVSDc before 6 months of age, however medical therapy is generally used in neonates, low weight young infants, and low birth-weight babies primarily because of technical concerns about the fragility of the common atrioventricular valve (CAVV) tissue.

The aims of this study were to evaluate the impact of weight less than 5 kg at operation on mortality and morbidity in patients with AVSDc undergoing total correction and to identify predictors associated with an increased risk of postoperative mortality and reoperation due to LAVVR.


   Material and methods
Top
 Abstract
 Introduction
 Material and methods
Results
 Comment
 References
 
Between January 1990 and December 2002, 190 consecutive patients with AVSDc undergoing total biventricular correction were divided in 2 groups: group I (n = 64 patients weighing < 5 kg) and group II (n = 126 patients weighing > 5 kg). All patients with AVSDc undergoing univentricular correction, or patients with AVSDc undergoing reoperation but who were undergoing initial complete correction at another institution, were excluded from the study.

Patient characteristics
Mean age in group I was 4.3 ± 2.37 months versus 24.74 ± 23.4 months in group II (Table 1). The age and weight distribution are given in Figures 1a and b. Seven patients presenting congestive heart failure were placed on mechanical ventilation and inotropic agents before surgery. Associated cardiac and LAVV malformations were found in 49 (25.8%) and 35 (18.4%) patients respectively.


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  		Table 1. Preoperative Demographic Characteristics

 


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  		Fig 1. Age (A) and weight distribution (B) in patients with complete atrioventricular septal defect undergoing initial total repair. Line = expected.

 
Surgical technique
All group II patients were placed on cardiopulmonary bypass with aortic and bicaval cannulation and moderate hypothermia. In 16 patients (group I), deep hypothermia (18°C) was reached to permit circulatory arrest. In the other 48 patients (group I), low flow perfusion under deep hypothermia was employed. The pericardial patch was harvested at the beginning of surgery and fixed in glutaraldehyde. A right atriotomy parallel to the right AV groove, extending from the right atrial auricle to the level of entrance of the inferior caval vein, was performed in all patients. The distance between the LAVV and the crest of the ventricular septum was accurately assessed to place the valve at a proper height above the septum and prevent subaortic stenosis. The CAVV apparatus was carefully inspected. A single pericardial patch fixed in glutaraldehyde was used to repair the entire septal defect in 151 (79.5%) patients. In these cases the bridging leaflets were divided. The interventricular component of the defect was first closed with interrupted or continuous 5-0 polypropylene suture. When the level of the CAVV orifice was reached the divided valve leaflets were sewn to the patch with interrupted non-absorbable pledget-supported sutures. Closure of the cleft in the newly created LAVV was performed with interrupted 5-0 or 6-0 polypropylene sutures which were usually carried out to the first order chordae tendinae. Complete closure of the cleft was performed in 153 (80.5%) patients. Cold saline solution was routinely injected into the left ventricular (LV) cavity to test the valve competence and to assess the leaflet motion and coaptation. Annular dilatation producing central LAVVR or right atrioventricular valve regurgitation (RAVVR) was treated by means of different reductive annuloplasty techniques. Attempts were made to reduce the diameter of the LAVV annulus to the normal values according to the patient's age and weight. In cases presenting with chordae elongation, the "split and tuck" technique was employed. Splitting and fenestration of interchordal spaces were performed in cases with single papillary muscle. At the end of any conservative procedure the LAVV annulus was sized with appropriate Hegar obturators. After resuspension and adjustment of the leaflets the pericardial patch was used to close the atrial component of the defect. During the last 2 years we employed the two-patch technique in 39 (20.5%) patients. In these cases the septal reconstruction was performed using a semilunar Gore-Tex (W.L. Gore & Associates, Newark, DE) patch for VSD closure and a separate autologous pericardial patch for atrial septal defect component closure. The coronary sinus was routinely left on the right side of the patch in all cases. Intraoperative transesophageal echocardiography was employed in 112 (59%) patients. Intraoperative epicardial echocardiography was employed in patients weighing less than 3 kg. All associated anomalies were repaired concomitantly. In this series 8 out of 9 patients with aortic coarctation or interrupted aortic arch underwent single stage repair. The intraoperative data are given in Table 2.


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  		Table 2. Intraoperative and Postoperative Data

 
The mean follow-up time was 4.1 ± 2.9 years (range 2 months–10.7years). All surviving patients underwent postoperative transthoracic echocardiography within 1 year after surgery.

The LAVVR was graded as trivial (I), mild (II), moderate (III), and severe (IV) depending upon the degree of opacification of the left atrium and observation under a color Doppler signal. Mitral valve (MV) stenosis was considered when the mean transvalvular gradient was more than 5 mm Hg. LAVV malformations were defined those LAVV valves presenting at least one of the following malformations: double orifice LAVV, parachute LAVV, accessory LAVV tissue, posterior cleft, leaflet perforation or prolapse, elongated chordae, and dysplastic valve tissue.

Statistical analysis
Group statistics were expressed as mean ± SD or by frequency percentage. The generalized Wilcoxon test for the continuous variables and Fischer exact test for the noncontinuous variables were employed for the statistical analysis between groups. The relationship between preoperative and postoperative variables within the same group was assessed by the McNemar test. Age and weight were analyzed as continuous variables and as dichotomous variables with division points for dichotomous analysis set at less than 6 months and less than 5 kg respectively. All the variables reaching the p value of 0.1 were included into the multivariate models. The multivariate Cox regression (including stepwise) analysis was performed to determine independent variables associated with late reoperation and adverse outcome. The logistic stepwise regression test was employed to determine predictors for poor early postoperative survival and adverse outcome. Long-term survival rates were calculated using the Kaplan–Meier method and statistical significance was calculated by the log-rank test. Significance between data were considered achieved when p less than 0.05.


   Results
Top
 Abstract
 Introduction
 Material and methods
 Results
Comment
 References
 
The in-hospital mortality in group I was 7.8% (5 patients) versus 8.7% (11 patients) in group II (p = 0.95). Seven out of 16 deaths in this series were less than 6 months of age (5 out of 7 deaths < 6 months of age were placed preoperatively on mechanical ventilation and inotropic support). The multivariate analysis revealed the major associated cardiac malformations and pulmonary hypertension as strong predictors for poor postoperative survival (Table 3). There were no significant differences between groups regarding the postoperative complications (Table 2). Twenty patients underwent early surgical revision due to significant bleeding (13 patients), diaphragmatic plication (2 patients), and LAVV repair (5 patients). A model including all early postoperative deaths and major postoperative adverse outcome was constructed. Major adverse outcome included the tracheostomy, surgical revisions, multiorgan failure, renal failure, extracorporeal membrane oxygenator, and ventricular assistance. The multivariate analysis revealed the major associated cardiac malformations (p = 0.001), pulmonary hypertension (p = 0.003), and previous palliation (p = 0.024) as strong predictors for poor early postoperative outcome.


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  		Table 3. Predictors According to the Multivariate Analysis (Regression Model) for Poor Postoperative Survival

 
Mean mechanical ventilation duration in group I was 32 ± 30 hours versus 23.8 ± 22 hours in group II (p = 0.034) and mean intensive care unit stay in group I was 3.7 ± 3.4 days versus 2.6 ± 3.2 days in group II (p = 0.03) (Table 2). All patients underwent series of echocardiographic examination postoperatively. At discharge the mean LAVVR grade in group I was 1.45 ± 1.2 versus 1.2 ± 1 in group II (p = 0.13)

The actuarial overall survival rates at 1, 3, 5, and 7 years were 96.5%, 92.5%, 91.5%, and 89% respectively (Fig 2a) however the actuarial overall free reoperation survival rates at 1, 3, 5, and 7 years were 95%, 87%, 84%, and 73% (Fig 2b). Twenty-three patients underwent reoperation due to severe LAVVR. Eight of them required a second reoperation and conservative valve surgery was possible in 87.5% of cases (Table 4). Associated major cardiac malformations were found in 4 out of 8 patients requiring a second reoperation and associated LAVV malformations were found in 6 out of 8 patients. Strong predictors for reoperation resulted to be the operation year before 1995 (p < 0.001), weight less than 5 kg (p = 0.023), preoperative CAVVR greater than or equal to 3 (p = 0.012), postoperative LAVVR greater than or equal to 2 (p = 0.0057), major associated cardiac malformations (p = 0.00018), associated LAVV malformations (p = 0.0015), and non or partial LAVV cleft closure (p = 0.002) (Table 5).



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  		Fig 2. Actuarial survival (A) and overall reoperation survival (B) in patients with complete atrioventricular septal defect undergoing initial total repair. Actuarial survival (C) and overall reoperative free survival (D) in patients weighing less than 5 kg versus patients weighing more than 5 kg undergoing correction of complete atrioventricular septal defect.

 

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  		Table 4. Patients Undergoing Second Reoperation Due to Left Atrioventricular Valve Regurgitation After Initial Correction of Complete Atrioventricular Septal Defect

 

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  		Table 5. Predictors for Postoperative Reoperation and Poor Overall Reoperation Free Survival After Total Correction of Complete Atrioventricular Septal Defect

 
The predictors for poor overall reoperation free survival according to the multivariate analysis were found to be the operation year before 1995, postoperative LAVVR >= 2, LAVV malformations, and major associated cardiac malformations (Table 5).

The actuarial survival rates between patients weighing less than 5 kg versus patients weighing more than 5 kg were similar (p = 0.51) (Fig 2c), however the overall reoperation free survival was significantly lower in patients weighing less than 5 kg (p = 0.022) (Fig 2d). The actuarial survival and overall reoperation free survival rates were significantly lower in patients with associated major cardiac malformations (p = 0.00062, p = 0.0005) (Fig 3a) and LAVV malformations (p = 0.00006, p = 0.0001) (Fig 3b), in patients with moderate-to-severe pulmonary hypertension (p = 0.0012, p = 0.0046) and in those with postoperative LAVVR greater than or equal to 2 (p = 0.0008, p = 0.0001) (Fig 3c) according to the log-rank test.



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  		Fig 3. Overall reoperation free survival in patients with (A) associated cardiac malformations, (B) associated left atrioventricular malformations (LAVV), and (C) postoperative left atrioventricular valve regurgitation (LAVVR) grade >= 2.

 

   Comment
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
References
 
Surgical correction of the AVSDc has undergone continuous improvements regarding the employed surgical techniques, myocardial protection, perioperative management, and decreased age at repair. The authors' opinion is that early primary correction is associated with better outcome. Repair before 6 months of age is common however medical therapy is generally used in neonates and low-weight birth babies primarily because of technical concerns about the fragility of the CAVV tissue. Delay of surgery in this setting leads to increased morbidity from respiratory infections, failure to thrive, valve tissue thickening, and distortion, and pulmonary vascular disease. The common scenario of the AVSDc is that soon after the fall of pulmonary vascular resistances (first month of life) the QP/QS (pulmonary [Qp] and systemic [Qs]) rises and chronic heart failure develops. Pulmonary vascular disease develops during the first year of life [15]. Intimal fibrosis of the pulmonary vessels can be found already at the age of 6 months [16]. Another argument in favor of repair in early infancy is the possible increase in degenerative changes of the CAVV as the age increases [17]. Postoperatively emphasis is placed on optimizing the cardiac output and avoiding pulmonary hypertensive crisis. In our experience we have employed nitric oxide in all patients with a pulmonary pressure greater than 50% of the systemic pressure at the end of the surgical procedure. Attention was paid to hypoxia, hypercapnea, acidosis, pain, and hypothermia which are the triggers of pulmonary vasospasm. Patients weighing less than 5 kg required longer mechanical ventilation and intensive care unit stay in this study. This is comprehensible because most of these patients were small or underweight babies, had a slower sloop towards improvement, and, as consequence, required major attention and treatment. The in-hospital mortality in this series was 8.4%. The in-hospital mortality in other reports varied between 3%–16% [7, 14] and still other studies demonstrated a 10% in-hospital mortality [5, 9, 18].

The operative repair of the AVSDc has undergone significant modification since early techniques were described. The single-patch technique offers a series of advantages such as a better exposure and visualization of the VSD and subvalvular apparatus, less sutures close to the valvular plane, and shorter aortic cross clamping times than the two-patch technique. However this technique requires the division of the common valve leaflets which when sewn back onto a single patch 3–4 mm of leaflet tissue is used up [17]. This situation is important in patients weighing less than 5 kg in which the sacrificed valve tissue comprises a greater proportion of the whole. The deficiency of valvular tissue predisposes a reduction of the mobile valve area due to incorporation of leaflet tissue in the suture line placed under tension. This might induce a higher incidence of suture dehiscence and, as a consequence, important postoperative LAVVR. One of the solutions might be the augmentation of the leaflet tissue according to the reported modified techniques [18–20]. Wilcox and associates [21] reported a modified single-patch technique consisting in suturing the CAVV to the ventricular septum offering the possibility to save the valvular tissue that is normally sacrificed when the leaflets are reattached to the patch. Nicholson and associates [22] modified this technique by adding a Dacron strip which acts as a form of LAVV annuloplasty to bring the leaflets components closer together. However most of the authors agree that sandwiching the valves between the pericardium and Gore-Tex according to the two-patch technique allows respect of valve architecture by avoiding the leaflets' division, therefore limiting the secondary tissue sequestration and decreasing the chance of dehiscence. Other recent studies have reported a reoperation rate between 6.8% and 14.7% in patients with AVSDc undergoing two-patch technique correction [6, 7, 10, 14, 23]. Similar reoperation rates due to LAVVR are reported in patients undergoing single-patch correction [8, 9]. Other reported AVSDc series including both techniques failed to statistically demonstrate the single-patch technique as a possible predictor for early and late reoperation [5, 18]. In our series of 174 survivors, 79.5% of patients underwent single-patch technique and the reoperation rate was 13% which is higher than some of the previously reported series. In our experience the technique of repair shifted from the single-patch technique to the two-patch technique during the last 3 years. In our series there was a trend for a higher reoperation rate in patients undergoing single-patch versus double-patch technique however we were not able to statistically demonstrate such a difference probably due to a shorter follow-up in patients undergoing the two-patch technique.

Another controversial issue is the mitral "cleft." Carpentier reintroduced this approach by presenting the new concept of the "septal commissure" [24]. The trifoliate approach prevents the aggressive manipulation of the LAVV and preserves the original and unique configuration of the valvular and subvalvular apparatus. Despite such advantages, other studies reported an increased LAVVR in patients undergoing trifoliate approach [4–13]. Najm and colleagues [18] demonstrated that cleft closure was associated with a statistically improved survival and decreased risk of reoperation suggesting that cleft closure independently confers an incremental benefit to the restoration of valve competence. Bando and associates [4] reported routine cleft closure with only a 4% reoperation rate for LAVVR. In 37 out of 190 patients in our series it was preferred to not close or to partially close the cleft of the LAVV in order to minimize the tension between leaflets. In other cases it was the surgeons' preference to not close the cleft. In this series partial or nonclosure of the LAVV cleft was identified as a strong predictor for postoperative reoperation due to LAVVR and for poor overall reoperation free survival. Although we found residual cleft or suture dehiscence between the leaflets and the patch in the majority of children undergoing reoperation, almost all of them required additional annuloplasty or other reparative techniques to improve valve function suggesting that other morphologic changes may also be equally important (ie, annular dilatation or chordal elongation). It is possible that regurgitation through the cleft produces annular dilatation or chordal elongation.

In our experience the suture dehiscence at the cleft site or between the leaflets and the patch was found mainly in patients undergoing correction during the first months of life and in low-weight patients. However the multivariate analysis did not reveal that weight less than 5 kg was a predictor for poor overall reoperation free survival. In all 14 patients weighing less than 5 kg, requiring reoperation due to severe LAVVR, we found that separation of the cleft suture or the leaflets was detached from the patch as previously reported [25]. The quantity of LAVV tissue in neonates is very limited and such technical difficulties increase when associated LAVV malformations (ie, double-orifice, parachute LAVV, or dysplastic leaflets' tissue) are present.

Annular dilatation is a progressive event that develops gradually until causing severe LAVVR. In a previous study we found that annular dilatation is an age-dependent event in patients undergoing reoperation due to LAVVR after surgical correction of various forms of AVSD [25]. Michielon and associates [14] found that even the diameter of the CAVV correlated well with the patient's age. In our series the incidence of various annuloplastic procedures of the LAVV during the first correction was significantly higher in older patients indirectly demonstrating a higher incidence of annular dilation in these patients. These findings support the hypothesis that the main LAVVR mechanism in older patients (preoperative powerful stimulus of chronically elevated QP/QS could play a role in the onset of annular dilatation and subsequent LAVVR) is annular dilatation which develops gradually and progressively in a setting of an abnormal LAVV.

A number of other factors have been identified as strong predictors for reoperation due to LAVVR after AVSDc correction such as the presence of a double-orifice LAVV [4, 18]. These include parachute MV [26], nonclosure of the cleft [18], associated LAVV anomalies [27], annular dilatation and non-Down's syndrome, and pulmonary hypertension [4]. In our study we were able to demonstrate that operation year before 1995, weight less than 5 kg, associated cardiac and LAVV malformations, residual LAVVR, and nonpartial or partial cleft closure were strong predictors for reoperation after AVSDc correction. Improvement in our surgical techniques and strategies and continued experience may have contributed to the improved outcome during the last years.

Study limitations
The main limits of this study included the fact that this was a retrospective study, that surgical techniques were employed according to the surgeons' preference, and, finally, that the operations were performed by four different surgeons. We may conclude that in the current era, repair of AVSDc can be carried out successfully in patients less than 5 kg however a weight less than 5 kg at initial complete repair seems to be a predictor for late reoperation due to LAVVR. Correction of AVSDc in patients weighing less than 5 kg is safe and beneficial not only in controlling the chronic heart failure but also in preventing annular dilatation, although suture's dehiscence at the cleft site or between the LAVV leaflets and the patch remain the main causes of postoperative LAVVR in this group of patients. Larger series of patients, longer follow-up, and prospective studies are required in order to clearly demonstrate that delaying operation until the child is more than 5 kg would increase the benefits in terms of late reoperation in such patients.


   References
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

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