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Ann Thorac Surg 2001;72:416-423
© 2001 The Society of Thoracic Surgeons

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Original article: cardiovascular

Outcomes of intraoperative device closure of muscular ventricular septal defects

^a Department of Pediatrics and Surgery, The Hospital For Sick Children, The University of Toronto School of Medicine, Toronto, Ontario, Canada
^b Division of Cardiology and Cardiovascular Surgery, The Hospital For Sick Children, The University of Toronto School of Medicine, Toronto, Ontario, Canada

Accepted for publication May 9, 2001.

Address reprint requests to Dr Benson, Division of Cardiology, The Hospital For Sick Children, 555 University Ave, Toronto, Ontario, Canada, M5G 1X8
e-mail: benson{at}sickkids.on.ca

	Abstract

Top Abstract Introduction Patients and methods Results Comment References

 
Background. The surgical management of muscular ventricular septal defects (mVSD) in the small infant is a challenge particularly when multiple and associated with complex cardiac lesions. Devices for percutaneous implantation have the advantage of ease of placement and for the double umbrella designs a wide area of coverage. We reviewed our experience and clinical outcomes of intraoperative mVSD device closure for such defects in small infants.

Methods. Since October 1989, intraoperative VSD device closure was a component of the surgical strategy in 14 consecutive patient implants (median age, 5.5 months; range, 3 to 11 kg), whose defects were thought difficult to approach using conventional techniques. Nine patients had associated complex cardiac lesions, 10 multiple mVSDs, and 4 patients had a previous pulmonary artery banding.

Results. There were 2 early deaths, 1 in a severely ill child who preoperatively had pulmonary hypertension and left ventricular failure and another in a patient with a hypoplastic left heart. Mean pulmonary to systemic flow ratio before device insertion was 3.5:1. Complete closure was achieved in 5 patients and clinically insignificant residual shunts persisted in 7. In 2 infants with significant residual lesions concomitant pulmonary artery banding was required. Postoperative mean pulmonary to systemic flow ratio was 1.7:1. In follow-up of the 12 surviving infants (mean, 41 months), 8 had complete closure and 3 persistent residual shunts. One patient with no residual shunting required heart transplantation for progressive ventricular failure 9 years after operation. All devices were well positioned on postoperative echocardiograms. There was 1 late death due to aspiration in a patient with a tiny residual shunt.

Conclusions. Infants requiring operative intervention with mVSDs are difficult to manage and have an increased mortality and morbidity. Intraoperative VSD device placement for closure of mVSDs is feasible, can avoid ventriculotomy, division of intracardiac muscle bands, and is ideally suited for the neonate or infant.

	Introduction

Top Abstract Introduction Patients and methods Results Comment References

 
Surgical repair of muscular ventricular septal defects (mVSDs) is associated with significant long-term morbidity and mortality. The incidence of an adverse outcome is increased when the defects are multiple, require a left ventriculotomy for closure, or additional complex heart lesions are present. Surgical approaches from both the right atrium, and right and left ventricles have been described [1–9], although approaches from the right side of the heart may not allow adequate defect visualization. A left ventriculotomy can result in long-term left chamber dysfunction, arrhythmias, residual shunts, and apical aneurysms [1–5]. Reports describing newer techniques, such as moderator band resection, oversized patches, a "sandwich" double patch method [6], or apical infundibulotomy [7] have decreased mortality. However, the difficulties of operation and management of this group of patients remain a challenge.

Transcatheter closure of congenital and residual post-surgical VSDs has proven to be a valuable alternative to operation in selected patients [10–24]. However, transcatheter closure may require the use of large venous sheaths for device delivery, and exposes small infants to the risk of peripheral vascular injury and unstable hemodynamics during implantation. On the other hand, intraoperative closure of mVSDs with a device during cardiopulmonary bypass has been described with good results [25–28]. In selected patients, particularly very small infants, this method appears advantageous, as it is simple, direct, and can avoid a ventriculotomy. Most of these studies, however, had limited follow-up and were small in numbers.

We have attempted intraoperative device closure of mVSDs in selected patients undergoing cardiac operations. The purpose of this review was to assess morbidity, mortality, the feasibility of the method, and outcomes in longer term follow-up.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment References

 
Terminology
The terminology and classification of ventricular defects is that of Soto and colleagues [29, 30].

Patients
Between October 1989 and July 2000, 14 patients ranging in age from 21 days to 17 months (mean, 5.5 months) underwent intraoperative device closure of mVSDs. There were 10 boys and 4 girls ranging in weight from 3 to 11 kg (mean, 5.5 kg). Preoperative diagnoses and hemodynamics are summarized in Table 1. The anatomic diagnosis was made by two-dimensional echocardiography with color-flow Doppler, visualized best in parasternal long axis and apical four-chamber views (Fig 1). Four patients had a single defect and 10 had multiple defects, including 1 patient with a so-called Swiss cheese septum (patient 6). Associated cardiac malformations were present in 9 patients and 5 had undergone a previous operation, including pulmonary artery (PA) banding in 4 patients.

View larger version (51K): [in this window] [in a new window]   Fig 1. Four-chamber view by transthoracic echocardiography from patient 11. (A) Preoperative study. Note the mid-muscular ventricular septal defect with a diameter of approximately 5 mm and dilated left ventricle. (B) One month after the device closure using a 17-mm CardioSEAL implant. Color-flow Doppler (not presented in this figure) showed a small residual shunt. (LV = left ventricle; RV = right ventricle; VSD = ventricular septal defect.)

View larger version (107K): [in this window] [in a new window]   Fig 2. Left axis oblique left ventriculogram from patient 5. (A) Preoperative study. Note an apical defect with a diameter of approximately 10 mm. (B) Two years after device closure using a 17-mm Clamshell. The device is in good position and there is no residual shunt.

Postoperative imaging of the ventricular septum was performed using transesophageal echocardiography once off bypass and the Qp:Qs was calculated using oxygen saturation values drawn simultaneously from right atrium, left atrium, and main pulmonary artery. Pressures were measured in the pulmonary artery or right ventricle and aorta, and the RVp/LVp calculated.

After operation, predischarge, and follow-up
Postoperatively, all patients underwent electrocardiograms and echocardiography, assessing arrhythmias, residual shunts, and ventricular function. Seven patients had Holter monitoring before discharge. The referring cardiologist followed the patients at 3- to 6-month intervals with serial electrocardiograms and echocardiography. In 4 patients, repeat cardiac catheterizations were performed.

Statistical analysis
Comparisons between data were made by Student’s t test. The level of statistical significance was set at p less than 0.05.

	Results

Top Abstract Introduction Patients and methods Results Comment References

 
Initial results
The mean cardiopulmonary bypass and aortic cross-clamp times were 112 minutes (range, 35 to 183 minutes) and 61 minutes (range, 22 to 105 minutes). Six patients had significant residual shunts on transesophageal echocardiography or saturation measurements (> 2:1) after weaning from cardiopulmonary bypass, and bypass was reinstated (discussed later). Circulatory arrest was required in 2 patients (for repair of associated lesions), each for 9 and 22 minutes.

Outcomes after device placement are summarized in Table 2. A Rashkind device was used in 1 patient, Clamshell device in 5, and CardioSEAL implant in 8 patients. One patient (patient 9) received two CardioSEAL devices. This child had a large apical and a smaller anterior mVSD (Fig 3). After closure with a 23-mm CardioSEAL device for the apical VSD, a residual defect just above the device and a moderate shunt (2:1) was noted on the transesophageal echocardiograph. Cardiopulmonary bypass was reinstituted and the device was moved to cover the more superior lesion and a second device (17-mm CardioSEAL) placed just below the initial implant (Fig 3). After the procedure, the shunt through the devices had decreased to 1.5:1. Three children had only device placement and no additional procedures, whereas in 6 (5 with aperimembranous and 1 with an inlet VSD) had additional patch techniques used for VSD closure. Two children (patients 4 and 10) underwent division of a moderator band in the right ventricle. Concomitant PA banding was also necessary in 2 children (patients 8 and 12) due to a persistent shunt (> 1.8:1) despite the transesophageal echocardiographic appearance of adequate device position. Absorbable suture was used for banding in patient 12, anticipating possible balloon dilatation as the residual shunt decreased.

View larger version (46K): [in this window] [in a new window]   Fig 3. A four-chamber view by transesophageal echocardiography from patient 9. (A) Preoperative examination noting an apical defect with a diameter of approximately 9 mm located below the moderator band. (B) After placement of a 23-mm CardioSEAL with a residual defect just above the device. (C) After a second device (17-mm CardioSEAL) placement, there was only a small leak by color-flow Doppler (not presented in this figure). (LV = left ventricle; RV = right ventricle; VSD = ventricular septal defect.)

Follow-up
Twelve patients were followed for a mean of 41 months, ranging from 1 month to 11 years. Follow-up echocardiographic studies noted that the implanted devices were well seated in all patients and any residual leaks had either improved or had not progressed (Figs 1 and 2). Four patients underwent postoperative catheterization and angiography at a median interval from operation to catheterization of 18 months. Although the Qp:Qs of patients 1, 2, and 5 were 1:1, decreasing after operation, that of patient 8 was 1.8:1.

Left ventricular diastolic dimensions were a mean of 106% of normal (range, 100% to 113% of normal) and left ventricular function was normal (mean ejection fraction, 65%). One patient (patient 1) required heart transplantation 9 years after the operation for progressive ventricular failure (ejection fraction, 19%; left ventricular diastolic dimension, 174% of normal). There were no statistical differences before or after operation for left ventricular diastolic dimensions or ejection fractions (p = 0.468 and 0.624, respectively) (Table 3). Examination of the explanted heart specimen from patient 1 showed marked endothelialization over the device. There was 1 late death, patient 8, with Down’s syndrome and gastroesophageal reflux, previous aspiration episodes, and tracheomalacia, who died of pneumonia 5 months after the operation. No autopsy was performed. No device arm fractures were identified by chest radiography in any device implant during follow-up.

	Comment

Top Abstract Introduction Patients and methods Results Comment References

 
Surgical interventions
Closure of mVSDs remains a surgical challenge, especially when multiple, situated in the lower or apical component of the interventricular septum and associated with complex cardiac lesions. In 1980, Kirklin and colleagues [1], presented the surgical management of multiple mVSDs describing approaches from right atrium, right or left ventricles. The mortality was 14% and reoperation rate for residual shunts 28%. Although surgical visualization and closure can be improved using a left ventriculotomy [31], an effective approach in adults after myocardial infarction, some investigators have described residual shunts, left ventricular dysfunction, apical aneurysm, or arrhythmias in long-term follow-up when performed in childhood [2–5]. Wollenek and associates [5] experienced a mortality after left ventriculotomy of 17% and reoperation rate of 10%, concluding that PA banding to be the surgical option in infants. In the report of Serraf and colleagues [4], muscular defects were approached through a right atriotomy with an operative mortality of 7.7% and a reoperation rate of 4.6%. These researchers emphasized that resection of the moderator band allowed for better visualization. Recent reports have described further refinements in technique, such as the use of oversized patches, a small apical left ventriculotomy, or a sandwich method (sandwiching the septum between two stiff Teflon patches), reducing mortality further to less than 5% [6–9]. A single large patch for the so-called Swiss cheese septal defects [8] and apical infundibulotomy (right ventriculotomy) for apical defects [9] are also useful approaches. However, the operation remains difficult and complications or residual shunts still remain. Kitagawa and colleagues [6] reported repair of muscular defects using these techniques in 33 patients, with 1 early death, 2 patients with complete heart block, and 2 patients requiring heart transplantation.

Transcatheter closure
Percutaneous transcatheter closure of mVSDs has proven to be an alternative to operation in selected patients. Lock and associates [10] first described the percutaneous approach in a postmyocardial infarction and congenital VSDs population in 1988, using the Clamshell device. Since then, the experience with percutaneous closure has increased and many device designs have been used expanding the Clamshell experience [11, 14], including the Rashkind implant [12, 13, 18, 22], the buttoned device [15], Gianturco [16] and detachable coils [17, 18], and the Amplatzer Septal Occluder (AGA Medical, Golden Valley, MN) [19–21, 23, 24]. However, transcatheter closure for such defects may require the use of a large sheath for device delivery to accommodate device diameters for closure of large defects. This approach can expose small infants to the risk of vascular injury and can be technically difficult. In addition, the percutaneous approach in the neonate and small infant exposes them to the catheter intervention risks, such as device embolization [10, 12], left ventricular outflow obstruction [10], tricuspid regurgitation [11], aortic regurgitation [15], or perforation of the aortic valve cusp [13]. Although with newer devices [21, 23], being lower in profile and retrievable, such instances are rare.

Intraoperative device closure
Leca and colleagues [32] took the unique approach to use fibrin glue to close small mVSDs intraoperatively. The mortality rate was 6% and there were no reoperations. However, this procedure risks the systemic embolization of fibrin glue particles. The intraoperative closure of mVSDs using devices designed for percutaneous closure was a logical extension of the technique to the small infant, where percutaneous implantation was considered technically difficult. Indeed, in an animal study, Amin and associates [28] reported a technique of the intraoperative closure using an Amplatzer device with a beating heart. Although the experience has been limited and variable due to the number of device designs available, it has generally been encouraging [25–28]. In these smaller studies, clinically significant shunts were present in 20% to 50% of patients, mortality 0% to 30%, and reoperations in 0% to 30% of patients. In our review, clinically significant residual shunts were present in 2 of 14 (14%) patients, with two perioperative deaths not related to the device or its implantation.

The rationale for intraoperative device closure for mVSDs in our institution in infants and small children was to avoid the potential need of a left ventriculotomy, reduce the need for extensive suturing of the septum, and shortened cross-clamp time for defect closure. Indeed, longer bypass times reflected time needed for repairing associated cardiac anomalies. Patients who underwent only device closure or whose associate cardiac anomaly were not complex, bypass time was less than 1 hour (patients 2 and 13) and cross-clamp time was less than 30 minutes (patients 2, 3, and 13). We used a variety of umbrella-type devices in this experience reflecting available designs over the decade, including a Rashkind device in 1 patient in the 1980s (patient 1), Clamshell devices in the early 1990s (patients 2 to 6), and CardioSEAL implants after the mid-to-late 1990s (patients 7 through 14). As the Rashkind device has no flexible elbows in the supporting arms and only two sizes (12-mm and 17-mm), application was limited, whereas the Clamshell device had one elbow in the supporting stainless steel arms and available in five device sizes. This device was initially designed for atrial septal defect closure. Because the Clamshell implant had a structural flaw resulting in supporting arm fracture, the CardioSEAL device was developed as a refined redesign. The CardioSEAL has two elbow joints in the supporting arms made of MP35N stainless steel, retaining the Dacron fabric covering for the umbrella. For patients with small multiple mVSDs, the umbrella may cover not only the target lesion, but also other small or surrounding defects. In our series, 9 patients had residual shunts immediately after closure. However, shunt flow significantly decreased and left ventricle dimensions normalized in medium-term follow-up in most patients.

Complications and assessment of failed patients
There were no severe complication associated device closures. Although right bundle branch block occurred in 4 patients and complete atrioventricular block in 3, these were not thought to be device related. Serraf and colleagues [4] observed that all patients who underwent resection of the moderator band had a right bundle branch block. In our series, in the 2 patients who required moderator band division, 1 patient developed right bundle branch block.

Four patients failed closure. Patient 1, who ultimately required a heart transplantation, had a moderate residual shunt (Qp:Qs, 2.3:1; RVp/LVp, 0.63) immediately after the closure, which decreased to trivial in follow-up. However, chronic asymptomatic left ventricular dysfunction and associated left ventricular noncompaction ultimately lead to pump failure 9 years after operation. Patient 3, with left ventricular hypoplasia died 1 day after the operation. In retrospect, this chamber was too small to support the systemic circulation. As a small-sized left ventricle and aorta are not uncommon in patients with mVSDs, it is paramount to carefully define morphology and chamber topology. Patient 6, who had severe pulmonary hypertension and poor left ventricular function preoperatively with a Swiss cheese septum, ultimately required ventriculotomies to visualize the defects, which resulted in pump failure and death. In patient 8, PA banding after VSD closure was required. Despite adequate device placement and apparent coverage of the defect, a residual moderate shunt remained. It was thought that the gap between the Dacron umbrella and the septum resulted in residual shunting. Subsequent patients had suturing of the right ventricular umbrella disc to the septum to avoid this occurrence. Several investigators have noted on pathologic examinations after intraoperative closure, using umbrella type devices, little endothelialization at 3 to 6 months after the operation, in part accounting for residual persistent shunting [26, 27]. Newer implants, such as the Amplatzer Septal Occluder, on pathologic examination, have shown complete endothelialization after 3 months in animal studies [20].

In conclusion, intraoperative VSD device placement for mVSDs is feasible, avoids ventriculotomy and division of intracardiac muscle bands, and can be applied in neonates or small infants. This procedure is simple, direct, and allows safe and generally effective closure of mVSDs.

	References

Top Abstract Introduction Patients and methods Results Comment References

 

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