Ann Thorac Surg 2009;88:1551-1555. doi:10.1016/j.athoracsur.2009.07.071
© 2009 The Society of Thoracic Surgeons
Original Articles: Pediatric Cardiac
Transcatheter Closure of Postoperative Residual Perimembranous Ventricular Septal Defects
Ming-Biao Gu, MD*,a,
Yuan Bai, MD*,a,
Xian-Xian Zhao, MDa,
Xing Zheng, MDa,
Wei-Ping Li, MDb,
Yong-Wen Qin, MDa,*
a Department of Cardiology, Changhai Hospital, Second Military Medical University, Shanghai, China
b Department of Echocardiography, Changhai Hospital, Second Military Medical University, Shanghai, China
Accepted for publication July 29, 2009.
* Address correspondence to Dr Qin, Department of Cardiology, Changhai Hospital, Second Military Medical University, 168 Changhai St, Yangpu District, Shanghai, 200433, China (Email: yongwenqin{at}yahoo.com).
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Abstract
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Background: The presence of postoperative residual perimembranous ventricular septal defect (PmVSD) is relatively uncommon. However, reoperation might be associated with an increased surgical risk. Transcatheter device closure is an alternative strategy for management of postoperative residual defects.
Methods: Between July 2002 and November 2008, transcatheter closure of postoperative residual PmVSDs was attempted in 26 patients (11 male, 15 female). Symmetric and asymmetric PmVSD occluders were used.
Results: The diameter of residual defects was from 3 mm to 10 mm (mean 6.3 ± 2.3 mm) on transthoracic echocardiography. In 24 of 26 patients, the residual defects were successfully closed. No direct residual defect was found on left ventriculography after the procedure. Total occlusion rate was 62% (15 of 24) at completion of the procedure, rising to 71% (19 of 24) at one week and 96% (23 of 24) during the follow-up. Twenty patients had only one device implanted, whereas 4 patients had two devices implanted. The waist size of occluders used ranged from 5 mm to 12 mm (mean 8.6 ± 2.5 mm). One patient presented with complete atrioventricular block 3 days after the procedure and recovered 2 weeks later. Hemolysis occurred in 3 patients after the procedure within 12 hours. These patients recovered 4 weeks, 4 days, and 8 days later, respectively. During follow-up, the devices were in a stable position with optimal shapes. No late complications were observed.
Conclusions: Transcatheter closure of postoperative residual PmVSDs is possible without the need for reoperation. The early and midterm prognosis of patients with transcatheter closure is good.
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Introduction
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Transcatheter device closure of ventricular septal defects has been increasingly performed, and this procedure is now offered as primary therapy at many institutions. The benefits of avoiding bypass are intuitive, and the relative ease of placement makes this procedure ultimately attractive. More recently, percutaneous techniques and devices have been developed specifically for transcatheter closure of perimembranous ventricular septal defects (PmVSDs) [1–3]. Surgery has been regarded as the gold standard for all types of VSDs [4]. Residual defects after surgical closure of PmVSDs are relatively uncommon [5, 6], but sometimes might be a problem. Residual defects less than 2 mm could close spontaneously; however, defects larger than 2 mm are unlikely to close spontaneously [6]. The latter carry a risk of endocarditis and heart failure, but reoperation might be associated with an increased surgical risk [7, 8]. Previous studies have reported the closure of postoperative residual defects using Amplatzer occluders and other devices [9–11]. In this article, we report our early and midterm follow-up results of percutaneous closure of postoperative residual PmVSDs in 26 subjects using new, modified, double-disk occluders.
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Material and Methods
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The Ethics Committee of our hospital approved the study, and informed patient consent was obtained.
Between December 2001 and December 2008, 577 patients with PmVSDs underwent successful transcatheter closure in our hospital. All patients with postoperative residual defects were screened with transthoracic echocardiography (TTE) in the long-axis parasternal view and apical five-chamber view to evaluate the rim under the aortic valve, and in the short-axis parasternal view to detect the rim from the tricuspid valve to the defect before catheterization. Inclusion criteria for closure were as follows: (1) age more than 3 years old; (2) no surgical closure of PmVSDs in the past 3 months; and (3) the diameter of residual defects 3 mm or more and 10 mm or less by TTE. Patients with any of the following conditions were excluded: (1) aortic valve prolapse, (2) moderate-to-severe aortic regurgitation, (3) moderate-to-severe tricuspid regurgitation, (4) mean pulmonary artery pressure 70 mm Hg or more or right-to-left shunt, and (5) New York Heart Association (NYHA) functional class IV.Twenty-six patients (15 female, 11 male) with residual defects were enrolled. The age of the patients ranged from 6 to 56 years (mean 23 ± 16). They all had a history of surgical closure of PmVSD, and 4 patients had reoperation. Fifteen of the 26 patients had repair of tetralogy of Fallot, including 1 who had a repair of Cantrell five of Fallot, and reoperation was not possible. In the remaining 10 patients, 1 had repair of PmVSD and atrial septal defect, and 9 had repair of isolated PmVSD. One patient was in NYHA functional class III and had a history of type 2 diabetes mellitus. Sixteen patients had complete right bundle branch block. Trivial aortic regurgitation was present in 3 cases, trivial-to-mild tricuspid regurgitation was present in 5, and trivial-to-mild mitral regurgitation was present in 2. All patients had undergone surgery a median of 3 years (range, 3 months to 19 years) before the transcatheter procedure.
The closure device used in this study was a modified double-disk occluder (Shanghai Shape Memory Alloy, Shanghai, China), according to the Amplatzer occluder. It comprises a nitinol wire mesh and is shaped into two disks with a central connecting 2-mm to 3 mm-long waist, which is available in sizes ranging from 4 to 20 mm. There are two types of perimembranous occluders: symmetric and asymmetric. The diameter of the right disk is 4 mm larger than that of the connecting waist in both types. The only difference between the two types of occluders is the shape of the left disk. In the asymmetric occluder, the diameter of the left disk is 6 mm larger than that of the waist. The left disk extends toward the apex, and no superior rim extends toward the aortic cusps. In the symmetric occluder, the left disk is symmetric, and the diameter is 4 mm or 8 mm larger than that of the waist, named A2B2 and A4B2, respectively [2].
The catheterization procedure was performed under conscious sedation in adult patients and children older than 10 years, general anesthesia was used for children 10 years old or less. Heparin, 100 IU/kg, was administered during the procedure. Shunt volume was calculated by oxymetric measurements. Morphologic assessment of the PmVSD about location, size, shape, and relationship with the aortic and tricuspid valves was performed by TTE in all standard views, and left ventriculography was performed at a 45/25-degree left anterior oblique/cranial projection. The diameter of the residual defects was determined by TTE at the time of largest diastolic diameter on two-dimensional echocardiography. The diameter of PmVSD with aneurysm formation was determined according to the size of entry to the aneurysm. The waist size of the device was selected so that it was at least 2 mm larger than the implanted defect size. Implantation of the VSD occluder was performed according to standard techniques described in the literature [12, 13]. When an asymmetric device was used, the platinum marker on the left disk was kept toward the apex. When an aneurysm was found, the occluder was placed on the left ventricular side of the defect, but sometimes placed a little toward the right ventricle. The device was released only when its proper position was obtained and interference with the aortic and tricuspid valves had been excluded based on left ventriculography, aortic angiography, and TTE. When high-velocity residual blood flow was found on TTE after device deployment, a larger device was used.
After the procedure, all patients had an electrocardiogram (ECG) monitored for 24 hours and antibiotic prophylaxis for 5 days to prevent endocarditis. Urinalysis was routinely performed to exclude hemolysis. Patients without complications were discharged 1 week after the procedure, advised to avoid contact sports, and treated with oral aspirin (3 to 5 mg/kg once daily) for 6 months. All patients had chest radiography and TTE before discharge. The follow-up protocol included assessments after 1 month and 6 months, and once a year thereafter. All visits included a routine physical examination, as well as chest radiography (once at 6 months), ECG, and TTE.
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Results
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Table 1
summarizes the procedure data. A PmVSD with aneurysm formation was noted in 7 patients. Three of them had multiple fenestrations. If a defect was close to the aortic annulus with a subaortic rim of 2 mm or less, an asymmetric occluder was used. If a defect was more than 2 mm away from the aortic annulus, a symmetric occluder was selected. When an aneurysm was found with multiple fenestrations, we closed the entrances of the residual defects with one thin-waist occluder (A4B2) through the largest fenestration. Device placement was successful in 24 patients. In 2 patients, the procedure was aborted. One patient failed the attempt, and the device was retrieved because of significant device-related aortic regurgitation. Another patient was found to have a right aortic cusp perforation on aortic angiography; blood flow from the aorta entered the right ventricle through the defect before the procedure, so the aortic regurgitation was not detected by TTE. Two patients were transferred for surgery, and the second patient had surgical repair of the aortic leaflet at the same time. In 2 patients, the residual defect with aneurysm formation and multiple fenestrations was closed with only one occluder. Four patients were found to have two separate residual defects with no aneurysm formation during the procedure, and they each had two occluders implanted (Fig 1). One patient had an atrial septal defect closed at the same time.
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Table 1 Procedural Data and Device Used in Patients With Postoperative Residual Perimembranous Ventricular Septal Defect (n = 26)
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Fig 1. (A) Left ventriculography showing an 8-mm residual perimembranous ventricular septal defect with a subaortic rim of 2 mm or less. (B) Left ventriculography showing the 10-mm asymmetric occluder in good position before its release and a large residual shunt. Transthoracic echocardiography confirmed another 6-mm residual defect behind the septal leaflet. (C) Another 8-mm symmetric occluder was placed. Left ventriculography shows two occluders in good position with trivial residual shunt. (D) An aortic angiogram shows no device-related aortic regurgitation.
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No death, vascular complications, or pericardial tamponade occurred. Two patients had transient left anterior hemiblock, and another patient had a new-onset right bundle branch block during and after the procedure. They all recovered within the first week after the procedure. Complete atrioventricular block occurred in a 43-year-old man. He had previous surgery for tetralogy of Fallot and required reoperation for residual defect and mitral valve replacement. The residual defect was closed with a 5-mm symmetric occluder. Syncope developed, and he was found to have complete atrioventricular block 3 days after the procedure; he recovered 2 weeks later with intravenous corticoid therapy and a temporary pacemaker.
No direct residual defect was found on left ventriculography after the procedure. The remaining intraprosthetic shunt was mostly diffused. Total occlusion rate was 62% (15 of 24) at completion of the procedure, rising to 71% (17 of 24) at 1 week and to 96% (23 of 24) during the follow-up. Hemolysis occurred in 3 patients with mild intraprosthetic residual shunt within 12 hours of the procedure. They all presented with hemoglubinemia, hemoglubinuria, anemia, icterus, elevated lactate dehydrogenase, and elevated white blood cell counts. A 6-year-old girl with Cantrell five of Fallot had moderately severe hemolysis and dyspnea; the procedure lasted for 2.5 hours. She was treated with a blood transfusion, sodium bicarbonate, fluid replacement, and she recovered 4 weeks later. The other 2 patients with hemolysis had two occluders implanted. They both had mild-to-moderate hemolysis and were treated with sodium bicarbonate and fluid replacement. Hemolysis resolved spontaneously in these 2 patients over 4 days and 8 days, respectively. A trivial intraprosthetic residual shunt was present in another 6 subjects at the end of the procedure. At 1 week, 5 patients had a trivial residual shunt, and 2 patients had a mild residual shunt with hemolysis. None of the patients had aortic or mitral regurgitation, but new-onset trivial-to-mild tricuspid regurgitation occurred in 4 patients (trivial in 2 and mild in 2). Preoperative aortic, tricuspid, or mitral valve regurgitation remained unchanged after the procedure.
Follow-up data were available for all patients. The median duration of follow-up was 35 months (range, 6 to 80). The TTE showed trivial residual shunt in 3 patients at 1 month, and in 1 patient after 6 months with no symptoms. Patients with tricuspid regurgitation were clinically asymptomatic. The devices were in a stable position with optimal shapes. There were no late complications, such as thrombosis, heart block, clinical hemolysis, or infective endocarditis.
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Comment
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Residual defects are relatively uncommon after surgical closure of ventricular septal defect [5, 6]. They arise mainly from suture disruption, patch dehiscence, or incomplete closure of the defect [14]. Transcatheter device closure is an alternative strategy for management of postoperative residual defects. Previous studies have proved the feasibility of closing the residual defects with devices [9–11]. In this report, we describe our experience with transcatheter closure of postoperative residual PmVSDs in 26 patients using new, modified, double-disk occluders. The success rate of the procedure was 92% (24 of 26).
In contrast to previous reports, we have not closed any congenital muscular VSDs in the trabecular septum by transcatheter occlusion [15, 16], nor have we ever encountered a postoperative residual muscular VSD [9–11]. In our study, if the residual defect was more than 2 mm away from the aortic annulus, we chose a symmetric device to close the shunt. The advantage of symmetric devices is that there is no need to adjust the orientation of the device during the procedure. Although there is muscular septum at the shunt margin, it may not be as thick as the other parts of the muscular septum. As the waist length of the symmetric occluder is only 2 to 3 mm, the right ventricular disk of the occluder has little effect on the septal leaflet of the tricuspid valve, its chordae tendineae, or the right ventricular outflow tract. With enough distance between the aortic valve and the defect, there is a reduced risk of abnormal aortic valve function after device implantation.
The most common areas of residual defects are in the posteroinferior and superior margins of the patch [17, 18]. As we have shown that 10 of 25 residual defects were below and close to the aortic annulus, the asymmetric occluder is suitable for residual defects close to the aortic annulus. In previous studies, PmVSDs with subaortic rim less than 2 mm were not included for transcatheter therapy [3, 13]. The residual defects were usually in the form of an aneurysm or an infundibulum. The inlets are concave on the right side and are larger than the outlets. The asymmetric occluder has no projecting superior end, so its superior margin could be deployed toward the right side of the defects and has no effect on the function of the aortic valves. The apical side of the left disk is relatively large and is supported by the muscular septum, which prevents dislodgement of the device. Aortic regurgitation is one complication in transcatheter closure of PmVSD. The device was retrieved in 1 patient because of significant device-related aortic regurgitation, and the patient was transferred for surgery.
Hemolysis is another serious complication of transcatheter therapy. Usually, it is due to a high-velocity residual shunt after device closure. Three patients had hemolysis in our study. Two of them were implanted with two occluders. Left ventriculography was performed after device closure, and the remaining shunt was mostly diffused. Fibrous formation and an irregular margin of the postoperative residual shunt may facilitate the diffusion of any shunt remaining after device closure. Hemolysis was seldom found in previous reports with PmVSDs that were not repaired [1–3]. Among the 4 patients implanted with two occluders in our series, 2 had hemolysis. In patients with two postoperative residual defects, reoperation should be considered. A trivial low-velocity residual shunt is clinically insignificant and can close spontaneously.
The frequency of the complete heart block is reported to be approximately 3.5% with device closure of PmVSD [19]. In our study, 1 patient had transient complete heart block. The residual defect was close to the septal leaflet on TTE and left ventriculography. Various mechanisms have been suggested before [1]. New-onset trivial-to-mild tricuspid regurgitation occurred in 4 patients. The likely explanation for tricuspid regurgitation was some restriction of movement of the tricuspid valve by the right side of the disk occluder. When an aneurysm was found, we closed the entrances of the residual defects. This technique had little effect on tricuspid valve function. Tricuspid regurgitation was clinically insignificant during follow-up, and the long-term effect of these devices on tricuspid function needs to be evaluated.
Our study has some limitations. As we do not use transesophageal echocardiography, some residual defects could not be clearly visualized before device closure, especially in patients with two defects. The preliminary results of our study need to be confirmed in a larger trial with longer-term follow-up.
In conclusion, this study showed that transcatheter closure of postoperative residual PmVSD is possible with the benefit of avoiding reoperation. Both symmetric and asymmetric occluders were successfully placed with a few complications. Further studies will be required to evaluate the early and long-term safety and efficacy of transcatheter therapy for postoperative residual PmVSD.
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Acknowledgments
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The authors thank Mrs Aleya Sultana for her help in revision of the manuscript.
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Footnotes
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* These authors contributed equally to this study. 
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References
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Abstract
Introduction
