- Email: [email protected]
Echocardiographic Guided Closure of Perimembranous Ventricular Septal Defects
Echocardiographic Guided Closure of Perimembranous Ventricular Septal Defects Wen-Bin Ou-Yang, MD, Shou-Jun Li, MD, Shou-Zheng Wang, MD, Da-Wei Zhang, MM, Yao Liu, MD, Zhe Zhang, MD, Yi Ge, MM, and Xiang-Bin Pan, MD
CONGENITAL HEART
National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China
Background. Transesophageal echocardiogram-guided minimally invasive periventricular device closure of perimembranous ventricular septal defects (pmVSDs) without cardiopulmonary bypass is a treatment option for pmVSDs. We introduce our improvements to this technique and mid-term follow-up results. Methods. From May 2011 to May 2014, 187 patients with pmVSDs aged 6 months to 31 years (8.2 ± 10.2 years) were enrolled in this study. The procedure was performed through a new transthoracic approach of 1 to 2 cm without sternotomy. Device selection and the operative procedure were monitored by transesophageal echocardiogram. The patients underwent follow-up examinations of echocardiography and electrocardiogram at 1 month, 3 months, 6 months, and 1 year after the operation and annually thereafter. Results. The defects were closed successfully in 179 patients (95.7%), and in 8 patients the operation was converted to conventional surgical repair. Six patients (3.4%)
had an incomplete right bundle branch block. One patient experienced an intermittent complete atrioventricular block on the fourth day after the operation, and sinus rhythm was restored by corticosteroid therapy after 5 days. A trivial residual shunt was observed in 8 patients (4.5%) during the procedure. The average hospital stay was 3.1 ± 0.9 days. Follow-up in all patients ranged from 1 month to 36 months (median, 12.6 months), and aortic regurgitation, malignant arrhythmia, and device dislocation were not observed in any patients. However, 3 patients (1.7%) still had a trivial residual shunt at their last follow-up. Conclusions. Periventricular device closure through a modified transthoracic approach without sternotomy is a potentially safe and effective treatment option for pmVSDs. Controlled studies with long-term follow-up are necessary.
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closure using a newly designed surgical approach without sternotomy and to present our mid-term follow-up results.
erimembranous ventricular septal defects (pmVSDs) are one of the most common congenital cardiac malformations [1, 2]. Surgical closure is considered the gold standard treatment for pmVSDs, allowing direct repair. However, open-heart surgical repair requires cardiopulmonary bypass. Percutaneous closure conventionally performed under the guidance of fluoroscopy is a minimally invasive and effective intervention. Unfortunately, this technique is not widely used because of an unacceptably high rate of postprocedural and late-onset heart block [3, 4]. In recent years, transesophageal echocardiogram (TEE)-guided minimally invasive transthoracic periventricular device closure of pmVSDs without cardiopulmonary bypass has become a treatment option for pmVSDs in China and some European countries [5–7]. The purpose of this study was to introduce our improvements to transthoracic periventricular device
Accepted for publication May 8, 2015. Presented at the Poster Session of the Fifty-first Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 24–28, 2015. Address correspondence to Dr Xiang-Bin Pan, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, 167 Beilishi Rd, XiCheng District, Beijing 100037, China; e-mail: [email protected].
Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2015;100:1398–402) Ó 2015 by The Society of Thoracic Surgeons
Patients and Methods Patients Between May 2011 and May 2014, 187 patients with pmVSDs aged 6 months to 31 years (8.2 10.2 years) were enrolled for minimally invasive periventricular device closure guided by TEE at Fuwai Hospital, Beijing, China. This study protocol was approved by the Institutional Ethics Committee of Fuwai Hospital. Informed consent to perform the procedure and to use the patient’s clinical records for this study was obtained from patients or their legal guardian. The indications for pmVSD device closure were as follows: (1) age 6 months or greater and weight 4 kg or greater; (2) clinical manifestation: symptoms of heart failure, recurrent respiratory infection, developmental delay, or history of bacterial endocarditis; (3) transthoracic echocardiographic assessment; diameter of pmVSD is greater than 3 mm and less than 10 mm; direction of blood flow from left ventricle to right ventricle is located at the position of 10 to 12 o’clock on the short axis view of the aorta (Fig 1); no aortic valve prolapse; and 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.05.036
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no pathologic aortic regurgitation. The exclusion criteria were as follows: (1) predominant right-to-left shunt; (2) more than mild aortic regurgitation; and (3) active infective endocarditis. TEE was performed intraoperatively to confirm the size and adjacent structures of the pmVSDs and select a suitable type of occluder.
Devices and Delivery System The pmVSD occluder (Shanghai Shape Memory Alloy Co, Ltd, Huangpu, Shanghai, China) is a self-expandable, double-disk device that contains a 0.005-inch nitinol wire mesh and fabric. The waist diameter of the occluders ranges from 4 to 16 mm in 1-mm increments. The waist height of the occluders is 4 mm, and the occluders were modified from Amplatzer occluders which have a waist height of 1.5 mm. The following 2 types of occluders were used in this study: (1) symmetric occluder (Figs 2A1, 2A2), which is 2-mm larger than the defect in both the left and right ventricular disk and is used for pmVSDs with a distance of more than 2 mm from the aortic valve; and (2) asymmetric occluder (Figs 2B1, 2B2): its left ventricular disk is partially edgeless and 6 mm larger than the waist with a platinum marker at one end; its right ventricular disk is the same as the symmetric occluder; it is used for pmVSDs with a distance of less than 2 mm from the aortic valve. The entire delivery system includes a trocar, 0.035 inch guide wire, dilator and delivery sheath, and a loading sheath (Shanghai Shape Memory Alloy Co Ltd). The size of the delivery sheath (5 to 9 Fr) is chosen according to the size of the occluder. Thoracoscopic instruments, including a retractor and a knotter, were used to perform the procedures through a 1 to 2 cm surgical incision (Fig 2C).
Procedures Patients received general anesthesia with endotracheal intubation in a standard operating room. The TEE probe was inserted, and the procedure was performed under TEE guidance. The location, size, flow direction of the pmVSD, valvular regurgitation, and distance between the pmVSD and the aortic valve were measured intraoperatively by
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TEE. Antibiotics and heparin (80 IU/kg) were administered intravenously before the operation. A median thoracic skin incision of 1 to 2 cm was made. Then, the subcutaneous tissue was dissected to the left fourth parasternal intercostal space. The intercostal muscles were dissected to establish the surgical approach. The free wall of the right ventricle was exposed by opening and suspending the pericardium (Fig 3). A purse-string suture was placed on the right ventricular free wall directly facing the direction of the pmVSD shunt. The right ventricle was punctured within the purse-string suture with a trocar. A 0.035-inch guide wire was placed in the trocar. After the guide wire was passed through the pmVSD, the trocar was removed and the dilator and delivery sheath were advanced through the pmVSD to the left ventricle along the guide wire. The size of the occluder was 1 to 2 mm larger than the diameter of the pmVSD. After removing the guide wire and dilator sheath, the selected occluder was deployed through the delivery sheath under the guidance of TEE. The TEE was used to reassess the shape and position of the occluder, the presence of a residual shunt, and valvular regurgitation before and after occluder release (Figs 4A–4F). Finally, the delivery sheath was withdrawn, and the purse-string suture was tied using the knotter (Fig 2C). After completing the operation, the patient was sent to the intensive care unit where the endotracheal tube was removed. Echocardiography and electrocardiogram were performed after the operation.
Follow-Up All patients received aspirin (3 to 5 mg/kg body weight, orally) every day for 6 months after the procedure. The TTE and electrocardiography were performed at 1 month, 3 months, 6 months, and 1 year after discharge and annually thereafter.
Statistical Analyses All continuous variables are expressed as means standard deviation and ranges, and nominal variables are presented as frequencies and percentages. The SPSS 20.0 for Windows (SPSS Inc, Chicago, IL) was used for the statistical analysis.
Results The pmVSDs were successfully closed in 179 patients (95.7%), and for the other 8 patients the surgery was converted to conventional surgical closure due to the following indications; 3 patients with residual shunts more than 2-mm wide and 5 patients with new aortic regurgitation even with an asymmetric occluder. The procedure was performed through a modified incision of 1 to 2 cm (1.52 0.45 cm) without sternotomy in all patients who underwent occluder implantation. A pericardial drain was not placed in these patients, and no patients developed hydropericardium in the early postoperative period. The size of the pmVSDs ranged from 3 to 10 mm (5.31 2.86 mm). The implanted
CONGENITAL HEART
Fig 1. Ideograph of short axis view of aorta (transthoracic echocardiography). The direction of blood flow from left ventricle to right ventricle is located at the position of 10 to 12 o’clock (shaded area). (LA ¼ left atrium; PA ¼ pulmonary artery; RA ¼ right atrium; RVOT ¼ right ventricular outflow tract.)
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Fig 2. Device and thoracoscopic instruments used in the operation. (A1) Image and (A2) schematic diagram of symmetric occluder. (B1) Image and (B2) schematic diagram of asymmetric occluder. (C) Retractor (black arrow) and knotter (white arrow).
Fig 3. (A) Intraoperative image and (B) ideograph of the surgical approach. A median thoracic skin incision of 1 to 2 cm was made. Next, the subcutaneous tissue was dissected to the left fourth parasternal intercostal space. The intercostal muscles were dissected to establish the surgical approach. (Red solid line ¼ skin incision; red dashed line ¼ intercostal space approach.)
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occluders ranged from 4 to 12 mm (6.68 3.07 mm) and included symmetric devices (n ¼ 133) and asymmetric devices (n ¼ 46). No worsening regurgitation was observed in patients who had existing tricuspid regurgitation before surgery. A trivial residual shunt (less than 2 mm) was observed in 8 patients (4.5%) during the procedure. No hemolysis occurred in these patients after administration of corticosteroids. Six patients (3.4%) had an incomplete right bundle branch block. One patient experienced an intermittent complete atrioventricular block on the fourth day after the operation, and sinus rhythm was restored after a 5-day course of corticosteroid therapy. Most patients were discharged within 3 days after the operation. The average hospital stay was 3.1 0.9 days. There were no deaths during the hospital stay or follow-up period. Follow-up information was available for all 179 patients, and the follow-up period ranged from 1 to 36 months (12.6 10.4 months). No severe complications, such as aortic regurgitation, malignant arrhythmia, or device dislocation occurred. Eight patients had a trivial residual shunt immediately after the operation, and in 5 of those patients, it had disappeared at the 3-month follow-up visit. However, the other 3 patients still had a trivial residual shunt at their last follow-up (1 month, 3 months, and 3 months). No other patients were found to have a new residual shunt during the follow-up period.
Comment Minimally invasive transthoracic device closure is considered a safe and effective treatment for pmVSDs [5, 6, 8–12]. The procedure is performed through a lower partial median sternotomy incision or the third (or fourth)
left intercostal space [5, 11–13]. Compared with conventional surgical closure and percutaneous device closure of pmVSDs, the advantages of this procedure are obvious, including less surgical trauma, no radiation, expansion of the age and weight limitations for percutaneous VSD occlusion, and avoidance of cardiopulmonary bypass and blood transfusion. We improved this procedure for selected patients by designing a new transthoracic approach and shortening the incision by using thoracoscopic instruments. These changes maintained the advantages mentioned above and further reduced surgical trauma by avoiding sternotomy and pericardial drainage. No patients developed hydropericardium after the procedure or during the follow-up period. Moreover, when conversion to conventional surgical closure became necessary during the operation, this incision was able to be easily extended to perform full median sternotomy and avoided the need for 2 skin incisions, which is necessary when conventional intercostal incision is converted to full sternotomy. Complete atrioventricular block (CAVB) is the most serious complication of pmVSD device closure, with an incidence ranging from 0.6% to 20% [5, 6, 8, 9, 11, 13–19]. In the present study only 1 patient experienced intermittent CAVB; this occurred on the fourth day after the operation, and sinus rhythm was restored after 5 days of corticosteroid therapy. This suggests that the inflammation and tissue edema that develop around pmVSDs due to compression of the occluder might play an essential role in the occurrence of early postoperative CAVB. No patients had permanent CAVB during follow-up, possibly because of the use of modified occluders with greater waist height. We used occluders with a waist height of 4 mm and a waist diameter of 1 to 2 mm greater
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Fig 4. Transesophageal echocardiogram views of the procedures. (A) Doppler view of perimembranous ventricular septal defects (pmVSDs) (arrow). (B) The guide wire (arrow) was inserted through the pmVSD to the left ventricle (LV). (C) The delivery sheath (arrow) was inserted through the pmVSD. (D) The LV disk of the occluder (arrow) was deployed. (E) The occluder (arrow) was deployed under the four-chamber view. (F) Occluder (arrow) and aortic valve under the long axis view of the aorta. (AO ¼ aorta; LA ¼ left atrium; RA ¼ right atrium; RV ¼ right ventricle.)
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than the diameter of the pmVSD to decrease the compression of tissues around the pmVSD. Device-induced aortic regurgitation is another severe complication of pmVSD device closure [20]. In the present study, in 5 patients the surgery was converted to conventional surgical closure because new aortic regurgitation was identified even though asymmetric occluders were used, and the surgery was converted regardless of whether the regurgitation was trivial or mild. Residual shunt is an important issue because a large residual shunt may affect the stability of the occluder [5, 19]. If any shunt more than 2 mm was identified, the surgery should be converted to conventional surgical closure. Therefore, in the present study 3 patients were converted to conventional surgical closure intraoperatively. A trivial residual shunt was observed in 8 patients during the procedure and it completely closed in 5 patients within 3 months after the procedure. Therefore, only a trivial residual shunt after adjustment of the position and size of the occluder can be accepted.
Study Limitations In this study the follow-up period was not sufficiently long to rule out late erosions or late heart block in this study population. Thus, the short follow-up period is an important limitation of this study. In addition, this was a retrospective, single-center study. Other centers may find different results when this technology is applied. Finally, no patients in the study population were under 6 months of age, and sheath length and delivery system are limitations to the periventricular approach in some infants. Therefore, the findings of this study cannot be applied in infants younger than 6 months of age.
Conclusions Periventricular device closure through a modified transthoracic approach without sternotomy is a potentially safe and effective treatment option for pmVSDs. Controlled studies with long-term follow-up are necessary.
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5.
6. 7. 8.
9.
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11. 12. 13.
14.
15.
16.
This work was supported by the Beijing Science and Technology Nova Program and the Nova of Peking Union Medical College Program.
17.
References
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1. Minette MS, Sahn DJ. Ventricular septal defects. Circulation 2006;114:2190–7. 2. Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol 2002;39:1890–900. 3. Sullivan ID. Transcatheter closure of perimembranous ventricular septal defect: is the risk of heart block too high a price? Heart 2007;93:284–6. 4. Fu YC, Bass J, Amin Z, et al. Transcatheter closure of perimembranous ventricular septal defects using the new
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Amplatzer membranous VSD occluder. Results of the U.S. Phase I trial. J Am Coll Cardiol 2006;47:319–25. Xing Q, Wu Q, Shi L, Xing Y, Yu G. Minimally invasive transthoracic device closure of isolated ventricular septal defects without cardiopulmonary bypass: long-term followup results. J Thorac Cardiovasc Surg 2015;149:257–64. Schreiber C, Vogt M, K€ uhn A, et al. Periventricular closure of a perimembranous vSD: treatment option in selected patients. Thorac Cardiovasc Surg 2012;60:78–80. Gan C, An Q, Lin K, et al. Perventricular device closure of ventricular septal defects: six months results in 30 young children. Ann Thorac Surg 2008;86:142–6. Quansheng X, Silin P, Zhongyun Z, et al. Minimally invasive perventricular device closure of an isolated perimembranous ventricular septal defect with a newly designed delivery system: preliminary experience. J Thorac Cardiovasc Surg 2009;137:556–9. Carminati M, Butera G, Chessa M, Drago M, Negura D, Piazza L. Transcatheter closure of congenital ventricular septal defect with Amplatzer septal occluders. Am J Cardiol 2005;96:52L–8L. Pan S, Xing Q, Cao Q, et al. Perventricular device closure of doubly committed subarterial ventral septal defect through left anterior minithoracotomy on beating hearts. Ann Thorac Surg 2012;94:2070–5. Gao Z, Wu Q, Zhao T, et al. A minimally invasive technique for occluding large muscular ventricular septal defects in infants. Cardiology 2014;127:196–202. Yang XC, Liu DB. Minimally invasive perventricular device closure of ventricular septal defect: a comparative study in 80 patients. Chin Med Sci J 2014;29:98–102. Zhang GC, Chen Q, Chen LW, et al. Transthoracic echocardiographic guidance of minimally invasive perventricular device closure of perimembranous ventricular septal defect without cardiopulmonary bypass: initial experience. Eur Heart J Cardiovasc Imaging 2012;13:739–44. Thanopoulos BD, Tsaousis GS, Karanasios E, Eleftherakis NG, Paphitis C. Transcatheter closure of perimembranous ventricular septal defects with the Amplatzer asymmetric ventricular septal defect occluder: preliminary experience in children. Heart 2003;89:918–22. Pinto RJ, Dalvi BV, Sharma S. Transcatheter closure of perimembranous ventricular septal defects using amplatzer asymmetric ventricular septal defect occluder: preliminary experience with 18-month follow up. Catheter Cardiovasc Interv 2006;68:145–52. Xing Q, Pan S, An Q, et al. Minimally invasive perventricular device closure of perimembranous ventricular septal defect without cardiopulmonary bypass: multicenter experience and mid-term follow-up. J Thorac Cardiovasc Surg 2010;139: 1409–15. Xing Q, Wu Q, Pan S, Ren Y, Wan H. Transthoracic device closure of ventricular septal defects without cardiopulmonary bypass: experience in infants weighting less than 8 kg. Eur J Cardiothorac Surg 2011;40:591–7. Yang R, Sheng Y, Cao K, et al. Transcatheter closure of perimembranous ventricular septal defect in children: safety and efficiency with symmetric and asymmetric occluders. Catheter Cardiovasc Interv 2011;77:84–90. Chen ZY, Lin BR, Chen WH, et al. Percutaneous device occlusion and minimally invasive surgical repair for perimembranous ventricular septal defect. Ann Thorac Surg 2014;97:1400–6. Yin S, Zhu D, Lin K, An Q. Perventricular device closure of congenital ventricular septal defects. J Card Surg 2014;29: 390–400.
CONGENITAL HEART
National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China
Background. Transesophageal echocardiogram-guided minimally invasive periventricular device closure of perimembranous ventricular septal defects (pmVSDs) without cardiopulmonary bypass is a treatment option for pmVSDs. We introduce our improvements to this technique and mid-term follow-up results. Methods. From May 2011 to May 2014, 187 patients with pmVSDs aged 6 months to 31 years (8.2 ± 10.2 years) were enrolled in this study. The procedure was performed through a new transthoracic approach of 1 to 2 cm without sternotomy. Device selection and the operative procedure were monitored by transesophageal echocardiogram. The patients underwent follow-up examinations of echocardiography and electrocardiogram at 1 month, 3 months, 6 months, and 1 year after the operation and annually thereafter. Results. The defects were closed successfully in 179 patients (95.7%), and in 8 patients the operation was converted to conventional surgical repair. Six patients (3.4%)
had an incomplete right bundle branch block. One patient experienced an intermittent complete atrioventricular block on the fourth day after the operation, and sinus rhythm was restored by corticosteroid therapy after 5 days. A trivial residual shunt was observed in 8 patients (4.5%) during the procedure. The average hospital stay was 3.1 ± 0.9 days. Follow-up in all patients ranged from 1 month to 36 months (median, 12.6 months), and aortic regurgitation, malignant arrhythmia, and device dislocation were not observed in any patients. However, 3 patients (1.7%) still had a trivial residual shunt at their last follow-up. Conclusions. Periventricular device closure through a modified transthoracic approach without sternotomy is a potentially safe and effective treatment option for pmVSDs. Controlled studies with long-term follow-up are necessary.
P
closure using a newly designed surgical approach without sternotomy and to present our mid-term follow-up results.
erimembranous ventricular septal defects (pmVSDs) are one of the most common congenital cardiac malformations [1, 2]. Surgical closure is considered the gold standard treatment for pmVSDs, allowing direct repair. However, open-heart surgical repair requires cardiopulmonary bypass. Percutaneous closure conventionally performed under the guidance of fluoroscopy is a minimally invasive and effective intervention. Unfortunately, this technique is not widely used because of an unacceptably high rate of postprocedural and late-onset heart block [3, 4]. In recent years, transesophageal echocardiogram (TEE)-guided minimally invasive transthoracic periventricular device closure of pmVSDs without cardiopulmonary bypass has become a treatment option for pmVSDs in China and some European countries [5–7]. The purpose of this study was to introduce our improvements to transthoracic periventricular device
Accepted for publication May 8, 2015. Presented at the Poster Session of the Fifty-first Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 24–28, 2015. Address correspondence to Dr Xiang-Bin Pan, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, 167 Beilishi Rd, XiCheng District, Beijing 100037, China; e-mail: [email protected].
Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2015;100:1398–402) Ó 2015 by The Society of Thoracic Surgeons
Patients and Methods Patients Between May 2011 and May 2014, 187 patients with pmVSDs aged 6 months to 31 years (8.2 10.2 years) were enrolled for minimally invasive periventricular device closure guided by TEE at Fuwai Hospital, Beijing, China. This study protocol was approved by the Institutional Ethics Committee of Fuwai Hospital. Informed consent to perform the procedure and to use the patient’s clinical records for this study was obtained from patients or their legal guardian. The indications for pmVSD device closure were as follows: (1) age 6 months or greater and weight 4 kg or greater; (2) clinical manifestation: symptoms of heart failure, recurrent respiratory infection, developmental delay, or history of bacterial endocarditis; (3) transthoracic echocardiographic assessment; diameter of pmVSD is greater than 3 mm and less than 10 mm; direction of blood flow from left ventricle to right ventricle is located at the position of 10 to 12 o’clock on the short axis view of the aorta (Fig 1); no aortic valve prolapse; and 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.05.036
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no pathologic aortic regurgitation. The exclusion criteria were as follows: (1) predominant right-to-left shunt; (2) more than mild aortic regurgitation; and (3) active infective endocarditis. TEE was performed intraoperatively to confirm the size and adjacent structures of the pmVSDs and select a suitable type of occluder.
Devices and Delivery System The pmVSD occluder (Shanghai Shape Memory Alloy Co, Ltd, Huangpu, Shanghai, China) is a self-expandable, double-disk device that contains a 0.005-inch nitinol wire mesh and fabric. The waist diameter of the occluders ranges from 4 to 16 mm in 1-mm increments. The waist height of the occluders is 4 mm, and the occluders were modified from Amplatzer occluders which have a waist height of 1.5 mm. The following 2 types of occluders were used in this study: (1) symmetric occluder (Figs 2A1, 2A2), which is 2-mm larger than the defect in both the left and right ventricular disk and is used for pmVSDs with a distance of more than 2 mm from the aortic valve; and (2) asymmetric occluder (Figs 2B1, 2B2): its left ventricular disk is partially edgeless and 6 mm larger than the waist with a platinum marker at one end; its right ventricular disk is the same as the symmetric occluder; it is used for pmVSDs with a distance of less than 2 mm from the aortic valve. The entire delivery system includes a trocar, 0.035 inch guide wire, dilator and delivery sheath, and a loading sheath (Shanghai Shape Memory Alloy Co Ltd). The size of the delivery sheath (5 to 9 Fr) is chosen according to the size of the occluder. Thoracoscopic instruments, including a retractor and a knotter, were used to perform the procedures through a 1 to 2 cm surgical incision (Fig 2C).
Procedures Patients received general anesthesia with endotracheal intubation in a standard operating room. The TEE probe was inserted, and the procedure was performed under TEE guidance. The location, size, flow direction of the pmVSD, valvular regurgitation, and distance between the pmVSD and the aortic valve were measured intraoperatively by
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TEE. Antibiotics and heparin (80 IU/kg) were administered intravenously before the operation. A median thoracic skin incision of 1 to 2 cm was made. Then, the subcutaneous tissue was dissected to the left fourth parasternal intercostal space. The intercostal muscles were dissected to establish the surgical approach. The free wall of the right ventricle was exposed by opening and suspending the pericardium (Fig 3). A purse-string suture was placed on the right ventricular free wall directly facing the direction of the pmVSD shunt. The right ventricle was punctured within the purse-string suture with a trocar. A 0.035-inch guide wire was placed in the trocar. After the guide wire was passed through the pmVSD, the trocar was removed and the dilator and delivery sheath were advanced through the pmVSD to the left ventricle along the guide wire. The size of the occluder was 1 to 2 mm larger than the diameter of the pmVSD. After removing the guide wire and dilator sheath, the selected occluder was deployed through the delivery sheath under the guidance of TEE. The TEE was used to reassess the shape and position of the occluder, the presence of a residual shunt, and valvular regurgitation before and after occluder release (Figs 4A–4F). Finally, the delivery sheath was withdrawn, and the purse-string suture was tied using the knotter (Fig 2C). After completing the operation, the patient was sent to the intensive care unit where the endotracheal tube was removed. Echocardiography and electrocardiogram were performed after the operation.
Follow-Up All patients received aspirin (3 to 5 mg/kg body weight, orally) every day for 6 months after the procedure. The TTE and electrocardiography were performed at 1 month, 3 months, 6 months, and 1 year after discharge and annually thereafter.
Statistical Analyses All continuous variables are expressed as means standard deviation and ranges, and nominal variables are presented as frequencies and percentages. The SPSS 20.0 for Windows (SPSS Inc, Chicago, IL) was used for the statistical analysis.
Results The pmVSDs were successfully closed in 179 patients (95.7%), and for the other 8 patients the surgery was converted to conventional surgical closure due to the following indications; 3 patients with residual shunts more than 2-mm wide and 5 patients with new aortic regurgitation even with an asymmetric occluder. The procedure was performed through a modified incision of 1 to 2 cm (1.52 0.45 cm) without sternotomy in all patients who underwent occluder implantation. A pericardial drain was not placed in these patients, and no patients developed hydropericardium in the early postoperative period. The size of the pmVSDs ranged from 3 to 10 mm (5.31 2.86 mm). The implanted
CONGENITAL HEART
Fig 1. Ideograph of short axis view of aorta (transthoracic echocardiography). The direction of blood flow from left ventricle to right ventricle is located at the position of 10 to 12 o’clock (shaded area). (LA ¼ left atrium; PA ¼ pulmonary artery; RA ¼ right atrium; RVOT ¼ right ventricular outflow tract.)
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Fig 2. Device and thoracoscopic instruments used in the operation. (A1) Image and (A2) schematic diagram of symmetric occluder. (B1) Image and (B2) schematic diagram of asymmetric occluder. (C) Retractor (black arrow) and knotter (white arrow).
Fig 3. (A) Intraoperative image and (B) ideograph of the surgical approach. A median thoracic skin incision of 1 to 2 cm was made. Next, the subcutaneous tissue was dissected to the left fourth parasternal intercostal space. The intercostal muscles were dissected to establish the surgical approach. (Red solid line ¼ skin incision; red dashed line ¼ intercostal space approach.)
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occluders ranged from 4 to 12 mm (6.68 3.07 mm) and included symmetric devices (n ¼ 133) and asymmetric devices (n ¼ 46). No worsening regurgitation was observed in patients who had existing tricuspid regurgitation before surgery. A trivial residual shunt (less than 2 mm) was observed in 8 patients (4.5%) during the procedure. No hemolysis occurred in these patients after administration of corticosteroids. Six patients (3.4%) had an incomplete right bundle branch block. One patient experienced an intermittent complete atrioventricular block on the fourth day after the operation, and sinus rhythm was restored after a 5-day course of corticosteroid therapy. Most patients were discharged within 3 days after the operation. The average hospital stay was 3.1 0.9 days. There were no deaths during the hospital stay or follow-up period. Follow-up information was available for all 179 patients, and the follow-up period ranged from 1 to 36 months (12.6 10.4 months). No severe complications, such as aortic regurgitation, malignant arrhythmia, or device dislocation occurred. Eight patients had a trivial residual shunt immediately after the operation, and in 5 of those patients, it had disappeared at the 3-month follow-up visit. However, the other 3 patients still had a trivial residual shunt at their last follow-up (1 month, 3 months, and 3 months). No other patients were found to have a new residual shunt during the follow-up period.
Comment Minimally invasive transthoracic device closure is considered a safe and effective treatment for pmVSDs [5, 6, 8–12]. The procedure is performed through a lower partial median sternotomy incision or the third (or fourth)
left intercostal space [5, 11–13]. Compared with conventional surgical closure and percutaneous device closure of pmVSDs, the advantages of this procedure are obvious, including less surgical trauma, no radiation, expansion of the age and weight limitations for percutaneous VSD occlusion, and avoidance of cardiopulmonary bypass and blood transfusion. We improved this procedure for selected patients by designing a new transthoracic approach and shortening the incision by using thoracoscopic instruments. These changes maintained the advantages mentioned above and further reduced surgical trauma by avoiding sternotomy and pericardial drainage. No patients developed hydropericardium after the procedure or during the follow-up period. Moreover, when conversion to conventional surgical closure became necessary during the operation, this incision was able to be easily extended to perform full median sternotomy and avoided the need for 2 skin incisions, which is necessary when conventional intercostal incision is converted to full sternotomy. Complete atrioventricular block (CAVB) is the most serious complication of pmVSD device closure, with an incidence ranging from 0.6% to 20% [5, 6, 8, 9, 11, 13–19]. In the present study only 1 patient experienced intermittent CAVB; this occurred on the fourth day after the operation, and sinus rhythm was restored after 5 days of corticosteroid therapy. This suggests that the inflammation and tissue edema that develop around pmVSDs due to compression of the occluder might play an essential role in the occurrence of early postoperative CAVB. No patients had permanent CAVB during follow-up, possibly because of the use of modified occluders with greater waist height. We used occluders with a waist height of 4 mm and a waist diameter of 1 to 2 mm greater
CONGENITAL HEART
Fig 4. Transesophageal echocardiogram views of the procedures. (A) Doppler view of perimembranous ventricular septal defects (pmVSDs) (arrow). (B) The guide wire (arrow) was inserted through the pmVSD to the left ventricle (LV). (C) The delivery sheath (arrow) was inserted through the pmVSD. (D) The LV disk of the occluder (arrow) was deployed. (E) The occluder (arrow) was deployed under the four-chamber view. (F) Occluder (arrow) and aortic valve under the long axis view of the aorta. (AO ¼ aorta; LA ¼ left atrium; RA ¼ right atrium; RV ¼ right ventricle.)
CONGENITAL HEART
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OU-YANG ET AL ECHOCARDIOGRAPHIC GUIDED CLOSURE OF PMVSD
than the diameter of the pmVSD to decrease the compression of tissues around the pmVSD. Device-induced aortic regurgitation is another severe complication of pmVSD device closure [20]. In the present study, in 5 patients the surgery was converted to conventional surgical closure because new aortic regurgitation was identified even though asymmetric occluders were used, and the surgery was converted regardless of whether the regurgitation was trivial or mild. Residual shunt is an important issue because a large residual shunt may affect the stability of the occluder [5, 19]. If any shunt more than 2 mm was identified, the surgery should be converted to conventional surgical closure. Therefore, in the present study 3 patients were converted to conventional surgical closure intraoperatively. A trivial residual shunt was observed in 8 patients during the procedure and it completely closed in 5 patients within 3 months after the procedure. Therefore, only a trivial residual shunt after adjustment of the position and size of the occluder can be accepted.
Study Limitations In this study the follow-up period was not sufficiently long to rule out late erosions or late heart block in this study population. Thus, the short follow-up period is an important limitation of this study. In addition, this was a retrospective, single-center study. Other centers may find different results when this technology is applied. Finally, no patients in the study population were under 6 months of age, and sheath length and delivery system are limitations to the periventricular approach in some infants. Therefore, the findings of this study cannot be applied in infants younger than 6 months of age.
Conclusions Periventricular device closure through a modified transthoracic approach without sternotomy is a potentially safe and effective treatment option for pmVSDs. Controlled studies with long-term follow-up are necessary.
Ann Thorac Surg 2015;100:1398–402
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This work was supported by the Beijing Science and Technology Nova Program and the Nova of Peking Union Medical College Program.
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