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Transcatheter Closure of Perimembranous and Intracristal Ventricular Septal Defects Using Amplatzer Duct Occluder II in Children

Transcatheter Closure of Perimembranous and Intracristal Ventricular Septal Defects Using... Hindawi Journal of Interventional Cardiology Volume 2021, Article ID 4091888, 9 pages https://doi.org/10.1155/2021/4091888 Research Article Transcatheter Closure of Perimembranous and Intracristal Ventricular Septal Defects Using Amplatzer Duct Occluder II in Children 1 2 1 1 1 Shenrong Liu , Wenqian Zhang , Junjie Li , Shushui Wang , Mingyang Qian , 1 1 1 Jijun Shi , Yumei Xie , and Zhiwei Zhang Department of Cardiac Pediatrics, Guangdong Cardiovascular Institute, Guangdong Academy of Medical Sciences, Guangdong Provincial People’s Hospital, Guangzhou 510080, China Department of Cardiovascular Surgery, Guangdong Provincial Hospital of Chinese Medicine, &e Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong, China Correspondence should be addressed to Zhiwei Zhang; drzhangzw@sohu.com Received 15 April 2021; Revised 1 August 2021; Accepted 24 August 2021; Published 13 September 2021 Academic Editor: Toshiko Nakai Copyright © 2021 Shenrong Liu et al. *is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Transcatheter closure of aneurysmal perimembranous ventricular septal defect (pmVSD), pmVSD near the aortic valve, and intracristal VSD (icVSD) with symmetrical or asymmetrical ventricular septal defect occluders still presents significant challenges. We report our experience with transcatheter closure of pmVSD and icVSD using Amplatzer duct occluder II (ADO II) in children. Method. We retrospectively analyzed all children, who presented to our hospital consecutively between March 2014 and June 2020 for attempted transcatheter closure of pmVSD or icVSD with the ADO II device. Standard safety and last-follow-up outcomes were assessed and compared. Results. In total, 41 patients underwent transcatheter closure of VSD with the ADO II (28 in pmVSD and 13 in icVSD groups) with a median age of 3.5 years (total range: 0.9 to 12 years) and median weight of 15.0 kg (total range: 10.0 to 43.0 kg). Implantation was successful in 40/41 patients (97.5%, 27/28 in pmVSD group, 13/13 in icVSD group). One patient with mild aortic valve prolapse in pmVSD group developed new-onset moderate aortic regurgitation after a 4/4 mm ADO II was deployed; however, this resolved after the device was retrieved and successfully replaced with a 5 mm zero eccentric VSD occluder. *ere was no procedure-related mortality. After a median follow-up of six months (total range: 6 to 72 months), complete closure rates were 85.1% and 76.9% among pmVSD and icVSD groups, respectively. In the pmVSD group, one case of new-onset moderate tricuspid regurgitation was observed at six months, and there was one case of severe tricuspid regurgitation that had progressed from mild tricuspid regurgitation at 12 months. No serious complications were noted in the icVSD group. Conclusion. ADO II provides a safe and reproducible alternative for the closure of perimembranous and intracristal ventricular septal defects with a diameter less than 5 mm in young children. associated with aneurysmal tissue or in close proximity to 1. Introduction the aortic and tricuspid valves still presents significant Perimembranous VSD (pmVSD) accounts for 70% of challenges [5]. VSDs, by far the most common form of congenital heart Intracristal VSD (icVSD) accounts for 5–29% of VSDs disease [1]. Since the first report of transcatheter VSD and was previously considered unsuitable for transcatheter closure in 1988 [2], along with the development of closure closure because of their proximity to the aortic and pul- device (either symmetrical or asymmetrical double disc monary valves [6]. Zero eccentric occluders have been used design), transcatheter closure of pmVSD has become an to close icVSD, achieving a successful closure rate of >90% accepted alternative to open heart surgery in selected cases [7].However, the incidence of aortic regurgitation requiring [3, 4]. However, transcatheter closure of pmVSD surgical repair remains relatively high [7]. 2 Journal of Interventional Cardiology 2.1. Device and Selection Protocol. *e ADO II is a self- Various devices have been used to minimize procedural risks and tackle complicated cases associated with VSD closure expanding fabric-free nitinol occluder consisting of dual symmetrical retention and flexible discs connected by a central [8–10]. For example, the KONAR-MF VSD occluder (LifeTech, Shenzhen, China) is designed to provide high waist. *e occluders are available in two lengths (4 and 6 mm) conformability to septal defects with a lower risk of heart block and four waist diameters (3, 4, 5, and 6 mm). *e retention and valvular interferences [8]. Patent ductus arteriosus discs have a diameter 6 mm greater than the waist size. occluders have also been used in pmVSD with the anatomic For icVSD and pmVSD without a membranous aneu- resemblance to a PDA [9]. However, the ADO II (Abbott, rysm, the waist diameter selected was 1 to 2 mm larger than USA) device is far softer than previous devices, as it has no the VSD defect size in the case of sufficient SAR or 1 mm polyester fabric and can be easily delivered via an antegrade or (±0.5 mm) larger for deficient SAR. For VSD associated with retrograde approach through a 4 F or 5 F delivery catheters a membranous aneurysm, implantation of the ADO II was considered in selected cases with suitable anatomic con- [11, 12]. Herein, we report our experience with transcatheter closure of pmVSD and icVSD using the ADO II in children. figurations as illustrated in Figures 1(a)–1(d). In these cases, the disk diameter selected covered the entire entry, specif- ically 1 to 2 mm larger than the LV entry diameter for a 2. Methods sufficient SAR or equal to the LV entry diameter for a de- Forty-one children, who underwent transcatheter closure of ficient SAR. A larger waist size was selected if sufficient SAR pmVSD and icVSD using the ADO II in Guangdong Pro- since elongation of the device through a relatively long duct vincial People’s Hospital (Guangzhou, China) between decreases the effective diameter of the central waist. *e March 2014 and June 2020, were enrolled in this study. All device length (4 or 6 mm) was selected based on VSD depth participants had isolated ventricular septal defect with a as measured on angiography. diameter< 5 mm. Most fulfilled at least one of the following For pmVSD and icVSD associated with AVP, the defect size is often underestimated on TTE. *erefore, the effective the criteria: recurrent respiratory infections, failure to thrive, or significant hemodynamic compromise (including signs of LV entry diameter should be measured based on multiple TTE views. Furthermore, we considered the larger of the jet left ventricular enlargement on electrocardiography (ECG), cardiomegaly on chest X-ray, or echocardiographic left atrial width measured on angiography or TTE images to aid in and/or left ventricular enlargement). *e exclusion criteria selecting a device waist size. *e waist diameter selected was were as follows: moderate-to-severe pulmonary hyperten- 1 mm (±0.5 mm) larger than this measurement. *e device sion, combined with other congenital heart defects requiring length selected was generally 4 mm. surgery, active local/systemic bacterial infections, VSD larger than 5 mm, body weight< 10 kg, and moderate-to- 2.2. Procedure. *e procedure has been described in detail in severe aortic regurgitation (AR). previous publications. Briefly, standard right and left cardiac All patients underwent comprehensive periprocedural catheterization and left ventriculography and aortography (left transthoracic echocardiography (TTE). pmVSD and icVSD ° ° anterior oblique 60 /cranial 20 projection for pmVSD and left were defined as defects located at 9–12 o’clock and 12–1:30 ° ° ° anterior oblique 70 –80 /cranial 20 for icVSD) were per- positions, respectively, in the short axis parasternal view formed in all cases. Two methods of device deployment were [13]. *e subaortic rim (SAR) was measured from the upper employed. *e conventional technique involves an antegrade margin of the defect to the aortic valve in the five-chamber approach, with the formation of an arteriovenous loop, and view and parasternal long axis view. AR was classified as initial deployment of the LV disc followed by RV disc. In the trivial (jet width/LVOT diameter< 10%), mild (jet width/ retrograde method, the delivery system is advanced over a long LVOT diameter � 10%–24%), moderate (jet width/LVOT exchangeable wire through femoral artery without creating an diameter � 25%–49%), or severe (jet width/LVOT diame- arteriovenous loop, followed by the initial deployment of the ter> 50%). Tricuspid regurgitation (TR) was classified as RV disc and the LV disc thereafter. We prefer a tangential trivial (within 1 cm of the valve), mild (regurgitant jet area ° ° fluoroscopic projection (left anterior oblique 40 /cranial 20 ) (RJA)/right atrial area (RAA)< 19%), moderate (RJA/ when releasing the device, as this provides a clear view of the RAA � 20%–40%), or severe (RJA/RAA> 41%) [14]. Re- relationship between the device and the ventricular septum. As sidual shunt was assessed by the width of the color jet at the the disc conforms to ventricular septum, it orients itself point of exit through the ventricular septum and classified as horizontally, and its position becomes relatively fixed. Sub- trivial (<1 mm color jet width), mild (1-2 mm color jet sequently, the waist and proximal disc can be released. In some width), moderate (2-3 mm color jet width), or severe cases, when appropriate disc conformance with ventricular (>3 mm color jet width) [15]. septum cannot be confirmed, TTE is useful to verify the lo- Aortic valve prolapse (AVP) was graded into three degrees cation and monitor whether the neighboring valve is affected. according to the morphology of the right coronary leaflet at the end of diastole during angiography: mild (buckling of the aortic cusp down the left ventricular outflow tract with minimal 2.3. Follow-Up. Patients without complications were dis- herniation into the VSD), moderate (prolapse of the cusp and charged 24 hours after the procedure. All patients under- its sinus with obvious herniation into the VSD), and severe went chest radiography, electrocardiography, and TTE (prolapse of the cusp and its sinus through the defect into the before discharge. Oral aspirin (5 mg/kg daily) was prescribed right ventricular outflow tract) [16, 17]. for 6 months. Follow-up visits were scheduled at 1, 3, and 6 Journal of Interventional Cardiology 3 (a) (b) (c) (d) Figure 1: Transthoracic echocardiography (TTE) and angiographic findings considered suitable for ADO II implantation: (a) tubular aneurysm, (b) aneurysm with two constrictions, (c) aneurysm with an elongated conical appearance, and (d) aneurysm with multiple small exits. months and annually thereafter. All visits included a routine estimated using Kaplan–Meier analyses, and event-free physical examination, electrocardiography, and TTE. Seri- survival curves were compared using the log-rank test. All ous complications relating to the procedure or device in- analyses were performed using R 3.6.2 software. cluded (1) death, (2) Mobitz II atrioventricular block or complete atrioventricular heart block (CAVB), (3) new onset 3. Results of more than moderate aortic regurgitation or tricuspid General procedural and follow-up characteristics of the 41 regurgitation, (4) tricuspid stenosis, (5) neurovascular events, (6) cardiac erosion, and (7) hemolysis. patients are summarized in Table 1. *e baseline charac- teristics of the study population were not significantly dif- ferent between pmVSD and icVSD. Implantation was 2.4. Statistical Analysis. Continuous variables are expressed successful in 40/41 patients (97.5%, 27/28 in pmVSD group, as median (range) and categorical variables as percentages 13/13 in icVSD group). One patient with mild aortic valve and numbers of patients. Cumulative event-free survival was prolapse in pmVSD group developed new-onset moderate 4 Journal of Interventional Cardiology Table 1: Baseline and procedural characteristics of the study sample. (All) pmVSD group icVSD group P value N � 41 N � 28 N � 13 Age (years) 3.5 [0.9–12.0] 3.6 [1.8–12.0] 3.3 [0.9–12.0] 0.933 Gender Male 22 (53.7%) 15 (53.6%) 7 (53.8%) 0.987 Female 19 (46.3%) 13 (46.4%) 6 (46.2%) Weight (kg) 15.0 [10.0–43.0] 15.2 [11.0–29.5] 15.0 [10.0–43.0] 0.674 Height (cm) 98.0 [73.0–152.0] 97.5 [80.0–141.0] 98.0 [73.0–152.0] 0.758 Aortic regurgitation None 35 (85.3%) 23 (82.1%) 12 (92.3%) 0.391 Trivial 6 (14.7%) 5 (17.9%) 1 (7.7%) Tricuspid regurgitation None 30 (73.2%) 21 (75.0%) 9 (69.2%) 0.698 Mild 11 (26.8%) 7 (25.0%) 4 (30.8%) AVP None 8 (19.5%) 9 (32.1%) 0 (0.00%) 0.031 Mild 30 (73.2%) 16 (57.1%) 13 (100%) Severe 3 (7.3%) 3 (10.7%) 0 (0.00%) SAR ≤2 (mm) 31 (75.6%) 19 (67.9%) 12 (92.3%) 0.090 >2 (mm) 10 (24.4%) 9 (32.1%) 1 (7.69%) Systolic PAP (mmHg) 28.0 [14.0–38.0] 28.0 [14.0–38.0] 28.0 [20.0–37.0] 0.683 Diastolic PAP (mmHg) 10.0 [3.0–17.0] 10.0 [3.0–16.0] 10.0 [4.0–17.0] 0.810 Mean PAP (mmHg) 16.0 [6.0–22.0] 16.0 [6.0–22.0] 16.0 [10.0–22.0] 0.725 Qp/Qs 1.36 [1.1–2.0] 1.33 [1.1–2.0] 1.47 [1.1–1.9] 0.518 Vascular approach Antegrade 33 (80.5%) 21 (75.0%) 12 (92.3%) 0.193 Retrograde 8 (19.5%) 7 (25.0%) 1 (7.69%) Procedure time (min) 64.0 [55.0–78.0] 63.5 [55.0–77.0] 67.0 [64.0–79.0] 0.501 Immediate RS None 24 (60.0%) 15 (55.6%) 9 (69.2%) Trivial 4 (10.0%) 2 (7.41%) 2 (15.4%) 0.605 Mild 8 (20.0%) 7 (25.9%) 1 (7.69%) Moderate 4 (10.0%) 3 (11.1%) 1 (7.69%) RS at the latest follow-up None 33 (82.5%) 23 (85.2%) 10 (76.9%) Trivial 2 (5.00%) 0 (0.00%) 2 (15.4%) 0.215 Mild 4 (10.0%) 3 (11.1%) 1 (7.69%) Moderate 1 (2.50%) 1 (3.70%) 0 (0.00%) VSD: ventricular septal defect; pmVSD: perimembranous VSD; icVSD: intracristal VSD; AVP: aortic valve prolapse; SAR: subaortic rim; PAP: pulmonary arterial pressure; Q /Q : pulmonary to systemic blood flow; RS: residual shunt. p s aortic regurgitation after a 4/4 mm ADO II was deployed; 7 patients with mild preoperative TR, TR disappeared in 2, however, this resolved after the device was retrieved and remained unchanged in 4, and progressed to moderate TR in successfully replaced with a 5 mm zero eccentric VSD 1 patient after the procedure. New-onset mild TR was ob- occluder. *e antegrade approach was used in 33 patients (12 served in 6 patients. In the icVSD group, 1 patient presented in icVSD group) and the retrograde approach in 8 patients (1 with trivial preoperative AR that remained unchanged after the procedure. New-onset trivial AR was observed in 1 in icVSD group). A retrograde approach was selected in 3 patients due to technical difficulties and 1 patient due to a patient with preoperative mild AVP. New-onset mild TR femoral venous malformation. For the remaining 4 patients, was observed in 1 patient. a retrograde approach was planned ahead of the procedure. Follow-up data were available for all patients. *e me- In 1 patient, a retrograde approach resulted in device in- dian follow-up for the participants was six months (total terference with the aortic valve resulting in moderate AR. On range: 6 to 72 months). Figure 2 shows the progression of subsequent switching to an anterograde approach, the AR new-onset complications on follow-up. One patient in disappeared. pmVSD group with preexisting tricuspid regurgitation In the pmVSD group, 5 patients with mild AVP had progressed to severe tricuspid regurgitation at the one-year follow-up. He was asymptomatic and continued to undergo trivial preoperative AR, among which the AR resolved postoperatively in 4 patients and remained unchanged in 1 close follow-up. One patient in the pmVSD group developed moderate tricuspid regurgitation at the 6-month follow-up. patient after the procedure. New-onset trivial AR was ob- served in 4 patients with preoperative mild AVP. Among the She was asymptomatic and her right atrium appeared Journal of Interventional Cardiology 5 24hours 12 6 41 1month 11 7 31 3months 86 21 6months 56 32 Latest 47 31 1 0 5 10 15 20 pmVSD (Number of cases) Complications Severe Tricuspid Regurgitation Mild Tricuspid Regurgitation Moderate Tricuspid Regurgitation Residual Shunt Trivial Aortic Regurgitation 24hours 41 1 1month 41 3 3months 42 2 6months 32 2 Latest 32 2 0 2 4 6 8 icVSD (Number of cases) Complications Trivial Aortic Regurgitation Mild Tricuspid Regurgitation Residual Shunt Figure 2: Progression of new-onset complications on follow-up. normal on TTE. No deaths, AV block, moderate or worse significant differences in the probability of complications aortic regurgitation, tricuspid stenosis, neurovascular between pmVSD and icVSD groups (P � 0.37, log-rank events, cardiac erosion, or hemolysis occurred during the test). No surgical or percutaneous reintervention was follow-up. Kaplan-Meier analyses (Figure 3) revealed no scheduled on this period of follow-up. 6 Journal of Interventional Cardiology 1.00 0.75 0.50 0.25 p = 0.37 0.00 0 20 40 60 80 Time (months) Number at risk pmVSD 27 4 2 1 0 icVSD 13 1 1 1 0 0 20 40 60 80 Time (months) pmVSD icVSD Figure 3: Kaplan–Meier curve depicting freedom from complications across follow-up. In our experience, implantation of ADO II in cases with 4. Discussion severe AVP (n � 3) did not result in AR after the im- *is study demonstrates that transcatheter closure of plantation (Figure 4(a)). ADO II was also found to be pmVSD and icVSD less than 5 mm in diameter with the suitable for closure of pmVSD associated with a mem- ADO II device is feasible and safe in children. *is is also branous aneurysm in selected cases with amenable mor- true for pmVSDs with a subaortic rim≤ 2 mm or aortic valve phologies. *ese morphologies are illustrated in prolapse. Figures 1(a)–1(d). Generally, aneurysms with a small exit on the right side can be closed with the ADO II. In such cases, we recommend a retrograde approach because the 4.1. Benefits of Utilizing ADO II in pmVSD. pmVSD close to delivery sheath is usually difficult to advance through an the aortic valve (≤2 mm) commonly leads to aortic valve antegrade approach. prolapse and subsequent aortic regurgitation because of the Venturi effect [18]. Typically, conventional symmetrical device implantation may worsen preexisting AR or result in 4.2. Benefits of Utilizing ADO II in icVSD. icVSD is located new-onset AR. close to the aortic valve and is usually associated with aortic We found that the ADO II is safe to implant in patients valve prolapse. With such defects, closure with the soft ADO with a relatively deficient aortic rim (up to 2 mm). As the II may be beneficial as it does not interfere with aortic valve upper rim of the ADO II is 3 mm larger than the waist, a function (Figure 4). subaortic rim> 3 mm would generally be required to avoid Other devices have also been used for the closure of aortic regurgitation [19]. However, we found that absent icVSD. Qin et al. reported the zero eccentric VSD occluder SAR or even more the presence of an AVP were not limi- can also be used to close icVSD with a successful closure rate tation factors. *is is possibly because the soft structure of of >90%. However, 2/38 patients developed AR, requiring the device allows it to move freely with the aortic valve leaflet surgical repair [3, 7]. In contrast, using the ADO II device for without disrupting the aortic valve motility when deployed similar defects, we did not observe any AR requiring surgical in a VSD with a deficient aortic rim. repair. Journal of Interventional Cardiology 7 (a) (b) Figure 4: (a) Ventricular septal defect with severe aortic valve prolapse. *e right coronary cusp prolapses into the right ventricular outflow tract (left, center). A 5/4 mm Amplatzer duct occluder II was successfully implanted without aortic regurgitation as shown by the an- giography (right). (b) Intracristal ventricular septal defect. Transthoracic echocardiography (left) shows the defect is close to aortic valve. ° ° Left ventricular angiography at 70 left anterior oblique and 20 cranial projection was performed to visualize the defect (center). A 5/4 mm Amplatzer duct occluder II completely closed the defect completely without residual shunt or interfering with the aortic valve (right). Furthermore, Qin et al. observed considerably longer entrapment within the chordal elements of the tricuspid procedural and fluoroscopic times with the zero eccentric valve and inability to advance the delivery sheath due to VSD occluder. Multiple procedure related issues may angulation of the path or a small defect; (2) bilateral femoral contribute to increased fluoroscopic time [20]. First, as the venous malformations. However, with accumulating expe- occluder is asymmetrical, it must be maneuvered back and rience, we have found that the retrograde approach involves forth to ensure the platinum marker on the left disk is fewer steps and reduces procedural costs (a snare set that positioned toward the apex. Additionally, the delivery costs more than 3000 yuan if not used). With this in mind, sheath of the zero eccentricity VSD occluder is thicker (4- we recommend that the retrograde approach can be planned ahead of the procedure in select cases such as VSD with small 5 Fr versus 6–8 Fr.) and therefore less flexible than the ADO II. *erefore, it is difficult to maneuver into the left exit. ventricle [21]. Overall, our observations suggest that the ADO II 4.4. Residual Shunts. Residual shunts were common in the occluder is safer, easier to implant, and may require less immediate postoperative period. In the pmVSD group, fluoroscopic and procedural time than the zero eccentric complete closure was achieved in 55.5% at 24 hours and VSD occluder system, particularly when delivered retro- 85.2% at the latest follow-up, respectively. In the icVSD gradely avoiding the A-V circuit formation. However, fur- group, complete closure was achieved in 69.2% at 24 hours ther research comparing the two devices is required to and 76.9% at the latest follow-up, respectively. However, confirm these speculations. these residual shunts were not hemodynamically significant as the heart murmur disappeared or decreased in intensity 4.3. Antegrade versus Retrograde Approach. In most cases, (grade 1–2/6) in all children. Further, no hemolysis or endocarditis was observed in our sample. the procedure was performed using the antegrade method in our study. *is technique creates a stable line through which Other studies utilizing the ADO II for VSD occlusion the delivery system can be advanced via venous access and also observed a similar trend. For instance, Wang et al. avoids the risk of arterial injury in young children. In ad- reported 32/45 (71.1%) trivial-to-mild residual shunts im- dition, the antegrade technique allows better control on the mediately after transcatheter closure of outlet-type VSDs aortic disc positioning, and therefore, it, theoretically, with the ADO II device, which gradually reduced to 19/45 should be the preferred technique for patients with deficient (42.2%) at the latest follow-up (range: 0.3–51.1 months) [22]. aortic rim and/or in VSD with AVP. Lyu et al. reported 10/51 (19.6%) instances of trivial residual Initially, we reserved the retrograde approach for the shunts after transcatheter closure of perimembranous VSD using ADO II and a 100% complete closure rate by the six- following situations: (1) venous closure could not be per- formed due to technical difficulties, including guidewire month follow-up [23]. 8 Journal of Interventional Cardiology We suspect that the high incidence of early shunts can be Acknowledgments attributed to the soft fabric-free design of the ADO II. *is study was supported by the Guangdong Provincial However, eventual thrombosis and occluder endotheliali- Clinical Research Center for Cardiovascular Disease zation may contribute toward residual shunt resolution [24]. (2020B1111170011) and Shenzhen Sanming Medical Project Given the high rate of resolution for early shunts associated of China (grant no. SZSM201612057). with ADO II implantation, a higher level of early shunting is acceptable during implantation. In our experience, ob- serving a reduction or resolution of the heart murmur and References confirming stable device position and optimal conformation on fluoroscopic imaging are sufficient to release the device, [1] D. E. Spicer, H. H. Hsu, J. Co-Vu, R. H. Anderson, and even if residual shunts are visible on TTE. However, some F. J. Fricker, “Ventricular septal defect,” Orphanet Journal of Rare Diseases, vol. 9, no. 1, p. 144, 2014. residual shunts may persist. *is may be due to device-defect [2] N. D. Bridges, S. B. Perry, J. F. Keane et al., “Preoperative mismatch or a failure to close the LV entry. In our sample, 7 transcatheter closure of congenital muscular ventricular septal cases had residual shunts on the latest follow-up. 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Bertram et al., “Interventional VSD- Data Availability closure with the nit-occlud lˆe VSD-coil in 110 patients: early and midterm results of the EUREVECO-registry,” Pediatric *e data used to support the findings of this study are Cardiology, vol. 38, no. 2, pp. 215–227, 2017. available from the corresponding author upon request. [11] K. Wongwaitaweewong, W. Promphan, S. Roymanee, and P. Prachasilchai, “Effect of transcatheter closure by Amplatzer (TM) Duct Occluder II in patients with small ventricular Conflicts of Interest septal defect,” Cardiovascular Intervention and &erapeutics, vol. 36, no. 3, pp. 375–383, 2020. *e authors declare no conflicts of interest. [12] R. N. Haddad, L. Daou, and Z. Saliba, “Device closure of perimembranous ventricular septal defect: choosing between amplatzer occluders,” Frontiers in Pediatrics, vol. 7, p. 300, Authors’ Contributions Shenrong Liu and Wenqian Zhang contributed equally to [13] D. Zhou, W. Pan, L. Guan, and J. 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Liu et al., “Safety and efficacy of transcatheter occlusion of perimembranous ventricular septal defect with aortic valve prolapse: a six-year follow-up study,” Journal of Interventional Cardiology, vol. 2021, Article ID 6634667, , 2021. [18] G.-L. Chen, H.-T. Li, H.-R. Li, and Z.-W. Zhang, “Trans- catheter closure of ventricular septal defect in patients with aortic valve prolapse and mild aortic regurgitation: feasibility and preliminary outcome,” Asian Pacific Journal of Tropical Medicine, vol. 8, no. 4, pp. 315–318, 2015. [19] M. Kanaan, P. Ewert, F. Berger, S. Assa, and S. Schubert, “Follow-up of patients with interventional closure of ven- tricular septal defects with Amplatzer Duct Occluder II,” Pediatric Cardiology, vol. 36, no. 2, pp. 379–385, 2015. [20] R. N. Haddad, C. Rizk, Z. Saliba, and J. Farah, “Percutaneous closure of ventricular septal defects in children: key param- eters affecting patient radiation exposure,” American journal of cardiovascular disease, vol. 11, no. 1, pp. 65–72, 2021. [21] M. Gu, X. You, X. Zhao, X. Zheng, and Y.-W. Qin, “Trans- catheter device closure of intracristal ventricular septal de- fects,” &e American Journal of Cardiology, vol. 107, no. 1, pp. 110–113, 2011. [22] H.-C. Lin, M.-T. Lin, C.-A. Chen et al., “Safety and efficacy of transcatheter closure of outlet-type ventricular septal defects in children and adults with Amplatzer Duct Occluder II,” Journal of the Formosan Medical Association, vol. 120, no. 1, pp. 180–188, 2021. [23] L.-J. Zhao, B. Han, J.-J. Zhang, Y.-C. Yi, D.-D. Jiang, and J.-L. Lyu, “Transcatheter closure of congenital perimem- branous ventricular septal defect using the Amplatzer duct occluder 2,” Cardiology in the Young, vol. 28, no. 3, pp. 447–453, 2018. [24] Q. Chen, Z.-N. Hong, G.-C. Zhang et al., “Intraoperative device closure of isolated ventricular septal defects: experience on 1,090 cases,” &e Annals of &oracic Surgery, vol. 105, no. 6, pp. 1797–1802, 2018. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Interventional Cardiology Hindawi Publishing Corporation

Transcatheter Closure of Perimembranous and Intracristal Ventricular Septal Defects Using Amplatzer Duct Occluder II in Children

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Copyright © 2021 Shenrong Liu et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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0896-4327
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10.1155/2021/4091888
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Abstract

Hindawi Journal of Interventional Cardiology Volume 2021, Article ID 4091888, 9 pages https://doi.org/10.1155/2021/4091888 Research Article Transcatheter Closure of Perimembranous and Intracristal Ventricular Septal Defects Using Amplatzer Duct Occluder II in Children 1 2 1 1 1 Shenrong Liu , Wenqian Zhang , Junjie Li , Shushui Wang , Mingyang Qian , 1 1 1 Jijun Shi , Yumei Xie , and Zhiwei Zhang Department of Cardiac Pediatrics, Guangdong Cardiovascular Institute, Guangdong Academy of Medical Sciences, Guangdong Provincial People’s Hospital, Guangzhou 510080, China Department of Cardiovascular Surgery, Guangdong Provincial Hospital of Chinese Medicine, &e Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong, China Correspondence should be addressed to Zhiwei Zhang; drzhangzw@sohu.com Received 15 April 2021; Revised 1 August 2021; Accepted 24 August 2021; Published 13 September 2021 Academic Editor: Toshiko Nakai Copyright © 2021 Shenrong Liu et al. *is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Transcatheter closure of aneurysmal perimembranous ventricular septal defect (pmVSD), pmVSD near the aortic valve, and intracristal VSD (icVSD) with symmetrical or asymmetrical ventricular septal defect occluders still presents significant challenges. We report our experience with transcatheter closure of pmVSD and icVSD using Amplatzer duct occluder II (ADO II) in children. Method. We retrospectively analyzed all children, who presented to our hospital consecutively between March 2014 and June 2020 for attempted transcatheter closure of pmVSD or icVSD with the ADO II device. Standard safety and last-follow-up outcomes were assessed and compared. Results. In total, 41 patients underwent transcatheter closure of VSD with the ADO II (28 in pmVSD and 13 in icVSD groups) with a median age of 3.5 years (total range: 0.9 to 12 years) and median weight of 15.0 kg (total range: 10.0 to 43.0 kg). Implantation was successful in 40/41 patients (97.5%, 27/28 in pmVSD group, 13/13 in icVSD group). One patient with mild aortic valve prolapse in pmVSD group developed new-onset moderate aortic regurgitation after a 4/4 mm ADO II was deployed; however, this resolved after the device was retrieved and successfully replaced with a 5 mm zero eccentric VSD occluder. *ere was no procedure-related mortality. After a median follow-up of six months (total range: 6 to 72 months), complete closure rates were 85.1% and 76.9% among pmVSD and icVSD groups, respectively. In the pmVSD group, one case of new-onset moderate tricuspid regurgitation was observed at six months, and there was one case of severe tricuspid regurgitation that had progressed from mild tricuspid regurgitation at 12 months. No serious complications were noted in the icVSD group. Conclusion. ADO II provides a safe and reproducible alternative for the closure of perimembranous and intracristal ventricular septal defects with a diameter less than 5 mm in young children. associated with aneurysmal tissue or in close proximity to 1. Introduction the aortic and tricuspid valves still presents significant Perimembranous VSD (pmVSD) accounts for 70% of challenges [5]. VSDs, by far the most common form of congenital heart Intracristal VSD (icVSD) accounts for 5–29% of VSDs disease [1]. Since the first report of transcatheter VSD and was previously considered unsuitable for transcatheter closure in 1988 [2], along with the development of closure closure because of their proximity to the aortic and pul- device (either symmetrical or asymmetrical double disc monary valves [6]. Zero eccentric occluders have been used design), transcatheter closure of pmVSD has become an to close icVSD, achieving a successful closure rate of >90% accepted alternative to open heart surgery in selected cases [7].However, the incidence of aortic regurgitation requiring [3, 4]. However, transcatheter closure of pmVSD surgical repair remains relatively high [7]. 2 Journal of Interventional Cardiology 2.1. Device and Selection Protocol. *e ADO II is a self- Various devices have been used to minimize procedural risks and tackle complicated cases associated with VSD closure expanding fabric-free nitinol occluder consisting of dual symmetrical retention and flexible discs connected by a central [8–10]. For example, the KONAR-MF VSD occluder (LifeTech, Shenzhen, China) is designed to provide high waist. *e occluders are available in two lengths (4 and 6 mm) conformability to septal defects with a lower risk of heart block and four waist diameters (3, 4, 5, and 6 mm). *e retention and valvular interferences [8]. Patent ductus arteriosus discs have a diameter 6 mm greater than the waist size. occluders have also been used in pmVSD with the anatomic For icVSD and pmVSD without a membranous aneu- resemblance to a PDA [9]. However, the ADO II (Abbott, rysm, the waist diameter selected was 1 to 2 mm larger than USA) device is far softer than previous devices, as it has no the VSD defect size in the case of sufficient SAR or 1 mm polyester fabric and can be easily delivered via an antegrade or (±0.5 mm) larger for deficient SAR. For VSD associated with retrograde approach through a 4 F or 5 F delivery catheters a membranous aneurysm, implantation of the ADO II was considered in selected cases with suitable anatomic con- [11, 12]. Herein, we report our experience with transcatheter closure of pmVSD and icVSD using the ADO II in children. figurations as illustrated in Figures 1(a)–1(d). In these cases, the disk diameter selected covered the entire entry, specif- ically 1 to 2 mm larger than the LV entry diameter for a 2. Methods sufficient SAR or equal to the LV entry diameter for a de- Forty-one children, who underwent transcatheter closure of ficient SAR. A larger waist size was selected if sufficient SAR pmVSD and icVSD using the ADO II in Guangdong Pro- since elongation of the device through a relatively long duct vincial People’s Hospital (Guangzhou, China) between decreases the effective diameter of the central waist. *e March 2014 and June 2020, were enrolled in this study. All device length (4 or 6 mm) was selected based on VSD depth participants had isolated ventricular septal defect with a as measured on angiography. diameter< 5 mm. Most fulfilled at least one of the following For pmVSD and icVSD associated with AVP, the defect size is often underestimated on TTE. *erefore, the effective the criteria: recurrent respiratory infections, failure to thrive, or significant hemodynamic compromise (including signs of LV entry diameter should be measured based on multiple TTE views. Furthermore, we considered the larger of the jet left ventricular enlargement on electrocardiography (ECG), cardiomegaly on chest X-ray, or echocardiographic left atrial width measured on angiography or TTE images to aid in and/or left ventricular enlargement). *e exclusion criteria selecting a device waist size. *e waist diameter selected was were as follows: moderate-to-severe pulmonary hyperten- 1 mm (±0.5 mm) larger than this measurement. *e device sion, combined with other congenital heart defects requiring length selected was generally 4 mm. surgery, active local/systemic bacterial infections, VSD larger than 5 mm, body weight< 10 kg, and moderate-to- 2.2. Procedure. *e procedure has been described in detail in severe aortic regurgitation (AR). previous publications. Briefly, standard right and left cardiac All patients underwent comprehensive periprocedural catheterization and left ventriculography and aortography (left transthoracic echocardiography (TTE). pmVSD and icVSD ° ° anterior oblique 60 /cranial 20 projection for pmVSD and left were defined as defects located at 9–12 o’clock and 12–1:30 ° ° ° anterior oblique 70 –80 /cranial 20 for icVSD) were per- positions, respectively, in the short axis parasternal view formed in all cases. Two methods of device deployment were [13]. *e subaortic rim (SAR) was measured from the upper employed. *e conventional technique involves an antegrade margin of the defect to the aortic valve in the five-chamber approach, with the formation of an arteriovenous loop, and view and parasternal long axis view. AR was classified as initial deployment of the LV disc followed by RV disc. In the trivial (jet width/LVOT diameter< 10%), mild (jet width/ retrograde method, the delivery system is advanced over a long LVOT diameter � 10%–24%), moderate (jet width/LVOT exchangeable wire through femoral artery without creating an diameter � 25%–49%), or severe (jet width/LVOT diame- arteriovenous loop, followed by the initial deployment of the ter> 50%). Tricuspid regurgitation (TR) was classified as RV disc and the LV disc thereafter. We prefer a tangential trivial (within 1 cm of the valve), mild (regurgitant jet area ° ° fluoroscopic projection (left anterior oblique 40 /cranial 20 ) (RJA)/right atrial area (RAA)< 19%), moderate (RJA/ when releasing the device, as this provides a clear view of the RAA � 20%–40%), or severe (RJA/RAA> 41%) [14]. Re- relationship between the device and the ventricular septum. As sidual shunt was assessed by the width of the color jet at the the disc conforms to ventricular septum, it orients itself point of exit through the ventricular septum and classified as horizontally, and its position becomes relatively fixed. Sub- trivial (<1 mm color jet width), mild (1-2 mm color jet sequently, the waist and proximal disc can be released. In some width), moderate (2-3 mm color jet width), or severe cases, when appropriate disc conformance with ventricular (>3 mm color jet width) [15]. septum cannot be confirmed, TTE is useful to verify the lo- Aortic valve prolapse (AVP) was graded into three degrees cation and monitor whether the neighboring valve is affected. according to the morphology of the right coronary leaflet at the end of diastole during angiography: mild (buckling of the aortic cusp down the left ventricular outflow tract with minimal 2.3. Follow-Up. Patients without complications were dis- herniation into the VSD), moderate (prolapse of the cusp and charged 24 hours after the procedure. All patients under- its sinus with obvious herniation into the VSD), and severe went chest radiography, electrocardiography, and TTE (prolapse of the cusp and its sinus through the defect into the before discharge. Oral aspirin (5 mg/kg daily) was prescribed right ventricular outflow tract) [16, 17]. for 6 months. Follow-up visits were scheduled at 1, 3, and 6 Journal of Interventional Cardiology 3 (a) (b) (c) (d) Figure 1: Transthoracic echocardiography (TTE) and angiographic findings considered suitable for ADO II implantation: (a) tubular aneurysm, (b) aneurysm with two constrictions, (c) aneurysm with an elongated conical appearance, and (d) aneurysm with multiple small exits. months and annually thereafter. All visits included a routine estimated using Kaplan–Meier analyses, and event-free physical examination, electrocardiography, and TTE. Seri- survival curves were compared using the log-rank test. All ous complications relating to the procedure or device in- analyses were performed using R 3.6.2 software. cluded (1) death, (2) Mobitz II atrioventricular block or complete atrioventricular heart block (CAVB), (3) new onset 3. Results of more than moderate aortic regurgitation or tricuspid General procedural and follow-up characteristics of the 41 regurgitation, (4) tricuspid stenosis, (5) neurovascular events, (6) cardiac erosion, and (7) hemolysis. patients are summarized in Table 1. *e baseline charac- teristics of the study population were not significantly dif- ferent between pmVSD and icVSD. Implantation was 2.4. Statistical Analysis. Continuous variables are expressed successful in 40/41 patients (97.5%, 27/28 in pmVSD group, as median (range) and categorical variables as percentages 13/13 in icVSD group). One patient with mild aortic valve and numbers of patients. Cumulative event-free survival was prolapse in pmVSD group developed new-onset moderate 4 Journal of Interventional Cardiology Table 1: Baseline and procedural characteristics of the study sample. (All) pmVSD group icVSD group P value N � 41 N � 28 N � 13 Age (years) 3.5 [0.9–12.0] 3.6 [1.8–12.0] 3.3 [0.9–12.0] 0.933 Gender Male 22 (53.7%) 15 (53.6%) 7 (53.8%) 0.987 Female 19 (46.3%) 13 (46.4%) 6 (46.2%) Weight (kg) 15.0 [10.0–43.0] 15.2 [11.0–29.5] 15.0 [10.0–43.0] 0.674 Height (cm) 98.0 [73.0–152.0] 97.5 [80.0–141.0] 98.0 [73.0–152.0] 0.758 Aortic regurgitation None 35 (85.3%) 23 (82.1%) 12 (92.3%) 0.391 Trivial 6 (14.7%) 5 (17.9%) 1 (7.7%) Tricuspid regurgitation None 30 (73.2%) 21 (75.0%) 9 (69.2%) 0.698 Mild 11 (26.8%) 7 (25.0%) 4 (30.8%) AVP None 8 (19.5%) 9 (32.1%) 0 (0.00%) 0.031 Mild 30 (73.2%) 16 (57.1%) 13 (100%) Severe 3 (7.3%) 3 (10.7%) 0 (0.00%) SAR ≤2 (mm) 31 (75.6%) 19 (67.9%) 12 (92.3%) 0.090 >2 (mm) 10 (24.4%) 9 (32.1%) 1 (7.69%) Systolic PAP (mmHg) 28.0 [14.0–38.0] 28.0 [14.0–38.0] 28.0 [20.0–37.0] 0.683 Diastolic PAP (mmHg) 10.0 [3.0–17.0] 10.0 [3.0–16.0] 10.0 [4.0–17.0] 0.810 Mean PAP (mmHg) 16.0 [6.0–22.0] 16.0 [6.0–22.0] 16.0 [10.0–22.0] 0.725 Qp/Qs 1.36 [1.1–2.0] 1.33 [1.1–2.0] 1.47 [1.1–1.9] 0.518 Vascular approach Antegrade 33 (80.5%) 21 (75.0%) 12 (92.3%) 0.193 Retrograde 8 (19.5%) 7 (25.0%) 1 (7.69%) Procedure time (min) 64.0 [55.0–78.0] 63.5 [55.0–77.0] 67.0 [64.0–79.0] 0.501 Immediate RS None 24 (60.0%) 15 (55.6%) 9 (69.2%) Trivial 4 (10.0%) 2 (7.41%) 2 (15.4%) 0.605 Mild 8 (20.0%) 7 (25.9%) 1 (7.69%) Moderate 4 (10.0%) 3 (11.1%) 1 (7.69%) RS at the latest follow-up None 33 (82.5%) 23 (85.2%) 10 (76.9%) Trivial 2 (5.00%) 0 (0.00%) 2 (15.4%) 0.215 Mild 4 (10.0%) 3 (11.1%) 1 (7.69%) Moderate 1 (2.50%) 1 (3.70%) 0 (0.00%) VSD: ventricular septal defect; pmVSD: perimembranous VSD; icVSD: intracristal VSD; AVP: aortic valve prolapse; SAR: subaortic rim; PAP: pulmonary arterial pressure; Q /Q : pulmonary to systemic blood flow; RS: residual shunt. p s aortic regurgitation after a 4/4 mm ADO II was deployed; 7 patients with mild preoperative TR, TR disappeared in 2, however, this resolved after the device was retrieved and remained unchanged in 4, and progressed to moderate TR in successfully replaced with a 5 mm zero eccentric VSD 1 patient after the procedure. New-onset mild TR was ob- occluder. *e antegrade approach was used in 33 patients (12 served in 6 patients. In the icVSD group, 1 patient presented in icVSD group) and the retrograde approach in 8 patients (1 with trivial preoperative AR that remained unchanged after the procedure. New-onset trivial AR was observed in 1 in icVSD group). A retrograde approach was selected in 3 patients due to technical difficulties and 1 patient due to a patient with preoperative mild AVP. New-onset mild TR femoral venous malformation. For the remaining 4 patients, was observed in 1 patient. a retrograde approach was planned ahead of the procedure. Follow-up data were available for all patients. *e me- In 1 patient, a retrograde approach resulted in device in- dian follow-up for the participants was six months (total terference with the aortic valve resulting in moderate AR. On range: 6 to 72 months). Figure 2 shows the progression of subsequent switching to an anterograde approach, the AR new-onset complications on follow-up. One patient in disappeared. pmVSD group with preexisting tricuspid regurgitation In the pmVSD group, 5 patients with mild AVP had progressed to severe tricuspid regurgitation at the one-year follow-up. He was asymptomatic and continued to undergo trivial preoperative AR, among which the AR resolved postoperatively in 4 patients and remained unchanged in 1 close follow-up. One patient in the pmVSD group developed moderate tricuspid regurgitation at the 6-month follow-up. patient after the procedure. New-onset trivial AR was ob- served in 4 patients with preoperative mild AVP. Among the She was asymptomatic and her right atrium appeared Journal of Interventional Cardiology 5 24hours 12 6 41 1month 11 7 31 3months 86 21 6months 56 32 Latest 47 31 1 0 5 10 15 20 pmVSD (Number of cases) Complications Severe Tricuspid Regurgitation Mild Tricuspid Regurgitation Moderate Tricuspid Regurgitation Residual Shunt Trivial Aortic Regurgitation 24hours 41 1 1month 41 3 3months 42 2 6months 32 2 Latest 32 2 0 2 4 6 8 icVSD (Number of cases) Complications Trivial Aortic Regurgitation Mild Tricuspid Regurgitation Residual Shunt Figure 2: Progression of new-onset complications on follow-up. normal on TTE. No deaths, AV block, moderate or worse significant differences in the probability of complications aortic regurgitation, tricuspid stenosis, neurovascular between pmVSD and icVSD groups (P � 0.37, log-rank events, cardiac erosion, or hemolysis occurred during the test). No surgical or percutaneous reintervention was follow-up. Kaplan-Meier analyses (Figure 3) revealed no scheduled on this period of follow-up. 6 Journal of Interventional Cardiology 1.00 0.75 0.50 0.25 p = 0.37 0.00 0 20 40 60 80 Time (months) Number at risk pmVSD 27 4 2 1 0 icVSD 13 1 1 1 0 0 20 40 60 80 Time (months) pmVSD icVSD Figure 3: Kaplan–Meier curve depicting freedom from complications across follow-up. In our experience, implantation of ADO II in cases with 4. Discussion severe AVP (n � 3) did not result in AR after the im- *is study demonstrates that transcatheter closure of plantation (Figure 4(a)). ADO II was also found to be pmVSD and icVSD less than 5 mm in diameter with the suitable for closure of pmVSD associated with a mem- ADO II device is feasible and safe in children. *is is also branous aneurysm in selected cases with amenable mor- true for pmVSDs with a subaortic rim≤ 2 mm or aortic valve phologies. *ese morphologies are illustrated in prolapse. Figures 1(a)–1(d). Generally, aneurysms with a small exit on the right side can be closed with the ADO II. In such cases, we recommend a retrograde approach because the 4.1. Benefits of Utilizing ADO II in pmVSD. pmVSD close to delivery sheath is usually difficult to advance through an the aortic valve (≤2 mm) commonly leads to aortic valve antegrade approach. prolapse and subsequent aortic regurgitation because of the Venturi effect [18]. Typically, conventional symmetrical device implantation may worsen preexisting AR or result in 4.2. Benefits of Utilizing ADO II in icVSD. icVSD is located new-onset AR. close to the aortic valve and is usually associated with aortic We found that the ADO II is safe to implant in patients valve prolapse. With such defects, closure with the soft ADO with a relatively deficient aortic rim (up to 2 mm). As the II may be beneficial as it does not interfere with aortic valve upper rim of the ADO II is 3 mm larger than the waist, a function (Figure 4). subaortic rim> 3 mm would generally be required to avoid Other devices have also been used for the closure of aortic regurgitation [19]. However, we found that absent icVSD. Qin et al. reported the zero eccentric VSD occluder SAR or even more the presence of an AVP were not limi- can also be used to close icVSD with a successful closure rate tation factors. *is is possibly because the soft structure of of >90%. However, 2/38 patients developed AR, requiring the device allows it to move freely with the aortic valve leaflet surgical repair [3, 7]. In contrast, using the ADO II device for without disrupting the aortic valve motility when deployed similar defects, we did not observe any AR requiring surgical in a VSD with a deficient aortic rim. repair. Journal of Interventional Cardiology 7 (a) (b) Figure 4: (a) Ventricular septal defect with severe aortic valve prolapse. *e right coronary cusp prolapses into the right ventricular outflow tract (left, center). A 5/4 mm Amplatzer duct occluder II was successfully implanted without aortic regurgitation as shown by the an- giography (right). (b) Intracristal ventricular septal defect. Transthoracic echocardiography (left) shows the defect is close to aortic valve. ° ° Left ventricular angiography at 70 left anterior oblique and 20 cranial projection was performed to visualize the defect (center). A 5/4 mm Amplatzer duct occluder II completely closed the defect completely without residual shunt or interfering with the aortic valve (right). Furthermore, Qin et al. observed considerably longer entrapment within the chordal elements of the tricuspid procedural and fluoroscopic times with the zero eccentric valve and inability to advance the delivery sheath due to VSD occluder. Multiple procedure related issues may angulation of the path or a small defect; (2) bilateral femoral contribute to increased fluoroscopic time [20]. First, as the venous malformations. However, with accumulating expe- occluder is asymmetrical, it must be maneuvered back and rience, we have found that the retrograde approach involves forth to ensure the platinum marker on the left disk is fewer steps and reduces procedural costs (a snare set that positioned toward the apex. Additionally, the delivery costs more than 3000 yuan if not used). With this in mind, sheath of the zero eccentricity VSD occluder is thicker (4- we recommend that the retrograde approach can be planned ahead of the procedure in select cases such as VSD with small 5 Fr versus 6–8 Fr.) and therefore less flexible than the ADO II. *erefore, it is difficult to maneuver into the left exit. ventricle [21]. Overall, our observations suggest that the ADO II 4.4. Residual Shunts. Residual shunts were common in the occluder is safer, easier to implant, and may require less immediate postoperative period. In the pmVSD group, fluoroscopic and procedural time than the zero eccentric complete closure was achieved in 55.5% at 24 hours and VSD occluder system, particularly when delivered retro- 85.2% at the latest follow-up, respectively. In the icVSD gradely avoiding the A-V circuit formation. However, fur- group, complete closure was achieved in 69.2% at 24 hours ther research comparing the two devices is required to and 76.9% at the latest follow-up, respectively. However, confirm these speculations. these residual shunts were not hemodynamically significant as the heart murmur disappeared or decreased in intensity 4.3. Antegrade versus Retrograde Approach. In most cases, (grade 1–2/6) in all children. Further, no hemolysis or endocarditis was observed in our sample. the procedure was performed using the antegrade method in our study. *is technique creates a stable line through which Other studies utilizing the ADO II for VSD occlusion the delivery system can be advanced via venous access and also observed a similar trend. For instance, Wang et al. avoids the risk of arterial injury in young children. In ad- reported 32/45 (71.1%) trivial-to-mild residual shunts im- dition, the antegrade technique allows better control on the mediately after transcatheter closure of outlet-type VSDs aortic disc positioning, and therefore, it, theoretically, with the ADO II device, which gradually reduced to 19/45 should be the preferred technique for patients with deficient (42.2%) at the latest follow-up (range: 0.3–51.1 months) [22]. aortic rim and/or in VSD with AVP. Lyu et al. reported 10/51 (19.6%) instances of trivial residual Initially, we reserved the retrograde approach for the shunts after transcatheter closure of perimembranous VSD using ADO II and a 100% complete closure rate by the six- following situations: (1) venous closure could not be per- formed due to technical difficulties, including guidewire month follow-up [23]. 8 Journal of Interventional Cardiology We suspect that the high incidence of early shunts can be Acknowledgments attributed to the soft fabric-free design of the ADO II. *is study was supported by the Guangdong Provincial However, eventual thrombosis and occluder endotheliali- Clinical Research Center for Cardiovascular Disease zation may contribute toward residual shunt resolution [24]. (2020B1111170011) and Shenzhen Sanming Medical Project Given the high rate of resolution for early shunts associated of China (grant no. SZSM201612057). with ADO II implantation, a higher level of early shunting is acceptable during implantation. In our experience, ob- serving a reduction or resolution of the heart murmur and References confirming stable device position and optimal conformation on fluoroscopic imaging are sufficient to release the device, [1] D. E. Spicer, H. H. Hsu, J. Co-Vu, R. H. Anderson, and even if residual shunts are visible on TTE. However, some F. J. Fricker, “Ventricular septal defect,” Orphanet Journal of Rare Diseases, vol. 9, no. 1, p. 144, 2014. residual shunts may persist. *is may be due to device-defect [2] N. D. Bridges, S. B. Perry, J. F. Keane et al., “Preoperative mismatch or a failure to close the LV entry. In our sample, 7 transcatheter closure of congenital muscular ventricular septal cases had residual shunts on the latest follow-up. However, defects,” New England Journal of Medicine, vol. 324, no. 19, none of them had a heart murmur suggesting that the re- pp. 1312–1317, 1991. sidual shunt may not be hemodynamically significant. [3] J. Yang, L. Yang, S. Yu et al., “Transcatheter versus surgical Furthermore, none of our patients developed endocarditis or closure of perimembranous ventricular septal defects in hemolysis during follow-up. Several reasons may cause a children,” Journal of the American College of Cardiology, device-defect mismatch, such as an underestimation of vol. 63, no. 12, pp. 1159–1168, 2014. defect size, or apprehension to implant an oversized device [4] Z.-N. Hong, Q. Chen, L.-Q. Huang, and H. 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Published: Sep 13, 2021

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