Transcatheter closure with Eccentric Occluder for Intracristal Ventricular Septal Defect: A Safety and Efficacy Assessment

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Abstract Background Intracristal ventricular septal defect (icVSD) pose unique challenges in interventional cardiology. This study evaluated the use of eccentric occluders in icVSD treatment compared with that of standard symmetrical occluders for perimembranous ventricular septal defect (pmVSD), aiming to inform clinical practice. Objective To evaluate the clinical outcomes of the use of eccentric occluders for treating icVSD compared to the use of standard symmetrical occluders for treating pmVSD, with a focus on the success rate, cardiac function, complications, and quality of life. Materials and methods We conducted a comparative analysis of 39 patients with icVSD treated with eccentric occluders and 416 patients with pmVSD treated with symmetrical occluders. A comprehensive assessment of cardiac function recovery, complication occurrence, and changes in quality of life was performed during the intermediate and short-term follow-up periods. Results Of the 39 patients with icVSD, 38 successfully underwent occluder implantation, achieving a surgical success rate of 97.4%. Among the 416 patients with pmVSD, 413 achieved successful occluder implantation, yielding a surgical success rate of 99.3%. No statistically significant difference was observed in the success rates between the two groups. During the follow-up, both patient cohorts demonstrated notable improvements in cardiac function, the absence of severe complications, and improvements in quality of life. These findings underscore the feasibility and superiority of eccentric occluders in transcatheter closure of icVSD. Conclusions Our study demonstrated the high safety and efficacy of percutaneous transcatheter closure using eccentric occluders for treating icVSD. This investigation not only enhances our understanding of transcatheter closure options for icVSD patients but also provides clinicians with robust scientific evidence to guide treatment strategies. Ultimately, this approach may offer patients with icVSD a broadened range of therapeutic options and improved clinical outcomes.
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Transcatheter closure with Eccentric Occluder for Intracristal Ventricular Septal Defect: A Safety and Efficacy Assessment | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Transcatheter closure with Eccentric Occluder for Intracristal Ventricular Septal Defect: A Safety and Efficacy Assessment Tianhe Xia, Nuo Chen, Yu Han, Songyue Zhang, Xing Rong, Rongzhou Wu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4604964/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Intracristal ventricular septal defect (icVSD) pose unique challenges in interventional cardiology. This study evaluated the use of eccentric occluders in icVSD treatment compared with that of standard symmetrical occluders for perimembranous ventricular septal defect (pmVSD), aiming to inform clinical practice. Objective To evaluate the clinical outcomes of the use of eccentric occluders for treating icVSD compared to the use of standard symmetrical occluders for treating pmVSD, with a focus on the success rate, cardiac function, complications, and quality of life. Materials and methods We conducted a comparative analysis of 39 patients with icVSD treated with eccentric occluders and 416 patients with pmVSD treated with symmetrical occluders. A comprehensive assessment of cardiac function recovery, complication occurrence, and changes in quality of life was performed during the intermediate and short-term follow-up periods. Results Of the 39 patients with icVSD, 38 successfully underwent occluder implantation, achieving a surgical success rate of 97.4%. Among the 416 patients with pmVSD, 413 achieved successful occluder implantation, yielding a surgical success rate of 99.3%. No statistically significant difference was observed in the success rates between the two groups. During the follow-up, both patient cohorts demonstrated notable improvements in cardiac function, the absence of severe complications, and improvements in quality of life. These findings underscore the feasibility and superiority of eccentric occluders in transcatheter closure of icVSD. Conclusions Our study demonstrated the high safety and efficacy of percutaneous transcatheter closure using eccentric occluders for treating icVSD. This investigation not only enhances our understanding of transcatheter closure options for icVSD patients but also provides clinicians with robust scientific evidence to guide treatment strategies. Ultimately, this approach may offer patients with icVSD a broadened range of therapeutic options and improved clinical outcomes. ventricular septal defect intracristal ventricular septal defect perimembranous ventricular septal defect eccentric occluder transcatheter closure follow-up study Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 1. Introduction Ventricular septal defect (VSD), with perimembranous VSD (pmVSD) as the predominant subtype, is a prevalent congenital heart anomaly [ 1 ] . Treatment modalities include surgical repair and percutaneous occlusion, the latter of which is preferred because of its reduced invasiveness and expedited recovery [ 2 – 3 ] . The supraventricular crest, a muscular arcuate tissue dividing the tricuspid and pulmonary valves, forms the apex and outflow tract septum of the right ventricle [ 4 ] . Depending on the position of the defect relative to the supraventricular crest, VSDs are further categorized into outflow tract, perimembranous, and muscular defects [ 5 ] . Among outflow tract VSDs, supracristal and intracristal ventricular septal defect (icVSD) are significant. Supracristal ventricular septal defects are contraindicated for transcatheter closure due to their proximity to the aortic and pulmonary valves. Similarly, the icVSD, owing to its close proximity to vital valvular structures, was once considered unsuitable for transcatheter closure because traditional symmetric occluders could overlay and impair valve function [ 6 ] . However, considering the unique anatomical characteristics of the icVSD, -which is located within the supraventricular crest structure of the right ventricular outflow tract and is surrounded by muscular tissue - this provides a basis for the design of occluders. China has introduced an eccentric occluder tailored to heart anatomy, optimizing occlusion efficiency while minimizing tissue injury [ 7 ] . Although clinical experience with eccentric occluders for icVSD is limited, this study explored our center's early and medium-term follow-up results with this approach and compared them to those of percutaneous occlusion of pmVSD using symmetric occluders during a similar period. 2. Methods 2.1 Study design A retrospective cohort study was conducted at the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, enrolling 39 patients with icVSD and 416 with pmVSD who underwent percutaneous occlusion using eccentric and symmetric occluders from 2011 to 2021. Informed consent was obtained from each patient in this study, and the study was conducted in accordance with the ethical guidelines of the 1975 Declaration of Helsinki, with prior approval from the institution's human research committee. Patients were grouped based on defect location (pmVSD or icVSD). Evaluation before closure of the transcatheter included TTE, electrocardiogram, chest X-ray, troponin, and brain natriuretic peptide testing. TTE, performed by experienced echocardiographers adhering to pediatric echocardiography guidelines [ 8 ] , utilized Philips EPIQ7C and IE Elite machines (2–9 MHz probes) to assess defect size, residual rim, aortic valve prolapse, and defect-structure relationships. TTE plays a crucial role in diagnosing pmVSD and icVSD and requires multisectional evaluation [ 9 , 10 ] . For pmVSD, the interruption or shunt flow of the interventricular septum echo in the short-axis view of the great vessels is located at the 9–12 o'clock position in the parasternal view. For icVSD, the following criteria were used: ① loss of interventricular septum echo or shunt flow in the short-axis view of the great vessels is located between 11:30 and 1:00; ② a distance between the right edge of the VSD and the root of the pulmonary valve greater than 2 mm in the short-axis view of the great vessels; and ③ in the parasternal long-axis view of the left ventricle, where the VSD or the upper edge of its shunt flow is often adjacent to the root of the right aortic cusp. The inclusion criterion was as follows [ 11 ] : (1) Age ≥ 2–3 years, weight ≥ 10 kg; (2) TTE examination: pmVSD defect diameter > 3 mm and < 14 mm, with a distance of ≥ 2 mm between the superior rim of the defect and the right coronary cusp of the aortic valve, and no prolapse of the right coronary cusp of the aortic valve into the VSD; icVSD defect diameter < 6mm, with a distance of ≥ 2 mm between the superior rim of the defect and the pulmonary valve annulus. Exclusion criteria [ 11 ] : (1) Infectious endocarditis or other infections causing bacteremia; (2) presence of thrombus at the site of occluder placement or venous thrombosis along the catheter insertion path; (3) VSD with significant aortic valve prolapse and aortic regurgitation; (4) pmVSD diameter ≥ 14 mm, icVSD defect diameter ≥ 6 mm; (5) supracristal ventricular septal defect; (6) severe pulmonary hypertension with bidirectional shunt; (7) abnormal coagulation function; (8) abnormal liver and kidney function; and (9) congestive heart failure. 2.2 Procedure 2.2.1 Radiologically Guided Percutaneous Transcatheter Closure for VSD (1) Preoperative Medication: Daily aspirin at 3–5 mg/kg was initiated 24 hours prior to surgery. (2) Anesthesia and heparinization: Local anesthesia was applied to the right groin, followed by IV heparin at 0.8 mg/kg to maintain an ACT > 250 seconds. (3) Angiography: Assessment of the VSD and aortic valve via the right femoral artery using a 5 Fc pigtail catheter. A MPA2 catheter was inserted via the right femoral vein to the pulmonary artery for pressure measurements. (4) Trajectory establishment: The transseptal pathway was created using a basket catheter and long guidewire, traversing the VSD from the femoral vein to the left ventricle. (5) Occluder Placement: A delivery sheath was advanced through the established trajectory, and its tip was positioned in the left ventricular apex. (6) Verification and Release: An appropriately sized occluder was deployed under echo and DSA guidance, ensuring correct positioning and shape. Postdeployment, confirmation of no significant shunt was confirmed via left ventricular angiography and no aortic regurgitation was confirmed by ascending aortic angiography prior to full occluder release. 2.2.2 Selection of occluder Based on intraoperative angiographic imaging and preoperative TTE findings, occluders were selected from the Cera™ Ceramic Membrane VSD (Symmetric) Occluder (Shenzhen Life Science Co., LTD., China) and the Cera™ Ceramic Membrane VSD (Eccentric) Occluder (Shenzhen Life Science Co., LTD., China). The detailed models and specifications are presented in Fig. 2 . When selecting the appropriate occluder size, symmetric occluders are preferred for defects located more than 2 mm away from the aortic valve, while eccentric occluders are preferred for defects closer than 2 mm. For pmVSD, the diameter of the selected occluder is typically 1–3 mm larger than the angiographically measured diameter. However, for icVSD or VSD with concurrent aortic valve prolapse, left ventricular angiography may not always reveal the full extent of the defect. In such cases, ultrasound or angiography can be employed after the delivery sheath passes through the VSD to observe the size of the ventricular septal flow jet, aiding in the determination of defect size and the selection of an appropriate occluder. 2.3 Follow-up Intraoperatively, TTE was used to monitor occluder placement. Postoperatively, day 3 TTE was used to assess the occluder morphology, position, residual shunt, regurgitation, and cardiac function. Daily ECG was used to monitor arrhythmias and conduction blocks. Standard care included oxygen, aspirin anticoagulation, methylprednisolone for inflammation/edema, and levocarnitine for myocardial nutrition. Uncomplicated patients were discharged after 3–5 days, advised to avoid strenuous activity, and prescribed aspirin (3–5 mg/kg/d) for 6 months. The patients were followed up with TTE, ECG, and chest X-ray at 1, 3, 6, 12, 24, 36, and 60 months postop, and the data were collected through Dec 2023. 2.4 Statistical analysis Continuous variables are presented as the means, medians, standard deviations, ranges, and quartiles, while categorical variables are presented in frequency tables and bar charts. All the statistical analyses were conducted in SPSS (v25.0) with MSTATA support. A P value < 0.05 was considered significant. 3. Results A total of 455 patients were enrolled based on the inclusion/exclusion criteria (Figure. 3). In the icVSD group, 38/39 patients underwent successful occluder implantation (97.4% success rate). One patient required surgical occlusion due to aortic valve prolapse and an underestimated defect diameter. In the pmVSD group, implantation was successful in 413/416 patients (99.3% success rate). Two patients experienced complications postimplantation, including hemolysis, aortic regurgitation, residual shunting, and arrhythmia, necessitating occluder removal and further surgical intervention. One patient with a VSD and a 2.2 mm fistula was also surgically treated. No significant difference in success rate was observed between the groups. 3.1 Baseline characteristics of patients Table 1 summarizes the baseline characteristics of the icVSD (39 patients) and pmVSD (416 patients) groups. When analyzing and comparing the differences between the two groups, we observed no significant differences in age, sex, weight, and birth weight. However, compared to pmVSD patients, icVSD patients exhibited longer hospitalization and catheterization durations. Notably, compared with pmVSD patients, icVSD patients had a lower incidence of ventricular septal membrane aneurysm (15% vs. 41% in pmVSD, P < 0.05) and a greater incidence of aortic valve prolapse ( P < 0.05). The defect diameters determined by TTE were similar, but the occluder diameters were smaller in icVSD. Preoperative BNP levels and intraoperative systolic pulmonary artery pressures were lower in icVSD ( P < 0.05). Table 1 Patient demographics and baseline characteristics Characteristic treatment p-value 2 pmVSD, N = 416 1 icVSD, N = 39 1 Age (month) 57 ± 49 75 ± 65 0.095 Gender 0.688 female 206 (50%) 18 (46%) male 210 (50%) 21 (54%) Weight(kg) 18 ± 9 23 ± 14 0.047 Birth weight(kg) 3.30 ± 1.68 3.22 ± 0.54 0.559 Length of stay(day) 9.61 ± 2.40 10.00 ± 3.37 0.492 Follow-up time(month) 26 ± 20 28 ± 20 0.492 Membranous aneurysms 0.002 None 242 (59%) 33 (85%) Aneurysms 170 (41%) 6 (15%) Aortic valve prolapse < 0.001 None 392 (95%) 15 (38%) Prolapse 19 (5%) 24 (62%) Radiography time(minutes) 58 ± 31 78 ± 32 0.002 Defect diameter by TTE(mm) 3.56 ± 1.44 3.33 ± 1.34 0.310 Amplatzer duct occluder size(mm) 6.78 ± 2.27 5.87 ± 1.12 < 0.001 BPN (pg/ml) 123 ± 107 87 ± 53 0.001 Systolic PA pressure (mmHg) 29 ± 7 27 ± 5 0.010 1 Mean ± SD; n (%) 2 Welch Two Sample t-test; Pearson's Chi-squared test; Fisher's exact test 3.2 Postoperative Complications Postoperative complications directly impact operation success and patient rehabilitation. In our study, 4 implantation failures were excluded from the complication analysis. No major bleeding, death, or serious complications occurred in either group. The icVSD group showed no mechanical hemolysis, whereas the pmVSD group experienced 4 cases (0.96%) of hematuria attributed to mechanical hemolysis. Three patients improved after treatment, while one patient with severe disease and a complete right bundle branch block and residual shunt required occluder removal and further surgery. Postoperatively, 1 pmVSD patient experienced minor pericardial effusion, which resolved spontaneously within 6 days. The median follow-up was 36 (1–60) months for icVSD and 24 (0.1–60) months for pmVSD. 3.2.1 Residual shunt TTE showed signs of a shunt at the edge of the occluder, suggesting a possible residual shunt [ 12 ] , but leakage through the occluder should be excluded. The detailed residual diversion rates are shown in Fig. 4 (a). Postoperatively, in the icVSD group, 7 patients (18.4%) exhibited a residual shunt, which resolved within 24 months, with most patients resolving within 3 months. In the pmVSD group, 69 patients (16.7%) had residual shunts, 27 of whom resolved within 1 month, and the remainder gradually resolved up to 36 months postoperatively. 3.2.2 Valve regurgitation Valve regurgitation, caused by incomplete valve closure, results in blood reflux between chambers. Using TTE, valve regurgitation was graded as follows: tricuspid regurgitation - none, mild (< 1.4 cm jet length, 4.5 cm jet length, > 10 cm² area) [ 13 ] ; aortic regurgitation - none, mild (jet not exceeding the anterior leaflet of the mitral valve, 47%) [ 14 ] ; and mitral regurgitation - none, mild ( 40%) [ 13 ] . Figure 4 (b) summarizes the echocardiographic findings of valve regurgitation in the icVSD group before and after surgery. Postoperatively, 10 patients (25.6%) exhibited valve regurgitation—4 (10.3%) with aortic regurgitation and 6 (15.4%) with tricuspid regurgitation. No cases of mitral regurgitation were noted. Preoperatively, the icVSD group was devoid of aortic regurgitation, yet 4 new cases appeared postoperatively, of which 1 was moderate and persisted for 36 months, while 3 mild cases resolved within 36 months. Preexisting mitral regurgitation required surgery in 1 patient and resolved spontaneously in another within 3 months, with no new cases emerging. Among the 6 preoperative tricuspid regurgitation patients, 3 persisted postoperatively, with 1 remaining after 6 months, while 4 new patients resolved within 3 months of surgery. In the pmVSD group, 139 patients (33.4%) presented with valve regurgitation three days postoperatively, including 15 (3.6%) with aortic regurgitation, 108 (26.0%) with tricuspid regurgitation, and 16 (3.8%) with mitral regurgitation. Among the aortic regurgitation cases, 10 pre-existing cases resolved in 5 patients and persisted in 5 patients, while 10 new cases emerged, mostly resolving by 24 months, except for one case that progressed from mild to moderate regurgitation over 24 months in a patient with a 4 mm defect from the aortic valve treated with a 7 mm symmetric occluder. Three new cases appeared at 6 months, with 2 resolving by 24 months and 1 persisting to 36 months. Among those with mitral regurgitation, 13 of 28 preoperative cases persisted. For tricuspid regurgitation, 64 preoperative cases and 44 new cases emerged postoperatively, mostly resolving during follow-up, except for 2 new moderate cases, one associated with bilateral pulmonary artery stenosis and the other with pulmonary hypertension. There were no statistically significant differences between the two groups in terms of the presence of residual shunts or the presence of various types of valve regurgitation at 3 days postoperatively, as detailed in Table 2 . Table 2 Comparison of abnormal indicators of echocardiography between the two groups on day 3 after surgery Variable pmVSD(n = 413) icVSD(n = 38) P -value Residual Shunt Tricuspid Regurgitation Aortic Regurgitation 69(16.7) 108(26.2) 15(3.6) 7(18.4) 6(15.8) 4(10.5) 0.787 0.160 0.109 Mitral Regurgitation 16(3.9) 0(0.0) 0.437 3.2.3 Arrhythmia In the icVSD group, one preoperative case of incomplete right bundle branch block (IRBBB) persisted postoperatively, without improvement, and ventricular extrasystoles emerged. Postoperatively, six new arrhythmia patients were noted, comprising two with IRBBB and four with ventricular premature contractions. In contrast, the pmVSD group exhibited 55 new arrhythmia cases, including seven complete right bundle branch block (CRBBB), two of which evolved from preoperative IRBBB. One patient normalized in three days, while another showed ECG improvement after seven days. Twenty-two patients remained with IRBBB, and one patient developed complete left bundle branch block with intermittent type A Wolff‒Parkinson White syndrome one month postoperatively. Following high-dose methylprednisolone therapy, significant ECG improvement was observed. Additionally, 10 new cases of left anterior fascicular block occurred, with eight gradually returning to normal within 10 days. One new left bundle branch block patient normalized within four days. A significant difference in new ventricular premature contractions was observed between the two groups at three days postoperatively ( P < 0.05). However, no significant differences in other arrhythmia types were noted during the same period, as detailed in Table 3 . Table 3 Comparison of new abnormal electrocardiogram indicators between the two groups 3 days after surgery Variable pmVSD(n = 413) icVSD(n = 38) P -value New arrhythmia Av block CRBBB 55(13.3) 11(2.7) 7(1.7) 6(15.8) 0(0.0) 0(0.0) 0.670 0.639 0.902 IRBBB Extrasystole Two or more exceptions 22(5.3) 6(1.5) 6(1.5) 2(5.3) 4(10.5) 1(2.6) 1.000 0.002 1.000 3.2.4 Cardiac function Changes in postoperative cardiac function serve as a direct indicator of surgical outcomes. As detailed in Table 4 , the comparison of the postoperative left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left atrial diameter (LAD), right ventricular diameter (RV), and left ventricular ejection fraction (EF) between the two groups revealed a decreasing trend in the LVEDD, LVESD, and LAD at three days postoperatively, with significant differences from the preoperative values ( P < 0.05). This trend continued at the one-month follow-up, exhibiting further reductions. However, from the three-month follow-up, these parameters stabilized, with no significant changes observed at the three- and six-month follow-ups. Given the subjects' growth and development, these parameters gradually increased after 12 months of follow-up. In contrast, the RV and EF values remained relatively stable during the entire follow-up period. Table 4 Comparison of preoperative and postoperative echocardiographic follow-up between the two groups Groups Variable Before 3-day 1-month 3-month 6-month 12-month 24-month 36-month 60-month pmVSD LVEDD (mm) 37.0 ± 25.9 34.0 ± 4.7 △ 33.8 ± 4.2 △ 34.0 ± 4.1 △ 34.0 ± 3.8 34.5 ± 4.1* △ 35.7 ± 4.0 36.6 ± 3.6 △ 38.5 ± 4.0 △ LVESD (mm) 22.2 ± 9.9 20.73 ± 3.0 △ 21.38 ± 10.8 20.68 ± 3.0 △ 20.85 ± 2.7 △ 21.32 ± 3.1* △ 22.27 ± 3.6 △ 22.79 ± 2.6 △ 23.79 ± 3.0 △ LAD (mm) 25.1 ± 4.5* 23.8 ± 3.8* △ 23.2 ± 3.9* △ 23.5 ± 3.7* △ 23.5 ± 3.7 △ 24.1 ± 3.7* △ 25.3 ± 4.1 25.7 ± 3.3 27.17 ± 3.77 RV (mm) 18.8 ± 5.4* 18.6 ± 5.0* 18.7 ± 5.2* 19.2 ± 4.9* 19.5 ± 4.9 20.0 ± 4.9* 21.4 ± 5.2 △ 21.9 ± 4.7 △ 24.4 ± 4.7 △ EF (%) 70.0 ± 5.2 70.0 ± 5.4 69.3 ± 4.3 70.1 ± 3.9 69.5 ± 4.3 △ 69.8 ± 4.6* 69.1 ± 4.2 68.5 ± 5.5 △ 69.4 ± 5.4 icVSD LVEDD (mm) 35.6 ± 5.6 35.3 ± 4.7 34.5 ± 4.6 35.1 ± 4.6 34.6 ± 4.5 36.4 ± 4.6* 35.1 ± 3.5 37.4 ± 3.6 △ 39.4 ± 5.1 △ LVESD (mm) 21.97 ± 3.0 21.08 ± 3.3 △ 21.39 ± 3.5 21.42 ± 2.8 21.29 ± 2.8 23.0 ± 3.4* △ 21.40 ± 2.2 22.32 ± 1.9 △ 24.14 ± 2.7 △ LAD (mm) 26.7 ± 3.6* 25.5 ± 3.7* △ 25.0 ± 3.8* △ 25.5 ± 3.7* △ 24.8 ± 3.4 △ 26.29 ± 3.1* 25.2 ± 4.8 25.68 ± 2.7 28.57 ± 4.2 RV (mm) 21.6 ± 5.0* 21.6 ± 5.1* 21.6 ± 4.8* 22.4 ± 4.9* 21.3 ± 5.0 23.5 ± 5.0* △ 21.6 ± 5.0 23.5 ± 3.6 26.4 ± 2.1 △ EF (%) 69.5 ± 4.6 71.3 ± 4.7 69.2 ± 5.1 69.6 ± 4.9 69.8 ± 3.8 67.7 ± 3.5* △ 70.2 ± 4.0 71.2 ± 4.3 68.50 ± 3.66 △: Statistically significant difference compared with preoperative comparison ( p < 0.05); *: statistically significant difference compared with two groups ( p < 0.05). 3.3 Electrocardiogram treadmill exercise test Patients were counseled against intense physical activity for the initial six postoperative months. Subsequently, 96 patients from the follow-up cohort, comprising 9 from the icVSD group and 87 from the pmVSD group, underwent an electrocardiogram (ECG) treadmill exercise test, and the results are detailed in Fig. 5 . In the icVSD group, 88.9% had negative test results, exhibiting no arrhythmias at rest or during exercise. One patient had suspicious results due to occasional ventricular extrasystoles. The pmVSD group had a 90.8% negative rate, with 79 patients without arrhythmias. Abnormalities in the pmVSD group included various electrocardiographic and symptomatic findings. Patients with negative test results were scheduled for follow-up after three years, while those with suspicious or positive results were advised on continued routine activity and repeat testing after one year. Positive result patients were recommended for further investigations and tailored treatment. 4. Discussion Ventricular septal defects (VSD) are classified into outflow tract, perimembranous (pmVSD), and muscular types. Well-established transcatheter closure techniques exist for pmVSD and muscular VSD [ 15 , 16 ] , but intracristal VSD (icVSD) remains challenging due to its proximity to the aortic valve. The recent development of eccentric occluders in China has offered new therapeutic prospects for icVSD, improving interventional outcomes and minimizing tissue damage. However, research on the use of eccentric occluders for icVSD is limited, and postoperative recovery reports are scarce. Here, we assessed the safety and feasibility of eccentric occluder-based transcatheter closure for treating icVSD through short- and medium-term follow-ups and compared the outcomes with those of pmVSD patients treated with symmetric occluders. In this study, the success rate of icVSD with eccentric occluders was 97.4%, which was not significantly different from that of pmVSD with symmetrical occluders (99.3%). This success rate is more prominent than that of traditional incisions of the lower end of the sternum and pericardium to place the occluder (96.3%) [ 17 ] . Overall, the eccentrically designed occluder demonstrated comparable success rates in transcatheter closure in the icVSD group compared to the pmVSD group and showed significant advantages over traditional surgical methods. The precise preoperative evaluation of VSD characteristics is crucial for transcatheter closure surgery. In the icVSD group, a case involving aortic valve prolapse demonstrated that the valve partially obscured the VSD, resulting in an underestimation of its size preoperatively. Consequently, despite test push-pull occlusion attempts, the occluder repeatedly dislodged into the right ventricle, preventing successful occlusion. While echocardiography is noninvasive, its limitations include operator experience and imaging plane selection. Incorporating intraoperative X-ray angiography can provide a comprehensive assessment to improve success rates. Notably, in icVSD, the shunt jet frequently adjoins the right coronary cusp of the aortic valve, potentially obscuring the defect. Additionally, the direction of the shunt jet may vary, and if the true size of the defect cannot be visualized even with increased angulation and if the shunt jet is directed posteriorly, transcatheter closure can be challenging. icVSD with concurrent aortic valve prolapse are not suitable for transcatheter closure, but small defects with mild aortic valve prolapse and no regurgitation may be amenable to occlusion attempts based on individual patient conditions. Studies have revealed that ventricular septum thickness increases with childhood growth, from 5 mm at birth to 12.5 mm by age 15 [ 18 ] . Our surgical observations indicate that older icVSD patients (> 16 years) possess thicker ventricular septums, suggesting a potential underestimation of the defect-aortic valve distance by preoperative echocardiography. This thicker ventricular septum provides better occluder placement support, minimizing the risk of postoperative aortic valve regurgitation and complications. We thus recommend long-term echocardiographic follow-up for childhood icVSD patients, considering transcatheter closure at a later age if aortic valve integrity is maintained. Hemolysis, an early complication after VSD occlusion surgery, occurs within days of the procedure, with a reported incidence of 4.7%-7.1%, often accompanied by residual shunts [ 19 , 20 ] . In our study, the hemolysis incidence in the icVSD and pmVSD groups was notably lower, at 0% and 0.96%, respectively. This reduction may be attributed to the bioceramic coating on the occluder, improving blood compatibility and reducing coagulation and hemolysis risks. Occluder diameter also impacts hemolysis, with larger diameters increasing blood-occluder contact. The four hemolysis patients in the pmVSD group had occluder diameters of 14–16 mm. For patients with hemolysis, most cases can be alleviated through conservative treatment such as timely hydration and alkalization of urine. However, for persistent or severe symptoms, early surgical removal of the occluder and repair of the VSD are recommended. Residual shunt is the most common complication after VSD occlusion surgery. While trace residual shunts may resolve spontaneously, severe residual shunts may lead to hemolysis, heart failure, endocarditis, pulmonary infection, and growth retardation. According to the literature, the early incidence of residual shunt after VSD surgery ranges from 16–23% [ 21 , 22 ] . Our study revealed residual shunt incidences of 17.9% and 16.6% in the icVSD and pmVSD groups, respectively, consistent with the literature. Over 12 months, these rates decreased to 2.6% and 4.3%, respectively, suggesting the effectiveness of our surgical techniques and occluder design. We attribute residual shunt occurrence to inappropriate occluder selection, either too large or too small. Additionally, the location and morphology of the VSD are also important factors that can influence the occurrence of residual shunt [ 23 ] . Therefore, detailed echocardiographic examination before surgery, intraoperative confirmation of the appropriate occluder size through angiography, and confirmation of no residual shunt or valve regurgitation during trial occlusion can all effectively reduce the incidence of postoperative residual shunt. Fortunately, in our study, none of the patients with residual shunt in either group developed cardiac enlargement, reduced cardiac function, or infectious endocarditis during the follow-up period, indicating that their prognosis was generally good and that the residual shunt gradually resolved over time. Therefore, we do not recommend increasing the diameter of the occluder used to prevent the occurrence of residual shunt. In transcatheter closure for VSD, icVSD and pmVSD pose unique challenges due to their complex relationships with surrounding tissues. These two types of VSDs are closely adjacent to the tricuspid valve and aortic valve, increasing the risk of damaging these critical valves during surgery, potentially leading to valvular insufficiency. In the icVSD group, the incidence of new-onset aortic regurgitation postoperatively was 10.26%, which is consistent with the reported literature. However, the incidence in the pmVSD group was only 3.37%, which was significantly lower than that previously reported [ 21 , 24 ] . Notably, there was no significant difference in the incidence of aortic regurgitation between the two groups during the early postoperative period or follow-up, and most cases were mild. During follow-up, aortic regurgitation improved in most patients, and no patients experienced significant surgical progression. The occurrence of aortic regurgitation in the icVSD group may be related to the proximity of the defect's superior margin to the aortic valve. Postclosure, the occluder may affect aortic closure or cause damage to the aortic valve during the establishment of the femoral artery-ventricular septal defect-femoral vein trajectory. Additionally, occluder displacement, another potential cause of aortic regurgitation [ 25 , 26 ] , did not occur in this study. In our study, both the icVSD and pmVSD groups exhibited lower incidences of tricuspid regurgitation than did the previous literature [ 24 , 27 , 28 ] . During follow-up, tricuspid regurgitation improved in most patients without further deterioration, and there was no significant difference between the two groups. Surgical factors, including the use of catheters and guidewires, are major risk factors. Studies have shown that friction between the occluder and chordae tendineae, as well as design flaws in the occluder itself, are risk factors for new-onset tricuspid regurgitation postoperatively [ 29 , 30 ] . Our practical experience suggests that the use of a pigtail compression delivery sheath during fixation in the left ventricle can easily cause damage to the tricuspid valve leaflets and chordae tendineae, which is the main cause of postoperative tricuspid insufficiency. The incidence of new-onset mitral regurgitation was minimal in both groups, with no cases in the icVSD group and a 0.72% incidence in the pmVSD group, consistent with previous reports. Since the catheter does not pass through the mitral valve during surgery, the incidence of mitral valve injury is very low [ 28 ] . However, high-pressure contrast media injected during left ventricular angiography could splash onto the chordae tendineae, potentially causing mitral valve damage. Additionally, a detailed analysis of the three patients with new-onset mitral regurgitation suggests that mitral valve injury may also be related to individual conditions. The anatomical proximity of the icVSD and pmVSD to the cardiac conduction system predisposes patients to arrhythmias. Our comparative analysis revealed that new-onset arrhythmias in icVSD patients were predominantly ventricular arrhythmias (10.3%), likely due to the extended 3 mm occluder side disk near the LV apex. In contrast, pmVSD patients exhibited a greater incidence of conduction blocks (9.6% vs 5.1% for the icVSD group). This discrepancy is attributed to the proximity of symmetric occluders in pmVSD to the His tract, whereas the eccentric occluder in icVSD is positioned relatively higher, avoiding the conduction tract. To mitigate arrhythmias, the occluder size should exceed the defect diameter by 1–2 mm, minimizing tissue compression and stimulation. For right bundle branch block, conventional-dose methylprednisolone is recommended, while for left bundle or anterior branch block, higher doses may be necessary. Ventricular and atrial diameter changes are pivotal for assessing cardiac function and structure. In this study, postoperative reductions in left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and left atrial diameter (LAD) were observed at three days, suggesting a beneficial impact of surgery on cardiac function and structure. The initial decrease may stem from surgical stress responses. At the one-month follow-up, further reductions likely reflect postoperative cardiac remodeling and recovery. Postoperative stabilization at three months suggested sustained improvements in cardiac structure and function. However, a gradual increase in these indices after 12 months, potentially linked to natural pediatric cardiac growth, was noted. Thus, long-term follow-up is essential for a comprehensive understanding of surgery's impact on pediatric cardiac structure and function, particularly during the growth and development phase. In addition to conventional indicators, electrocardiographic treadmill testing was utilized to assess patients' postoperative recovery of exercise function. This method, a standard cardiac evaluation, monitors electrocardiographic changes during exercise to assess cardiac reserve and tolerance. Our findings revealed high negative treadmill test rates of 88.9% and 90.8% for the icVSD and pmVSD surgeries, respectively. For patients with negative results, we advise a three-year follow-up to monitor long-term cardiac stability. Suspicious or positive results may require guided exercise, with treadmill testing repeated after a year. Positive test outcomes necessitate further targeted examinations and comprehensive analysis to guide treatment. These patients should refrain from intense exercise to avoid cardiac overburden. In summary, most patients who undergo transcatheter closure exhibit satisfactory postoperative recovery, enabling them to resume daily and physical activities and significantly enhancing their quality of life and societal integration. However, regular cardiac monitoring is crucial to ensure long-term cardiac health. 5. Conclusion This study demonstrated that percutaneous transcatheter closure using eccentric occluders for intracristal ventricular septal defect achieved comparable success rates and complication profiles to those reported for perimembranous ventricular septal defect. The outcomes are also comparable to surgical data in the literature [ 17 ] , indicating the safety and efficacy of this interventional approach for intracristal ventricular septal defect. For eligible intracristal ventricular septal defect patients, percutaneous transcatheter closure offers a minimally invasive alternative with significant clinical value and promising applications. Declarations Funding: None. Competing interests: The authors declare that they have no competing interests. Author Contribution T.X. and N.C. drafted the manuscript and reviewed relative literatures, so they contributed equally to this study. Y.H. revised and polished it. Under the guidance of R.W., S.Z., and X.R. operated interventional operation and they were also involved in the interpretation of data. Acknowledgement We are grateful to Li Hao for providing partial data and Shi Youyang for her guidance on echocardiography. Consent to Participate declaration : This was a retrospective review of cases of patients treated at the Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University. All participant received were considered standard care for their condition. The treatment these patients received was considered standard care for their condition. The Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University approved this retrospective study, and all patients provided written informed consent before the procedure and gave consent for their information to be used for this study. Clinical Trial Number : 2024-K-190-01 Data Availability declaration : The datasets generated during and/or analysed during the current study arenot publicly available due to protecting participant confidentiality but areavailable from the corresponding author on reasonable request. References Anderson RH, Becker AE, Tynan M. Description of ventricular septal defects—or how long is a piece of string. Int J Cardiol. 1986;13:267–78. Baumgartner H, Bonhoeffer P, De Groot NM. a1. ESC guidelines for the management of grown-up congenital heart disease(new version 2010). Eur Heart J. 2010;31(23):2915–57. Carminati M, Butera G, Chessa M, et al. Investigators of the European VSD Registry. Transcatheter closure of congenital ventricular septal defects: results of the European Registry. Eur Heart J. 2007;28(19):2361–8. Dean JW, Ho SY, Rowland E, et al. Clinical anatomy of the atrioventricular junctions. J Am Coll Cardiol. 1994;24(7):1725–31. Lopez L, Houyel L, Colan SD, et al. Classification of Ventricular Septal Defects for the Eleventh Iteration of the International Classification of Diseases-Striving for Consensus: A Report From the International Society for Nomenclature of Paediatric and Congenital Heart Disease. Ann Thorac Surg. 2018;106(5):1578–89. Arora R, Trehan V, Kumar A, et al. Transcatheter closure of congenital ventricular septal defects: experience with various devices [J]. J Interv Cardiol. 2003;16:83–91. Qin YW, Zhao XX, Li WP, et al. Application of Self-made Occluder for Transcatheter Closure of Membranous Ventricular Septal Defect [J]. J Interventional Radiol. 2002;11(2):130. Lai WW, Geva T, Shirali GS, et al. Guidelines and standards for performance of a pediatric echocardiogram: a report from the Task Force of the Pediatric Council of the American Society of Echocardiography. J Am Soc Echocardiogr. 2006;19(12):1413–30. Chen F, Li P, Liu S, et al. Transcatheter Closure of Intracristal Ventricular Septal Defect With Mild Aortic Cusp Prolapse Using Zero Eccentricity Ventricular Septal Defect Occluder. Circ J. 2015;79(10):2162–8. Gu M, You X, Zhao X, et al. Transcatheter device closure of intracristal ventricular septal defects. Am J Cardiol. 2011;107(1):110–3. Chinese Medical Doctor Association, Branch CD, Congenital Heart Disease Working Committee. Chinese Expert Consensus on Interventional Treatment for Common Congenital Heart Diseases [J]. J Interventional Radiol January 2011, 20, No. 1. Oses P, Hugues N, Dahdah N, et al. Treatment of isolated ventricular septal defects in children: amplatzer versus surgical closure. Ann Thorac Surg. 2010;90(5):1593–8. Chen SB. Congenital Heart Disease Imaging Diagnosis [M]. Beijing: People's Medical Publishing House; 2004. pp. 339–56. Ren WD, Chang C. Ultrasonic Diagnostics [M]. Beijing: People's Medical Publishing House; 2022. pp. 98–103. Turner ME, Bouhout I, Petit CJ, et al. Transcatheter Closure of Atrial and Ventricular Septal Defects: JACC Focus Seminar. J Am Coll Cardiol. 2022;79(22):2247–58. Li H, Shi Y, Zhang S, et al. Short- and medium-term follow-up of transcatheter closure of perimembranous ventricular septal defects. BMC Cardiovasc Disord. 2019;19(1):222. Xing Q, Pan S, An Q. et a1. 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(6):1409–15. Gui YH, Xue XD. Pediatrics [M]. Beijing: People's Medical Publishing House; 2015. pp. 241–83. El Said HG, Bratincsak A, Gordon BM, et al. Closure of perimembranous ventricular septal defects with aneurysmal tissue using the Amplazter Duct Occluder I: lessons learned and medium term follow up. Catheter Cardiovasc Interv. 2012;80(6):895–903. Esteves CA, Solarewicz LA, Cassar R, et al. Occlusion of the perimembranous ventricular septal defect using CERA® devices. Catheter Cardiovasc Interv. 2012;80(2):182–7. Roos-Hesselink JW, Meijboom FJ, Spitaels SE, et al. Outcome of patients after surgical closure of ventricular septal defect at young age: longitudinal follow-up of 22–34 years. Eur Heart J. 2004;25(12):1057–62. Oses P, Hugues N, Dahdah N, et al. Treatment of isolated ventricular septal defects in children: amplatzer versus surgical closure. Ann Thorac Surg. 2010;90(5):1593–8. Zhang YS, Li H, Liu JP, et al. Analysis of Complications in Interventional Treatment of Membranous Ventricular Septal Defects. Chin J Pediatr. 2005;43(1):35–8. Rahmath MR, Numan M, Dilawar M. Medium to long-term echo follow-up after ventricular septal defect device closure. Asian Cardiovasc Thorac Ann. 2016;24(5):422–7. Chen F, Li P, Liu S, et al. Transcatheter Closure of Intracristal Ventricular Septal Defect With Mild Aortic Cusp Prolapse Using Zero Eccentricity Ventricular Septal Defect Occluder. Circ J. 2015;79(10):2162–8. Gu M, You X, Zhao X, et al. Transcatheter device closure of intracristal ventricular septal defects. Am J Cardiol. 2011;107(1):110–3. Zuo J, Xie J, Yi W, et al. Results of transcatheter closure of perimembranous ventricular septal defect. Am J Cardiol. 2010;106(7):1034–7. Xue W, Jiang J, Shi CY, et al. A Comparative Study of the Impact of Interventional Occlusion and Surgical Repair on Valve Function in Ventricular Septal Defects. Adv Mod Biomed. 2016;16(10):1878–83. Shah JH, Saraiya SP, Nikam TS, et al. Transcatheter device closure of perimembranous ventricular septal defect in pediatric patients: long-term outcomes. Heart Views. 2020;21(1):17–21. Haddad RN, Daou L, Saliba Z. Device Closure of perimembranous ventricular septal defect: choosing between amplatzer occluders. Front Pediatr. 2019;7:300. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4604964","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":343424109,"identity":"e1de482f-0dcd-4d8d-937d-67b2da54f264","order_by":0,"name":"Tianhe Xia","email":"","orcid":"","institution":"Second Affiliated Hospital \u0026 Yuying Children's Hospital of Wenzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Tianhe","middleName":"","lastName":"Xia","suffix":""},{"id":343424111,"identity":"8d08d0a3-2954-40cd-b905-92a83231e6e1","order_by":1,"name":"Nuo Chen","email":"","orcid":"","institution":"Second Affiliated Hospital \u0026 Yuying Children's Hospital of Wenzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Nuo","middleName":"","lastName":"Chen","suffix":""},{"id":343424112,"identity":"4ffca0c7-647e-4a9e-8d46-36135c55da80","order_by":2,"name":"Yu Han","email":"","orcid":"","institution":"Second Affiliated Hospital \u0026 Yuying Children's Hospital of Wenzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Yu","middleName":"","lastName":"Han","suffix":""},{"id":343424114,"identity":"5679e587-a0a4-4bea-99f3-58b5102fc49f","order_by":3,"name":"Songyue Zhang","email":"","orcid":"","institution":"Second Affiliated Hospital \u0026 Yuying Children's Hospital of Wenzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Songyue","middleName":"","lastName":"Zhang","suffix":""},{"id":343424115,"identity":"d0f5e916-73ca-4634-8e22-27bf31d5d215","order_by":4,"name":"Xing Rong","email":"","orcid":"","institution":"Second Affiliated Hospital \u0026 Yuying Children's Hospital of Wenzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Xing","middleName":"","lastName":"Rong","suffix":""},{"id":343424116,"identity":"e2d3c576-bb5e-4503-8e4e-ded02141dae1","order_by":5,"name":"Rongzhou Wu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAuklEQVRIiWNgGAWjYHAC9h8JFQfArAMPiNUj8eDMAQYekJYEYrVIPmyDaGEgSovB7eMPDBLn3ZGzFzv8EGiLnZxuAyEt5xISEhK3PTPmkU4zAGpJNjY7QECL2RmGAwcStx1O7JFOAGkBsglrYWxsSJwD0pL+gVgtzMwMiQ0gLTlE2mJ/ho2NIeHYYWOe2zkFBxIMiPCLZA/7M8YfNYfl2Genb/7wocJOjqAWNGBAmvJRMApGwSgYBTgAADKQSCSVk+aMAAAAAElFTkSuQmCC","orcid":"","institution":"Second Affiliated Hospital \u0026 Yuying Children's Hospital of Wenzhou Medical University","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Rongzhou","middleName":"","lastName":"Wu","suffix":""}],"badges":[],"createdAt":"2024-06-19 09:52:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4604964/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4604964/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":63887042,"identity":"13d865d7-920b-4021-867d-375a76f4514f","added_by":"auto","created_at":"2024-09-03 11:35:41","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1589919,"visible":true,"origin":"","legend":"\u003cp\u003eComparison of preoperative, intraoperative and postoperative images of a child with icVSD: (a) Pre-operative echocardiographic five-chamber section, (b) Preoperative echocardiographic view of the short axis of the great artery, showing the defect at 12-1:30, (c) Preoperative echocardiographic section of left ventricle long-axis, (d) Preoperative left ventricular angiography, which revealed the defect margin of 2.5mm, (e) Left ventricular angiography 15 minutes after surgery, 5mm eccentric occluder to close the defect, no residual shunt, (f) Five-chamber section of postoperative echocardiography showed clear echo of eccentric occluder, confirming normal position of occluder.\u003c/p\u003e","description":"","filename":"Figure.1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4604964/v1/0aa616eeda82368d84bc96dc.jpg"},{"id":63887039,"identity":"cea2b6c2-6865-4834-8235-64c0b2f6d251","added_by":"auto","created_at":"2024-09-03 11:35:41","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":662958,"visible":true,"origin":"","legend":"\u003cp\u003e(a)Cera™ Membranous VSD (Symmetric) Occluder models and specifications. (b) Cera™ Membranous VSD(Eccentric) Occluder models and specifications.\u003c/p\u003e","description":"","filename":"Figure.2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4604964/v1/90c84da87d17da0386e2ce1b.jpg"},{"id":63887041,"identity":"ed3024da-75bb-437b-9fb2-346bd70752d8","added_by":"auto","created_at":"2024-09-03 11:35:41","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":201411,"visible":true,"origin":"","legend":"\u003cp\u003eInclusion and exclusion criteria for patients\u003c/p\u003e","description":"","filename":"Figure.3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4604964/v1/57ebb8dfc42be0eb4aa1e1d3.jpg"},{"id":63888315,"identity":"a377f0fc-1a4b-4ba9-9b12-8aef76dab522","added_by":"auto","created_at":"2024-09-03 11:43:41","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":340275,"visible":true,"origin":"","legend":"\u003cp\u003ePostoperative ultrasound follow-up (a)Postoperative residual diversion rate of patients in the two groups, (b)Number of patients with valve regurgitation during follow-up in both groups\u003c/p\u003e","description":"","filename":"Figure.4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4604964/v1/5f564e2fa1c3a71512f7a52f.jpg"},{"id":63887043,"identity":"21ca4adc-d41c-402c-9d30-075a7a8f4df8","added_by":"auto","created_at":"2024-09-03 11:35:41","extension":"jpg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":107130,"visible":true,"origin":"","legend":"\u003cp\u003eResults of postoperative electrocardiogram treadmill exercise test\u003c/p\u003e","description":"","filename":"Figure.5.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4604964/v1/27b0ab938c1f6d4af8adc954.jpg"},{"id":98380771,"identity":"c9059100-44de-43f8-ba6d-28e6f7852740","added_by":"auto","created_at":"2025-12-17 07:40:57","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":7326416,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4604964/v1/5bf89e45-002c-41bb-aa2b-19879eb3db54.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eTranscatheter closure with Eccentric Occluder for Intracristal Ventricular Septal Defect: A Safety and Efficacy Assessment\u003c/p\u003e","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eVentricular septal defect (VSD), with perimembranous VSD (pmVSD) as the predominant subtype, is a prevalent congenital heart anomaly \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. Treatment modalities include surgical repair and percutaneous occlusion, the latter of which is preferred because of its reduced invasiveness and expedited recovery \u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. The supraventricular crest, a muscular arcuate tissue dividing the tricuspid and pulmonary valves, forms the apex and outflow tract septum of the right ventricle \u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. Depending on the position of the defect relative to the supraventricular crest, VSDs are further categorized into outflow tract, perimembranous, and muscular defects \u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e. Among outflow tract VSDs, supracristal and intracristal ventricular septal defect (icVSD) are significant. Supracristal ventricular septal defects are contraindicated for transcatheter closure due to their proximity to the aortic and pulmonary valves. Similarly, the icVSD, owing to its close proximity to vital valvular structures, was once considered unsuitable for transcatheter closure because traditional symmetric occluders could overlay and impair valve function \u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eHowever, considering the unique anatomical characteristics of the icVSD, -which is located within the supraventricular crest structure of the right ventricular outflow tract and is surrounded by muscular tissue - this provides a basis for the design of occluders. China has introduced an eccentric occluder tailored to heart anatomy, optimizing occlusion efficiency while minimizing tissue injury \u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e. Although clinical experience with eccentric occluders for icVSD is limited, this study explored our center's early and medium-term follow-up results with this approach and compared them to those of percutaneous occlusion of pmVSD using symmetric occluders during a similar period.\u003c/p\u003e"},{"header":"2. Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Study design\u003c/h2\u003e \u003cp\u003eA retrospective cohort study was conducted at the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, enrolling 39 patients with icVSD and 416 with pmVSD who underwent percutaneous occlusion using eccentric and symmetric occluders from 2011 to 2021. Informed consent was obtained from each patient in this study, and the study was conducted in accordance with the ethical guidelines of the 1975 Declaration of Helsinki, with prior approval from the institution's human research committee. Patients were grouped based on defect location (pmVSD or icVSD). Evaluation before closure of the transcatheter included TTE, electrocardiogram, chest X-ray, troponin, and brain natriuretic peptide testing. TTE, performed by experienced echocardiographers adhering to pediatric echocardiography guidelines \u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e, utilized Philips EPIQ7C and IE Elite machines (2\u0026ndash;9 MHz probes) to assess defect size, residual rim, aortic valve prolapse, and defect-structure relationships. TTE plays a crucial role in diagnosing pmVSD and icVSD and requires multisectional evaluation \u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e. For pmVSD, the interruption or shunt flow of the interventricular septum echo in the short-axis view of the great vessels is located at the 9\u0026ndash;12 o'clock position in the parasternal view. For icVSD, the following criteria were used: ① loss of interventricular septum echo or shunt flow in the short-axis view of the great vessels is located between 11:30 and 1:00; ② a distance between the right edge of the VSD and the root of the pulmonary valve greater than 2 mm in the short-axis view of the great vessels; and ③ in the parasternal long-axis view of the left ventricle, where the VSD or the upper edge of its shunt flow is often adjacent to the root of the right aortic cusp.\u003c/p\u003e \u003cp\u003e \u003cb\u003eThe inclusion criterion was as follows\u003c/b\u003e \u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e:\u003c/p\u003e \u003cp\u003e(1) Age\u0026thinsp;\u0026ge;\u0026thinsp;2\u0026ndash;3 years, weight\u0026thinsp;\u0026ge;\u0026thinsp;10 kg; (2) TTE examination: pmVSD defect diameter\u0026thinsp;\u0026gt;\u0026thinsp;3 mm and \u0026lt;\u0026thinsp;14 mm, with a distance of \u0026ge;\u0026thinsp;2 mm between the superior rim of the defect and the right coronary cusp of the aortic valve, and no prolapse of the right coronary cusp of the aortic valve into the VSD; icVSD defect diameter\u0026thinsp;\u0026lt;\u0026thinsp;6mm, with a distance of \u0026ge;\u0026thinsp;2 mm between the superior rim of the defect and the pulmonary valve annulus.\u003c/p\u003e \u003cp\u003e \u003cb\u003eExclusion criteria\u003c/b\u003e \u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e:\u003c/p\u003e \u003cp\u003e(1) Infectious endocarditis or other infections causing bacteremia; (2) presence of thrombus at the site of occluder placement or venous thrombosis along the catheter insertion path; (3) VSD with significant aortic valve prolapse and aortic regurgitation; (4) pmVSD diameter\u0026thinsp;\u0026ge;\u0026thinsp;14 mm, icVSD defect diameter\u0026thinsp;\u0026ge;\u0026thinsp;6 mm; (5) supracristal ventricular septal defect; (6) severe pulmonary hypertension with bidirectional shunt; (7) abnormal coagulation function; (8) abnormal liver and kidney function; and (9) congestive heart failure.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2 Procedure\u003c/h2\u003e \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e \u003ch2\u003e2.2.1 Radiologically Guided Percutaneous Transcatheter Closure for VSD\u003c/h2\u003e \u003cp\u003e(1) Preoperative Medication: Daily aspirin at 3\u0026ndash;5 mg/kg was initiated 24 hours prior to surgery.\u003c/p\u003e \u003cp\u003e(2) Anesthesia and heparinization: Local anesthesia was applied to the right groin, followed by IV heparin at 0.8 mg/kg to maintain an ACT\u0026thinsp;\u0026gt;\u0026thinsp;250 seconds.\u003c/p\u003e \u003cp\u003e(3) Angiography: Assessment of the VSD and aortic valve via the right femoral artery using a 5 Fc pigtail catheter. A MPA2 catheter was inserted via the right femoral vein to the pulmonary artery for pressure measurements.\u003c/p\u003e \u003cp\u003e(4) Trajectory establishment: The transseptal pathway was created using a basket catheter and long guidewire, traversing the VSD from the femoral vein to the left ventricle.\u003c/p\u003e \u003cp\u003e(5) Occluder Placement: A delivery sheath was advanced through the established trajectory, and its tip was positioned in the left ventricular apex.\u003c/p\u003e \u003cp\u003e(6) Verification and Release: An appropriately sized occluder was deployed under echo and DSA guidance, ensuring correct positioning and shape. Postdeployment, confirmation of no significant shunt was confirmed via left ventricular angiography and no aortic regurgitation was confirmed by ascending aortic angiography prior to full occluder release.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e \u003ch2\u003e2.2.2 Selection of occluder\u003c/h2\u003e \u003cp\u003eBased on intraoperative angiographic imaging and preoperative TTE findings, occluders were selected from the Cera\u0026trade; Ceramic Membrane VSD (Symmetric) Occluder (Shenzhen Life Science Co., LTD., China) and the Cera\u0026trade; Ceramic Membrane VSD (Eccentric) Occluder (Shenzhen Life Science Co., LTD., China). The detailed models and specifications are presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003eWhen selecting the appropriate occluder size, symmetric occluders are preferred for defects located more than 2 mm away from the aortic valve, while eccentric occluders are preferred for defects closer than 2 mm. For pmVSD, the diameter of the selected occluder is typically 1\u0026ndash;3 mm larger than the angiographically measured diameter. However, for icVSD or VSD with concurrent aortic valve prolapse, left ventricular angiography may not always reveal the full extent of the defect. In such cases, ultrasound or angiography can be employed after the delivery sheath passes through the VSD to observe the size of the ventricular septal flow jet, aiding in the determination of defect size and the selection of an appropriate occluder.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Follow-up\u003c/h2\u003e \u003cp\u003eIntraoperatively, TTE was used to monitor occluder placement. Postoperatively, day 3 TTE was used to assess the occluder morphology, position, residual shunt, regurgitation, and cardiac function. Daily ECG was used to monitor arrhythmias and conduction blocks. Standard care included oxygen, aspirin anticoagulation, methylprednisolone for inflammation/edema, and levocarnitine for myocardial nutrition. Uncomplicated patients were discharged after 3\u0026ndash;5 days, advised to avoid strenuous activity, and prescribed aspirin (3\u0026ndash;5 mg/kg/d) for 6 months. The patients were followed up with TTE, ECG, and chest X-ray at 1, 3, 6, 12, 24, 36, and 60 months postop, and the data were collected through Dec 2023.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e2.4 Statistical analysis\u003c/h2\u003e \u003cp\u003eContinuous variables are presented as the means, medians, standard deviations, ranges, and quartiles, while categorical variables are presented in frequency tables and bar charts. All the statistical analyses were conducted in SPSS (v25.0) with MSTATA support. A P value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Results","content":"\u003cp\u003eA total of 455 patients were enrolled based on the inclusion/exclusion criteria (Figure. 3). In the icVSD group, 38/39 patients underwent successful occluder implantation (97.4% success rate). One patient required surgical occlusion due to aortic valve prolapse and an underestimated defect diameter. In the pmVSD group, implantation was successful in 413/416 patients (99.3% success rate). Two patients experienced complications postimplantation, including hemolysis, aortic regurgitation, residual shunting, and arrhythmia, necessitating occluder removal and further surgical intervention. One patient with a VSD and a 2.2 mm fistula was also surgically treated. No significant difference in success rate was observed between the groups.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003e3.1 Baseline characteristics of patients\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e summarizes the baseline characteristics of the icVSD (39 patients) and pmVSD (416 patients) groups. When analyzing and comparing the differences between the two groups, we observed no significant differences in age, sex, weight, and birth weight. However, compared to pmVSD patients, icVSD patients exhibited longer hospitalization and catheterization durations. Notably, compared with pmVSD patients, icVSD patients had a lower incidence of ventricular septal membrane aneurysm (15% vs. 41% in pmVSD, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05) and a greater incidence of aortic valve prolapse (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). The defect diameters determined by TTE were similar, but the occluder diameters were smaller in icVSD. Preoperative BNP levels and intraoperative systolic pulmonary artery pressures were lower in icVSD (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePatient demographics and baseline characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003etreatment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep-value\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003epmVSD, N\u0026thinsp;=\u0026thinsp;416\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eicVSD, N\u0026thinsp;=\u0026thinsp;39\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge (month)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e57\u0026thinsp;\u0026plusmn;\u0026thinsp;49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e75\u0026thinsp;\u0026plusmn;\u0026thinsp;65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.095\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGender\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.688\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003efemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e206 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18 (46%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003emale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e210 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21 (54%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWeight(kg)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18\u0026thinsp;\u0026plusmn;\u0026thinsp;9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23\u0026thinsp;\u0026plusmn;\u0026thinsp;14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.047\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBirth weight(kg)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.30\u0026thinsp;\u0026plusmn;\u0026thinsp;1.68\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.22\u0026thinsp;\u0026plusmn;\u0026thinsp;0.54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.559\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eLength of stay(day)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.61\u0026thinsp;\u0026plusmn;\u0026thinsp;2.40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.00\u0026thinsp;\u0026plusmn;\u0026thinsp;3.37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.492\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFollow-up time(month)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26\u0026thinsp;\u0026plusmn;\u0026thinsp;20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28\u0026thinsp;\u0026plusmn;\u0026thinsp;20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.492\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMembranous aneurysms\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.002\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e242 (59%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33 (85%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAneurysms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e170 (41%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (15%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAortic valve prolapse\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e392 (95%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15 (38%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProlapse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24 (62%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRadiography time(minutes)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e58\u0026thinsp;\u0026plusmn;\u0026thinsp;31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e78\u0026thinsp;\u0026plusmn;\u0026thinsp;32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.002\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDefect diameter by TTE(mm)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.56\u0026thinsp;\u0026plusmn;\u0026thinsp;1.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.33\u0026thinsp;\u0026plusmn;\u0026thinsp;1.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.310\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAmplatzer duct occluder size(mm)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6.78\u0026thinsp;\u0026plusmn;\u0026thinsp;2.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.87\u0026thinsp;\u0026plusmn;\u0026thinsp;1.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBPN (pg/ml)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e123\u0026thinsp;\u0026plusmn;\u0026thinsp;107\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e87\u0026thinsp;\u0026plusmn;\u0026thinsp;53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSystolic PA pressure (mmHg)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29\u0026thinsp;\u0026plusmn;\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27\u0026thinsp;\u0026plusmn;\u0026thinsp;5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.010\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003e\u003csup\u003e1\u003c/sup\u003eMean \u0026plusmn; SD; n (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003e\u003csup\u003e2\u003c/sup\u003eWelch Two Sample t-test; Pearson's Chi-squared test; Fisher's exact test\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e3.2 Postoperative Complications\u003c/h2\u003e \u003cp\u003ePostoperative complications directly impact operation success and patient rehabilitation. In our study, 4 implantation failures were excluded from the complication analysis. No major bleeding, death, or serious complications occurred in either group. The icVSD group showed no mechanical hemolysis, whereas the pmVSD group experienced 4 cases (0.96%) of hematuria attributed to mechanical hemolysis. Three patients improved after treatment, while one patient with severe disease and a complete right bundle branch block and residual shunt required occluder removal and further surgery. Postoperatively, 1 pmVSD patient experienced minor pericardial effusion, which resolved spontaneously within 6 days. The median follow-up was 36 (1\u0026ndash;60) months for icVSD and 24 (0.1\u0026ndash;60) months for pmVSD.\u003c/p\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003e3.2.1 Residual shunt\u003c/h2\u003e \u003cp\u003eTTE showed signs of a shunt at the edge of the occluder, suggesting a possible residual shunt \u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e, but leakage through the occluder should be excluded. The detailed residual diversion rates are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e(a). Postoperatively, in the icVSD group, 7 patients (18.4%) exhibited a residual shunt, which resolved within 24 months, with most patients resolving within 3 months. In the pmVSD group, 69 patients (16.7%) had residual shunts, 27 of whom resolved within 1 month, and the remainder gradually resolved up to 36 months postoperatively.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003e3.2.2 Valve regurgitation\u003c/h2\u003e \u003cp\u003eValve regurgitation, caused by incomplete valve closure, results in blood reflux between chambers. Using TTE, valve regurgitation was graded as follows: tricuspid regurgitation - none, mild (\u0026lt;\u0026thinsp;1.4 cm jet length, \u0026lt;\u0026thinsp;2 cm\u0026sup2; area), moderate (1.4\u0026ndash;2.9 cm jet length, 2-3.9 cm\u0026sup2; area), or severe (\u0026gt;\u0026thinsp;4.5 cm jet length, \u0026gt;\u0026thinsp;10 cm\u0026sup2; area) \u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e; aortic regurgitation - none, mild (jet not exceeding the anterior leaflet of the mitral valve, \u0026lt;\u0026thinsp;25% jet width/LVOT), moderate (jet to papillary muscle level, 25%-46%), or severe (beyond the papillary muscle to apex, \u0026gt;\u0026thinsp;47%) \u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/sup\u003e; and mitral regurgitation - none, mild (\u0026lt;\u0026thinsp;20% jet/left atrial area ratio), moderate (20%-40%), or severe (\u0026gt;\u0026thinsp;40%) \u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e(b) summarizes the echocardiographic findings of valve regurgitation in the icVSD group before and after surgery. Postoperatively, 10 patients (25.6%) exhibited valve regurgitation\u0026mdash;4 (10.3%) with aortic regurgitation and 6 (15.4%) with tricuspid regurgitation. No cases of mitral regurgitation were noted. Preoperatively, the icVSD group was devoid of aortic regurgitation, yet 4 new cases appeared postoperatively, of which 1 was moderate and persisted for 36 months, while 3 mild cases resolved within 36 months. Preexisting mitral regurgitation required surgery in 1 patient and resolved spontaneously in another within 3 months, with no new cases emerging. Among the 6 preoperative tricuspid regurgitation patients, 3 persisted postoperatively, with 1 remaining after 6 months, while 4 new patients resolved within 3 months of surgery.\u003c/p\u003e \u003cp\u003eIn the pmVSD group, 139 patients (33.4%) presented with valve regurgitation three days postoperatively, including 15 (3.6%) with aortic regurgitation, 108 (26.0%) with tricuspid regurgitation, and 16 (3.8%) with mitral regurgitation. Among the aortic regurgitation cases, 10 pre-existing cases resolved in 5 patients and persisted in 5 patients, while 10 new cases emerged, mostly resolving by 24 months, except for one case that progressed from mild to moderate regurgitation over 24 months in a patient with a 4 mm defect from the aortic valve treated with a 7 mm symmetric occluder. Three new cases appeared at 6 months, with 2 resolving by 24 months and 1 persisting to 36 months. Among those with mitral regurgitation, 13 of 28 preoperative cases persisted. For tricuspid regurgitation, 64 preoperative cases and 44 new cases emerged postoperatively, mostly resolving during follow-up, except for 2 new moderate cases, one associated with bilateral pulmonary artery stenosis and the other with pulmonary hypertension.\u003c/p\u003e \u003cp\u003eThere were no statistically significant differences between the two groups in terms of the presence of residual shunts or the presence of various types of valve regurgitation at 3 days postoperatively, as detailed in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of abnormal indicators of echocardiography between the two groups on day 3 after surgery\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003epmVSD(n\u0026thinsp;=\u0026thinsp;413)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eicVSD(n\u0026thinsp;=\u0026thinsp;38)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResidual Shunt\u003c/p\u003e \u003cp\u003eTricuspid Regurgitation\u003c/p\u003e \u003cp\u003eAortic Regurgitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e69(16.7)\u003c/p\u003e \u003cp\u003e108(26.2)\u003c/p\u003e \u003cp\u003e15(3.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7(18.4)\u003c/p\u003e \u003cp\u003e6(15.8)\u003c/p\u003e \u003cp\u003e4(10.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.787\u003c/p\u003e \u003cp\u003e0.160\u003c/p\u003e \u003cp\u003e0.109\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMitral Regurgitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16(3.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0(0.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.437\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section3\"\u003e \u003ch2\u003e3.2.3 Arrhythmia\u003c/h2\u003e \u003cp\u003eIn the icVSD group, one preoperative case of incomplete right bundle branch block (IRBBB) persisted postoperatively, without improvement, and ventricular extrasystoles emerged. Postoperatively, six new arrhythmia patients were noted, comprising two with IRBBB and four with ventricular premature contractions. In contrast, the pmVSD group exhibited 55 new arrhythmia cases, including seven complete right bundle branch block (CRBBB), two of which evolved from preoperative IRBBB. One patient normalized in three days, while another showed ECG improvement after seven days. Twenty-two patients remained with IRBBB, and one patient developed complete left bundle branch block with intermittent type A Wolff‒Parkinson White syndrome one month postoperatively. Following high-dose methylprednisolone therapy, significant ECG improvement was observed. Additionally, 10 new cases of left anterior fascicular block occurred, with eight gradually returning to normal within 10 days. One new left bundle branch block patient normalized within four days. A significant difference in new ventricular premature contractions was observed between the two groups at three days postoperatively (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). However, no significant differences in other arrhythmia types were noted during the same period, as detailed in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of new abnormal electrocardiogram indicators between the two groups 3 days after surgery\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003epmVSD(n\u0026thinsp;=\u0026thinsp;413)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eicVSD(n\u0026thinsp;=\u0026thinsp;38)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNew arrhythmia\u003c/p\u003e \u003cp\u003eAv block\u003c/p\u003e \u003cp\u003eCRBBB\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e55(13.3)\u003c/p\u003e \u003cp\u003e11(2.7)\u003c/p\u003e \u003cp\u003e7(1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6(15.8)\u003c/p\u003e \u003cp\u003e0(0.0)\u003c/p\u003e \u003cp\u003e0(0.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.670\u003c/p\u003e \u003cp\u003e0.639\u003c/p\u003e \u003cp\u003e0.902\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIRBBB\u003c/p\u003e \u003cp\u003eExtrasystole\u003c/p\u003e \u003cp\u003eTwo or more exceptions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22(5.3)\u003c/p\u003e \u003cp\u003e6(1.5)\u003c/p\u003e \u003cp\u003e6(1.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(5.3)\u003c/p\u003e \u003cp\u003e4(10.5)\u003c/p\u003e \u003cp\u003e1(2.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.000\u003c/p\u003e \u003cp\u003e0.002\u003c/p\u003e \u003cp\u003e1.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section3\"\u003e \u003ch2\u003e3.2.4 Cardiac function\u003c/h2\u003e \u003cp\u003eChanges in postoperative cardiac function serve as a direct indicator of surgical outcomes. As detailed in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e, the comparison of the postoperative left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left atrial diameter (LAD), right ventricular diameter (RV), and left ventricular ejection fraction (EF) between the two groups revealed a decreasing trend in the LVEDD, LVESD, and LAD at three days postoperatively, with significant differences from the preoperative values (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). This trend continued at the one-month follow-up, exhibiting further reductions. However, from the three-month follow-up, these parameters stabilized, with no significant changes observed at the three- and six-month follow-ups. Given the subjects' growth and development, these parameters gradually increased after 12 months of follow-up. In contrast, the RV and EF values remained relatively stable during the entire follow-up period.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of preoperative and postoperative echocardiographic follow-up between the two groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"11\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroups\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBefore\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3-day\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1-month\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3-month\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6-month\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003e12-month\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003e24-month\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c10\"\u003e \u003cp\u003e36-month\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c11\"\u003e \u003cp\u003e60-month\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epmVSD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLVEDD\u003c/p\u003e \u003cp\u003e(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd 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colname=\"c5\"\u003e \u003cp\u003e21.38\u0026thinsp;\u0026plusmn;\u0026thinsp;10.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e20.68\u0026thinsp;\u0026plusmn;\u0026thinsp;3.0\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e20.85\u0026thinsp;\u0026plusmn;\u0026thinsp;2.7\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e21.32\u0026thinsp;\u0026plusmn;\u0026thinsp;3.1*\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e22.27\u0026thinsp;\u0026plusmn;\u0026thinsp;3.6\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e22.79\u0026thinsp;\u0026plusmn;\u0026thinsp;2.6\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e 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align=\"left\" colname=\"c7\"\u003e \u003cp\u003e23.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.7\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e24.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.7*\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e25.3\u0026thinsp;\u0026plusmn;\u0026thinsp;4.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e25.7\u0026thinsp;\u0026plusmn;\u0026thinsp;3.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e27.17\u0026thinsp;\u0026plusmn;\u0026thinsp;3.77\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRV\u003c/p\u003e \u003cp\u003e(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18.8\u0026thinsp;\u0026plusmn;\u0026thinsp;5.4*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e18.7\u0026thinsp;\u0026plusmn;\u0026thinsp;5.2*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e19.2\u0026thinsp;\u0026plusmn;\u0026thinsp;4.9*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e19.5\u0026thinsp;\u0026plusmn;\u0026thinsp;4.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e20.0\u0026thinsp;\u0026plusmn;\u0026thinsp;4.9*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e21.4\u0026thinsp;\u0026plusmn;\u0026thinsp;5.2\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e21.9\u0026thinsp;\u0026plusmn;\u0026thinsp;4.7\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e24.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.7\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEF\u003c/p\u003e \u003cp\u003e(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e70.0\u0026thinsp;\u0026plusmn;\u0026thinsp;5.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e70.0\u0026thinsp;\u0026plusmn;\u0026thinsp;5.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e69.3\u0026thinsp;\u0026plusmn;\u0026thinsp;4.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e 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colname=\"c2\"\u003e \u003cp\u003eLVEDD\u003c/p\u003e \u003cp\u003e(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35.3\u0026thinsp;\u0026plusmn;\u0026thinsp;4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e34.5\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e35.1\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e34.6\u0026thinsp;\u0026plusmn;\u0026thinsp;4.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e36.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e 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\u003cp\u003e24.14\u0026thinsp;\u0026plusmn;\u0026thinsp;2.7\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLAD\u003c/p\u003e \u003cp\u003e(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26.7\u0026thinsp;\u0026plusmn;\u0026thinsp;3.6*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.7*\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e25.0\u0026thinsp;\u0026plusmn;\u0026thinsp;3.8*\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e25.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.7*\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e24.8\u0026thinsp;\u0026plusmn;\u0026thinsp;3.4\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e26.29\u0026thinsp;\u0026plusmn;\u0026thinsp;3.1*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e25.2\u0026thinsp;\u0026plusmn;\u0026thinsp;4.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e25.68\u0026thinsp;\u0026plusmn;\u0026thinsp;2.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e28.57\u0026thinsp;\u0026plusmn;\u0026thinsp;4.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRV\u003c/p\u003e \u003cp\u003e(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.1*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e21.6\u0026thinsp;\u0026plusmn;\u0026thinsp;4.8*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.9*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e21.3\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e23.5\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0*\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e21.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e23.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e26.4\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEF\u003c/p\u003e \u003cp\u003e(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e69.5\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e71.3\u0026thinsp;\u0026plusmn;\u0026thinsp;4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e69.2\u0026thinsp;\u0026plusmn;\u0026thinsp;5.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e69.6\u0026thinsp;\u0026plusmn;\u0026thinsp;4.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e69.8\u0026thinsp;\u0026plusmn;\u0026thinsp;3.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e67.7\u0026thinsp;\u0026plusmn;\u0026thinsp;3.5*\u003csup\u003e△\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e70.2\u0026thinsp;\u0026plusmn;\u0026thinsp;4.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e71.2\u0026thinsp;\u0026plusmn;\u0026thinsp;4.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e68.50\u0026thinsp;\u0026plusmn;\u0026thinsp;3.66\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"11\"\u003e△: Statistically significant difference compared with preoperative comparison (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05);\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e*: statistically significant difference compared with two groups (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003e3.3 Electrocardiogram treadmill exercise test\u003c/h2\u003e \u003cp\u003ePatients were counseled against intense physical activity for the initial six postoperative months. Subsequently, 96 patients from the follow-up cohort, comprising 9 from the icVSD group and 87 from the pmVSD group, underwent an electrocardiogram (ECG) treadmill exercise test, and the results are detailed in Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e. In the icVSD group, 88.9% had negative test results, exhibiting no arrhythmias at rest or during exercise. One patient had suspicious results due to occasional ventricular extrasystoles. The pmVSD group had a 90.8% negative rate, with 79 patients without arrhythmias. Abnormalities in the pmVSD group included various electrocardiographic and symptomatic findings. Patients with negative test results were scheduled for follow-up after three years, while those with suspicious or positive results were advised on continued routine activity and repeat testing after one year. Positive result patients were recommended for further investigations and tailored treatment.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eVentricular septal defects (VSD) are classified into outflow tract, perimembranous (pmVSD), and muscular types. Well-established transcatheter closure techniques exist for pmVSD and muscular VSD \u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e, but intracristal VSD (icVSD) remains challenging due to its proximity to the aortic valve. The recent development of eccentric occluders in China has offered new therapeutic prospects for icVSD, improving interventional outcomes and minimizing tissue damage. However, research on the use of eccentric occluders for icVSD is limited, and postoperative recovery reports are scarce. Here, we assessed the safety and feasibility of eccentric occluder-based transcatheter closure for treating icVSD through short- and medium-term follow-ups and compared the outcomes with those of pmVSD patients treated with symmetric occluders.\u003c/p\u003e \u003cp\u003eIn this study, the success rate of icVSD with eccentric occluders was 97.4%, which was not significantly different from that of pmVSD with symmetrical occluders (99.3%). This success rate is more prominent than that of traditional incisions of the lower end of the sternum and pericardium to place the occluder (96.3%) \u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e. Overall, the eccentrically designed occluder demonstrated comparable success rates in transcatheter closure in the icVSD group compared to the pmVSD group and showed significant advantages over traditional surgical methods.\u003c/p\u003e \u003cp\u003eThe precise preoperative evaluation of VSD characteristics is crucial for transcatheter closure surgery. In the icVSD group, a case involving aortic valve prolapse demonstrated that the valve partially obscured the VSD, resulting in an underestimation of its size preoperatively. Consequently, despite test push-pull occlusion attempts, the occluder repeatedly dislodged into the right ventricle, preventing successful occlusion. While echocardiography is noninvasive, its limitations include operator experience and imaging plane selection. Incorporating intraoperative X-ray angiography can provide a comprehensive assessment to improve success rates. Notably, in icVSD, the shunt jet frequently adjoins the right coronary cusp of the aortic valve, potentially obscuring the defect. Additionally, the direction of the shunt jet may vary, and if the true size of the defect cannot be visualized even with increased angulation and if the shunt jet is directed posteriorly, transcatheter closure can be challenging. icVSD with concurrent aortic valve prolapse are not suitable for transcatheter closure, but small defects with mild aortic valve prolapse and no regurgitation may be amenable to occlusion attempts based on individual patient conditions.\u003c/p\u003e \u003cp\u003eStudies have revealed that ventricular septum thickness increases with childhood growth, from 5 mm at birth to 12.5 mm by age 15 \u003csup\u003e[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e. Our surgical observations indicate that older icVSD patients (\u0026gt;\u0026thinsp;16 years) possess thicker ventricular septums, suggesting a potential underestimation of the defect-aortic valve distance by preoperative echocardiography. This thicker ventricular septum provides better occluder placement support, minimizing the risk of postoperative aortic valve regurgitation and complications. We thus recommend long-term echocardiographic follow-up for childhood icVSD patients, considering transcatheter closure at a later age if aortic valve integrity is maintained.\u003c/p\u003e \u003cp\u003eHemolysis, an early complication after VSD occlusion surgery, occurs within days of the procedure, with a reported incidence of 4.7%-7.1%, often accompanied by residual shunts \u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e. In our study, the hemolysis incidence in the icVSD and pmVSD groups was notably lower, at 0% and 0.96%, respectively. This reduction may be attributed to the bioceramic coating on the occluder, improving blood compatibility and reducing coagulation and hemolysis risks. Occluder diameter also impacts hemolysis, with larger diameters increasing blood-occluder contact. The four hemolysis patients in the pmVSD group had occluder diameters of 14\u0026ndash;16 mm. For patients with hemolysis, most cases can be alleviated through conservative treatment such as timely hydration and alkalization of urine. However, for persistent or severe symptoms, early surgical removal of the occluder and repair of the VSD are recommended.\u003c/p\u003e \u003cp\u003eResidual shunt is the most common complication after VSD occlusion surgery. While trace residual shunts may resolve spontaneously, severe residual shunts may lead to hemolysis, heart failure, endocarditis, pulmonary infection, and growth retardation. According to the literature, the early incidence of residual shunt after VSD surgery ranges from 16\u0026ndash;23% \u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e. Our study revealed residual shunt incidences of 17.9% and 16.6% in the icVSD and pmVSD groups, respectively, consistent with the literature. Over 12 months, these rates decreased to 2.6% and 4.3%, respectively, suggesting the effectiveness of our surgical techniques and occluder design. We attribute residual shunt occurrence to inappropriate occluder selection, either too large or too small. Additionally, the location and morphology of the VSD are also important factors that can influence the occurrence of residual shunt \u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e. Therefore, detailed echocardiographic examination before surgery, intraoperative confirmation of the appropriate occluder size through angiography, and confirmation of no residual shunt or valve regurgitation during trial occlusion can all effectively reduce the incidence of postoperative residual shunt. Fortunately, in our study, none of the patients with residual shunt in either group developed cardiac enlargement, reduced cardiac function, or infectious endocarditis during the follow-up period, indicating that their prognosis was generally good and that the residual shunt gradually resolved over time. Therefore, we do not recommend increasing the diameter of the occluder used to prevent the occurrence of residual shunt.\u003c/p\u003e \u003cp\u003eIn transcatheter closure for VSD, icVSD and pmVSD pose unique challenges due to their complex relationships with surrounding tissues. These two types of VSDs are closely adjacent to the tricuspid valve and aortic valve, increasing the risk of damaging these critical valves during surgery, potentially leading to valvular insufficiency. In the icVSD group, the incidence of new-onset aortic regurgitation postoperatively was 10.26%, which is consistent with the reported literature. However, the incidence in the pmVSD group was only 3.37%, which was significantly lower than that previously reported \u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/sup\u003e. Notably, there was no significant difference in the incidence of aortic regurgitation between the two groups during the early postoperative period or follow-up, and most cases were mild. During follow-up, aortic regurgitation improved in most patients, and no patients experienced significant surgical progression. The occurrence of aortic regurgitation in the icVSD group may be related to the proximity of the defect's superior margin to the aortic valve. Postclosure, the occluder may affect aortic closure or cause damage to the aortic valve during the establishment of the femoral artery-ventricular septal defect-femoral vein trajectory. Additionally, occluder displacement, another potential cause of aortic regurgitation \u003csup\u003e[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]\u003c/sup\u003e, did not occur in this study.\u003c/p\u003e \u003cp\u003eIn our study, both the icVSD and pmVSD groups exhibited lower incidences of tricuspid regurgitation than did the previous literature \u003csup\u003e[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e. During follow-up, tricuspid regurgitation improved in most patients without further deterioration, and there was no significant difference between the two groups. Surgical factors, including the use of catheters and guidewires, are major risk factors. Studies have shown that friction between the occluder and chordae tendineae, as well as design flaws in the occluder itself, are risk factors for new-onset tricuspid regurgitation postoperatively \u003csup\u003e[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]\u003c/sup\u003e. Our practical experience suggests that the use of a pigtail compression delivery sheath during fixation in the left ventricle can easily cause damage to the tricuspid valve leaflets and chordae tendineae, which is the main cause of postoperative tricuspid insufficiency.\u003c/p\u003e \u003cp\u003eThe incidence of new-onset mitral regurgitation was minimal in both groups, with no cases in the icVSD group and a 0.72% incidence in the pmVSD group, consistent with previous reports. Since the catheter does not pass through the mitral valve during surgery, the incidence of mitral valve injury is very low \u003csup\u003e[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e. However, high-pressure contrast media injected during left ventricular angiography could splash onto the chordae tendineae, potentially causing mitral valve damage. Additionally, a detailed analysis of the three patients with new-onset mitral regurgitation suggests that mitral valve injury may also be related to individual conditions.\u003c/p\u003e \u003cp\u003eThe anatomical proximity of the icVSD and pmVSD to the cardiac conduction system predisposes patients to arrhythmias. Our comparative analysis revealed that new-onset arrhythmias in icVSD patients were predominantly ventricular arrhythmias (10.3%), likely due to the extended 3 mm occluder side disk near the LV apex. In contrast, pmVSD patients exhibited a greater incidence of conduction blocks (9.6% vs 5.1% for the icVSD group). This discrepancy is attributed to the proximity of symmetric occluders in pmVSD to the His tract, whereas the eccentric occluder in icVSD is positioned relatively higher, avoiding the conduction tract. To mitigate arrhythmias, the occluder size should exceed the defect diameter by 1\u0026ndash;2 mm, minimizing tissue compression and stimulation. For right bundle branch block, conventional-dose methylprednisolone is recommended, while for left bundle or anterior branch block, higher doses may be necessary.\u003c/p\u003e \u003cp\u003eVentricular and atrial diameter changes are pivotal for assessing cardiac function and structure. In this study, postoperative reductions in left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and left atrial diameter (LAD) were observed at three days, suggesting a beneficial impact of surgery on cardiac function and structure. The initial decrease may stem from surgical stress responses. At the one-month follow-up, further reductions likely reflect postoperative cardiac remodeling and recovery. Postoperative stabilization at three months suggested sustained improvements in cardiac structure and function. However, a gradual increase in these indices after 12 months, potentially linked to natural pediatric cardiac growth, was noted. Thus, long-term follow-up is essential for a comprehensive understanding of surgery's impact on pediatric cardiac structure and function, particularly during the growth and development phase.\u003c/p\u003e \u003cp\u003eIn addition to conventional indicators, electrocardiographic treadmill testing was utilized to assess patients' postoperative recovery of exercise function. This method, a standard cardiac evaluation, monitors electrocardiographic changes during exercise to assess cardiac reserve and tolerance. Our findings revealed high negative treadmill test rates of 88.9% and 90.8% for the icVSD and pmVSD surgeries, respectively. For patients with negative results, we advise a three-year follow-up to monitor long-term cardiac stability. Suspicious or positive results may require guided exercise, with treadmill testing repeated after a year. Positive test outcomes necessitate further targeted examinations and comprehensive analysis to guide treatment. These patients should refrain from intense exercise to avoid cardiac overburden. In summary, most patients who undergo transcatheter closure exhibit satisfactory postoperative recovery, enabling them to resume daily and physical activities and significantly enhancing their quality of life and societal integration. However, regular cardiac monitoring is crucial to ensure long-term cardiac health.\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003eThis study demonstrated that percutaneous transcatheter closure using eccentric occluders for intracristal ventricular septal defect achieved comparable success rates and complication profiles to those reported for perimembranous ventricular septal defect. The outcomes are also comparable to surgical data in the literature \u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e, indicating the safety and efficacy of this interventional approach for intracristal ventricular septal defect. For eligible intracristal ventricular septal defect patients, percutaneous transcatheter closure offers a minimally invasive alternative with significant clinical value and promising applications.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003eNone.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCompeting interests:\u003c/strong\u003e \u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eT.X. and N.C. drafted the manuscript and reviewed relative literatures, so they contributed equally to this study. Y.H. revised and polished it. Under the guidance of R.W., S.Z., and X.R. operated interventional operation and they were also involved in the interpretation of data.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eWe are grateful to Li Hao for providing partial data and Shi Youyang for her guidance on echocardiography.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConsent to Participate declaration\u003c/strong\u003e\u003cstrong\u003e:\u003c/strong\u003eThis was a retrospective review of cases of patients treated at the Second Affiliated Hospital and Yuying Children\u0026rsquo;s Hospital of Wenzhou Medical University. All participant received were considered standard care for their condition. The treatment these patients received was considered standard care for their condition. The Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University approved this retrospective study, and all patients provided written informed consent before the procedure and gave consent for their information to be used for this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical Trial Number\u003c/strong\u003e\u003cstrong\u003e:\u003c/strong\u003e2024-K-190-01\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability declaration\u003c/strong\u003e\u003cstrong\u003e:\u003c/strong\u003eThe datasets generated during and/or analysed during the current study arenot publicly available due to protecting participant confidentiality but areavailable from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAnderson RH, Becker AE, Tynan M. Description of ventricular septal defects\u0026mdash;or how long is a piece of string. Int J Cardiol. 1986;13:267\u0026ndash;78.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBaumgartner H, Bonhoeffer P, De Groot NM. a1. ESC guidelines for the management of grown-up congenital heart disease(new version 2010). Eur Heart J. 2010;31(23):2915\u0026ndash;57.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCarminati M, Butera G, Chessa M, et al. Investigators of the European VSD Registry. Transcatheter closure of congenital ventricular septal defects: results of the European Registry. Eur Heart J. 2007;28(19):2361\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDean JW, Ho SY, Rowland E, et al. Clinical anatomy of the atrioventricular junctions. J Am Coll Cardiol. 1994;24(7):1725\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLopez L, Houyel L, Colan SD, et al. 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Results of transcatheter closure of perimembranous ventricular septal defect. Am J Cardiol. 2010;106(7):1034\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXue W, Jiang J, Shi CY, et al. A Comparative Study of the Impact of Interventional Occlusion and Surgical Repair on Valve Function in Ventricular Septal Defects. Adv Mod Biomed. 2016;16(10):1878\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShah JH, Saraiya SP, Nikam TS, et al. Transcatheter device closure of perimembranous ventricular septal defect in pediatric patients: long-term outcomes. Heart Views. 2020;21(1):17\u0026ndash;21.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaddad RN, Daou L, Saliba Z. Device Closure of perimembranous ventricular septal defect: choosing between amplatzer occluders. Front Pediatr. 2019;7:300.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"ventricular septal defect, intracristal ventricular septal defect, perimembranous ventricular septal defect, eccentric occluder, transcatheter closure, follow-up study","lastPublishedDoi":"10.21203/rs.3.rs-4604964/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4604964/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e \u003cp\u003eIntracristal ventricular septal defect (icVSD) pose unique challenges in interventional cardiology. This study evaluated the use of eccentric occluders in icVSD treatment compared with that of standard symmetrical occluders for perimembranous ventricular septal defect (pmVSD), aiming to inform clinical practice.\u003c/p\u003e\u003cp\u003e\u003cb\u003eObjective\u003c/b\u003e\u003c/p\u003e \u003cp\u003eTo evaluate the clinical outcomes of the use of eccentric occluders for treating icVSD compared to the use of standard symmetrical occluders for treating pmVSD, with a focus on the success rate, cardiac function, complications, and quality of life.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMaterials and methods\u003c/b\u003e\u003c/p\u003e \u003cp\u003eWe conducted a comparative analysis of 39 patients with icVSD treated with eccentric occluders and 416 patients with pmVSD treated with symmetrical occluders. A comprehensive assessment of cardiac function recovery, complication occurrence, and changes in quality of life was performed during the intermediate and short-term follow-up periods.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003eOf the 39 patients with icVSD, 38 successfully underwent occluder implantation, achieving a surgical success rate of 97.4%. Among the 416 patients with pmVSD, 413 achieved successful occluder implantation, yielding a surgical success rate of 99.3%. No statistically significant difference was observed in the success rates between the two groups. During the follow-up, both patient cohorts demonstrated notable improvements in cardiac function, the absence of severe complications, and improvements in quality of life. These findings underscore the feasibility and superiority of eccentric occluders in transcatheter closure of icVSD.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions\u003c/b\u003e\u003c/p\u003e \u003cp\u003eOur study demonstrated the high safety and efficacy of percutaneous transcatheter closure using eccentric occluders for treating icVSD. This investigation not only enhances our understanding of transcatheter closure options for icVSD patients but also provides clinicians with robust scientific evidence to guide treatment strategies. Ultimately, this approach may offer patients with icVSD a broadened range of therapeutic options and improved clinical outcomes.\u003c/p\u003e","manuscriptTitle":"Transcatheter closure with Eccentric Occluder for Intracristal Ventricular Septal Defect: A Safety and Efficacy Assessment","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-09-03 11:35:36","doi":"10.21203/rs.3.rs-4604964/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"109f2ed8-8932-425e-9758-e2d73560ddd6","owner":[],"postedDate":"September 3rd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-12-17T07:40:27+00:00","versionOfRecord":[],"versionCreatedAt":"2024-09-03 11:35:36","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4604964","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4604964","identity":"rs-4604964","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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