Off‐label use of duct occluder devices to close hemodynamically significant perimembranous ventricular septal defects: A multicenter experience

Cate, Floris E.A. Udink ten; Sobhy, Rodina; Kalantre, Atul; Sachdev, Sakshi; Subramanian, Ashwanth; Koneti, Nageswara Rao; Kumar, Raman Krishna; Hamza, Hala; Mahimarangaiah, Jayaranganath; Sreeram, Narayanswami

doi:10.1002/ccd.27792

Cited by 14 publications

(9 citation statements)

References 20 publications

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“…Considering the worldwide experience, especially in Asia, transcatheter VSD closure can be performed with finally good results and low complication rates. However, effective devices are often used off‐label; the ADO II is such an off‐labelly used device, which is highly effective in treating perimembranous VSDs, but limited by its size.…”

Section: Resultsmentioning

confidence: 99%

Percutaneous closure of perimembranous ventricular septal defects utilizing almost ideal Amplatzer Duct Occluder II: Why limitation in sizes?

Esmaeili

Behnke-Hall

Schrewe

et al. 2018

Congenital Heart Disease

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Aim:The purpose of this study is to describe the special aspects of perimembranous ventricular septal defects (pmVSD) closure by utilizing Amplatzer Duct Occluder II (ADO II) devices with a rational request for bigger ADO-II sizes, based on our experience in transcatheter device closure of pmVSD. Methods and Results: At our institution, placement of an ADO II device was used in 15 patients with pmVSD; the patients' age ranged between 6 months and 20 years.The indications for closure were CHF (n = 4), hemodynamically significant shunt (n = 7), tricuspid regurgitation (n = 3), and high risk for infective endocarditis (n = 2), respectively. The location of the VSD was infracristal in 13 patients, supracristal in 1, and a postsurgical Gerbode VSD in another one. Implantation of the device was successfully performed without embolization, any evidence of an AV block, or other conductance abnormalities during implantation and follow-up in the mean of 2.5 years (range 2 months-6.5 years). Conclusions: Transcatheter closure of a pmVSD with ADO II is feasible in all pediatricand young adult age groups, by considering the device diameter limitations. The offlabel use of ADO II implantation seems to be safe for VSDs closure up to 6 mm of size and feasible for various locations including unusual morphology such as postsurgical Gerbode defect. K E Y W O R D SAmplatzer Duct Occluder II, pediatric, perimembranous ventricular septal defect, transcatheter closure

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Section: Resultsmentioning

confidence: 99%

Percutaneous closure of perimembranous ventricular septal defects utilizing almost ideal Amplatzer Duct Occluder II: Why limitation in sizes?

Esmaeili

Behnke-Hall

Schrewe

et al. 2018

Congenital Heart Disease

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“…However, the use of an eccentric occluder has been reduced increasingly in recent years, due to the risk of complete left bundle branch block [25,26].…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Transcatheter Occlusion of Perimembranous Ventricular Septal Defect with Aortic Valve Prolapse: A Six-Year Follow-Up Study

Zhang

Wang

Liu

et al. 2021

Journal of Interventional Cardiology

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Background. With the rapid development of transcatheter techniques and instruments, transcatheter occlusion for patients with perimembranous ventricular septal defect (pVSD) and aortic valve prolapse (AVP) was constantly being tried, while the efficacy and safety of pVSD with AVP remain controversial. Objective. The aim of this study was to evaluate long-term efficacy and safety of transcatheter occlusion of pVSD with AVP. Methods. We retrospectively analyzed 164 children with pVSD and AVP who underwent transcatheter occlusion between January 2013 and November 2014. AVP was divided into 3 degrees according to right coronary leaflet morphology at end-diastole during aortic root angiography. Patient demographic and clinical data were collected. Results. There were 97 males and 67 females (median age, 40.0 (30.0–62.7) months; average weight, 16.94 ± 9.02 kg). Mild (n = 63), moderate (n = 89), and severe (n = 12) AVP success rates were 93.7%, 89.9%, and 58.3%, respectively. Immediately after procedure, there was no new-onset aortic regurgitation (AR) above trivial degree, residual shunt above mild degree, or complications requiring medication or operation, except for 1 patient who developed transient complete atrioventricular block. During follow-up, 1 mild AVP patient aggravated from mild to moderate AR and 1 moderate AVP patient aggravated from trivial to moderate AR. The new-onset AR in mild, moderate, and severe AVP was 2%, 1.8%, and 20%, respectively. AR disappeared in 17 patients. Residual shunt occurred in 9 patients after procedure, 4 of which disappeared during the follow-up period. No serious complications occurred in any patient during follow-up. Five-year cardiovascular event-free survival rates for mild, moderate, and severe AVP were 89.6%, 94.5%, and 80.0%, respectively. Conclusion. Transcatheter occlusion of pVSD with mild and moderate AVP has a high success rate and few complications, which is safe and effective in long-term follow-up. Transcatheter occlusion of pVSD with severe AVP has low success rates and high AR incidence. Therefore, transcatheter occlusion of pVSD with AVP is recommended for mild to moderate, but not severe, AVP.

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“…Previously reported occurrence rates of cAVB using eccentric and symmetric VSD occluders varied from 1.7 to 5.8% (2,3,13) and 0.6 to 1.4% (13)(14)(15), respectively. The incidence of cAVB after transcatheter closure of pmVSD using ADO I is about 1.3-1.4% in recent studies (11,12). Wang et al (15) used symmetric VSD occluders to perform transcatheter closure of pmVSD in 2,114 children, and 57 cases developed CLBBB with an incidence of 2.7%.…”

Section: Discussionmentioning

confidence: 99%

“…The performers choose the closure device according to the defect shape and their experience. The Amplatzer Duct Occluder I (ADO I) and spring coil can also be chosen for some special pmVSD ( 2 , 11 , 12 ).…”

Section: Discussionmentioning

confidence: 99%

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The Efficacy and Medium to Long-Term Follow-Up of Transcatheter Retrograde Closure of Perimembranous Ventricular Septal Defects via the Femoral Artery With Amplatzer Duct Occluder II in Children

et al. 2021

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Objective: The aim of this study was to assess the efficacy and safety of transcatheter retrograde closure of perimembranous ventricular septal defect (pmVSD) via the femoral artery with an Amplatzer Duct Occluder II (ADO II) in children.Methods: The clinical and follow-up data of 102 children who had successfully undergone transcatheter retrograde closure of pmVSD via the femoral artery with Amplatzer Duct Occluder II (ADO II) from February 2012 to June 2019 in our center were retrospectively reviewed.Results: In 102 of 103 patients, the defects were successfully closed (99.0%). The average age was 4.03 ± 1.84 years and the mean weight was 17.50 ± 5.58 kg. The mean diameter of the defects was 2.58 ± 0.63 mm. Hundred of the occluders had a waist length of 4 mm. The complete closure rate was 89.2% 24 h after the procedure and 98% at the last follow-up. The follow-up period ranged from 6 to 92 months, with a median of 36 months. One child developed new mild aortic regurgitation (AR), and 9 patients developed new mild tricuspid regurgitation (TR). During follow-up, TR disappeared in 5 patients and decreased in 4 patients, and AR relieved in one patient. One patient developed intermittent complete left bundle branch block 4 days after the procedure and recovered sinus rhythm 2 days later. No serious complications occurred.Conclusion: Transcatheter retrograde closure of pmVSD via the femoral artery with ADO II in children is safe, feasible, and effective in selected patients.

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Off‐label use of duct occluder devices to close hemodynamically significant perimembranous ventricular septal defects: A multicenter experience

Abstract: The immediate results of transcatheter pmVSD closure using a duct occluder device with a single retention disc are promising. It is an effective technique with a lower rate of complications than for other currently available devices.

Cited by 14 publications

References 20 publications

Percutaneous closure of perimembranous ventricular septal defects utilizing almost ideal Amplatzer Duct Occluder II: Why limitation in sizes?

Percutaneous closure of perimembranous ventricular septal defects utilizing almost ideal Amplatzer Duct Occluder II: Why limitation in sizes?

Safety and Efficacy of Transcatheter Occlusion of Perimembranous Ventricular Septal Defect with Aortic Valve Prolapse: A Six-Year Follow-Up Study

The Efficacy and Medium to Long-Term Follow-Up of Transcatheter Retrograde Closure of Perimembranous Ventricular Septal Defects via the Femoral Artery With Amplatzer Duct Occluder II in Children

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