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Transcatheter Closure of Perimembranous Ventricular Septal Defect Using the Lifetech Konar-Multi Functional Occluder: Early to Midterm Results of the Indonesian Multicenter Study Cover

Transcatheter Closure of Perimembranous Ventricular Septal Defect Using the Lifetech Konar-Multi Functional Occluder: Early to Midterm Results of the Indonesian Multicenter Study

Global Heart
Volume 17 (2022): Issue 1
By: Rahmat Budi Kuswiyanto,  Eka Gunawijaya,  Mulyadi M. Djer,  Noormanto Noormanto,  Mahrus A. Rahman,  Indah K. Murni,  Rubiana Sukardi,  Alit Utamayasa,  Rizky Ardiansyah,  Ria Nova,  Sri Liliyanti,  Sri E. Rahayuningsih,  Shirley L. Anggriawan,  Tri Yanti Rahayuningsih,  Dyahris Koentartiwi,  Renny Soewarniaty,  Venny Kartika Yantie,  Sasmito Nugroho,  Taufiq Hidayat,  Teddy Ontoseno,  Tina C. Tobing,  Muhamad Ali,  Muhammad Hasan Bashari,  Denny S. Yosy,  Nadya Arafuri,  Dany Hilmanto,  Piprim B. Yanuarso,  Najib Advani,  Sudigdo Sastroasmoro and  Sukman Tulus Putra  
Open Access
|Feb 2022
Figures & tables

Figures & Tables

Image/Figure 1

The KONAR-Multi Functional Occluder. Device components denomination: D. Disc diameter; D1. Waist Diameter Right Ventricular side; D2. Waist Diameter Left Ventricular side.

Table 1

The Konar-multi functional occluder specification.

SIZED*D1*D2*L*DELIVERY SHEATH (F)PATIENTS N, %
5–3103544–518 (13.6)
6–4104644–538 (28.8)
7–512574526 (19.7)
8–612684525 (18.9)
9–714794612 (9.1)
10–814810468 (6.2)
12–10161012474 (3.0)
14–12181214471 (0.7)

[i] D = Diameter of retention disc; D1 = right waist diameter, D2 = left waist diameter, L = total length of the device, *in millimeter, N = 132.

Image/Figure 2

Angiography and echocardiography after closure.

Table 2

Subject characteristics and procedural data.

CHARACTERISTICS AND PROCEDURAL DATA (N = 132)MEDIANMINIMUMMAXIMUM1ST QUARTILE3RD QUARTILEIQR
Age in years4.50.317.42.57.24.6
Body weight in kilogram14.83.557.010.020.210.2
Defect size on LV in mm4.51.011.03.36.33.0
Defect size on RV in mm3.41.08.12.44.42.0
Flow ratio1.61.34.91.51.80.3
Mean pulmonary arterial pressure in mmHg18.07.079.013.723.09.3
Fluoroscopy-time in minute18.03.891.012.025.513.5
Procedure-time in minute75.026.0290.060.092.032.0

[i] LV, left ventricle; IQR, interquartile range; RV, right ventricle.

Image/Figure 3

Flow chart of transcatheter in ventricular septal defect closure of a multicenter study in Indonesia.

Table 3

Baseline characteristic and procedural data of infants undergoing transcatheter VSD closure (n = 8).

BASELINE AND PROCEDURAL DATA
Age (months), Mina, Median, Maxb (IQRc)3.3, 6.3, 12.0 (6.3)
Male sex, n (%)2 (25)
Body weight (kilogram), Mina, Median, Maxb (IQRc)3.5, 4.8, 8.0 (1.8)
Defect size on LV (mm), Mina, Median, Maxb (IQRc)5.9, 8.1, 9.8 (1.6)
Defect size on RV (mm), Mina, Median, Maxb (IQRc)3.0, 5.2, 8.1 (3.8)
Septal aneurysm, n (%)2 (25)
Flow ratio, Mina, Median, Maxb (IQRc)1.6, 2.4, 4.9 (0.7)
Mean pulmonary arterial pressure (mmHg)
Mina, Median, Maxb (IQRc)		23, 32.5, 79 (14.3)
Fluoroscopy time (minute), Mina, Median, Maxb (IQRc)16.8, 28.1, 91.0 (7.6)
Procedure time (minute), Mina, Median, Maxb (IQRc)70, 131.5, 290 (71.7)
Device size; n (%)
      6–41 (12.5)
      8–64 (50)
      12–102 (25)
      14–121 (12.5)

[i] Mina, Minimum.

Maxb, Maximum.

IQRc, Inter Quartile Range.

Table 4

Indications for Intervention.

INDICATIONSNUMBER OF CHILDREN (%)
Pulmonary to systemic flow ratio (Qp/Qs) ≥ 1.5101 (76.5)
Pulmonary to systemic flow ratio more than 1.5 with growth failure18 (13.6)
Pulmonary to systemic flow ratio (Qp/Qs) < 1.5 with additional indication:
      Growth failure4 (0.7)
      Recurrent respiratory tract infections4 (0.7)
      Psychosocial indication2 (1.5)
      History of endocarditis3 (2.3)

[i] Qp/Qs, pulmoary flow/systemic flow.

Table 5

Short term outcome of transcatheter closure of perimembranous ventricular septal defect using the Lifetech Konar-multi functional occluder stratified by age of patients (N = 132).

COMPLETE CLOSURE N (%)RESIDUAL SHUNT N (%)MIGRATION N (%)FAIL TO CLOSE N (%)
TRIVIALSMALLMODERATELARGE
Immediate result
<1 year0 (0)4 (3.0)2 (1.5)1 (0.7)1 (0.7)0 (0)0 (0)
1–5 year48 (36.4)15(11.4)1 (0.7)2 (1.5)1(0.7)0 (0)0 (0)
5–18 year42 (31.8)11(8.3)3 (2.3)0 (0)1 (0.7)0 (0)0 (0)
Total90 (68.2)30(22.7)6 (4.5)3 (2.3)3 (2.3)0 (0)0 (0)
Result at discharge
<1 year3 (2.3)1 (0.7)2 (1.5)0 (0)0 (0)1 (0.7)1 (0.7)
1–5 year58 (43.9)6 (4.5)0 (0)0 (0)0 (0)2 (1.5)1 (0.7)
5–18 year48 (36.4)8 (6.0)0 (0)0 (0)0 (0)0 (0)1 (0.7)
Total109 (82.6)15(11.4)2 (1.5)0 (0)0 (0)3 (2.2)3 (2.3)
Table 6

Comparison of transcatheter in ventricular septal defect closure approach.

ANTEROGRADERETROGRADEP VALUE
Number of patients, n (%)91 (68.9)41 (31.1)0.001
Weight in kg, mean (SD)16.3 (9.5)18.3 (10.4)0.28
      ≤10 kg, n (%)26 (28.6)8 (19.5)0.29
      >10 kg, n (%)65 (71.4)33 (80.5)
Age in years, mean (SD)5.2 (3.6)5.5 (4.1)0.62
Fluoroscopy time, mean (SD)23.7 (16.8)18.1 (12.5)0.05
Procedure time, mean (SD)89.5 (40.2)69.4 (27.8)0.004

[i] SD, standard deviation.

Table 7

Short term complication of transcatheter in ventricular septal defect closure stratified by age of patients (N = 132).

COMPLICATIONN = 132 (%)
Death0 (0)
Hemolysis0 (0)
Ventricle Fibrillation
      <1 year1 (0.7)
First degree AV block
      <1 year2 (1.5)
      5–18 year1 (0.7)
Right Bundle Branch Block
      1–5 year1 (0.7)
Total AV block0 (0)
Supraventricular tachycardia
      <1 year1 (0.7)
Systemic hypotension
      <1 year1 (0.7)
      1–5 year1 (0.7)
Fever 24 hour after intervention
      1–5 year1 (0.7)
Mild Aortic Regurgitation
      1–5 year2 (1.6)
Trivial Aortic Regurgitation
      <1 year2 (1.6)
      1–5 year6 (4.5)
      5–18 year5 (3.7)
Moderate Tricuspid Regurgitation
      <1 year3 (2.3)
      1–5 year1 (0.7)
Trivial to Mild Tricuspid Regurgitation
      <1 year1 (0.7)
      1–5 year7 (5.3)
      5–18 year6 (4.5)

[i] AV, arteriovenous.

Table 8

Long term outcome of transcatheter in ventricular septal defect closure using the Lifetech Konar-multi functional occluder in Indonesia.

OUTCOME1 MONTH3 MONTHS6 MONTHS12 MONTHS
Complete closure, n (%)120 (95.2)123 (97.6)125 (99.2)125 (99.2)
Trivial residual shunts, n (%)6 (4.8)3 (2.4)1 (0.7)1 (0.7)
ADO II: Amplatzer Duct Occluder II
AVB: atrioventricular heart block
AR: aortic regurgitation
D: the diameter of the left disc
D1: the diameter of right disc
D2: the diameter of base of the cone
JR: Judgkin Right
LV: left ventricle
MFO: the KONAR-multi functional occluder
pmVSD: perimembranous ventricular septal defect
PTFE: polytetrafluoroethylene
RV: right ventricle
TR: tricuspid regurgitation
TTE: transthoracic echocardiography
VSD: ventricle septal defect
DOI: https://doi.org/10.5334/gh.1106 | Journal eISSN: 2211-8179
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Language: English
Submitted on: Dec 24, 2021
Accepted on: Feb 2, 2022
Published on: Feb 24, 2022
Published by: Ubiquity Press
In partnership with: Paradigm Publishing Services
Publication frequency: 1 issue per year
Keywords:
Perimembranous ventricular septal defect,
transcatheter closure,
KONAR-multi functional occluder

© 2022 Rahmat Budi Kuswiyanto, Eka Gunawijaya, Mulyadi M. Djer, Noormanto Noormanto, Mahrus A. Rahman, Indah K. Murni, Rubiana Sukardi, Alit Utamayasa, Rizky Ardiansyah, Ria Nova, Sri Liliyanti, Sri E. Rahayuningsih, Shirley L. Anggriawan, Tri Yanti Rahayuningsih, Dyahris Koentartiwi, Renny Soewarniaty, Venny Kartika Yantie, Sasmito Nugroho, Taufiq Hidayat, Teddy Ontoseno, Tina C. Tobing, Muhamad Ali, Muhammad Hasan Bashari, Denny S. Yosy, Nadya Arafuri, Dany Hilmanto, Piprim B. Yanuarso, Najib Advani, Sudigdo Sastroasmoro, Sukman Tulus Putra, published by Ubiquity Press
This work is licensed under the Creative Commons Attribution 4.0 License.

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