Early Outcome  of Pediatric Heart Catheterization Procedure for Ventricular Septal Defect, 5 Years Experience in Cardiac Remote Hospital

doi:10.21203/rs.3.rs-2457174/v1

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Early Outcome of Pediatric Heart Catheterization Procedure for Ventricular Septal Defect, 5 Years Experience in Cardiac Remote Hospital

https://doi.org/10.21203/rs.3.rs-2457174/v1

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Background: Cardiac interventions in the child with VSD was required due to the condition followed by the clinical sign of heart failure. Data report about the early outcome, complications, and problems related defect type, size, and conditions that affect the outcome of catheterization of VSD are still limited in Indonesia.

Methods: Retrospective study of child patients with VSD who underwent transcatheter procedures at dr.Chasbullah Abdul Majid General Hospital, Bekasi, from September 2017 to May 2022. Inclusion was VSD patients with weight above 5 kg and had a ratio left to right shunt >1.5:1. Exclusion were multiple congenital anomalies and incomplete data records. Early outcomes after catheterization and problem-related subjects who need to be referred for surgery were analyzed.

Results: From 104 patients, the most common type of VSD was perimembranous 85% followed by doubly committed sub-arterial 12.5% and multiple VSD 1.9%. After the transcatheter procedure, 76% had complete closure, 1.9% had small residual, and 15.4% did not undergo transcatheter closure and had to be referred for surgical closure. Most of the patients with complete closure had smaller VSD sizes with mean of 3.66 (1.17)mm, and small residual defects had mean VSD size of 3.5 (0.70)mm, while patients who had device migration and failed to close VSD were then referred for surgical closure presenting larger VSD size 5.2 (4.46)mm and patients who were indeed referred for surgical correction showed the highest mean of the defect 7.73 (3.80)mm.

Conclusions: Complete closure VSD transcatheter was excellent. The patient had to undergo surgery due to having a larger defect, aortic regurgitation, and multiple VSD.

VSD

cardiac catheterization

perimembranous

doubly committed sub arterial

Ventricular septal defect (VSD) is a congenital heart disease (CHD) that is found in children, approximately 20% of all types of CHD. Small VSD is generally asymptomatic and found incidentally on clinical examination. Approximately 80% of children with asymptomatic small VSD without pulmonary hypertension will experience spontaneous closure within the first year of life without the need for intervention. But VSD patients with clinical signs of pulmonary hypertension, hemodynamic problems, respiratory problems, abnormalities of aortic valve regurgitation, and signs of heart failure may need interventions to close the defect either by transcatheter or surgical procedures. ^1–2

Cardiac catheterization with a device occluder was popular with a good outcome while surgical procedures with patch closure became standard management. Cardiac catheterization may be required in patients with pulmonary hypertension to occlude defects in muscular and perimembranous VSD.^2–3 Kuswiyanto et all reported the rates of complete occlusion of VSD at 1 month, 3 months, 6 months, and 12 months after the intervention was 95.2%, 97.6%, 99.2%, and 99.2%, respectively. complete closure rate with an Amplantzer Duct Occluder II (ADO II) and other types of occluder devices have success ranges from 81–93%. Patients with large or multiple VSDs are usually considered for surgical closure of the VSD which became a standard procedure.^4–6

Although many reports of cardiac catheterization show high success, there are some risks and problems with the procedure, such as arrhythmias, concurrent heart failure, valve regurgitation, and defects that cannot be closed with the device. For this reason, early monitoring was needed to improve good outcomes after cardiac catheterization of VSD patients. The purpose of this study was to report the outcome, early complications of transcatheter intervention, and problems related to the type of defect, size, and conditions that affect the outcome of VSD patients based on experience in the integrated heart center dr. Chasbullah Abdul Majid General Hospital, Bekasi, West Java.

We reviewed child patients with VSD who underwent angiography and transcatheter procedures at dr. Chasbullah Abdul Majid General Hospital, Bekasi City, West Java. A retrospective analysis of patient's medical records was carried out from September 2017 to May 2022. 104 pediatric patients with VSD diagnosis were evaluated by echocardiography and underwent cardiac transcatheter evaluation. The inclusion of patients were patients with a VSD weighing above 5 kg and having a ratio left to right shunt > 1.5:1 who were ideally placed to undergo a transcatheter procedure for diagnostic evaluation and intervention for VSD closure. Children with multiple congenital anomalies with unstable hemodynamic clinical conditions were excluded from the selection as subjects. Patients with incomplete data records were also excluded.

We collected data characteristics of the patient's condition such as gender, weight, type of VSD, defect size, aortic pressure, ventricular pressure before the procedure, length of time for the catheterization procedure, and post-procedure outcomes in the form of complete closure conditions and the findings of subjects who need to be referred for surgery.

Transcatheter Cardiac Evaluation And Vsd Closure Interventions Procedure

The transcatheter intervention was performed in the pediatric cardiac catheterization laboratory using fluoroscopy and transesophageal echocardiography (TEE) guidance. Devices used as VSD closure occlusions were ADOII, MFO, and PDA occluders whose sizes were adjusted to the estimated VSD size from previous studies using echocardiography. In the group of children who did not undergo transcatheter VSD closure, a diagnostic evaluation of transcatheter angiography was performed as additional data for surgical closure of VSD that will be carried out in the future.

Under general anesthesia and TEE guidance, a catheterization procedure was performed, with cannulation of the right femoral artery and right femoral vein using a 5F sheath. Heparin 100iu/kg BW and cefazolin 50mg/kg BW were given during the procedure. The pigtail diagnostic catheter was introduced into the Right Femoral Artery (RFA) or left femoral artery (LFA) into the descending aorta and into the left ventricle. The angiographic evaluation was performed to assess the shape of the VSD, size of the VSD, aortic pressure, and ventricular pressure. Multipurpose angiography (MPA2) catheter is also introduced to the right femoral vein (RFV) or left femoral vein (LFV) to the inferior cava vein (ICV), right atrium (RA), right ventricle (RV), and pulmonary artery. The results of the LV angiographic study were taken into consideration when the type of VSD occluder was inserted. A cutting pigtail or MPA2 catheter was inserted into the LV close to the defect and with angled guide wire crossed VSD to RV. To close VSD we performed an antegrade or retrograde approach depending on VSD positions, whether close to the aorta annulus or not. VSD occluder matches the size of the defect then inserted through the tip cable and removed from the storage sheath and deployed. Good device positioning and complete or residual closure were assessed by a transesophageal echocardiogram (TEE) or transthoracic echocardiogram (TTE), then the procedure was completed. If the condition of the device was not properly deployed, the device will be retrieved and redeployed or changed with another device that has a larger or smaller size. TTE evaluation was carried out 1 day after the procedure to determine whether the condition of the device was still the same or not embolized. If there were migration of the device such as to the right or left pulmonary artery, a repeat transcatheter procedure was immediately performed to retrieve the embolic device and reinstallation with an appropriate device. If the closure was not successful after the device is removed, the patient will be referred to cardiac surgery for operative VSD closure

Statistic Analysis

Characteristic data were presented in mean (SD) and median (range) for numerical variables and frequency (%) for categorical. The normality test with Kolmogorov-Smirnov analysis was carried out to determine the distribution of the data, then a non-parametric comparison test for the outcome of VSD closure related to VSD size, left ventricular pressure status and aortic pressure was carried out with the Kruskall Walls test. Statistical analysis using the SPSS application (SPSS version 25).

In this study, there were 104 VSD patients who underwent transcatheter intervention evaluation for diagnostic procedures and intervention transcatheter closure. The baseline characteristics are described in Table. I. Most of the VSD patients were male 60 (57.7%) while female 44 (42.3%). The mean age of children was 44.30 (± 37.24) months with an age range of 12–144 months. The average patient weight was 13.79 (± 8.30)kg with a range of 5–63 kg. The most common type of VSD was PMO in 89 patients (85%) followed by DCSA in 13 patients (12.5%) and multiple VSD defects in 2 patients (1.9). LV pressure mean was 100.82 (± 22.6) mmHg and aortic pressure was 99.36(± 14.92) mmHg. The time duration of the transcatheter procedure was an average of 81.82(± 37.87) minutes and the duration of the fluoroscopy was 26.55(± 18.58) minutes.

Early outcome post transcatheter could be seen in Table II. After transcatheter evaluation and intervention VSD closure, 79 patients (76%) had complete closure. There were 2 patients (1.9%) who had a small residual defect after interventions. A total of 16 patients (15.4%) in the evaluation of transcatheter angiography ultimately did not undergo transcatheter closure and had to be referred for surgical closure of the VSD. There were 3 patients (2.9%) who had migration of the device then successfully completed closure after snarring and using a larger occluder, while there were 4 patients (3.8%) who had migration of the device away from the VSD location and underwent retrieval of the occluder device. This patient's group was eventually referred to a cardiac surgeon because the transcatheter closure of the VSD was unsuccessful.

The initial complication of arrhythmia that occurred was Ventricle extra systole (VES) in 42 patients (40.4%). This VES condition arises when the catheter and occluder are inserted and then disappear after the catheter device is released. There were 4 patients (3.8%) who had bradycardia and this also disappeared after the procedure was completed most of the patients had no post-procedure arrhythmia complications 58 patients (55.8%).

In Table III we found the comparison of VSD size, LV pressure, and aorta pressure-related outcome after the transcatheter procedure. Most of the patients with complete VSD closure transcatheter intervention had a small VSD size with a mean of 3.66(± 1.17)mm. Patients who had a small residual defect after transcatheter closure had mean VSD size of 3.5 (± 0.70)mm, while those who had migration devices and were successfully closed after snaring had a lower mean VSD size of 3.4 (± 0.81)mm. Patients who experienced device migration and failed to closure then referred for surgical closure had mean VSD size of 5.2(± 4.46)mm and patients who were indeed referred for surgical correction of VSD closure showed the highest mean defect was 7.73 (3.80)mm. Comparison analysis about the size of the defect in patients who could be closed transcatheter compared to those who had to be referred for surgical closure shows a significant difference in the VSD size (P = 0.001).

We also measured left ventricular (LV) and aortic pressure during transcatheter and echo evaluation procedures before intervention, there was no significant difference between patients who underwent complete closure versus those with small residual conditions and who had to be referred for surgery. in Table IV the most common problems that made patients have to refer for surgical closure after catheterization evaluation were large VSD in 12 patients (11.5%), failed transcatheter closure due to migration of detachable devices in 4 patients (4.8%), multiple VSD 2 patients (1.9%), severe aortic regurgitation in 1 patient (1%) and moderate aortic regurgitation 1 patient (1%) that required surgical correction also.

In this study, we report the outcomes of angiography and interventional transcatheter closure of VSD at 5 years in pediatric patients. The intervention procedure was carried out in the age group of 12–144 months, weighing 5–63 kg. These conditions were by several guidelines and procedural reports of VSD intervention that have been commonly performed in several cardiac intervention centers. Current recommendations for VSD closure are based on age, body weight, type of VSD condition, pulmonary to systemic blood flow ratio usually above 1.5:1, size of the defect, and clinical signs of heart failure. Generally, VSD intervention is carried out until the age of 1–2 years with body weight above 5 kg in small and medium defects. In patients with heart failure, cardiomegaly, poor growth, or other clinical abnormalities, usually, closure procedures should be performed immediately. Intervention transcatheter VSD closure is usually performed on the muscular and perimembranous types with high success, whereas surgery is usually performed on multiple defect lesions or patients with aortic regurgitation. ^7–8

We also found the most common type of VSD was PMO at 85%, followed by 12.5% DCSA and multiple VSD at 1.9%. PMO defect has been reported to be the most common form of VSD compared to other types. The 3-year follow-up report on the types of VSD undergoing transcatheter intervention by Sahar et all also found that PMO was 96% of cases. Schipper et all also report in contemporary surgical outcomes of VSD patients, PMO appeared in 79% of patients and muscular 5.8%. ^9–10 Several reports of follow-up studies on VSD interventions also support that the highest incidence of VSD was PMO. Another report also explained that PMO and muscular were the most common but the form of DSCA was rare. ^11–13

The mean VSD size was 4.33(± 2.44)mm with a size range of 1.7-14mm. 76% of patients had complete closure and 1.9% with residual lesions after a transcatheter intervention. In terms of VSD size, the mean size of the defect that underwent complete closure was 3.66 (± 1.17)mm, and the post-intervention small residue was 3.5(± 0.70)mm. In problems with device migration and success after redeployment, we found the mean VSD size was 3.4 (± 0.81)mm, and patients with device migration that referred to surgery were 5.2(± 4.46)mm. Meanwhile, patients with defects who had to be referred for surgery after a transcatheter evaluation showed a larger mean defect size with a mean of 7.73(± 3.80)mm. Outcome analysis of the transcatheter evaluation showed that larger defect lesion was significantly associated with the findings of device migration and the need for referral for surgery (P = 0.001). Smaller defects will lead the patient to a good outcome for complete closure. Device migration findings were rare but should be noted. Polat et all in their report on VSD transcatheter intervention also showed similar results where most defects could be completely closed 81–93% in follow-up after intervention and several months of follow-up. The success rate of complete closure is also influenced by the age of the child and the size of the defect, generally, In general, the success rate for closing PMO and muscular defects is quite high, 70–91% in 3 months to 2 years after intervention.^{4, 14}

We also report on the patient's condition regarding the need for referral for surgical VSD closure after angiographic and transcatheter evaluation. Patients who had to undergo surgical referral were mostly due to large VSD 11.5%, device migration problems and failure of transcatheter closure 3.8%, multiple VSD in 2 patients (1.9%), 1% severe aortic regurgitation and 1% moderate aortic regurgitation. The results of this study indicate that the outcome of transcatheter VSD closure was very good with high success. A small number of patients were referred to surgery because their conditions could only be fixed surgery such as large defect lesions, aortic regurgitation, and multiple VSDs.

The success rate of interventions for complete closure VSD transcatheter was excellent. The problem that requires the patient to undergo surgery VSD correction were a larger defect, aortic regurgitation, and multiple that require surgical procedures to be an option.

Ethics approval and consent to participate

All procedures performed in studies involving human participants were by the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was approved by the Ethics Committee of dr. Chasbullah General Hospital, Bekasi.. The objective protocol of the study was explained to the child's parents and informed consent was taken. No unique identifier for the children was collected. Confidentiality of the data collected was maintained throughout the study period.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Competing interests

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Funding

The authors received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors

Author contributions

All authors read and approved the final manuscript.

Acknowledgments

The authors are grateful to all the parents for their assistance and cooperation in this study.

Author details

¹Pediatrics Cardiology Division, dr. Chasbullah Abdulmadjid General Hospital, Bekasi, West Java. Indonesia ²Department of Child Health, Universitas Sumatera Utara/ Adam Malik Hospital, Medan. Indonesia ³Universitas Syiah Kuala Medical School, Banda Aceh, Indonesia.

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Levi DS. Congenital Heart Disease Intervention, An Issue of Interventional Cardiology Clinics: Elsevier Health Sciences; 2018.
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Table I. The baseline characteristics of VSD patients

Patients (n)

104

Sex (F/M), n(%)

44 (42.3)/ 60 (57,7)

Age, month, mean (SD)/

median (range)

44.30 (37.24)/

36( 12-144)

Weight, kg, mean (SD)/

median (range)

13.79 (8.30)/

11( 5-63)

Type of VSD, n(%)

PMO

DCSA

Multiple

89 (85)

13 (12,5)

2 (1,9)

VSD size, mm, mean (SD)/

median (range)

4.33 (2.44)/

3.5 (1.7-14

LV pressure, mmHg, mean (SD)/

median( range)

100.82 (22.61)/

94( 63-141)

Aorta pressure, mmHg, mean (SD)/

median (range)

99.36(14.92)/

98 (74-133)

Procedure Time, mean (SD),

median (range), min

81.82(37.87)/

65.5 (12-200)

Fluoroscopy time, mean (SD),

median (range), min

26.55 (18.59)/

21 (2-81)

Table II. Outcome Cardiac transcatheter Procedure in VSD patients

Outcome, n(%)
Complete closure	79 (76)
small residual	2 (1.9)
migration, complete closure after snaring, and redeploy	3 (2.9)
migration, refer for surgical procedure	4 (3.8)
Consul for surgical	16 (15.4)
Early arrhythmia complication, n(%)
VES	42 (40.4)
Bradikardia	4 (3.8)
No complication	58 (55.8)

Table III. outcome transcatheter vsd closure-related defect VSD size, Left ventricle, and Aorta pressure

Variable	VSD size	P	LV pressure	P	aorta pressure	P
Complete closure, mm, mean(SD), median (range)	3.66 (1.17)/ 3.3(1.7-7.2)	0.001	100.43 (20.97)/ 93 (63-141)	0.893	98(13.71)/ 98(74-133)	0.771
Small residual, mm, mean(SD), median (range)	3.5(0.70)/ 3.5 (3-4)		96(19.79)/ 96(82-110)		105 (27.57)/ 105 (86-125)
Migration device complete closure after snaring and redeploying bigger device, mm, mean(SD), median (range)	3.4 (0.81)/ 3 (2.8-4.4)		105.66(31.39)/ 95(81-141)		107.66(22.14)/ 98(92-133)
Migration device refer for surgical, mm, mean(SD), median (range)	5.2 (4.46)/ 3.05(2.8-11.9)		106 (23.41)/ 105 (85-131)		104 (21.71)/ 103 (85-125)
Refer for surgical procedure, mean(SD), median (range)	7.73 (3.80)/ 9(3-14)		95.09(21.51)/ 105(74-141)		102(17.18)/ 98(76-133)

Table IV. Patient condition that was refered for surgical VSD closure after transcatheter evaluation

Patients, n(%)	20 (19.2)
Large VSD, n(%)	12 (11.5)
Severe Aortic regurgitation, n(%)	1 (1)
Moderate Aortic regurgitation, n(%)	1 (1)
multiple VSD. n(%)	2 (1.9)
migration, fail transcatheter procedure, n(%)	4 (3.8)

No competing interests reported.

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Early Outcome of Pediatric Heart Catheterization Procedure for Ventricular Septal Defect, 5 Years Experience in Cardiac Remote Hospital

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Abstract

Introduction

Subjects And Methods

Transcatheter Cardiac Evaluation And Vsd Closure Interventions Procedure

Statistic Analysis

Results

Discussion

Conclusion

Declarations

References

Tables

Additional Declarations

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