European Journal of Cardiovascular Medicine

Congenital heart disease (CHD) is defined as a gross structural abnormality of heart or intra thoracic great vessels that has functional or potential significance at birth or at a later date[1]. CHDs account for 1/3rd of all major congenital anomalies and it has variable prevalence and pattern geographically and is a rising global health problem. [2] Globally the incidence of congenital heart disease is 8 per 1000 live births[3]

In 1976, King and Mills originally described, and subsequently demonstrated, feasibility of closing ASD using a device..The King-Mills performed the first case of ASD Closure without surgery by using Umbrella Device on a 17 young girl in 1975 in Louisiana, USA.[3]First Time in the India a Non-surgical Heart Hole (ASD) Closure by using Monodisk Device Transcatheter Atrial Septal Defect Closure with Monodisk device in Sept 1992 by Dr. P. Lal in Chennai.[4]

The first Cardio Thoracic Surgery Department was started at Vellore in 1949. Ligation of patent ductus arteriosus was the first surgery for congenital heart disease. In 1966 Rashkind and Miller described a non surgical procedure to create an atrial septal defect, using a balloon catheter in patients with transposition of great vessels. In 1982, first balloon mitral dilation  led to huge scope for cardiac intervention in pediatric patients. Echocardiography, in 1985 became very popular and widely accessible. Interventions were of of great interest among patients and cardiologists due to treatment without need of cardiopulmonary bypass and no scar on chest. Later devices were introduced to close defects causing left to right shunts ASD, PDA, some VSD in cath lab.[6]

This study focuses on the outcome of  pediatric cardiac interventions and it’s efficacy in leading to replacement of open heart surgery by transcatheter cardiac procedures.

Objective:

1.To study the demographic data among the number of pediatric cardiac interventions in a tertiary care teaching hospital in western Maharashtra 

2.To look for outcome associated with procedures.

Type of study: Retrospective study

Inclusion criteria:

All age group with congenital heart disease

Exclusion criteria:

Complex congenital heart disease requiring surgical procedure

Relatives refusing consent.

Study period: 1.5 years Feb 2023 to July 2024.

The present study was conducted in tertiary care hospital. After obtaining approval from Institutional Ethics Committee, medical record data was reviewed retrospectively of all patients undergoing cardiac intervention from Feb 2023 to July 2024 over a period of 1.5 years. All these patients were referred from various hospitals with a provisional diagnosis of congenital heart disease. Detailed clinical examination was performed. Echocardiography was performed in all patients by GE VIVID e95 2 dimensional echocardiography machine , and majority of patients were assigned either medical or surgical management based on their diagnosis and clinical condition. In patients where for various reasons clear decision was not possible cardiac catheterization was performed.All the device closures done in Cath lab were reviewed with due consent. Clinical examination and 2D Echo with Doppler were used to confirm the diagnosis of congenital heart disease and mode of treatment. All the ASD device closure were done with LIFETECH septal occluder, PDA were closed with LIFETECH duct occluder except 1 patient, a preterm male child weighing 1.2 kg whose PDA was closed using AMPLATZER PICCOLO duct occluder. 1 BPV patient was treated using TYSHAK balloon for relieving pulmonary stenosis.

The objective was to assess the pediatric cardiac interventions- number, various age groups of patients included and any immediate postoperative complication associated with same.

STATISTICAL ANALYSIS

The presentation of the Categorical variables was done in the form of number and percentage (%). On the other hand, the quantitative data were presented as the means ± SD and as median with 25th and 75th percentiles (interquartile range).  The association of the variables which were qualitative in nature were analysed using Fisher’s exact test as atleast one cell had an expected value of less than 5. The data entry was done in the Microsoft EXCEL spreadsheet and the final analysis was done with the use of Statistical Package for Social Sciences (SPSS) software, IBM manufacturer, Chicago, USA, ver 25.0. For statistical significance, p value of less than 0.05 was considered statistically significant.

Table 1:- Parameters distribution.

Figure 1:- Parameters distribution.

Distribution of parameters among the study subjects was as follows: Age of 8 (36.36%) cases was >1 to 5 years, 7 (31.82%) cases was 0 to 1 year, 5 (22.73%) cases was 6 to 12 years and 2 (9.09%) cases was >12 years. Mean ± SD age was 5.33 ± 7.9 years, with median (25th-75th percentile) of 2.5 (1-6.75) years. Weight of 13 (59.09%) cases was 10 to 19 kg, 7 (31.82%) cases was 0 to 9 kg and 2 (9.09%) cases was >30 kg. Mean ± SD weight was 15.09 ± 13.93 kg, with median (25th-75th percentile) of 12.5 (7.85-17.35) kg. Total of 14 (63.64%) patients were female and 8 (36.36%) patients were male (Table 1, Figure 1).

Table 2:- Diagnosis distribution.

Figure 2:- Diagnosis distribution.

Distribution of diagnosis among the study subjects was as follows: 16 (72.73%) cases were diagnosed with PDA, 5 (22.73%) cases with ASD and 1 (4.55%) case with congenital PS (Table 2, Figure 2).

Table 3:- Procedure distribution.

Figure 3:- Procedure distribution.

Distribution of procedures among the study subjects was as follows: 16 (72.73%) casesunderwent PDA DC, 5 (22.73%) cases underwent ASD DC and 1 (4.55%) case underwent BPV (Table 3, Figure 3).

Table 4:- Post procedure complications distribution.

Figure 4:- Post procedure complications distribution.

All 22 (100%) cases had no complications (Table 4, Figure 4).

Table 5:-Association of procedure with age.

^* Fisher's exact test

Figure 5:-Association of procedure with age.

Proportion of patients undergoing different procedures varied significantly across age groups: PDA DC procedure was significantly higher in those aged 0 to 1 year and >1 to 5 years compared to those aged 6 to 12 years and >12 years (100%, 87.50% vs. 40% and 0%, respectively), BPV procedure was significantly higher in those aged >1 to 5 years compared to those aged 0 to 1 year, 6 to 12 years and >12 years (12.50% vs. 0%, 0% and 0%, respectively), ASD DC procedure was significantly higher in those aged >12 years compared to those aged 0 to 1 year, >1 to 5 years and 6 to 12 years (100% vs. 0%, 0% and 60%, respectively) (p value = 0.002) (Table 5, Figure 5).

Table 6:-Association of procedure with weight.

^* Fisher's exact test

Figure 6:-Association of procedure with weight.

Proportion of patients undergoing different procedures varied significantly across weight categories: BPV was significantly higher in those weighing 10 to 19 kg compared to 0 to 9 kg and >30 kg (7.69% vs. 0% and 0%, respectively). PDA DC was significantly higher in those weighing 0 to 9 kg compared to 10 to 19 kg and >30 kg (100% vs. 69.23% and 0%, respectively). ASD DC was significantly higher in those weighing >30 kg compared to 0 to 9 kg and 10 to 19 kg (100% vs. 0% and 23.08%, respectively) (p value = 0.035) (Table 6, Figure 6).

Table 7:-Association of procedure with gender.

^* Fisher's exact test

Figure 7:-Association of procedure with gender.

Compared to females, males had comparable distribution of procedures: ASD DC (12.50% in males vs. 28.57% in females), BPV (12.50% vs. 0%) and PDA DC (75% vs. 71.43%) (p value = 0.297) (Table 7, Figure 7).

In1929, when Werner Forsman, a young surgeon in Germany performed first catheterization of the living human heart on himself cardiac catheterization has evolved study of heart as same as electrocardiography.[6]

According to reference[3] large part of CHD is reported in Asia of 9.3 per 1000 live births. Transcatheter device closure is the preferred approach for most secundum atrial septal defects.Ventricular septal defects are more often treated surgically, but transcatheter closure is an option in selected cases. Successful closure rates are >95%, with serious adverse events reported in ≤5%.[4] Porstmann et al [8] introduced transcatheter PDA device closure.

As per Turner et al [5] recommendations for the ASD device closure are given below

PDA (Patent Ductus

Arteriosus) Classification

• Large PDA: Associated with significant left heart volume overload, congestive heart failure, and severe pulmonary arterial hypertension. PDA murmur is unlikely to be audible.
• Moderate PDA: Some degree of left heart overload, mild-to-moderate pulmonary artery hypertension, and no/mild congestive heart failure. Murmur +
• Small PDA: Minimal or no left heart overload. No pulmonary hypertension or congestive heart failure.Murmur +
• Silent PDA: Diagnosed only on echo Doppler. These are hemodynamically insignificant, produce no murmur and there is no pulmonary hypertension.[2]

BPV was done in critical pulmonary stenosis (PV gradient more than 60-70 mmHg). In the present study, the amount of transcatheter procedures were 22, however, there were no significant post procedure complications and minimal hospital stay, as compared to open heart surgery, it was cosmetically more favourable due to no big scar or smaller surgical scar at right groin site.

In Mir A B et al[10], congenital heart disease were more common in males than females with a ratio of 1.52:1, whereas in our study, there were more females than males with a ratio of 1.75:1, it also included majority of Large number of patients were diagnosed to have PDA followed by ASD, congenital pulmonary stenosis. There are limited studies on pattern and prevalence of congenital heart disease in India. According to Anita Saxena[6], the prevalence of congenital heart disease in India is huge, however cardiac centre’s necessary for screening the patient are mostly available in urban areas, leading to inability of rural area children having CHD to undergo treatment due to financial difficulties, lack of awareness, however, government of India is focusing on improving health of children through its various program and schemes that are likely to benefit children with congenital heart disease, especially those who are vulnerable and marginalized. The amount of transcatheter procedures done at our setup were funded by the government. In Leafy et al [7], in 2019, the first transcatheter occlusion device was approved in the United States for infants >700 g. PDA transcatheter closure is preferred over invasive PDA ligation and is associated with lesser risk of sepsis in preterm neonates, in a similar manner PDA transcatheter closure was done in our setup in a preterm neonate weighing 1.2 kg using Amplatzer Piccolo Occluder, which was not associated with any post operative complications and lead to faster recovery, weight gain and early discharge from NICU. According to Sathanandam SK[8], Amplatzer Piccolo Occluder had implant success rate of 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). Nair et al [9] stated post op complications of ASD device closure (Figulla® Flex 2 Occlutech ASD occluder) due to presence of nickel in the device leading to symptoms like chest tightness radiation to back, confusion, severe migraine, though patient had history of migraine prior to ASD device closure. The device is made of nitinol wire mesh which is self expandable double disc device. But in our study, there were no complications or no symptoms were seen in patients suggesting nickel allergy or hypersensitivity.

Congenital heart disease incidence is increasing presenting as important health problem and transcatheter device closure is safe and effective technique for treating acyanotic heart disease. In our case, transcatheter procedures done were PDA device closure> ASD device closure> BPV. Majority of patients were females. There were no immediate post operative complications associated with procedures

Limitations of the study:

The study was retrospective. VSD device closures were not performed, rather referred for surgical closure. As per Ghosh B et al[13] VSD device closure in pediatric age group is challenging. Moreover choosing the right device and procedure technique is difficult due to lack of discrete guidelines. Infants with low weight usually are referred for surgical VSD closure. Complications in VSD device closure are fewer- embolization of device, complete heart block seen usually more common in membranous VSD device closure due to which the VSD patients were directly referred for surgical closure.

Abbreviations:

ASD- Atrial Septal Defect

BPV- Balloon Pulmonary Valvoplasty, BAV- Balloon Aortic Valvoplasty

CHD- Congenital Heart Disease

2D- 2 Dimensional

PDA- Patent Ductus Arteriosus

VSD- Ventricular Septal Defect

PS- Pulmonary Stenosis

NICU- Neonatal Intensive Care Unit.

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