The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters

Study Overview
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Brief Summary
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In this study; we evaluated the heart rate variability parameters of pediatric patients whose VSDs were closed with the transcatheter method before and after, and compared with the control group.

Detailed Description
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Heart rate variability (HRV) is a sign of cardiac autonomic nervous system. Evaluation of HRV in pediatric ventricular septal defect (VSD) cases before and after transcatheter closure will enlighten us in terms of cardiac autonomic control. Methods: 19 VSD cases treated with transcatheter closure method and 18 healthy children were enrolled in the study. 24 hours Holter rhythm monitorization was applied to all patients before closure of VSD and to the control group. In the patient group, Holter rhythm monitorization was repeated in the third months. HRV parameters were obtained from Cardio Scan Premier 12® program. Frequency domain (Total power, VLF, LF, HF, LF/HF ratio) and time domain analysis (SDNN, SDANN, SDNNi, pNN50, rMSSD) were applied.

Official Title
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The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters

Conditions
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Ventricular Septal Defect, Closure; Interventricular Septum, Autonomic Nervous System Imbalance

Intervention / Treatment
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* Diagnostic Test: 24 hours ambulatory Holter monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VSD diameter <6mm Significant left-to-right shunt Left atrial and ventricular enlargement detected by echocardiography or calculation of Qp/Qs ratio above 1.5 in the catheterization laboratory (Qp/Qs>1.5) Exclusion Criteria: Patients with arrhythmia after the procedure Young patients who may be inconsistent during Holter records

Ages Eligible for Study
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Minimum Age: 56 Months
Maximum Age: 136 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transchateter VSD closure group<br>VSD cases treated with transcatheter closure method. | Diagnostic Test: 24 hours ambulatory Holter monitoring<br> <br> |
| Control group<br>Healty children | Diagnostic Test: 24 hours ambulatory Holter monitoring<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability parameters | Time Domain analysis: After ectopic beats and artifacts were excluded, the following indices were calculated for time domian analysis in the whole Holter recording. SDNN: Standard deviation of all filtered RR intervals SDANN: Standard deviation of 5-minute averages of RR intervals SDNNindex: Mean of the standard deviation of all RR intervals for all the 5-minute segments rMSSD: Square root of the mean of the sum of square differences between adjacent filtered RR interval PNN50: Percentage of the difference between adjacent RR intervals greater than 50 milliseconds Frequency domain analysis: We determined spectral power over three frequency. Very low frequency (VLF) index (0.003-0.04 Hz) Low frequency (LF) index (0.04 - 0.15 Hz) High frequency (HF) index (0.15 - 0.40 Hz) Total power: Variance of all NN intervals approximately <0.4 Hz | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventricular septal defect, heart rate variability, percutaneous VSD closure