Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study

Introduction: The presence of pulmonary hypertension (PH) in atrial septal defect (ASD) poses a clinical challenge on whether or not to close the defect. Closing the defect increases the risk of low cardiac output syndrome (LCOS), while leaving the defect open may eventually lead to irreparable shunt reversal, hypoxemia, and death. The implementation of a fenestrated patch may halt LCOS while adding volume to the left heart.

Methods: this is an analytical observational study involving patients with ostium secundum defect with PH who were operated on in Dr. Soetomo Hospital between January 2017 and October 2021. The aim of this study is to evaluate the improvement in left ventricular size during both systole and diastole.

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Key information

Conditions

Atrial Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Soetomo General Academic Hospital

Surabaya, East Java, Indonesia

About this study

Atrial septal defect (ASD) is one of the most common congenital heart diseases. It is typically characterized by a left-to-right shunt which results in volume overload of the right ventricle and overcirculation of the pulmonary vascularization (le Gloan et al., 2018). This may further result in arrhythmia, right ventricular dysfunction, and pulmonary hypertension (PH). Pulmonary hypertension is caused by endothelial dysfunction, remodelling of the pulmonary vascularization, which increases pulmonary vascular resistance, and eventually causes shunt reversal into right-to-left (Eisenmenger's syndrome). At this point, closure of the defect is contraindicated.

Small LV, although less extensively studied than dilated LV, also implies impaired LV function. Small LV means less tolerance to volume overload, which in turn impairs cardiac output and presents higher risk of heart failure and mortality (Saito et al., 2021).

ASD closure in cases with severe pulmonary hypertension (PH) presents a clinical challenge. Complete closure may cause pulmonary hypertensive crisis and low cardiac output syndrome; however, if left untreated, the disease progresses, the pulmonary vascular resistance increases, which may also lead to Eisenmenger's syndrome and shunt reversal. Today, this condition is treated with fenestrated closure, either with patch or fenestrated septal occluder. The fenestration is hypothesized to provide protective effect against pulmonary hypertensive crisis because it allows blood to flow from right to left heart. The added volume into the left heart is then, hypothesized, to provide volume training for the left heart, mainly in the case of small LV. Therefore, this study aims to evaluate the effect of fenestrated closure compared to non- fenestrated closure to the left ventricular size at systole and diastole.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with ASD secundum and pulmonary hypertension with complete preoperative and postoperative echocardiography (LVIDd and LVIDs) data
Patients with ASD secundum and pulmonary hypertension with complete preoperative but incomplete postoperative echocardiography (LVIDd and LVIDs) data, but willing to present upon invitation to complete missing postoperative data

Exclusion criteria

Patients with ASD secundum and pulmonary hypertension who are unwilling to participate in the study, or in a condition that prevents the patient to present for echocardiographic evaluation
Patients with incomplete medical records

Treatment and study plan

ASD closure with fenestrated/non-fenestrated patch

Procedure

A PTFE patch is used to surgically close the interatrial defect. If closure with fenestrated patch is deemed necessary, a small opening is created on the patch

Primary outcomes

Improvement in left ventricular diameter during systole and diastole

Time frame: January 2017 - October 2021

The change in left ventricular diameter during both systole and diastole is measured preoperatively and postoperatively

Sponsors and collaborators

Lead sponsor

Dr. Soetomo General Hospital

Other Gov

Registry information

Official study title

Improvement In Left Ventricular Diameter After Closure Of Atrial Septal Defect With Fenestrated Patch: A Cross-sectional Study

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Nov 18, 2023
Registry last updated: Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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