Pediatric Cardiac Surgery Center, Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
NCT Number: NCT07132593
This study was a retrospective descriptive case series analyzing outcomes of a novel surgical approach This study aimed to evaluate a modified surgical technique-called the Sandwich Procedure-for reconstructing the heart after resection of cardiac fibromas in children. Cardiac fibroma is a rare benign tumor that can compress vital cardiac structures and cause serious symptoms such as arrhythmia, heart failure, or obstruction of blood flow. Surgical removal is often required, but large tumors may leave defects in the heart wall that are challenging to repair, especially in young children.
The Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding. This retrospective, observational study includes pediatric patients who underwent this procedure between 2018 and 2023. We report on its surgical feasibility, short- and mid-term outcomes, and potential benefits in preserving cardiac function.
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Notify MeUp to 14 year
All sexes
Observational
Beijing, Beijing Municipality, 100037, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding.
Time frame: up to 5 years
all-cause mortality or cardiac reoperation
Time frame: up to 5 years
left ventricular ejection fraction (LVEF) < 55% or right ventricular fractional area change (RVFAC) < 45% by echocardiography
Time frame: up to 5 years
newly formed segmental dyskinesia with localized dilation
Time frame: up to 5 years
sustained ventricular tachycardia, ventricular fibrillation, or frequent polymorphic premature ventricular contractions requiring medical intervention
Time frame: up to 5 years
any new onset of high-degree atrioventricular block (Mobitz II or complete AVB), as well as complete left bundle branch block (CLBBB) by ECG
Time frame: before discharge
including low cardiac output syndrome [cardiac index < 2.0 L/(min·m2)], delayed sternal closure, prolonged invasive mechanical ventilation (≥ 7 days) and need for extra-corporeal membrane oxygenation (ECMO)
China National Center for Cardiovascular Diseases
Other Gov
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