Columbia University
The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will undergo a ventricular assist device (VAD) placement. The investigators want to study the correlation of having a 3D printed model with improvement in patient outcomes and compare those with patients who have had a VAD placement without a 3D model.
Congenital heart disease (CHD) remains the most common type of major congenital malformation and the leading cause of mortality from birth defects \[1-4\]. Advances in effective treatment for these lesions have significantly extended the lifespan of affected patients, especially for the most complex subtypes of disease. However, these patients are at higher risk of heart failure (HF) secondary to longer life expectancy. This includes patients with a systemic right ventricle and a single ventricle circulation palliated by a Fontan procedure \[5, 6\]. HF has been documented in up to 30% of patie…
Inclusion Criteria: * Patients who weigh over 3 kilograms with CHD HF who are candidates for MCS will be prospectively identified at the participating centers. Exclusion Criteria: * Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.
To assess if a 3D printed cardiac model improves visualization of VAD and cannula placement sites in CHD-HF patients as compared to 2D imaging. The investigators will prospectively enroll CHD-HF patients at multiple centers and randomize to group A (3D printed models will be used for pre-VAD planning) or Group B (controls).