Multi-Band Surgery for Repaired Tetralogy of Fallot Patients With Reduced Right Ventricle Ejection Fraction: A Pilot Study

INTRODUCTION: Right ventricle (RV) failure is one of the most common symptoms among patients with repaired tetralogy of Fallot (TOF). The current surgery treatment approach including pulmonary valve replacement (PVR) showed mixed post-surgery outcomes. A novel PVR surgical strategy using active contracting bands is proposed to improve the post-PVR outcome. In lieu of testing the risky surgical procedures on real patients, computational simulations (virtual surgery) using biomechanical ventricle models based on patient-specific cardiac magnetic resonance (CMR) data were performed to test the feasibility of the PVR procedures with active contracting bands. Different band combination and insertion options were tested to identify optimal surgery designs. METHOD: Cardiac magnetic resonance data were obtained from one TOF patient (male, age 23) whose informed consent was obtained. A total of 21 finite element models were constructed and solved following our established procedures to investigate the outcomes of the band insertion surgery. The non-linear anisotropic Mooney–Rivlin model was used as the material model. Five different band insertion plans were simulated (three single band models with different band locations, one model with two bands, and one model with three bands). Three band contraction ratios (10, 15, and 20%) and passive bands (0% contraction ratio) were tested. RV ejection fraction was used as the measure for cardiac function. RESULTS: The RV ejection fraction from the three-band model with 20% contraction increased to 41.58% from the baseline of 37.38%, a 4.20% absolute improvement. The RV ejection fractions from the other four band models with 20% contraction rate were 39.70, 39.45, and 40.70% (two-band) and 39.17%, respectively. The mean RV stress and strain values from all of the 21 models showed only modest differences (5–11%). CONCLUSION: This pilot study demonstrated that the three-band model with 20% band contraction ratio led to 4.20% absolute improvement in the RV ejection fraction, which is considered as clinically significant. The passive elastic bands led to the reduction of the RV ejection fractions. The modeling results and surgical strategy need to be further developed and validated by a multi-patient study and animal experiments before clinical trial could become possible. Tissue regeneration techniques are needed to produce materials for the contracting bands.