Early results of Pulsta® transcatheter heart valve in patients with enlarged right ventricular outflow tract and severe pulmonary regurgitation due to transannular patch

Objective: The purpose of this study is to assess the feasibility, effectivity, and safety of a novel self-expandable valve system, Pulsta (R) transcatheter heart valve in patients with tetralogy of fallot and severe pulmonary regurgitation after transannular patch repair. Background: Severe pulmonary regurgitation after tetralogy of fallot repair is a life-threatening problem and should be treated by pulmonary valve implantation. Although percutaneous pulmonary valve implantation has been ever increasingly used for this purpose, available balloon-expandable valves have limitations and cannot be used by most patients. Pulsta (R) transcatheter heart valve is a new self-expandable valve system and offers a new solution to be used in patients with different types of native right ventricular outflow tract geometry. Patients and Methods: Ten patients with severe regurgitation after tetralogy of fallot repair with a transannular patch have been enrolled in the study according to echocardiographic examination. MRI was used in asymptomatic patients to delineate the indication and the right ventricular outflow tract geometry. Pulsta (R) transcatheter heart valve implantation was performed in ten patients, and preprocedural, procedure, and 6 months follow-up findings of the patients were evaluated. Results: Pulsta (R) pulmonary valve implantation was performed in ten patients successfully without any severe complications. Valve functions were perfect in six of ten patients, while the others had insignificant regurgitation by echocardiographic examination at the end of 6 months follow-up. Conclusions: This study showed that Pulsta (R) transcatheter heart valve is a feasible, effective, and safe method in the treatment of severe pulmonary regurgitation due to transannular patch repair in patients with tetralogy of fallot.