Key result
Pulsta transcatheter heart valve implantation was successfully performed in 10 patients with tetralogy of Fallot, resulting in perfect valve function in 6 patients and insignificant regurgitation in 4 patients at 6 months.
Why the study?
Available balloon-expandable valves for percutaneous pulmonary valve implantation have limitations in native right ventricular outflow tracts, creating a need to evaluate the feasibility, effectivity, and safety of the novel self-expandable Pulsta transcatheter heart valve.
Does Pulsta transcatheter heart valve implantation safely improve pulmonary regurgitation in patients with tetralogy of Fallot and enlarged right ventricular outflow tract?
Comparison
Pulsta transcatheter heart valve implantation
Follow-up
6 months
Authors
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Initial Pulsta data in repaired TOF may guide early device choice; leaves open durability and outcome questions.
Observational (n=10)
No
Does Pulsta transcatheter heart valve implantation safely improve pulmonary regurgitation in patients with tetralogy of Fallot and enlarged right ventricular outflow tract?
The Pulsta self-expandable transcatheter heart valve is a feasible, effective, and safe option for treating severe pulmonary regurgitation in patients with Tetralogy of Fallot and enlarged native right ventricular outflow tracts.
Ödemiş et al. (2022) conducted an observational in Tetralogy of Fallot with severe pulmonary regurgitation after transannular patch repair (n=10). Pulsta transcatheter heart valve was evaluated on Successful valve implantation and valve function at 6 months. Pulsta transcatheter heart valve implantation was successfully performed in 10 patients with tetralogy of Fallot, resulting in perfect valve function in 6 patients and insignificant regurgitation in 4 patients at 6 months.
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