# Evaluating the Sapien® XT Valve in Native Right Ventricular Outflow Tracts After Tetralogy of Fallot Repair: Mid- and Long-Term Results

## TL;DR

This study evaluates the mid- and long-term outcomes of using the Sapien® XT valve in the right ventricular outflow tract after Tetralogy of Fallot repair, finding generally good results but some long-term complications.

## Contribution

The study provides mid- and long-term follow-up data on balloon-expandable percutaneous valves in native right ventricular outflow tracts, highlighting tricuspid valve issues as a new concern.

## Key findings

- 97.4% of patients did not need further intervention after one year, decreasing to 70.2% by year seven.
- Tricuspid valve problems emerged as a significant long-term issue not previously considered.
- Patients needing reintervention showed similar outcomes to surgical valve long-term results.

## Abstract

Although the long-term outcomes of the surgical grafts are well defined and reported, the data regarding the mid-and long-term results of the balloon-expandable percutaneous valves in the native right ventricular outflow tract (RVOT) is limited. We retrospectively evaluated 42 patients who underwent PPVI (Sapien® XT valve) to native RVOT due to severe pulmonary regurgitation (PR) and/or moderate to severe pulmonary stenosis (PS) between August 2015 and November 2020. The median patient age at the time of PPVI was 13.4 years (6.1–36.5 years). The median body weight of the patients was 42 kg (15–110 kg). The rate of patients who were followed up without the need for percutaneous or surgical intervention was 97.4% at the end of year 1, 89.3% at the end of year 3, and 85.8% at the end of year 5. At the end of year 6, the proportion of patients requiring no procedure remained constant, with year 5 at 85.8%, but decreased to 70.2% at the end of year 7. Although the early results are very encouraging, it is seen that PPVI in patients with RVOT in the long term brings some problems. The most important of these is tricuspid valve problems, which were not considered before the procedure. Patients requiring reintervention due to pulmonary regurgitation show similar characteristics to surgical valves’ long-term results.