Native Right Ventricular Outflow Tract (NRVOT) Dysfunction Treated with the Alterra Adaptive Prestent and SAPIEN 3: 6-month Outcomes of the US Early Feasibility Study
Presenter
Vasiliki Vivian Dimas, M.D., FSCAI, Medical City Children’s Hospital, Dallas, TX
Vasiliki Vivian Dimas, M.D., FSCAI, Medical City Children’s Hospital, Dallas, TX
Keywords: Coronary Interventions in Pediatrics, Interventional Management for Neonatal Tetralogy of Fallot (TOF) and Transcatheter Pulmonary Valve Replacement (TPVR)
Background:
Many patients with NRVOT dysfunction are not candidates for percutaneous valve replacement due to RVOT size and geometry. The Edwards self-expanding Alterra Adaptive Prestent internally reduces and reconfigures the RVOT to provide a stable landing zone for Edwards SAPIEN 3 29 mm transcatheter heart valve. This study was conducted to demonstrate the safety and functionality of the Alterra Prestent with the SAPIEN 3 in patients with NRVOT dysfunction and moderate-severe pulmonary regurgitation (PR).
Methods:
Eligible patients from 4 US sites weighed ≥20 kg, had moderate to severe PR, and RVOT diameter ≥27 mm – ≤38 mm and length
>35 mm. Primary endpoint was device success, defined as: one Alterra Adaptive Prestent deployed in desired location, single Sapien 3 implanted within Prestent in intended location, right ventricular-pulmonary artery peak-to-peak gradient <35 mmHg post-implantation, <mild PR at discharge, and no explant 24 hours post-implant. Safety was monitored. Descriptive statistics were used.
Results:
Patients (N=15) were (median) 30.5 years old and weighed 69.5 kg; 93.3% were New York Heart Association class I or II. From February 2018 to May 2018, device success was achieved in all patients during a single procedure. Table 1 displays 30-day follow-up data; 6-month data will be available at the time of the presentation. No significant safety signals were reported.
Conclusions
:
This early feasibility study demonstrated Alterra Adaptive Prestent safety and functionality in patients with NRVOT dysfunction and moderate-severe PR. Further study of durability and long-term outcomes are needed.
