Three-Year Outcomes from the Harmony Native Outflow Tract Early Feasibility Study
Presenter
Lee N. Benson, M.D., MSCAI, The Hospital for Sick Children, Toronto, ON, Canada
Lee N. Benson, M.D., MSCAI, The Hospital for Sick Children, Toronto, ON, Canada
Keywords: Imaging and Physiology and Transcatheter Pulmonary Valve Replacement (TPVR)
Background:
The Harmony transcatheter pulmonary valve (TPV) was designed to treat pulmonary valve regurgitation (PR) occurring during follow-up after surgical repair of right ventricular outflow tracts (RVOT).
Methods:
The Native TPV Early Feasibility Study (EFS) is a prospective, multicenter, non-randomized feasibility study designed to evaluate the Harmony TPV device in 20 patients. Here we report 3-year follow-up clinical, echocardiographic, and CT outcomes.
Results:
Of 20 implanted patients, 17 completed 3-year follow-up (max: 4.1 y). There were no deaths but 2 early explants (previously reported). One patient did not complete a 3-year visit. In remaining patients with available 3-year echo data, paravalvular leak (PVL) was mild in 1 patient and no/trace in the remainder; PR was mild in 1 patient and no/trace in the remainder. The 3-year mean RVOT gradient was 15.7±5.5 mm Hg. No significant frame fractures were identified via radiography. Two patients required catheter reintervention due to development of significant outflow tract obstruction; subsequently, a follow-up CT scan was obtained (n=16) 3.2±1.5 months after the index procedure (Figure). The degree of luminal loss (intraluminal in-growth) was compared to the immediate post-implant scan at 3 predesignated frame locations and averaged (median [Q1,Q3] of 20% [11,34] inflow, 9% [-1, 14] valve housing, and 19% [12, 31] outflow), excluding the 2 patients with catheter reintervention
. Conclusions:
The 3-year results from the Native TPV EFS demonstrate consistent valve function without moderate/severe PVL, PR or valve stenosis, and a stable Harmony TPV frame without significant frame fractures.
