Device-Related Findings on Computed Tomography After Transcatheter Pulmonary Valve Replacement With the Harmony Valve.

Background: Self-expanding transcatheter pulmonary valves (TPV) offer a promising alternative to surgical valve replacement in patients with a large patched or native right ventricular outflow tract. Little is known about remodeling of the implanted valve or valve-anatomy interactions.

Methods: We reviewed all patients who underwent TPV replacement with the Harmony valve (Medtronic, Inc) at our center and had a postimplant computed tomography angiogram.

Results: Of 63 patients who underwent TPV replacement, 36 had a computed tomography angiogram performed 0.2 to 4.9 years (median 1 year) after implant, in most cases for surveillance. Hypoattenuated leaflet thickening was identified in 28% of patients and tissue ingrowth/thickening on the luminal aspect of the device was observed in 39%. In most cases, these findings were mild and were not associated with valve stenosis or regurgitation. Most patients were discharged after TPV replacement on aspirin without anticoagulation, but addition of oral anticoagulants reversed TPV replacement in 2 patients who underwent a second follow-up computed tomography angiogram 6 months later. New frame deformation and stent fracture were uncommon, and erosion of the valve through the pulmonary artery did not occur. The outflow portion of the TPV frame was frequently close to the left coronary artery, but did not cause compression.

Conclusions: This study provides novel data related to hypoattenuated leaflet thickening, tissue ingrowth within the TPV frame, and proximity of the implanted valve to the coronary arteries, which should help clinicians evaluate and manage patients before and after Harmony valve implant.