Transcatheter Pulmonary Valve Replacement With the Harmony Valve in Patients Who Do Not Meet Recommended Oversizing Criteria on the Screening Perimeter Plot.

Background: Anatomic selection for Harmony valve implant is determined with the aid of a screening report and perimeter plot (PP) that depicts the perimeter-derived radius along the right ventricular outflow tract (RVOT) and projects device oversizing. The PP provides an estimation of suitability for implant, but its sensitivity as a screening method is unknown. This study was performed to describe anatomic features and outcomes in patients who underwent Harmony TPV25 implant despite a PP that predicted inadequate oversizing.
Methods: We reviewed RVOT anatomic features and measurements in patients who underwent transcatheter pulmonary valve replacement with the Harmony TPV25 device despite a PP that predicted inadequate oversizing.
Results: This study included 22 patients. There were no unsuccessful implants or adverse valve-related events. Anatomic features varied, but all patients fit into 1 of 3 anatomic types characterized by differences in RVOT dimensions. Type 1 patients (n=9) had a long RVOT with a choke point and a wide main pulmonary artery. Type 2 patients (n=6) had a short RVOT that was pyramidal in shape, with no choke point, and extensive main pulmonary artery lengthening/expansion during systole. Type 3 patients (n=7) had a short, bulbous main pulmonary artery with a choke point and an open pulmonary artery bifurcation.
Conclusions: Transcatheter pulmonary valve replacement with the Harmony valve is feasible in some patients whose PP fit analysis predicts inadequate oversizing. All cases in this series fit into 1 of 3 anatomic patterns, which are not identified in the screening report. Implanters must review cases individually to assess the feasibility of the implant.
Competing Interests: Disclosures Drs McElhinney and Aboulhosn worked as Proctor and consultant for Medtronic and Edwards. Dr Gillespie is a consultant and proctor for Medtronic and W.L. Gore and Associates. Dr Cabalka is a Consultant for Medtronic, Edwards, and B. Braun. Dr Morray worked as Proctor and consultant for Medtronic and Abbott. Dr Balzer worked as Proctor and consultant for Medtronic, Edwards, and Abbott. Dr Qureshi worked as proctor and consultant for Medtronic, W.L. Gore and Associates, and B. Braun. Dr Goldstein worked as consultant and Proctor for Medtronic and W.L. Gore & Associates, Consultant for Edwards, Consultant and Advisory Board Member for PECA Labs and Mezzion Pharmaceuticals.