Patient Selection Process for the Harmony Transcatheter Pulmonary Valve Early Feasibility Study

This early feasibility study was designed to obtain in vivo data to confirm assumptions on device loading conditions of the Medtronic Harmony transcatheter pulmonary valve (TPV). Secondary objectives included procedural feasibility, safety, and valve performance. The Harmony TPV was developed for no...

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Bibliographic Details
Published in:The American journal of cardiology 2017-10, Vol.120 (8), p.1387-1392
Main Authors: Gillespie, Matthew J., Benson, Lee N., Bergersen, Lisa, Bacha, Emile A., Cheatham, Sharon L., Crean, Andrew M., Eicken, Andreas, Ewert, Peter, Geva, Tal, Hellenbrand, William E., Hor, Kan N., Horlick, Eric M., Jones, Thomas K., Mayer, John, McHenry, Brian T., Osten, Mark D., Powell, Andrew J., Zahn, Evan M., Cheatham, John P.
Format: Article
Language:English
Subjects:
Adult
Anatomy
Cardiac Catheterization - methods
Children & youth
Clinical Studies as Topic
Computed tomography
Criteria
Design
Echocardiography
Electrocardiography
Enrollments
Feasibility Studies
Female
Follow-Up Studies
Heart
Heart diseases
Heart Valve Prosthesis Implantation - methods
Heart Ventricles - diagnostic imaging
Heart Ventricles - physiopathology
Hospitals
Humans
Implantation
In vivo methods and tests
Magnetic resonance imaging
Magnetic Resonance Imaging, Cine
Male
Medical equipment
Medical imaging
Medical technology
Morphology
Patient Selection
Patients
Prospective Studies
Prostheses
Pulmonary arteries
Pulmonary artery
Pulmonary Valve - surgery
Pulmonary Valve Insufficiency - diagnosis
Pulmonary Valve Insufficiency - surgery
Screening
Surgery
Surgical implants
Technology assessment
Time Factors
Treatment Outcome
Veins & arteries
Ventricle
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Description
Summary:This early feasibility study was designed to obtain in vivo data to confirm assumptions on device loading conditions of the Medtronic Harmony transcatheter pulmonary valve (TPV). Secondary objectives included procedural feasibility, safety, and valve performance. The Harmony TPV was developed for nonsurgical pulmonary valve replacement in non–right ventricle-pulmonary artery conduit patients. The Native Outflow Tract TPV Research Clinical Study was the first study approved under the Food and Drug Administration Early Feasibility Study guidance. Enrollment required that patient anatomy be precisely matched to the single-size Harmony TPV implant, necessitating a rigorous selection process. The study was nonrandomized, prospective, and performed at 3 sites. All patients met standard indications for surgical pulmonary valve replacement. The goal of the screening committee was to match the candidate anatomy to predetermined engineering criteria thought to be predictive of secure Harmony TPV implantation for the single-size device under study. A majority of the screening committee was required to recommend a patient as eligible for implant. A total of 270 patients underwent prescreening cardiac magnetic resonance imaging, 66 were enrolled and received a computed tomography scan (24%), 21 met criteria for implant and were catheterized (8%), and 20 underwent implant. Nineteen of 20 met criteria for implant success. In conclusion, the Medtronic Harmony TPV represents an emerging therapeutic option for patients with complex postoperative right ventricular outflow tract failure. The initial clinical evaluation of this technology was unique, and the highly variable anatomy of this population required careful screening to ensure acceptable device fit.
ISSN:0002-9149
1879-1913
DOI:10.1016/j.amjcard.2017.07.034