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JACC Cardiovasc Interv. 2017 Sep 11;10(17):1763-1773. doi: 10.1016/j.jcin.2017.05.034.

Harmony Feasibility Trial: Acute and Short-Term Outcomes With a Self-Expanding Transcatheter Pulmonary Valve.

Author information

1
Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts. Electronic address: lisa.bergersen@cardio.chboston.org.
2
Division of Cardiology, Labatt Family Heart Center, Hospital for Sick Children, Toronto, Ontario, Canada.
3
Department of Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
4
Department of Cardiology, Nationwide Children's Hospital, Columbus, Ohio.
5
Peter Munk Cardiac Centre, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada; Joint Department of Medical Imaging, Toronto General Hospital, Toronto, Ontario, Canada.
6
Peter Munk Cardiac Centre, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.
7
Coronary and Structural Heart Clinical Department, Medtronic, Santa Rosa, California.
8
Coronary and Structural Heart Research and Innovation Department, Medtronic, Mounds View, Minnesota.
9
Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.

Abstract

OBJECTIVES:

This study sought to obtain in vivo data to confirm assumptions on device loading conditions and assess procedural feasibility, safety, and valve performance.

BACKGROUND:

The Harmony transcatheter pulmonary valve (Medtronic, Minneapolis, Minnesota) was designed for patients with severe pulmonary regurgitation who require pulmonary valve replacement.

METHODS:

Three sites participated in this first Food and Drug Administration-approved early feasibility study using an innovative device design to accommodate the complex anatomy of the right ventricular outflow tract. Potentially eligible patients underwent review by a screening committee to determine implant eligibility. Six-month outcomes are reported.

RESULTS:

Between May 2013 and May 2015, 66 subjects were enrolled, and 21 were approved for implant and underwent catheterization; 20 were implanted. Catheterized patients had a median age of 25 years, were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%), and had trivial or mild stenosis. The device was delivered in the desired location in 19 of 20 (95%) patients. Proximal migration occurred in 1 patient during delivery system removal. Two devices were surgically explanted. Premature ventricular contractions related to the procedure were reported in 3 patients; 2 were resolved without treatment. One patient had ventricular arrhythmias that required treatment and later were resolved. At 1 month, echocardiography revealed none or trivial pulmonary regurgitation in all and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range 6 to 31 mm Hg).

CONCLUSIONS:

In this feasibility study of the Harmony transcatheter pulmonary valve device, there was high procedural success and safety, and favorable acute device performance.

KEYWORDS:

Harmony TPV; RVOT conduit; tetralogy of Fallot; transcatheter pulmonary valve

PMID:
28882284
DOI:
10.1016/j.jcin.2017.05.034
[Indexed for MEDLINE]
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