Early clinical experience with a novel self-expanding percutaneous stent-valve in the native right ventricular outflow tract.
BACKGROUND
Balloon expandable transcatheter pulmonary valve systems are not applicable to the large majority of patients with chronic severe pulmonary regurgitation (PR) following surgical right ventricular outflow tract (RVOT) rehabilitation. This report describes the clinical use and short-term follow-up of a novel transcatheter self-expanding pulmonary valve system (Venus P Valve) for rehabilitation of the RVOT in patients with chronic severe PR.


METHODS
Patients with native RVOT and severe PR were selected on a case-by-case basis as part of early clinical experience with this valve. Patient demographics and pre-procedural, intra-procedural, and follow-up data were reviewed.


RESULTS
Five patients (four females) with a mean weight of 54.8 ± 11.4 kg were selected for attempted valve deployment. Patients were either NYHA class II (n = 3) or class III (n = 2) at baseline. PR was grade 4 in all cases with mean right ventricular end-diastolic volumes of 155.0 ± 16.6 ml/m(2) on cardiac MRI. Mean minimum "annular" diameter on transthoracic echocardiogram was 22.8 ± 2.5 mm and mean RVOT diameter was 31.8 ± 5.1 mm. Uncomplicated successful valve delivery was achieved in all five cases with a mean fluoroscopy time of 22.8 ± 8.8 min. Valve sizes used were 26 (n = 3), 30 (n = 1), and 32 (n = 1). Mean pulmonary artery diastolic pressure increased from 3 ± 3.7 mm Hg to 9.9 ± 6.9 mm Hg (P = 0.06). On mean follow-up of 3.4 ± 2.5 months PR grade is 0 (n = 3) or 1 (n = 2) in all cases. NYHA class has improved at least one class in all cases and right ventricular volumes assessed by echocardiography have normalized in all three patients with follow-up to 3 months.


CONCLUSIONS
The Venus P Valve provides excellent short-term pulmonary valvar function in the native RVOT of patients with surgically induced chronic severe PR.
Rush Center for Congenital and Structural Heart Disease, Rush University Medical Center, Chicago, Illinois.
Qi-Ling
QL
Cao
Damien
D
Kenny
Daxin
D
Zhou
Wenzhi
W
Pan
Lihua
L
Guan
Junbo
J
Ge
Ziyad M
ZM
Hijazi
D000328:Adult; D000368:Aged; D000818:Animals; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000379:methods*; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014694:Ventricular Outflow Obstruction / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*
congenital heart disease, adults; congenital heart disease, pediatrics; percutaneous valve therapy; surgery, congenital heart disease