First in Man Implantation of the Self Expandable Med-Zenith PT Valve in the Native Right Ventricular Outflow Tract for Severe PR
Xiaoke Shang, Sr., Shu Chen, Changdong Zhang, Nianguo Dong.
Union Hospital, Wuhan, China.
Background:Surgical management of residual pulmonary regurgitation (PR) after initial repair of some congenital heart defects is truly challenging. Transcatheter pulmonary valve replacement (TPVR) is a new, less invasive alternative to surgical valve replacement. We report the first in man implantation using an Novel designed TPV device for patient with severe residual PR in native RVOT. Method:Patients with native RVOT and severe residual PR were selected on a case-by-case basis according to the anatomy feature of the patient and design of the valve. Patient demographics and pre-procedural, intra-procedural, and follow-up data were reviewed. Result: Four patients (2 females) with severe residual (grade 4+) were enrolled in this study with mean age of 35.50±5.67 years. 3 patients had previous surgery for tetralogy of Fallot and 1 for congenital pulmonary stenosis. All patients were symptomatic with NYHA heart function III at baseline. The inflow and out flow landing zone in this four patients was 41/39mm, 27/31mm, 27/31mm and 28/30mm, four device (44mm/36mm/36mm/36mm) was used for these patients respectively. Successful valve implantation was achieved in all four patients. No device malposition, coronary obstruction, reduced flow to the PA branches, and paravalvular leak were noted during the procedures. Mean pulmonary artery diastolic pressure increased from 3.7±1.5mmHg to 16.5±3.6mm Hg (P<0.05). In one month follow-up, MRI revealed positive RV remodeling with RVEDV volume decreased from 164.3±5.5ml to 89.8±3.1ml after intervention (P<0.05) with mean RVOT pressure gradient was 7± 0.7mmHg.
Conclusion: This first in man study demonstrates the initial safety and feasibility of the Med-Zenith PT Valve in the treatment of sever PR.
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