Page 135 - Journal of Structural Heart Disease Volume 5, Issue 4

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Meeting Abstracts
Methods: This is a retrospective review of infants and children who underwent implantation of the bioabsorb- able everolimus-eluting stents (Absorb) and everolimus pharmacokinetics.
Results: During the period between September 2016 and October 2017, 17 Absorb stents were implanted into 15 blood vessels of 13 patients. The median patient age and weight were 180 (17, 511) days and 6.0 (2.9, 12.2) kg respectively. Stented blood vessels were left pulmonary artery (n=7), lower left pulmonary artery (n=3), right pul- monary artery (n=1) and pulmonary vein (n=6). All stents were 3.5 mm nominal diameter inflated to 4.0 mm. Six (40%) of the blood vessels had ineffective balloon dilations prior to stent implantation. There were no procedural complications.
Peak serum everolimus level was 21.2 ng/mL at 1 hour. All patients were within or below therapeutic range at 24 hours and were all below therapeutic level by 5 days (n=11). No patient experienced adverse events related to the everolimus drug.
Thirteen (87%) stented vessels required and were suc- cessfully treated – balloon dilation alone (n=10), balloon dilation with additional stent implantation (n=1), addi- tional stent (n=2) at a median interval of 96 (9, 356) days. Indications for intervention were progressive vessel nar- rowing in n=20 (80%) and need for further vessel enlarge- ment in 5 vessels.
Conclusions: Bioabsorbable everolimus-eluting stents provided effective and safe improvement of severely ste- notic blood vessels. The re-intervention rate was high but anticipated. Stented blood vessels were amenable to re-intervention prior to complete resorption.
179. THE MED-ZENITH PT-VALVETMFOR SEVERE PULMONARY REGURGITATION
John Cheatham1, NianGuo Dong2, Shu Chen2, XiaoKe Shang2, Qingliang Zhou2, Sharon Cheatham1, Jian Meng2
1Nationwide Children's Hospital, Columbus, USA. 2Beijing Med- Zenith Medical Scientific Co, Beijing, China
In China, there are ~15,000 open-heart surgeries/yr for TOF, leaving most patients with life-long significant PR. Transcatheter pulmonary valve (TPV) therapy in 2000 did not initially address this problem. Designing TPV for severe PR is much more challenging and was 1streported ~ 10 years ago. However, there have been few and slow advancements in the US, with more rapid progress in Asia in this therapy.
We are reporting the initial results of the Med-Zenith PT-ValveTMfor severe PR in China. The frame design is a unique, symmetric shape comprised of laser-cut nitinol covered with porcine pericardium, and a porcine pericar- dial valve sewn inside. Three anchors at the proximal frame for attachment to the delivery system allows easy loading, delivery, and controlled-release of the valve. Currently, there are 3 valve sizes (20, 23, and 26mm) and 5 frame dimensions (TPV2820, 3223, 3626, 4026, and 4426), with 2 additional larger frames with a 29mm valve being devel- oped (TPV4829 and 5229). The current delivery profile is 21Fr, with a 24Fr profile required for the 2 new valves.
After bench testing, animal implants were performed in the US and in China followed by a Clinical Protocol submit- ted to the CFDA for 100 patients in 5-6 sites. Prior to the Clinical Trial, there have been 14 implants in China. Below are the preliminary results in these patients.
Patient Demographics, Valves Implanted, & Implant Sites:
AGE: 24-56y/o; WEIGHT: 42-75Kg; GENDER: M-10, F-4; VALVE SIZE: TPV4426-7, 3626-3, 4026-2, 3223-1, 2820-1; IMPLANT SITES: Wuhan-9, Anzhen-2, & 1 implant at 3 other sites.
Results:14/14 successful implants. Post Implant: no signif- icant PR/paravalve leak 14/14. No SAE. Longest follow up 1year.
Conclusions: 1) Early results of the Med-Zenith PT-ValveTMfor severe PR are promising. 2) An experienced proctor was available for the 1stcase, but the other 13 implants were performed without an experienced proctor present...demonstrating ease of use. 3) The largest avail- able PT-Valve was used in 7/14 cases, however 2 larger valve sizes are being developed. 4) Plans are to begin the Clinical Trial in China in 2019.
180. FEASIBILITY OF AIRWAY SEGMENTATION FROM THREE DIMENSIONAL ROTATIONAL ANGIOGRAPHY
Sebastian Goreczny1,2, Alexander Haak3,4, Gareth Morgan2,3,
Jenny Zablah2
1Polish Mother's Memorial Hospital, Research Institute, Lodz,
Poland. 2Children's Hospital Colorado, Aurora, Colorado, USA.
3University of Colorado Hospital, Aurora, Colorado, USA. 4Philips Healthcare, Andover, Massachusetts, USA
Background: Modern imaging platforms allow not only visualization of the three dimensional (3D) structure of the vascular anatomy, but also present the spatial relation of vascular segments to non-vascular structures such as
Hijazi, Z
22nd Annual PICS/AICS Meeting