Page 100 - Journal of Structural Heart Disease Volume 4, Issue 4

Meeting Abstracts
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161. PRECLINICAL EVALUATION OF A NOVEL ZINC BIORESORBABLE STENT FOR USE IN CONGENITAL HEART DISEASE
EC Kish, A Glavan, KM O'Neill, J Li, G Tensol, HG Bezerra, HG Moran, ML Bocks
UH Hospitals, Cleveland, USA
Background: Infants and children with vascular stenoses associated with congenital heart disease are often treated with bare metal stents typically approved for coronary or peripheral artery disease in adults. These stents often cannot be dilated much beyond their implantation diam- eters, which can result in impaired growth of the vessel relative to somatic growth. Bioresorbable stents o er the potential for treatment in infancy without the concern for vessel growth restriction as vascular enlargement can pro- ceed once the stent material resorbs. We report the results of bench and in vivo preclinical testing of our novel zinc bioresorbable stent (ZBS).
Methods: Various lengths and diameters of the ZBS were evaluated for radial hoop strength, recoil, and foreshort- ening by a certi ed laboratory following ASTM stan- dards. Twenty-two 10mm ZBS mounted on 6mm balloons (NuMed Inc.) were implanted in 11 mini Yucatan swine and were followed out 30 days (n=3), 90 days (n=4), 150 days (n=2), and 180 days (n=2). Comprehensive evaluations with angiography, optical coherence tomography (OCT), micro CT, and histopathology were performed on all ani- mals to assess for stent patency, neointimal hyperplasia (NIH), thrombus formation, apposition, and stent integrity.
Results: The 6 mm ZBS had higher radial force compared to the Cook Formula 418 stent and the Cordis Palmaz Blue stent. The 10 mm ZBS had slightly lower radial strength compared to the IntraStent double-strut LD stent. Angiography and OCT revealed minimal NIH, no restriction to vessel growth, no vascular injury, no thrombus, and near perfect wall apposition out to 180 days. Stent fractures related to tendency of the material become brittle over time with degradation were observed, but did not com- promise stent integrity.
Conclusion: Early bench and in vivo testing demonstrates that the ZBS possess baseline radial strength similar to stents widely used in pediatric interventional cardiology. In vivo performance was very encouraging with excellent wall apposition and endothelialization, complete patency, no migration, no dissection, minimal NIH, no thrombus, and modest in ammatory response. Further work to opti- mize alloy content to make material less prone to fracture
is ongoing as this will ensure maintenance of radial force for the desired period of time.
162. AORTIC DISEASES TREATED WITH “PEDIATRIC DEVICES”
Bogdan Cherpak, Nataliia Yashchuk, Igor Ditkivskyy, Bodan
Batsak, Vasyl Lazoryshynets
Amosov National Institute of Cardiovascular Surgery, Kiev, Ukraine
Background: The gold standard for aortic disease manage- ment remain surgery or endovascular aortic stent-grafting. But sometimes “pediatric” percutaneous devices may play a role when surgery is too risky and stent-grafts do not t due to the variability of aortic anatomy. We present six cases of aortic disease management with pediatric devices.
Cases presentation: In our small group three patients pre- sented with huge ascending aortic pseudoaneurysms at the needle or cannulation site following valve surgery. The rst one was successfully treated percutaneously with 12 mm Figula Flex II ASD device. In second case, ascending aortic pseudoaneurysm was managed with 10 mm AGA pmVSD asymmetric device. After intervention this patient had tiny leak at the site of asymmetric disk. Six month fol- lowing intervention routine ECHO examination showed that aneurysmal sack did not collapse. The leak was treated with 5 mm Co-Med ASD device with complete sack throm- bosis according to the ECHO data. The third patient was managed with 16 mm PushMed ASD device. Angiography showed new entry site to the pseudoaneurysm and aneu- rysmal sack to right atrium shunt also appeared. The patient was regarded to have infective endocarditis due to fragile aortic wall and anamnesis of high fever and con- verted to surgery at the same day.
One patient had coarctation repaired by Andrastent with simultaneous closure of collateral network aneurysm. The feeding vessel was occluded with the couple of Cook coils and then entry site of the aneurysm was occluded with SHSMA pmVSD asymmetric device.
One man had Bental de Bono procedure more than ten years ago with the graft wrapping with the native tissue, distal suture line incompetence and surgically created stula from false lumen (native tissue sack) to the right atrium. The entry site to the sack was managed with 12-14 mm LifeTech PDA occluder then stula to the right atrium was closed with 10 mm MemoPart PDA device.
Journal of Structural Heart Disease, August 2018
Volume 4, Issue 4:114-206