Page 24 - Journal of Structural Heart Disease Volume 5, Issue 4

Meeting Abstracts
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A large residual shunt was noted possibly due to ePTFE tear. Three commercially available covered CP Stents (2x45mm and 1x40mm) were deployed inside the custom stent to close the residual shunt. Final angiography showed good stent position without significant residual shunt. Mean Fontan pressure was recorded at 14mmHg. The patient was discharged to home after 2-days of observation with systemic oxygen saturation in the low 90s on room air. At 3-weeks follow-up, baseline oxygen saturation was 93% on room air with improved exercise tolerance and saturation of 87% at peak exercise.
Conclusion: Transcatheter Fontan completion can be achieved in select cases after thorough evaluation using advanced imaging technologies. Custom-made stents may be required for specific and unique anatomy for minimally invasive Fontan completion.
21. EXPANDED ACCESS TO INVESTIGATIONAL AND CUSTOM-MADE DEVICES FOR EMERGENCY AND COM- PASSIONATE USE: A SINGLE CENTER EXPERIENCE Bennett Samuel1, Brittany Karll2, Deepthi Datla3, Allison Amidon1, Nathalie Hautala1, Rebecca Vanderzand1, Bassel Mohammad Nijres1, E. Oliver Aregullin1,4, Joseph Vettukattil1,4 1Spectrum Health Helen DeVos Children's Hospital, Grand Rapids, USA. 2Spectrum Health Office of Research, Grand Rapids, USA. 3Spectrum Health Hospitals, Grand Rapids, USA. 4Michigan State University College of Human Medicine, Grand Rapids, USA
Background: Approval of Class III medical devices by the U.S. Food and Drug Administration (FDA) can take from 3 to 7 years. However, patients with serious or life-threat- ening conditions have limited time to wait for device approval for necessary treatment or therapy. In these patients, expanded access to investigational devices may be the only treatment option. The FDA’s Center for Devices and Radiological Health (CDRH) regulates and authorizes expanded access including the manufacturing and use of patient-specific custom medical devices. We present our experience in providing expanded access to investigational devices to our patients through emergency and compas- sionate use of unapproved and custom-made devices with exemplary support from the FDA, which is often considered to be an impediment by physician implanters. Methods: From January 2014 to March 2019, 7 patients underwent transcatheter intervention at the Congenital Heart Center, Spectrum Health Helen DeVos Children’s Hospital, Grand Rapids, MI with expanded access investigational devices.
Results: Two female patients, aged 54 and 60 years, under- went emergency use of the Occlutech® Atrial Flow Regulator device (Occlutech International AB, Helsingborg, Sweden)
for severe pulmonary arterial hypertension. A 62-year old male underwent compassionate use of a custom-made vas- cular plug for closure of saphenous vein graft aneurysm 23 years following coronary artery bypass graft surgery. Two female patients, aged 41 and 56 years, underwent com- passionate use of the Occlutech® Fenestrated Atrial Septal Defect device (Occlutech International AB, Helsingborg, Sweden) for atrial septal defect-associated pulmonary hypertension. Two patients underwent compassionate use of custom-made Cheatham-Platinum StentTM (NuMED, Inc., Hopkinton, NY, USA): one for transcatheter Fontan com- pletion in a 15-year-old male, and the other in a 53-year- old male for closure of superior sinus venosus atrial septal defect with redirection of flow from the partial anomalous pulmonary venous return to the left atrium. The request for emergency/compassionate use was initially authorized by the institutional review board (IRB) chair, and institu- tional risk and compliance prior to applying to the FDA. In one case, the IRB authorized compassionate use pend- ing FDA determination prior to providing IRB chair letter of concurrence. Risk & compliance authorization included review and modification of the informed consent form to meet institutional compliance. Insurance authorization for all patients was received following peer-to-peer consulta- tion. All devices were successfully implanted. Conclusions: The FDA has a number of pathways for expanded use of unapproved medical devices for patients where there are no comparable or satisfactory therapies or alternative treatment options available in the country. The FDA-CDRH is a great resource and provides excellent support to physi- cians for expanded access to investigational devices. Local IRB and institutional risk and compliance often provide additional guidelines and support for expanded access cases. Peer-to-peer review for insurance authorization may be required based on the patient’s insurance and state or local laws. Expanded access to investigational devices can be made available to patients with no other treatment options with guidance from the FDA, IRB, and institutional risk & compliance.
22. BAILOUT TECHNIQUE FOR UNEXPECTED PROX- IMAL MIGRATION OF MELODY VALVE DURING DEPLOYMENT
E. Oliver Aregullin1,2, Bassel Mohammad Nijres1, Bennett Samuel1, Joseph Vettukattil1,2
1Spectrum Health Helen DeVos Children's Hospital, Grand Rapids, USA. 2Michigan State University College of Human Medicine, Grand Rapids, USA
Introduction: Transcatheter pulmonary valve replace- ment is a minimally invasive procedure. However, it is not risk-free as complications may occur in any step during
Journal of Structural Heart Disease, August 2019
Volume 5, Issue 4:75-205