Optimus covered stent: Advanced covered stent technology
for complex congenital heart disease
Gareth J. Morgan MB BaO BCh MPhil MRCPCH FSCAI
Matteo Ciuffreda MD
Isabella Spadoni MD
Joseph DeGiovanni MD FRCP FDCPCH
The Heart Institute, Children’s Hospital of
Colorado and University Hospital Colorado,
Aurora, Colorado, USA
Cardiovascular Department, “Papa Giovanni
XXIII” Hospital, Bergamo, Italy
Fondazione Regione Toscana G.
Monasterio, Massa, Pisa, Italy
Department of Pediatric Cardiology,
Birmingham Children’s Hospital,
Birmingham, United Kingdom
Gareth J. Morgan, The Heart Institute,
Children’s Hospital of Colorado, Anshutz
Medical Campus, Denver, CO 80045.
Aim: To assess the acute results of the first human use of the Optimus covered stent in complex
coarctation of the aorta.
Methods and Results: We successfully implanted the Optimus covered stent in eight cases in
patients whose preprocedural anatomy looked challenging for currently available covered stents. Six
of the patients had native coarctation with one recoarctation following surgical repair. There were
no significant complications with reduction in the mean invasive gradient from 22 to 1 mm Hg. The
length of stents used ranged from 33 to 57 mm with a median shortening after expansion of 13%.
Postprocedural follow-up with magnetic resonance imaging or computed tomography has not shown
evidence of fracture or migration or renarrowing. The median duration of follow-up is 10 months.
Conclusions: Preliminary results show that the Optimus covered stent is safe and efficacious for
use in patients with coarctation of challenging morphology. A systemic trial will be required to
evaluate this stent for more widespread practice.
coarctation of the aorta, congenital, innovation
Routine availability of covered stents should lead to an increased
confidence and application of stent implantation in complex coarctation
and right ventricular outflow tracts.
There remains concern about
the performance of NuMed’s Cheatham-Platinum (CP) (NuMed,
Hopkington, New York) stent in larger diameter vessels where
stretching of the polytetrafluoroethylene (PTFE) covering may lead to
relative malfunction of the stent. Occasionally in complex coarctation,
one needs to perforate through the PTFE membrane of a covered
stent. The behavior of the covering in response to intentional
perforation in order to reanimate head and neck vessels is unknown in
vitro or in vivo (although this technique has been performed clinically).
The response of the community to the large caliber Avanta V12
(Atrium, Mijdrecht, The Netherlands) stent has been varied with reports
of poor acute and medium term performance.
The Bentley BeGRAFT
(Bentley Innomed GmbH, Hechingen, Germany) has recently been CE
marked and may offer a covered stent alternative outside the United
States, but little has been published regarding this stent so far.
We describe procedural outcomes and early follow-up of the first
eight human implants of the Optimus covered stent in patients with
complex coarctation of the aorta.
PROCEDURAL METHODS AND RESULTS
The Optimus covered stent (AndraTec GmbH, Koblenz, Germany) rep-
resents a novel design of PTFE covered stent; available in a vast array
of sizes. Its basic design is very similar to a bare metal stent (Andras-
tent; Andramed GmBh, Reutlingen, Germany) which has had wide
usage in Europe.
The Optimus is a non-premounted, balloon expanda-
ble, hybrid cell design cobalt chromium stent sandwiched by PTFE
membranes which are thermally bonded to all of the metal struts of the
stent. One half of a row of cells remains uncovered at either end of the
stent (Figure 1). Its hybrid nature allows expansion to greater than
26 mm with acceptable shortening characteristics. The presence of
cobalt chromium in the stent’s construction promises good radial
strength and resistance to fracture. It is available in two sizes; L
2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/chd Congenital Heart Disease. 2018;13:458–462.
Received: 5 November 2017
Revised: 3 January 2018
Accepted: 14 January 2018