©

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© 2022 EDIZIONI MINERVA MEDICA The Journal of Cardiovascular Surgery 2023 February;64(1):18-25
Online version at https://www.minervamedica.it DOI: 10.23736/S0021-9509.22.12564-4

REVIEW
AORTIC ARCH

Technical tips and clinical experience

with the Gore Thoracic Branch Endoprosthesis®
Andrea VACIRCA, Emanuel R. TENORIO, Thomas MESNARD, Titia SULZER,
Aidin BAGHBANI-OSKOUEI, Aleem K. MIRZA, Ying HUANG, Gustavo S. ODERICH *

Advanced Aortic Research Program, McGovern Medical School, Department of Cardiothoracic and Vascular Surgery, Memorial
Hermann Medical Plaza, University of Texas Health Science Center at Houston, Houston, TX, USA
*Corresponding author: Gustavo S. Oderich, Advanced Aortic Research Program, McGovern Medical School, Department of Cardiothoracic and Vascular
Surgery, Memorial Hermann Medical Plaza, University of Texas Health Science Center at Houston, Fannin Street 6400, 77030 Houston, TX, USA.
E-mail: [email protected]

A B S T RA C T
Thoracic endovascular aortic repair (TEVAR) has been widely accepted as a treatment option in patients with thoracic aortic aneurysms and
dissections who have suitable anatomy. It is estimated that up to 60% of patients treated by TEVAR require extension of the repair into the distal
aortic arch across Ishimaru zone 2. In these patients, coverage of the left subclavian artery (LSA) without revascularization has been associated
with increased risk of arm ischemia, stroke, and spinal cord injury. The Gore Thoracic Branch Endoprosthesis (TBE, WL Gore, Flagstaff, AZ,
USA) is the first off-the-shelf thoracic branch stent-graft approved by the Federal Drug Administration for treatment of distal aortic arch lesions
requiring extension of the proximal seal into zone 2. This article summarizes the technical pitfalls and clinical outcomes of the TBE® device in
zone 2.
(Cite this article as: Vacirca A, Tenorio ER, Mesnard T, Sulzer T, Baghbani-Oskouei A, Mirza AK, et al. Technical tips and clinical experience with
the Gore Thoracic Branch Endoprosthesis®. J Cardiovasc Surg 2023;64:18-25. DOI: 10.23736/S0021-9509.22.12564-4)
Key words: Aneurysm, aortic arch; Aortic dissection; Endovascular aneurysm repair; Acute aortic syndrome.

T horacic endovascular aortic repair (TEVAR) has been

widely used for treatment of a wide range of aortic le-
sions including aneurysms, dissections, blunt aortic injury,
repair with carotid-subclavian bypass or transposition is
a safe and widely utilized procedure, but is associated
with risks of cranial and phrenic nerve injury, hematoma
and other rarities affecting the descending thoracic aorta and prolonged hospitalization.9-13 Endovascular repair of
(DTA).1 Compared to historical results of open surgical distal aortic arch lesions can be performed using parallel
repair, TEVAR is associated with significant decrease in grafts, fenestrated or branched devices. The latter option
30-day mortality and spinal cord injury (SCI).2-7 Similar to has potential advantages of off-the-shelf applications, flex-
other segments of the aorta, selection of suitable proximal ible deployment, and durable sealing. The Gore Thoracic
and distal sealing zones is the single-most important crite- Branch Endoprosthesis® (TBE®, WL Gore, Flagstaff, AZ,
ria for durable aneurysm exclusion. It is estimated that up USA) is the first off-the-shelf arch branch stent-graft that
to 60% of patients undergoing TEVAR require extension received approval of the Federal Drug Administration for
of the proximal seal into Ishimaru zone 2. In these patients, clinical use in patients with distal aortic arch lesions re-
coverage of the left subclavian artery (LSA) without re- quiring seal in zone 2. In this article we summarize the
vascularization has been associated with increased risk TBE® device characteristics, anatomical criteria, technical
of arm ischemia, stroke and spinal cord injury.8 Hybrid pitfalls and outcomes in the feasibility and pivotal trials.

18 The Journal of Cardiovascular Surgery February 2023

 ©
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TIPS AND CLINICAL EXPERIENCE WITH GORE TBE® VACIRCA

Gore TBE® characteristics stent-graft has a distal flared configuration with proximal
diameters of 8 or 12 mm, distal diameters of 8 to 20 mm
The Gore TBE® is a modular off-the-shelf device that con- and 60 mm length. The stent segments include the proxi-
sists of an aortic and a side branch component. Although mal 25 mm, which is designed to seal in the retrograde
the device was designed for incorporation of any of the internal portal with increased radial force and retrograde
supra-aortic trunk vessels, clinical use is approved for in- anchors; the intermediate 20 mm segment, which starts
corporation of the LSA into zone 2, whereas incorporation the distal flare and has increased flexibility and the distal
of the left common carotid artery (LCCA) and innominate 15 mm segment, which has increased radial force and re-
artery (IA) into zones 1 and 0 remain investigational and inforced sealing cuffs. Radiopaque gold markers are pres-
are considered off-label indications of the device. The ent in the proximal and distal ends of the aortic and side
proximal aortic component is built on the time-tested branch components (Figure 1) to improve visualization
Gore C-TAG® platform using expanded polytetrafluoro- and allow for precise deployment. The retrograde portal
ethylene (ePTFE) supported by self-expandable nitinol of the aortic component has two radiopaque gold bands
stents (Figure 1). The device has either an 8 or 12 mm positioned in the proximal 15 mm to indicate the sealing
retrograde internal branch or portal, which allows place- segment of the portal. The side branch component has one
ment of a specially designed self-expandable side branch distal and two proximal radiopaque gold bands, which
component. The aortic component has proximal and distal are spaced by 5 mm and are designed to improve visu-
non-tapered diameters ranging from 21 to 45 mm with alization during deployment in the retrograde portal. The
lengths of 100, 150 or 200 mm. The proximal segment deployment mechanism of the TBE® aortic component
of the device, which is designed for sealing, has length starts at the level of the retrograde internal portal with
of either 20, 25 or 40 mm. The device has a short proxi- simultaneous release of the proximal and distal ends of
mal uncovered bare metal nitinol stent that measures 3 to the device. Different from the C-TAG® active control (C-
6.5 mm in length depending on the device diameter. The TAG® AC) stent-graft, the TBE® does not have the added
side branch component was designed to accommodate the features of proximal device conformability and the two-
anatomical challenges of a retrograde branch configura- step deployment starting from distal to proximal. The side
tion with three different stent segments (Figure 1). The branch component deploys proximal to distal. In addition,

Proximal
segment length:
20 Internal portal
25 length: Internal portal
40 mm 15 mm diameter: 5 mm
8 or 12 mm
Internal portal
Diameter: diameter:
8 -20 mm 8 or 12 mm

Diameter:
15 mm 20 mm 25 mm
21
26
30 Length:
34 100
37 150 6 cm
40 200 mm
45 mm

120 cm (14 Fr)

A B
Figure 1.—Diameters and lengths of the Gore thoracic branch endoprosthesis (TBE®, WL Gore, Flagstaff, AZ, USA) aortic component (A) and the
TBE® (WL Gore) side branch component (B).

Vol. 64 - No. 1 The Journal of Cardiovascular Surgery 19

 ©
or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access
COPYRIGHT 2023 EDIZIONI MINERVA MEDICA
cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.
This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically

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VACIRCA TIPS AND CLINICAL EXPERIENCE WITH GORE TBE®

the device has a proximal aortic cuff extension with iden- a single or two-stage procedure using bypass or transpo-
tical proximal device diameters and lengths of 36 to 46 sition. A computed tomography angiography (CTA) with
mm. Contrary to the TBE®, the proximal cuff extension 1-2mm cuts extending from the angle of the jaw to the
has conformability comparable to the C-TAG® AC. femoral bifurcation is recommended for adequate evalua-
tion of anatomical suitability. In patients with carotid and/
Anatomical criteria
or vertebral artery disease or unusual anatomy, imaging
The Gore TBE® device instructions for use recommended of the extra- and intra-cranial circulation is recommended
indications include endovascular treatment of lesions of using CTA or magnetic resonance imaging/ angiography
the DTA, while maintaining flow into the LSA in patients (MRI/MRA). The Gore TBE® aortic component profile
who are at high risk for debranching subclavian proce- ranges from 20 to 26 French, with the largest 26 French
dures. Clinically approved indications include degenera- profile required for devices of 40 mm or larger. Assessment
tive aneurysms, dissections, intramural hematomas, pen- of adequate iliofemoral access is of paramount importance
etrating aortic ulcers and blunt traumatic aortic injuries to avoid inadvertent disruption during the procedure. In
with the proximal entry tear or affected segment distal to patients with small iliofemoral vessels open surgical or
the LSA. The use of the device for lesions requiring seal endovascular conduit is recommended. The anatomical
into zones 1 and 0 is not approved by the Federal Drug requirements include a minimum proximal sealing zone
Administration and remain under clinical investigation or of 20 mm length with <10% variation in inner aortic di-
are considered off-label use of the device. In these cases, ameter, which should range between 16 to 42 mm (Figure
revascularization of the LCCA and/or LSA is performed in 2). The distance from proximal edge of the fabric to por-

Figure 2.—Anatomical requirements for implan-

tation of the Gore thoracic branch endoprosthesis
(TBE®, WL Gore, Flagstaff, AZ, USA).

LSA diameter:
6-18 mm

Minimum length LSA:

2.5-3 mm

A: Prox.
8 mm portal: diameter:
length ≥20-25 mm 16-42 mm
12 mm portal:
length ≥40 mm

B: Distal
8 mm portal: Distal diameter:
length ≥15-20 mm landing 16-42 mm
12 mm portal: zone
length ≥33.5-36 mm outer
curve: ≥2
cm (max.
Prox. and distal to CA)
landing zones
should be free from
aneurysm, dissection,
heavy calcifications,
and thrombosis

20 The Journal of Cardiovascular Surgery February 2023

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TIPS AND CLINICAL EXPERIENCE WITH GORE TBE® VACIRCA

tal is an important anatomical requirement, which varies Technique

according to portal (8 or 12mm) and device diameter. In
general, the 8 mm portal is indicated in most patients re- Endovascular repair is performed in a dedicated hybrid
quiring LSA incorporation, except for patients with longer operating room with fixed advanced imaging includ-
length between the LCCA and LSA or who had prior arch ing on-lay fusion and cone beam computed tomography
repair with proximalization of the LCCA branch (Figure (CBCT). Although these features are considered optional,
2). The minimum length measured at the outer arch curva- we routinely utilized advanced imaging for all endovas-
ture from the mid LCCA to distal LSA should be greater cular aortic repairs. Adequate ancillary endovascular tools
than 20 or 25 mm for the 8 mm portal and greater than 40 are recommended (Table I) including availability of long
mm for the 12 mm portal device. The more stringent ana- wires, snares, balloons and DrySeal® sheaths (WL Gore).
tomical criteria are the length from distal LCCA to distal Although the procedure can be performed under local an-
LSA, which should be at least 15 to 20 mm for the 8 mm esthesia with monitored anesthesia care, our preference is
portal and greater than 34 to 46 mm for the 12 mm por- for general endotracheal anesthesia. The patient is posi-
tal depending on the selected Gore TBE® diameter. The tioned supine. The neck, chest, abdomen, and entire left
distal landing zone must be greater than 20 mm in length upper extremity are prepped and draped in standard sterile
proximal to celiac artery with an aortic diameter ranging fashion. We do not routinely use cerebrospinal fluid drain-
between 16 and 42 mm. The aortic wall in both the proxi- age, electro-encephalogram (EEG) or motor evoked po-
mal and distal sealing segments should be free from any tential (MEP) monitoring for these repairs. The use of CO2
aneurysmal dilation, calcification, or thrombosis. Require- flushing is routinely applied to polyester stent-grafts but
ments of the LSA include an inner diameter of 6 and 18 has minimal to no utility for Gore aortic devices and there-
mm and a length from the aorta to vertebral artery origin of fore is not recommended. Single or bilateral percutaneous
2.5 to 3-cm. The Gore TBE® device is indicated for preser- femoral access and left trans-radial access is established
vation of the LSA and vertebral artery flow and therefore in standard fashion using duplex ultrasound guidance with
intentional coverage of the vertebral artery is considered a micro-puncture kit. These are exchanged for 0.035-inch
off-label. All side branch components are 14 French pro- system. The patient is systematically heparinized with in-
file and can be introduced bare back via the aortic device travenous heparin (100 units/kg) and an activated clotting
sheath using the through-and-through wire into the portal time greater than 250 seconds is maintained during the pro-
without support of a dedicated side branch sheath. cedure. The large profile femoral access is preclosed using

Table I.—Endovascular ancillary tools recommended to perform a Gore TBE® implant.

Category Manufacturer Application
Introducer-sheaths
20-26 Fr DrySeal sheath (33 or 65 cm) WL Gore, Flagstaff, AZ, USA Femoral access for aortic component
5-6 Fr Shuttle sheath (90 cm) Cook Medical Inc., Bloomington, IN, USA Diagnostic angiography from radial access and advancement
of side branch component
5-6 Fr Ansel Sheath (55 cm) Multiple Diagnostic angiography from femoral access
Wires
Bentson wire 0.035 in. (150 cm) Boston Scientific, Bloomington, MN, USA Initial access
Soft glidewire 0.035 in. (260 cm) Multiple DTA catheterization from radial access
Metro wire 0.035 in. (480 cm) Cook Medical Inc. Left radial-femoral through-and-through
Lunderquist wire 0.035 in. (300 cm) Cook Medical Inc. Aortic component advancement
Catheters
Diagnostic flush catheter 5 Fr (100 cm) Multiple Diagnostic angiography
C2 catheter 5 Fr (100 cm) Multiple DTA catheterization from radial access
Balloons
Gore MOB balloon WL Gore Aortic component ballooning
8 mmx2 cm angioplasty balloon Multiple Side branch component ballooning
Snares
Indy OTW vascular retriever snare Cook Medical Inc. Through-and-through access
(100 cm)
Closure devices
Proglide Perclose closure-system Abbott Vascular, Abbott Park, IL Femoral access closure
TR Band radial compression device Terumo, Somerset, NJ, USA Radial access closure

Vol. 64 - No. 1 The Journal of Cardiovascular Surgery 21

 ©
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VACIRCA TIPS AND CLINICAL EXPERIENCE WITH GORE TBE®

A C
Figure 3.—Left percutaneous radial approach and establishment of radial-femoral through-and-through guidewire access (A). Advancement of the
Gore thoracic branch endoprosthesis (TBE®, WL Gore, Flagstaff, AZ, USA) aortic component in the distal arch using the on-lay fusion to assess the
origin of the supra-aortic trunks (B). Once the device is in position, the radial can be used for limited angiography to demonstrate the origin of the
LSA. The radial sheath is advanced across the portal into the descending thoracic aorta (C).

two Perclose devices (Abbott Vascular, Abbott Park, IL, exchanged over a 0.035-inch Bentson wire (Boston Sci-
USA). Once preclosure is completed, a catheter and glide- entific, Bloomington, MN) to introduce a short 5 French
wire are advanced into the ascending aorta and exchanged sheath and C2 catheter. Using a glidewire, the C2 catheter
for a double curve Lunderquist wire (Cook Medical Inc., is advanced into the distal aortic arch and used for cath-
Bloomington, IN, USA), followed by introduction of the eterization of the descending thoracic aorta for the snaring
Dryseal® sheath into the aorta (Figure 3). If the patient has maneuver. We recommend avoiding catheter manipula-
excessive arch or aortic tortuosity, we recommend using tions and snaring in the proximal aortic arch or ascending
the longer Dryseal® 65-cm sheath for advancement of the aorta, unless it is technically difficult to perform the snare
aortic component. A 6 French contra-lateral femoral sheath in the distal arch. It is often easier to perform the snare
may be added for diagnostic angiography or alternatively in the abdominal aorta where the diameter is narrower.
a diagnostic flush catheter may be introduced as a “bud- Our preference is to snare a 0.035-inch 480-cm Metro®
dy” system alongside the aortic device via the Dryseal® wire (Cook Medical Inc.), which allows double exchange
sheath. Preparation of the radial access site is important. length and traction for advancement of the side branch
To prevent spasm, we recommend local administration of component. Once the radial-femoral through-and-through
vasodilators including Heparin (3000 UI), Verapamil (2.5 wire is established the short left radial sheath is exchanged
mg) and Nitroglycerin (200 mcg) upon establishing ini- for a 5 or 6 French 90 cm Shuttle® sheath (Cook Medical
tial access with the micropuncture sheath. The system is Inc.) as shown in Figure 3. The Gore TBE® aortic compo-

22 The Journal of Cardiovascular Surgery February 2023

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or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access
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TIPS AND CLINICAL EXPERIENCE WITH GORE TBE® VACIRCA

nent is flushed with heparinized saline and introduced into distally in the arch. The Gore TBE® device is deployed,
the Lunderquist wire, while the Metro® wire is carefully and its delivery system is removed (Figure 3). Advance-
advanced into the preloaded stylet, which is positioned in ment of the side branch component can be difficult due
the retrograde portal. Once the device is loaded into both to the soft, malleable edges of the inner portal. In these
wires, it is partially advanced into the DrySeal® sheath, ex- cases, the radial-femoral wire support is most useful to
cept for the distal 5-cm, which allows blood filling of the facilitate advancement and deployment. We recommend
device for deairing. The Gore TBE® device is advanced first to advance the radial sheath backwards through the
into the upper thoracic aorta. At this point any guidewire portal into the descending thoracic aorta, which is per-
wrapping is recognized and undone. It is useful to advance formed without difficulty. The side branch component is
the radial sheath close to the Gore TBE® device to al- introduced into the preloaded radial-femoral wire via the
low easier identification of any wrapping. Limited distal DrySeal® sheath after adequate flushing and deairing us-
arch angiography is performed to locate the origins of the ing the maneuver already described. The side branch stent-
LCCA and LSA and calibrate the on-lay fusion. The Gore graft delivery system is hubbed into the Shuttle® sheath,
TBE® device is advanced into position, ‘hugging’ the outer while two hemostatic clamps are applied into each end. To
aortic curvature, while gentle and minimal traction of the navigate advancement of the bridging stent-graft into the
radial-femoral wire is performed by the assistant operator portal without force or risk of dislodgement, a push and
(Figure 3). Excessive traction of the radial-femoral wire is pull maneuver is utilized (Figure 4). If there is resistance
not recommended and may forcefully dislodge the device at the portal edge, pushing the device from femoral while

0-5 mm

Pull

Push

A C
Figure 4.—The tip of the side branch component is hubbed into the radial sheath while clamps are applied into each end of the radial-femoral
through-and-through guidewire system for the push and pull maneuver (A). Once the side branch component is advanced into position, the radi-
opaque markers of the constrained device should be 0-5 mm proximal to the trailing gold marker of the aortic component internal portal, and angi-
ography via the radial sheath is obtained to demonstrate the origin of the vertebral artery (B). Following completion angiography and removal of the
delivery system, radial artery hemostasis is obtained with manual compression using TR band radial compression device (C).

Vol. 64 - No. 1 The Journal of Cardiovascular Surgery 23

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VACIRCA TIPS AND CLINICAL EXPERIENCE WITH GORE TBE®

creating resistance from the radial side causes the delivery days without reintervention. There was one asymptomatic
system to seek the outer curvature of the aorta avoiding LSA branch occlusion at 6-months. A recent publication
the edge of the portal and allowing advancement. The side summarized the mid-term outcomes with mean follow-up
branch component is advanced into position and separated of 3.8±1.5 years. Patient survival was 90% at 1- and 74%
from the Shuttle® sheath, which is used for limited angiog- at 5-years, with freedom from aortic-related mortality of
raphy to demonstrate the origin of the left vertebral artery 100% at 5-years. Primary patency of the LSA branch was
(Figure 4). The side branch stent-graft is deployed, fol- 94% at 5-years. There was one patient with Type IA en-
lowed by ballooning of the portal and proximal subclavian doleak and two patients who had aneurysm sac expansion.
segments using a Gore MOB® balloon (WL Gore, Flag- Finally, two patients had any stroke or transient ischemic
staff AZ). We do not recommend routine balloon dilata- attack during follow-up.15 The Gore TBE® Pivotal Study
tion of the proximal and distal aortic sealing zones nor the included 246 patients treated for zone 2 lesions in 34 cen-
distal LSA sealing zone. The remaining of the procedure ters. Indications included aortic dissections in 132 patients,
includes placement of distal C-TAG® stent-graft exten- aneurysms in 90 patients, blunt aortic injuries in 10 pa-
sions if indicated and a completion rotational digital sub- tients and other lesions in 13 patients.16 The clinical data
traction angiography and CBCT with and without contrast. on the first 84 patients treated for degenerative aneurysms
The large profile femoral access is closed using the two was analyzed. There were 53 male (63%) and 31 female
Proglide Perclose devices (Abbott Vascular) and the per- patients with mean age of 70±11 years old. Aneurysm mor-
cutaneous radial access can be closed with manual com- phology was fusiform in 43 patients (51%) and saccular in
pression using the trans-radial (TR) band device (Terumo, 41 (49%), with a mean diameter of 56±11 mm. Technical
Somerset, NJ, USA) as shown in Figure 4. Patients are success was 92%. Seven patients had technical failure due
monitored in the intensive care unit for 24 to 48 hours and to inaccurate deployment in three patients, device delivery
dismissed home in one to three days. We recommend using system retrieval in one patient and unanticipated additional
aspirin perioperatively and indefinitely, and do not routine procedures in four patients. There was no mortality within
use of clopidogrel. Follow-up is obtained with clinical ex- 30-days or hospital stay. Three patients (4%) had disabling
amination, CTA and ankle-brachial indices are 1-, 6- and stroke and two patients (2%) had spinal cord injury, in-
12-months and annually thereafter. cluding one (1%) patient with permanent paraplegia. Mean
follow-up was 30 months (range 3-51 months). There were
Clinical experience
no LSA branch occlusions. There were three patients with
The Gore TBE® device was approved by the FDA May 13, Type I endoleak (4%) and five patients (6%) with Type III
2022, for endovascular treatment of distal aortic arch le- endoleak, which resolved spontaneously in seven patients.
sions requiring placement of the aortic component in zone One patient (1%) had sac enlargement. There were no
2 and incorporation of the LSA. The Gore TBE® Pivotal aortic rupture or lesion-related mortality. At 2-years, four
study continues to enroll patients for clinical evaluation patients (5%) died from non-aortic related causes. The
of the device in zones 1 and 0. The Gore TBE® device Gore TBE® instructions for use also provide a summary
has been investigated in two prospective non-randomized of outcomes on 132 patients treated for aortic dissections
studies. The Gore TBE® feasibility study included 40 pa- with incorporation of the LSA. In that cohort, there were
tients treated in six academic centers in the United States. 99 male (75%) and 33 female (25%) patients with mean
Of these, 31 patients underwent treatment of distal aortic age of 63±11 years old. Technical success was 98%. One
arch lesions in zone 2. There were 16 (52%) male and patient had aortic rupture in the first 30-days, which re-
15 (48%) female patients with mean age of 74±11 years sulted in lesion-related mortality. There was one disabling
old.14 Aneurysm morphology was fusiform in 12 patients stroke and no spinal cord injury. At 2-years, six patients
and saccular in 19 patients, with no inclusion of dissec- (6%) patients died, including three patients who had aortic
tions or other lesions. Early and mid-term results were re- and three patients who had non-aortic related causes.
ported in separate publications. There were no mortality,
major stroke or early LSA branch stent occlusions. Techni- Conclusions
cal success, defined by delivery of the intended aortic and
side branch components, was 100% with no LSA branch The Gore TBE® device offers an off-the-shelf solution for
occlusion. There were no mortality or paraplegia in the incorporation of the LSA in patients who require TEVAR
postoperative period. One patient had a minor stroke at 30 in zone 2. The device results in both the feasibility and

24 The Journal of Cardiovascular Surgery February 2023

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TIPS AND CLINICAL EXPERIENCE WITH GORE TBE® VACIRCA

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Conflicts of interest.—Gustavo S. Oderich has received consulting fees and grants from Cook Medical, W. L. Gore, Centerline Biomedical, and GE Healthcare
(all paid to Mayo Clinic and The University of Texas Health Science at Houston with no personal income).
Authors’ contributions.—Andrea Vacirca, Emanuel R. Tenorio, Thomas Mesnard, Aidin Baghbani-Oskouei and Titia Sulzer have given substantial contribu-
tions to the manuscript draft, Aleem K. Mirza, Ying Huang, and Gustavo S. Oderich revised it critically. All authors read and approved the final version of
the manuscript.
History.—Article first published online: December 19, 2022. - Manuscript accepted: November 29, 2022. - Manuscript received: November 21, 2022.

Vol. 64 - No. 1 The Journal of Cardiovascular Surgery 25