zenith alpha™ thoracic experience - linc2015.cncptdlx.com cao.pdf · zenith™ alpha thoracic...
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Zenith Alpha™ thoracic experience
Piergiorgio Cao, MD, FRCS Chief of Vascular Surgery
Azienda Ospedaliera S. Camillo – Forlanini, Rome Professor of Vascular Surgery, University of Perugia
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Disclosure
Speaker name:
Piergiorgio Cao
I have the following potential conflicts of interest to report:
Consulting, Research Grant, Speaker‘s Fee:
Bolton Medical
Boston Scientific
Cook Medical
Gore & Associates
Medtronic Inc.
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- TAAs are currently being treated by using stent
grafting
- However, not all patients with TAAs are eligible
for this less invasive approach
- The analysis of anatomic features of
aneurysms and access vessels, that make
endovascular repair challenging or impossible,
is guiding the development of new generation
devices
Background
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J Vasc Surg 2007
126 patients with TAA screened for TEVAR
33 (26%) rejected for anatomic reasons
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J Thorac Cardiovasc Surg 2014
126 TEVAR: 15 (12%) with access complications
p=0.047
Iliofemoral complications reduced late survival as a
result of increased mortality within the first year
IMS: Absent = 0; Mild = 1; Moderate = 2; Severe = 3
(according to Calcification, Average diameter, Iliac tortuosity
index)
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J Vasc Surg 2014
649 TEVAR: 279 women (43%) and 370 men (57%)
These results suggest a need
for decreased device
delivery size and
improvements in endovascular
technology
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Device Overview
• The lowest profile sheath available
• Improved conformability
• Nitinol stents
• Graft diameters: 18-46 mm
• 16-20 Fr (ID) introduction system
Zenith Alpha™ Thoracic Endovascular Graft
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Comparison to Zenith® TX2®
Zenith™ Alpha Thoracic Endovascular Graft
Zenith® TX2® Endovascular Graft
Nitinol stents Stainless steel Z-stents
Thinner, more tightly woven polyester
Standard polyester
Bare rounded proximal stent Covered proximal stent
16–20 Fr introduction system
20–22 Fr Z-Trak Plus® introduction system
18–46 mm diameter grafts 22–42 mm diameter grafts
MR conditional MR conditional
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Notable Features: ARC Technology
Proprietary technology designed to provide endoleak and migration resistance and deliver a durable repair
Active fixation Proximal and distal anchoring barbs to resist migration
Radial force Nitinol self-expanding stents provide optimal graft-to-vessel apposition to minimize endoleaks
Columnar strength Two-piece system mimics natural anatomy, and features a balance of length, stability and flexibility
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Notable Features: Highly Flexible Inner Nitinol Cannula
Designed to improve deliverability and ensure proximal conformance • Pre-curved introduction system—cannula has “candy cane” shape that hugs
the inner curve
• Bare proximal stent optimizes apposition
• Utilizes Pro-Form™ on 40–46 mm diameters (not required on smaller sizes)
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Notable Features: Introduction System
• New rotation handle
• Kink-resistant Flexor® sheath with hydrophilic coating
• Sheath length: 85 cm (10 cm longer than TX2®)
• Introducer sheath – 18–30 mm, 16 Fr (19 Fr OD) – 32–38 mm, 18 Fr (21 Fr OD) – 40–46 mm, 20 Fr (23 Fr OD)*
*40–46 mm sizes utilize Pro-Form™
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Notable Features: Introduction System
3 simple steps to deployment:
• Minimized deployment force
• Internal wire deployment
• No tip to recapture
• Retains the precision and control of previous generation device
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Female, 61 yo, TAA Previous elephant trunk for arch aneurysm
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Post-op CTA
No access complications
(percutaneous approach)
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Pivotal Studies of the Zenith Alpha
Thoracic Endovascular Graft (Zenith TX2 Low-Profile)
Two ongoing pivotal clinical studies on two indications:
Thoracic aneurysms or ulcers (TX2 Low Profile
trial)
Blunt thoracic aortic injuries (TRANSFIX trial)
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• Prospective, non-randomized, multicenter study in Europe, Japan, and the U.S.
• Target enrollment of 110 patients was completed in January 2013
– The device received CE Mark in August 2013
• Primary study endpoints
– Safety: 30-day freedom from major adverse events (MAEs)
– Effectiveness: 12-month device success
(To be compared with performance goals derived from the predicate TX2 pivotal clinical study.)
TX2 Low Profile Trial (Aneurysm/Ulcer)
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Procedural Results
% (n/N)
Access Method
Percutaneous
Cutdown
Conduit
36% (40/110)
64% (70/110)
0% (0/110)
• Percutaneous access in 36% of patients, compared to 2.5% in the Zenith TX2 pivotal study (Matsumura et al. J Vasc Surg 2008;47:247-57)
• Success device implantation in 108 of 110 patients
In 2 patients, the delivery system could not be advanced through the anatomy (heavy iliac calcification in 1 patient; previous AAA repair in 1 patient)
One-year results presented at the 2014 Eastern
Vascular Society Annual Meeting (September
11-14th) by Karl Illig (International PI)
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• Prospective, non-randomized, multicenter study in the U.S.
• Target enrollment of 50 patients was completed in May 2014
• Primary study endpoints
– Safety: all-cause and aortic-injury-related mortality at 30 days
– Effectiveness: device success at 30 days
TRANSFIX Trial (Blunt Thoracic Aortic Injury)
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Procedural Results
Mean ± SD (range)
Procedure time (min) 85 ± 45 (34-278)
Estimated blood loss (cc) 107 ± 148 (0-1000)
Duration of ICU stay (days) 14 ± 12 (1-51)
Duration of hospital stay (days) 23 ± 21 (2-120)
Technical success 100% (48/48)
Percutaneous access 40% (19/48)
Intraoperative mortality -
Preliminary 30-day results were presented at
the 2014 SVS meeting
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Aor cArch,161DTA,193
TAAA,140
AbdominalAorta,1183
Aor cinterven on:1677
Ospedale San Camillo 09/2009 – 01/2015
OPEN26%
ENDO74%
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Ospedale San Camillo 12/2013 – 01/2015
Zenith Alpha™ Thoracic Endovascular Graft
Patients 33
Male 22 (66%)
Female 11 (33%)
Mean age 69.8 (49-80)
Disease extension
Arch - Supra-aortic revascularization - Eleph. Tr. completion
14 (42%) 10 4
DTAA 12 (36%)
TAAA (associated with branched/fen stentgraft) 7 (21%)
Indication
Aneurysm 28 (85%)
Dissection (Eleph. Tr. completion) 3 (9%)
PAU 2 (6%)
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Male, 68 yo, TAAA
Previous
Asc Ao
repair
Asymptomatic
chronic L iliac
axis occlusion
Cook
T-branch
Cook
Alpha
Cook
AUI
Cook
Alpha
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Ospedale San Camillo 12/2013 – 01/2015
Zenith Alpha™ Thoracic Endovascular Graft
30-day outcomes n/N (%)
Technical success 33/33 (100%)
Mortality 0 (0%)
SCI 1*/33 (3%)
Stroke 0 (0%)
Reintervention - Fem-fem crossover bypass - Iliac bare stent (intraoperative)
2/33 (6%)
1/33 (3%) 1/33 (3%)
* transient in a patient with type II TAAA
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Female, 79 yo, TAA Right sided arch
External iliac dissection at
delivery removal
External iliac stenting
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Conclusion
- TEVAR is associated with access and device
delivery challenges and alternative access are
often needed
- Alternative access routes (ascending aorta,
iliac, subclavian) may be encumbered by
increased morbidity
- The development of new generation thoracic
stentgraft with innovative features in terms of
profile, confomability, fixation and size range,
represents the right way to break down the
limits of TEVAR
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Zenith Alpha™ thoracic experience
Piergiorgio Cao, MD, FRCS Chief of Vascular Surgery
Azienda Ospedaliera S. Camillo – Forlanini, Rome Professor of Vascular Surgery, University of Perugia