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
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.
- 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
J Vasc Surg 2007
126 patients with TAA screened for TEVAR
33 (26%) rejected for anatomic reasons
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)
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
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
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
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
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)
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™
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
Female, 61 yo, TAA Previous elephant trunk for arch aneurysm
Post-op CTA
No access complications
(percutaneous approach)
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)
• 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)
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)
• 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)
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
Aor cArch,161DTA,193
TAAA,140
AbdominalAorta,1183
Aor cinterven on:1677
Ospedale San Camillo 09/2009 – 01/2015
OPEN26%
ENDO74%
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%)
Male, 68 yo, TAAA
Previous
Asc Ao
repair
Asymptomatic
chronic L iliac
axis occlusion
Cook
T-branch
Cook
Alpha
Cook
AUI
Cook
Alpha
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
Female, 79 yo, TAA Right sided arch
External iliac dissection at
delivery removal
External iliac stenting
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
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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