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