Low profile TEVAR: is it an added value? Michel Bosiers, G. Torsello Münster
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1 Low profile TEVAR: is it an added value? Michel Bosiers, G. Torsello Münster
2 Disclosure Speaker name:...michel Bosiers... I have the following potential conflicts of interest to report: Consulting Employment in industry Shareholder in a healthcare company Owner of a healthcare company Other(s) X I do not have any potential conflict of interest
3 Reason for unsuitability - Access issues: 20-30% -
4 Size of introduction system for current thoracic devices is French Company Device Metal Covering Tapered Free flow Outer diameter of delivery system (Fr) Medtronic Valiant Nitinol Polyester Yes Proximal Gore TAG Nitinol eptfe No No NA* Cook ZenithTX 2 Stainless steel Polyester Yes Distal Duke Vascular TAArget Nitinol eptfe Yes Proximal Jotec Evita Nitinol Polyester Yes Prox-Distal Bolton Relay Nitinol Polyester Yes Proximal *18 24 ID; Sheath required.
5 α
6 Zenith Alpha Low Profile TAA Endovascular Graft Zenith Alpha was designed to: Address vascular access issues associated with larger profile devices Enable magnetic resonance compatibility Improve conformability in tortuous anatomy Increase TEVAR applicability
7 Comparison to Zenith TX2 Zenith TX2 TAA Endovascular Graft Stainless steel Z-stents Standard Dacron Covered proximal stent Zenith TX2 Low Profile TAA Endovascular Graft Nitinol Z-stents Thinner, more tightly woven Dacron Bare rounded proximal stent Fr Z-Trak Plus Introduction System Fr Z-Trak Plus Introduction System mm diameter devices mm diameter devices - MR compatible
8 TEVAR attempted with other graft Stenosis of the right iliac /wound problem left groin
9 Angiography after TEVAR and PTA of the right iliac artery
10
11 Aneurysm Exclusion with TX2-LP 1-month CT 24-month CT
12 Type I endoleak after treatment of ruptured TAA with Zenith Alpha
13 Videoscopic view of the Zenith LP Endograft after coil embolization
14 Study Overview Prospective, non-randomized, multicenter study in Europe, Japan, and the U.S. Target enrollment of 110 patients was completed in January 2013 Patients will be followed for 5 years Results up to 1 year for the first 35 patients are presented
15 Demographics Result (n = 35) Age (years) 71 ± 11 (42-87) Gender Male Female Ethnicity Asian Black/African-American White/Caucasian 57% (20/35) 43% (15/35) 31% (11/35) 9% (3/35) 60% (21/35) 43% female patients compared to 27% in the Zenith TX2 pivotal study (Matsumura et al. J Vasc Surg 2008;47:247-57)
16 Procedural Measures Access method for TX2-LP Percutaneous 31% (11/35) Cutdown 69% (24/35) Procedure time (min) (n = 35) 97 ± 63 Anesthesia time (min) (n = 35) 167 ± 78 31% of patients had percutaneous access, compared to 2.5% in the Zenith TX2 pivotal study (J VS 2008)
17 Mortality Freedom from all cause mortality: 94.2% at 12 months
18 Preliminary Outcomes Item 12-month Rupture 0 Conversion to open repair 0 Paraplegia 0 Paraparesis 0 Stent fracture* 0 Barb separation* 0 Migration* 0 *Based on core lab analysis
19 1-year outcomes Distal type I endoleak: 2 patients - aneurysm size decreased or stable - no treatment performed to date Aneurysm size decreased or stayed stable in most patients evaluated Aneurysm growth in 1 patient at 12 months - no observed endoleak - secondary intervention with distal extension
20 Preliminary device performance is promising No TAA-related mortality, rupture, or conversion No paraplegia or paraparesis One secondary intervention to date No device migration or integrity issues Results indicate expanded applicability with increased female population Follow-up is ongoing Summary
21 MCQ Do you think LP will decrease the durability? A: yes B: no C: no idea
22 homepage: Thank you! Universitätsklinik Münster St. Franziskushospital Münster
23 Aneurysm Exclusion with TX2- LP Maximum aneurysm size decreased from 62 mm at 1 month to 41 mm at 24 months
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