Off-the-Shelf Devices Mark A Farber, MD FACS Director, Aortic Center Professor of Radiology and Surgery University of North Carolina
Disclosures Cook - Research Support, Consultant, Clinical Trials WL Gore - Consultant, Clinical Trials Bolton Medical - Consultant
Treatment Region Iliac Bifurcation Visceral Section Distal Aortic Arch Aortic Arch
Iliac Branch Gore-IBE
Clinical Trial Update PI: Darren Schneider Total Enrollment: 94 implants
Procedure
Demographics Primary Enrollment Continued Access N=64 N=29 Sex at Birth Male 98.4% 100% Female 1.6% 0% Ethnicity Not Hispanic or Latino 95.3% 89.3% Hispanic or Latino 1.6% 10.7% Unknown 3.1% 0% Race White 92.2% 82.8% Black 7.8% 13.8% Age (yrs) Mean (Std Dev) 69.6(8.4) 68.4(11.7) Median 69.5 71.0
Treatment (cont.) Primary Enrollment Continued Access N=63 N=24 N=4 Unilateral Bilateral Procedure Time (minutes) Mean (Std Dev) 151.8(47.6) 163.6(59.9) 310.8(116.9) Median 145 148 261 Range (68,334) (85,305) (236,485) Blood Loss (ml) Mean (Std Dev) 247.6(181.9) 306.8(324.7) 550.0(708.3) Median 200 200 275 Range (0,1000) (0,1400) (50,1600) Procedure Survival 100.0% 100.0% 100.0% Additional Procedures at Treatment 14.3% 33.3% 25.0% Stent 7.9% 12.5% 0.0% PTA 0.0% 4.2% 0.0% Thrombectomy 0.0% 0.0% 0.0% Embolization 3.2% 4.2% 0.0% Other 6.3% 12.5% 25.0%
Technical Success Primary Enrollment Continued Access N=63 N=28 Technical Success 95.2% 96.4% Successful access 100.0% 100.0% Successful deployment of IBE and EXCLUDER components 98.4%¹ 100.0% Patent IBE and EXCLUDER components 100.0% 100.0% Absence of Type I and III endoleaks 96.8%² 96.4%³ Successful removal of IBE delivery catheters 100.0% 100.0% Successful access site closure 100.0% 100.0% 1. Site had difficulty advancing IIC into the internal iliac artery, withdrew component before deploying, and, thinking they had no additional IICs, elected to implant an Iliac Extender. 2. One small Type III endoleak (between components) noted on final angiography. Physician reballooned the overlap of the components but elected not to do another angiogram. Endoleak absent on 30-day follow-up. One small Type IB on IBE treatment side. Core lab identified only Type II endoleak at 1 month FU. 3. One procedural Type Ia endoleak, site decided to not treat due to accessory renal
Site Reported Data (n=84) 1 month follow up, n=81 1 procedural Type II endoleak that required embolization 0 migrations 0 claudications on IBE treatment side 1 Reintervention IBE side: placement of a stent to treat a left external iliac artery dissection (POD 26) distal to a bare metal stent 5 site reported occlusions of the IIC (asymptomatic, no treatment) 1 site reported occlusions on the non-ibe side POD 1, thrombectomy 6 month follow up, n=61 0 migrations 1 claudication (location not reported by site) 1 reintervention (embolized Type II endoleak) 1 year follow up, n=37 No reinterventions, migrations, claudications, occlusions or endoleaks (Type I or III)
Cook Preserve Trial IBD trial 40 pt Pivotal study PI: Anthony Lee Straight IBD device with i-cast stent as internal iliac component
PRESERVE II Follow-up (pivotal, n=40) Visit Eligible for Follow-up CTA Angiography Death Procedure 40 NA 100.0% (40/40) 0 1-month 40 100% (40/40) NA 1 6-months 31 83.9% (27/31) NA 0 12-months 9 55.6% (5/9) NA 0 Enrollment: Pivotal - 40/40 patients No reports of internal iliac artery occlusion or stenosis on the same side as Branch Graft. Device approval based upon I-cast FDA submission
How Applicable Is It?
Results 25.3% 18.2% Most common exclusion: Hypogastric diameter
Other Devices Bif-Bif Device Helical Branch
Visceral Devices Ventana Medtronic Branch p-branch t-branch TAMBE
Ventana Pivotal trial halted CA/SMA Scallop Worldwide Implants: 133 Several device complications Renal stent Ventana proximal component Movable Renal Fenestrations Endologix Ventana Device Pararenal Design
Medtronic Future Technologies AAA Branch Stent Graft Main Stent Graft Bifurcated configuration based on Endurant design Off-the-shelf, broad applicability Main body constraining ties Infrarenal (neck<10mm), juxtarenal & suprarenal AAA Integrated 22F delivery system with ports to accommodate precannulated lumens and BSG delivery Branch Stent Graft Nitinol/ePTFE Self Expanding 6,7 mm diameter 4,5,6 cm length 9F delivery system The products shown are under development and are not approved for sale in the US or OUS.
Results from a Prospective Multicenter Feasibility Study of Zenith p-branch Stent Graft Mark Farber, MD 1, Gustavo Oderich, MD 2, Carlos Timaran, MD 3, Luis Sanchez, MD 4, Feiyi Jia, PhD 5 1 University of North Carolina, Chqpel Hill, NC, 2 Mayo Clinic, Rochester, MN, 3 UT Southwestern, Dallas, TX, 4 Washington University, St. Louis, MO, 5 Cook Inc, Bloomington, IN On behalf of the Zenith p-branch investigators
Zenith p-branch Device
Study Status Enrollment (30 patients) was completed over 30 month January 2013 and June 2015 10 U.S. sites Subject enrollment was anatomically adjudicated prior to enrollment (28/30) Mean study follow-up: 20.3 ± 9.8 months (1.2-37.7 months) as of January 2017 Follow-up through 5 years is ongoing to assess long-term results
Implants Procedural Outcomes Configurations used A: 56.7% (17/30) B: 43.3% (13/30) Config A Config B Technical success: 96.7% (29/30) p-branch was deployed below the renal arteries due to difficulty in cannulating the renal vessels (no renal or SMA stents were placed), N=1** **Right renal stent could not be placed in another. N=1 Variable Mean ± SD (N = 30) Procedure time (min) 226.3 ± 70.5 Total fluoroscopy time (min) Amount of contrast used (cc) 69.4 ± 29 a 109.8 ± 66 a Days in ICU 0.8 ± 1.1 Days to discharge 3.6 ± 2.1 a Data available in 29 patients
Clinical Outcomes 93% at 24 months 30-day mortality: 0% Mortality @ 1 year: 6.7% (2/30) neither aneurysm related 1 death on day 234 due to a cerebral aneurysm 1 death on day 276 due to dissection of a pre-existing proximal thoracic aortic aneurysm No rupture of the study aneurysm or surgical conversion
Renal Events Within 30 days (1) After 30 days (5) Renal artery occlusion 1 POD 15 Left renal artery occlusion, unsuccessful SI on POD 21. Creatinine levels decreased at 6 and 12 months 2 POD 266 unsuccessful right renal stenting on POD 35, eventual right renal occlusion fenestration plugged POD 364 right renal occlusion, successful SI on POD 366 Renal infarct 0 1 POD 35 no clinical sequelae Renal insufficiency a 0 Renal failure 0 1 POD 399 secondary to right renal artery stenosis 1 POD 45 history of chronic renal insuff, no renal artery occlusion or stenosis, not needing dialysis a Defined as serum creatinine elevation >30% above baseline resulting in a persistent value > 2 mg/dl on two or more follow-up tests
Primary Renal Artery Patency (K-M) 89% at 24 months (ZFEN: 91% at 24 months)
Secondary interventions 11 patients (36.7%) underwent 15 secondary interventions (SIs) Within 30 days (4 SIs) Renal Occlusion: 1 SMA Occlusion: 1 Endoleak Type I: 1 (technical failure case) Type III: 1 After 30 days (11 SIs) Renal Occlusion: 1 Stenosis: 4 Kink: 1 SMA Stenosis: 1 Lower Extremity Claudication: 2 (same patient) Endoleak Type I: 1 (right renal stent not placed during the index procedure)
OTS Devices for TAAA
TAMBE Four vessel device design in two configurations All four branches antegrate CA + SMA antegrade, renals retrograde Viabahn Balloon Expandable US feasibility trial completed US Sites: UNC, Mayo, WashU, Dartmouth, and Pitt
t-branch Four vessel design Branches CA - 8 mm 1 o'clock SMA 8 mm 12 o'clock RRA - 6 mm 10 o'clock LRA - 6 mm 3 o'clock
Custom Manufactured versus OTS 46 pts (23 CMD, 22 OTS) Technical Success: 100% Mortality: C 8%/ O: 0% p=ns Freedom from Re-intervention C:100% vs O: 90% p=0.07 all renal arteries Bisdas, T., Donas, K. P., Bosiers, M. J., Torsello, G., & Austermann, M. (2014). Custom-made versus off-the-shelf multibranched endografts for endovascular repair of thoracoabdominal aortic aneurysms. Journal of Vascular Surgery 2014; 60:1186-95.
Suitability for Endovascular TAAA Repair Upward angled artery Analyzed 14 anatomic components to difficulty Results: 60% of TAAA would be suitable for branched/fen EVAR Exclusions: arch angulation: 27% DTA angulation: 24% Visceral stenosis: 7-31% Rodd et al. The Suitability of Thoraco-abdominal Aortic Aneurysms for Branched or Fenestrated Stent Grafts - And the Development of a New Scoring Method to Aid Case Assessment. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery (2011) vol. 41 (2) pp. 175-85.
Fenestrated/Branched Device Implants ZFEN + Physician Sponsored-IDE 90 TAAA 82 68 65 54 45 23 18 10 6 0 FY 13 FY14 FY15 (Annualized) Custom Devies Category Axis OTS % Linear (Custom Devies) Mortality: 1.6%
Gore Side Branch Device Completed feasibility study PI: Michael Dake Enrollment: Zone 2: 20 pts (M:F 50:50) Zone 0: 2 pts Phase I: Cervical debranching Phase II: TSSB No strokes, death or SCI Pivotal Trial Enrolling
Medtronic Mona-LSA 9 subjects enrolled Four (50%) endoleaks in 8 pts Type II - 2 Undetermined - 2 Major strokes: 0 Minor strokes: 4 (3 pts - 33%) No L arm ischemia or deaths @ 30 days http://dx.doi.org/10.1016/j.jvs.2015.07.078
Aortic Arch Pts: 38 with a mean age of 71 Technical Success: 84.1% Mortality: 13.2% Cerebrovascular Complications: 15.8% Haulon S, Greenberg RK, Spear R, Eagleton M, Abraham C, Lioupis C, et al. Global experience with an inner branched arch endograft. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1709 16.
A-Branch (Arch Dissection) Bilateral Carotid-SCA Bypass
Conclusions OTS devices play a critical role in providing complete endovascular treatments for patients with aneurysmal disease Safety and feasibility studies have been successful in various areas Pivotal studies are currently being conducted Anticipated that if successful, OTS devices for Iliac Branch - 1 or 2 devices available Visceral - 2-4 years from FDA approval Arch - 3-5 years from FDA approval