The Ventana Off-the-Shelf Graft for Pararenal AAA Andrew Holden Associate Professor of Radiology Auckland Hospital
Disclosures Andrew Holden, MBChB, FRANZCR Investigator in Nellix and Ventana Trials Clinical Consultant to Endologix
Ventana Fenestrated System Designed for Broad Range of Anatomies Fenestrations are movable in situ Integrated System Pre-cannulated fenestrations with 6Fr sheaths Renal Stent Grafts compatible with 6Fr sheaths 120-cm length, 6Fr compatible angiographic catheters Anatomical Fixation For foundational stability and bifurcation preservation 22Fr OD delivery system
Procedure Steps Outer sheath retracted and 6Fr sheath exposure RA cannulation with device fully constrained Proximal deployment with reference to SMA (encompass SMA and celiac) Distal deployment to overlap bifurcated body Covered renal stent positioning, expansion, and flaring
Ventana Clinical Program Overview Enrolled 15 2 sites Pilot Enrolled 34 8 sites Feasibility Enrolled 76 22 sites US IDE Total Enrollment = 125 Compassionate Use = 8 2010 2011 2012 2013 2014 2015
Ventana Initial Clinical Experience Enrollment (N=15) 11/10 08/11 Holden A, et al. J Vasc Surg 2013;57:1235-45.
Ventana CE Trial Enrollment (N=31) 11/10 04/12 Adequate iliac /femoral artery access Renal arteries with length 13mm, diameters 4 to 8mm, and with <70% ostial stenosis Absence of essential accessory renal artery (supplies <25% of parenchyma) Limited suprarenal mural thrombus Infra-SMA neck length 15mm, diameter 18 to 34mm, angle to the aneurysm sac 60 Renal arteries 0 to 35mm below the SMA, within ±30mm and 90 to 210 (clock) Celiac artery to SMA angle 60 (clock) SMA to bifurcation length 90mm Ventana overlap with bifurcated device at least 3cm length
CE Trial Sites Indiana University A. Sawchuk, MD Cleveland Clinic M. Eagleton, MD St. George s Institute M. Thompson, MD Hôpital Mondor JP Becquemin, MD UCLA Medical Ctr W. Quiñones-Baldrich, MD Pontifica Universidad Católica R. Mertens, MD Auckland City Hospital A. Holden, MD
Anatomical Baseline Characteristics Parameter Mean ± SD (Range) N=31 Sac Diameter, cm 6.0 ± 0.9 (4.9, 10) Infra-SMA Neck Length (mm) 27 ± 11 (9, 35) Infra-SMA Neck Diameter (mm) 25 ± 2.8 (21, 30) Infra-renal Neck Length (mm) 6.9 ±3.4 (0, 14) Infra-SMA to Sac Angle, 36 ± 12 (20, 53) SMA to Celiac Artery, (clockface) 14 ± 9.0 (0.8, 30) L to R Renal Artery, (clockface) 148 ± 25 (96, 204) L to R Renal Artery Length (mm) 6.6 ±5.0 (0, 20)
Major Adverse Events at 30 Days Event Ventana Endograft 1 (n=31) Infrarenal Endograft 2 (n=192) Open Surgical Control 2 (n=66) Patients with >1 MAE 5 (16%) 16 (8.3%) 44 (67%) All Cause Mortality 0 2 (1.0%) 4 (6.1%) Bowel Ischemia 0 0 6 (9.1%) Myocardial Infarction 0 3 (1.5%) 5 (7.6%) Paraplegia 0 0 0 Renal Failure 0 2 (1.0%) 6 (9.1%) Respiratory Failure 1 (3.2%) 2 (1.0%) 5 (7.6%) Stroke 0 0 1 (1.5%) Blood Loss > 1,000cc 4 (13%) 11 (5.7%) 38 (58%) 1 Quinones-Baldrich W, et al. J Vasc Surg 2013 (in press). 2 Carpenter JP, et al. J Endovasc Ther 2010;17:1153-62.
Results >30 Days to 18 Months Device Performance in 30-properly selected patients o No Conversion to Open or Aneurysm Rupture o No Type I, III, IV Endoleaks o No Migration or Aneurysm Sac Expansion o No aneurysm-related death Secondary Procedure (n=4) 1. Liquid embolization (n=1) for endoleak of unknown origin 2. Balloon angioplasty and self expanding stent deployment (n=2) for distal renal artery stenosis 3. Renal bypass due to device movement and bilateral stent fracture (n=1) Renal re-intervention 3/31 (9.7%)
Post f-evar Renal Re-Intervention Author Reference Number of Centers N Mean follow up (mos) Renal Reintervention Rate O Neill EJVES 2006 1 119 19 3.5% Greenberg JVS 2009 5 30 24 8.8% Verhoeven EJVES 2010 1 100 24 3.0% Amiot EJVES 2010 16 134 15 3.7% Vallabhaneni Circulation 2012 14 318 15 3.7% Mastracci JVS 2013 1 650 36 2.7% Quinones- Baldrich JVS 2013 7 31 16 9.7%
Ventana Clinical Experience 2010 2011 2012 2013 CE Trial and OUS Experience US IDE Experience
Ventana Interim IDE Observations Baseline Aneurysm Characteristics Parameter Maximum aneurysm diameter (mm) Infra-SMA neck length (mm) Infra-renal neck length (mm) Infra-SMA to aneurysm sac angle ( ) SMA to aortic bifurcation length (mm) Renal-renal angulation ( ) Total 58.4 ±7.9 (43.8, 91.8) 26.1 ±3.3 (17.6, 33.7) 4.1 ±8.2 (-49.4, 18.7) 32.2 ±12.9 (4.8, 58.8) 136.9 ±17.0 (101.8, 179.5) 143.6 ±27.4 (85.6, 214.3)
All procedures completed successfully US IDE Trial Cohort is free from rupture or conversion to open repair Core Lab (CCF PVCL) identifies no type I/III endoleak, gross migration, or sac diameter enlargement Major Adverse Events 0-30 Days (N=74 Enrolled) 31 Dy to 1 Yr (N=61) Pts. with 1 MAE 8 (11%) 2 (3.3%) All-Cause Mortality 2 (2.7%) 1 (1.6%) Bowel Ischemia 1 (1.4%) 0 Myocardial Infarction 2 (2.7%) 0 Paraplegia 0 0 Renal Failure 5 (6.8%) 1 (1.6%) Respiratory Failure 2 (2.7%) 1 (1.6%) Blood Loss >1,000cc 3 (4.1%) ---
Considerations in Renal Artery Stenting Pre SES Stenting - Expiration Pre SES Stenting - Inspiration Post SES Stenting - Expiration Post SES Stenting - Inspiration
5mm *Fenestration Marker
Before 59mm X 54mm 1 Month 58mm X 53mm 6 Months 55mm X 52mm 12 Months 53mm X 51mm
Conclusion The multicenter experience supports the early safety and feasibility of the ready to implant Ventana Fenestrated System in selected patients with juxtarenal AAA Because of some of the device issues, Endologix has paused enrolment in the US IDE Trial as well as the European launch Re-release of Ventana will occur once the company are satisfied durable solutions have been reached