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LINC 2015 |
TriVascular Ovation Prime® System – Expanding EVAR Safely
Thomas Nolte, MD
Herz und Gefaßzentrum Bad Bevensen, Germany
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
Disclosure
Thomas Nolte:
.................................................................................
I have the following potential conflicts of interest to report:
Consulting
√
LINC 2015 |
What a Beauty!
LINC 2015 |
At 14F, the ultra-low profile system enables smooth access to the aneurysm
Staged deployment of suprarenal stent allows simple, precise placement
Polymer-filled sealing ring creates a custom seal and protects the aortic neck
Low permeability PTFE enables effective aneurysm exclusion and device patency
Conformable, kink resistant iliac limbs designed to reduce risk of occlusion
Ovation Prime® Abdominal Stent Graft
4 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
Ovation® Global Pivotal Trial A pivotal clinical evaluation of the safety and effectiveness of the TriVascular Ovation Abdominal Stent Graft System
• Primary Endpoint
– MAE within 30 days of the procedure as determined by clinical events committee
• Primary Effectiveness Endpoint
– Successful Delivery and Deployment – Freedom from Rupture and Conversion to Open Surgical Repair – Freedom from Type I and III Endoleaks, Migration, and Enlargement
as determined by Core Lab
• Follow-up: 1 month, 6 month and annual to 5 years
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 5
LINC 2015 |
• AAA max.Ø ≥ 5.0 cm
• Ø increase ≥ 5 mm in 6 months
• Ø exceeds aortic diameter by 1.5
• Proximal Landing Zone: – ≥ 7 mm
– 16 to 30 mm ID
– ≤ 45° angle (neck < 10 mm)
– ≤ 60° angle (neck ≥ 10 mm)
Ovation Global Pivotal Trial Selected Inclusion Criteria
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 6
• Distance from lowest RA to hypogastric
• ≥ 130 mm
Distal Iliac landing zone: ≥ 10 mm 8 to 20 mm ID#
LINC 2015 |
Investigator Site
Botti, Charles Riverside Methodist Hospital
Cheema, Mohiuddin Hartford Hospital
Clair, Daniel Cleveland Clinic
Eidt, John Central Arkansas VA
Eskandari, Mark Northwestern Memorial
Glickman, Mark Sentara Medical Group
Gray, Bruce Greenville Hospital
Haser, Paul UMDNJ
Hassoun, Heitham Methodist Hospital
Henretta, John Mission Hospital
Hodgson, Kim Southern Illinois University
Jain, Ash Washington Hospital
Jicha, Douglas Santa Rosa Memorial
Jones, Paul Mercy Medical Center
Jordan, William UAB
Kasirajan, Karthik Emory University
Krajcer, Zvonimir St. Luke’s Hospital
Laird, John UC Davis
Maini, Brijeshwar Moffitt Heart and Vascular
Makaroun, Michel UPMC
Maldonado, Thomas NYU Hospital
Mehta, Manish Albany Medical Center
Mishkel, Gregory Prairie Heart
Moore, Wesley UCLA
Motew, Stephen Forsyth Medical Center
Murkherjee, Dipankar Inova Fairfax Hospital
Rizvi, Adnan Minneapolis Heart Institute
Sternberg, Charles Ochsner Health System
Investigator Site
Brunkwall, Jan Uni. Klinik Koln
Krankenberg, Hans Medizinisches Versorgungszentrum, HH
Mathias, Klaus Klinikum Dortmund
Nolte, Thomas Herz und Gefaßzentrum, Bad Bevensen
Scheinert, Dierk Park Krankenhaus, Leipzig
Sievert, Horst CVC, Frankfurt
Torsello, Giovanni St. Franziskus-Hospital, Münster
Investigator Site
Valdes, Francisco Catholic University
161 patients across 36 sites enrolled in Chile, Germany and USA • Chile: 20 patients / 1 site • Germany: 30 patients / 7 sites • USA: 111 patients / 28 sites
Ovation Global Pivotal Trial Enrolling Institutions
7 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
Patient Medical History1 Global (N=161)
Germany (N=30)
ASA Grade III or IV 66.5% (107/161) 26.7% (8/30)
Hypertension 84.5% (136/161) 73.3% (22/30)
Hyperlipidemia 70.2% (113/161) 46.7% (14/30)
Smoking History 70.2% (113/161) 60.0% (18/30)
Coronary Artery Disease 44.7% (72/161) 30.0% (9/30)
Chronic Obstructive Pulmonary Disease (COPD)
27.3% (44/161) 23.3% (7/30)
Ovation Global Pivotal Trial Baseline Patient Characteristics
8 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
1Conditions listed with frequency ≥25% in global population 2Imaging core lab reported measurements 3Investigator reported measurements 4Measurement @ 13mm distal to distal renal artery
Patient Aortoiliac Characteristics2 Global (N=161)
Germany (N=30)
Proximal Neck Length, mm3,4 23.0 ± 12.5 24 ± 11
Proximal Neck Diameter, mm3 22.7 ± 3.1 23 ± 3
Juxtarenal Angle, degrees 19.1 ± 13.5 19 ± 17
Maximum Aneurysm Diameter, mm 53.6 ± 9.0 55 ± 11
Left Minimum Iliac Access Diameter, mm 7.0 ± 1.6 7.2 ± 1.9
Right Minimum Iliac Access Diameter, mm 7.0 ± 1.6 7.5 ± 1.7
Patient Demographics Global (N=161)
Germany (N=30)
Bad Bevensen (N=295)
Age, yr 73 ± 8 72 ± 6 72 ± 8
Gender 87.6% (141/161) 90.0% (27/30) 87 % (37/295)
LINC 2015 |
Ovation Global Pivotal Trial 3 Year Results @ July 25 2014
9 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Safety1 Global 731 to 1095 Days
Germany 731 to 1095 Days
Rupture 0/154 0/27
Conversion to Open Repair 0/154 0/27
Limb Occlusions2 0/154 0/27
Effectiveness3 Global 3 Years
Germany 3 Years
Type I and III Endoleaks 0/106 0/23
Migration 0/113 0/23
1Rupture and Conversion to Open Repair based on investigator reports 2Limb Occlusions defined as re-interventions due to limb occlusion 3 Endoleaks and Migration rates based on Core Lab Data (M2S) 4Type II endoleaks reported in all cases of AAA Enlargement.
Aneurysm Assessment4 Global 3 Years
Germany 3 Years
Stable or Decrease (≥5mm) 100/113 20/23
LINC 2015 | 10 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 | 11 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Expanding EVAR Safely: Still open Questions?
LINC 2015 |
Durability of Ovation System’s Seal
Patients treated with the Ovation™ system had no neck dilatation and no late Type I endoleaks at 3 years.4
1 Rodway Eur J Endovasc Surg 2008; 35: 685-93 EVAR: N=67, Open: N=56 2 Monahan JVS 2010: 52: 303-7 N=46 3 Core Lab measurements, Ovation Global Pivotal Study N=131 4 Neck dilatation in proximal neck defined as growth > 2mm at renals, 10mm below renals, and 15 mm below renals; N=131
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Self-Expanding Stents Open AAA Repair Ovation System
LINC 2015 |
CASE STUDY REVIEW
©2014 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
• Patient History:
• 53 year old male – Obesity
– mild anemia of unknown origin
• AAA max. Ø 62 mm – neck length: 30 mm
– angulation: 55°
– Ø @ 13mm: 27 mm
• Pre-operative images
Case Study- 1
©2014 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
Follow Up: (Post-Market-Study)
©2014 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
FDG-PET-CT For Pulmonary Nodes
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 16
LINC 2015 | 17 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
Autopsy after sudden Death @ 23 Months
• Bled to death for undiagnosed AADA
• entry supracoronary, reentry above Ovation crown
• Root cause:
– Giant cell arteritis • explains PET-CT findings!
– no pulmonary cancer
– would steroids have changed the fate?
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 18
LINC 2015 |
• Patient History:
• 77 year old female – CRI III
• AAA max. Ø 53 mm – perirenal pathology
– neck length: 0 mm
– angulation: 8°
– Ø @ 13mm: 29 mm
• Pre-operative images
Case Study- 2
©2014 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
OVATION Stent Graft: 34mm MB
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 20
LINC 2015 |
Follow-Up: (Post-Market-Study)
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 21
LINC 2015 |
Postop: @ 36 Months
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 22
LINC 2015 |
Conclusion:
• suprarenal pathology prevented from safe fixation
– barbs never ever caught the aortic wall
– migration
• no endoleakage, sac stable
• 80 years old, CRI
• fenestrated graft as option
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 23
LINC 2015 |
• Patient History:
• 78 year old female – smoker
– left mastectomy for cancer 2007
• AAA max. Ø 57mm – neck length: 3 mm
– angulation: 33°
– Ø @ 13mm: 29/34 mm
• Pre-operative images
Case Study- 3
©2014 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LINC 2015 |
OVATION PRIME Graft: 34mm MB + Stent
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 25
LINC 2015 |
Follow-Up: (Post-Market-Study)
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 26
LINC 2015 |
Postop: @ 30 Months
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 27
LINC 2015 |
Conclusion:
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 28
• persistent sac and neck-enlarge
ment with loss of wall contact of the sealing rings
• stable fixation
• no evidence of type 1 or 3 endoleak
Root cause:
• persistent type 2 endoleak after previous ONYX-embolisation
• second embolisation planned
LINC 2015 |
Summary
• Ovation Prime System has proven safe and stable results in the Global Pivotal Study over 3 Years now.
• The Ovation Prime sealing ring preserves the aortic neck with an innovative, less-invasive, clinically proven solution for the broadest range of AAA anatomies.
• Usage for iuxta- and perirenal Aneurysms should be considered with care, especially in elderly women
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
29
LINC 2015 |
TriVascular Ovation Prime® System – Expanding EVAR Safely
Thomas Nolte, MD
Herz und Gefaßzentrum Bad Bevensen, Germany
©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.