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14.54 krajcer global experience with tri vascular
1. Texas Heart Institute™
Zvonimir Krajcer, MD
Director, Peripheral Intervention
St. Luke’s Episcopal Hospital,
Texas Heart Institute
Global Experience With TriVascular
Ovation Abdominal Stent Graft System
2. Texas Heart Institute™
• On the speaker’s bureau for W.L. Gore, Endologix,
Medtronic, Volcano, Abbott Vascular, TriVascular,
Lombard
• Training courses for: W.L. Gore, Endologix, Medtronic,
Volcano, BARD, Lombard, TriVascular
Disclosures
3. Texas Heart Institute™
Short Aortic Necks
(<15mm)
Reverse Tapered Necks
Calcium
Thrombus
Severe Angulation
Large Diameter
Calcium/Thrombus lined Necks
Reverse Tapered Necks
At Inferior
Renal Artery
At IR + 5
At IR + 13
48% Patients < 15mm Necks*
M2S Database – 43,000 CT Scans
* Derived from M2S Measurement Database of 43,000 AAA CT Scans
63% Women < 15mm Necks**
(CHAP) Collaborative effort – 1,063 CT Scans
** New England Society for Vascular Surgery, Matthew P. Sweet, MD et all
The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repair
Clinician-FDA Collaborative effort, Characterization of Human Aortic Anatomy Project (CHAP), 1063 CT Scans
Persistent EVAR Challenges
Hostile Neck Anatomy
4. Texas Heart Institute™
Narrow Access Vessels
Access Vessel Tortuosity
Narrow (<6mm)
Occluded
Torturous
Calcified
Aneurysmal
40% Patients < 6mm*
M2S Database – 43,000 CT Scans
* Derived from M2S Measurement Database of 43,000 AAA CT Scans
3.2
mm
5.3 mm
55% Female Patients <6mm **
(CHAP) Collaborative effort – 1,063 CT Scans
** New England Society for Vascular Surgery, Matthew P. Sweet, MD et all
The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repair Clinician-FDA
Collaborative effort, Characterization of Human Aortic Anatomy Project (CHAP), 1063 CT Scans
Persistent EVAR Challenges
Hostile Access Anatomy
5. Texas Heart Institute™
Hostile Neck
Adjunctive
procedures
Intra-op
endoleaks
All cause
mortality
On label 9.9% 0.5% 1.1%
2 hostile neck
parameters
26.7% 6.7% 13.3%
>2 hostile neck
parameters
50% 16.7% 16.7%
Speziale et al. shows greater proximal seal complication risks as the number of hostile neck
parameters increases
Speziale F et al, Annals of Vascular Surgery (2014), doi: 10.1016/j.avsg.2014.06.057.
Greater than 1 hostile neck parameter significantly increases mortality, major adverse
events, intra-op endoleaks and adjunctive procedures
Influence of Multiple Hostile Neck Parameters
6. Texas Heart Institute™
At 14F, the ultra-low
profile system
enables smooth
access to the
aneurysm
Staged deployment of
suprarenal stent allows
simple, precise placement
Inflatable & conformable
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 PTFE iliac limbs
designed to reduce risk of
occlusion
Ovation Prime® System
Water tight
seal in ring (IR+13)
• IFU neck length > 7mm
• Diameter, not length, is key
to pt. selection
• Seal achieved if diameter is
15.5-30.4 mm at IR+13.
7. Texas Heart Institute™
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 Köln
Krankenberg, Hans Medizinisches Versorgungszentrum,
HH
Mathias, Klaus Klinikum Dortmund
Nolte, Thomas Herz und Gefäßzentrum, 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 enrolled in Chile, Germany & USA
• First Global IDE Trial
Ovation® Global Pivotal Trial
8. Texas Heart Institute™
Safety2 0 to 30 Days
N=161
31 to 365
Days
N=159
366 to 730
Days
N=154
731 to 1095
Days
N=138
Major Adverse Events 2.5% 3.8% -- --
Device Related Major Adverse
Events
0% 0% -- --
Rupture 0% 0% 0% 0%
Conversion to Open Repair 0% 0% 0% 0%
Limb Occlusions
3
0.6% 0.6% 0% 0.7%
Effectiveness4
30 Day 1 Year 2 Years 3 Years
Type I and III Endoleaks 0% (0/153) 0% (0/143) 0% (0/121) 0% (0/106)
Migration Baseline 0% (0/150) 0% (0/133) 0% (0/113)
Technical Success1
N=161
Defined as successful, delivery and deployment of one aortic body and two iliac limbs 100%
Data as of July 25, 2014
1Technical Success based on investigator reports
2 Major Adverse Events and Device Related Major Adverse Events based on Clinical Events Committee (CEC) adjudicated data. Rupture and Conversion to Open
Repair based on investigator reports
3Limb Occlusions defined as re-interventions due to limb occlusion
4 Endoleaks and Migration rates based on Core Lab Data (M2S)
Ovation Global Pivotal
Trial 3 Year Results
10. Texas Heart Institute™
40% (66/161) of patients treated had access vessels <6mm, aortic neck length <10mm, or both.
1Major Adverse Events and Device Related Major Adverse Events based on Clinical Events Committee (CEC) adjudicated data.
2Limb Occlusions defined as re-interventions due to limb occlusion
3 Endoleaks and Migration rates based on Core Lab Data (M2S)
Safety1
0-30
Days
N=66
31-365
Days
N=66
366-730 Days
N=63
731-1095 Days
N=53
Major Adverse Events 0% 3.0% -- --
Device Related MAEs 0% 0% -- --
Rupture 0% 0% 0% 0%
Conversion to Open
Repair
0% 0% 0% 0%
Limb Occlusions
2
1.5% 0% 0% 0%
Effectiveness3a 30 Days 1 Year 2 Years 3 Years
Type I and III Endoleaks 0% (0/64) 0% (0/59) 0% (0/48) 0% (0/36)
Migration Baseline 0% (0/62) 0% (0/54) 0% (0/41)
Ovation Global Pivotal Trial
Challenging Subgroup Analysis
11. Texas Heart Institute™
GA
Percutan
eous
43%
Access Type
Cut-Down Percutaneous
Major Adverse Event @ 30 Days 3.3% (3/92) 1.4% (1/69)
Treatment Success @ 1-year 98.9% (91/92) 100% (69/69)
Anesthesia Time (mean) 191 minutes 149 minutes
Procedure Time (mean) 118 minutes 98 minutes
Hospitalization (median) 2 days 1 day
Subjects undergoing percutaneous access achieved similar clinical outcomes with
slightly lower time spent related to anesthesia, procedure and hospitalization time.
Low Profile Device Well Suited for
Percutaneous Access
12. Texas Heart Institute™
• Multicenter, prospective, post-market study
• 501 patients enrolled @ 30 sites across Europe
• Enrolled May 2011 – December 2013
• Safety and Performance Endpoints assessed by Investigator at
1-month, 6-month, and annually to 5 years
• Study Completion: 2019
• Primary Endpoints
Technical success
Freedom from Type I and III endoleaks, aneurysm rupture,
expansion, conversion, occlusion, and migration
• CEC adjudication of device related adverse events
OVATION Post-Market Registry
13. Texas Heart Institute™
*Data as of January 6, 2015 based on investigator reported data.
1Limb Occlusions defined as re-interventions due to limb occlusion
2Ns represent the number of completed follow-up visits for 1m, 6m, 1yr, and 2yr
3Multiple imaging modalities were used during follow up
A multicenter, prospective, European post-market registry to evaluate the
safety and performance of the TriVascular Ovation® / Ovation Prime® Systems
Performance2 30 Day 1 Year 2 Years
Type I and III Endoleaks 1.1% (5/454) 1.6% (6/384) 0.5% (1/196)
Migration 0% (0/440) 0.3% (1/378) 0% (0/195)
Technical Success
All
N=501
Successful, delivery and deployment of one aortic body and two iliac limbs 99.6%
Safety
0 to 30 Days
N=501
31 to 365 Days
N=499
366 to 730 Days
N=472
Rupture 0.2% 0% 0%
Conversion to Open Repair 0% 0.2% 0.4%
Iliac Occlusion
1
1.2% 1.2% 0%
OVATION Post-Market Registry
2 Year Results
14. Texas Heart Institute™
• Over 6500 patients worldwide have been treated with
Ovation and Ovation Prime Abdominal Stent Graft
Systems, with over 700 subjects in a tightly controlled
study or registry
161 patients enrolled in the Ovation Global Pivotal Trial
77 patients enrolled in the Ovation Continued Access Trial
Over 80 patients enrolling in US Post-Approval Study
501 patients enrolled in the OVATION Post Market Registry
Additional 400+ subjects enrolling in current post market
registries
• Patient demographics, anatomical characteristics, and procedural
characteristics indicate a challenging patient cohort
• These data provide compelling evidence that the Ovation system
offers significant advantages and safely expands EVAR.
Conclusion
Editor's Notes
Conventional self expanding devices are not well suited or approved for use in necks shorter than 10mm, with most devices requiring 15mm or more of neck length
However, about ½ of AAA patients and almost 2/3 of women have aneurysm necks < 15mm.
In addition, adverse neck geometry and the presence of thrombus and/or calcium in this area can also preclude use of conventional devices, which do not conform well to irregular surfaces and can also displace thrombus in the sealing zone.
The Ovation system is designed to directly address these needs and provide an effective endovascular option for this rather large group of AAA patients.
About 40% of AAA patients, and 55% of women, have external iliac diameters < 6mm, smaller than the delivery system sizes of all other FDA approved stent grafts.
Challenges:
Advancing catheters into smaller access vessels can injure such vessels, and add time and risk to the overall procedure.
Pre-dilation of access vessels or employing iliac conduits also increase time and risk to the patient.
Larger delivery sheaths and catheters can also be occlusive and pose the risk of re-perfusion injuries in extended duration procedures.
The ultra-low profile of the Ovation system directly addresses these challenges, easily traversing most access vessels, virtually eliminating the need for iliac conduits, and avoiding distal occlusion in most patients.
[Text in slide graphic is consistent and should be verbalized]
In Europe, CE Mark approval was based on a 30 day safety study. Following approval, TriVascular initiated a patient registry to assess “real world” device performance across 30 sites in Europe. The main difference between a FDA IDE study and a post-market registry is that the clinical results are investigator reported versus core lab.
In Europe, CE Mark approval was based on a 30 day safety study. Following approval, TriVascular initiated a patient registry to assess “real world” device performance across 30 sites in Europe. The main difference between a FDA IDE study and a post-market registry is that the clinical results are investigator reported versus core lab.
The 2-year results of the 501 patient study were excellent. There have been no reported device migrations and a low rate of device-related type I and type III endoleaks.
These real-world results are encouraging and mirror the positive outcomes demonstrated in the pivotal clinical study.
In total, these data provide compelling evidence that the Ovation system offers significant advantages in addressing current EVAR challenges and safely expands EVAR to more patients.
