1. EVAR: “Not Just For Surgeons Anymore”
J Michael Bacharach MD, MPH, FACC
Section Head, Vascular Medicine & Intervention
North Central Heart Institute
Professor of Clinical Medicine, Sanford School of Medicine, University of South Dakota
Associate Professor of Surgery, Mayo Clinic Graduate School of Medicine

2. J. Michael Bacharach, MD, MPH
I/we have no real or apparent conflicts of interest to report.

3. Presenter Disclosure Information
J. Michael Bacharach, MD, MPH, FACC
“ I have no relevant financial relationships to disclose with regard to this continuing medical education activity”.

4. “Busting The Myths”

5. MYTHS Aneurysmal disease can only be treated by surgeons
Endografts require surgical cut-down for access
Inability to perform open aneurysmectomy or emergently convert a patient to open repair prohibits an operator from performing endovascular repairs
EVAR is so complicated that non-surgeons cannot learn how to do it

6. Current Utilization of EVAR by Specialty
The combined utilization rate per 100,000 of the two types of interventions for AAA (EVAR and OSR) decreased from 121 in 2001 to 119 in In performing EVAR, procedure volume and market share in 2006 by specialty were
1) 22,003 procedures by surgeons, a 76% share;
2) 3,287 procedures by radiologists, an 11% share;
3) 1,915 procedures by cardiologists, a 7% share; and
4) 1,732 procedures by all other physicians, a 6% share.
J Am Coll Radiol 2009;6:

7. “What Hasn’t Changed “

8. Elements of Management of the Patient With AAA
Recognize and diagnose aneurysmal disease
Apply appropriate imaging to risk stratify and determine need for intervention
Risk factor management and management of co-morbidities
Intervention
On-going care and surveillance

9. Components of Treating Patients with Aneurysmal Disease
Recognition….clearly a physician trained to care for patients can through history, examination and adjunctive imaging identify aneurysmal disease
Imaging….requires familiarity with both advances and limitations of modern imaging, and the ability to convert the imaging into data that can be translated into determining the suitability of a patient for endovascular treatment

10. Components of Treating Patients with Aneurysmal Disease
Judgment and experience….knowing when to say “NO”
Catheter-based skills….needed for procedural success, familiarity with device characteristics and the ability to adapt the best device to achieve the best outcome
Surveillance….commitment to continue to follow and care for the patient after the procedure

11. “What Has Changed?”

12. Changes in Technology
This change in technology has required a new set of skills
Imaging and the recognition that certain aortic morphology is well suited for EVAR and recognizing those who are not
Catheter based skills
No longer is cutting and suturing required
Rather manipulation of small catheters and wires under fluoroscopic guidance and without the aid of direct tactile manipulation

13. Development Mature Technology Development Innovation
1) Percutaneous approach with pre-close
2) Development of smaller delivery systems that allow percutaneous placement .
3) Newer smaller profile graft systems
Development
Innovation

14. Advances
Historically devices were very large and required surgical access
Sheath and delivery systems were very large, difficult to deliver
Complications when they occurred often led to surgical conversion

15. Problems with Commonly Used Stent Grafts
Large bore EVAR Devices have the potential to cause access related complications
©2012 TriVascular, Inc. All Rights Reserved. CE Marked. Device not for commercial distribution in the U.S.A. Please refer to current Ovation Prime Instructions for Use rA

18. Access Improved sheath systems for safer delivery
Smaller and coated delivery systems
Preclose technique for percutaneous access

19. SoloPath Terumo Expandable Sheath

20. Percutaneous Approach
Improvements in device delivery systems, smaller sheath sizes and shorter procedure times have contributed to success
The key has been the development of suture-mediated closure devices

23. Changing Profile of Endovascular Aortic devices

24. Ovation Prime™ Abdominal Stent Graft
Tri-modular design
14F OD main body
©2012 TriVascular, Inc. All Rights Reserved. CE Marked. Device not for commercial distribution in the U.S.A. Please refer to current Ovation Prime Instructions for Use rA
Low-viscosity, radiopaque, fill polymer
13-14F OD conformable iliac limbs

25. Novel Design Paradigm
©2013 TriVascular, Inc.  All rights reserved.  Caution:  Federal (USA) law restricts this device to sale by or on the order of a physician rB 1 2
The Ovation Prime aortic body is comprised of two key components delivered sequentially:
Suprarenal stent with integral anchors deployed in stages to secure the system and reduce the risk of migration
Biocompatible polymer delivered to inflate novel sealing rings for a robust and conformable seal

26. Bifurcated stent graft
Stent Graft Design
Proximal extension stent graft
Stent
Cobalt chromium alloy
Single-wire construction
Bifurcated unibody design
Graft
Proprietary, High density ePTFE
Fully supported
Attached to stent at ends to reduce cage stress and support long-term durability
Uni-body
Bifurcated stent graft 26

27. PEVAR Trial
A 94% procedural technical success rate was achieved in a multicenter setting
The primary trial endpoint was met (P<.0036), demonstrating non-inferiority of PEVAR to surgical EVAR
Favorable trending of PEVAR in several clinical utility outcomes including reduced anesthesia time, reduced blood loss and need for transfusion, shorter hospital length of stay, and less analgesics prescribed for groin pa

28. Summary
The clinical recognition and elements of management of aortic aneurysm have not changed
Technologic improvements in devices ,delivery systems and newer access management techniques have allowed for safer and percutaneous treatment options