1. PEVAR with Local Anesthesia: Current Status and Upcoming Prospective, Multicenter, RCT
Zvonimir Krajcer, MD Director, Peripheral Vascular Intervention, Department of Cardiology, Texas Heart Institute/St. Luke’s Episcopal Hospital, Houston, TX
CRT, 2, -21, 2010

2. Zvonimir Krajcer, MD DISCLOSURES Grants/Contracted Research Honoraria
Boston Scientific Corporation
Honoraria
Endologix, W.L. Gore & Associates, Inc

3. Closure Devices for PEVAR using “Preclose Technique”
ProGlide™
Prostar XL ™
Prostar XL™
ProGlide™
Profile
10 F 6F
Suture(s)
Tevdek, braided
Monofilament
Knot
Operator tied
Pre-formed
No. of devices 1 2
CRT, 2, -21, 2010

4. Percutaneous EVAR with Local Anesthesia: “Preclose Technique”
Prostar XL
“Preclose technique” using one 10Fr Prostar XL for one FA
After stent graft deployment, sutures are separated & sliding knot technique is used
Since 1995: 1,530 pts underwent EVAR at THI
Since 1998: 1,041 pts. had PEVAR
CRT, 2, -21, 2010

5. What are the goals of PEVAR & with Local Anesthesia ?
Final Result
To reduce mortality & morbidity
To reduce hospital stay
To offer quicker return to a normal life stile
CRT, 2, -21, 2010

6. Tips for Successful PEVAR: Pre-procedural Evaluation
Good for PEVAR
Is FA Suitable for PEVAR?
Use CT to determine
suitability for PEVAR:
Patients with CFA anterior wall and circumferential calcification are not suitable candidates!
Not good for PEVAR!
The only preoperative evaluation that is usually required is the thin-collimated computerized tomography (CT) with 3-dimensional reconstruction. This test measures all the parameters necessary to determine the suitability for percutaneous endovascular aneurysm repair. Appropriate device lengths and diameters are chosen on the basis of this test. Information is obtained on the femoral access sites and aortic accessibility through the iliac vessels. This test also determines the iliofemoral artery diameters, vessel tortuosity, degree of calcification, and specific location of the femoral bifurcation.
Reference:
Morasch MD. Percutaneous thoracic and abdominal aortic aneurysm repair. Ann Vasc Surg. 2005;19:
[Morasch, 2005](/p585/col2/para2)
CRT, 2, -21, 2010

7. Tips for Successful PEVAR: Is FA access site suitable for PEVAR?
Procedural Findings: Meticulous access is essential to avoid problems!
Micropuncture kit
Doppler needle
Fluoroscopy
Duplex (USN)
FA Angiogram
Micropuncture- 21F Needle
Rt. FA
Access site: 30° RAO
Always perform FA sheath angiogram in 30° oblique view !
CRT, 2, -21, 2010

8. Tips for Successful PEVAR Is it for Every Patient?
Anatomy
Absolute contra-indications
Small vessels (≤ 5mm)
Severe, circumferential FA calcifications
Too low access ( SFA or Profunda)
Too high access ( above the inguinal ligament)
Relative contraindications
Severe obesity
Artificial conduits
CRT, 2, -21, 2010

9. Precautions and Limitations
Expertise with arterial closure devices is mandatory!
Learning curve is Steep!
Know well bailout steps!
Operating room & vascular surgeon on standby
Use of suture-mediated closure devices for endovascular aneurysm repair is off-label in the US (approved technique in EU!)
Preferably, percutaneous access should be performed by a surgeon in an operating room. When percutaneous access is performed in a cardiac catheterization lab/interventional radiology suite, an operating room with a surgeon on standby may be required to handle potential complications. Expertise in and familiarity with arterial closure devices are prerequisites before abandoning open access. Avoid or exercise caution in patients with small, severely calcified arteries or aneurysmal femoral arteries, or those with previous femoral dissection. Treating morbidly obese patients may prove to be challenging, but these patients would gain the most if the procedure is successful. The use of suture-mediated closure devices in EVAR is off-label.
References:
Morasch MD, Kibbe MR, Evans ME, et al. Percutaneous repair of abdominal aortic aneurysm. J Vasc Surg. 2004;40:12-16.
Morasch MD. Percutaneous thoracic and abdominal aortic aneurysm repair. Ann Vasc Surg. 2005;19:
[Morasch, 2004](/p15/col1/para2,4;/col2/para2) (/p16/col1/para1)
[Morasch, 2005](/p587/col2/para2,4,5,6) (/p588/col1/para1) (/p589/col1/para1,2)
CRT, 2, -21, 2010

10. Current Practice of PEVAR at THI
Since 2004, only one 10F Prostar XL for all sheath sizes!
12F
18F
Author
Ref.
Pts.
Sheath Size (F)
Techn. Success
Conversion Rate (%)
Krajcer
EVT 2005
429
12-22 97
2.5
CRT, 2, -21, 2010

11. ↓op time, ↓time to ambulation ↓op time, ↓anesthesia time
Selected PEVAR Published Outcomes
Author and Year
Phys Spec
Sheath Fr
SMCD
Pts
Technical Success
Compared to S-EVAR…
Haas 1999
VS/IC
16-22 PS 12
100%
---
Traul 2000 VS
16-24 17
64%
Teh 2001
VS/IR 44
85%
Rachel 2002
76%
↓groin complications
Howell 2002 IC 30
96%
↓op time, ↓blood loss
Torsello 2003
14-25 15
93%
↓op time, ↓time to ambulation
Morasch 2004
12-18 47
↓op time, ↓anesthesia time
Starnes 2006
12-24 49
94%
Dosluoglu 2007
12-22 PG
90%
Jean-Baptiste 2007 19
92%
↓time to discharge
Lee 2007
101
↓op time
Lee 2008
292
McDonnell 2008
71%
Smith 2009 nr
PG/PS 22
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12. FDA-Approved IDE Trial Overview
The
Trial
The First Prospective, Multicenter, Randomized Controlled Trial of Totally Percutaneous EVAR.
Trial Devices
Endologix, Inc. IntuiTrak Endovascular System
Abbott Vascular, Inc. Prostar XL and ProGlide Closures
Up to 20 Trial Sites with Expertise in PEVAR
2:1 Randomization, PEVAR:SEVAR
CRT, 2, -21, 2010

13. PEVAR Trial Design Primary Endpoint: Treatment Success at 30 Days
Composite of Procedural, Vascular and Major AEs
Non-inferiority, Test vs. Control
Closure-Specific Safety and Efficacy Analyses
Secondary Endpoints
Clinical Utility Outcomes
Quality of Life (global and pain evaluations)
Six-Month Assessment
CRT, 2, -21, 2010