PEVAR CASE STUDY:

Improving Patient Satisfaction With Percutaneous Evar

Scott W. Kujath, MD, FACS

Kansas City, MO

BACKGROUNDIn our twenty years of experience performing EVAR cases, we have become accustomed to common side effects expected with the standard surgical cut down. To minimize procedural invasiveness, we reduced incision size to as little as 3 cm, however, patients still reported pain in the groin, numbness and the occasional wound infection.

Over the last year, patients began actively inquiring about percutaneous repair, and we decided it was the time to incorporate the PEVAR technique in our practice. Since Endologix’s system has received a specific indication for use for PEVAR, their comprehensive training course was the perfect opportunity to learn and refine this technique. Given increased patient awareness, attending on-label training adds credibility to what we are offering our patients.

The one and a half day course is comprised of didactic hands-on training and live case observation. The course has provided the necessary confidence to begin doing large hole closures percutaneously. The intimate details and tips shared by an experienced instructor, as well as a live case observation and a thorough hands-on session were instrumental in learning the steps necessary for mastering this technique.

IMPACT OF PEVAR ON OUR PRACTICESince attending the training we have performed numerous PEVAR procedures and so far nearly all our patients qualified for percutaneous access. Consistent with the data demonstrated in PEVAR trial and clinical literature (Table 1), we are simply no longer seeing the side effects associated with surgical cut down. Our patients now require less pain medication postoperatively and upon release from the hospital. The nursing staff consistently report that PEVAR patients do not complain about pain in the groin, poor appetite and constipation issues that we have previously observed after standard EVAR. Nearly all of them go home the morning after aneurysm repair. As a result, PEVAR has quickly become the standard of care in our practice.

Most importantly, implementing PEVAR has had unexpectedly significant impact on patient satisfaction. The patients feel more comfortable going into the procedure, and afterwards many find it difficult to believe that they underwent a surgery at all. Hearing our patients exclaim “I can’t believe you have done any thing to me at all, Doc!” has been as surprising as it has been rewarding.

“We are simply no longer seeing the side effects associated with surgical cut down.”

“Attending on-label training adds credibility to what we are offering our patients.”

INDICATIONS FOR USE: The Endologix AFX/AFX2 Endovascular AAA Systems are indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair using a surgical vascular access technique or a bilateral percutaneous technique; adequate iliac/femoral access compatible with the required delivery systems (diameter ≥ 6.5mm); a non-aneurysmal aortic neck between the renal arteries and the aneurysm: with length of ≥ 15mm, diameter ≥ 18 to ≤ 32mm and neck angle of 60° to the body of the aneurysm; aortic length ≥ 1.0cm longer than the body portion of the chosen bifurcated model; common iliac artery distal fixation site with length ≥ 15mm, diameter of ≥ 10 to ≤ 23mm, and with ability to preserve at least one hypogastric artery; and with an iliac angle of 90° to the aortic bifurcation. Extension stent grafts must have the ability to overlap the bifurcated stent graft by at least 30 to 40mm proximally and at least 15 to 20mm distally.

CONTRAINDICATIONS: The Endologix AFX/AFX2 Endovascular AAA Systems are contraindicated for use in patents who have a condition that threatens to infect the graft and in patients with sensitivities or allergies to the device materials.

Refer to the Instructions for Use for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

NOTE: The AFX® Endovascular AAA System and associated components are not available in all countries or regions. Please contact your Endologix representative for details regarding product availability.

CE marked. Please refer to current product instructions for use.

Endologix and AFX are registered trademarks of Endologix, Inc. All other trademarks are the property of their respective owners.

©2016 Endologix, Inc. All rights reserved. MM0628 Rev 02

CONCLUSIONSWe believe that attending a structured training course has been essential to fast and successful implementation of PEVAR technique in our practice. The practice management tools available after the course allowed us to share our experience with patients and the referring community. With growing awareness and changing expectations, our belief is that it won’t be long before PEVAR becomes a standard of care for each and every AAA case.

INNOVATION THAT EMPOWERSOne of the fastest-growing, publically-traded cardiovascular companies in the world, Endologix is the leading innovator in the treatment of life-threatening aortic aneurysms. By developing and manufacturing minimally invasive solutions that enable aneurysmal sealing, Endologix empowers physicians to provide patients with the highest quality care and medical technology.

* Treatment Success is defined as: the composite of technical success, endovascular (EVAR) success, and absence of major adverse event or vascular complication at one month.

PEVAR TrialKey PEVAR/ProGlide® Results

• 94% ‘Pre-Close’ Technical Success• 100% Endovascular (EVAR) Success• Significantly shorter time to hemostasis vs. SEVAR, 9.8 min vs. 23 min

(P=.002)• Significantly shorter procedure time vs. SEVAR, 107 min vs. 141 min

(P=.006)• Treatment Success* (Primary Endpoint) non-inferior to SEVAR,

88% vs. 78% (P=.004) These results were sustained to 6 mo • Trends Favoring PEVAR vs. SEVAR – Less blood loss (213 cc vs. 280 cc) – Fewer patients requiring blood transfusion (4% vs. 14%) – Fewer patients with serious adverse events (10% vs. 26%) – Fewer patients prescribed analgesics for groin pain at discharge

(18% vs. 30%) – Shorter hospitalization time (1.3 days vs. 1.8 days)

Table 1

“It won’t be long before PEVAR becomes a standard of care for each and every AAA case.”