1
Inguinal Ligament Right Common Femoral Artery Right Profunda Femoral Artery Right Superficial Femoral Artery Right Popliteal Artery Right Posterior Tibial Artery Right Anterior Tibial Artery Right Peroneal Artery Improved Clinical Performance of a Lower Extremity Bypass Graft Provides Economic Value for Healthcare Providers Darlene L. Krohn, PhD; Antoinette L. Sheen, MBA; Mike J. Martinell, MBA; Paul D. Goodman, PhD; Jennifer B. Recknor, PhD W. L. Gore & Associates, Inc. • PO Box 2400 • Flagstaff, Arizona 860032400 • USA • [email protected] Introduction Synthetic lower extremity bypass grafts may require surgical reintervention to maintain blood flow as peripheral arterial disease (PAD) progresses. Multiple reinterventions are costly to health care systems and burdensome for patients. Further, failure to restore blood flow may result in amputation. The highest rate of reintervention occurs in bypasses to infrapopliteal arteries (Figure 1). The heparin-bonded GORE ® PROPATEN ® Vascular Graft (Figure 2) requires fewer reinterventions than standard ePTFE grafts, according to clinical literature. 1–7 Objective Model the cumulative average cost per patient of infrapopliteal bypass using the GORE ® PROPATEN ® Vascular Graft compared to standard ePTFE over a 3-year period. Methods Cost of bypass procedures, follow-up visits and reinterventions (in USD) were obtained using Medicare national average cost methodology. Amputation and rehabilitation costs were determined from a clinical publication. 8 Patency and limb salvage rates for GORE ® PROPATEN ® Vascular Graft and ePTFE grafts one to three years after infrapopliteal bypass were obtained from clinical literature. Cumulative average cost per patient was calculated by combining the cost of the bypass procedure and typical reinterventions. Figure 1: Lower extremity arterial anatomy Figure 2: GORE ® PROPATEN ® Vascular Graft Results Conclusion The clinical value of the GORE ® PROPATEN ® Vascular Graft—reduced amputation and reintervention rates— translates directly to the economic value of reduced cumulative cost over time. References a. Weighted average of data from references 1–6. b. Critical limb ischemia subset from reference 5. 1. Daenens K, et al. Journal of Vascular Surgery 2009;49(5):1210-1216. 2. Hugl B, et al. Journal of Cardiovascular Surgery 2009;50(2):195-203. 3. Kirkwood ML, et al. Vascular & Endovascular Surgery 45(4):329-334. 4. Lösel-Sadée H, Alefelder C. Journal of Cardiovascular Surgery 2009;50(3):339-343. 5. Peeters P, et al. Journal of Vascular & Endovascular Surgery 2008;15(3):143-148. 6. Pulli R, et al. Journal of Vascular Surgery 2010;51(5):1167-1177. 7. Albers M, et al. Journal of Vascular Surgery 2003;37(6):1263-1269. 8. MacKenzie EJ, et al. Journal of Bone and Joint Surgery 2007;89(8):1685-1692. 100 80 60 40 20 0 Primary Patency 71% 59% 62% 48% 53% 41% 1 Year 2 Years 3 Years 100 80 60 40 20 0 Secondary Patency 86% 66% 75% 57% 62% 51% 1 Year 2 Years 3 Years 100 80 60 40 20 0 Limb Salvage 90% 78% 90% 71% 86% 66% 1 Year 2 Years 3 Years GORE ® PROPATEN ® Vascular Graft a Standard ePTFE 7 GORE ® PROPATEN ® Vascular Graft 5 Standard ePTFE 7 GORE ® PROPATEN ® Vascular Graft b Standard ePTFE 7 $45,000 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 1 Year 2 Years 3 Years Cumulative Average Cost Per Patient $19,177 $23,476 $23,653 $33,830 $29,928 $44,835 GORE ® PROPATEN ® Vascular Graft Standard ePTFE Products listed may not be available in all markets. GORE ® , PERFORMANCE THROUGH DATA, PROPATEN ® , and designs are trademarks of W. L. Gore & Associates. © 2012 W. L. Gore & Associates, Inc. AR0394-EN1 AUGUST 2012 ®

Abstract Poster by W. L. Gore & Associates

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Page 1: Abstract Poster by W. L. Gore & Associates

Inguinal Ligament

Right Common Femoral Artery

Right Profunda Femoral Artery

Right Superficial Femoral Artery

Right Popliteal Artery

Right Posterior Tibial Artery

Right Anterior Tibial Artery

Right Peroneal Artery

Improved Clinical Performance of a Lower Extremity Bypass GraftProvides Economic Value for Healthcare Providers

Darlene L. Krohn, PhD; Antoinette L. Sheen, MBA; Mike J. Martinell, MBA; Paul D. Goodman, PhD; Jennifer B. Recknor, PhD

W. L. Gore & Associates, Inc. • PO Box 2400 • Flagstaff, Arizona 86003–2400 • USA • [email protected]

IntroductionSynthetic lower extremity bypass grafts may require surgical reintervention to maintain blood flow as peripheral arterial disease (PAD) progresses.Multiple reinterventions are costly to health care systems and burdensome for patients. Further, failure to restore blood flow may result in amputation.The highest rate of reintervention occurs in bypasses to infrapopliteal arteries (Figure 1). The heparin-bonded GORE® PROPATEN® Vascular Graft (Figure 2) requires fewer reinterventions than standard ePTFE grafts, according to clinical literature.1–7

ObjectiveModel the cumulative average cost per patient of infrapopliteal bypass using the GORE® PROPATEN® Vascular Graft compared to standard ePTFE over a 3-year period.

MethodsCost of bypass procedures, follow-up visits and reinterventions (in USD) were obtained using Medicare national average cost methodology. Amputation and rehabilitation costs were determined from a clinical publication.8

Patency and limb salvage rates for GORE® PROPATEN® Vascular Graft and ePTFE grafts one to three years after infrapopliteal bypass were obtained from clinical literature. Cumulative average cost per patient was calculated by combining the cost of the bypass procedure and typical reinterventions.

Figure 1: Lower extremity arterial anatomy

Figure 2: GORE® PROPATEN® Vascular Graft

Results

Conclusion The clinical value of the GORE® PROPATEN® Vascular Graft—reduced amputation and reintervention rates—translates directly to the economic value of reduced cumulative cost over time.

Referencesa. Weighted average of data from references 1 –6.

b. Critical limb ischemia subset from reference 5.

1. Daenens K, et al. Journal of Vascular Surgery 2009;49(5):1210-1216.

2. Hugl B, et al. Journal of Cardiovascular Surgery 2009;50(2):195-203.

3. Kirkwood ML, et al. Vascular & Endovascular Surgery 45(4):329-334.

4. Lösel-Sadée H, Alefelder C. Journal of Cardiovascular Surgery 2009;50(3):339-343.

5. Peeters P, et al. Journal of Vascular & Endovascular Surgery 2008;15(3):143-148.

6. Pulli R, et al. Journal of Vascular Surgery 2010;51(5):1167-1177.

7. Albers M, et al. Journal of Vascular Surgery 2003;37(6):1263-1269.

8. MacKenzie EJ, et al. Journal of Bone and Joint Surgery 2007;89(8):1685-1692.

100

80

60

40

20

0

Primary Patency

71% 59% 62% 48% 53% 41%

1 Year 2 Years 3 Years

100

80

60

40

20

0

Secondary Patency

86% 66% 75% 57% 62% 51%

1 Year 2 Years 3 Years

100

80

60

40

20

0

Limb Salvage

90% 78% 90% 71% 86% 66%

1 Year 2 Years 3 Years

GORE® PROPATEN® Vascular Graft a Standard ePTFE 7

GORE® PROPATEN® Vascular Graft 5 Standard ePTFE 7

GORE® PROPATEN® Vascular Graft b Standard ePTFE 7

$45,000

40,000

35,000

30,000

25,000

20,000

15,000

10,000

5,000

01 Year 2 Years 3 Years

Cumulative Average Cost Per Patient

$19,177 $23,476 $23,653 $33,830 $29,928 $44,835

GORE® PROPATEN® Vascular Graft Standard ePTFE

Products listed may not be available in all markets.GORE®, PERFORMANCE THROUGH DATA, PROPATEN®, and designs are trademarks of W. L. Gore & Associates. © 2012 W. L. Gore & Associates, Inc. AR0394-EN1 AUGUST 2012

®