powerful patency. a decade of performance. · department of vascular surgery, university of...

LITERATURE SUMMARY

Above-knee Data

1 Year a: 84%N=528

Overall weighted average primary patency

A decade of performance.Powerful patency.

2 Years a: 78%N=320

3 Years a: 76%N=222

1 Year a: 76%N=745

2 Years a: 67%N=631

3 Years a: 60%N=477

5 Years b: 52%N=212 9 Years b: 41%

N=212

4 Years a: 45%N=631

Below-knee Data

More Data.More Patients.

MoreConfidence.*

®

† Weighted Average = (N1 x Primary Patency1 ) + (N2 x PP2 ) + ... + (Nn x PPn )

N1 + N2 + ... + Nn

* Data based on an analysis of current literature: several MEDLINE® Database searches were performed to identify publications pertaining to ePTFE synthetic vascular graft and vein infragenicular bypasses. Search criteria included (1) articles published from January 2000 to January 2012, (2) key words used were below knee, polytetrafluoroethylene, prosthetic, bypass, patency, (3) articles in English language, (4) N equal or greater than 30 bypasses, (5) clinical publications, (6) reviews, case reports or meta-analysis articles were excluded, (7) articles containing the key word AV access (including synonyms) were excluded. Articles that did not meet the above criteria were deemed ineligible for this analysis. Data of analysis on file.

§ In studies where 1-year and 3-year patency data were reported, but 2-year patency data were not reported, the 2-year patency rate used in this analysis was interpolated as the average of the 1-year and 3-year patency rates.

◊ Below-knee (BK) inclusion criteria for GORE® PROPATEN® Vascular Graft literature used in this analysis were (1) articles in English language, (2) clinical journal articles or book chapters, (3) non-overlapping patient populations, (4) BK bypass primary patency reported for at least 12 months of follow-up, and (5) N = 50 or more BK bypasses. Additional exclusion criteria were (1) reviews, case reports or meta-analysis articles, and (2) articles containing the key word AV access (including synonyms). Data of analysis on file.

40 50 60 70 80 90

1 Year

76%◊

GORE® PROPATEN® Vascular Graft

(N = 745)

79%*Vein

(N = 11,956)

60%*ePTFE

Vascular Graft(N = 2,549)

2 Years

67%◊


(N = 631)

77%*§

Vein(N = 10,458)

46%*ePTFE


40 50 60 70 80 90

3 Years

60%◊


(N = 477)

75%*Vein

(N = 9,867)

40%*ePTFE


40 50 60 70 80 90

4 Years

45%◊


(N = 631)

72%*§

Vein(N = 9,260)

29%*ePTFE

Vascular Graft(N = 599)

25 35 45 55 65 75

Overall Weighted Average† Primary Patency in Below-knee Bypasses

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[ 2 ]

[ 3 ]

Summary of Primary Patency from GORE® PROPATEN® Vascular Graft Literature in Below-knee Bypasses

N = 342

N = 403

BK Infrapopliteal

BK Fem-Pop

TOTAL N = 745 76% 67%

1 year 2 years

79%

72%

45%

71%

62%

60%

3 years

64%

53%

4 years

47%

42%

Overall Weighted Average Primary Patency

N = Number of bypasses

N = 45

N = 30

BK Fem-Crural

BK Fem-Pop

1 year 2 years

64.4%

77.3%

56.8%

71.4%

49.7%

71.4%

49.7%

71.4%

49.7%

UD*

3 years 4 years 5 years

Lösel-Sadée, et al. 2009 2

Dorigo, et al. 2012 3

Pulli, et al. 2010 4

Monaca, et al. 2013 1

BK Fem-Pop N = 212 51.7%

5 years 9 years

41.2%

* UD: undeterminable because of small patient numbers

4 years

45.2%

39%N = 142

N = 414

BK Infrapopliteal

BK Fem-Pop

N = 86

N = 238

BK Infrapopliteal

BK Fem-Pop

1 year 2 years

75%

3 years

57% 52%

67% 61%

66%

[ 4 ]

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Daenens, et al. 2009 6

Neville, et al. 2012 7

Hugl, et al. 2009 8

Peeters, et al. 2008 5

N = 37

N = 41

BK Infrapopliteal

BK Fem-Pop

1 year 2 years

86%

3 years

60% 60%

79% 75%

71%

N = 97

N = 57

BK Infrapopliteal

BK Fem-Pop

1 year 2 years

92%

69%

83%

79%

75.4%BK Fem-Distal N = 621 year

1 year

74%

79%N = 15

N = 37

BK Infrapopliteal

BK Fem-Pop

[ 5 ]

Subpopliteal revascularization. Criteria analysis for the use of ePTFE [GORE® PROPATEN® Vascular Graft] as first choice conduit: Multicenter Italian Registry Group V. Monaca, et al. 1

Vittorio Emanuele Policlinic University Hospital Presidio Ospedaliero Ferrarotto, Catania, Italy

Primary Patency GORE® PROPATEN® Vascular Graft

BK Fem-Pop N = 212 51.7%

5 years 9 years

41.2%

Patient Characteristics

Rutherford Classification % of Patients

3 41%

4 43%

5 16%

Proximal Anastomosis Number of Bypasses

Common femoral artery 212

Distal Anastomosis Number of Bypasses

BK popliteal 154

TP trunk 58

Study Details

• Retrospective analysis of multi-center registry data

• Patients were considered at a low risk for thrombosis: exclusion criteria included re-do operations, poor plantar and perimalleolar circulation, severe tissue loss, and single-vessel runoff

• Secondary patency at 5 and 9 years was 58.3%, and limb salvage at 5 and 9 years was 93.1%

Conclusion

“…in low thrombotic risk patients mid-and long-term patency of vein and Propaten® graft [GORE® PROPATEN® Vascular Graft] is comparable. In case of PTFE use, we reported shorter surgery time, reduced hospital stay and wound complications. These observations led us to primarily choose the prosthetic graft in that subset of cases, saving the VSG [great saphenous vein] for distal revascularization in case of occlusive disease progression.” — V. Monaca

[ 6 ]

Heparin-bonded expanded polytetrafluoroethylene graft for infragenicular bypass: 5-year results H. Lösel-Sadée and C. Alefelder 2 Department of Vascular Surgery Sana Kliniken Dusseldorf, Dusseldorf, Germany


N = 45

N = 30

BK Fem-Crural

BK Fem-Pop

1 year 2 years

64.4%

77.3%

56.8%

71.4%

49.7%

71.4%

49.7%

71.4%

49.7%

UD*

3 years 4 years 5 years


Number of BypassesBK fem-pop 30Fem-crural 45i) Anterior tibial 14ii) Tibioperoneal trunk 12iii) Posterior tibial 9iv) Peroneal 9v) Dorsalis pedis 1

Study Details

• Retrospective single-center study

• Vein cuffs were created at the distal anastomosis in 5 patients; no patches were used

• The 3-year and 4-year secondary patency rates for below-knee fem-pop and fem-crural bypasses were 82.5% and 71.5%, respectively

• The 5-year limb salvage rate was 84%

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* UD: undeterminable because of small patient numbers

[ 7 ]

Results from an Italian multicentric registry comparing heparin-bonded ePTFE graft and autologous saphenous vein in below-knee popliteal bypasses W. Dorigo, et al. 3

Department of Vascular Surgery, University of Florence, Florence, Italy


4 years

45.2%

39%N = 142

N = 414

BK Infrapopliteal

BK Fem-Pop


% of Patients

Diabetes 45.5%

ESRD 15%

Hypertension 87%

Smoking 72%

Hyperlipidemia 59%

Coronary artery disease 45%


BK popliteal 414

T-P trunk 69

Anterior tibial 27

Posterior tibial 35

Peroneal 11

Study Details

• Retrospective analysis of a multi-center registry of GORE® PROPATEN® Vascular Graft and autologous saphenous vein

• There was no statistically significant difference in secondary patency or limb salvage between GORE® PROPATEN® Vascular Graft and autologous saphenous vein

Conclusion

“…we had a 13% increase in secondary patency rates in ePTFE group, whereas the corresponding figure was only 6% in patients with occluded vein, thus confirming both the possibility of effectively treating occluded heparin-bonded grafts and the difficulty of dealing with occluded vein bypasses.”

“In patients with critical limb ischemia, the rates both of amputations at 4 years and of amputation-free survival were not different between autologous vein and heparin-bonded ePTFE…and this is an encouraging result, considering that limb salvage probably represents the main outcome in all these critical patients.” — W. Dorigo

Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded ePTFE graft: Italian Registry Group R. Pulli, et al.4

Department of Vascular Surgery, University of Florence, Italy


N = 86

N = 238

BK Infrapopliteal

BK Fem-Pop

1 year 2 years

75%

3 years

57% 52%

67% 61%

66%

Patient Characteristics (Total N = 425)*


4 54%

5 34%

6 12%

Runoff Score % of Patients

0 – 1 44%

2 – 3 56%

Adjunctive Procedures–Distal Anastomosis % of Patients

Vein cuff 10.5%

Patching 5%

Tibial angioplasty 1%

Other procedures 3%

Study Details

• Multi-center, retrospective, non-randomized study

• All patients had Critical Limb Ischemia (CLI)

• Combined fem-pop and infrapopliteal limb salvage rate at 3 years was 81% in these CLI patients

Conclusion

“…the good results at 3 years in primary interventions in patients with more than one distal vessel and with rest pain could suggest a significant role of the heparin-bonded graft in these subgroups of patients.” — R. Pulli

“Primary and secondary patency rates make this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable, or of poor quality.” — R. Pulli

* Includes 101 patients with AK bypasses

[ 8 ]

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[ 9 ]

Will heparin-bonded PTFE replace autologous venous conduits in infrapopliteal bypass? P. Peeters, et al.5

Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium


N = 37

N = 41

BK Infrapopliteal

BK Fem-Pop

1 year 2 years

86%

3 years

60% 60%

79% 75%

71%


Number of BypassesBK fem-pop 41Fem-crural 37i) Fem-anterior tibial artery 10ii) Fem-tibiofibular trunk 11iii) Fem-posterior tibial artery 10iv) Fem-peroneal artery 6

Study Details

• Prospective, multi-center study

• No adjunctive techniques (patches or cuffs) were used in the study

• The 3-year secondary patency rate for below-knee fem-pop and fem-crural bypasses were 80% and 62%, respectively

• The 3-year limb salvage rate for all CLI patients was 86%*

Conclusion

“PROPATEN® Vascular Graft [GORE® PROPATEN® Vascular Graft] may succeed in bridging the gap between venous and regular PTFE bypass...especially for infrapopliteal bypasses.” — P. Peeters

* Limb salvage rates are for both above-knee and below-knee bypasses.

[ 10 ]

Heparin-bonded ePTFE grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results K. Daenens, et al.6

University Hospital Gasthuisberg, Belgium


N = 97

N = 57

BK Infrapopliteal

BK Fem-Pop

1 year 2 years

92%

69%

83%

79%


Number of BypassesBK fem-pop 57Fem-crural 97i) Fem-tibiofibular trunk 10ii) Fem-anterior tibial artery 37iii) Fem-fibular (peroneal) artery 21iv) Fem-posterior tibial artery 29

Study Details

• Retrospective, non-randomized study

• Study compared results from GORE® PROPATEN® Vascular Graft to autologous vein bypasses

• Adjunctive techniques:

— Below-knee fem-pop: 2 Miller cuff, 2 Taylor patch, 2 Linton patch

— Below-knee fem-crural: 11 Miller cuff, 3 Taylor patch, 7 Linton patch, 15 AV fistula

• The 2-year limb salvage rates for below-knee fem-pop and fem-crural bypasses were 98% and 87%, respectively

• 2-year autologous vein patency rates for below-knee fem-pop and infrapopliteal were 72% and 64%, respectively

Conclusion

“In this large retrospective study, heparin-bonded ePTFE grafts had 1- and 2-year primary patency results that were not significantly different from those for ASV grafts. Results in BK FP and FC applications were especially promising.” — K. Daenens

“Overall, our results...provide solid additional evidence that heparin-bonded ePTFE grafts represent an important new option in the treatment of peripheral arterial disease.” – K. Daenens

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A comparison of tibial artery bypass performed with heparin-bonded expanded polytetrafluoroethylene and great saphenous vein to treat critical limb ischemia R. Neville, et al.7

Division of Vascular Surgery, George Washington University, Washington, DC, USA


75.4%BK Fem-Distal N = 621 year



3 8%

4 27%

5 48%

6 16%

% of Patients

Prior bypass 44%

Diabetes 47%

ESRD 13%

Hypertension 73%


Anterior tibial 15

Posterior tibial 22

Peroneal 21

Dorsalis pedis 4

Study Details

• Retrospective single-center study comparing GORE® PROPATEN® Vascular Graft to great saphenous vein

• Distal vein patch was used at all distal anastomoses

• There was no statistically significant difference in primary patency or limb salvage between GORE® PROPATEN® Vascular Graft and single-segment great saphenous vein

Conclusion

“This experience with heparin-bonded ePTFE grafts for solely tibial artery bypass yielded patency and limb salvage rates that are comparable to intact great saphenous vein.”

“We believe that a quality saphenous vein remains the ideal conduit for tibial bypass, although HePTFE should be considered when intact ipsilateral or contralateral vein is not available. In our practice, HePTFE has emerged as the choice over arm vein, especially in the ESRD patient who needs upper extremity vein for dialysis access. We would also choose HePTFE over composite short saphenous vein given the increased dissection required and length of conduit.” — R. Neville

[ 11 ]

[ 12 ]

PEPE II – a multicenter study with an end-point heparin-bonded expanded polytetrafluoroethylene vascular graft for above and below-knee bypass surgery: determinants of patency B. Hugl, et al.8

Department of Vascular Surgery, Medical University, Innsbruck, Austria


1 year

74%

79%N = 15

N = 37

BK Infrapopliteal

BK Fem-Pop

Patient Characteristics (Total N = 139)

Vessel Run-off Scores * % of Patients

1 Vessel 29%

2 Vessels 36%

3 Vessels 34%

Fontaine Classification Stage * % of Patients

Stage I < 1%

Stage II 45%

Stage III 19%

Stage IV 36%

Study Details


• Patients without suitable autologous vein

• The 1-year secondary patency rates for below-knee fem-pop and fem-distal bypasses were 79% and 85%, respectively

• Overall 1-year patency and limb salvage rates were 80% and 96%, respectively *

Conclusion

“…present data show that using the endpoint heparin bonded ePTFE graft for lower limb revascularization produces excellent results for AK bypasses and encouraging results for BK bypasses, when compared with data obtained from studies which used other prosthetic material. These encouraging results for BK bypasses were even seen in the subgroup of patients that generally have worse revascularization results due to the presence of risk factors.” — B. Hugl

“…our data suggests that the use of this graft is an excellent option when no autologous vein is available.” — B. Hugl

* Includes 87 patients with AK bypasses

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† Weighted Average = (N1 x Primary Patency1 ) + (N2 x PP2 ) + ... + (Nn x PPn )

N1 + N2 + ... + Nn

* Above-knee (AK) inclusion criteria for GORE® PROPATEN® Vascular Graft literature used in this analysis were (1) articles in English language, (2) clinical journal articles or book chapters, (3) non-overlapping patient populations, and (4) AK bypass primary patency reported for at least 12 months of follow-up. Additional exclusion criteria were (1) reviews, case reports or meta-analysis articles, and (2) articles containing the key word AV access (including synonyms). Data of analysis on file.

[ 14 ]

40 50 60 70 80 90

1 Year

84%GORE® PROPATEN®


2 Years



40 50 60 70 80 90

3 Years



40 50 60 70 80 90

Overall Weighted Average† Primary Patency in Above-knee Bypasses*

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Lindholt, et al. 2011 10

Kirkwood, et al. 2011 11

Pulli, et al. 2010 4

Samson, et al. 2013 9

[ 15 ]

AK Fem-Pop 87.8% 87.8% 87.8%

1 year 2 years 3 years

N = 46

AK Fem-Pop N = 112 81%

1 year


1 year

AK Fem-Pop N = 101 80% 72%


72%

N = Number of bypasses

Summary of Primary Patency from GORE® PROPATEN® Vascular Graft Literature in Above-knee Bypasses

Overall Weighted Average Primary Patency

AK Fem-Pop N = 528 84% 78%

1 year 2 years

76%

3 years

Daenens, et al. 2009 6

Walluschek, et al. 2005 12

Peeters, et al. 2008 5

[ 16 ]

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AK Fem-Pop N = 75 81.1%


77.6% 75.4%

AK Fem-Pop N = 86 92% 83%

1 year 2 years

91% 68%AK Fem-Pop N = 12

1 year 2 years

Improved three year patency rates for heparin-bonded ePTFE femoropopliteal bypass grafts versus ePTFE grafts without heparin R. Samson and L. Morales 9

Florida State University Medical School, Sarasota, Florida, USA


AK Fem-Pop 87.8% 87.8% 87.8%


N = 46

Patient Characteristics (GORE® PROPATEN® Vascular Graft Group, N = 70)*

% of Patients

Diabetes 48.6%

Hypertension 81.4%

Smoking 34.3%

Hyperlipidemia 72.9%

Coronary artery disease 47.1%

Indication for Bypass % of Patients

Claudication 34.3%

Rest pain 27.1%

Ulceration 35.7%

Gangrene 21.4%

Study Details

• Retrospective, single-center study of GORE® PROPATEN® Vascular Graft (2007 – present) and standard ePTFE grafts (1998 – 2007)

• There was a statistically significant difference in primary patency between GORE® PROPATEN® Vascular Graft and standard ePTFE from 1 through 3 years

Conclusion

“Based on our data we will preferentially use heparin-bonded expanded polytetrafluoroethylene for above-knee femoropopliteal bypasses except in young patients who have available suitable autogenous saphenous vein.”

“The three-year patency for above-knee heparin-bonded expanded polytetrafluoroethylene described in our series is similar to reported patency rates for autogenous saphenous vein (87.8%).” — R. Samson

* Includes 24 patients with BK bypasses.

[ 17 ]

The Scandinavian Propaten® [GORE® PROPATEN® Vascular Graft] Trial — 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses – a randomised clinical controlled multi-centre trialJ. Lindholt, et al.10

Vascular Research Unit, Department of Vascular Surgery, Viborg Hospital, Denmark



1 year

Patient Characteristics (GORE® PROPATEN® Vascular Graft Group, N = 272)*

% of Patients

Smokers 53.3%

Diabetes mellitus 15.0%

Critical limb ischemia 36.0%

Study Details

• Total N = 546 patients

• Multi-center (11 centers), prospective, randomized study comparing GORE® PROPATEN® Vascular Graft versus standard ePTFE

• Fem-pop (majority above-knee) and fem-fem bypasses

• Statistically significant improvement in primary and secondary patency with GORE® PROPATEN® Vascular Graft versus standard ePTFE for all bypasses

• In fem-pop patients with CLI, GORE® PROPATEN® Vascular Graft primary patency was 80% while standard ePTFE patency was 58% (p < 0.05)

Conclusion

• GORE® PROPATEN® Vascular Graft reduced the risk of graft occlusion by 40% overall, and by 50% in patients with CLI.

“We have seen that the GORE® PROPATEN® Vascular Graft keeps its promise as shown inpreviously conducted prospective and retrospective studies.” — Jes S. Lindholt, MD, PhD

* Includes 160 patients with fem-fem bypasses.

[ 18 ]

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Lower limb revascularization for PAD using GORE® PROPATEN® Vascular GraftM. Kirkwood, et al.11

Division of Vascular Surgery and Endovascular Therapy

University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA



1 year

Patient Characteristics (Total N = 68)

Characteristic * % of Patients

Critical limb ischemia 67%

1 – 2 vessel runoff score 60%

Diabetes 41%

Indications for Surgery * % of Patients

Diabling claudication 33%

Rest pain 34%

Tissue loss 33%

Study Details

• Retrospective, single-center, single-arm study

• Patients did not have “appropriate autologous vein”

• 18-month follow-up

• Primary patency rates at 18 months for fem-fem (n = 22) and ax-fem (n = 7) bypasses were 95% and 100%, respectively

Conclusion

“…when appropriate autologous vein is not available or the integrity of existing vein is questionable for infrainguinal bypass, the PROPATEN graft [GORE® PROPATEN® Vascular Graft] is an excellent alternative with impressive patency and low morbidity.” — M. Kirkwood

“These results are especially encouraging, when the severity of patient disease is considered…” — M. Kirkwood

“These results, especially in the BK and the tibial bypasses, have been better than our own historical experience with standard PTFE, and therefore we have altered practice to include using PROPATEN [GORE® PROPATEN® Vascular Graft] when a prosthetic conduit is necessary.” — M. Kirkwood

* Includes 29 patients with BK bypasses, 22 with fem-fem bypasses, 7 with ax-fem bpyasses, and 1 with an ilio-fem bypass.

[ 19 ]

[ 20 ]

Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded ePTFE graft R. Pulli, et al.4

Department of Vascular Surgery, University of Florence, Italy


AK Fem-Pop N = 101 80% 72%


72%



4 54%

5 34%

6 12%

Runoff Score % of Patients

0 – 1 44%

2 – 3 56%

Study Details

• Multi-center, retrospective, non-randomized study

• All patients had critical limb ischemia

• The above-knee fem-pop limb salvage rate at 3 years was 87%

Conclusion

“…the good results at 3 years in primary interventions in patients with more than one distal vessel and with rest pain could suggest a significant role of the heparin-bonded graft in these subgroups of patients.” — R. Pulli

“Primary and secondary patency rates make this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable, or of poor quality.” — R. Pulli

* Includes 324 patients with BK bypasses

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Will heparin-bonded PTFE replace autologous venous conduits in infrapopliteal bypass? P. Peeters, et al.5

Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium


AK Fem-Pop N = 75 81.1%


77.6% 75.4%


% of PatientsRutherford 3 56%Rutherford 4 19%Rutherford 5 25%Diabetes 27%Hypertension 64%Coronary artery disease 30%Nicotine use 48%

Study Details


• No adjunctive techniques (patches or cuffs) were used in the study

• 73% of patients had been previously treated for Peripheral Vascular Disease (PVD)

• The 3-year limb salvage rate for all Critical Limb Ischemia (CLI) patients was 86%**

Conclusion

“…it is our opinion that the Propaten Vascular Graft [GORE® PROPATEN® Vascular Graft] may succeed in bridging the gap between venous conduits and regular ePTFE grafts.” — P. Peeters

* Includes patients that underwent 97 BK bypasses. ** Limb salvage rates are for both above-knee and below-knee bypasses.

[ 21 ]

Heparin-bonded ePTFE grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results K. Daenens, et al.6

University Hospital Gasthuisberg, Belgium


AK Fem-Pop N = 86 92% 83%

1 year 2 years

Patient Characteristics (GORE® PROPATEN® Vascular Graft Group)

% of PatientsRutherford 3 26%Rutherford 4 25%Rutherford 5 35%Rutherford 6 7%Smokers 62%Re-do bypass 36%

Study Details

• Retrospective, non-randomized study

• Study compared results from GORE® PROPATEN® Vascular Graft to autologous vein bypasses

• The 1 and 2 year primary patency rates for above-knee fem-pop bypasses using autologous vein were 91% and 80%, respectively

Conclusion

“Overall, our results...provide solid additional evidence that heparin-bonded ePTFE grafts represent an important new option in the treatment of peripheral arterial disease.” – K. Daenens

[ 22 ]

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Infrainguinal ePTFE vascular graft with bioactive surface heparin bonding — first clinical results K.P. Walluscheck, et al.12

University Hospital Schleswig-Holstein / Campus Kiel, Germany


91% 68%AK Fem-Pop N = 12

1 year 2 years


Fontaine Class Number of BypassesStage II b 3Stage III 3Stage IV 6

Study Details

• Retrospective study

• Patients with lack of or inadequate saphenous vein

• Linton patch was used in 2 cases for distal anastomoses to the above-knee popliteal artery

• After 2 years, the limb salvage rate was 98%*

Conclusion

“...the bioactive heparinized ePTFE graft evaluated in this study provides patency rates comparable with autologous vein grafts.”, “...at our department the Propaten graft [GORE® PROPATEN® Vascular Graft] is the prosthesis of choice when autologous vein is not available.” — K.P. Walluscheck

* Limb salvage rates are for both above-knee and below-knee bypasses.

[ 23 ]

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REFERENCES1. Monaca V, Battaglia G, Turiano SA, Tringale R, Catalfamo S. Sub popliteal revascularization. Criteria analysis for use of E-P.T.F.E.

(Propaten®) as first choice conduit. Italian Journal of Vascular & Endovascular Surgery 2013;20(3):165-169.

2. Lösel-Sadée H, Alefelder C. Heparin-bonded expanded polytetrafluoroethylene graft for infragenicular bypass: five-year results. Journal of Cardiovascular Surgery 2009;50(3):339-343.

3. Dorigo W, Raffaele P, Piffaretti G. Results from an Italian multicentric registry comparing heparin-bonded ePTFE graft and autologous saphenous vein in below-knee femoro-popliteal bypasses. Journal of Cardiovascular Surgery 2012;53(2):187-193.

4. Pulli R, Dorigo W, Castelli P, et al; Propaten Italian Registry Group. Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded ePTFE graft. Journal of Vascular Surgery 2010;51(5):1167-1177.

5. Peeters P, Verbist J, Deloose K, Bosiers M. Will heparin-bonded PTFE replace autologous venous conduits in infrapopliteal bypass? Italian Journal of Vascular & Endovascular Surgery 2008;15(3):143-148.

6. Daenens K, Schepers S, Fourneau I, Houthoofd S, Nevelsteen A. Heparin-bonded ePTFE grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results. Journal of Vascular Surgery 2009;49(5):1210-1216.

7. Neville RF, Capone A, Amdur R, Lidsky M, Babrowicz J, Sidawy AN. A comparison of tibial artery bypass performed with heparin-bonded expanded polytetrafluoroethylene and great saphenous vein to treat critical limb ischemia. Journal of Vascular Surgery 2012;56(4):1008-1014.

8. Hugl B, Nevelsteen A, Daenens K, et al; PEPE II Study Group. PEPE II - a multicenter study with an end-point heparin-bonded expanded polytetrafluoroethylene vascular graft for above and below knee bypass surgery: determinants of patency. Journal of Cardiovascular Surgery 2009;50(2):195-203.

9. Samson RH, Morales L. Improved three year patency rates for heparin-bonded ePTFE femoropopliteal bypass grafts vs. ePTFE grafts without heparin. In: Greenhalgh RM, ed. Vascular & Endovascular Challenges Update. London, UK: BIBA Publishing; 2013:315-320.

10. Lindholt JS, Gottschalksen B, Johannesen N, et al. The Scandinavian Propaten® Trial – 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses – a randomised clinical controlled multi-centre trial. European Journal of Vascular & Endovascular Surgery 2011;41(5):668-673.

11. Kirkwood ML, Wang GJ, Jackson BM, Golden MA, Fairman RM, Woo EY. Lower limb revascularization for PAD using a heparin-coated PTFE conduit. Vascular & Endovascular Surgery 2011;45(4):329-334.

12. Walluscheck KP, Bierkandt S, Brandt M, Cremer J. Infrainguinal ePTFE vascular graft with bioactive surface heparin bonding- first clinical results. Journal of Cardiovascular Surgery 2005;46(4):425-430.

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COVER PAGE REFERENCES:

* As compared to clinical studies listed on clinicaltrials.gov for peripheral arterial bypass.

a. Overall weighted average primary patency is based on data from 11 peer-reviewed publications meeting pre-determined inclusion criteria. Visit goremedical.com/propatenperformance to see inclusion criteria, explore the data, see publications, and request reprints.

b. Monaca V, Battaglia G, Turiano SA, Tringale R, Catalfamo S. Sub popliteal revascularization. Criteria analysis for use of E-P.T.F.E. (Propaten®) as first choice conduit. Italian Journal of Vascular & Endovascular Surgery. In press.

powerful patency. a decade of performance. · department of vascular surgery, university of...

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