Infrainguinal Polytetrafluoroethylene Grafts: Saved Limbs or Wasted Effort? A Report on Ten Years' Experience M.G. Davies, FRCSI, T.M. Feeley, MCh, FRCSI, M.K. O'Malley, MCh, FRCSI, M.P. Colgan, MD, D.J. Moore, MD, FRCSI, G.D. Shanik, MD, FRCSI, Dublin, Ireland

Two-hundred and twenty-four infrainguinal polytetrafluoroethylene reconstructions were performed for critical ischemia over a 10 year period: 48 to the above-knee popliteal artery, 113 to the below-knee popliteal artery, and 63 to the tibial vessels. The cumulative patency rates were 84 _+ 6% and 63 +- 9% for above-knee popliteal, 53 -+ 5% and 35 __ 7% for below-knee popliteal, 45 _+ 6% and 30 _+ 9% for tibial vessels at one and five years respectively. Limb salvage rates were 81 _+ 6% and 73 __ 9% (above-knee popliteal), 69 -+ 5% and 57 _+ 9% (below-knee popliteal), 64 _ 7% and 32 __ 10% (tibial vessels) at one and five years respectively. Graft occlusion did not result in limb loss in 32 cases. Preoperatively, 54% of the patients had limited mobility while 43% were regarded as severely restricted. At follow-up, 57% of the patients were considered to be independent, 26% had limited mobility, and 17% were still severely restricted. Polytetrafluoroethylene provides good short-term limb salvage and improved mobility in patients with critical ischemia and poor life expectancy. Its use is well worth the effort. (Ann Vasc Surg 1991 ;5:519-524). KEY WORDS: PTFE graft; infrainguinal grafts; limb salvage; peripheral vascular ischemia; claudicaUon; graft occlusion.

Infrainguinal arterial reconstruction for critical ischemia and claudication is now a major part of a vascular surgical practice. In patients requiring lower limb revascularization, autogenous saphenous vein when available, is the preferred conduit. Inability to utilize vein (in-situ, reverse or composite) due to whatever reason necessitates the use of a prosthetic graft or primary amputation. Since 1973, when Matsumato [l] first reported its use as a small arterial substitute, polytetrafluoroethylene (PTFE) has become the synthetic graft of choice for infrainguinal bypass and has given good short-term results From the Department of Vascular Surgery, St. James' Hospital, Dublin, Ireland. Reprint requests: Professor Gregor D. Shanik, Department of Vascular Surgery, St. James' Hospital, James's Street, Dublin 8, Ireland.

[2-4]. This report details 10 years experience with infrainguinal PTFE bypass from June 1978 to June 1988 in the Vascular Unit, St. James' Hospital Dublin.

MATERIALS AND METHODS An audit of all infrainguinal arterial reconstructions for limb salvage utilizing PTFE identified 193 patients with 224 bypass procedures; 13 patients had more than one operation on the same limb and 18 had bilateral procedures. Polytetrafluoroethylerie grafts were used when no suitable vein was available. There were 154 men and 39 women who ranged in age from 54 to 82 years (mean 65 years). Thirty-one percent of patients were hypertensive, 24% were diabetics, 24% had ischemic heart dis-

519

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ease, and 84% were smokers. Thirty-eight percent (73) had had previous vascular surgery. The principal presenting symptoms were rest pain (47%), ulceration (21%) and gangrene (32%). Thirty-seven of these limbs required amputation o f one or more digits and 13 others needed forefoot amputations. A further 19 limbs required debridement and skin grafting for ulceration. Preoperatively, all patients underwent lower limb Doppler pressure studies and aortofemoral arteriography. For the purposes of analysis, the patients were separated into three groups based o n the insertion level: above-knee popliteal, below-knee popliteal and infrapopliteal groups. All procedures were carried out under heparinization using 6 mm PTFE grafts (Gore-tex*) and 5-0 or 6-0 polypropylene (Prolene) suture in a running fashion for the anastomosis. Prophylactic antibiotic therapy was used in all cases. The origins and insertions are shown in Table I. Follow-up in the postoperative period consisted of regular, three times monthly, clinical and Doppler assessments. Graft patency was determined by the presence of a palpable pulse or by Doppler ultrasound pressure measurements. Patient mobility was assessed pre- and postoperatively using four categories: bedbound (unable to leave the bed); housebound (unable to leave their homes without assistance); limited (normal lifestyle restricted due to symptoms but not requiring assistance); and independent (returned to normal lifestyle). Expected graft patency and limb salvage were calculated by life table analysis [5]. Primary patency was defined as continued patency without intervention and secondary patency defined as including these grafts and those that remained open following surgical intervention. Limb salvage was defined as the presence of a viable foot for walking with or without toe or transmetatarsal amputation. 9Operative mortality was considered as a death occurring within 30 days of surgery [6]. Statistical methods were by log rank analysis.

RESULTS

Morbidity and mortality

The average hospital stay was 39 days. Nine patients (4.7%) died within 30 days, all due to cardio-respiratory diseases. Of the 193 patients included in the study, 126 (65%) were dead at five years follow-up: 17/43 (40%) of the above-knee popliteal group; 58/93 (62%) of the below-knee popliteal group; and 51/57 (89%) of the tibial group. Sixty-one patients (32%) had postoperative complications: 35 respiratory infections, seven myocardial infarctions, nine wound infections, five wound hematomas, five cellulitis, five lymphocoele and two graft infections.

Patency

In the 10 year period, there were 101 (45%) graft closures. The primary patency rates of the aboveknee popliteal insertions were better than those to the below-knee popliteal artery: 71 --- 7% versus 46 _+ 5% at one year and 54 --- 11% versus 23 - 5% at five years respectively (p < 0.01). The secondary patency rates were: 84 -+ 6% versus 56 --- 5% at one year (p < 0.05) and 63 --+ 9% versus 35 --- 7% at five years (p < 0.005), respectively. In reconstructions to the tibial vessels, the primary patency rate was 37 -+ 6% and 22 -+ 7% at one and five years. Following interventions for graft failure, these rates improved to 45 --+ 6% and 30 -+ 9% at one and five years. Postoperatively, the mean rise in the ankle/brachial index was 0.42 (0.37 to 0.79). Cumulative graft patencies illustrated in Figures 1 and 2 and life table analysis data are shown in Tables II-IV.

[~

I00-

*W.L. Gore and Associates, Inc., Wakefield, Massachusetts.

Above Knee Below Knee

Tlblal

80-

60-

TABLE I.--Origins and insertions of the grafts .=.

Origins

Common femoral Superficial femoral Profunda femoral Insertions

Above-knee popliteal Below-knee popliteal Tibioperoneal trunk Tibial vessels

Number

Percent of total

179 31 14

80 14 6

Number

Percent of total

48 113 17 46

21 50 8 21

40.=

==

|

20

8 0

9 ,~

" , Intervel

,

~

"

~

"

~

(months)

Fig. 1. Primary patency rates for above-knee popliteal (48), below-knee popliteal (113), and tibial vessel (63) groups. Values are mean _.+ SEM.

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AbOVe knee Below Knee Tibial

I00-

80-

60-

40-

=, 20-

0

Interval (months)

Fig. 2. Secondary patency rates for above-knee popliteal (48), below-knee popliteal (113), and tibial vessel (63) groups. Values are mean __ SEM.

Limb salvage

The limb salvage rates in the above-knee popliteal group were 81 -+ 6% and 73 -+ 9% at one and five years. Below-knee popliteal insertions had a limb salvage rate of 69 -+ 5% and 57 -+ 9% at one and

five years. In patients with tibial vessel bypasses, the limb salvage rates were 64 -+ 7% and 32 - 10% at one and five years, respectively. Seventy-three out of 224 (33%) limbs operated on were lost. There were 44 (60%) above-knee and 29 (40%) below-knee amputations. Forty-seven limbs (29%) were amputated in the popliteal group: 11 (23%) with aboveknee insertions and 36 (32%) with below-knee insertions. Twenty-six limbs (42%) were lost in the infrapopliteal group. Sixty-nine limbs (31%) were lost due to graft closure. Thirty-two grafts (14%) closed without subsequent limb loss. Four amputations were undertaken with patent grafts present. Limb salvage rates are illustrated in Figure 3 and life table analysis data can be found in Tables II-IV.

Interventions

Of the 101 graft occlusions, no intervention was undertaken in 54 cases. Forty-four closed grafts had a single thrombectomy but three others required multiple thrombectomies (2,3,5 respectively). The 21 of these 47 grafts required revision procedures: non-vein distal bypass (13), vein distal bypass (6), and extensions (2).

TABLE II.--Above-knee popliteal reconstructions

Primary patency Interval (months) 0-1 1-6 7-12 13-24 25-36 37-48 49-60

Number at risk

Number closed

Duration

Interval patency

48 39 30 27 21 14 12

8 3 2 2 2 1 0

1 6 1 4 5 1 4

83.1 91.6 93.2 92.0 89.1 92.5 100.0

Number closed

Duration

Interval patency

48 44 36 33 27 20 18

3 2 2 2 1 1 2

1 6 1 4 6 1 4

Number at risk

Number lost

Duration

Interval salvage

48 45 36 32 26 19 18

2 3 3 2 1 0 0

1 6 1 4 6 1 4

95.7 92.8 91.5 93.5 95.6 100.0 100.0

Secondary patency Interval Number (months) at risk 0-1 1-6 7-12 13-24 25-36 37-48 49-60

Limb salvage Interval (months) 0-1 1-6 7-12 13-24 25-36 37-48 49-60 SE = standard error

93.6 95.1 94.3 93.5 95.8 94.8 87.5

Cumulative patency _+ SE 83.1 76.2 71.0 65.3 58.3 53.9 53.9

+__4.9 +_ 5.9 _+ 7 +- 7.4 + 8.2 +_ 9.8 -+ 10.6

Cumulative patency __- SE 93.6 89.1 84.0 78.6 75.3 71.5 62.5

-+ 3.4 _+ 4.4 _ 5.6 +- 6.3 _+ 7.2 +- 8.5 _+ 9.0

Cumulative salvage _+ SE 95.7 88.9 81.4 76.0 72.6 72.6 72.6

_+ 2.8 -+ 4.4 _+ 5.8 _+ 6.6 _+ 7.4 _+ 8.7 _+ 8.9

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TABLE III.--Below-knee popliteal reconstructions

Primary patency Interval (months) 0-1 1-6 7-12 13-24 25-36 37-48 49-60

Number at risk

Number closed

113 73 48 40 29 24 14

34 18 5 3 0 1 2

Secondary patency Interval Number (months) at risk 0-1 1-6 7-12 13-24 25-36 37-48 49-60

Limb salvage Interval (months) 0-1 1-6 7-12 13-24 25-36 37-48 49-60

Duration 6 7 3 8 5 8 3

Interval patency 69.0 74.1 89.2 91.6 100.0 90.0 60.0

Number closed

Duration

Interval patency

113 77 51 43 31 25 15

27 16 5 3 0 3 2

9 10 3 9 6 9 4

75.1 77.7 89.9 92.2 100.0 95.1 76.9

Number at risk

Number lost

Duration

Interval salvage

113 90 67 54 39 29 17

14 13 4 2 1 1 1

9 10 9 13 9 11 7

87.1 84.7 93.6 95.7 97.1 95.7 92.5

Cumulative patency _+ SE 69.0 51.1 45.6 41.8 41.8 37.6 22.6

-+ 3.6 -+ 4.2 + 4.9 -+ 5.0 -+ 5.9 -+ 6.1 _+ 5.3

Cumulative patency -+ SE 75.1 58.4 52.5 48.4 48.4 46.0 35.4

_+ 3.5 - 4.3 -+ 5.1 -+ 5.3 +- 6.2 + 6.8 _+ 7.4

Cumulative salvage __. SE 87.1 73.7 69.0 66.1 64.9 61.4 56.9

+ 2.9 + 4.0 -+ 4.7 _+ 5.2 + 6.1 + 7.1 _+ 9.1

SE = standard error

Mobility

Preoperatively, 54% of the patients had limited mobility while 43% were regarded as severely restricted (housebound/bedbound). At follow-up, 57% of the patients were considered tO be independent, 26% had limited mobility while 17% were still severely restricted (Table V).

DISCUSSION Femoropopliteal and femorodistal bypasses for lower limb ischemia have become established through widespread experience as worthwhile procedures. Using PTFE for femoropopliteal bypass, cumulative patency rates have been reported as 63-95% at one year and 5%74% at five years [8-10]. Above-knee grafts have a significantly better patency at five years than grafts with a below-knee anastomosis (63% and 44%, respectively). Limb salvage rates range from 73-87% at five years [7-11]. Reports on infrapopliteal PTFE reconstructions have demonstrated a patency rate of 40-55% at one year and 18-37% at five years. The five year limb salvage rates have been shown to be 38-58% [9-11].

In this series, there was a low cumulative patency rate for insertions to the tibial vessels. These results are comparable to other series [8-11] but poor in comparison to series using vein grafts [13-21]. All patients in the tibial vessel group presented with rest pain and 81% had tissue loss. In the past, poor patency and limb salvage results observed in patients who required PTFE tibial bypasses prompted some authors to advocate primary amputation as the more suitable mode of treatment [11]. The ultimate goal of vascular surgery is to maintain a viable and functioning limb and return the patient to a more mobile, independent lifestyle. Few authors have attempted to assess the quality of life, postoperatively. Although patency and limb salvage rates are accurate indicators of surgical success, they do not reflect the benefits or improvements in the patient's life. We have attempted to demonstrate this benefit by assessing the patients mobility pre- and postoperatively on a crude four category scale. Our results suggest that there is a significant increase in patient mobility and, presumably, quality of life in more than 50% of cases. Although mortality at five years in this series is comparable to other reports, a larger proportion of the patients with bypasses to the tibial vessels died

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TABLE IV.--Tibial vessel reconstructions

Primary potency Interval (months)

Number closed

Duration

63 37 24 20 17 13 7

25 9 4 2 1 2 1

i 4 0 1 3 4 0

Number closed

Duration

Interval patency

63 43 28 23 19 15 8

18 9 5 2 0 2 1

2 6 0 2 4 5 0

70.9 77.5 82.1 90.0 100.0 84.0 87.5

Number at risk

Number lost

Duration

Interval salvage

63 47 34 25 18 11 7

11 6 3 2 1 1 2

5 7 6 5 6 3 2

0-1 1-6 7-12 13-24 25-36 37-48 49-60

Secondary potency Interval Number (months) at risk 0-1 1-6 7-12 13-24 25-36 37-48 49-60

Limb salvage Interval (months)

Interval patency

Number at risk

0-1 1-6 7-12 13-24 25-36 37-48 49-60

Cumulative patency +_ SE

60.0 74.2 83.3 89.7 93.5 81.8 60.0

60.0 44.5 37.1 33.3 31.1 25.5 21.8

-+ 4.8 -+ 5.3 -+ 6.0 -+ 6.1 -+ 6.3 -+ 6.1 + 7,3

Cumulative patency --- SE 70.9 55.0 45.1 41.0 41.0 34.5 30.1

-+ 4.8 + 5.6 -+ 6.3 -+ 6.6 +- 7.2 -+ 7.2 -+ 8.9

Cumulative salvage _+ SE

81.8 86.2 90.6 91.8 93.3 89.4 66.6

81.8 70.5 63.7 58.0 54.2 48,4 32.3

-- 4.4 +- 5.6 -+ 6.6 +- 7.5 -+ 8.6 +- 10,4 - 10.0

S E = s t a n d a r d error

within five years. It is important to realize that many of these died with their limbs functionally intact and therefore must be considered as surgical successes. Considering the low perioperative mortality (4.7%) and the high proportion of patients who live out their remaining life with intact functioning limbs, the use o f P T F E to the tibial vessels I00-

Above knee Knee

Below libial

t

806040-

must be a worthwhile and appropriate use of surgical resources.

CONCLUSIONS The use of P T F E on elderly patients with critical ischemia provides an excellent opportunity to preserve a functioning limb and avoid the loss of i n d e p e n d e n c e and other complications associated with amputation. We would r e c o m m e n d that surgeons consider the use of a P T F E graft if no vein is available and if conditions allow. In our opinion, the use of P T F E is worth the effort.

.=

=. 8

'it o

1

TABLE V.--Preoperative and postoperative mobility

of patients ,'2

2'4

3'6

~

Preoperative Number Percent

Intervol (months)

Fig. 3. Limb salvage rates for above-knee popliteal (48), below-knee popliteal (113), and tibial vessel (63) groups. Values are mean _+ SEM.

Bedbound Housebound Limited Independent

29 54 104 6

15 28 54 3

Postoperative Number Percent 14 19 50 110

7 10 26 57

INFRAINGUINAL PTFE GRAFTS

524

REFERENCES l l. 1. MATSUMATO H, HASEGAWA T, FUSE K. A new vascular prosthesis for a small calibre artery. Surgery 1973;74: 578-582. 2. VEITH FJ, GUPTA SK, ASCER E, et al. Six years prospective multicenter randomized comparison of autogenous saphenous vein and expanded PTFE grafts in infrainguinal arterial reconstructions. J Vasc Surg 1986;3:104-114. 3. BURNHAM SJ, FLANIGAN P, GOOGREAU JJ, et al. Non vein bypass in below knee reoperation for lower limb ischemia. Surgery 1978;84:417--422. 4. ASCER E, VEITH FJ, GUPTA SK, et al. Six year experience with expanded PTFE arterial grafts for limb salvage. J Cardiovasc Surg 1985;26:468-472. 5. COLTON T. Statistics in Medicine. Boston: Little Brown & Co. 1974, pp 237-250. 6. RUTHERFORD AE, FLANIGAN MD, GUPTA SK, et al. Suggested standards for reports dealing with lower limb ischemia. J Vasc Surg 1986;4:80-94. 7. McAULEY CE, STEED DL, WEBSTER MW. Seven year follow up of expanded PTFE femoropopliteal bypass grafts. Ann Surg 1984;199:57-63. 8. QUINONES-BALDRICH WJ, MARTIN-PAREGAN J, BAKER JD, et al. PTFE grafts as the first choice arterial substitute in femoropopliteal revascularization. Arch Surg 1984;119:1238-1243. 9. CHARLESWORTH PM, BREWSTER DC, DARLING RC, et al. The fate of PTFE grafts in lower limb bypass surgery: a six year follow up. Br J Surg 1985;72:896-899. 10. McLOUGHLIN R, O'LEARY G, FITZGERALD LP, et al.

mmm

12.

13.

14. 15. 16. 17. 18. 19.

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The effect of distal anastomotic site on PTFE graft patency in lower extremity bypass. Eur J Vasc Surg 1989;3:417-419. HOBSON RW, LYNCH TG, JAMIL Z. Results of revascularization and amputation in severe lower extremity ischemia: a five year clinical experience. J Vasc Surg 1985:2:174185. SHANIK GD, MOORE DJ, FEELEY TM. The value and limitations of in-situ bypass: realistic expectations. In: VEITH FJ, (ed). Current Critical Problems in Vascular Surgery. St. Louis: Quality Medical Publishing Inc. 1989, pp 34-39. CRANLEY J, HAFNER CD. Revascularization of the femoropopliteal arteries using saphenous vein, PTFE and umbilical vein grafts. Five and six year results. Arch Surg 1982;117:1543-1550. BERGAN J J, VEITH FJ, BERNHARD VM, et al. Randomization of autogenous and PTFE grafts in femorodistal reconstructions. Surgery 1972;92:921-930. HALLETT JW Jr, BREWSTER CD, DARLING RC. The limitations of PTFE in reconstruction of femoropopliteal and tibial arteries. Surg Gynecol Obstet 1981;152:819-821. TAYLOR LM, PHINNEY ES, PORTER JM. Present status of reversed vein bypass for lower extremity revascularization. J Vasc Surg 1986;3:288-297. CUTLER BS, THOMPSON JE, KLEINSASSER LJ, et al. Autologous saphenous vein femoropopliteal bypass: analysis of 298 cases. Surgery 1976;79:325-331. DE WEESE JA, ROB CG. Autogenous venous grafts ten years later. Surgery 1977;82:775-784. LEATHER RP, KARMODY AM, In-situ saphenous vein arterial bypass. In: RUTHERFORD RB (ed). Vascular Surgery. Philadelphia: WB Saunders 1984: pp 620-630.

Infrainguinal polytetrafluoroethylene grafts: saved limbs or wasted effort? A report on ten years' experience.

Two-hundred and twenty-four infrainguinal polytetrafluoroethylene reconstructions were performed for critical ischemia over a 10 year period: 48 to th...
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