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Preferential Use of Nonreversed Vein Grafts in Above-Knee Femoropopliteal Bypasses for Critical Ischemia: Midterm Outcome
Preferential Use of Nonreversed Vein Grafts in Above-Knee Femoropopliteal Bypasses for Critical Ischemia: Midterm Outcome Nelson De Luccia,1 Francisco C. Brochado-Neto,2 Marcello Romiti,2 Marise Kikuchi,2 Jose Maciel Caldas dos Reis,2 Anai Espinelli S. Durazzo,1 and Maximiano Tadeu Villa Albers,2 S~ ao Paulo, Brazil
We evaluated nonreversed vein grafts in above-knee bypasses for chronic critical limb ischemia in a retrospective study with intention-to-treat analysis in patients who underwent above-knee bypass grafting. During a 4-year period, 51 patients (men, 32; women, 19; mean age ¼ 66 years) with 53 critically ischemic lower extremities underwent above-knee femoropopliteal bypass grafting. The follow-up evaluation consisted of clinical examination, assessment of the ankle-brachial systolic blood pressure index, and, whenever necessary, duplex scanning. Three (5.7%) deaths occurred within 30 days, two from myocardial infarction and one from an undetermined cause. The 2-year cumulative success rate was 82.5 ± 9.6% for primary patency, 84.6 ± 8.9% for secondary patency, 90.1 ± 7.3% for tertiary patency, 86.9 ± 7.6% for limb salvage, 77.7 ± 8.4% for survival, 68.0 ± 11.1% for composite patency, and 68.4 ± 9.3% for amputation-free survival; the corresponding estimates for vein grafts alone were 86.6 ± 9.2%, 88.9 ± 8.6%, 89.0 ± 8.5%, 88.1 ± 8.1%, 81.1 ± 9.1, 76.8 ± 11.1%, and 72.6 ± 10.2%. Three prosthetic grafts failed and were replaced with an arm vein graft. Nonreversed vein bypass grafts in above-knee revascularization of critically ischemic limbs are justified.
INTRODUCTION The greater saphenous vein (GSV) is the best conduit for femoropopliteal arterial bypasses above or below the knee,1,2 but the use of prosthetic grafts above the knee is naturally attractive because of the shortened operating time, the small number of incisions required, and the hope of equivalent durability for some time.3 As a consequence, Rosen et al.4 proposed a staged approach to infrainguinal revascularization that uses an initial prosthetic graft above the knee, thereby sparing the GSV for a hypothetical future bypass below the knee, a position where prosthetic grafts perform poorly.1 In contrast,
1
University of S~ ao Paulo, S~ ao Paulo, Brazil.
2
Lusiada Foundation, UNILUS, Santos, S~ ao Paulo, Brazil. Correspondence to: Nelson De Luccia, Avenida S~ ao Gualter, 346, 05455-000, S~ ao Paulo, SP, Brazil, E-mail: [email protected] Ann Vasc Surg 2008; 22: 668-675 DOI: 10.1016/j.avsg.2008.05.002 Ó Annals of Vascular Surgery Inc. Published online: June 24, 2008
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proponents of a policy of autogenous tissue grafting have preferred the GSV even in above-knee bypasses but, when reporting their experience, have neglected the occasional use of prosthetic grafts and have not studied patients with critical ischemia separately.5-7 Given the current interest in percutaneous transluminal angioplasty (PTA) of femoropopliteal lesions,8-10 it became necessary to reassess the potentials of different techniques of open bypass surgery. In comparison with reversed vein bypass, the in situ and nonreversed vein bypasses exhibit a better size match at the anastomotic sites,7,11,12 an increased luminal area after valve lysis,13 and reverse flow during diastole.14 However, the in situ vein bypass is not particularly tailored for aboveknee revascularization because vein mobilization leaves little of the GSV in its original position15 and it is more technically demanding and less versatile than the nonreversed GSV bypass.11 With the latter, the proximal anastomosis becomes easier and safer, a patch from the common femoral vein is not necessary, valve incision is better controlled,
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the graft can be translocated to a deeper plane or another region, and residual arteriovenous fistulae are avoided. Because of a much better size match at the anastomotic sites, the nonreversed orientation may be particularly useful in arm vein bypass grafting.16-18 Because of our long-lasting interest in nonreversed vein grafting16,19,20 and the encouraging experience of others,11,12,21 our current strategy for infrainguinal bypass relies on nonreversed vein grafts, avoids prosthetic grafts as far as possible, and restricts surgery to patients with critical ischemia. In this study, we assessed the midterm outcomes of above-knee bypasses as an important component of this strategy. We evaluated nonreversed saphenous vein as the main strategy of treatment for above-knee bypasses, including on an intention-to-treat basis, prosthetic grafts being done in the same position.
MATERIALS AND METHODS Design This retrospective study was an intention-to-treat analysis of a cohort of consecutive patients who underwent above-knee bypass grafting. Prospectively acquired data were entered into an electronic database, but medical records were also reviewed retrospectively in order to retrieve missing baseline data.
Above-knee nonreversed vein graft
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leg, (2) a strong femoral pulse in the groin but a weak or absent popliteal pulse, and (3) an above-knee femoropopliteal bypass done between January 1, 2002, and December 31, 2005. Surgical Technique A surgical team composed of a staff vascular surgeon and two residents in vascular surgery performed the bypass procedures. After the sites of the proximal and distal anastomoses had been exposed and the GSV or another vein had been harvested through short, separate skin incisions, heparin (5,000 IU) was administered intravenously. The femoral anastomosis was done first, and once this was completed, the arterial clamps were released to allow the venous conduit to distend with normothermic blood under arterial blood pressure. A Mills-Leather valvulotome was then introduced into the vein through its transected distal end or a side branch to allow retrograde valve incision as described for in situ vein grafting.25 The pulsatile, valveless vein was then translocated to a tunnel near the native arteries. After preparing the popliteal artery, a distal end-to-side anastomosis was created with the help of surgical loupes (3.5-fold optical magnification). Intraoperative angioscopy, which is often used to assist valve incision,12,17,18 was unavailable. Completion arteriograms were not routinely obtained. Follow-Up
The main outcomes were primary and secondary graft patency, limb salvage, and patient survival defined according to the Ad Hoc Committee of the Society for Vascular Surgery and the North American Chapter of the International Society for Cardiovascular Surgery.22 Tertiary patency, composite patency, amputation-free survival, and the need of prosthetic grafts were also investigated. Tertiary patency reflects the contribution of repeated bypass surgery with a new graft and, like the rate of use of prosthetic grafts, measures the success of the policy adopted. Composite patency, as a more rigorous measure, combines the absence of graft occlusion, death within 30 days, removal of an infected open graft, extension of the graft to a below-knee position, and major amputation.23 Amputation-free survival has been used to compare the different strategies of revascularization.24
The patients were prescribed aspirin (150 mg/day) and simvastatin (20 mg/day), unless their use was contraindicated, and advised to return for followup visits at 1, 3, and 6 months and at 6-month intervals thereafter. The ankle-brachial systolic blood pressure index (ABPI) was calculated during each visit, whereas duplex scanning was used selectively. Delay in lesion healing, recurrence of pain, or drop of ABPI in the presence of palpable pulses was indicative for duplex surveillance. The criteria adopted for duplex examination were those proposed in the Trans-Atlantic Inter-Society Consensus (TASC) document; i.e., a peak systolic velocity outside the range 45-150 cm/sec was indicative of stenosis.26 Postoperative arteriograms were obtained only when graft revision was envisaged. Telephone calls and home visits were used to reduce the loss to follow-up, which was defined as no information on graft or limb status for more than 1 year and was last assessed on December 31, 2006.
Criteria for Inclusion
Statistical Methods
The following entry criteria were used: (1) the presence of tissue loss or rest pain in the index foot or
Estimates of long-term success were calculated using the Kaplan-Meier product-limit method, and
Outcome Measures
670 De Luccia et al.
standard errors were calculated with the method of Peto et al.27 Sensitivity analysis considered that one or two of the four vein grafts lost to follow-up failed in the second month after operation.
RESULTS Patients and Grafts During the interval covered by this study, infrainguinal bypass surgery was done in 234 patients with chronic critical ischemia, of whom 51 underwent above-knee femoropopliteal bypass procedures in 53 limbs. Three successful iliac balloon PTAs and two femoropopliteal stent grafts that eventually failed had been done in the index leg 5209 days before five bypasses (vein, 2; prosthetic, 3). The prevalence rates for male patients, diabetes mellitus, hypertension, and smoking were higher than 60% (Table I). The affected limbs showed rest pain (n ¼ 3), nonhealing ulcers (n ¼ 17), gangrene (n ¼ 31), or unspecified tissue loss (n ¼ 2). In three limbs with rest pain alone, there was diffuse pain in the foot, whereas in 50 remaining limbs the ischemic lesion was located in the toes (n ¼ 24), forefoot or midfoot (n ¼ 6), heel (n ¼ 3), leg (n ¼ 13), multiple sites (n ¼ 2), and unspecified site (n ¼ 2). The median ABPI calculated for 44 limbs was 0.4. The bypass procedure was done 1-374 days (median ¼ 7) after digital subtraction angiography. Nine grafts (vein, 8; prosthetic, 1) were used to bypass stenotic lesions, 37 grafts (vein, 30; prosthetic, 7) were used to bypass occlusive lesions, and seven vein grafts were used to bypass undetermined lesions in the superficial femoral artery. The anesthetic management in 45 procedures included spinal anesthesia (n ¼ 43), epidural anesthesia (n ¼ 1), and general anesthesia (n ¼ 1) but was not recorded for the remaining eight procedures. There was a predominance of unisegment GSV grafts, of veins with a minimal caliber of 4 mm, of bypasses originating at the common femoral artery, and of runoff scores of 1 (Table II). All of the vein grafts were fashioned nonreversedly. Graft Patency Of the 53 grafts at risk, 45 were censored because of study duration (vein, 31; prosthetic, 1), death (vein, 5; prosthetic, 3), and loss to follow-up (vein, 4; prosthetic, 1), whereas eight eventually failed (vein, 5; prosthetic, 3). Of the five vein grafts that failed, two led to major amputation within a week of failure, one was successfully revised with thrombectomy plus a vein patch in the first postoperative
Annals of Vascular Surgery
Table I. Demographic profile and clinical variables of 51 patients
Mean age, years (range) Male sex Diabetes mellitus Hypertension Smoking Heart disease Tissue loss Median ABPI (range)
n (%)
Missing data
66 (42-91) 31(61) 33 (67) 31 (69) 36 (76) 9 (19) 50 (94) 0.4 (0-1)
0 0 2 6 4 3 2 9
Values are number (percentage) except for age and ABPI.
Table II. Main features and patency outcomes of 53 bypasses n
ABPI >0.4 0.4 Unrecorded Graft type Vein alone Prosthetics Vein caliber 4 mm <4 mm Prosthetics Unrecorded Runoff score22 1 2-9 10 Unrecorded Origin CFA SFA/PFA Unspecified
Primary Secondary Tertiary Composite failure failure failure failure
20 3 24 5 9 0
3 4 0
0 4 0
4 10 0
45 5 8 3
4 3
4 0
8 6
26 9 8 10
4 1 3 0
3 1 3 0
3 1 0 0
6 1 6 0
19 17 10 7
2 4 2 0
2 4 1 0
1 2 1 0
5 5 4 0
29 4 18 4 6 0
3 4 0
2 2 0
6 8 0
CFA, common femoral artery; SFA/PFA, superficial femoral or popliteal artery.
day, one was not revised until death 15 months later, and the remaining graft was not revised during the available follow-up of 25 months. All three failed prosthetic grafts were successfully replaced with a below-knee femoropopliteal arm vein bypass. Composite graft failure occurred in 14 of the 53 grafts as a result of seven graft occlusions (vein, 4; prosthetic, 3), one vein graft rupture, three amputations (vein, 2; prosthetic, 1), and three early deaths (vein, 1; prosthetic, 2). The 2-year cumulative success rates for all bypasses and for vein bypasses alone were 82.5%
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Limb Salvage One limb was already amputated below the knee. Of the 52 limbs still at risk, five (vein, 4; prosthetic, 1) underwent major amputation and 47 were censored because of duration (n ¼ 36), death (n ¼ 7), and loss to follow-up (n ¼ 4). The graft was still patent in three (vein, 2; prosthetic, 1) newly amputated limbs and already occluded in the other two (vein, 2). The cumulative rate of loss to follow-up per limb was 7.5% at 30 days and 3 years. The 2-year cumulative limb salvage rate was 86.9% overall and 88.1% for limbs treated with vein grafts alone (Table III). Of the 47 lower extremities without a major amputation, 21 underwent minor amputation, 21 remained intact, and five were censored because of loss to follow-up or death. Patient Survival Three patients with viable limbs and patent grafts (vein, 1; prosthetic, 2) died within 30 days (myocardial infarction, 2; undetermined cause, 1). There were also nine late deaths, of which two occurred soon after major amputation and seven were unrelated to this event. The 2-year cumulative rates of survival and amputation-free survival were 77.7% and 68.4% overall and 81.1% and 72.6% for patients treated with vein grafts alone, respectively (Table III, Fig. 3). Other Outcomes The cumulative rate of use of a prosthetic graft was 15% at 30 days and beyond. In 50 limbs with tissue loss, the ischemic lesion and the site of toe amputation healed completely (n ¼ 24) or partially (n ¼ 10),
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Cumulative patency
100% 90%
90.1%
80%
77.5% 75.7%
70% 61.8%
60% 50%
0
6
12
18
24
30
36
1yr 37 38 40 31
2yr 37 38 40 30
42
Months N Primary patency Secondary patency Tertiary patency Composite patency
1mo 41 42 42 37
6mo 37 38 40 31
3yr 33 34 40 27
Fig. 1. Primary patency (black line), secondary patency (blue line), tertiary patency ( gray line), and composite patency (red line) for 53 above-knee femoropopliteal bypass grafts. Dotted lines, standard error >10%. 100%
Cumulative patency
and 86.6% for primary patency, 84.6% and 88.9% for secondary patency, 90.1% and 89.0% for tertiary patency, and 68.0% and 76.8% for composite patency, respectively (Table II, Figs. 1 and 2). Primary failure of a vein graft occurred in one small-caliber bypass for 3,866 graft days and four good-caliber bypasses for 10,420 graft days (relative risk ¼ 0.67), whereas there were two primary failures for 7,799 graft days for runoff grade 1 vs. six primary failures for 9,185 graft days for runoff grades 2-10 (relative risk ¼ 1.11). The ABPI decreased by more than 0.1 in one leg, and duplex scanning indicated moderate graft stenosis in two vein grafts; none of the three grafts involved was revised. Sensitivity analysis revealed an absolute decrease of 1.5% and 3.0% in the 3-year cumulative secondary patency rate when one or two lost grafts, respectively, were considered as secondarily failed.
Above-knee nonreversed vein graft
88.9%
90%
86.6% 80%
77.5%
70% 60% 50%
0
6
12
18
24
30
36
42
Months N Primary patency Secondary patency Composite patency
1mo 37 38 34
6mo 34 35 32
1yr 34 35 32
2yr 34 35 30
3yr 34 35 30
Fig. 2. Primary patency (black line), secondary and tertiary patency (blue line), and composite patency (red line) for 45 above-knee femoropopliteal vein bypass grafts. Dotted lines, standard error >10%.
failed to heal (n ¼ 2), led to major amputation (n ¼ 5), was censored because of death (n ¼ 5) or loss to follow-up (n ¼ 3), or had an undetermined course (n ¼ 1). Of the 51 patients, 31 retained their ability to walk (salvaged, 29; amputated, 2), nine could no longer walk (salvaged, 7; amputated, 2), nine were censored because of death or loss to follow-up (salvaged, 7; amputated, 2), and two did not have their ability to walk assessed (salvaged, 2).
DISCUSSION Most of the logical foundations of staged infrainguinal revascularization have been rejected. Indeed,
672 De Luccia et al.
Annals of Vascular Surgery
Table III. Short-term and midterm outcomes Graft
1 month
Primary patency All 93.6 Vein alone 92.7 Secondary patency All 95.5 Vein alone 94.9 Tertiary patency All 95.5 Vein alone 94.9 Limb salvage All 95.2 Vein alone 94.7 Survival All 93.8 Vein alone 97.5 Composite patency All 84.6 Vein alone 87.2 Amputation-free survival All 85.2 Vein alone 89.9
6 months
1 year
2 years
3 years
± 3.9 ± 4.4
82.5 ± 6.5 86.6 ± 6.1
82.5 ± 7.2 86.6 ± 6.8
82.5 ± 9.6 86.6 ± 9.2
75.7 ± 21.5 86.6 ± 15.9
± 3.3 ± 3.7
84.6 ± 6.2 88.9 ± 5.6
84.6 ± 6.8 88.9 ± 6.2
84.6 ± 8.9 88.9 ± 8.6
77.5 ± 18.4 88.9 ± 14.8
± 3.3 ± 3.7
90.1 ± 5.0 89.0 ± 5.5
90.1 ± 5.5 89.0 ± 6.2
90.1 ± 7.3 89.0 ± 8.5
90.1 ± 10.7 89.0 ± 14.8
± 3.2 ± 3.6
90.2 ± 4.8 92.0 ± 4.6
90.2 ± 5.2 92.0 ± 5.1
86.9 ± 7.6 88.1 ± 8.1
86.9 ± 12.8 88.1 ± 13.6
± 3.5 ± 2.5
80.6 ± 5.9 84.6 ± 5.9
80.6 ± 6.3 84.6 ± 6.3
77.7 ± 8.4 81.1 ± 9.1
72.2 ± 13.5 81.1 ± 15.8
± 5.6 ± 5.7
71.6 ± 7.5 81.1 ± 7.1
71.6 ± 8.1 81.1 ± 7.7
68.0 ± 11.1 76.8 ± 11.1
61.8 ± 22.1 76.8 ± 21.3
± 5.2 ± 4.8
74.0 ± 6.6 79.3 ± 6.6
74.0 ± 7.0 79.3 ± 7.1
68.4 ± 9.3 72.6 ± 10.2
68.4 ± 14.5 72.6 ± 17.0
Values are cumulative rates and their standard errors.
Cumulative rate
100% 90% 80% 72.6%
70%
68.4%
60% 50%
0
6
12
18
24
30
36
42
Months N All Vein alone
1mo 38 36
6mo 38 32
1yr 38 32
2yr 30 29
3yr 30 29
Fig. 3. Amputation-free survival for all patients (black line) and for patients with vein grafts only ( gray line). Dotted line, standard error >10%.
only a few patients require a secondary bypass with a spared GSV,2 the best alternative to an unavailable GSV for below-knee bypass is a vein from another source and not a prosthetic graft,28,29 and the interval of equivalence between GSV grafts and prosthetic grafts above the knee may be extremely short for patients with critical ischemia.2 On the contrary, the strict policy of using all autogenous tissue grafts remains valid for all levels of infrainguinal revascularization.7,11,30 The analysis of such policy, however, has neglected the occasional use
prosthetic grafts above the knee and has not considered patients with critical ischemia separately.5,7 The present study thus seems to be unique in that all of the patients had critical ischemia, 94% had tissue loss, only above-knee bypasses were considered, nonreversed vein grafting was widely preferred, and prosthetic grafts were included in an intention-totreat analysis. This was a realistic analysis because not every patient will have a vein usable for bypass and because convenience rather than necessity may dictate the surgeon’s primary choice of a prosthesis.31 Indeed, this occurred at least for three patients with a failed prosthetic graft who subsequently received an arm vein bypass. In any case, the 84.9% rate of usage of a nonreversed vein surpassed the rates of 73% and 79% reported in two studies that used reversed GSV in preference to a prosthetic conduit.32,33 Additionally, a nonreversed arm vein used in one primary and three secondary bypasses contributed to tertiary patency and limb salvage. Arm vein grafts may elongate and dilate after 4 years, but this is of questionable importance in the setting of critical limb ischemia.34 Worth noting, the nonreversed orientation is particularly useful because an arm vein may exhibit a wide variation in caliber.16-18 With the nonreversed vein bypass, the technical advantage of a better size match at the anastomotic sites typical of the in situ vein bypass is maintained. Despite opinion to the contrary,15 tapering of the
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GSV in the thigh may not be uncommon, as indicated by the use of small-caliber veins in at least 20% of the vein grafts. The practical importance of other features of nonreversed vein grafts was also noted as all bypasses originated directly from the donor artery, valve incision was done easily, and the grafts were systematically tunneled near the native artery. In addition to using vein grafts in a large proportion of bypasses, optimal patency outcomes were obtained. The graft patency of above-knee bypasses for critical ischemia has been better with GSVs than with prosthetic grafts. A large multicenter randomized trial reported a 2-year cumulative primary assisted patency rate of 81% for GSV grafts vs. 69% for prosthetic grafts,35 whereas in a meta-analysis by Pereira et al.2 the 2-year pooled estimate was 81% vs. 61.9% for primary patency and 84% vs. 70% for secondary patency, respectively. In the current study of consecutive patients, the 2-year cumulative primary and secondary graft patency rates of 86.6% and 88.9% (vein grafts alone) and 82.5% and 84.6% (all grafts), respectively, were thus rewarding. Not surprisingly, the policy of revascularization adopted implied using several less than optimal veins. There were fewer primary failures with such veins than with prosthetic grafts, but the successful replacement of three occluded prosthetic grafts with arm vein grafts provided nearly equal tertiary failures and, more importantly, indicated the futility of sparing the GSV. Bypasses to a popliteal artery with a runoff score of 10 performed poorly, but as for vein caliber, missing information and the small study size precluded a reliable analysis of the association between runoff and patency or limb salvage. Of more concern than inferior graft patency, a higher frequency of acute ischemia and the deterioration of clinical symptoms have been seen after failure of prosthetic bypass grafts.36 These problems may be even more serious for patients primarily operated for critical ischemia, as in the present study in which all three patients with a failed prosthetic graft but only one of the four patients with a failed vein graft required an additional bypass. Although there is no consensus on the fate of failed grafts,37 the incidence and importance of periprosthetic infection must not be neglected.38 Finally, the allegation that an easier, more expeditious procedure can be accomplished with a prosthetic graft is untenable in view of the obligation to respect patient autonomy, particularly by disclosing the best available information; to promote health benefits; and to avoid harm.39 On the other hand, these ethical principles demand the use of a prosthetic graft for reasons such as an exhausted venous pool, a poor health
Above-knee nonreversed vein graft
673
condition, or the occurrence of unexpected events during surgery. Such a negative selection of cases explains why six of the eight patients with a prosthetic graft did not maintain composite patency. Finally, PTA poses an additional challenge to prosthetic grafts.40 There has been a recent trend toward using PTA rather than surgical bypass in femoropopliteal revascularization whenever possible.8,9 In the study of Haider et al.9 on patients with critical ischemia, the 2-year cumulative rates of success were slightly better with PTA than with bypass for primary patency, 75% vs. 69%, respectively, and for limb salvage, 90% vs. 87%, respectively. Although the patency rates for above-knee bypasses in our study were clearly superior to those reported by Haider et al., which suggests a great amount of bias against bypass in the latter study, a remarkable equivalence was noted for limb salvage. Such equivalence likely reflected not only the effectiveness of the primary treatment but also the joint effects of subsequent bypasses. Possibly, PTAs are less effective than vein grafts in any condition and as effective as prosthetic grafts for treating stenotic lesions.40,41 Since only one graft was inserted for such lesions, this topic remained beyond the scope of our study. However, there is hope of further improvement in the treatment of occlusive lesions with subintimal dissection.10 This study has some limitations that could not be handled adequately. Indeed, the small study size combined with low event rates precluded a precise estimation of success beyond 2 years, the measurements of vein caliber and runoff were often neglected, and intraoperative angioscopy was not used to assist valve incision. Despite such problems, several features support this study’s validity. First, since all of the patients had chronic critical limb ischemia, in most cases with tissue loss, and since a standardized vein bypass procedure was done, external validity was warranted. Second, an intentionto-treat analysis of consecutive patients reduced sample selection bias and yielded more realistic results. Third, the rate of incomplete follow-up was acceptable, and both the healing of ischemic lesions and ambulatory status were assessed. Fourth, the use of composite patency and amputation-free survival as more comprehensive measures may be more meaningful for the patient, the surgeon, and the decision analyst. Finally, sensitivity analysis showed that the estimation of graft patency was robust. In conclusion, the preference for nonreversed vein bypass grafts in above-knee revascularization of critically ischemic limbs is justified because the
674 De Luccia et al.
use of autogenous vein grafts is maximized with no additional harm. REFERENCES 1. Veith FJ, Gupta SK, Ascer E, et al. Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstruction. J Vasc Surg 1986;3:104-114. 2. Pereira CE, Albers M, Romiti M, Brochado-Neto FC, Pereira CAB. Meta-analysis of femoropopliteal bypass grafts for lower extremity arterial insufficiency. J Vasc Surg 2006;44:510-517. 3. Quin˜ones-Baldrich WJ, Busuttil RW, Baker JD, et al. Is the preferential use of polytetrafluoroethylene grafts for femoropopliteal bypass justified? J Vasc Surg 1988;8:219-228. 4. Rosen RC, Johnson WC, Bush HL, Jr, Cho SI, O’Hara ET, Nabseth DC. Staged infrainguinal revascularization: initial prosthetic above-knee bypass followed by a distal vein bypass for recurrent ischemia. A valid concept for extending limb salvage? Am J Surg 1986;152:224-230. 5. Donaldson MC, Whittemore AD, Mannick JA. Further experience with an all-autogenous tissue policy for infrainguinal reconstruction. J Vasc Surg 1993;18:41-48. 6. Taylor LM, Jr, Phinney ES, Porter JM. Present status of reversed vein bypass for lower extremity revascularization. J Vasc Surg 1986;3:288-297. 7. Eugster T, Stierli P, Guerke L, Obeid T, Hess P. Present status of infrainguinal arterial bypass procedures following an all autogenous policy: long-term results of a single center. Swiss Surg 2002;8:171-175. 8. Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg 2005;41: 423-435. 9. Haider SN, Kavanagh EG, Forlee M, et al. Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg 2006;43:504-512. 10. Bolia A. Subintimal angioplasty in lower limb ischaemia. J Cardiovasc Surg (Torino) 2005;46:385-394. 11. Belkin M, Knox J, Donaldson MC, Mannick JA, Whittemore AD. Infrainguinal arterial reconstruction with nonreversed greater saphenous vein. J Vasc Surg 1996;24: 957-962. 12. Stierli P, Eugster T, Hess P, Gu¨uke L, Verschluss der A. Femoralis superficialis. Der autologe Venenbypass zur supragenualen A. Poplitea Gefa¨sschirurgie 2001;6(Suppl. 1):S43-S46. 13. Chin AK, Mayer DN, Goldman RK, Lerman JA, Olcott C, IV, Fogarty TJ. The effect of valvulotomy on the flow rate through the saphenous vein graft: clinical implications. J Vasc Surg 1988;8:316-320. 14. Andros G. Bypass to the plantar arteries. In: Bergan JJ, Yao JST eds. Techniques in Arterial Surgery. Philadelphia: W.B. Saunders, 1990. pp. 157-168. 15. Harris RW, Andros G, Dulawa LB, Oblath RW, Apyan R, Salles-Cunha S. The transition to "in situ" vein bypass grafts. Surg Gynecol Obstet 1986;163:21-28. 16. Brochado-Neto FC, Albers M, Pereira CA, Gonzalez J, Cinelli M, Jr. Prospective comparison of arm veins and greater saphenous veins as infrageniculate bypass grafts. Eur J Vasc Endovasc Surg 2001;22:146-151. 17. Harward TR, Govostis DM, Rosenthal GJ, Carlton LM, Flynn TC, Seeger JM. Impact of angioscopy on infrainguinal graft patency. Am J Surg 1994;168:107-110.
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18. Ho¨lzenbein TJ, Pomposelli FB, Jr, Miller A, et al. The upper arm basilic cephalic loop for distal bypass grafting: technical considerations and follow-up. J Vasc Surg 1995;21: 586-594. 19. Albers M, De Luccia N, Aun R, Presti C. Long-term comparison of in situ and nonreversed saphenous vein grafts for infrapopliteal reconstruction. Vasc Surg 1995;29:379-386. 20. Albers MTV, De Luccia N, Manasterski J, Bouabci AS, Langer B, Puech Le~ao LE. Femorotibial bypass with nonreversed saphenous vein. Report of 5 cases. Rev Paul Med 1985;103:290-292. 21. Bo¨hmig HJ, Zeidler G, Schwierz T, Loy E. 20 years orthograde venous bypass for infrainguinal arterial reconstruction. Chirurg 1995;66:120-126. 22. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 1997;26:517-538. 23. Berglund J, Bjo¨rck M, Elfstro¨m J. on behalf of the SWEDVASC Femoro-popliteal Study Group. Long-term results of above knee femoro-popliteal bypass depend on indication for surgery and graft-material. Eur J Vasc Endovasc Surg 2005;29: 412-418. 24. Adam DJ, Beard JD, Cleveland T, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925-1934. 25. Leather RP, Powers SR, Karmody AM. A reappraisal of the in situ saphenous vein arterial bypass: its use in limb salvage. Surgery 1979;86:453-461. 26. Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Concensus (TASC). J Vasc Surg 2000;31(1 Pt 2): S1-S296. 27. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples. Br J Cancer 1977;35:1-39. 28. Albers M, Romiti M, Brochado-Neto FC, Pereira CAB. Metaanalysis of alternate autologous vein bypass grafts to infrapopliteal arteries. J Vasc Surg 2005;42:449-455. 29. Faries PL, Logerfo FW, Arora S, et al. A comparative study of alternative conduits for lower extremity revascularization: all-autogenous conduit versus prosthetic grafts. J Vasc Surg 2000;32:1080-1090. 30. Maini BS, Orr RK, O’Mara P, Hendershott T. Outcomes and resource utilization in a managed care setting for lower extremity vein bypass grafts. Am J Surg 1996;172:113-116. 31. Calligaro KD. In discussion of Faries PL, Arora S, Pomposelli FB Jr, Pulling MC, Smakowski P, Rohan DI, et al. The use of arm vein in lower-extremity revascularization: results of 520 procedures performed in eight years. J Vasc Surg 2000; 31(Pt 1):50-59. 32. Wilson YG, Wyatt MG, Currie IC, Baird RN, Lamont PM. Preferential use of vein for above-knee femoropopliteal grafts. Eur J Vasc Endovasc Surg 1995;10:220-225. 33. Archie JP, Jr. Femoropopliteal bypass with either adequate ipsilateral reversed saphenous vein or obligatory polytetrafluoroethylene. Ann Vasc Surg 1994;8:475-484. 34. Schulman ML, Badhey MR. Late results and angiographic evaluation of arm veins as long bypass grafts. Surgery 1982;92:1032-1041. 35. Johnson WC, Lee KK. A comparative evaluation of polytetrafluoroethylene, umbilical vein, and saphenous vein bypass grafts for femoral-popliteal above-knee revascularization: a prospective randomized Department of Veterans Affairs cooperative study. J Vasc Surg. 20;32:268-277.
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36. Jackson MR, Belott TP, Dickason T, et al. The consequences of a failed femoropopliteal bypass grafting: comparison of saphenous vein and PTFE grafts. J Vasc Surg 2000;32: 498-504. 37. Smeets L, Ho GH, Tangelder MJ, et al. Dutch BOA Study Group. Outcome after occlusion of infrainguinal bypasses in the Dutch BOA Study: comparison of amputation rate in venous and prosthetic grafts. Eur J Vasc Endovasc Surg 2005;30:604-609. 38. Pedersen G, Laxdal E, Hagala M, Aune S. Local infections after above-knee prosthetic femoropopliteal bypass for
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intermittent claudication. Surg Infect (Larchmt) 2004;5: 174-179. 39. Gillon R. Medical ethics: four principles plus attention to scope. BMJ 1994;309:184-188. 40. Surowiec SM, Davies MG, Eberly SW, et al. Percutaneous angioplasty and stenting of the superficial femoral artery. J Vasc Surg 2005;41:269-278. 41. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, de Vries J, Harrington DP. Revascularization for femoropopliteal disease. A decision and cost-effectiveness analysis. JAMA 1995;274:165-171.
We evaluated nonreversed vein grafts in above-knee bypasses for chronic critical limb ischemia in a retrospective study with intention-to-treat analysis in patients who underwent above-knee bypass grafting. During a 4-year period, 51 patients (men, 32; women, 19; mean age ¼ 66 years) with 53 critically ischemic lower extremities underwent above-knee femoropopliteal bypass grafting. The follow-up evaluation consisted of clinical examination, assessment of the ankle-brachial systolic blood pressure index, and, whenever necessary, duplex scanning. Three (5.7%) deaths occurred within 30 days, two from myocardial infarction and one from an undetermined cause. The 2-year cumulative success rate was 82.5 ± 9.6% for primary patency, 84.6 ± 8.9% for secondary patency, 90.1 ± 7.3% for tertiary patency, 86.9 ± 7.6% for limb salvage, 77.7 ± 8.4% for survival, 68.0 ± 11.1% for composite patency, and 68.4 ± 9.3% for amputation-free survival; the corresponding estimates for vein grafts alone were 86.6 ± 9.2%, 88.9 ± 8.6%, 89.0 ± 8.5%, 88.1 ± 8.1%, 81.1 ± 9.1, 76.8 ± 11.1%, and 72.6 ± 10.2%. Three prosthetic grafts failed and were replaced with an arm vein graft. Nonreversed vein bypass grafts in above-knee revascularization of critically ischemic limbs are justified.
INTRODUCTION The greater saphenous vein (GSV) is the best conduit for femoropopliteal arterial bypasses above or below the knee,1,2 but the use of prosthetic grafts above the knee is naturally attractive because of the shortened operating time, the small number of incisions required, and the hope of equivalent durability for some time.3 As a consequence, Rosen et al.4 proposed a staged approach to infrainguinal revascularization that uses an initial prosthetic graft above the knee, thereby sparing the GSV for a hypothetical future bypass below the knee, a position where prosthetic grafts perform poorly.1 In contrast,
1
University of S~ ao Paulo, S~ ao Paulo, Brazil.
2
Lusiada Foundation, UNILUS, Santos, S~ ao Paulo, Brazil. Correspondence to: Nelson De Luccia, Avenida S~ ao Gualter, 346, 05455-000, S~ ao Paulo, SP, Brazil, E-mail: [email protected] Ann Vasc Surg 2008; 22: 668-675 DOI: 10.1016/j.avsg.2008.05.002 Ó Annals of Vascular Surgery Inc. Published online: June 24, 2008
668
proponents of a policy of autogenous tissue grafting have preferred the GSV even in above-knee bypasses but, when reporting their experience, have neglected the occasional use of prosthetic grafts and have not studied patients with critical ischemia separately.5-7 Given the current interest in percutaneous transluminal angioplasty (PTA) of femoropopliteal lesions,8-10 it became necessary to reassess the potentials of different techniques of open bypass surgery. In comparison with reversed vein bypass, the in situ and nonreversed vein bypasses exhibit a better size match at the anastomotic sites,7,11,12 an increased luminal area after valve lysis,13 and reverse flow during diastole.14 However, the in situ vein bypass is not particularly tailored for aboveknee revascularization because vein mobilization leaves little of the GSV in its original position15 and it is more technically demanding and less versatile than the nonreversed GSV bypass.11 With the latter, the proximal anastomosis becomes easier and safer, a patch from the common femoral vein is not necessary, valve incision is better controlled,
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the graft can be translocated to a deeper plane or another region, and residual arteriovenous fistulae are avoided. Because of a much better size match at the anastomotic sites, the nonreversed orientation may be particularly useful in arm vein bypass grafting.16-18 Because of our long-lasting interest in nonreversed vein grafting16,19,20 and the encouraging experience of others,11,12,21 our current strategy for infrainguinal bypass relies on nonreversed vein grafts, avoids prosthetic grafts as far as possible, and restricts surgery to patients with critical ischemia. In this study, we assessed the midterm outcomes of above-knee bypasses as an important component of this strategy. We evaluated nonreversed saphenous vein as the main strategy of treatment for above-knee bypasses, including on an intention-to-treat basis, prosthetic grafts being done in the same position.
MATERIALS AND METHODS Design This retrospective study was an intention-to-treat analysis of a cohort of consecutive patients who underwent above-knee bypass grafting. Prospectively acquired data were entered into an electronic database, but medical records were also reviewed retrospectively in order to retrieve missing baseline data.
Above-knee nonreversed vein graft
669
leg, (2) a strong femoral pulse in the groin but a weak or absent popliteal pulse, and (3) an above-knee femoropopliteal bypass done between January 1, 2002, and December 31, 2005. Surgical Technique A surgical team composed of a staff vascular surgeon and two residents in vascular surgery performed the bypass procedures. After the sites of the proximal and distal anastomoses had been exposed and the GSV or another vein had been harvested through short, separate skin incisions, heparin (5,000 IU) was administered intravenously. The femoral anastomosis was done first, and once this was completed, the arterial clamps were released to allow the venous conduit to distend with normothermic blood under arterial blood pressure. A Mills-Leather valvulotome was then introduced into the vein through its transected distal end or a side branch to allow retrograde valve incision as described for in situ vein grafting.25 The pulsatile, valveless vein was then translocated to a tunnel near the native arteries. After preparing the popliteal artery, a distal end-to-side anastomosis was created with the help of surgical loupes (3.5-fold optical magnification). Intraoperative angioscopy, which is often used to assist valve incision,12,17,18 was unavailable. Completion arteriograms were not routinely obtained. Follow-Up
The main outcomes were primary and secondary graft patency, limb salvage, and patient survival defined according to the Ad Hoc Committee of the Society for Vascular Surgery and the North American Chapter of the International Society for Cardiovascular Surgery.22 Tertiary patency, composite patency, amputation-free survival, and the need of prosthetic grafts were also investigated. Tertiary patency reflects the contribution of repeated bypass surgery with a new graft and, like the rate of use of prosthetic grafts, measures the success of the policy adopted. Composite patency, as a more rigorous measure, combines the absence of graft occlusion, death within 30 days, removal of an infected open graft, extension of the graft to a below-knee position, and major amputation.23 Amputation-free survival has been used to compare the different strategies of revascularization.24
The patients were prescribed aspirin (150 mg/day) and simvastatin (20 mg/day), unless their use was contraindicated, and advised to return for followup visits at 1, 3, and 6 months and at 6-month intervals thereafter. The ankle-brachial systolic blood pressure index (ABPI) was calculated during each visit, whereas duplex scanning was used selectively. Delay in lesion healing, recurrence of pain, or drop of ABPI in the presence of palpable pulses was indicative for duplex surveillance. The criteria adopted for duplex examination were those proposed in the Trans-Atlantic Inter-Society Consensus (TASC) document; i.e., a peak systolic velocity outside the range 45-150 cm/sec was indicative of stenosis.26 Postoperative arteriograms were obtained only when graft revision was envisaged. Telephone calls and home visits were used to reduce the loss to follow-up, which was defined as no information on graft or limb status for more than 1 year and was last assessed on December 31, 2006.
Criteria for Inclusion
Statistical Methods
The following entry criteria were used: (1) the presence of tissue loss or rest pain in the index foot or
Estimates of long-term success were calculated using the Kaplan-Meier product-limit method, and
Outcome Measures
670 De Luccia et al.
standard errors were calculated with the method of Peto et al.27 Sensitivity analysis considered that one or two of the four vein grafts lost to follow-up failed in the second month after operation.
RESULTS Patients and Grafts During the interval covered by this study, infrainguinal bypass surgery was done in 234 patients with chronic critical ischemia, of whom 51 underwent above-knee femoropopliteal bypass procedures in 53 limbs. Three successful iliac balloon PTAs and two femoropopliteal stent grafts that eventually failed had been done in the index leg 5209 days before five bypasses (vein, 2; prosthetic, 3). The prevalence rates for male patients, diabetes mellitus, hypertension, and smoking were higher than 60% (Table I). The affected limbs showed rest pain (n ¼ 3), nonhealing ulcers (n ¼ 17), gangrene (n ¼ 31), or unspecified tissue loss (n ¼ 2). In three limbs with rest pain alone, there was diffuse pain in the foot, whereas in 50 remaining limbs the ischemic lesion was located in the toes (n ¼ 24), forefoot or midfoot (n ¼ 6), heel (n ¼ 3), leg (n ¼ 13), multiple sites (n ¼ 2), and unspecified site (n ¼ 2). The median ABPI calculated for 44 limbs was 0.4. The bypass procedure was done 1-374 days (median ¼ 7) after digital subtraction angiography. Nine grafts (vein, 8; prosthetic, 1) were used to bypass stenotic lesions, 37 grafts (vein, 30; prosthetic, 7) were used to bypass occlusive lesions, and seven vein grafts were used to bypass undetermined lesions in the superficial femoral artery. The anesthetic management in 45 procedures included spinal anesthesia (n ¼ 43), epidural anesthesia (n ¼ 1), and general anesthesia (n ¼ 1) but was not recorded for the remaining eight procedures. There was a predominance of unisegment GSV grafts, of veins with a minimal caliber of 4 mm, of bypasses originating at the common femoral artery, and of runoff scores of 1 (Table II). All of the vein grafts were fashioned nonreversedly. Graft Patency Of the 53 grafts at risk, 45 were censored because of study duration (vein, 31; prosthetic, 1), death (vein, 5; prosthetic, 3), and loss to follow-up (vein, 4; prosthetic, 1), whereas eight eventually failed (vein, 5; prosthetic, 3). Of the five vein grafts that failed, two led to major amputation within a week of failure, one was successfully revised with thrombectomy plus a vein patch in the first postoperative
Annals of Vascular Surgery
Table I. Demographic profile and clinical variables of 51 patients
Mean age, years (range) Male sex Diabetes mellitus Hypertension Smoking Heart disease Tissue loss Median ABPI (range)
n (%)
Missing data
66 (42-91) 31(61) 33 (67) 31 (69) 36 (76) 9 (19) 50 (94) 0.4 (0-1)
0 0 2 6 4 3 2 9
Values are number (percentage) except for age and ABPI.
Table II. Main features and patency outcomes of 53 bypasses n
ABPI >0.4 0.4 Unrecorded Graft type Vein alone Prosthetics Vein caliber 4 mm <4 mm Prosthetics Unrecorded Runoff score22 1 2-9 10 Unrecorded Origin CFA SFA/PFA Unspecified
Primary Secondary Tertiary Composite failure failure failure failure
20 3 24 5 9 0
3 4 0
0 4 0
4 10 0
45 5 8 3
4 3
4 0
8 6
26 9 8 10
4 1 3 0
3 1 3 0
3 1 0 0
6 1 6 0
19 17 10 7
2 4 2 0
2 4 1 0
1 2 1 0
5 5 4 0
29 4 18 4 6 0
3 4 0
2 2 0
6 8 0
CFA, common femoral artery; SFA/PFA, superficial femoral or popliteal artery.
day, one was not revised until death 15 months later, and the remaining graft was not revised during the available follow-up of 25 months. All three failed prosthetic grafts were successfully replaced with a below-knee femoropopliteal arm vein bypass. Composite graft failure occurred in 14 of the 53 grafts as a result of seven graft occlusions (vein, 4; prosthetic, 3), one vein graft rupture, three amputations (vein, 2; prosthetic, 1), and three early deaths (vein, 1; prosthetic, 2). The 2-year cumulative success rates for all bypasses and for vein bypasses alone were 82.5%
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Limb Salvage One limb was already amputated below the knee. Of the 52 limbs still at risk, five (vein, 4; prosthetic, 1) underwent major amputation and 47 were censored because of duration (n ¼ 36), death (n ¼ 7), and loss to follow-up (n ¼ 4). The graft was still patent in three (vein, 2; prosthetic, 1) newly amputated limbs and already occluded in the other two (vein, 2). The cumulative rate of loss to follow-up per limb was 7.5% at 30 days and 3 years. The 2-year cumulative limb salvage rate was 86.9% overall and 88.1% for limbs treated with vein grafts alone (Table III). Of the 47 lower extremities without a major amputation, 21 underwent minor amputation, 21 remained intact, and five were censored because of loss to follow-up or death. Patient Survival Three patients with viable limbs and patent grafts (vein, 1; prosthetic, 2) died within 30 days (myocardial infarction, 2; undetermined cause, 1). There were also nine late deaths, of which two occurred soon after major amputation and seven were unrelated to this event. The 2-year cumulative rates of survival and amputation-free survival were 77.7% and 68.4% overall and 81.1% and 72.6% for patients treated with vein grafts alone, respectively (Table III, Fig. 3). Other Outcomes The cumulative rate of use of a prosthetic graft was 15% at 30 days and beyond. In 50 limbs with tissue loss, the ischemic lesion and the site of toe amputation healed completely (n ¼ 24) or partially (n ¼ 10),
671
Cumulative patency
100% 90%
90.1%
80%
77.5% 75.7%
70% 61.8%
60% 50%
0
6
12
18
24
30
36
1yr 37 38 40 31
2yr 37 38 40 30
42
Months N Primary patency Secondary patency Tertiary patency Composite patency
1mo 41 42 42 37
6mo 37 38 40 31
3yr 33 34 40 27
Fig. 1. Primary patency (black line), secondary patency (blue line), tertiary patency ( gray line), and composite patency (red line) for 53 above-knee femoropopliteal bypass grafts. Dotted lines, standard error >10%. 100%
Cumulative patency
and 86.6% for primary patency, 84.6% and 88.9% for secondary patency, 90.1% and 89.0% for tertiary patency, and 68.0% and 76.8% for composite patency, respectively (Table II, Figs. 1 and 2). Primary failure of a vein graft occurred in one small-caliber bypass for 3,866 graft days and four good-caliber bypasses for 10,420 graft days (relative risk ¼ 0.67), whereas there were two primary failures for 7,799 graft days for runoff grade 1 vs. six primary failures for 9,185 graft days for runoff grades 2-10 (relative risk ¼ 1.11). The ABPI decreased by more than 0.1 in one leg, and duplex scanning indicated moderate graft stenosis in two vein grafts; none of the three grafts involved was revised. Sensitivity analysis revealed an absolute decrease of 1.5% and 3.0% in the 3-year cumulative secondary patency rate when one or two lost grafts, respectively, were considered as secondarily failed.
Above-knee nonreversed vein graft
88.9%
90%
86.6% 80%
77.5%
70% 60% 50%
0
6
12
18
24
30
36
42
Months N Primary patency Secondary patency Composite patency
1mo 37 38 34
6mo 34 35 32
1yr 34 35 32
2yr 34 35 30
3yr 34 35 30
Fig. 2. Primary patency (black line), secondary and tertiary patency (blue line), and composite patency (red line) for 45 above-knee femoropopliteal vein bypass grafts. Dotted lines, standard error >10%.
failed to heal (n ¼ 2), led to major amputation (n ¼ 5), was censored because of death (n ¼ 5) or loss to follow-up (n ¼ 3), or had an undetermined course (n ¼ 1). Of the 51 patients, 31 retained their ability to walk (salvaged, 29; amputated, 2), nine could no longer walk (salvaged, 7; amputated, 2), nine were censored because of death or loss to follow-up (salvaged, 7; amputated, 2), and two did not have their ability to walk assessed (salvaged, 2).
DISCUSSION Most of the logical foundations of staged infrainguinal revascularization have been rejected. Indeed,
672 De Luccia et al.
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Table III. Short-term and midterm outcomes Graft
1 month
Primary patency All 93.6 Vein alone 92.7 Secondary patency All 95.5 Vein alone 94.9 Tertiary patency All 95.5 Vein alone 94.9 Limb salvage All 95.2 Vein alone 94.7 Survival All 93.8 Vein alone 97.5 Composite patency All 84.6 Vein alone 87.2 Amputation-free survival All 85.2 Vein alone 89.9
6 months
1 year
2 years
3 years
± 3.9 ± 4.4
82.5 ± 6.5 86.6 ± 6.1
82.5 ± 7.2 86.6 ± 6.8
82.5 ± 9.6 86.6 ± 9.2
75.7 ± 21.5 86.6 ± 15.9
± 3.3 ± 3.7
84.6 ± 6.2 88.9 ± 5.6
84.6 ± 6.8 88.9 ± 6.2
84.6 ± 8.9 88.9 ± 8.6
77.5 ± 18.4 88.9 ± 14.8
± 3.3 ± 3.7
90.1 ± 5.0 89.0 ± 5.5
90.1 ± 5.5 89.0 ± 6.2
90.1 ± 7.3 89.0 ± 8.5
90.1 ± 10.7 89.0 ± 14.8
± 3.2 ± 3.6
90.2 ± 4.8 92.0 ± 4.6
90.2 ± 5.2 92.0 ± 5.1
86.9 ± 7.6 88.1 ± 8.1
86.9 ± 12.8 88.1 ± 13.6
± 3.5 ± 2.5
80.6 ± 5.9 84.6 ± 5.9
80.6 ± 6.3 84.6 ± 6.3
77.7 ± 8.4 81.1 ± 9.1
72.2 ± 13.5 81.1 ± 15.8
± 5.6 ± 5.7
71.6 ± 7.5 81.1 ± 7.1
71.6 ± 8.1 81.1 ± 7.7
68.0 ± 11.1 76.8 ± 11.1
61.8 ± 22.1 76.8 ± 21.3
± 5.2 ± 4.8
74.0 ± 6.6 79.3 ± 6.6
74.0 ± 7.0 79.3 ± 7.1
68.4 ± 9.3 72.6 ± 10.2
68.4 ± 14.5 72.6 ± 17.0
Values are cumulative rates and their standard errors.
Cumulative rate
100% 90% 80% 72.6%
70%
68.4%
60% 50%
0
6
12
18
24
30
36
42
Months N All Vein alone
1mo 38 36
6mo 38 32
1yr 38 32
2yr 30 29
3yr 30 29
Fig. 3. Amputation-free survival for all patients (black line) and for patients with vein grafts only ( gray line). Dotted line, standard error >10%.
only a few patients require a secondary bypass with a spared GSV,2 the best alternative to an unavailable GSV for below-knee bypass is a vein from another source and not a prosthetic graft,28,29 and the interval of equivalence between GSV grafts and prosthetic grafts above the knee may be extremely short for patients with critical ischemia.2 On the contrary, the strict policy of using all autogenous tissue grafts remains valid for all levels of infrainguinal revascularization.7,11,30 The analysis of such policy, however, has neglected the occasional use
prosthetic grafts above the knee and has not considered patients with critical ischemia separately.5,7 The present study thus seems to be unique in that all of the patients had critical ischemia, 94% had tissue loss, only above-knee bypasses were considered, nonreversed vein grafting was widely preferred, and prosthetic grafts were included in an intention-totreat analysis. This was a realistic analysis because not every patient will have a vein usable for bypass and because convenience rather than necessity may dictate the surgeon’s primary choice of a prosthesis.31 Indeed, this occurred at least for three patients with a failed prosthetic graft who subsequently received an arm vein bypass. In any case, the 84.9% rate of usage of a nonreversed vein surpassed the rates of 73% and 79% reported in two studies that used reversed GSV in preference to a prosthetic conduit.32,33 Additionally, a nonreversed arm vein used in one primary and three secondary bypasses contributed to tertiary patency and limb salvage. Arm vein grafts may elongate and dilate after 4 years, but this is of questionable importance in the setting of critical limb ischemia.34 Worth noting, the nonreversed orientation is particularly useful because an arm vein may exhibit a wide variation in caliber.16-18 With the nonreversed vein bypass, the technical advantage of a better size match at the anastomotic sites typical of the in situ vein bypass is maintained. Despite opinion to the contrary,15 tapering of the
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GSV in the thigh may not be uncommon, as indicated by the use of small-caliber veins in at least 20% of the vein grafts. The practical importance of other features of nonreversed vein grafts was also noted as all bypasses originated directly from the donor artery, valve incision was done easily, and the grafts were systematically tunneled near the native artery. In addition to using vein grafts in a large proportion of bypasses, optimal patency outcomes were obtained. The graft patency of above-knee bypasses for critical ischemia has been better with GSVs than with prosthetic grafts. A large multicenter randomized trial reported a 2-year cumulative primary assisted patency rate of 81% for GSV grafts vs. 69% for prosthetic grafts,35 whereas in a meta-analysis by Pereira et al.2 the 2-year pooled estimate was 81% vs. 61.9% for primary patency and 84% vs. 70% for secondary patency, respectively. In the current study of consecutive patients, the 2-year cumulative primary and secondary graft patency rates of 86.6% and 88.9% (vein grafts alone) and 82.5% and 84.6% (all grafts), respectively, were thus rewarding. Not surprisingly, the policy of revascularization adopted implied using several less than optimal veins. There were fewer primary failures with such veins than with prosthetic grafts, but the successful replacement of three occluded prosthetic grafts with arm vein grafts provided nearly equal tertiary failures and, more importantly, indicated the futility of sparing the GSV. Bypasses to a popliteal artery with a runoff score of 10 performed poorly, but as for vein caliber, missing information and the small study size precluded a reliable analysis of the association between runoff and patency or limb salvage. Of more concern than inferior graft patency, a higher frequency of acute ischemia and the deterioration of clinical symptoms have been seen after failure of prosthetic bypass grafts.36 These problems may be even more serious for patients primarily operated for critical ischemia, as in the present study in which all three patients with a failed prosthetic graft but only one of the four patients with a failed vein graft required an additional bypass. Although there is no consensus on the fate of failed grafts,37 the incidence and importance of periprosthetic infection must not be neglected.38 Finally, the allegation that an easier, more expeditious procedure can be accomplished with a prosthetic graft is untenable in view of the obligation to respect patient autonomy, particularly by disclosing the best available information; to promote health benefits; and to avoid harm.39 On the other hand, these ethical principles demand the use of a prosthetic graft for reasons such as an exhausted venous pool, a poor health
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condition, or the occurrence of unexpected events during surgery. Such a negative selection of cases explains why six of the eight patients with a prosthetic graft did not maintain composite patency. Finally, PTA poses an additional challenge to prosthetic grafts.40 There has been a recent trend toward using PTA rather than surgical bypass in femoropopliteal revascularization whenever possible.8,9 In the study of Haider et al.9 on patients with critical ischemia, the 2-year cumulative rates of success were slightly better with PTA than with bypass for primary patency, 75% vs. 69%, respectively, and for limb salvage, 90% vs. 87%, respectively. Although the patency rates for above-knee bypasses in our study were clearly superior to those reported by Haider et al., which suggests a great amount of bias against bypass in the latter study, a remarkable equivalence was noted for limb salvage. Such equivalence likely reflected not only the effectiveness of the primary treatment but also the joint effects of subsequent bypasses. Possibly, PTAs are less effective than vein grafts in any condition and as effective as prosthetic grafts for treating stenotic lesions.40,41 Since only one graft was inserted for such lesions, this topic remained beyond the scope of our study. However, there is hope of further improvement in the treatment of occlusive lesions with subintimal dissection.10 This study has some limitations that could not be handled adequately. Indeed, the small study size combined with low event rates precluded a precise estimation of success beyond 2 years, the measurements of vein caliber and runoff were often neglected, and intraoperative angioscopy was not used to assist valve incision. Despite such problems, several features support this study’s validity. First, since all of the patients had chronic critical limb ischemia, in most cases with tissue loss, and since a standardized vein bypass procedure was done, external validity was warranted. Second, an intentionto-treat analysis of consecutive patients reduced sample selection bias and yielded more realistic results. Third, the rate of incomplete follow-up was acceptable, and both the healing of ischemic lesions and ambulatory status were assessed. Fourth, the use of composite patency and amputation-free survival as more comprehensive measures may be more meaningful for the patient, the surgeon, and the decision analyst. Finally, sensitivity analysis showed that the estimation of graft patency was robust. In conclusion, the preference for nonreversed vein bypass grafts in above-knee revascularization of critically ischemic limbs is justified because the
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use of autogenous vein grafts is maximized with no additional harm. REFERENCES 1. Veith FJ, Gupta SK, Ascer E, et al. Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstruction. J Vasc Surg 1986;3:104-114. 2. Pereira CE, Albers M, Romiti M, Brochado-Neto FC, Pereira CAB. Meta-analysis of femoropopliteal bypass grafts for lower extremity arterial insufficiency. J Vasc Surg 2006;44:510-517. 3. Quin˜ones-Baldrich WJ, Busuttil RW, Baker JD, et al. Is the preferential use of polytetrafluoroethylene grafts for femoropopliteal bypass justified? J Vasc Surg 1988;8:219-228. 4. Rosen RC, Johnson WC, Bush HL, Jr, Cho SI, O’Hara ET, Nabseth DC. Staged infrainguinal revascularization: initial prosthetic above-knee bypass followed by a distal vein bypass for recurrent ischemia. A valid concept for extending limb salvage? Am J Surg 1986;152:224-230. 5. Donaldson MC, Whittemore AD, Mannick JA. Further experience with an all-autogenous tissue policy for infrainguinal reconstruction. J Vasc Surg 1993;18:41-48. 6. Taylor LM, Jr, Phinney ES, Porter JM. Present status of reversed vein bypass for lower extremity revascularization. J Vasc Surg 1986;3:288-297. 7. Eugster T, Stierli P, Guerke L, Obeid T, Hess P. Present status of infrainguinal arterial bypass procedures following an all autogenous policy: long-term results of a single center. Swiss Surg 2002;8:171-175. 8. Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg 2005;41: 423-435. 9. Haider SN, Kavanagh EG, Forlee M, et al. Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg 2006;43:504-512. 10. Bolia A. Subintimal angioplasty in lower limb ischaemia. J Cardiovasc Surg (Torino) 2005;46:385-394. 11. Belkin M, Knox J, Donaldson MC, Mannick JA, Whittemore AD. Infrainguinal arterial reconstruction with nonreversed greater saphenous vein. J Vasc Surg 1996;24: 957-962. 12. Stierli P, Eugster T, Hess P, Gu¨uke L, Verschluss der A. Femoralis superficialis. Der autologe Venenbypass zur supragenualen A. Poplitea Gefa¨sschirurgie 2001;6(Suppl. 1):S43-S46. 13. Chin AK, Mayer DN, Goldman RK, Lerman JA, Olcott C, IV, Fogarty TJ. The effect of valvulotomy on the flow rate through the saphenous vein graft: clinical implications. J Vasc Surg 1988;8:316-320. 14. Andros G. Bypass to the plantar arteries. In: Bergan JJ, Yao JST eds. Techniques in Arterial Surgery. Philadelphia: W.B. Saunders, 1990. pp. 157-168. 15. Harris RW, Andros G, Dulawa LB, Oblath RW, Apyan R, Salles-Cunha S. The transition to "in situ" vein bypass grafts. Surg Gynecol Obstet 1986;163:21-28. 16. Brochado-Neto FC, Albers M, Pereira CA, Gonzalez J, Cinelli M, Jr. Prospective comparison of arm veins and greater saphenous veins as infrageniculate bypass grafts. Eur J Vasc Endovasc Surg 2001;22:146-151. 17. Harward TR, Govostis DM, Rosenthal GJ, Carlton LM, Flynn TC, Seeger JM. Impact of angioscopy on infrainguinal graft patency. Am J Surg 1994;168:107-110.
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36. Jackson MR, Belott TP, Dickason T, et al. The consequences of a failed femoropopliteal bypass grafting: comparison of saphenous vein and PTFE grafts. J Vasc Surg 2000;32: 498-504. 37. Smeets L, Ho GH, Tangelder MJ, et al. Dutch BOA Study Group. Outcome after occlusion of infrainguinal bypasses in the Dutch BOA Study: comparison of amputation rate in venous and prosthetic grafts. Eur J Vasc Endovasc Surg 2005;30:604-609. 38. Pedersen G, Laxdal E, Hagala M, Aune S. Local infections after above-knee prosthetic femoropopliteal bypass for
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