Clinical Research Multilevel Bypass Grafting: Is it Worth it? Alistair Sharples, Mark Kay, Timothy Sykes, Anthony Fox, and Andrew Houghton, Shrewsbury, United Kingdom
Background: Traditionally, multilevel arterial disease has been treated with an inflow procedure only but simultaneous multilevel bypass graft procedures have been attempted. However, these procedures are potentially high risk. We report our single-center experience of performing multilevel bypass grafts over the last 15 years. Methods: We retrospectively identified patients undergoing simultaneous aortoiliac and infrainguinal bypasses between January 1996 and January 2011 at a single district general hospital. Results: There were 32 multilevel procedures performed. Indication for surgery was acute ischemia in 10 (31.3%), critical ischemia without tissue loss in 10 (31.3%), with tissue loss in 10 (31.3%), and claudication in 2 (6.3%). In 23 (71.9%) cases inflow was restored using a direct iliofemoral or aortofemoral reconstruction. In the remaining 9 (28.1%), an extra-anatomic bypass was constructed. Two (6.3%) patients died within 30 days of surgery. Twenty-nine (90.6%) patients survived to discharge. Twenty-eight patients (87.5%) were alive 1 year after surgery. Limb salvage was 96.9%, 85.7%, and 75.9% at 30 days, 1 year, and 5 years, respectively. Twelve (37.5%) patients required a total of 19 further ipsilateral vascular procedures. Conclusions: Our results demonstrate that multilevel bypass procedures can be performed with good long-term outcomes and acceptable mortality, in what is typically a high-risk group with extensive comorbidities. In patients with severe critical limb ischaemia and tissue loss, who have a combination of aortoiliac and infrainguinal disease, there are significant benefits to a primary multilevel grafting procedure.
INTRODUCTION Peripheral vascular disease affects 1 in 5 people between the ages of 55 and 75 years, with 25% having symptoms of intermittent claudication.1 Severe disease affecting multiple arterial segments is less common but causes more severe clinical features. Such ‘‘multilevel’’ arterial disease is present in >50% of patients requiring aortoiliac surgery2e4 and is even more prevalent in patients presenting with critical limb ischaemia, where it contributes to the poor Department of Vascular Surgery, Shrewsbury and Telford NHS Trust, Shrewsbury, UK. Correspondence to: Alistair Sharples, MBChB, Shrewsbury and Telford NHS Trust, Mytton Oak Road, Shrewsbury SY3 8XQ, UK; E-mail: [email protected] Ann Vasc Surg 2014; -: 1–6 http://dx.doi.org/10.1016/j.avsg.2014.03.027 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: November 4, 2012; manuscript accepted: March 24, 2014; published online: ---.
prognosis; in 1 study only 56% of patients were alive with both legs 1 year after diagnosis.5 The management of multilevel arterial disease is variable and depends on a number of patient factors and the surgical and radiologic expertise available. Traditionally, it has been treated with an inflow procedure only but this approach is often inadequate by itself and a further infrainguinal procedure is often required at a later date.6,7 In view of these relatively poor results, a number of surgeons have attempted simultaneous multilevel bypass grafting, combining an iliofemoral or aortofemoral procedure with an infrainguinal bypass. Early experiences using this combined approach were poor,8 however later studies have demonstrated acceptable graft patency and limb salvage rates without excessive perioperative mortality.9,10 Relatively, little has been written on the subject over the last decade. This is in part due to the 1
2 Sharples et al.
emergence of less invasive endovascular techniques. A number of authors have described the combined use of aortoiliac angioplasty and/or stenting with femoropopliteal bypass grafting showing good results.11e13 However, not all inflow lesions are amenable to endovascular intervention and some patients will undoubtedly continue to require more extensive surgical reconstruction. We report our single center experience of performing multilevel bypass grafts over the last 15 years on patients who are not suitable for endovascular intervention.
MATERIALS AND METHODS Thirty-two patients underwent multilevel bypass graft procedures between January 1996 and January 2011 at a large district general hospital. All the procedures were performed by or under the immediate supervision of 1 of 3 experienced vascular consultants. Information for analysis was obtained retrospectively from 2 sources, from a departmental vascular database and from the patients’ case notes. With the obvious exception of those patients requiring emergency procedures for acute limbthreatening ischemia, all cases were discussed at a multidisciplinary meeting involving surgeons and interventional radiologists. Patients with multilevel disease were generally considered for a multilevel procedure if either they were critically ischemic with tissue loss or they alternatively had very poor runoff from the planned distal anastomotic site of the inflow graft. A superficial femoral artery occlusion in the presence of a severely diseased profunda femoris artery, for example, would be considered an indication for a multilevel procedure. Our center has a very experienced interventional radiology department and all patients were considered for endovascular treatment. Endovascular treatment is generally the first line intervention for inflow disease if suitable, and most patients presenting with multilevel disease will undergo endovascular intervention as part of their therapy. All the patients included in this study were deemed by the multidisciplinary team not to be suitable candidates for endovascular therapy. In addition to these planned multilevel procedures, others were converted to a multilevel procedure intraoperatively as a result of operative findings or complications. Both groups of patients have been included in the study. Categorical data were demonstrated by frequency and percentage, and continuous data were described using the mean or median. Survival, limb salvage, and patency were reported at 30 days
Annals of Vascular Surgery
and estimated at 1 year and 5 years using Kaplane Meier estimates.
RESULTS In total there were 32 multilevel procedures performed during the study period. Twenty-three (71.9%) patients were male and 9 (28.1%) female. The mean age was 68.7 years. The indications for surgery are shown in Table I. Fifteen (46.9%) patients had had previous vascular interventions (Table II). Median length of stay was 10.0 days (range 5e47 days) and mean follow-up was 69 months. In 23 (71.9%) cases, the inflow was established using an anatomical direct aortofemoral or iliofemoral reconstruction. In the remaining 9 (28.1%) patients extra-anatomic bypasses were constructed (Table III). The multilevel procedure was unplanned in 6 cases. In each of these cases, the limb was acutely ischemic following a proximal grafting procedure, and a decision was made in the theater to perform an additional infrainguinal procedure. All but 1 inflow procedure was constructed using a prosthetic graft. In 1 case, an iliofemoral graft was constructed using reversed superficial femoral vein. Outflow reconstruction involved infrainguinal bypass to the above-knee popliteal in 18 (56.3%), below-knee popliteal in 11 (34.4%), and a distal vessel in 3 (9.4%). The graft material used for the outflow procedures is detailed in Table IV. Thirtyday, 1-year, and 5-year mortality rates, graft patency, and limb salvage rates are displayed in Table V. Two patients died within 30 days of surgery and a further patient died on the same admission. In total, 29 (90.6%) patients survived to discharge. Of the 30-day mortalities, both patients underwent procedures for critical ischemia with tissue loss and both underwent ipsilateral iliofemoral reconstructions with femoropopliteal bypass. Both patients died of cardiac causes within 24 hr of surgery. The third patient died on day 36 of a gastrointestinal hemorrhage after an iliofemoral reconstruction with an above-knee femoropopliteal graft. Twenty-eight patients (87.5%) were alive 1 year after their initial multilevel surgery. After successful discharge from hospital after primary surgery there was only 1 death within the subsequent year. This 76-year-old patient underwent a left axillofemoral and femoropopliteal bypass for critical ischemia. He had significant cardiac comorbidities and died of cardiac causes 5 months after surgery. In total, 18 (59.3%) patients were known to be alive at 5 years (Fig. 1).
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Multilevel bypass grafting 3
Table I. Indications for multilevel surgery
Table IV. Graft material for outflow procedures
Indication for surgery
Number of procedures [n (%)]
Acute ischemia Critical ischemia without tissue loss Critical ischemia with tissue loss Claudication Not recorded
10 10 9 2 1
(31.3) (31.3) (28.1) (6.3) (3.1)
Previous intervention
Contralateral infrainguinal bypass Ipsilateral infrainguinal bypass Ipsilateral femoral endarterectomy Contralateral iliac stent Contralateral infrainguinal angioplasty
4 2 3 2 4
(12.5) (6.3) (9.4) (6.3) (12.5)
Table III. Type of inflow procedure performed Number of procedures [n (%)]
19 4 3 4 1 1
Reversed long saphenous vein Reversed cephalic/basilica vein Prosthetic graft Composite graft
23 6 2 1
Outcome Number of procedures [n (%)]
Ipsilateral iliofemoral graft Iliofemoral crossover graft Femorofemoral crossover graft Aortobifemoral graft Axillofemoral graft (unilateral) Crossover graft from previous axillofemoral graft to contralateral femoral
Number of procedures [n (%)]
(71.2) (18.8) (6.3) (3.1)
Table V. Outcomes
Table II. Previous vascular procedures
Inflow procedure
Graft material
(59.4) (12.5) (9.4) (12.5) (3.1) (3.1)
Of the surviving patients, limb salvage was 29 of 30 (96.9%) patients at 30 days after the primary multilevel procedure, 85.7% at 1 year and 75.9% at 5 years (Fig. 2). Five amputations were performed within 1 year of surgery. Two patients required amputation later than 1 year after their multilevel procedure. Two of the amputations were performed in the presence of patent grafts (1 secondary to extensive venous ulceration and the other secondary to sepsis from an infected postoperative hematoma). The remaining amputations were all due to ischemia secondary to graft failure. Two (6.3%) patients required revision grafting within a year of their surgery and a further 5 (15.6%) patients required this within 5 years. A further 7 patients demonstrated radiologic evidence of an occluded graft but did not require amputation. In all cases, it was the outflow graft that had occluded; in 3 (42.9%) cases this
30-day 1-year (95% CI)
Mortality 6.3 (%) 96.9 Limb salvage (%) 93.8 Graft patency (%)
12.5 (0.2e24.8)
5-year (95% CI)
40.7 (16.6e64.8)
85.7 (71.7e99.7) 75.9 (52.6e99.1)
83.3 (67.0e99.7) 73.5 (40.8e100.0)
was asymptomatic; in the remaining 4 (57.1%) cases patients had symptoms of claudication alone and were treated conservatively. Overall graft patency rates among the remaining grafts were 93.8%, 83.3%, and 73.5% at 30 days, 1 year and 5 years, respectively (Fig. 3). In total, 12 (37.5%) patients required a total of 19 further ipsilateral vascular procedures (including 10 redo bypasses, 5 interventions for false aneurysms, 2 angioplasties, and 1 endarterectomy). Five patients required a redo multilevel procedure at a mean of 43 months. One patient died 5 months after the revision multilevel procedure of unrelated medical comorbidities. The remaining 4 patients were alive and amputation free 12 months after their revision multilevel procedure.
DISCUSSION This study was designed to investigate the role of multilevel bypass grafting for those with combined aortoiliac and infrainguinal arterial occlusive disease, who are not candidates for endovascular therapy. Such patients are often discussed at vascular multidisciplinary team meetings, where a decision as to which approach to take has to be made. Some patients respond to proximal revascularization alone,14 but up to a third of patients have an unsatisfactory functional result from this, requiring distal revascularization to address outflow disease.2e4,6,8,15e22 Because preoperative identification of patients who respond well to inflow revascularization alone
4 Sharples et al.
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Fig. 1. KaplaneMeier curve showing the estimated survival (dotted line: standard error > 10%).
Fig. 2. KaplaneMeier curve showing the estimated limb salvage (dotted line: standard error > 10%).
Fig. 3. KaplaneMeier curve showing the estimated graft patency (dotted line: standard error > 10%).
is difficult, many people have taken the traditional staged approach to management of addressing the inflow problem first and, if necessary, dealing with the outflow problem later. This ‘‘staged approach’’ allows for the evaluation of a patient’s response to inflow reconstruction but risks exposing patients to a second vascular procedure and its associated risks. In addition, patients presenting with limb
threatening ischemia and tissue loss are faced with a very real risk of limb loss if perfusion is not reestablished adequately with the primary procedure. The ‘‘wait-and-see’’ staged approach may result in progression of tissue loss combined with a decline in patient morale and often exacerbation of sepsis and other comorbidities, with the result that a definitive amputation becomes inevitable. Because of this,
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many authors advise consideration of a single multilevel procedure in patients with severe infrainguinal disease (particularly profunda disease) in association with tissue loss.3,6,7,17,23 We would suggest that the presence or absence of tissue loss is the crucial factor and would advise a primary multilevel procedure for patients with multilevel disease in association with tissue loss. An inflow procedure alone should be performed for patients with rest pain but no tissue loss, provided the runoff from the inflow procedure is adequate. Endovascular treatment of aortoiliac lesions is now well established, with a recent systematic review demonstrating results comparable to traditional bypass surgery.24 Long-term patency rates of >90% have been reported for stenting of iliac occlusions.25 A number of authors have also described the use of endovascular techniques combined with surgical infrainguinal bypass.11e13 There is a concern, however, regarding the long-term patency rates following endovascular intervention. It has been suggested that patency rates may be lower when endovascular therapy is combined with infrainguinal bypass than when performed alone, 59% compared with 84% at 3 years according to 1 study.26 This may suggest that patients with extensive multilevel disease have a more aggressive atherosclerotic process, which may be better suited to surgical bypass. Despite this, it is reasonably well accepted and certainly common practice to adopt an endovascular approach as first line treatment in most of the patients, particularly for the inflow component of their disease. However, not all patients are suitable for endovascular therapy and will continue to require operative bypass. Our results suggest that multilevel bypass procedures can be performed safely with reasonable long-term outcomes. Our 30-day mortality of 6.3% compares favorably with previous studies9,10,15,27 and 87.5% of patients were alive 1 year after their primary procedure. The reported range for 30-day mortality after aortobifemoral grafting alone is 2e5%.16,28e30 Patients with multilevel disease are typically older and more likely to have associated comorbidities and advanced peripheral vascular disease.2,3,17e19,22 Taking these factors into consideration, our results would suggest there is little excess mortality associated with the addition of a synchronous infrainguinal bypass procedure. Our 5-year limb salvage rate of 75.9% is encouraging and again suggests benefit from this aggressive
Multilevel bypass grafting 5
surgical approach. Dalman et al.10 similarly demonstrated a limb salvage rate of 90.9% at 2 years. Our 5-year infrainguinal graft patency rate of 73.5% compares with the results of other authors who have demonstrated 4-year graft patency rates of 69e80%.9,15,27 Infrainguinal graft patency rates were significantly lower than limb salvage rates at all stages, with the difference becoming more marked with the passage of time. In most cases, it was the distal graft that had occluded whereas the proximal inflow graft remained patent. Failure of the proximal graft invariably led to distal graft occlusion and was associated with return of symptoms and the need for reintervention. Failure of the distal outflow graft alone at a later stage however was not often associated with significant morbidity. The tissue loss and minor digital amputation wounds had usually healed by then, and graft occlusion usually only caused minor claudication symptoms that could be managed conservatively. It could be argued that this suggests the distal bypass was unnecessary; however, we feel it to be more likely that the period of time between the procedure and the subsequent graft failure had enabled more robust collaterals to develop, which were able to provide adequate tissue perfusion even after distal graft failure. It also requires a much better blood supply to heal a tissue defect than to perfuse a healed limb without skin defect, with the latter usually being the case after a prolonged period of multilevel graft function.
CONCLUSIONS Combining aortoiliac angioplasty and stenting with infrainguinal bypass grafting is well described. However for patients with severe critical limb ischemia and tissue loss, who have a combination of aortoiliac and infrainguinal disease, and who are not candidates for endovascular therapy, a primary multilevel grafting procedure is often their only chance of limb salvage. We have shown that multilevel bypass procedures can be performed with good long-term outcomes and acceptable mortality, in what is typically a high-risk group with extensive comorbidities.
REFERENCES 1. Cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease. National Institute for Health and Clinical Excellence, 2011.
6 Sharples et al.
2. Martinez BD, Hertzer NR, Beven EG. Influence of distal arterial occlusive disease on prognosis following aortobifemoral bypass. Surgery 1980;88:795e805. 3. Royster TS, Lynn R, Mulcare RJ. Combined aortoiliac and femoropopliteal occlusive disease. Surg Gynecol Obstet 1976;143:949e52. 4. Mulcare RJ, Royster TS, Lynn RA, et al. Long-term results of operative therapy for aortoiliac disease. Arch Surg 1978;113: 601e4. 5. Smith FCT. Non-surgical treatment of critical leg ischaemia. In: Earnshaw JJ, Murie JA eds. The Evidence for Vascular Surgery. 2nd edn. Shrewsbury: Tfm Publishing, 2007. pp 81e90. 6. Brewster DC, Perler BA, Robison JG, et al. Aortofemoral graft for multilevel occlusive disease. Predictors of success and need for distal bypass. Arch Surg 1982;117:1593e600. 7. Sumner DS, Strandness DE. Aortoiliac reconstruction in patients with combined iliac and superficial femoral arterial occlusion. Surgery 1978;84:348e55. 8. Benson JR, Whelen TJ, Cohen A, et al. Combined aortoiliac and femoropopliteal occlusive disease: limitations of total aortofemoropopliteal bypass. Ann Surg 1966;163:121e30. 9. Eidt J, Charlesworth D. Combined aortobifemoral and femoropopliteal bypass in the management of patients with extensive atherosclerosis. Ann Vasc Surg 1986;1:453e9. 10. Dalman RL, Taylor LM Jr, Moneta GL, et al. Simultaneous operative repair of multilevel lower extremity occlusive disease. J Vasc Surg 1991;13:211e21. 11. Mousa A, Abdel-Hamid M, Ewida A, et al. Combined percutaneous endovascular iliac angioplasty and infrainguinal surgical revascularization for chronic lower extremity ischemia: preliminary result. Vascular 2010;18:71e6. 12. Lau H, Cheng SW. Intraoperative endovascular angioplasty and stenting of iliac artery: an adjunct to femoro-popliteal bypass. J Am Coll Surg 1998;186:414e5. 13. Liu C, Guan H, Li Y, et al. Combined intraoperative iliac artery stents and femoro-popliteal bypass for multilevel atherosclerotic occlusive disease. Chin Med Sci J 2001;16:165e8. 14. Charlesworth D, Harris PL, Cave FD, et al. Undetected aortoiliac insufficiency: a reason for early failure of saphenous vein bypass grafts for obstruction of the superficial femoral artery. Br J Surg 1975;62:567e70. 15. Harris PL, Bigley DJ, McSweeney L. Aortofemoral bypass and the role of concomitant femorodistal reconstruction. Br J Surg 1985;72:317e20.
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16. Malone JM, Moore WS, Goldstone J. The natural history of bilateral aortofemoral bypass grafts for ischemia of the lower extremities. Arch Surg 1975;110:1300e6. 17. Samson RH, Scher LA, Veith FJ. Combined segment arterial disease. Surgery 1985;97:385e96. 18. Brewster DC, Darling RC. Optimal methods of aortoiliac reconstruction. Surgery 1978;84:739e48. 19. Hill DA, McGrath MA, Lord RS, et al. The effect of superficial femoral artery occlusion on the outcome of aortofemoral bypass for intermittent claudication. Surgery 1980;87: 133e6. 20. Edwards WH, Wright RS. A technique for combined aortofemoral-popliteal arterial reconstruction. Ann Surg 1974;179: 572e9. 21. Bone GE, Hayes AC, Slaymaker EE, et al. Value of segmental limb blood pressures in predicting results of aortofemoral bypass. Am J Surg 1976;132:733e8. 22. Galland RB, Hill DA, Gustave R, et al. The functional results of aorto-iliac reconstruction. Br J Surg 1980;67:344e6. 23. Heyden B, Vollmar J, Voss EU. Principles of operation for combined aortoiliac and femoropopliteal occlusive lesions. Surg Gynecol Obstet 1980;151:519e24. 24. Jongkind V, Akkersdijk GJ, Yeung KK, et al. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg 2010;52:1376e83. 25. Gandini R, Fabiano S, Chiocchi M, et al. Percutaneous treatment in iliac artery occlusion: long-term results. Cardiovasc Intervent Radiol 2008;31:1069e76. 26. Kashyap VS, Pavkov ML, Bena JF, et al. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg 2008;48:1451e7. 27. Harward TR, Ingegno MD, Carlton L, et al. Limb-threatening ischemia due to multilevel arterial occlusive disease. Simultaneous or staged inflow/outflow revascularization. Ann Surg 1995;221:498e503. discussion 503e506. 28. Madiba TE, Robbs JV. Aortobifemoral bypass for the critically ischaemic limbeis it worth while? S Afr J Surg 1991;29:138e41. 29. Moore WS, Cafferata HT, Hall AD, et al. In defense of grafts across the inguinal ligament. An evaluation of early and late results of aorto-femoral bypass grafts. Ann Surg 1968;168: 207e14. 30. de Vries SO, Hunink MG. Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta-analysis. J Vasc Surg 1997;26:558e69.
Background: Traditionally, multilevel arterial disease has been treated with an inflow procedure only but simultaneous multilevel bypass graft procedures have been attempted. However, these procedures are potentially high risk. We report our single-center experience of performing multilevel bypass grafts over the last 15 years. Methods: We retrospectively identified patients undergoing simultaneous aortoiliac and infrainguinal bypasses between January 1996 and January 2011 at a single district general hospital. Results: There were 32 multilevel procedures performed. Indication for surgery was acute ischemia in 10 (31.3%), critical ischemia without tissue loss in 10 (31.3%), with tissue loss in 10 (31.3%), and claudication in 2 (6.3%). In 23 (71.9%) cases inflow was restored using a direct iliofemoral or aortofemoral reconstruction. In the remaining 9 (28.1%), an extra-anatomic bypass was constructed. Two (6.3%) patients died within 30 days of surgery. Twenty-nine (90.6%) patients survived to discharge. Twenty-eight patients (87.5%) were alive 1 year after surgery. Limb salvage was 96.9%, 85.7%, and 75.9% at 30 days, 1 year, and 5 years, respectively. Twelve (37.5%) patients required a total of 19 further ipsilateral vascular procedures. Conclusions: Our results demonstrate that multilevel bypass procedures can be performed with good long-term outcomes and acceptable mortality, in what is typically a high-risk group with extensive comorbidities. In patients with severe critical limb ischaemia and tissue loss, who have a combination of aortoiliac and infrainguinal disease, there are significant benefits to a primary multilevel grafting procedure.
INTRODUCTION Peripheral vascular disease affects 1 in 5 people between the ages of 55 and 75 years, with 25% having symptoms of intermittent claudication.1 Severe disease affecting multiple arterial segments is less common but causes more severe clinical features. Such ‘‘multilevel’’ arterial disease is present in >50% of patients requiring aortoiliac surgery2e4 and is even more prevalent in patients presenting with critical limb ischaemia, where it contributes to the poor Department of Vascular Surgery, Shrewsbury and Telford NHS Trust, Shrewsbury, UK. Correspondence to: Alistair Sharples, MBChB, Shrewsbury and Telford NHS Trust, Mytton Oak Road, Shrewsbury SY3 8XQ, UK; E-mail: [email protected] Ann Vasc Surg 2014; -: 1–6 http://dx.doi.org/10.1016/j.avsg.2014.03.027 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: November 4, 2012; manuscript accepted: March 24, 2014; published online: ---.
prognosis; in 1 study only 56% of patients were alive with both legs 1 year after diagnosis.5 The management of multilevel arterial disease is variable and depends on a number of patient factors and the surgical and radiologic expertise available. Traditionally, it has been treated with an inflow procedure only but this approach is often inadequate by itself and a further infrainguinal procedure is often required at a later date.6,7 In view of these relatively poor results, a number of surgeons have attempted simultaneous multilevel bypass grafting, combining an iliofemoral or aortofemoral procedure with an infrainguinal bypass. Early experiences using this combined approach were poor,8 however later studies have demonstrated acceptable graft patency and limb salvage rates without excessive perioperative mortality.9,10 Relatively, little has been written on the subject over the last decade. This is in part due to the 1
2 Sharples et al.
emergence of less invasive endovascular techniques. A number of authors have described the combined use of aortoiliac angioplasty and/or stenting with femoropopliteal bypass grafting showing good results.11e13 However, not all inflow lesions are amenable to endovascular intervention and some patients will undoubtedly continue to require more extensive surgical reconstruction. We report our single center experience of performing multilevel bypass grafts over the last 15 years on patients who are not suitable for endovascular intervention.
MATERIALS AND METHODS Thirty-two patients underwent multilevel bypass graft procedures between January 1996 and January 2011 at a large district general hospital. All the procedures were performed by or under the immediate supervision of 1 of 3 experienced vascular consultants. Information for analysis was obtained retrospectively from 2 sources, from a departmental vascular database and from the patients’ case notes. With the obvious exception of those patients requiring emergency procedures for acute limbthreatening ischemia, all cases were discussed at a multidisciplinary meeting involving surgeons and interventional radiologists. Patients with multilevel disease were generally considered for a multilevel procedure if either they were critically ischemic with tissue loss or they alternatively had very poor runoff from the planned distal anastomotic site of the inflow graft. A superficial femoral artery occlusion in the presence of a severely diseased profunda femoris artery, for example, would be considered an indication for a multilevel procedure. Our center has a very experienced interventional radiology department and all patients were considered for endovascular treatment. Endovascular treatment is generally the first line intervention for inflow disease if suitable, and most patients presenting with multilevel disease will undergo endovascular intervention as part of their therapy. All the patients included in this study were deemed by the multidisciplinary team not to be suitable candidates for endovascular therapy. In addition to these planned multilevel procedures, others were converted to a multilevel procedure intraoperatively as a result of operative findings or complications. Both groups of patients have been included in the study. Categorical data were demonstrated by frequency and percentage, and continuous data were described using the mean or median. Survival, limb salvage, and patency were reported at 30 days
Annals of Vascular Surgery
and estimated at 1 year and 5 years using Kaplane Meier estimates.
RESULTS In total there were 32 multilevel procedures performed during the study period. Twenty-three (71.9%) patients were male and 9 (28.1%) female. The mean age was 68.7 years. The indications for surgery are shown in Table I. Fifteen (46.9%) patients had had previous vascular interventions (Table II). Median length of stay was 10.0 days (range 5e47 days) and mean follow-up was 69 months. In 23 (71.9%) cases, the inflow was established using an anatomical direct aortofemoral or iliofemoral reconstruction. In the remaining 9 (28.1%) patients extra-anatomic bypasses were constructed (Table III). The multilevel procedure was unplanned in 6 cases. In each of these cases, the limb was acutely ischemic following a proximal grafting procedure, and a decision was made in the theater to perform an additional infrainguinal procedure. All but 1 inflow procedure was constructed using a prosthetic graft. In 1 case, an iliofemoral graft was constructed using reversed superficial femoral vein. Outflow reconstruction involved infrainguinal bypass to the above-knee popliteal in 18 (56.3%), below-knee popliteal in 11 (34.4%), and a distal vessel in 3 (9.4%). The graft material used for the outflow procedures is detailed in Table IV. Thirtyday, 1-year, and 5-year mortality rates, graft patency, and limb salvage rates are displayed in Table V. Two patients died within 30 days of surgery and a further patient died on the same admission. In total, 29 (90.6%) patients survived to discharge. Of the 30-day mortalities, both patients underwent procedures for critical ischemia with tissue loss and both underwent ipsilateral iliofemoral reconstructions with femoropopliteal bypass. Both patients died of cardiac causes within 24 hr of surgery. The third patient died on day 36 of a gastrointestinal hemorrhage after an iliofemoral reconstruction with an above-knee femoropopliteal graft. Twenty-eight patients (87.5%) were alive 1 year after their initial multilevel surgery. After successful discharge from hospital after primary surgery there was only 1 death within the subsequent year. This 76-year-old patient underwent a left axillofemoral and femoropopliteal bypass for critical ischemia. He had significant cardiac comorbidities and died of cardiac causes 5 months after surgery. In total, 18 (59.3%) patients were known to be alive at 5 years (Fig. 1).
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Table I. Indications for multilevel surgery
Table IV. Graft material for outflow procedures
Indication for surgery
Number of procedures [n (%)]
Acute ischemia Critical ischemia without tissue loss Critical ischemia with tissue loss Claudication Not recorded
10 10 9 2 1
(31.3) (31.3) (28.1) (6.3) (3.1)
Previous intervention
Contralateral infrainguinal bypass Ipsilateral infrainguinal bypass Ipsilateral femoral endarterectomy Contralateral iliac stent Contralateral infrainguinal angioplasty
4 2 3 2 4
(12.5) (6.3) (9.4) (6.3) (12.5)
Table III. Type of inflow procedure performed Number of procedures [n (%)]
19 4 3 4 1 1
Reversed long saphenous vein Reversed cephalic/basilica vein Prosthetic graft Composite graft
23 6 2 1
Outcome Number of procedures [n (%)]
Ipsilateral iliofemoral graft Iliofemoral crossover graft Femorofemoral crossover graft Aortobifemoral graft Axillofemoral graft (unilateral) Crossover graft from previous axillofemoral graft to contralateral femoral
Number of procedures [n (%)]
(71.2) (18.8) (6.3) (3.1)
Table V. Outcomes
Table II. Previous vascular procedures
Inflow procedure
Graft material
(59.4) (12.5) (9.4) (12.5) (3.1) (3.1)
Of the surviving patients, limb salvage was 29 of 30 (96.9%) patients at 30 days after the primary multilevel procedure, 85.7% at 1 year and 75.9% at 5 years (Fig. 2). Five amputations were performed within 1 year of surgery. Two patients required amputation later than 1 year after their multilevel procedure. Two of the amputations were performed in the presence of patent grafts (1 secondary to extensive venous ulceration and the other secondary to sepsis from an infected postoperative hematoma). The remaining amputations were all due to ischemia secondary to graft failure. Two (6.3%) patients required revision grafting within a year of their surgery and a further 5 (15.6%) patients required this within 5 years. A further 7 patients demonstrated radiologic evidence of an occluded graft but did not require amputation. In all cases, it was the outflow graft that had occluded; in 3 (42.9%) cases this
30-day 1-year (95% CI)
Mortality 6.3 (%) 96.9 Limb salvage (%) 93.8 Graft patency (%)
12.5 (0.2e24.8)
5-year (95% CI)
40.7 (16.6e64.8)
85.7 (71.7e99.7) 75.9 (52.6e99.1)
83.3 (67.0e99.7) 73.5 (40.8e100.0)
was asymptomatic; in the remaining 4 (57.1%) cases patients had symptoms of claudication alone and were treated conservatively. Overall graft patency rates among the remaining grafts were 93.8%, 83.3%, and 73.5% at 30 days, 1 year and 5 years, respectively (Fig. 3). In total, 12 (37.5%) patients required a total of 19 further ipsilateral vascular procedures (including 10 redo bypasses, 5 interventions for false aneurysms, 2 angioplasties, and 1 endarterectomy). Five patients required a redo multilevel procedure at a mean of 43 months. One patient died 5 months after the revision multilevel procedure of unrelated medical comorbidities. The remaining 4 patients were alive and amputation free 12 months after their revision multilevel procedure.
DISCUSSION This study was designed to investigate the role of multilevel bypass grafting for those with combined aortoiliac and infrainguinal arterial occlusive disease, who are not candidates for endovascular therapy. Such patients are often discussed at vascular multidisciplinary team meetings, where a decision as to which approach to take has to be made. Some patients respond to proximal revascularization alone,14 but up to a third of patients have an unsatisfactory functional result from this, requiring distal revascularization to address outflow disease.2e4,6,8,15e22 Because preoperative identification of patients who respond well to inflow revascularization alone
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Fig. 1. KaplaneMeier curve showing the estimated survival (dotted line: standard error > 10%).
Fig. 2. KaplaneMeier curve showing the estimated limb salvage (dotted line: standard error > 10%).
Fig. 3. KaplaneMeier curve showing the estimated graft patency (dotted line: standard error > 10%).
is difficult, many people have taken the traditional staged approach to management of addressing the inflow problem first and, if necessary, dealing with the outflow problem later. This ‘‘staged approach’’ allows for the evaluation of a patient’s response to inflow reconstruction but risks exposing patients to a second vascular procedure and its associated risks. In addition, patients presenting with limb
threatening ischemia and tissue loss are faced with a very real risk of limb loss if perfusion is not reestablished adequately with the primary procedure. The ‘‘wait-and-see’’ staged approach may result in progression of tissue loss combined with a decline in patient morale and often exacerbation of sepsis and other comorbidities, with the result that a definitive amputation becomes inevitable. Because of this,
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many authors advise consideration of a single multilevel procedure in patients with severe infrainguinal disease (particularly profunda disease) in association with tissue loss.3,6,7,17,23 We would suggest that the presence or absence of tissue loss is the crucial factor and would advise a primary multilevel procedure for patients with multilevel disease in association with tissue loss. An inflow procedure alone should be performed for patients with rest pain but no tissue loss, provided the runoff from the inflow procedure is adequate. Endovascular treatment of aortoiliac lesions is now well established, with a recent systematic review demonstrating results comparable to traditional bypass surgery.24 Long-term patency rates of >90% have been reported for stenting of iliac occlusions.25 A number of authors have also described the use of endovascular techniques combined with surgical infrainguinal bypass.11e13 There is a concern, however, regarding the long-term patency rates following endovascular intervention. It has been suggested that patency rates may be lower when endovascular therapy is combined with infrainguinal bypass than when performed alone, 59% compared with 84% at 3 years according to 1 study.26 This may suggest that patients with extensive multilevel disease have a more aggressive atherosclerotic process, which may be better suited to surgical bypass. Despite this, it is reasonably well accepted and certainly common practice to adopt an endovascular approach as first line treatment in most of the patients, particularly for the inflow component of their disease. However, not all patients are suitable for endovascular therapy and will continue to require operative bypass. Our results suggest that multilevel bypass procedures can be performed safely with reasonable long-term outcomes. Our 30-day mortality of 6.3% compares favorably with previous studies9,10,15,27 and 87.5% of patients were alive 1 year after their primary procedure. The reported range for 30-day mortality after aortobifemoral grafting alone is 2e5%.16,28e30 Patients with multilevel disease are typically older and more likely to have associated comorbidities and advanced peripheral vascular disease.2,3,17e19,22 Taking these factors into consideration, our results would suggest there is little excess mortality associated with the addition of a synchronous infrainguinal bypass procedure. Our 5-year limb salvage rate of 75.9% is encouraging and again suggests benefit from this aggressive
Multilevel bypass grafting 5
surgical approach. Dalman et al.10 similarly demonstrated a limb salvage rate of 90.9% at 2 years. Our 5-year infrainguinal graft patency rate of 73.5% compares with the results of other authors who have demonstrated 4-year graft patency rates of 69e80%.9,15,27 Infrainguinal graft patency rates were significantly lower than limb salvage rates at all stages, with the difference becoming more marked with the passage of time. In most cases, it was the distal graft that had occluded whereas the proximal inflow graft remained patent. Failure of the proximal graft invariably led to distal graft occlusion and was associated with return of symptoms and the need for reintervention. Failure of the distal outflow graft alone at a later stage however was not often associated with significant morbidity. The tissue loss and minor digital amputation wounds had usually healed by then, and graft occlusion usually only caused minor claudication symptoms that could be managed conservatively. It could be argued that this suggests the distal bypass was unnecessary; however, we feel it to be more likely that the period of time between the procedure and the subsequent graft failure had enabled more robust collaterals to develop, which were able to provide adequate tissue perfusion even after distal graft failure. It also requires a much better blood supply to heal a tissue defect than to perfuse a healed limb without skin defect, with the latter usually being the case after a prolonged period of multilevel graft function.
CONCLUSIONS Combining aortoiliac angioplasty and stenting with infrainguinal bypass grafting is well described. However for patients with severe critical limb ischemia and tissue loss, who have a combination of aortoiliac and infrainguinal disease, and who are not candidates for endovascular therapy, a primary multilevel grafting procedure is often their only chance of limb salvage. We have shown that multilevel bypass procedures can be performed with good long-term outcomes and acceptable mortality, in what is typically a high-risk group with extensive comorbidities.
REFERENCES 1. Cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease. National Institute for Health and Clinical Excellence, 2011.
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2. Martinez BD, Hertzer NR, Beven EG. Influence of distal arterial occlusive disease on prognosis following aortobifemoral bypass. Surgery 1980;88:795e805. 3. Royster TS, Lynn R, Mulcare RJ. Combined aortoiliac and femoropopliteal occlusive disease. Surg Gynecol Obstet 1976;143:949e52. 4. Mulcare RJ, Royster TS, Lynn RA, et al. Long-term results of operative therapy for aortoiliac disease. Arch Surg 1978;113: 601e4. 5. Smith FCT. Non-surgical treatment of critical leg ischaemia. In: Earnshaw JJ, Murie JA eds. The Evidence for Vascular Surgery. 2nd edn. Shrewsbury: Tfm Publishing, 2007. pp 81e90. 6. Brewster DC, Perler BA, Robison JG, et al. Aortofemoral graft for multilevel occlusive disease. Predictors of success and need for distal bypass. Arch Surg 1982;117:1593e600. 7. Sumner DS, Strandness DE. Aortoiliac reconstruction in patients with combined iliac and superficial femoral arterial occlusion. Surgery 1978;84:348e55. 8. Benson JR, Whelen TJ, Cohen A, et al. Combined aortoiliac and femoropopliteal occlusive disease: limitations of total aortofemoropopliteal bypass. Ann Surg 1966;163:121e30. 9. Eidt J, Charlesworth D. Combined aortobifemoral and femoropopliteal bypass in the management of patients with extensive atherosclerosis. Ann Vasc Surg 1986;1:453e9. 10. Dalman RL, Taylor LM Jr, Moneta GL, et al. Simultaneous operative repair of multilevel lower extremity occlusive disease. J Vasc Surg 1991;13:211e21. 11. Mousa A, Abdel-Hamid M, Ewida A, et al. Combined percutaneous endovascular iliac angioplasty and infrainguinal surgical revascularization for chronic lower extremity ischemia: preliminary result. Vascular 2010;18:71e6. 12. Lau H, Cheng SW. Intraoperative endovascular angioplasty and stenting of iliac artery: an adjunct to femoro-popliteal bypass. J Am Coll Surg 1998;186:414e5. 13. Liu C, Guan H, Li Y, et al. Combined intraoperative iliac artery stents and femoro-popliteal bypass for multilevel atherosclerotic occlusive disease. Chin Med Sci J 2001;16:165e8. 14. Charlesworth D, Harris PL, Cave FD, et al. Undetected aortoiliac insufficiency: a reason for early failure of saphenous vein bypass grafts for obstruction of the superficial femoral artery. Br J Surg 1975;62:567e70. 15. Harris PL, Bigley DJ, McSweeney L. Aortofemoral bypass and the role of concomitant femorodistal reconstruction. Br J Surg 1985;72:317e20.
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16. Malone JM, Moore WS, Goldstone J. The natural history of bilateral aortofemoral bypass grafts for ischemia of the lower extremities. Arch Surg 1975;110:1300e6. 17. Samson RH, Scher LA, Veith FJ. Combined segment arterial disease. Surgery 1985;97:385e96. 18. Brewster DC, Darling RC. Optimal methods of aortoiliac reconstruction. Surgery 1978;84:739e48. 19. Hill DA, McGrath MA, Lord RS, et al. The effect of superficial femoral artery occlusion on the outcome of aortofemoral bypass for intermittent claudication. Surgery 1980;87: 133e6. 20. Edwards WH, Wright RS. A technique for combined aortofemoral-popliteal arterial reconstruction. Ann Surg 1974;179: 572e9. 21. Bone GE, Hayes AC, Slaymaker EE, et al. Value of segmental limb blood pressures in predicting results of aortofemoral bypass. Am J Surg 1976;132:733e8. 22. Galland RB, Hill DA, Gustave R, et al. The functional results of aorto-iliac reconstruction. Br J Surg 1980;67:344e6. 23. Heyden B, Vollmar J, Voss EU. Principles of operation for combined aortoiliac and femoropopliteal occlusive lesions. Surg Gynecol Obstet 1980;151:519e24. 24. Jongkind V, Akkersdijk GJ, Yeung KK, et al. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg 2010;52:1376e83. 25. Gandini R, Fabiano S, Chiocchi M, et al. Percutaneous treatment in iliac artery occlusion: long-term results. Cardiovasc Intervent Radiol 2008;31:1069e76. 26. Kashyap VS, Pavkov ML, Bena JF, et al. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg 2008;48:1451e7. 27. Harward TR, Ingegno MD, Carlton L, et al. Limb-threatening ischemia due to multilevel arterial occlusive disease. Simultaneous or staged inflow/outflow revascularization. Ann Surg 1995;221:498e503. discussion 503e506. 28. Madiba TE, Robbs JV. Aortobifemoral bypass for the critically ischaemic limbeis it worth while? S Afr J Surg 1991;29:138e41. 29. Moore WS, Cafferata HT, Hall AD, et al. In defense of grafts across the inguinal ligament. An evaluation of early and late results of aorto-femoral bypass grafts. Ann Surg 1968;168: 207e14. 30. de Vries SO, Hunink MG. Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta-analysis. J Vasc Surg 1997;26:558e69.
