Clinical Research Hybrid Revascularization Procedures in Acute Limb Ischemia Christos Argyriou,1 Efstratios Georgakarakos,1 George S. Georgiadis,1 George A. Antoniou,2 Nikolaos Schoretsanitis,1 and Miltos Lazarides,1 Alexandroupolis and Athens, Greece
Background: Although the clinical efficacy of hybrid procedures in patients with chronic limb ischemia has been well reported in the literature, sufficient evidence is lacking in the acute setting. Our aim was to evaluate the immediate and midterm clinical results on 28 patients with acute lower limb ischemia treated with hybrid reconstructions on emergent basis, from January 2010 to March 2013 in our tertiary referral vascular center. Methods: A total of 28 patients (31 operated limbs) underwent emergent hybrid revascularization, with endovascular treatment performed proximally or distally to the site of open reconstruction. The median follow-up period was 6 months (range: 1e26). The immediate technical success was clinically and hemodynamically evaluated with an ankle brachial pressure index (ABPI) measurement. Six-month overall patency, limb salvage, and survival rate were also estimated. All analyses were performed with KaplaneMeier life table method, using the STATISTICA 7.0 statistical program. Results: Twenty-seven patients presented with grade IIb and 1 with grade III ischemia, respectively. Technical success was achieved in all patients, whereas hemodynamic improvement rate was achieved in 98%. ABPI preoperatively was increased from 0.14 ± 0.1 to 0.69 ± 0.28 postoperatively (P < 0.05). Perioperative morbidity and mortality rates were 21% and 11% respectively. Six-month overall patency, limb salvage, and survival rate were 86%, 92%, and 79%, respectively. Conclusions: Hybrid revascularization in immediately threatened limbs provides an effective and durable option with acceptable mortality and amputation rate in these high-risk patients. These findings should be further confirmed by larger scale clinical studies.
INTRODUCTION Acute limb ischemia (ALI) results from a sudden compromise of blood flow to the limb due to
C.A. and E.G. have equally contributed to the article. 1 Department of Vascular Surgery, ‘‘Democritus’’ Medical School, University Hospital of Alexandroupolis, Alexandroupolis, Greece. 2 Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece.
Correspondence to: Efstratios Georgakarakos, MD, Department of Vascular Surgery, ‘‘Democritus’’ Medical School, University Hospital of Alexandroupolis, 68100 Alexandroupolis, Greece; E-mail: [email protected] Ann Vasc Surg 2014; -: 1–7 http://dx.doi.org/10.1016/j.avsg.2014.01.019 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: July 26, 2013; manuscript accepted: January 23, 2014; published online: ---.
arterial embolus, bypass graft thrombosis, or in situ thrombosis resulting in limb loss and/or major adverse effects if left untreated.1While single-level arterial disease can be treated with either endovascular or open surgical procedures, multilevel patterns of occlusive arterial disease, most commonly associated with critical limb ischemia, comprise either extensive operative procedures or a combination of endovascular techniques and open vascular surgery, performed in a single or multiple settings.2 Hybrid revascularization procedures can be categorized into 1) those involving endovascular treatment proximal to the site of open reconstruction, 2) endovascular procedures distal to the site of open surgery, and 3) interventions consisting of open arterial reconstruction with both proximal and distal endovascular procedures.2 Hybrid interventions can 1
2 Argyriou et al.
also be categorized according to the anatomic complexity of the endovascular-treated segment. Endoluminal treatment of segments classified as Trans-Atlantic Inter-Society Consensus (TASC) II A or B have been described as simple hybrid procedures, whereas endovascular reconstruction of TASC II C or D lesions have been identified as complex hybrid procedures.3 Hybrid procedures have been used in patients with chronic limb ischemia (CLI) to obviate the need for major arterial reconstruction, by minimizing surgical stress and trauma, thus causing less physiological impact and avoiding complications of major surgery. Although their clinical efficacy in patients with CLI has been well reported in the literature,2e19 sufficient evidence is lacking in the acute setting. The aim of this study was to evaluate the immediate and midterm clinical results on 28 patients with ALI treated by emergent vascular hybrid reconstructions (n ¼ 31).
MATERIALS AND METHODS We performed a retrospective study including 28 patients (31 limbs) with ALI who underwent a total of 31 emergent hybrid vascular reconstructions from January 2010 to March 2013 in Alexandroupolis University Hospital, a tertiary referral center in northern Greece. During the study period, 87 patients presented with ALI, 28 (32%) of whom underwent a hybrid revascularization procedure. All patients gave informed consent before operative management. Patients presenting with ALI were categorized according to the Rutherford classification of limb ischemia.20 Patients’ characteristics, comorbidities, and history of previous ipsilateral lower limb revascularization procedures were recorded. Only patients with grade IIb were included in the emergent protocol, which comprised color duplex sonography for exclusion of abdominal aortic aneurysm or any thrombosed popliteal aneurysm, and immediate admission to the operating room for intraoperative angiography with portable C-arm. Planning of digital subtraction angiography (DSA) and consequent scheduled revascularization was reserved only for patients with less-severe ischemia (grade I or IIa). A key point for the hybrid approach was the presence of stenotic lesions in common femoral artery (CFA), rendering the endarterectomy with patch mandatory, followed by a single-staged endovascular procedure.21 This approach was amenable for 31% of patients (27 individuals) presented with
Annals of Vascular Surgery
grade IIb ischemia, whereas the rest were treated either endovascularly or surgically. The type of intervention, level of reconstruction, accompanying operations (concomitant vascular operation on the contralateral limb and/or minor amputations), perioperative data (total operative time, blood transfusion, and type of anesthesia), and postoperative information were collected and retrospectively reviewed using in-hospital charts, operative and outpatient clinic records, and telephone communication. All patients underwent preoperative peripheral vascular examination, ankle brachial pressure index (ABPI) measurement, and duplex ultrasonography (in selected cases). The same team of vascular surgeons selected the patients, planned, and conducted the hybrid arterial reconstructions under anesthesiologist assistance and monitoring. The procedures were performed in the operating theater by means of a portable C-arm device (Philips BV Endura; Philips Medical Systems, 2.2.3, Eindhoven, the Netherlands). Iliac lesions and femoropopliteal lesions were categorized according to the TASC II.1 TASC A, B, and C iliac lesions were treated with angioplasty and/ or stenting. Open arterial reconstruction was the treatment of choice for TASC D lesions. The procedures were performed under spinal anesthesia in 13 patients (47%), general anesthesia in 11 patients (39%), and local anesthesia in 4 patients (14%). All patients received 5,000 IU of standard heparin at the beginning of the procedure. For TASC A to C iliofemoral or femoropopliteal lesions, angioplasty was attempted as the first-line therapy, with stenting reserved only for cases of residual stenosis (>30%), elastic recoil, or flow-limiting dissection. Tibial vessels were managed with angioplasty alone. Because the femoral bifurcation is the key area of interest of the open component of the hybrid procedure, the CFA and the origins of the superficial and profunda femoral artery (PFA) are dissected free from the surrounding structures, followed by endarterectomy and reconstruction with bovine or synthetic patch in most of the cases. In addition, the open surgical stage can also comprise femoropopliteal, femorodistal, or crossover femorofemoral bypass. Accordingly, the endovascular part of the operation may proceed or follow in case of iliac or infrainguinal diseases, respectively. The endovascular procedure is usually carried out via a 5F to 7F arterial sheath placed through the patch or the bypass graft material, in the antegrade or retrograde fashion, depending on the site of the endovascular target (Fig. 1). Completion angiography was always
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Table I. Patient characteristics
Fig. 1. Common femoral artery angioplasty with synthetic patch followed by insertion of a 0.0350 hydrophilic guidewire through a 7F sheath for iliac angioplasty.
performed at the end of the procedure, and the femoral incision was sutured in a standard fashion. Only 1 patient was lost on follow-up. The other patients underwent a postoperative surveillance program that consisted of clinical examination and ABPI measurement at 3, 6, 12, and 24 months. Patients with worsening symptoms, absence of femoral pulse, and ABPI decrease >0.15 were further assessed with DSA or computed tomography angiography and treated accordingly, when necessary. Definitions and End Points Technical success was defined as restoration of blood flow with residual stenosis of 0.1 according to the reporting standards.22 Clinical success was defined as improvement by at least 1 level in Rutherford scale,20 except in cases of actual tissue loss, where the ‘‘clinical success’’ should be moved up by at least 2 categories. Adverse effects and death occurring within 30 days of the procedure were considered as procedure-related morbidity and mortality, respectively. Patency and limb salvage analysis was performed using KaplaneMeier life table method, with the STATISTICA 7.0 (StatSoft, Tulsa, OK) statistical program.
RESULTS Demographic and clinical data of the study population are shown in Table I. The mean age of the population was 73 ± 13 years (range: 52e96) with a male predominance (15 men, 54%). Seven (25%)
Number of limbs Mean age (years) Sex Male Female Hypertension Diabetes mellitus Coronary artery disease Dyslipidemia Smoking Previous vascular operations Indication for intervention (according to Rutherford classification19) IIb III
31 73 (47e96) 15 13 21 12 7 10 8 8
(54%) (46%) (75%) (43%) (25%) (36%) (29%) (29%)
30 (98%) 1 (2%)
patients had a history of peripheral arterial disease before their operation, whereas 21 (75%) patients were asymptomatic (no history of intermittent claudication or previous vascular intervention). Grade IIb ischemia was present in 48 (55%) patients. The time from the onset of symptoms to the patient’s admission ranged between 3 and 6 hrs, and the duration of hospitalization was 6.1 ± 2.8 days. Thirty (98%) patients were treated emergently for Rutherford category IIb ischemia, whereas only 1 patient was categorized as type III. Among the 23 limbs treated for combined iliacfemoral disease, nearly half of the iliac lesions (11/ 23, 48%) were classified as TASC B, whereas TASC A and C were met in 26% and 26% of cases, respectively. Accordingly, the lesions in the femoropopliteal segment in patients treated with infrainguinal disease were classified as TASC A, B, and C in 25%, 25%, and 50% of cases, respectively. The types of combined open and endovascular procedures are presented in Table II. Three patients underwent simultaneous vascular operations in both limbs. The most common open procedure was endarterectomy of the femoral bifurcation combined with patch closure (23/31, 74%). CFA-to-PFA jump-graft was performed in 13% (4/31). Femorofemoral bypass was performed in 4 patients, and femoropopliteal bypass in 1 patient, whereas 1 patient underwent interposition graft between the CFA and superficial femoral artery (SFA). Iliac artery angioplasty and/or stenting was the most frequently performed endovascular procedure (20/31, 68%) followed by angioplasty/stenting of SFA/popliteal arteries (8/31, 26%). Other endovascular procedures included angioplasty of tibial vessels in 2 patients and 1 stent graft placement in the SFA. The mean operative time was 139 ± 54.6 min.
4 Argyriou et al.
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Table II. Types of open and endovascular procedures performed in 31 limbs in the acute setting Procedures
Open procedures Femoral bifurcation endarterectomy Femorofemoral crossover bypass Femoropopliteal bypass CFA-SFA interposition graft Common femoral-femoralis profunda bypass Endovascular procedures PTA/stent CIA/EIA PTA/stent SFA/popliteal artery PTA in infragenicular arteries PTA/stent of prosthetic graft
Total
23 4 1 1 2 20 8 2 1
CIA, common iliac artery; EIA, external iliac artery; PTA, percutaneous transluminal angioplasty; SFA, superficial femoral artery.
Perioperative transfusion was 1 ± 1 units of blood. No patient received intraoperative thrombolysis. Immediate Results Technical success was achieved in 100% of patients. ABPI was increased from 0.14 ± 0.1 preoperatively to 0.69 ± 0.28 postoperatively (P < 0.05). Hemodynamic success was achieved in all but 1 patient (98%). Perioperative mortality and morbidity rates were 11% and 21%, respectively. One patient died because of metabolic acidosis on the first postoperative day. This 82-year-old male patient with acute aortic thrombosis was subjected to bilateral iliac artery angioplasty and stenting, followed by endarterectomy and patch arterioplasty of the right CFA. His metabolic deterioration was attributed to reperfusion syndrome, soon after the operation. Two patients suffered a fatal myocardial infarction on the third and fifth postoperative day, respectively. The first patient was subjected to iliac artery angioplasty/stenting and ipsilateral common femoral to deep femoral artery bypass. Although the clinical result was suboptimal with only marginal increase of the ankle brachial index, he did not consent to further revascularization, because of advanced age (86 years). The second death (of cardiac origin) occurred in a 63-year-old heavy smoker, whose medical history revealed a chronic untreated coronary artery disease. He underwent iliac artery angioplasty/ stenting followed by common femoral endarterectomy with polytetrafluoroethylene patch closure and femoropopliteal (above-knee) bypass. Perioperative complications occurred in 6 patients (21%), including occlusion of a femoropopliteal bypass (with no further attempt for revascularization)
in 1 patient, groin hematoma in 2 patients, contrast-induced acute renal failure in 1 patient, and surgical wound infections in 1 patient. In addition, 1 patient underwent subtotal colectomy because of acute mesenteric ischemia, which was further complicated by a stroke and a right-sided hemiplegia. Outcome on Follow-up The median follow-up was 6 months (range: 1e26). The 6-month overall patency, limb salvage, and survival rate were 86%, 92%, and 79%, respectively (Fig. 2). One patient was lost on follow-up, because of suffering from a major stroke. There were 4 deaths during the follow-up period. Two patients underwent an amputation during the second and third months, respectively.
DISCUSSION Hybrid vascular reconstructions provide an alternative method for treating multilevel disease in highrisk surgical patients. The use of hybrid procedures has been shown to constitute approximately 5e 21% of all vascular reconstructions.3,22 Their efficacy in terms of immediate technical success, primary, primary-assisted, and secondary patency rates, as well as limb salvage rates in CLI have been well reported.2,3,5,14e16,19,20,23,24 Antoniou et al.2 reported a perioperative mortality rate of 3% with high technical and hemodynamic success rates of 100% and 95%, respectively, confirming the immediate efficacy of the hybrid approach in CLI, whereas the primary and primary-assisted patency rates at 12 months were 71% and 98%, respectively. Furthermore, another report of 171 patients having undergone 193 hybrid procedures revealed a 5-year primary, primary-assisted, and secondary patency rates of 60%, 97%, and 98%, respectively.15 However, sufficient evidence for the therapeutic option of hybrid procedures in emergent situations for the treatment of ALI is lacking. Because native artery occlusions usually occur in patients with severe atherosclerotic disease, the increase in prevalence of peripheral arterial disease raises the percentage of ALI attributed to thrombosis.25 Indeed, a series of 380 patients subjected to thromboembolectomy for ALI with concomitant on-table angiography revealed that almost 25% presented an underlying stenotic lesion that was subsequently treated with angioplasty.26 Interestingly, the risk of limb loss in ALI ranges from 5% to 30% with mortality rates approaching 18%.27e29
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Fig. 2. KaplaneMeier analysis showing cumulative patency, limb, and patient survival (standard deviation exceeds 10% at 12 months only for patency).
Baril et al.30 have recently reported on the outcomes of bypass procedures, performed for ALI in a series of 323 patients. Interestingly, these interventions were associated with higher rates of limb loss and mortality when compared with elective operations (22.4% vs. 9.7%, P < 0.0001 and 20.9% vs. 13.1%, P < 0.0001, respectively). The higher mortality and amputation rates were attributed to the impaired medical optimization of the patients before the operation and the higher perioperative adverse events. In addition, a recent retrospective study by Balaz et el.31 compared hybrid procedures among 163 patients, with 19% having either urgent or emergent revascularization. Nine patients in this study were categorized as type IIb ischemia. No statistical significance in perioperative morbidity between patients with claudication, CLI, and ALI was shown despite the higher risk of amputation in the ALI group.31 Hybrid reconstructions are considered lessinvasive procedures especially in patients with significant comorbid conditions, decreasing the magnitude of the procedure, limiting the incision to the groin, and obviating the need for adjunctive thrombolysis and major surgery. However, their advantages in the acute setting (ALI) remain to be confirmed, because the impaired general status of vascular patients in conjunction with the metabolic reperfusion tissue damage is expected to negatively affect limb salvage and patient survival.30 Obviously, a study directly comparing clinical outcomes of hybrid interventions between ALI and CLI patients, or the efficacy of open surgical versus hybrid procedures in ALI patients would provide additional clinical information to improve treatment of ischemic limbs and delineate the utility of combined
Hybrid management in acute ischemia 5
hybrid procedures. These comprise future study tasks of our department. Most of the iliofemoral and femoropopliteal lesions in our study group were TASC II C, and successful endovascular treatment was involved in most of the cases (Table II). The immediate technical success and clinical efficacy of combined (hybrid) iliac stenting and open femoral endarterectomy for complex iliofemoral lesions present satisfactory results compared with more extensive and complex open reconstructions.23,32,33 In addition, the technical success of endovascular treatment in femoropopliteal TASC II B and C lesions has been adequately documented in contrast to TASC D lesions, whereas the freedom from restenosis/occlusion at 12 and 24 months was estimated to be 59% and 48%, respectively, according to Baril et al.34,35 Moreover, the overall assisted primary and secondary patency rates were 87% and 94% at 3 years, respectively, with no significant differences between TASC B and C lesions.32 Because hybrid techniques have been associated with comparable clinical efficacy to the open reconstructions, but shorter hospital length and lower morbidity, we chose to apply these for the treatment of ALI.32e35 Our study showed a perioperative morbidity and mortality of 21% and 11%, respectively, in 28 patients who underwent 31 hybrid vascular reconstructions emergently. It seems that although old people with multilevel disease benefit from lessinvasive revascularization procedures, the pathophysiologic aspects of sudden hypoperfusion of the limbs with consequent postoperative reperfusion injuries result in severe cardiovascular, renal, and metabolic disturbances, deteriorating patients’ general status.36 One should also take into account the suboptimal preoperative evaluation because of the urgent setting of the disease, contributing also to the high perioperative or postoperative risk. Our early experience showed that no intraoperative thrombolysis was mandatory in any patient. Had it been considered necessary, according to the surgeon’s opinion, a time-limited local catheterdirected delivery of thrombolytic agent within the lesion would have been attempted. However, we avoided the use of thrombolysis as part of our practice because it usually requires a prolonged time of action, not available in grade IIb ischemia. As previously mentioned, there is a lack of evidence in the literature regarding direct comparison between open and hybrid procedures in the acute setting,2,25,31 depicting the need for larger prospective series and report of midterm and longterm results. Prospective studies of hybrid revascularization procedures in the acute and chronic
6 Argyriou et al.
setting are expected to offer further clarification on perioperative morbidity and mortality of hybrid procedures in the acute setting group, the cost effectiveness of hybrid management compared with open surgery, the procedural cost as well as the intensive care or hospital stay. In addition, future research should compare hybrid operations with alternative strategies, such as 2-staged reconstructions (open or endovascular), because the latter may be associated with less impact on renal function (avoiding contrast material) and less operative exposure. Admittedly, potential limitations of our study were its retrospective nature and the small number of treated patients with lack of homogeneity between various reconstructive procedures for direct comparison. The short follow-up could be partly explained by the advanced age of the study group and their associated increased morbidity. However, we believe that the short-term and midterm results in our patient sample justify the role of these procedures in an emergency setting. Moreover, the runoff vessel status was not documented in detail, because of the inability of older generation C-arm devices to provide a high resolution and thorough mapping of the entire tibial runoff. Admittedly, more sophisticated equipment in modern endovascular suites could offer an additional insight to the tibial runoff, determining factors to improve the clinical outcome.
CONCLUSIONS Hybrid vascular operations in the acute setting provide an effective option in the treatment of multilevel arterial disease. Our study identified a considerable perioperative mortality of these emergent hybrid procedures compared with previous reports of elective interventions, underscoring the need for further clinical research in this challenging and innovative field. REFERENCES 1. Norgren L, Hiatt WR, Dormandy JA, et al., TASC II working group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007; 45(Suppl):S5e67. 2. Antoniou GA, Sfyroeras GS, Karathanos C, et al. Hybrid endovascular and open treatment for severe multilevel lower extremity arterial disease. Eur J Vasc Endovasc Surg 2009;38:616e22. 3. Dosluoglu HH, Lall P, Cherr GS, et al. Role of simple and complex hybrid revascularization procedures for symptomatic lower extremity occlusive disease. J Vasc Surg 2010; 51:1425e35.
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4. Spoelstra H, Nevelsteen A, Wilms G, et al. Balloon angioplasty combined with vascular surgery. Eur J Vasc Surg 1989;3:381e8. 5. Brewster DC, Cambria RP, Darling RC, et al. Long-term results of combined iliac balloon angioplasty and distal surgical revascularization. Ann Surg 1989;210:324e30. 6. Perler BA, Williams GM. Does donor iliac artery percutaneous transluminal angioplasty or stent placement influence the results of femorofemoral bypass? Analysis of 70 consecutive cases with long-term follow up. J Vasc Surg 1996;24: 363e9. 7. Madera FA, Orecchia PM, Razzino RA, et al. Balloon angioplasty by vascular surgeons. Am J Surg 1997;174:152e6. 8. Aburahma AF, Robinson PA, Cook CC, et al. Selecting patients for femorofemoral bypass grafting and iliac balloon angioplasty and stenting for bilateral iliac disease. J Vasc Surg 2001;33:S93e9. 9. Schneider PA, Caps MT, Ogawa DY, et al. Intraoperative superficial femoral artery balloon angioplasty and popliteal to distal bypass graft: an option for combined open and endovascular treatment of diabetic gangrene. J Vasc Surg 2001;33:955e62. 10. Nelson PR, Powell RJ, Schermerhorn ML, et al. Early results of external iliac artery stenting combined with common femoral artery endarterectomy. J Vasc Surg 2002;35: 1107e13. 11. Dougherty MJ, Young LP, Calligaro KD. One-hundred twenty-five concominant endovascular and open procedures for lower extremity arterial disease. J Vasc Surg 2003;37:316e22. 12. Schneider PA. Iliac angioplasty and stenting combined with infraguinal bypasses: timing and techniques. Semin Vasc Surg 2003;16:291e9. 13. Miyahara T, Miyata T, Shigematsu H, et al. Long-term results of combined iliac endovascular intervention and infraguinal surgical revascularization for treatment of multilevel peripheral arterial disease. Int Angiol 2005;24:340e8. 14. Cotroneo AR, Iezzi R, Marano G, et al. Hybrid therapy in patients with complex peripheral multifocal steno-obstructive vascular disease: two-year results. Cardiovasc Intervent Radiol 2007;30:355e61. 15. Chang RW, Goodney PP, Baek JH, et al. Long-term results of combined femoral endarterectomy and iliac stenting/stent grafting for occlusive disease. J Vasc Surg 2008;48:362e7. 16. Balaz P, Rokosny S, Koznar B, et al. Combined infrainguinal reconstruction and infrapopliteal intraluminal angioplasty for limb salvage in critical limb ischemia. Interact Cardiovasc Thorac Surg 2009;9:191e4. 17. Nishibe T, Kondo Y, Dardik A, et al. Hybrid surgical and endovascular therapy in multifocal peripheral TASC D lesions: up to three-year follow-up. J Cardiovasc Surg 2009;50:493e9. 18. Matsagkas M, Kouvelos G, Arnaoutoglou E, et al. Hybrid procedures for patients with critical limb ischemia and severe common femoral artery atherosclerosis. Ann Vasc Surg 2011;25:1063e9. 19. Aho P-S, Venermo M. Hybrid procedures as a novel technique in the treatment of critical limb ischemia. Scand J Surg 2012;101:107e13. 20. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 1997;26:517e38. 21. Sharafuddin MJ, Kresowik TF, Hoballah JJ, et al. Combined direct repair and inline inflow stenting in the management of aortoiliac disease extending into the common femoral artery. Vasc Endovascular Surg 2011;45:274e82.
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22. Ebaugh JL, Gagnon D, Owens CD, et al. Comparison of costs of staged versus simultaneous lower extremity arterial hybrid procedures. Am J Surg 2008;196:634e40. 23. Piazza M, Ricotta JJ 2nd, Bower TC, et al. Iliac artery stenting combined with femoral endarterectomy is as effective as open surgical reconstruction for severe iliac and common femoral occlusive disease. J Vasc Surg 2011;54:402e11. 24. Zou J, Xia Y, Yang H, et al. Hybrid endarterectomy and endovascular therapy in multilevel lower extremity arterial disease involving the femoral artery bifurcation. Int Surg 2012;97:56e64. 25. Costantini V, Lenti M. Treatment of acute occlusion of peripheral arteries. Thromb Res 2002;106:V285e94. 26. Zaraca F, Stringari C, Ebner JA, et al. Routine versus selective use of intraoperative angiography during thromboembolectomy for acute lower limb ischemia: analysis of outcomes. Ann Vasc Surg 2010;24:621e7. 27. Tawes RL Jr, Harris EJ, Brown WH, et al. Arterial thromboembolism. A 20-year perspective. Arch Surg 1985;120:595e9. 28. Hynes BG, Margey RJ, Ruggiero N 2nd, et al. Endovascular management of acute limb ischemia. Ann Vasc Surg 2012;26:110e24. 29. Creager MA, Kaufman JA, Conte MS. Acute limb ischemia. N Engl J Med 2012;366:2198e206.
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30. Baril DT, Patel VI, Judelson DR, et al., Vascular Study Group of New England. Outcomes of lower extremity bypass performed for acute limb ischemia. J Vasc Surg 2013; http:// dx.doi.org/10.1016/j.jvs.2013.04.036. 31. Balaz P, Rokosny S, Wohlfahrt P, et al. Early and late outcomes of hybrid endovascular and open repair procedures in patients with peripheral arterial disease. Vasa 2013;42:292e300. 32. Sim o G, Banga P, Darabos G, et al. Stent-assisted remote iliac artery endarterectomy: an alternative approach to treating combined external iliac and common femoral artery disease. Eur J Vasc Endovasc Surg 2011;42:648e55. 33. Sachwani GR, Hans SS, Khoury MD, et al. Results of iliac stenting and aortofemoral grafting for iliac artery occlusions. J Vasc Surg 2013;57:1030e7. 34. Baril DT, Marone LK, Kim J, et al. Outcomes of endovascular interventions for TASC II B and C femoropopliteal lesions. J Vasc Surg 2008;48:627e33. 35. Baril DT, Chaer RA, Rhee RY, et al. Endovascular interventions for TASC II D femoropopliteal lesions. J Vasc Surg 2010;51:1406e12. 36. Beyersdorf F, Matheis G, Kruger S, et al. Avoiding reperfusion injury after revascularization: experimental observations and recommendations for clinical application. J Vasc Surg 1989;9:757e66.
Background: Although the clinical efficacy of hybrid procedures in patients with chronic limb ischemia has been well reported in the literature, sufficient evidence is lacking in the acute setting. Our aim was to evaluate the immediate and midterm clinical results on 28 patients with acute lower limb ischemia treated with hybrid reconstructions on emergent basis, from January 2010 to March 2013 in our tertiary referral vascular center. Methods: A total of 28 patients (31 operated limbs) underwent emergent hybrid revascularization, with endovascular treatment performed proximally or distally to the site of open reconstruction. The median follow-up period was 6 months (range: 1e26). The immediate technical success was clinically and hemodynamically evaluated with an ankle brachial pressure index (ABPI) measurement. Six-month overall patency, limb salvage, and survival rate were also estimated. All analyses were performed with KaplaneMeier life table method, using the STATISTICA 7.0 statistical program. Results: Twenty-seven patients presented with grade IIb and 1 with grade III ischemia, respectively. Technical success was achieved in all patients, whereas hemodynamic improvement rate was achieved in 98%. ABPI preoperatively was increased from 0.14 ± 0.1 to 0.69 ± 0.28 postoperatively (P < 0.05). Perioperative morbidity and mortality rates were 21% and 11% respectively. Six-month overall patency, limb salvage, and survival rate were 86%, 92%, and 79%, respectively. Conclusions: Hybrid revascularization in immediately threatened limbs provides an effective and durable option with acceptable mortality and amputation rate in these high-risk patients. These findings should be further confirmed by larger scale clinical studies.
INTRODUCTION Acute limb ischemia (ALI) results from a sudden compromise of blood flow to the limb due to
C.A. and E.G. have equally contributed to the article. 1 Department of Vascular Surgery, ‘‘Democritus’’ Medical School, University Hospital of Alexandroupolis, Alexandroupolis, Greece. 2 Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece.
Correspondence to: Efstratios Georgakarakos, MD, Department of Vascular Surgery, ‘‘Democritus’’ Medical School, University Hospital of Alexandroupolis, 68100 Alexandroupolis, Greece; E-mail: [email protected] Ann Vasc Surg 2014; -: 1–7 http://dx.doi.org/10.1016/j.avsg.2014.01.019 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: July 26, 2013; manuscript accepted: January 23, 2014; published online: ---.
arterial embolus, bypass graft thrombosis, or in situ thrombosis resulting in limb loss and/or major adverse effects if left untreated.1While single-level arterial disease can be treated with either endovascular or open surgical procedures, multilevel patterns of occlusive arterial disease, most commonly associated with critical limb ischemia, comprise either extensive operative procedures or a combination of endovascular techniques and open vascular surgery, performed in a single or multiple settings.2 Hybrid revascularization procedures can be categorized into 1) those involving endovascular treatment proximal to the site of open reconstruction, 2) endovascular procedures distal to the site of open surgery, and 3) interventions consisting of open arterial reconstruction with both proximal and distal endovascular procedures.2 Hybrid interventions can 1
2 Argyriou et al.
also be categorized according to the anatomic complexity of the endovascular-treated segment. Endoluminal treatment of segments classified as Trans-Atlantic Inter-Society Consensus (TASC) II A or B have been described as simple hybrid procedures, whereas endovascular reconstruction of TASC II C or D lesions have been identified as complex hybrid procedures.3 Hybrid procedures have been used in patients with chronic limb ischemia (CLI) to obviate the need for major arterial reconstruction, by minimizing surgical stress and trauma, thus causing less physiological impact and avoiding complications of major surgery. Although their clinical efficacy in patients with CLI has been well reported in the literature,2e19 sufficient evidence is lacking in the acute setting. The aim of this study was to evaluate the immediate and midterm clinical results on 28 patients with ALI treated by emergent vascular hybrid reconstructions (n ¼ 31).
MATERIALS AND METHODS We performed a retrospective study including 28 patients (31 limbs) with ALI who underwent a total of 31 emergent hybrid vascular reconstructions from January 2010 to March 2013 in Alexandroupolis University Hospital, a tertiary referral center in northern Greece. During the study period, 87 patients presented with ALI, 28 (32%) of whom underwent a hybrid revascularization procedure. All patients gave informed consent before operative management. Patients presenting with ALI were categorized according to the Rutherford classification of limb ischemia.20 Patients’ characteristics, comorbidities, and history of previous ipsilateral lower limb revascularization procedures were recorded. Only patients with grade IIb were included in the emergent protocol, which comprised color duplex sonography for exclusion of abdominal aortic aneurysm or any thrombosed popliteal aneurysm, and immediate admission to the operating room for intraoperative angiography with portable C-arm. Planning of digital subtraction angiography (DSA) and consequent scheduled revascularization was reserved only for patients with less-severe ischemia (grade I or IIa). A key point for the hybrid approach was the presence of stenotic lesions in common femoral artery (CFA), rendering the endarterectomy with patch mandatory, followed by a single-staged endovascular procedure.21 This approach was amenable for 31% of patients (27 individuals) presented with
Annals of Vascular Surgery
grade IIb ischemia, whereas the rest were treated either endovascularly or surgically. The type of intervention, level of reconstruction, accompanying operations (concomitant vascular operation on the contralateral limb and/or minor amputations), perioperative data (total operative time, blood transfusion, and type of anesthesia), and postoperative information were collected and retrospectively reviewed using in-hospital charts, operative and outpatient clinic records, and telephone communication. All patients underwent preoperative peripheral vascular examination, ankle brachial pressure index (ABPI) measurement, and duplex ultrasonography (in selected cases). The same team of vascular surgeons selected the patients, planned, and conducted the hybrid arterial reconstructions under anesthesiologist assistance and monitoring. The procedures were performed in the operating theater by means of a portable C-arm device (Philips BV Endura; Philips Medical Systems, 2.2.3, Eindhoven, the Netherlands). Iliac lesions and femoropopliteal lesions were categorized according to the TASC II.1 TASC A, B, and C iliac lesions were treated with angioplasty and/ or stenting. Open arterial reconstruction was the treatment of choice for TASC D lesions. The procedures were performed under spinal anesthesia in 13 patients (47%), general anesthesia in 11 patients (39%), and local anesthesia in 4 patients (14%). All patients received 5,000 IU of standard heparin at the beginning of the procedure. For TASC A to C iliofemoral or femoropopliteal lesions, angioplasty was attempted as the first-line therapy, with stenting reserved only for cases of residual stenosis (>30%), elastic recoil, or flow-limiting dissection. Tibial vessels were managed with angioplasty alone. Because the femoral bifurcation is the key area of interest of the open component of the hybrid procedure, the CFA and the origins of the superficial and profunda femoral artery (PFA) are dissected free from the surrounding structures, followed by endarterectomy and reconstruction with bovine or synthetic patch in most of the cases. In addition, the open surgical stage can also comprise femoropopliteal, femorodistal, or crossover femorofemoral bypass. Accordingly, the endovascular part of the operation may proceed or follow in case of iliac or infrainguinal diseases, respectively. The endovascular procedure is usually carried out via a 5F to 7F arterial sheath placed through the patch or the bypass graft material, in the antegrade or retrograde fashion, depending on the site of the endovascular target (Fig. 1). Completion angiography was always
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Table I. Patient characteristics
Fig. 1. Common femoral artery angioplasty with synthetic patch followed by insertion of a 0.0350 hydrophilic guidewire through a 7F sheath for iliac angioplasty.
performed at the end of the procedure, and the femoral incision was sutured in a standard fashion. Only 1 patient was lost on follow-up. The other patients underwent a postoperative surveillance program that consisted of clinical examination and ABPI measurement at 3, 6, 12, and 24 months. Patients with worsening symptoms, absence of femoral pulse, and ABPI decrease >0.15 were further assessed with DSA or computed tomography angiography and treated accordingly, when necessary. Definitions and End Points Technical success was defined as restoration of blood flow with residual stenosis of 0.1 according to the reporting standards.22 Clinical success was defined as improvement by at least 1 level in Rutherford scale,20 except in cases of actual tissue loss, where the ‘‘clinical success’’ should be moved up by at least 2 categories. Adverse effects and death occurring within 30 days of the procedure were considered as procedure-related morbidity and mortality, respectively. Patency and limb salvage analysis was performed using KaplaneMeier life table method, with the STATISTICA 7.0 (StatSoft, Tulsa, OK) statistical program.
RESULTS Demographic and clinical data of the study population are shown in Table I. The mean age of the population was 73 ± 13 years (range: 52e96) with a male predominance (15 men, 54%). Seven (25%)
Number of limbs Mean age (years) Sex Male Female Hypertension Diabetes mellitus Coronary artery disease Dyslipidemia Smoking Previous vascular operations Indication for intervention (according to Rutherford classification19) IIb III
31 73 (47e96) 15 13 21 12 7 10 8 8
(54%) (46%) (75%) (43%) (25%) (36%) (29%) (29%)
30 (98%) 1 (2%)
patients had a history of peripheral arterial disease before their operation, whereas 21 (75%) patients were asymptomatic (no history of intermittent claudication or previous vascular intervention). Grade IIb ischemia was present in 48 (55%) patients. The time from the onset of symptoms to the patient’s admission ranged between 3 and 6 hrs, and the duration of hospitalization was 6.1 ± 2.8 days. Thirty (98%) patients were treated emergently for Rutherford category IIb ischemia, whereas only 1 patient was categorized as type III. Among the 23 limbs treated for combined iliacfemoral disease, nearly half of the iliac lesions (11/ 23, 48%) were classified as TASC B, whereas TASC A and C were met in 26% and 26% of cases, respectively. Accordingly, the lesions in the femoropopliteal segment in patients treated with infrainguinal disease were classified as TASC A, B, and C in 25%, 25%, and 50% of cases, respectively. The types of combined open and endovascular procedures are presented in Table II. Three patients underwent simultaneous vascular operations in both limbs. The most common open procedure was endarterectomy of the femoral bifurcation combined with patch closure (23/31, 74%). CFA-to-PFA jump-graft was performed in 13% (4/31). Femorofemoral bypass was performed in 4 patients, and femoropopliteal bypass in 1 patient, whereas 1 patient underwent interposition graft between the CFA and superficial femoral artery (SFA). Iliac artery angioplasty and/or stenting was the most frequently performed endovascular procedure (20/31, 68%) followed by angioplasty/stenting of SFA/popliteal arteries (8/31, 26%). Other endovascular procedures included angioplasty of tibial vessels in 2 patients and 1 stent graft placement in the SFA. The mean operative time was 139 ± 54.6 min.
4 Argyriou et al.
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Table II. Types of open and endovascular procedures performed in 31 limbs in the acute setting Procedures
Open procedures Femoral bifurcation endarterectomy Femorofemoral crossover bypass Femoropopliteal bypass CFA-SFA interposition graft Common femoral-femoralis profunda bypass Endovascular procedures PTA/stent CIA/EIA PTA/stent SFA/popliteal artery PTA in infragenicular arteries PTA/stent of prosthetic graft
Total
23 4 1 1 2 20 8 2 1
CIA, common iliac artery; EIA, external iliac artery; PTA, percutaneous transluminal angioplasty; SFA, superficial femoral artery.
Perioperative transfusion was 1 ± 1 units of blood. No patient received intraoperative thrombolysis. Immediate Results Technical success was achieved in 100% of patients. ABPI was increased from 0.14 ± 0.1 preoperatively to 0.69 ± 0.28 postoperatively (P < 0.05). Hemodynamic success was achieved in all but 1 patient (98%). Perioperative mortality and morbidity rates were 11% and 21%, respectively. One patient died because of metabolic acidosis on the first postoperative day. This 82-year-old male patient with acute aortic thrombosis was subjected to bilateral iliac artery angioplasty and stenting, followed by endarterectomy and patch arterioplasty of the right CFA. His metabolic deterioration was attributed to reperfusion syndrome, soon after the operation. Two patients suffered a fatal myocardial infarction on the third and fifth postoperative day, respectively. The first patient was subjected to iliac artery angioplasty/stenting and ipsilateral common femoral to deep femoral artery bypass. Although the clinical result was suboptimal with only marginal increase of the ankle brachial index, he did not consent to further revascularization, because of advanced age (86 years). The second death (of cardiac origin) occurred in a 63-year-old heavy smoker, whose medical history revealed a chronic untreated coronary artery disease. He underwent iliac artery angioplasty/ stenting followed by common femoral endarterectomy with polytetrafluoroethylene patch closure and femoropopliteal (above-knee) bypass. Perioperative complications occurred in 6 patients (21%), including occlusion of a femoropopliteal bypass (with no further attempt for revascularization)
in 1 patient, groin hematoma in 2 patients, contrast-induced acute renal failure in 1 patient, and surgical wound infections in 1 patient. In addition, 1 patient underwent subtotal colectomy because of acute mesenteric ischemia, which was further complicated by a stroke and a right-sided hemiplegia. Outcome on Follow-up The median follow-up was 6 months (range: 1e26). The 6-month overall patency, limb salvage, and survival rate were 86%, 92%, and 79%, respectively (Fig. 2). One patient was lost on follow-up, because of suffering from a major stroke. There were 4 deaths during the follow-up period. Two patients underwent an amputation during the second and third months, respectively.
DISCUSSION Hybrid vascular reconstructions provide an alternative method for treating multilevel disease in highrisk surgical patients. The use of hybrid procedures has been shown to constitute approximately 5e 21% of all vascular reconstructions.3,22 Their efficacy in terms of immediate technical success, primary, primary-assisted, and secondary patency rates, as well as limb salvage rates in CLI have been well reported.2,3,5,14e16,19,20,23,24 Antoniou et al.2 reported a perioperative mortality rate of 3% with high technical and hemodynamic success rates of 100% and 95%, respectively, confirming the immediate efficacy of the hybrid approach in CLI, whereas the primary and primary-assisted patency rates at 12 months were 71% and 98%, respectively. Furthermore, another report of 171 patients having undergone 193 hybrid procedures revealed a 5-year primary, primary-assisted, and secondary patency rates of 60%, 97%, and 98%, respectively.15 However, sufficient evidence for the therapeutic option of hybrid procedures in emergent situations for the treatment of ALI is lacking. Because native artery occlusions usually occur in patients with severe atherosclerotic disease, the increase in prevalence of peripheral arterial disease raises the percentage of ALI attributed to thrombosis.25 Indeed, a series of 380 patients subjected to thromboembolectomy for ALI with concomitant on-table angiography revealed that almost 25% presented an underlying stenotic lesion that was subsequently treated with angioplasty.26 Interestingly, the risk of limb loss in ALI ranges from 5% to 30% with mortality rates approaching 18%.27e29
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Fig. 2. KaplaneMeier analysis showing cumulative patency, limb, and patient survival (standard deviation exceeds 10% at 12 months only for patency).
Baril et al.30 have recently reported on the outcomes of bypass procedures, performed for ALI in a series of 323 patients. Interestingly, these interventions were associated with higher rates of limb loss and mortality when compared with elective operations (22.4% vs. 9.7%, P < 0.0001 and 20.9% vs. 13.1%, P < 0.0001, respectively). The higher mortality and amputation rates were attributed to the impaired medical optimization of the patients before the operation and the higher perioperative adverse events. In addition, a recent retrospective study by Balaz et el.31 compared hybrid procedures among 163 patients, with 19% having either urgent or emergent revascularization. Nine patients in this study were categorized as type IIb ischemia. No statistical significance in perioperative morbidity between patients with claudication, CLI, and ALI was shown despite the higher risk of amputation in the ALI group.31 Hybrid reconstructions are considered lessinvasive procedures especially in patients with significant comorbid conditions, decreasing the magnitude of the procedure, limiting the incision to the groin, and obviating the need for adjunctive thrombolysis and major surgery. However, their advantages in the acute setting (ALI) remain to be confirmed, because the impaired general status of vascular patients in conjunction with the metabolic reperfusion tissue damage is expected to negatively affect limb salvage and patient survival.30 Obviously, a study directly comparing clinical outcomes of hybrid interventions between ALI and CLI patients, or the efficacy of open surgical versus hybrid procedures in ALI patients would provide additional clinical information to improve treatment of ischemic limbs and delineate the utility of combined
Hybrid management in acute ischemia 5
hybrid procedures. These comprise future study tasks of our department. Most of the iliofemoral and femoropopliteal lesions in our study group were TASC II C, and successful endovascular treatment was involved in most of the cases (Table II). The immediate technical success and clinical efficacy of combined (hybrid) iliac stenting and open femoral endarterectomy for complex iliofemoral lesions present satisfactory results compared with more extensive and complex open reconstructions.23,32,33 In addition, the technical success of endovascular treatment in femoropopliteal TASC II B and C lesions has been adequately documented in contrast to TASC D lesions, whereas the freedom from restenosis/occlusion at 12 and 24 months was estimated to be 59% and 48%, respectively, according to Baril et al.34,35 Moreover, the overall assisted primary and secondary patency rates were 87% and 94% at 3 years, respectively, with no significant differences between TASC B and C lesions.32 Because hybrid techniques have been associated with comparable clinical efficacy to the open reconstructions, but shorter hospital length and lower morbidity, we chose to apply these for the treatment of ALI.32e35 Our study showed a perioperative morbidity and mortality of 21% and 11%, respectively, in 28 patients who underwent 31 hybrid vascular reconstructions emergently. It seems that although old people with multilevel disease benefit from lessinvasive revascularization procedures, the pathophysiologic aspects of sudden hypoperfusion of the limbs with consequent postoperative reperfusion injuries result in severe cardiovascular, renal, and metabolic disturbances, deteriorating patients’ general status.36 One should also take into account the suboptimal preoperative evaluation because of the urgent setting of the disease, contributing also to the high perioperative or postoperative risk. Our early experience showed that no intraoperative thrombolysis was mandatory in any patient. Had it been considered necessary, according to the surgeon’s opinion, a time-limited local catheterdirected delivery of thrombolytic agent within the lesion would have been attempted. However, we avoided the use of thrombolysis as part of our practice because it usually requires a prolonged time of action, not available in grade IIb ischemia. As previously mentioned, there is a lack of evidence in the literature regarding direct comparison between open and hybrid procedures in the acute setting,2,25,31 depicting the need for larger prospective series and report of midterm and longterm results. Prospective studies of hybrid revascularization procedures in the acute and chronic
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setting are expected to offer further clarification on perioperative morbidity and mortality of hybrid procedures in the acute setting group, the cost effectiveness of hybrid management compared with open surgery, the procedural cost as well as the intensive care or hospital stay. In addition, future research should compare hybrid operations with alternative strategies, such as 2-staged reconstructions (open or endovascular), because the latter may be associated with less impact on renal function (avoiding contrast material) and less operative exposure. Admittedly, potential limitations of our study were its retrospective nature and the small number of treated patients with lack of homogeneity between various reconstructive procedures for direct comparison. The short follow-up could be partly explained by the advanced age of the study group and their associated increased morbidity. However, we believe that the short-term and midterm results in our patient sample justify the role of these procedures in an emergency setting. Moreover, the runoff vessel status was not documented in detail, because of the inability of older generation C-arm devices to provide a high resolution and thorough mapping of the entire tibial runoff. Admittedly, more sophisticated equipment in modern endovascular suites could offer an additional insight to the tibial runoff, determining factors to improve the clinical outcome.
CONCLUSIONS Hybrid vascular operations in the acute setting provide an effective option in the treatment of multilevel arterial disease. Our study identified a considerable perioperative mortality of these emergent hybrid procedures compared with previous reports of elective interventions, underscoring the need for further clinical research in this challenging and innovative field. REFERENCES 1. Norgren L, Hiatt WR, Dormandy JA, et al., TASC II working group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007; 45(Suppl):S5e67. 2. Antoniou GA, Sfyroeras GS, Karathanos C, et al. Hybrid endovascular and open treatment for severe multilevel lower extremity arterial disease. Eur J Vasc Endovasc Surg 2009;38:616e22. 3. Dosluoglu HH, Lall P, Cherr GS, et al. Role of simple and complex hybrid revascularization procedures for symptomatic lower extremity occlusive disease. J Vasc Surg 2010; 51:1425e35.
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