Does Deep Femoral Artery Revascularization as an Isolated Procedure Play a Role in Chronic Critical Limb Ischemia?

Transcription

1 J ENDOVASC THER 119 CLINICAL INVESTIGATION Does Deep Femoral Artery Revascularization as an Isolated Procedure Play a Role in Chronic Critical Limb Ischemia? Nicolas Diehm, MD; Hannu Savolainen, MD*; Felix Mahler, MD; Jürg Schmidli, MD*; Do-Dai Do, MD; and Iris Baumgartner, MD Divisions of Angiology and *Cardiovascular Surgery, Swiss Cardiovascular Centre, University Hospital, Bern, Switzerland. Purpose: To prospectively evaluate the midterm outcome after balloon angioplasty or surgical profundaplasty of the deep femoral artery (DFA) as an isolated procedure in chronic critical limb ischemia (CLI). Methods: Between 1995 and 2001, 21 limbs in 20 patients (mean age 778 years) were treated by revascularization of the deep femoral artery (DFA) as an isolated procedure for limb salvage. All patients had long-segment femoropopliteal occlusions unsuitable for revascularization and critical obstruction of the DFA. Clinical outcome was assessed at 1, 3, 6, and 12 months. Clinical treatment efficacy was defined as resolved CLI in surviving patients without major amputation after isolated DFA revascularization. Repeat target limb revascularization, major amputation, and death were solitary study endpoints; survival analyses were performed using the Kaplan-Meyer method. Results: Angioplasty with or without stenting was performed in 14 (67%) limbs and surgical profundaplasty in 7 (33%) limbs, with a technical success rate of 100%. Clinical treatment efficacy was 25% at 12 months; the cumulative rates of repeat target limb revascularization, major amputation, and death were 49%, 36%, and 55%, respectively. Major amputation and persistent CLI dominated in patients with stage IV disease (89%), whereas rest pain resolved in the majority of patients with stage III disease (67%; p0.05). Conclusions: Isolated DFA revascularization seems insufficient to support wound healing in CLI, but might be a treatment option in CLI patients with rest pain. J Endovasc Ther Key words: critical limb ischemia, occlusion, deep femoral artery, profundaplasty, balloon angioplasty, survival analysis, amputation, mortality, rest pain In patients with long occlusions of the superficial femoral or popliteal artery, collateral blood flow to the lower limb is provided by the deep femoral artery (DFA). A concomitant critical stenosis or occlusion of the DFA may thus result in critical limb ischemia (CLI) under these circumstances. Atherosclerotic involvement of the DFA, which is less common than in the superficial femoral artery, is most often localized in the initial vascular segment. 1 Treatment options to improve blood flow to the lower limb are surgical bypass grafting, open or endovascular revascularization of the DFA, 2,3 and sympathectomy. 4 Endovascular treatment of the DFA was first described by Mahler et al. 5 in 1978, and although percutaneous angioplasty of the DFA has been proved feasible and safe, 6,7 isolated Address for correspondence and reprints: I. Baumgartner, MD, Attending Physician and Director of Vascular Research, Swiss Cardiovascular Centre, Division of Angiology, University Hospital, Freiburgstrasse, 3010 Bern, Switzerland. Fax: ; iris.baumgartner@insel.ch 2004 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at

2 120 ISOLATED DEEP FEMORAL ARTERY REVASCULARIZATION J ENDOVASC THER TABLE 1 Demographic and Risk Factor Data in 20 CLI Patients Treated With Deep Femoral Artery Revascularization in 21 Limbs Median age SD, y Men Rest pain* Ischemic lesion* Smoking history Hyperlipidemia Hypertension Diabetes mellitus Coronary heart disease Cerebrovascular disease * Per limb (57%) 9 (43%) 6 (30%) 8 (40%) 11 (55%) 4 (20%) 6 (30%) 8 (40%) endovascular DFA angioplasty remains controversial as a therapeutic approach in CLI. 8,9 Surgical profundaplasty is well accepted as an adjunct to inflow procedures to maintain graft patency and to reduce the need for subsequent or simultaneous distal reconstruction. 10 Similar to the endovascular approach, the role of surgical profundaplasty as an isolated procedure in CLI is controversial. Clinical success rates after isolated surgical revascularization of this vascular area have ranged between 49% and 67% in patients with peripheral arterial occlusive disease of varying severity at 3 years follow-up. 11 The purpose of this study was to analyze the procedural and clinical outcome of isolated DFA revascularization in a consecutive, selected series of CLI patients at risk for major amputation. METHODS Between 1995 and 2001, 20 consecutive patients (12 men; 778 years) (Table 1) underwent endovascular (14 limbs) or surgical (7 limbs) revascularization of the DFA as an isolated procedure for CLI, which was defined according to the Second European Consensus Document on Chronic Critical Leg Ischemia. 12 All patients had long-segment femoropopliteal occlusions, mostly from the origin, which left the stenotic or occluded DFA as the only inflow vessel to the lower limb (Table 2). The patients were regarded as unsuitable for bypass surgery owing to insufficient autologous TABLE 2 Angiographic Findings in the Endovascular Versus Surgical Treatment Groups Angioplasty (n14) Profundaplasty (n7) Patent runoff vessels (71%) 4 (29%) 0 (0%) 5 (71%) 1 (14%) 1 (14%) Popliteal artery patency 4 (29%) 4 (57%) DFA stenosis Isolated Multifocal Ostial Nonostial 70% 80% 80% 99% 10 (71%) 2 (14%) 3 (21%) 11 (79%) 1 (7%) 11 (79%) 2 (29%) 3 (43%) 6 (86%) 1 (14%) 0 (0%) 5 (71%) DFA occlusion 2 (14%) 2 (29%) DFA: deep femoral artery. vein (n2), poor infrapopliteal runoff (n4), recurrent bypass occlusion (n3), patient refusal for bypass surgery (n3), or high operative risk (n8) due to significant comorbidities (myocardial infarction [MI] with low ejection fraction, major stroke, pulmonary embolism, chronic obstructive lung disease, and pneumonectomy). Patients with options for bypass surgery but with high risk of bypass failure (e.g., femoropopliteal bypass to isolated popliteal segment/femorodistal composite or prosthetic graft) were selected for isolated DFA revascularization based on a consensus decision, leaving bypass surgery as a last-resort procedure. Angioplasty with or without stenting (Fig. 1) was performed via a standard crossover approach under local anesthesia 5,8 and heparinization (5000-unit intra-arterial bolus). Technical success, which was assessed by angiography immediately after the procedure, was defined as a 30% residual diameter stenosis by visual estimation. Surgical profundaplasty was performed as described by Martin et al. 2 Patients were prospectively followed at 1, 3, 6, and 12 months with noninvasive measurement of the ankle-brachial index (ABI) and assessment of clinical outcomes (death, repeat target limb revascularization [TLR], major amputation, Fontaine stage, change in clinical limb status 9 ).

3 J ENDOVASC THER ISOLATED DEEP FEMORAL ARTERY REVASCULARIZATION 121 Figure 1(A) Isolated high-grade stenosis of the proximal deep femoral artery (arrow) and complete occlusion of the superficial femoral artery (arrowhead). (B) Angioplasty using a 520-mm balloon in a crossover procedure. (C) Angiographic result showing a 30% residual stenosis by visual estimation. Clinical treatment efficacy was defined as resolved CLI without major amputation after isolated DFA revascularization in surviving patients. Repeat surgical or endovascular TLR, major amputation, and death were individual study endpoints. Recurrent TLR included bypass surgery (femoropopliteal or femorodistal) and repeat dilation of the DFA. Infrapopliteal runoff was based on the number of patent below-knee arteries evident angiographically before revascularization; poor runoff was defined as 1 patent infrapopliteal artery. Major periprocedural complications were death, a cardiovascular event (MI, transient ischemic attack, ischemic stroke), major bleeding, or dialysis-dependent nephropathy within 30 days after revascularization. Figure 2Kaplan-Meier analysis of clinical treatment efficacy (survivors with resolved CLI and no major amputation) after isolated revascularization of the deep femoral artery in CLI patients. Statistical Analysis Statistical analysis software (StatView, version 4.57; SAS, Cary, NC, USA) was used to generate Kaplan-Meier survival estimates for clinical treatment efficiency and rates of individual study endpoints. The Fisher exact test was used to analyze predictors of clinical outcome, and the Wilcoxon signed rank test was used to compare ABI before and after revascularization. Differences achieving p0.05 were considered significant. RESULTS Angioplasty alone (11 limbs) or with stent insertion (3 limbs) was performed in 13 (65%) of 20 patients for 11 DFA stenoses, 2 occlusions, and a postsurgical restenosis. Surgical profundaplasty was done in 7 (33%) of 21 limbs for 5 stenoses and 2 occlusions. Technical success and in-hospital limb salvage was 100%. No major periprocedural complications or in-hospital mortality were observed after angioplasty, but 2 fatal MIs in the 7 surgical patients led to an in-hospital mortality of 29% for open repair. Follow-up was a mean months (median 5.1). Clinical treatment efficacy was 25% at 12 months (Fig. 2). Three of 9 patients with resolved CLI died during follow-up. The clinical success rate was significantly higher in patients with stage III as compared to stage

4 122 ISOLATED DEEP FEMORAL ARTERY REVASCULARIZATION J ENDOVASC THER Figure 3Individual ankle-brachial index (ABI) values before and after revascularization of the deep femoral artery in 21 limbs. IV disease at baseline (p0.02). Rest pain resolved in 8 (67%) of 12 limbs, but healing of ischemic lesions was observed in only 1 (11%) of 9 limbs. Although statistically not significant (p0.08), a more favorable outcome was seen in patients with a patent popliteal artery. An upward shift of limb status 9 (i.e., improvement of clinical category and/or ABI increase 0.1) after DFA revascularization was achieved in 12 (57%) of 21 limbs: a 2 upward shift (moderately improved) was observed in 9 (43%) and a 1 upward shift (minimally improved) in 3 (14%). Improvement in limb status was significantly better in patients with stage III as compared to stage IV disease. The ABI significantly improved from at baseline to after DFA revascularization (p0.05); however, improvement by at least 0.1 was limited to 8 (38%) of 21 limbs (Fig. 3). Neither patency of Figure 5Kaplan-Meier analysis of major amputation after isolated revascularization of the deep femoral artery. the popliteal artery nor infrapopliteal runoff predicted a significant change in ABI. The cumulative 12-month rates of repeat TLR (Fig. 4), major amputation (Fig. 5), and mortality (Fig. 6) were 49%, 36%, and 55%, respectively. Repeat TLR was needed in 8 patients after endovascular DFA revascularization (redo angioplasty in 4, second-line bypass surgery in 4) and in 1 patient after surgical profundaplasty (bypass surgery). Surgical profundaplasty facilitated angiographic identification of an infrapopliteal runoff vessel suitable for bypass surgery that was not seen at baseline. Major amputation was necessary in 3 patients (1 in the angioplasty group and 2 profundaplasty patients), whereas a minor amputation was required in 2 patients within 3 months of endovascular DFA revascularization. No significant correlation was observed between clinical outcome, antithrombotic treatment, presence of diabetes, and infrapopliteal runoff. Figure 4Kaplan-Meier analysis of repeat target limb revascularization after isolated revascularization of the deep femoral artery. Figure 6Kaplan-Meier cumulative survival analysis of CLI patients after isolated revascularization of the deep femoral artery.

5 J ENDOVASC THER ISOLATED DEEP FEMORAL ARTERY REVASCULARIZATION 123 DISCUSSION Although reports on isolated DFA revascularization have been published, 5,8,13 22 little evidence is currently available regarding its efficacy in CLI. Hoffmann et al. 19 published a series of 43 patients undergoing angioplasty for peripheral arterial occlusive disease of varying severity. CLI resolved in 15 (68%) of 22 patients within 1 to 3 months after endovascular revascularization of the DFA. Although there was no statistically significant difference in success and failure rates between different groups, there was a trend toward a more favorable outcome for nondiabetics and patients with good distal runoff. According to the literature, limb salvage rates for isolated surgical profundaplasty in patients with CLI vary between 23% to 83%, with most series giving a success rate in the range of 50%. 9,23,25,27 The opinion regarding isolated profundaplasty to treat CLI is contradictory. One-year treatment efficacy (i.e., no CLI or amputation) was only 25% in our series. We found the most predictive factor for a poor result was the presence of ischemic lesions; ulcer healing was observed in only 1 patient. Patients with CLI limited to rest pain showed a significantly better clinical response rate compared to patients with skin lesions, probably reflecting considerably higher perfusion needs for wound healing. Strict definition of CLI according to the Second European Consensus Document 12 and rigid selection of patients unsuitable for bypass surgery may explain our poor results compared to others. 19,24 CLI represents a subgroup of patients with a particularly severe form of atherosclerosis and a high rate of systemic and local complications. In our study, the 55% 12-month mortality rate and the 36% amputation rate were an expression of the severity of disease, the latter possibly indicating that DFA revascularization does not influence the natural course of CLI. The small number of patients in our study, however, calls into question the clinical relevance of our findings. The high number of repeat TLR primarily reflects the possible need for reconstructive bypass surgery after isolated DFA revascularization. Bypass procedures were performed exclusively in patients with ischemic lesions and not those with ischemic rest pain. A major limitation for assessment of the real anatomical restenosis rate was lack of systematic angiographic or duplex sonographic surveillance of treated DFA lesions. Therefore, the clinical results obtained in our study do not necessarily reflect DFA patency. Although the ABI significantly improved after isolated DFA revascularization in one third of the patients, the slow clinical improvement of some patients probably reflects the time needed for the profunda-popliteal collateral system to develop and to readapt in response to an increased perfusion pressure. 19 Thighbrachial indices, which are supposed to indicate the success of isolated DFA revascularization, 28 were not assessed in this study. In this special subset of patients, these measurements might have reflected the quality of the profunda-popliteal collateral system, but with 50% of our patients having a patent popliteal artery, the thigh-brachial index might not have predicted treatment success. In conclusion, due to high rates of major amputation and repeat target limb revascularization, the role of isolated profundaplasty remains controversial in patients with CLI. It seems that isolated DFA revascularization does not suffice to achieve wound healing in CLI, whereas isolated DFA revascularization might be a safe and efficient treatment option in CLI patients with rest pain. REFERENCES 1. Walden R, Adar R, Rubinstein ZJ, et al. Distribution and symmetry of arteriosclerotic lesions of the lower extremities: an arteriographic study of 200 limbs. Cardiovasc Intervent Radiol. 1985;8: Hunink MG, Wong JB, Donaldson MC, et al. Patency results of percutaneous and surgical revascularization for femoropopliteal arterial disease. Med Decis Making. 1994;14: Martin P, Frawley JE, Barabas AP, et al. On the surgery of atherosclerosis of the profunda femoris artery. Surgery. 1972;71: Walker PM, Johnston KW. Predicting the success of a sympathectomy: a prospective study using discriminant function and multiple regression analysis. Surgery. 1980;87: Mahler F, Grüntzig A, Schlumpf M. Translumi-

6 124 ISOLATED DEEP FEMORAL ARTERY REVASCULARIZATION J ENDOVASC THER nal dilatation of a stenosis in the deep femoral artery. In: Zeitler E, Grüntzig A, Schoop W, eds. Percutaneous Vascular Recanalization: Technique, Application, Clinical Results. New York: Springer-Verlag; 1978: Varty K, London NJ, Ratliff DA, et al. Percutaneous angioplasty of the profunda femoris artery: a safe and effective endovascular technique. Eur J Vasc Surg. 1993;7: Silva JA, White CJ, Ramee SR, et al. Percutaneous profundaplasty in the treatment of lower extremity ischemia: results of long-term surveillance. J Endovasc Ther. 2001;8: Bulvas M, Chochola M, Herdova J, et al. Percutaneous transluminal angioplasty of the deep femoral artery. Cor Vasa. 1993;35: Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26: TASC Working Group. Management of peripheral arterial disease (PAD). TransAtlantic Inter- Society Consensus (TASC). J Vasc Surg. 2000; 31(1 Pt 2):S1 S Kalman PG, Johnston KW, Walker PM. The current role of isolated profundaplasty. J Cardiovasc Surg (Torino). 1990;31: Second European consensus document on chronic critical leg ischemia. Circulation. 1991; 84(4 Suppl):IV Belcastro S, Azzena G, Pampolini M, et al. Angioplasty of the profunda femoris in revascularisation of the lower extremity. J Cardiovasc Surg (Torino). 1979;20: Bernhard WM, Ray LI, Militello JP. The role of angioplasty of the profunda femoris artery in revascularization of the ischemic limb. Surg Gynecol Obstet. 1976;142: Cotton LT, Roberts VC. Extended deep femoral angioplasty: an alternative to femoropopliteal bypass. Br J Surg. 1975;62: Dacie JE, Tennant D. A new approach to percutaneous transluminal angioplasty of profunda femoris origin stenosis. Cardiovasc Intervent Radiol. 1990;13: Dacie JE, Daniell SJ. The value of percutaneous transluminal angioplasty of the profunda femoris artery in threatened limb loss and intermittent claudication. Clin Radiol. 1991;44: Grun B, Roth FJ. Percutaneous transluminal angioplasty of the deep femoral artery. Retrospective evaluation of early technical and clinical results in 196 cases of catheterization [in German]. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr. 1995;163: Hoffmann U, Schneider E, Bollinger A. Percutaneous transluminal angioplasty (PTA) of the deep femoral artery. Vasa. 1992;21: Hull DA, Babcock GK, Hyde GL, et al. Femoral artery profundaplasty. Am J Surg. 1978;136: Motarjeme A, Keifer JW, Zuska AJ. Percutaneous transluminal angioplasty of the deep femoral artery. Radiology. 1980;135: Stevenson IM, Wake PN, Santer GJ. Extended deep femoral angioplasty and lumbar sympathectomy as a limb salvage procedure. Ann R Coll Surg Engl. 1979;61: Sladen JG, Burgess JJ. Profundoplasty: expectations and ominous signs. Am J Surg. 1980; 140: Taylor LM, Baur GM, Eidemiller LR, et al. Extended profundaplasty. Indications and techniques with results of 46 procedures. Am J Surg. 1981;141: Thompson BW, Read RC, Campbell GS, et al. The role of profundaplasty in revascularization of the lower extremity. Am J Surg. 1976;132: Towne JB, Bernhard VM, Rollins DL, et al. Profundaplasty in perspective: limitations in the long-term management of limb ischemia. Surgery. 1981;90: Towne JB, Rollins DL. Profundaplasty: its role in limb salvage. Surg Clin North Am. 1986;66: Boren CH, Towne JB, Bernhard VM, et al. Profundapopliteal collateral index. A guide to successful profundaplasty. Arch Surg. 1980;115: