IMP 28 22-12-2006 14:23 Pagina 169 DISTAL ANGIOPLASTY FOR LIMB SALVAGE WITH FREQUENT STENT PLACEMENT. IS IT WORTHWHILE? 28 E. DUCASSE, X. BÉRARD, G. SASSOUST, D. BISCAY, J-C. BASTE, D. MIDY Abstract During the last years, revascularization of tibioperoneal arteries observed an increasing amount in the diabetic population. Each surgeon or interventional radiologist is now trained with the peripheral endovascular procedures. Many of us are tempted by the distal angioplasty for critical limb ischemia without education for results or specific technical indications. We report the actual data and our personal experience in these indications and perspectives. Introduction Critical limb ischemia is defined by the Transatlantic Inter Society Conference (TASC) as persistent recurring ischemic rest pain requiring opiate analgesics for at least 14 days, ulceration or gangrene of the foot or toes and ankle-brachial index <0.40, toe pressure <30 mm Hg, systolic ankle pressure <50 mmhg, flat pulse volume waveform, and absent pedal pulses 1. Treatment options include surgical revascularisation, amputation and endovascular intervention. Historically, the gold standard for treatment of critical limb ischemia has been surgical revascularisation, however, this approach is limited to subjects with good distal target vessels, good cutaneal approach, venous graft available and lack of severe comorbid condition. In absence of revascularisation, it is anticipated that in this patient population, a major amputation will also be required within 6 months to a year in the absence of significant improvement. Amputation does not only constitute a personal tragedy, it is also associated with a high economic cost in lost wages and disability. Still recently, the endovascular treatment of the infrapopliteal arteries was cited in the literature as the forgotten region 2. However, with an increasing amount of diabetic patients with a high incidence of infrapopliteal disease, as in our routinely practice, and in absence of adapted surgical treatment, the endovascular option has been increasingly and successfully applied since then, with promising results 3, 4. However, specific indications and moreover techniques, as stenting or not, are so far unclear. We report the actual data from literature, and more than our study (retrospective and not randomized) we also report our experience and technical choices. Our experience Even if one third of arteries in the prospective, randomized Basil study were abovethe-knee, this study remains technically instructive for many reasons 5. First, the fact that
IMP 28 22-12-2006 14:23 Pagina 170 170 Controversies and updates in vascular surgery surgical revascularization remains more reliable than endovascular. The immediate failure rate was 3% for surgical procedure versus 20% of immediate technical failure for endovascular. The technical failures were due to the fact that the distal lumen could not be reentered, the lesion not be entered or completely crossed or in few cases after vessel perforation. Equally, 34% of patients were not randomly assigned because the leg could not be revascularised by either surgery or angioplasty. Thus, the first challenge in distal procedures remains to determine after explorations the specific, good cases and anticipate the procedural success. Anyway, when distal endovascular is feasible, it offers a good alternative to distal bypasses. In the Basil study, if there were no significant differences in survival at 1 and 3 years, surgery was associated with a significantly higher rate of morbidity (57%) than the rate with angioplasty (41%) 5. In mid-term, after 6 months, the two strategies did not differ significantly in amputation-free survival. Now, distal angioplasty for critical ischemia appears as a safe technique and a new tool in our practice for revascularization. Moreover, when an angioplasty-first strategy is a success, it costs about a third less than the surgery-first strategy 5. Actually, when it is technically possible, the poor cumulative survival of the population involved and the lower cost call for the endovascular option to treat the tibioperoneal lesions 6-8. Moreover, we suppose that the endovascular option increase the rate of interventional procedures especially in accordance with patients with a poor cutaneous approach in critical limb ischemia (Leriche IV). The major challenge remains the initial success which is evaluated at 98% in stenotic and 77% in occluded vessels 9. In our experience with more than 50 procedures, the rate of technical success is approximately equivalent. Results of our experience are given in Table 28.I and 28.II. The first step in the tibioperoneal endovascular option remains to cross the lesion with the guide-wire. In the Basil study, the angioplasties in which a guide-wire was passed TABLE 28.I. Specifications of 57 procedures including 83 lesions in our experience. 83 LESIONS IN 57 PROCEDURES OCCLUSION STENOSIS OVERALL Number 40 43 83 Technical success (%) 88 97 92 Length of the lesion (median cm) 2.3 1.3 1.8 Localisation All proximal All proximal Proximal Stent application (%) 94 88 91 TABLE 28.II. Results observed in our experience with a median time period of 27 months. (%) OCCLUSION STENOSIS OCCLUSION VS STENOSIS OVERALL Post op. mortality 4.5 Follow-up Survival 78 6 months patency 94 97 NS 95 18 months patency 88 86 NS 87 Overall clinical success 84 85 85
IMP 28 22-12-2006 14:23 Pagina 171 Distal angioplasty for limb salvage with frequent stent placement. Is it worthwhile? 171 A B C Fig. 28.1. A) Stenotic lesions on tibioperoneal trunk, ostia of peroneal and tibial posterior arteries. B) Double.018-inch guide wire to treat distal lesions. C) Double balloon inflation (with bare-metal stents application) to avoid contra lateral obstruction. across at least part of the lesion to be treated, 36% were transluminal, 50% were subintimal and 14% were mixed 5. The technological progress now allows the use of 0.018- inch and 0.014-inch guide-wires with significant stiffness for recanalization and flexibility for tortuous lesion crossover. Our personal preference is for the 0.018-inch guidewire with sufficient stiffness and allows kissing balloon procedures (V18-Control-Wire, Boston Scientific Corporation, Miami, FL) (Fig. 28.1). Although a standard guide-wire (.035-inch hydrophilic) may be useful for stenotic lesions. Occlusions particularly long occlusions require a more aggressive approach with a 0.018-inch stiff support. An important stiffness support is also required to support the push applied when the balloon croses the lesions. Also hydrophilic wires have higher risk for perforation and thus should be used with caution. Generally, balloons of 2 mm to 4.5 mm diameters are used and the new-generation balloon achieving success in the tibioperoneal arteries has thinner walls, higher material strength and smaller profiles. Most of the time a single inflation is necessary, but in few cases a prolonged (> to 2 min) is required after dissection or recoil. The use of the cutting balloon avoiding overdilatation and barotrauma is still associated with a 20% rate of dissection and inadequate result, necessitating the use of adjunctive stenting. However, cutting balloons may have niche uses, such as treating ostial lesion or restenosis by intimal hyperplasia lesion 10. Initially, studies concerning the use of stents in the infrapopliteal arteries have been limited. The most common reasons to use stents were arterial dissections and recoil. Because the stents used in initial investigations had already been proven effective in arteries of similar sizes (in the coronary arteries), it appears that stents must be developed and evaluated in tibioperoneal lesions. In a randomized, prospective study, Rand have investigated the patency of stent (Carbostent Sorin Biomedica, Modena, Italy) versus angioplasty alone in infrapopliteal arteries 11. The 6-month cumulative patency probability was 83.7% for stent application and 61.1% for angioplasty alone. The result was statistically signifi-
IMP 28 22-12-2006 14:23 Pagina 172 172 Controversies and updates in vascular surgery A B Fig. 28.2. A) Stents application after treatment of the tibioperoneal trunk lesion. B) Final control with minor bifurcation dissection requiring an upper stent application. cant (P=0.02). Thus, in this study, the use of stents was shown to be superior to angioplasty in term of permeability. Moreover, in a study directed by Siablis comparing sirolimuseluting stents versus bare-metal stents in tibioperoneal arteries, no cases of stent deformation or fracture were reported 12. In this report, the 6-month cumulative patency rate was 92% for sirolimus-eluting stents versus 68.1% for bare-stent with restenosis respectively equivalent to 4% versus 55.3%. In our experience, most of stenotic or recanalized lesions need a systematic stent application. In accordance with recent studies and systematic antiplatelets medication the in-stent thrombosis appears as an anecdotic and rare event. The problem of restenosis by intimal hyperplasia still remains. Because intimal hyperplasia occurs after smooth muscle cells proliferation, migration, change of phenotype from contractile to secretory and production of extracellular matrix, we thought that in distal atherosclerotic and diabetic arteries without any parietal cellular substrate, the intimal hyperplasia is also a rare event during follow-up. After angioplasty, these calcified arteries need to be treated mechanically by stent application to maintain the ruptured lesion and allows durable permeability. The primary stent application allows specific techniques as kissing application in ostial bifurcation (Fig. 28.2). Thus, with adapted material, the indications and techniques applied are these actually recognized for iliac endovascular treatment. Today, specific stent and devices are dedicated to distal lesions with CE approving (Motion explorer, Biotronik, Ch) and small diameter (up to 4 mm) self-expanding stents are now available (Xpert, Abbott Vascular Devices, Abbott Park, IL) which may have a role on flexible arteries as distal popliteal artery, tibioperoneal trunk and tibial anterior ostium. For more distal arteries we suppose that bare-metal stents are sufficient according to anatomical protection in the leg without external compression. Concerning the drug eluting stent use in tibioperoneal arteries few studies are available. Sirolimus-eluting stents appear to be a safe and effective treatment for infrapopliteal angioplasty including recanalization allowing a significant improvement of the angiographic patency rate and reduction of clinical event 12, 13. These isolates studies call for randomized multicentric trials.
IMP 28 22-12-2006 14:23 Pagina 173 Conclusions Distal angioplasty for limb salvage with frequent stent placement. Is it worthwhile? 173 Infrapopliteal revascularization with endovascular tool represents now a very viable option with specific indications with an increasing amount of procedures. The last results with the use of most recent devices of balloon-expandable stents for tibioperoneal lesions are encouraging and may be superior to angioplasty alone. An aggressive approach, as we routinely practise, with large stenting of infrapopliteal arteries for treatment of critical limb ischemia has certainly the potential to improve both the immediate procedural success as well as the mid- and long-term clinical outcome. References 01. Management of peripheral arterial disease (PAD): Transatlantic Inter Society Concensus (TASC). Section D: Chronic critical limb ischemia. Eur J Vasc Endovasc Surg 2000;19(suppl A):S144-S243. 02. Wagner HJ, Rager G. Infrapopliteal angioplasty: a forgotten region? Rofo 1998;168:415-20. 03. Bakal CW, Cynamon J, Sprayregen S. Infrapopliteal percutaneous transluminal angioplasty: what we know. Radiology 1996;200:36-43. 04. Krankenberg H, Sorge I, Zeller T, Tubler T. Percutaneous transluminal angioplasty of infrapopliteal arteries in patients with intermittent claudication: acute and one year results. Catheter Cardiovasc Interv 2005;64:12-7. 05. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al.; BASIL trial participants. BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925-34. 06. Dorros G, Jaff MR, Dorros AM, Mathiak LM, He T. Tibioperoneal (outflow lesion) angioplasty can be used as primary treatment in 235 patients with critical limb ischemia: five-year followup. Circulation 2001;104:2057-62. 07. Faglia E, Dalla Paola L, Clerici G, Clerissi J, Graziani L, Fusaro M, et al. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc Surg 2005;29:620-7. 08. Brillu C, Picquet J, Villapadierna F, et al. Percutaneous transluminal angioplasty for management of critical ischemia in arteries below the knee. Ann Vasc SUrg 2001;15:175-81. 09. Dorros G, Jaff MR, Murphy KJ, Mathiak L. The acute outcome of tibioperoneal vessel angioplasty in 417 cases with claudication and critical limb ischemia. Cathet Cardiovasc Diagn 1998;45:251-6. 10. Ansel GM, Sample NS, Botti III CF Jr, Tracy AJ, Silver MJ, Marshall BJ, et al. Cutting balloon angioplasty of the popliteal and infrapopliteal vessels for symptomatic limb ischemia. Catheter Cardiovasc Interv 2004;61:1-4. 11. Rand T, Basile A, Cejna M, Fleischmann D, Funovics M, Gschwendtner M, et al. PTA versus Carbofilm coated stents in infrapopliteal arteries : pilot study. CVIR 2005;29:29-38. 12. Siablis D, Kraniotis P, Karnabatidis D, Kagadis GC, Katsanos K, Tsolakis J. Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-month angiographic results from a nonrandomized prospective single-center study. J Endovasc Ther 2005;12:685-95. 13. Scheinert D, Ulrich M, Scheinert S, et al. Comparison of sirolimus-eluting vs. Bare-metal stents for the treatment of infrapopliteal obstructions. Eurointervention 2006. In Press.