Distal Percutaneous Transluminal Angioplasty Through Infrainguinal Bypass Grafts

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1 Eur J Vasc Endovasc Surg 23, (2002) doi: /ejvs , available online at on Distal Percutaneous Transluminal Angioplasty Through Infrainguinal Bypass Grafts A.-M. Löfberg 1, S. Karacagil 2, C. Ljungman 2, R. Nyman 1, A. Tulga Ulus 2, A. Boström and G. Östholm 2 Departments of 1 Radiology and 2 Surgery, University Hospital, Uppsala, Sweden Aim: to evaluate the results of transluminal angioplasty (PTA) performed through infrainguinal bypass grafts for stenotic or occlusive lesions at the distal anastomosis and/or in the runoff arteries. Design: retrospective clinical study. Material and methods: forty-one patients underwent 57 procedures at the distal anastomosis (n=13), in the runoff arteries (n=32) or at both locations (n=12) at a median of 9.6 months (range, 2 76 months) after infrainguinal bypass grafting. Nineteen procedures were on the popliteal artery, the rest on the crural arteries. Eleven procedures related to occlusions less than 5 cm in length. Results: technical success was achieved in 91%. Primary and primary assisted graft patency rates at 3 years were 32% and 53%, respectively. There were no significant differences in patency rates with regard to the graft material, the type of lesion, the level of PTA, the status of runoff and the use of thrombolysis before PTA. No patients underwent amputation as a direct consequence of failed PTA or graft occlusion. One patient underwent acute surgical intervention due to graft occlusion at the time of attempted PTA. Conclusion: the results of PTA at the distal anastomosis and/or in the runoff arteries in limbs with infrainguinal bypass seemed to be inferior to the results of surgical revisions reported in literature. However, as failed PTA did not jeopardise vein-patch angioplasty or jump grafting, it is a reasonable alternative to surgical intervention in selected cases. Key Words: PTA; Infrainguinal bypass; Runoff; Distal anastomosis. Introduction Infrainguinal bypass grafting remains the most established procedure for treatment of atherosclerotic disease of the femoropopliteal and crural arteries, especially in limbs with critical limb ischaemia (CLI). However, occlusion of bypass reconstruction continues to occur and might lead to limb loss in a substantial number of patients. 1 Inflow, graft or runoff related lesions are responsible for the majority of failures occurring beyond the initial 30 day period. 1 5 Localised lesions in the iliac arteries are usually managed with endovascular intervention while the choice of intervention for graft stenoses is still controversial. Lesions affecting the distal anastomosis or runoff arteries can be successfully treated with vein patch angioplasty or a jump graft to the crural arteries; but this can be technically demanding Percutaneous transluminal angioplasty (PTA) is mainly used for the treatment of vein graft stenosis. There is little information on the Please address all correspondence to: A.-M. Löfberg, Department of Radiology, University Hospital, Uppsala, , Sweden. use of PTA as an alternative to surgery. 5,10 13 The aim of the present study was to assess the feasibility and the results of PTA performed through infrainguinal bypass grafts for treatment of stenotic or occlusive lesions at the site of distal anastomosis and/or in the runoff vessels. Material and Methods Patients Between June 1992 and January 2000, the records of 41 patients undergoing 57 PTA procedures performed through femoropopliteal or femorocrural bypass (a total of 46 grafts, five patients with bilateral infra- inguinal bypass) due to stenosis or occlusion at the site of distal anastomosis and/or in the runoff arteries were retrospectively studied. Patient characteristics are shown in Table 1. Infrainguinal grafts with stenoses at the proximal anastomoses or in the graft (including PTFE-vein anastomosis stenosis) without associated distal lesions undergoing PTA were excluded as were /02/ $35.00/ Elsevier Science Ltd. All rights reserved.

2 PTA Through Bypass Grafts 213 Table 1. Patient characteristics (41 patients). in the recipient artery or crural vessels was defined Male/Female 1:1.2 as runoff lesion (Figs 2 and 3). Age (median-range) 70 (49 93) years The median (range) duration from the initial bypass CAD 46% grafting to the PTA procedure was 9.6 (2 76 months). CVD 19% Diabetes mellitus 36% The indications for intervention at the time of bypass Hypertension 51% grafting were rest pain in 36 and ulcer or gangrene in Smoking 61% 10 limbs. Thirty limbs had CLI according to SVS/ CAD: coronary artery disease; CVD: cerebrovascular disease. ICSVS reporting standards while 16 limbs had either falsely elevated ankle pressures or ankle brachial pressure index (ABPI) <0.5 but ankle pressures over 40 mmhg. 1 The latter group was considered as having subcritical ischaemia. 14 In 24 limbs, the distal anastomosis those receiving intra-arterial thrombolytic therapy for was onto the popliteal artery (12 cases below graft occlusion without additional PTA. Grafts with the knee level) and in the remaining 22 cases, onto the combined proximal and distal lesions as well as crural arteries. The graft material was saphenous vein patients receiving thrombolysis followed by PTA at in 33, composite polytetrafluoroethylene (PTFE)-vein the distal anastomosis or in the runoff vessels were in four and PTFE in nine limbs. included. Distal anastomotic stenosis was defined as Infrainguinal bypass grafts with totally or partially a stenosis of the graft or native artery within 2 cm of vein conduits were followed by routine clinical ex- graft insertion (Fig. 1). More distal stenosis or occlusion amination, ankle brachial pressure index meas- Fig. 1. A 74-year-old male with a femoropopliteal above knee PTFE graft performed due to rest pain 16 months previously, had a tight stenosis at the distal anastomosis (a), and (b) after successful PTA the graft was patent for 8 months (last visit).

3 214 A.-M. Löfberg et al. Fig. 2. A 75-year-old female with a femoropopliteal below knee PTFE bypass due to non-healing ulcer above the medial malleolus (8 months after surgery). (a) Angiography showing occlusion of the posterior tibial and peroneal arteries and a stenosis in the proximal part of the anterior tibial artery. (b) The peroneal artery was successfully recanalised. The graft was patent at 6 months follow-up and the ulcer healed. urements (ABPI) and duplex surveillance at the following intervals: before discharge and 1 month after surgery followed by 3 months intervals for 1 year, every 6 months for the following 2 years and then at yearly basis for two more years. Surveillance in limbs with totally prosthetic grafts was performed at discharge and at 1, 6, 12 months followed by 12 month intervals. Grafts with duplex scan detected abnormalities were followed at 1 month or 3 month intervals depending on the nature of lesions. Grafts, undergoing surgical or endovascular intervention, were followed by the same surveillance programme used initially. Surveillance 5 years after surgery was not performed. There were no strict guidelines for selection of treatment modality in limbs with infrainguinal graft lesions. However, PTA was the treatment of choice for localised stenotic lesions (less than 2 cm in length) in the graft and/or at the distal anastomosis detected after the initial 6 month period following surgery. PTA was also the choice of initial treatment for stenoses or occlusions <5 cm in length in the runoff arteries. In cases where PTA was considered unsuitable due to extensive crural artery changes, femorodistal jump bypass grafting was the choice of treatment if technically feasible (presence of a patent distal vessel). During the same period, 35 redo surgery were performed for treatment of distal anastomotic or runoff lesions (16 vein patch at the distal anastomosis and 19 jump grafts). The patients were selected for endovascular intervention with the findings obtained from duplex scanning. Peak systolic velocity (PSV) ratio >3 was the indication for intervention in grafts with stenosis. 15 The following duplex criteria were used for definition of grafts at risk of occlusion in limbs with runoff lesions: PSV in the graft <45 cm/s irrespective of symptoms and/or decrease in ABPI measurements greater

4 PTA Through Bypass Grafts 215 Fig. 3. (a) Angiography showing a patent femorotibial in situ vein bypass 16 months after insertion in a 58-year-old male with end-stage renal disease and severe rest pain. (b) Multiple lesions in the recipient artery were successfully dilated. The patient had a patent graft after 12 months and still had intermittent rest pain. than 0.15 combined with rest pain or ulcer. At the time of PTA procedures, 26 limbs were symptom free, four had claudication, 23 had rest pain and four had ulcers. The median (range) ABPI was 0.42 ( ) in 42 limbs without falsely elevated ankle pressures. Techniques of angiography and PTA In 40 procedures PTA was performed with a crossover technique from the contralateral side in order to avoid post-pta compression of the graft. Antegrade puncture of the femoral artery was used in 17 procedures where pre-pta duplex scanning showed patent iliac arteries without significant stenoses and where the proximal anastomosis of the graft was not in conflict with the puncture site. Catheterisation was made through a 6 8 F introducer. Balloons with a shaft size of 5 or 6 F (Schneider-Europe AG, Zurich, Switzerland) and a balloon diameter ranging from 2.5 to 5 mm were used. Prophylaxis against vasospasm was not routinely used but when it occurred, 200 μg nitroglycerin was injected in the graft or in the runoff arteries. For recanalisation of total occlusions a low friction inch guide wire was used (Terumo Co., Japan). Immediate postangioplasty angiograms were obtained in all cases. Technical success was defined as PTA resulting in less than 50% residual stenosis after dilatation. Intra-arterial heparin (5000 units) was injected before crossing the lesion. The patients received low molecular heparin (enoxaparin 40 mg/s) 4 6 h after procedure and were put on life-time antiplatelet (acetylsalicyclic acid/ 160 mg daily) treatment. Level of PTA Thirteen procedures were performed only at the distal anastomosis, 12 at the distal anastomosis combined

5 216 A.-M. Löfberg et al. Table 2. Level of PTA and type of lesions. patency but allowed endovascular procedures to be Site of PTA Type of lesion performed on a patent bypass. (artery) Stenosis Occlusion (n=46) (n=11) Popliteal 15 4 Results Tibioperoneal trunk 3 1 Peroneal 6 1 Posterior tibial 15 Immediate technical success rate Anterior tibial 7 4 Dorsal pedal 1 A technically successful PTA was achieved in 52 procedures (91%). In two cases with acute femorodistal graft occlusion (both PTFE grafts with distal vein cuff) with runoff arteries and 32 in the runoff arteries. No following successful thrombolysis, the stenoses at the attempts were made to recanalise more than 5 cm long distal anastomosis could not be successfully reocclusions. In 11 patients with graft occlusion, PTA of canalised. Both patients underwent surgical revision the distal anastomosis (n=2), runoff arteries (n=7) with vein patch angioplasty. One of these patients or both (n=2) were performed following successful died 4 months after surgery with patent graft and the thrombolysis (t-pa with doses ranging from other underwent amputation after graft occlusion at mg/h and a total dose of mg). In 12 3 months. In one patient with femoropopliteal vein patients additional PTA in the body of the graft or at graft and poor distal runoff, PTA of multiple short the proximal anastomosis were performed following stenoses in the proximal anterior tibial and peroneal a distal procedure during the same session. The level arteries failed. This patient underwent amputation of PTA and the type of lesions are shown in Table 2. with patent graft after 1 month. In the fourth patient with femoropopliteal vein bypass and poor distal runoff the graft occluded following PTA attempt at the Definition of runoff distal anastomosis. Following urgent graft thrombectomy and patch angioplasty, the graft occluded after 2 months and the patient underwent amputation The concept of angiographic runoff classification has after 28 months. In the fifth patient with femorobeen described in detail previously. 16,17 In summary, popliteal vein bypass, there was a residual stenosis good runoff was defined as patency of two or three greater than 50% after PTA at the distal anastomotic lower leg arteries to the foot, or one patent vessel site. The graft was patent at 26 months with duplex continuous with an intact anterior or posterior pedal verified distal stenosis and the patient had moderate arch in femoropopliteal and proximal femorodistal claudication. bypasses, and integrity of both arches in low femorodistal bypasses where the distal anastomosis was placed at midcalf or at ankle level. All other angiographic flow patterns were considered as poor. Early complications (within 30 days) Follow-up The patients were followed with clinical examination, ankle-brachial pressure index (ABPI) measurements and duplex scanning according to the above mentioned surveillance program. Life-tables for patency rates were constructed by the actuarial method according to SVS/ICSVS reporting standards. 18 All the patency rates were calculated from the time of PTA, not from the time of original graft insertion. Primary patency was defined as uninterrupted duplex scan verified patency with no additional endovascular or surgical procedures performed on the graft or its anastomoses. Primary assisted patency was defined as uninterrupted There was no mortality during the initial 30 day period. In five cases, insignificant haematoma was observed at the puncture site, i.e. did not require surgical intervention or blood transfusion. Only in one patient PTA attempt at the distal anastomosis resulted in graft occlusion and this patient underwent urgent graft thrombectomy and patch angioplasty as mentioned above. Patency and limb salvage The median (range) ABPI measurements increased from 0.42 ( ) to 0.53 (0.3 1) following technically successful PTA. Overall primary patency following

6 PTA Through Bypass Grafts 217 PTA and one jump graft). The median (range) interval from the time of initial PTA to amputation was 5 (1 23) months. Fig. 4. Cumulative primary life table patency. SE less than 10 at the end of 3 years and the numbers at risk are given. Discussion There are no universally accepted guidelines for detection and management of inflow, graft or runoff related problems. Atherosclerotic disease affecting the inflow arteries are usually managed with endovascular intervention as the results of iliac artery PTA are satisfactory. 19 The choice of treatment between endovascular or surgical intervention with regard to intrinsic lesions located in the graft itself depends on the time interval after surgery and the policy of the centre. The durability of PTA for treatment of vein graft stenoses has been questioned by some authors, yet others have reported patency rates of more than 80%. 5,10,11,20 24 Sanchez et al. 24 reviewed 95 cases of vein graft and anastomotic lesions treated with PTA. They did not use strict selection criteria for selection of treatment modality. The 21 month patency rate for the surgically treated group (86%) was significantly better than the 42% patency rate for all lesions treated with PTA. There were no PTAs performed for treatment of runoff lesions. The early patency rates (6 months) of proximal PTA was 32% at the end of 3 years (Fig. 4). The majority of events, either re-intervention in patent grafts or graft occlusions occurred during the initial 6 month period after PTA (23 out of 37 events). In eight patients following graft occlusion after a median (range) interval of 10 (1 35) months, no further intervention or amputation was performed. Five of these patients had claudication and three had subcritical ischaemia at the time of the last visit (a median of 11 months after occlusion). Sixteen additional endovascular inter- anastomotic, mid-graft and distal anastomotic lesions ventions were required in 10 patients. Twelve of were comparable. Simple lesions had a significantly these procedures were performed due to duplex veri- better patency rate at 24 months (66%) compared with fied restenosis or occlusion at the site of the previous that of complex lesions (17%). Complex lesions were PTA in patent grafts. These additional procedures defined as multiple, recurrent, >1.5 cm in length, or resulted in a primary assisted patency of 53% at 3 within grafts that had a <3 mm minimal diameter. years (Fig. 4). Femorocrural or jump bypass grafting Lesions affecting the distal anastomoses or the runoff was performed following graft occlusion in one and vessels that jeopardize the graft patency can be suc- duplex verified stenosis or occlusion at the site of cessfully managed by surgical intervention. Long-term PTA with patent graft in three cases. There were no assisted graft patency in excess of 80% have been significant differences in patency rates with respect to reported following vein patch angioplasty or jump the graft material, the site of distal anastomosis, the grafting However, these procedures are more tech- status of distal runoff, the presence of diabetes mellitus, nically demanding than the surgical management of the type of lesion (stenosis or occlusion), combined more proximal lesions and many of these patients, do PTA at the proximal anastomosis or graft, and the use not have suitable vein conduits. Endovascular interventions of thrombolysis before dilatation. The limb salvage might be an alternative in these cases and rate at 36 months was 83%. that was the reason for separate analysis of results of There were six major amputations during the followup distal PTA through infrainguinal bypass grafts in the period. Two patients underwent amputation with- present study. Previously, few studies with a limited out re-intervention at 1 and 7 months following PTA number of patients have been reported on the use of respectively. Graft occlusion occurred due to poor PTA in the runoff arteries, following infrainguinal distal runoff. Another patient with CLI was amputated bypass grafting. 5,11 13,20,24 In these studies, the results of with a patent but haemodynamically failed graft. In runoff PTA were difficult to interpret as the series three patients major amputations were performed following included graft lesions at other locations and separate re-intervention (two thrombolysis and distal analyses were not performed. We have previously

7 218 A.-M. Löfberg et al. reported a high technical success rate of crural artery References PTA in patients with severe lower limb ischaemia. 25 Although the secondarry cumulative patency rate at 1Davies AH, Magee TR, Sheffield E, Baird RN, Horrocks M. The aetiology of vein graft stenosis. Eur J Vasc Surg 1994; 8: 3 years was only 44%, we suggested that crural artery PTA might be an alternative to surgical intervention 2Gutierrez IZ, Barone DL, Makula P. Progression of arterisclerotic disease in the failed infrainguinal bypass. Am Surg in selected patients with localised lesions. The com- 1987; 53: plication rate necessitating amputation directly related 3Palumbo PJ, O Fallon WM, Osmundson PJ et al. Progression to the procedure was very low. Failed PTA did not of peripheral occlusive arterial disease in diabetes mellitus. What alter the possibility of performing bypass grafting. factors are predictive? Arch Int Med 1991; 151: McLafferty RB, Moneta GL, Masser PA, Taylor LM Jr,Porter The results of the present study demonstrated a JM. Progression of atherosclerosis in arteries distal to lower high technical success rate (91%) and no major com- extremity vascularizations. J Vasc Surg 1995; 22: plications directly related to the procedure. Graft ocradiology in the maintenance of infrainguinal vein graft patency. 5London NJM, Sayers RD, Thompson MM et al. Interventional clusion related to the PTA procedure occurred only in Br J Surg 1993; 80: one patient in whom graft thrombectomy and patch 6Bandyk DF, Bergamini TM, Towne JB, Schmitt DD, Seabrook angioplasty resulted in early success. The primary GR. Durability of vein graft revision: the outcome of secondary procedures. J Vasc Surg 1991; 13: patency rates following PTA at 12 and 36 months were 7Sullivan TR Jr, Welch HJ, Iafrati MD, Mackey WC, O Don- 41% and 32%, respectively. Sixteen additional PTA nel TF Jr. Clinical results of common strategies used to revise procedures were required due to restenosis or re- infrainguinal vein grafts. J Vasc Surg 1996; 24: Veith FJ, Weiser RK, Gupta SK et al. Diagnosis and management occlusion at the PTA sites in order to achieve 53% of failing lower extremity arterial reconstructions prior to graft primary assisted patency at 3 years. occlusion. J Cardiovasc Surg 1984; 25: Duplex scanning plays an important role in detection 9Nehler MR, Moneta GL, Yeager RA et al. Surgical treatment of threatened reversed infrainguinal vein grafts. J Vasc Surg 1994; of these lesions and surveillance is strongly re- 20: commended. 10 Analysis of several anatomical factors 10 Avino AJ, Bandyk DE, Gonsalves AJ et al. Surgical and endovascular intervention for infrainguinal vein graft stenosis. J such as the site of PTA, the type of lesion, the status Vasc Surg 1999; 29: of runoff, the presence of diabetes and the use of 11 Whittemore AD, Donaldson MC, Polak JF, Mannick JA. thrombolysis before PTA in occluded grafts did not Limitations of balloon angioplasty for vein graft stenosis. J Vasc show a subgroup with significantly lower patency Surg 1991; 14: Thompson JF, McShane MD, Gazzard V, Clifford PC, Chant rates. However, as the numbers in each group are ADB. Limitations of percutaneous transluminal angioplasty in limited, no clear conclusions can be made. Early or the treatment of femoro-distal graft stenosis. Eur J Vasc Endovasc late failures of PTA did not negatively affect the pos- Surg 1998; 3: Favre JP, Malouki I, Sobhy M et al. Angioplasty of distal venous sibility of performing bypass surgery. bypasses: is it worth the cost? J Cardiovasc Surg 1996; 37 (Suppl. In conclusion, PTA at the distal anastomotic site or 1): runoff arteries following infrainguinal bypass grafting 14 Wolfe JH, Wyatt MG. Critical and subcritical ischemia. Eur J is technically feasible and offers satisfactory but in- Vasc Endovasc Surg 1997; 13: Olojugba DH, McCarthy MJ, Naylor AR, Bell PR, London ferior results compared to surgical revisions reported NJ. At what peak velocity ratio should duplex detected infrainguinal vein graft stenoses be revised? Eur J Vasc Endovasc Surg in literature. As the complications with regard to technical failures did not affect the possibility of per- 1998; 15: Karacagil S, Almgren B, Bergström R, Bowald S, Eriksson I. forming surgical intervention, PTA might be con- Postoperative predictive value of a new method of intraoperative sidered as an alternative in a selected group with angiographic assessment of runoff in femoro-popliteal bypass suitable lesions. Multiple factors should be taken into grafting. J Vasc Surg 1989; 10: Karacagil S, Almgren B, Bowald S, Eriksson I. A new method consideration when deciding on the treatment mod- of angiographic runoff evaluation in femorodistal reality, including surgical risk, the absence of vein con- constructions. Arch Surg 1990; 125: duits, the type of lesions and the time interval between 18 Rutherford RB, Baker D, Ernst C et al. Recommended stand- ards for reports dealing with lower extremity ischaemia: revised initial surgery and the detection of lesions. The guide- version. J Vasc Surg 1997; 26: lines for surveillance after infrainguinal bypass graft- 19 Johnston KW. Iliac arteries: reanalysis of results of balloon ing and indications for intervention in patients with angioplasty. Radiology 1993; 186: Tonessen KH, Holstein P, Rordam L et al. Early results of asymptomatic atherosclerotic lesions in the runoff ar- percutaneous transluminal angioplasty (PTA) of failing belowteries are still controversial and larger series with knee bypass grafts. Eur J Vasc Endovasc Surg 1998; 15: longer follow-up are needed. 21 Taylor PR, Gould D, Harris P, Al-Kutoubi A, Wolfe JH. Balloon dilation of graft stenoses reasons for failure. Br J Surg 1991; 78: 371. Acknowledgement 22 Houghton AD, Todd C, Pardy B, Taylor PR, Reidy JF. Percutaneous angioplasty for infrainguinal graft-related stenoses. Funding for this study was received from the Swedish Medical Eur J Vasc Endovasc Surg 1997; 14: Research Council, grant no , Swedish Heart and Lung Foundation. GM. Balloon dilatation versus surgical revision of 23 Perler BA, Österman FA, Mitchell SE, Burdick JF, Williams infra-inguinal

8 PTA Through Bypass Grafts 219 autogenous vein graft stenoses: long-term follow-up. J Cardiovasc 25 Löfberg AM, Lörelius LE, Karacagil S et al. The use of belowknee Surg 1990; 31: percutaneous transluminal angioplasty in arterial occlusive 24 Sanchez LA, Suggs WD, Marin ML et al. Is percutaneous balloon disease causing chronic critical limb ischaemia. Cardiovasc Inangioplasty appropriate in treatment of graft and anastomotic tervent Radiol 1996; 19: lesions responsible for failing vein bypass? Am J Surg 1994; 168: Accepted 28 November 2001