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Comparison of Results of Subintimal Angioplasty and Percutaneous Transluminal Angioplasty in Superficial Femoral Artery Occlusions
Eur J Vasc Endovasc Surg (2008) 36, 101e106
Comparison of Results of Subintimal Angioplasty and Percutaneous Transluminal Angioplasty in Superficial Femoral Artery Occlusions A. Antusevas a,*, N. Aleksynas a, R.S. Kaupas b, D. Inciura a, S. Kinduris a a b
Department of Vascular Surgery, Kaunas University of Medicine, Kaunas, Lithuania Department of Radiology, Kaunas University of Medicine, Kaunas, Lithuania
Submitted 20 November 2007; accepted 12 February 2008 Available online 25 April 2008
KEYWORDS Subintimal angioplasty; Percutaneous transluminal angioplasty; Superficial femoral artery occlusions; Patency rate
Abstract Objectives: To report results of subintimal angioplasty (SA) of superficial femoral artery occlusions and to compare these results with percutaneous transluminal angioplasty (PTA) of similar lesions. Design: Prospective study. Patients: In the period from June 2002 to August 2006, 73 SA procedures were performed in 71 patients and 75 PTA procedures were performed in 75 patients. Methods: All cases treated with SA or PTA for superficial femoral artery occlusions were prospectively registered and reviewed. Assessments of comorbidities, indication for procedure, run-off, occlusion length, calcification of the artery and graft patency were recorded. Results: The technical success rate of SA was 87.7% versus 81.3% for PTA. Primary patency rates in the SA group at 1, 6, 12, 24 months were respectively 84.9 4.2, 71.2 5.1, 68.5 5.3 and 65.8 5.2%; in the PTA group e 81.3 4.4, 45.3 5.7, 42.7 5.6 and 38.7 5.5% respectively. At the same time-points primary assisted patency rates were in SA group 84.9 4.2, 83.6 4.2, 71.2 5.2 and 68.5 5.3%; and in the PTA group 81.3 4.4, 62.5 5.5, 44 5.6 and 42.7 5.6%. Calcification was associated with SA failure. There were no amputations in the follow up of either SA or PTA procedures. Conclusion: Results from subintimal angioplasty of superficial femoral artery occlusions was superior to the results of PTA. ª 2008 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
Introduction * Corresponding author. A. Antusevas, MD, PhD, Professor, Kaunas University of Medicine, Head Division of Vascular Surgery, Eiveniu 2, LT-50009 Kaunas, Lithuania. E-mail address: [email protected] (A. Antusevas).
During the last two decades major changes have taken place in the diagnostic and treatment techniques for peripheral arterial disease (PAD). In the past, the main treatments for PAD were thrombectomy, endarterectomy
1078-5884/$34 ª 2008 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.ejvs.2008.02.010
102 and bypass surgery.1e3 Today occlusions can be corrected by means of percutaneous transluminal angioplasty,4 subintimal angioplasty,5 laser angioplasty,6 thrombolysis,7 endovascular thrombadsorbtion8 and endovascular stenting.9 Due to increasing longevity patients now present with more coexistent illnesses, which often increase the risk of surgery for PAD. Today many lesions can be treated by endovascular methods, which are less invasive, can be performed under local anaesthesia and are relatively cheap. The aim of this study was to compare the results of subintimal angioplasty (SA) and percutaneous transluminal angioplasty (PTA) for treatment of chronic occlusions of the superficial femoral artery (SFA) and to identify factors associated with the success or failure of subintimal angioplasty.
Patients and Methods One hundred and forty six patients with SFA occlusions were treated from June 2002 to August 2006. Seventy three subintimal angioplasties were performed in 71 patients (SA group), while 75 percutaneous transluminal angioplasties were performed in 75 patients (PTA group). The SA group consisted of 51 men (71.8%) and 20 women (28.2%), mean age 65.9 10.42 years (range from 36 to 84 years). Before SA treatment patients with intermittent claudication underwent a 3 month period of medical treatment, smoking cessation and regular walking exercises. All patients, received 100e250 mg of aspirin daily, unless contraindicated. The indication for endovascular procedures (SA and PTA) was chronic SFA occlusion. Exclusion criteria in both groups (SA and PTA) were as follows: acute limb ischaemia; significant haemodynamic stenosis in the aorto-iliac segment; stenosis of SFA; significant haemodynamic stenosis or occlusion of the popliteal artery. For the SA procedure the following criteria were used: all occlusion lengths, preferably 5 cm or longer occlusions; flush occlusion of the SFA. The criteria for PTA were short occlusions (<5 cm length) or non flush occlusion of the SFA. The lengths of SFA occlusions were defined into type A, B, C, D, according to TASC recommendations.10 SA was performed by a single interventional radiologist, experienced in conventional percutaneous transluminal angioplasty. Recanalizations were performed as described by Bolia and Reekers.11,12 The ipsilateral antegrade approach was used in all cases. Subintimal entry was achieved by pushing a 5 French straight angiography catheter into the lesion. The occluded segment was then traversed with a 0.0350 hydrophilic guide wire. The tip of guide wire was looped during the passage and followed by a 5 French straight catheter. After re-entry at the distal end of the lesion, the subintimal passage was dilated with either a 5 or 6 mm balloon angioplasty catheter, depending on the diameter of the normal artery. If the new lumen was not stable or was too narrow after the dilatation, Self-Expandable Peripheral Nitinol Stents were implanted. An open canal with good antegrade flow at the end of the procedure was defined as technical success. Good antegrade flow was defined by the radiologist during angiography after the SA procedure. Procedures in which it was impossible to gain entry, re-entry or obtain an acceptable flow through the canal
A. Antusevas et al. were regarded as technical failures. During the SA procedure the patient was routinely given 5000 IU of intraarterial heparin and in cases of arteriospasm 0.5e1.0 mg of intra-arterial glyceryl trinitrate was administered. After the procedure, outpatient examinations were performed at 1, 6, 12 and 24 months. Routine follow-up consisted of colour-flow duplex scanning in the department of radiology (Toshiba Applio model SSA-770 A, Fundamentals 2B 730-595 E*J, Japan), ankle-brachial blood pressure index (ABI) measurements at every follow-up visit and evaluation of symptom recurrence. If the peak systolic velocity (Vmax) increased more than 2-fold in either the SA or PTA region, in comparison to early duplex scanning in this SFA region after SA or PTA, the patient was referred for angiography and, if necessary, the SFA stenosis was treated by PTA. If SFA occlusion was observed, bypass surgery was performed. If haemodynamically significant (>50%) stenosis could not be confirmed by angiography, no further intervention was performed and the patient continued under routine follow-up. The primary and primary assisted patency were defined according to TASC recommendations.10 All PTA procedures were performed by standard technique. The ipsilateral antegrade approach was used in most procedures.
Statistical Methods Post procedural data were collected into a computerized registry and analyzed with SPSS 13 for Windows. Cumulative SFA patency was estimated by Kaplan-Meier method. Comparisons of primary and primary assisted patency between groups was performed using log rank (ManteleCox) test. Statistical analysis of the data was performed using Fisher’s exact test and Pearson’s c2 test for categorical data and Student’s t-test for continuous variables, with statistical significance set at p < 0.05. Continuous variables are presented as mean standard deviation (SD), patency rates as percentage standard error (SE). Patency rates and limb salvage rates are based on the number of treated legs. When a defined endpoint (occlusion) was not reached, the data were censored at the last known follow-up.
Results The indications for SA were disabling intermittent claudication (IC) in 38 cases (52.1%) and critical ischaemia (CI) as defined by the TransAtlantic Inter-Society Consensus10 in 35 cases (47.9%). The indications for PTA were disabling IC in 29 cases (38.7%) and CI in 46 cases (61.3%). The demographic, clinical characteristics and risk factors of the SA and PTA groups are compared in Table 1. The results from angiography for both SA and PTA patients are shown in Table 2. The quality of the run-off was defined by the number of patients with passable calf arteries: in the SA group good run-off (2e3 arteries) was found in 53 limbs (72.6%) and poor run-off (0e1 arteries) in 20 limbs (27.4%), while in the PTA group in good run-off was found in 48 limbs (64%) and poor run-off in 27 (36%) limbs. The difference between the numbers of the occluded calf arteries in the SA and PTA groups was not statistically significant.
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Table 1 The demographic and clinical characteristics of the subintimal angioplasty and the percutaneous transluminal angioplasty groups Variables
SA group (73 procedures)
% or SD
PTA group (75 procedures)
% or SD
Male/female Age (years) Age 75 years Smoking history Arterial hypertension Diabetes mellitus Ischaemic heart disease Intermittent claudication Critical ischaemia Ankle-brachial pressure index Previous bypass surgery
53/20 65.9 14 53 47 11 39 38 35 0.34 3
72.6/27.4 10.42 19.2 72.6 64.4 15.1 53.4 52.1 47.9 0.14 4.1
57/18 65.6 10 53 41 9 40 29 46 0.35 0
76/24 10.37 13.3 70.7 54.7 12 53.3 38.7 61.3 0.12 0
SD e standard deviation.
Sixty four of 73 SA procedures were considered technically successful. Technical failures occurred in 7 cases. In addition, slow antegrade flow after SA was observed in 2 cases, which also were defined as technical failures. In three cases Self-Expandable Peripheral Nitinol Stents for SA procedure were used. Two procedures that were complicated by distal embolization were treated successfully by thrombectomy in one case and thrombolysis in the other. Other complications included superficial haematomas in two cases and arterial spasm in a further two other cases. The initial outcomes of treatment by SA and PTA are presented in Table 3. Primary patency rates in SA group at 1, 6, 12, 24 months were respectively 84.9 4.2, 71.2 5.1, 68.5 5.3 and 65.8 5.2% and in PTA group 81.3 4.4, 45.3 5.7, 42.7 5.6 and 38.7 5.5%, (Fig. 1). SA primary patency was significantly higher than PTA primary patency (log rank (ManteleCox) method e c2 Z 18.959; p < 0.001). Primary assisted patency rates calculated on intention to treat basis in the SA group at 1, 6, 12, 24 months were respectively 84.9 4.2, 83.6 4.2, 71.2 5.2 and 68.5 5.3% versus 81.3 4.4, 62.5 5.5, 44 5.6 and 42.7 5.6% for the PTA group (Fig. 2). SA primary assisted patency was statistically significantly higher than for PTA (log rank (ManteleCox) method e c2 Z 70.889; p < 0.001).
The median follow-up duration was 13 months (0e36) in the SA group and 13.2 months (0e36) in the PTA group. During follow-up no limb amputations were performed that were attributed to either the SA or the PTA procedures. Similarly no deaths were reported in either group. Conversion to bypass surgery was performed in seven cases due to the technical inability to perform subintimal angioplasty of the SFA. We observed that technical failures of SA occurred more often when calcification of the SFA occlusion had been noted (p Z 0.002). No factors were associated with the results of SA. Detailed analysis of the factors that were investigated influenced primary, primary assisted patency and could predict technical failure of subintimal angioplasty in the SA group patients is presented iare shown Table 4.
Discussion Endovascular treatment of long SFA occlusions is controversial because of unsatisfactory long-term patency and complication rates. The promising results of subintimal femoropopliteal recanalization published by London et al., with one year patency rates of 71%, indicated a new safe approach to this problem that merits consideration.13 In three recent prospective studies Florenes et al., Lazaris
Table 2 The angiographic examination data of patients in the subintimal angioplasty and the control percutaneous transluminal angioplasty groups and their comparison Factor
SA group (73 procedures)
%
PTA group (75 procedures)
%
Mean length of occlusion (cm) (SD) Long occlusions (10 cm) Occlusion type A (cm) Occlusion type B (cm) Occlusion type C (cm) Occlusion type D (cm) Good run-off (Run e off 3/2 artery patent) Bad run-off (Run e off 1/0 artery patent) Calcification in SFA occlusion
12 (5.57)* 40* 2 37 22 12 53 20 15
e 54.8 2.7 50.7 30.2 16.4 72.6 27.4 20.5
6.3 (3.56)* 12* 17 51 6 1 48 27 18
e 16 22.7 68 8 1.3 64 36 24
*p < 0.05 between groups, SD e standard deviation, SFA e superficial femoral artery.
104
A. Antusevas et al.
Table 3 The comparison of initial treatment outcomes in the subintimal angioplasty group and the control percutaneous transluminal angioplasty group Factor
SA group (73 procedures)
%
PTA group (75 procedures)
%
Technical success Pulsation of popliteal artery ABI mean after treatment (SD) Increasing ABI up to 0.15 after treatment Angiographical success with fast antegrade flow Angiographical success with slow antegrade flow Improvement of limb symptoms Improvement of intermittent claudication (II st.) Improvement of pain at rest (III st.) Improvement when tissue loss is present (IV st.) No improvement of limb symptoms Complications
64/73 53/73 0.9 (0.2) 66/73 64/73 2/73 66/73 36/38 11/14 19/21 7 6
87.7 72.6 e 90.4 87.7 2.7 90.4 94.7 78.6 90.5 9.6 8.2
61/75 56/75 0.87 (0.23) 63/75 61/75 7/75 62/75 27/29 24/30 11/13 13 10
81.3 74.7 e 84 81.3 9.3 82.6 93.1 80 84.6 17.3 13.3
ABI e ankle-brachial index, SD e standard deviation.
et al. and McCarthy et al. presented 12 month overall patency rates for SA ranging from 53 to 70%.14e16 Our results of a primary patency rate of 68.5% are similar. In contrast, Laxdal et al. recently reported a 37% primary patency at one year for femoropopliteal subintimal angioplasties.17 These results are poor compared to bypass surgery where patency rates at one year are reported to be between 81% and 100%.18,19 PTA of moderate and long-segment SFA occlusive disease is still controversial due to unsatisfactory success and patency rates. The use of self-expanding nitinol stents in these lesions seems to improve the results of the procedure. In the SIROCCO I and II trials the primary patency rates at 6 months were 76.5% and 92.3% among patients with bare nitinol stents.20,21 Mid-term findings in these studies showed a restenosis rate at 24 months of only 21%.22 However, average lesion length in SIROCCO was only 8.0 cm and only 2/3 of lesions were fully occluded.
In the ABSOLUTE trial Schillinger et al. reported that the 6 month primary patency rate in stented patients was 76%.23 The recently published 2 year data from this trial also favours the use of stents for long SFA lesions, with a sustained benefit of primary stent implantation being observed.24 It seems surprising that although lesion lengths were similar in our study and the ABSOLUTE trial (average lesion length was 13.2 cm and 12 cm, respectively), total occlusions constituted only 1/3 of all lesions in the ABSOLUTE trial. Nevertheless SA may be better than conventional PTA/stenting because at 24 months primary patency rates in our study and the ABSOLUTE trial were similar (65.8% and 54.3%).24 In our study the majority of re-occlusions occurred within the first 6 months after SA. Therefore the early
Figure 1 Kaplan-Meier probability curves of primary patency after subintimal angioplasty and percutaneous transluminal angioplasty.
Figure 2 Kaplan-Meier probability curves of primary assisted patency after subintimal angioplasty and percutaneous transluminal angioplasty.
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Table 4 The detailed analysis of the factors predicting technical failure, primary and primary assisted patency in patients of subintimal angioplasty group Factor
Calcification in SFA occlusion Long occlusions (10 cm) Stage of chronic limb ischaemia Arterial hypertension Ischaemic heart disease Bad run-off (Run e off 1/ 0 artery patent) Diabetes mellitus Age 75 years Smoking Sex Previous bypass surgery
Technical Primary Primary failure patency assisted p value p value patency p value 0.002 1.00 0.29 0.48 0.29 0.25
0.11 0.12 0.18 0.30 0.40 0.41
0.33 0.10 0.32 0.10 0.30 0.95
0.62 1.00 0.69 0.42 1.00
0.46 0.51 0.59 0.62 0.81
0.31 0.82 0.74 0.51 0.14
post-procedural follow up is particularly important for identifying factors associated with poor patency and for the prevention of SFA re-occlusion. The selection of patients suitable for SA has not yet been defined clearly. Reekers et al., Aleksynas et al. found that arterial calcification was predictive of technical failure.12,25 In our study calcification of SFA also influenced technical success, but it did not affect primary assisted patency. Bolia et al., in addition, stated that the extensive calcification, recent (3e6 months) occlusions and distal atherosclerotic disease should not be treated with subintimal recanalization.26 In our study, distal run-off was not related to reocclusion. London et al. found that run-off, smoking and occlusion length were independent risk factors for reocclusion.13 In our study, occlusion length and smoking were not significantly associated with primary and primary assisted patency. Recently, Lazaris et al. described a clinical study of 51 infrainguinal SA procedures in 46 patients suffering from CI. The 12 month patency in patients with more than one run-off vessel was 81% compared to 25% in patients with only one run-off vessel. Regarding the length of angioplasty, the hazard of re-occlusion was 1.02 for every centimetre of occlusion (P Z 0.049).27 London et al. reported similar results in patients with femoropopliteal occlusion treated by SA.13 Comparable results have also been reported by other investigators for percutaneous transluminal infrainquinal angioplasty.28e30 The single-centre, non-randomized design of this prospective controlled study warrants careful interpretation of the results, and the small cohorts (SA n Z 73, PTA n Z 75) might have introduced bias. Such bias can only be removed by a randomized trial comparing SA and PTA of SFA occlusions. Another limitation of our study was that the types of occlusion, particularly for types A, C, D differed too between the SA and PTA groups. Subintimal angioplasty appeared superior to conventional PTA of SFA occlusions. Calcification of SFA had a significant predictive value for technical failure of SA procedure. Subintimal angioplasty
does not preclude later successful vascular surgery and, in our Department, SA now is the first choice procedure for patients with PAD, especially those with severe comorbidities.
References 1 Lerwick ER. Oscillating loop endarterectomy for peripheral vascular reconstruction. Surgery 1985;9(5):574e84. 2 Rosenthal D, Schubart PJ, Kinney EV, Martin JD, Sharma R, Matsuura JH, et al. Remote superficial femoral artery endarterectomy: multicentre medium-term results. J Vasc Surg 2001;43: 428e32. 3 Johnson WC, Lee KK. A comparative evaluation of polytetrafluorethylene, umbilical vein and saphenous vein bypass grafts for femoral-popliteal above knee revascularization. A prospective randomized department of veterans affairs cooperative study. J Vasc Surg 2000;32:268e77. 4 Varty K, Nydahl S, Butterworth P, Errington M, Bolia A, Bell PR. Changes in the management of critical limb ischaemia. Br J Surg 1996;83:953e6. 5 Bolia A. Subintimal angioplasty in lower limb ischaemia. J Cardiovasc Surg 2005;46:385e94. 6 Laird JR, Zeller T, Gray BH, Scheinert D, Vranic M, Reiser C, et al. Limb salvage following laser-assisted angioplasty for critical limb ischemia: results of the LACI multicenter. trial. J Endovasc Ther 2006 Feb;13(1):1e11. 7 Shrivastava CP, Devgarha S. Urokinase thrombolysis in acute-onchronic vascular occlusion of lower limb. Asian Cardiovasc Thorac Ann 2007 Oct;15(5):405e7. 8 Rogers JH, Laird JR. Overview of new technologies for lower extremity revascularization. Circulation 2007 Oct 30;116(18): 2072e85. 9 Johannes Ruef MS, Hofman M, Haase J. Endovascular interventions in iliac and infrainquinal occlusive artery disease. J Interv Cardiol 2004;17:427e35. 10 Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Concensus (TASC). J Vasc Surg 2000;31:S1e296. 11 Bolia A, Miles KA, Brennan J, Bell FRF. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol 1990;13:357e63. 12 Reekers JA, Bolia A. Percutaneous intentional extraluminal (subintimal) recanalization: how to do it yourself. Eur J Radiol 1998;28:192e8. 13 London NJ, Srinivasan R, Naylor AR, Hartshorne T, Ratliff DA, Bell PR, et al. Subintimal angioplasty of femoropopliteal artery occlusions: the long-term results. Eur J Vasc Surg 1994;8:148e55. 14 Florenes T, Bay D, Sandbaek G, Saetre T, Jorgensen JJ, Slagsvold CE, et al. Subintimal angioplasty in the treatment of patients with intermittent claudication: long term results. Eur J Vasc Endovasc Surg 2004;28:645e50. 15 Lazaris AM, Tsiamis AC, Fishwick G, Bolia A, Bell PR. Clinical outcome of primary infrainguinal subintimal angioplasty in diabetic patients with critical lower limb ischemia. J Endovasc Ther 2004;11:447e53. 16 McCarthy RJ, Neary W, Roobottom C, Tottle A, Ashley S. Shortterm results of femoropopliteal subintimal angioplasty. Br J Surg 2000;87:1361e5. 17 Laxdal E, Jenssen GL, Pedersen G, Aune S. Subintimal angioplasty as a treatment of femoropopliteal artery occlusions. Eur J Vasc Endovasc Surg 2003;25:578e82. 18 Klinkert P, Schepers A, Burger DH, Van Bockel JH, Breslau PJ. Vein versus polytetrafluoroethylene in above-knee femoropopliteal bypass grafting: five-year results of a randomized controlled trial. J Vasc Surg 2003;37:149e55.
106 19 Ballotta E, Renon L,Toffano M, Giau G. Prospective randomized study on bilateral above knee femoropopliteal revascularization: polytetrafluoroethylene graft versus reversed saphenous vein. J Vasc Surg 2003;38:1051e5. 20 Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, et al. Sirolimus eluting stents for the treatment of obstructive superficial femoral artery disease: 6-months results. Circulation 2002;106:1505e9. 21 Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A, et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol 2005;16:331e8. 22 Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther 2006;13:701e10. 23 Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Schlager O, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 2006;354:1879e88. 24 Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, et al. Sustained benefit at 2 years of primary
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femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation 2007;115:2745e9. Aleksynas N, Kaupas RS. The influence of various factors on results of subintimal angioplasty of superficial femoral artery occlusions. Medicina (Kaunas) 2007;43(1):43e50. Bolia A, Brennan J, Bell PR. Recanalisation of femoro-popliteal occlusions: improving success rate by subintimal recanalisation. Clin Radiol 1989;40:325. Lazaris AM, Salas C, Tsiamis AC, Vlachou PA, Bolia A, Fishwick G, et al. Factors affecting patency of subintimal infrainguinal angioplasty in patients with critical lower limb ischemia. Eur J Vasc Endovasc Surg 2006;32(6):668e74. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, Harrington DP. Patency results of percutaneous and surgical revascularization for femoropopliteal arterial disease. Med Decis Making 1994;14(1):71e81. Ja ¨mse ´n T, Manninen H, Tulla H, Matsi P. The final outcome of primary infrainguinal percutaneous transluminal angioplasty in 100 consecutive patients with chronic critical limb ischemia. J Vasc Interv Radiol 2002;13(5):455e63. Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology 1992;183(3):767e71.
Comparison of Results of Subintimal Angioplasty and Percutaneous Transluminal Angioplasty in Superficial Femoral Artery Occlusions A. Antusevas a,*, N. Aleksynas a, R.S. Kaupas b, D. Inciura a, S. Kinduris a a b
Department of Vascular Surgery, Kaunas University of Medicine, Kaunas, Lithuania Department of Radiology, Kaunas University of Medicine, Kaunas, Lithuania
Submitted 20 November 2007; accepted 12 February 2008 Available online 25 April 2008
KEYWORDS Subintimal angioplasty; Percutaneous transluminal angioplasty; Superficial femoral artery occlusions; Patency rate
Abstract Objectives: To report results of subintimal angioplasty (SA) of superficial femoral artery occlusions and to compare these results with percutaneous transluminal angioplasty (PTA) of similar lesions. Design: Prospective study. Patients: In the period from June 2002 to August 2006, 73 SA procedures were performed in 71 patients and 75 PTA procedures were performed in 75 patients. Methods: All cases treated with SA or PTA for superficial femoral artery occlusions were prospectively registered and reviewed. Assessments of comorbidities, indication for procedure, run-off, occlusion length, calcification of the artery and graft patency were recorded. Results: The technical success rate of SA was 87.7% versus 81.3% for PTA. Primary patency rates in the SA group at 1, 6, 12, 24 months were respectively 84.9 4.2, 71.2 5.1, 68.5 5.3 and 65.8 5.2%; in the PTA group e 81.3 4.4, 45.3 5.7, 42.7 5.6 and 38.7 5.5% respectively. At the same time-points primary assisted patency rates were in SA group 84.9 4.2, 83.6 4.2, 71.2 5.2 and 68.5 5.3%; and in the PTA group 81.3 4.4, 62.5 5.5, 44 5.6 and 42.7 5.6%. Calcification was associated with SA failure. There were no amputations in the follow up of either SA or PTA procedures. Conclusion: Results from subintimal angioplasty of superficial femoral artery occlusions was superior to the results of PTA. ª 2008 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
Introduction * Corresponding author. A. Antusevas, MD, PhD, Professor, Kaunas University of Medicine, Head Division of Vascular Surgery, Eiveniu 2, LT-50009 Kaunas, Lithuania. E-mail address: [email protected] (A. Antusevas).
During the last two decades major changes have taken place in the diagnostic and treatment techniques for peripheral arterial disease (PAD). In the past, the main treatments for PAD were thrombectomy, endarterectomy
1078-5884/$34 ª 2008 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.ejvs.2008.02.010
102 and bypass surgery.1e3 Today occlusions can be corrected by means of percutaneous transluminal angioplasty,4 subintimal angioplasty,5 laser angioplasty,6 thrombolysis,7 endovascular thrombadsorbtion8 and endovascular stenting.9 Due to increasing longevity patients now present with more coexistent illnesses, which often increase the risk of surgery for PAD. Today many lesions can be treated by endovascular methods, which are less invasive, can be performed under local anaesthesia and are relatively cheap. The aim of this study was to compare the results of subintimal angioplasty (SA) and percutaneous transluminal angioplasty (PTA) for treatment of chronic occlusions of the superficial femoral artery (SFA) and to identify factors associated with the success or failure of subintimal angioplasty.
Patients and Methods One hundred and forty six patients with SFA occlusions were treated from June 2002 to August 2006. Seventy three subintimal angioplasties were performed in 71 patients (SA group), while 75 percutaneous transluminal angioplasties were performed in 75 patients (PTA group). The SA group consisted of 51 men (71.8%) and 20 women (28.2%), mean age 65.9 10.42 years (range from 36 to 84 years). Before SA treatment patients with intermittent claudication underwent a 3 month period of medical treatment, smoking cessation and regular walking exercises. All patients, received 100e250 mg of aspirin daily, unless contraindicated. The indication for endovascular procedures (SA and PTA) was chronic SFA occlusion. Exclusion criteria in both groups (SA and PTA) were as follows: acute limb ischaemia; significant haemodynamic stenosis in the aorto-iliac segment; stenosis of SFA; significant haemodynamic stenosis or occlusion of the popliteal artery. For the SA procedure the following criteria were used: all occlusion lengths, preferably 5 cm or longer occlusions; flush occlusion of the SFA. The criteria for PTA were short occlusions (<5 cm length) or non flush occlusion of the SFA. The lengths of SFA occlusions were defined into type A, B, C, D, according to TASC recommendations.10 SA was performed by a single interventional radiologist, experienced in conventional percutaneous transluminal angioplasty. Recanalizations were performed as described by Bolia and Reekers.11,12 The ipsilateral antegrade approach was used in all cases. Subintimal entry was achieved by pushing a 5 French straight angiography catheter into the lesion. The occluded segment was then traversed with a 0.0350 hydrophilic guide wire. The tip of guide wire was looped during the passage and followed by a 5 French straight catheter. After re-entry at the distal end of the lesion, the subintimal passage was dilated with either a 5 or 6 mm balloon angioplasty catheter, depending on the diameter of the normal artery. If the new lumen was not stable or was too narrow after the dilatation, Self-Expandable Peripheral Nitinol Stents were implanted. An open canal with good antegrade flow at the end of the procedure was defined as technical success. Good antegrade flow was defined by the radiologist during angiography after the SA procedure. Procedures in which it was impossible to gain entry, re-entry or obtain an acceptable flow through the canal
A. Antusevas et al. were regarded as technical failures. During the SA procedure the patient was routinely given 5000 IU of intraarterial heparin and in cases of arteriospasm 0.5e1.0 mg of intra-arterial glyceryl trinitrate was administered. After the procedure, outpatient examinations were performed at 1, 6, 12 and 24 months. Routine follow-up consisted of colour-flow duplex scanning in the department of radiology (Toshiba Applio model SSA-770 A, Fundamentals 2B 730-595 E*J, Japan), ankle-brachial blood pressure index (ABI) measurements at every follow-up visit and evaluation of symptom recurrence. If the peak systolic velocity (Vmax) increased more than 2-fold in either the SA or PTA region, in comparison to early duplex scanning in this SFA region after SA or PTA, the patient was referred for angiography and, if necessary, the SFA stenosis was treated by PTA. If SFA occlusion was observed, bypass surgery was performed. If haemodynamically significant (>50%) stenosis could not be confirmed by angiography, no further intervention was performed and the patient continued under routine follow-up. The primary and primary assisted patency were defined according to TASC recommendations.10 All PTA procedures were performed by standard technique. The ipsilateral antegrade approach was used in most procedures.
Statistical Methods Post procedural data were collected into a computerized registry and analyzed with SPSS 13 for Windows. Cumulative SFA patency was estimated by Kaplan-Meier method. Comparisons of primary and primary assisted patency between groups was performed using log rank (ManteleCox) test. Statistical analysis of the data was performed using Fisher’s exact test and Pearson’s c2 test for categorical data and Student’s t-test for continuous variables, with statistical significance set at p < 0.05. Continuous variables are presented as mean standard deviation (SD), patency rates as percentage standard error (SE). Patency rates and limb salvage rates are based on the number of treated legs. When a defined endpoint (occlusion) was not reached, the data were censored at the last known follow-up.
Results The indications for SA were disabling intermittent claudication (IC) in 38 cases (52.1%) and critical ischaemia (CI) as defined by the TransAtlantic Inter-Society Consensus10 in 35 cases (47.9%). The indications for PTA were disabling IC in 29 cases (38.7%) and CI in 46 cases (61.3%). The demographic, clinical characteristics and risk factors of the SA and PTA groups are compared in Table 1. The results from angiography for both SA and PTA patients are shown in Table 2. The quality of the run-off was defined by the number of patients with passable calf arteries: in the SA group good run-off (2e3 arteries) was found in 53 limbs (72.6%) and poor run-off (0e1 arteries) in 20 limbs (27.4%), while in the PTA group in good run-off was found in 48 limbs (64%) and poor run-off in 27 (36%) limbs. The difference between the numbers of the occluded calf arteries in the SA and PTA groups was not statistically significant.
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Table 1 The demographic and clinical characteristics of the subintimal angioplasty and the percutaneous transluminal angioplasty groups Variables
SA group (73 procedures)
% or SD
PTA group (75 procedures)
% or SD
Male/female Age (years) Age 75 years Smoking history Arterial hypertension Diabetes mellitus Ischaemic heart disease Intermittent claudication Critical ischaemia Ankle-brachial pressure index Previous bypass surgery
53/20 65.9 14 53 47 11 39 38 35 0.34 3
72.6/27.4 10.42 19.2 72.6 64.4 15.1 53.4 52.1 47.9 0.14 4.1
57/18 65.6 10 53 41 9 40 29 46 0.35 0
76/24 10.37 13.3 70.7 54.7 12 53.3 38.7 61.3 0.12 0
SD e standard deviation.
Sixty four of 73 SA procedures were considered technically successful. Technical failures occurred in 7 cases. In addition, slow antegrade flow after SA was observed in 2 cases, which also were defined as technical failures. In three cases Self-Expandable Peripheral Nitinol Stents for SA procedure were used. Two procedures that were complicated by distal embolization were treated successfully by thrombectomy in one case and thrombolysis in the other. Other complications included superficial haematomas in two cases and arterial spasm in a further two other cases. The initial outcomes of treatment by SA and PTA are presented in Table 3. Primary patency rates in SA group at 1, 6, 12, 24 months were respectively 84.9 4.2, 71.2 5.1, 68.5 5.3 and 65.8 5.2% and in PTA group 81.3 4.4, 45.3 5.7, 42.7 5.6 and 38.7 5.5%, (Fig. 1). SA primary patency was significantly higher than PTA primary patency (log rank (ManteleCox) method e c2 Z 18.959; p < 0.001). Primary assisted patency rates calculated on intention to treat basis in the SA group at 1, 6, 12, 24 months were respectively 84.9 4.2, 83.6 4.2, 71.2 5.2 and 68.5 5.3% versus 81.3 4.4, 62.5 5.5, 44 5.6 and 42.7 5.6% for the PTA group (Fig. 2). SA primary assisted patency was statistically significantly higher than for PTA (log rank (ManteleCox) method e c2 Z 70.889; p < 0.001).
The median follow-up duration was 13 months (0e36) in the SA group and 13.2 months (0e36) in the PTA group. During follow-up no limb amputations were performed that were attributed to either the SA or the PTA procedures. Similarly no deaths were reported in either group. Conversion to bypass surgery was performed in seven cases due to the technical inability to perform subintimal angioplasty of the SFA. We observed that technical failures of SA occurred more often when calcification of the SFA occlusion had been noted (p Z 0.002). No factors were associated with the results of SA. Detailed analysis of the factors that were investigated influenced primary, primary assisted patency and could predict technical failure of subintimal angioplasty in the SA group patients is presented iare shown Table 4.
Discussion Endovascular treatment of long SFA occlusions is controversial because of unsatisfactory long-term patency and complication rates. The promising results of subintimal femoropopliteal recanalization published by London et al., with one year patency rates of 71%, indicated a new safe approach to this problem that merits consideration.13 In three recent prospective studies Florenes et al., Lazaris
Table 2 The angiographic examination data of patients in the subintimal angioplasty and the control percutaneous transluminal angioplasty groups and their comparison Factor
SA group (73 procedures)
%
PTA group (75 procedures)
%
Mean length of occlusion (cm) (SD) Long occlusions (10 cm) Occlusion type A (cm) Occlusion type B (cm) Occlusion type C (cm) Occlusion type D (cm) Good run-off (Run e off 3/2 artery patent) Bad run-off (Run e off 1/0 artery patent) Calcification in SFA occlusion
12 (5.57)* 40* 2 37 22 12 53 20 15
e 54.8 2.7 50.7 30.2 16.4 72.6 27.4 20.5
6.3 (3.56)* 12* 17 51 6 1 48 27 18
e 16 22.7 68 8 1.3 64 36 24
*p < 0.05 between groups, SD e standard deviation, SFA e superficial femoral artery.
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Table 3 The comparison of initial treatment outcomes in the subintimal angioplasty group and the control percutaneous transluminal angioplasty group Factor
SA group (73 procedures)
%
PTA group (75 procedures)
%
Technical success Pulsation of popliteal artery ABI mean after treatment (SD) Increasing ABI up to 0.15 after treatment Angiographical success with fast antegrade flow Angiographical success with slow antegrade flow Improvement of limb symptoms Improvement of intermittent claudication (II st.) Improvement of pain at rest (III st.) Improvement when tissue loss is present (IV st.) No improvement of limb symptoms Complications
64/73 53/73 0.9 (0.2) 66/73 64/73 2/73 66/73 36/38 11/14 19/21 7 6
87.7 72.6 e 90.4 87.7 2.7 90.4 94.7 78.6 90.5 9.6 8.2
61/75 56/75 0.87 (0.23) 63/75 61/75 7/75 62/75 27/29 24/30 11/13 13 10
81.3 74.7 e 84 81.3 9.3 82.6 93.1 80 84.6 17.3 13.3
ABI e ankle-brachial index, SD e standard deviation.
et al. and McCarthy et al. presented 12 month overall patency rates for SA ranging from 53 to 70%.14e16 Our results of a primary patency rate of 68.5% are similar. In contrast, Laxdal et al. recently reported a 37% primary patency at one year for femoropopliteal subintimal angioplasties.17 These results are poor compared to bypass surgery where patency rates at one year are reported to be between 81% and 100%.18,19 PTA of moderate and long-segment SFA occlusive disease is still controversial due to unsatisfactory success and patency rates. The use of self-expanding nitinol stents in these lesions seems to improve the results of the procedure. In the SIROCCO I and II trials the primary patency rates at 6 months were 76.5% and 92.3% among patients with bare nitinol stents.20,21 Mid-term findings in these studies showed a restenosis rate at 24 months of only 21%.22 However, average lesion length in SIROCCO was only 8.0 cm and only 2/3 of lesions were fully occluded.
In the ABSOLUTE trial Schillinger et al. reported that the 6 month primary patency rate in stented patients was 76%.23 The recently published 2 year data from this trial also favours the use of stents for long SFA lesions, with a sustained benefit of primary stent implantation being observed.24 It seems surprising that although lesion lengths were similar in our study and the ABSOLUTE trial (average lesion length was 13.2 cm and 12 cm, respectively), total occlusions constituted only 1/3 of all lesions in the ABSOLUTE trial. Nevertheless SA may be better than conventional PTA/stenting because at 24 months primary patency rates in our study and the ABSOLUTE trial were similar (65.8% and 54.3%).24 In our study the majority of re-occlusions occurred within the first 6 months after SA. Therefore the early
Figure 1 Kaplan-Meier probability curves of primary patency after subintimal angioplasty and percutaneous transluminal angioplasty.
Figure 2 Kaplan-Meier probability curves of primary assisted patency after subintimal angioplasty and percutaneous transluminal angioplasty.
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Table 4 The detailed analysis of the factors predicting technical failure, primary and primary assisted patency in patients of subintimal angioplasty group Factor
Calcification in SFA occlusion Long occlusions (10 cm) Stage of chronic limb ischaemia Arterial hypertension Ischaemic heart disease Bad run-off (Run e off 1/ 0 artery patent) Diabetes mellitus Age 75 years Smoking Sex Previous bypass surgery
Technical Primary Primary failure patency assisted p value p value patency p value 0.002 1.00 0.29 0.48 0.29 0.25
0.11 0.12 0.18 0.30 0.40 0.41
0.33 0.10 0.32 0.10 0.30 0.95
0.62 1.00 0.69 0.42 1.00
0.46 0.51 0.59 0.62 0.81
0.31 0.82 0.74 0.51 0.14
post-procedural follow up is particularly important for identifying factors associated with poor patency and for the prevention of SFA re-occlusion. The selection of patients suitable for SA has not yet been defined clearly. Reekers et al., Aleksynas et al. found that arterial calcification was predictive of technical failure.12,25 In our study calcification of SFA also influenced technical success, but it did not affect primary assisted patency. Bolia et al., in addition, stated that the extensive calcification, recent (3e6 months) occlusions and distal atherosclerotic disease should not be treated with subintimal recanalization.26 In our study, distal run-off was not related to reocclusion. London et al. found that run-off, smoking and occlusion length were independent risk factors for reocclusion.13 In our study, occlusion length and smoking were not significantly associated with primary and primary assisted patency. Recently, Lazaris et al. described a clinical study of 51 infrainguinal SA procedures in 46 patients suffering from CI. The 12 month patency in patients with more than one run-off vessel was 81% compared to 25% in patients with only one run-off vessel. Regarding the length of angioplasty, the hazard of re-occlusion was 1.02 for every centimetre of occlusion (P Z 0.049).27 London et al. reported similar results in patients with femoropopliteal occlusion treated by SA.13 Comparable results have also been reported by other investigators for percutaneous transluminal infrainquinal angioplasty.28e30 The single-centre, non-randomized design of this prospective controlled study warrants careful interpretation of the results, and the small cohorts (SA n Z 73, PTA n Z 75) might have introduced bias. Such bias can only be removed by a randomized trial comparing SA and PTA of SFA occlusions. Another limitation of our study was that the types of occlusion, particularly for types A, C, D differed too between the SA and PTA groups. Subintimal angioplasty appeared superior to conventional PTA of SFA occlusions. Calcification of SFA had a significant predictive value for technical failure of SA procedure. Subintimal angioplasty
does not preclude later successful vascular surgery and, in our Department, SA now is the first choice procedure for patients with PAD, especially those with severe comorbidities.
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