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Determinants of Patency After Percutaneous Angioplasty and Atherectomy of Occluded Superficial Femoral Arteries Ian L

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Determinants of Patency After Percutaneous Angioplasty and Atherectomy of Occluded Superficial Femoral Arteries Ian L Determinants of Patency After Percutaneous AngiOplasty and Atherectomy of Occluded Superficial Femoral Arteries Ian L. Gordon, MD, PhD, Robert M. Conroy, MD, Jonathan M. Tobis, MD, Cheryl Kohl, RN, Samuel E. Wilson, MD, Orange and Long Beach, California BACKGROUND: Patients undergoing percutaneous were more likely to remain patent than long eecannlization of chronically occluded superficial ones, but overall patency was lower than de- femoral arteries were studied to determine scribed in other series. which factors correlated with 1-year patency. {nunediate change in ankle:brachial index (ABI), he patient with claudication because of chronic oc- length of occlusion, tibial run-off, and the per- T clusion of the superficial femoral artery (SFA) is not formance of supplemental catheter atherectomy generally considered a suitable candidate for bypass were evaluated. surgery unless the symptoms are incapacitating. The pos- METHODS: Eligible patients had at least one sibility that percutaneous recanalization of the occluded patent tibial run-off vessel and the absence of SFA with interventional radiology techniques can yield ~hnb-threatening ischemia. Recanalization was satisfactory clinical results has led us to study this ap- performed via passage of a guidewire followed proach. Our basic method entails penetrating the occlusion by balloon angioplasty. Tibial run-off was scored in the SFA with a guidewire and positioning the tip in the based on a modification of the angiogram scor- true lumen distally; this recanalization step is then followed ing system of the Society for Vascular Surgery by balloon catheter angioplasty. We report here the results and the International Society for Cardiovascular of attempted mechanical SFA recanalization in 57 limbs Surgery. Supplemental transcutaneous extraction with patency analyzed based on the length of the SFA oc- catheter atherectomy was randomly assigned to clusion, whether supplemental catheter atherectomy was a sub-group of patients after initial experience performed, the immediate change in ankle:brachial index with the recanalization technique. Clinical fol- (ABI) pressures achieved by the procedure, and the qual- low-up was employed to determine patency. ity of the tibial run-off vessels. RESULTS: Forty-two of 57 attempts (74%) at re- canalization were immediately successful. Overall PATIENTS AND METHODS 1-year patency was 40% in 40 limbs that could Between June 1989 and October 1993, recanalization was be followed. In limbs with balloon angioplasty attempted in 57 occluded SFAs (49 patients total) at the alone (n = 23), patency was 43% compared with Veterans Administration Medical Center (Long Beach, 35% in those having supplemental atherectomy. California) according to one of two protocols approved by T'd~ial run-off did not vary significantly between the institutional review board. In both protocols, only pa- patent and occluded groups. When ABI in- tients with angiographicaUy demonstrated complete SFA creased by 0.3 or more, patency was 56% com- occlusion and suprageniculate popliteal reconstruction with pared with 26% when the ABI increase was less one or more intact tibial run-off vessels were eligible. The than or equal to 0.1 (P ffi 0.13). Occlusion length of occlusion and the presence of calcification were length averaged 18.1 ± 10.6 cm for all limbs not criteria for inclusion or exclusion. Patients were ex- and did not vary significantly between early suc- cluded if ischemic rest pain, ulceration, or gangrene was cesses and failures. Limbs with short occlusions present or if previous vascular reconstruction of the femoral (less than or equal to 5 cm, n = 8) had 63% or distal vessels had been performed. Until October 1991, patency compared with 38% patency for limbs patients underwent balloon angioplasty after re.canalization with long occlusions (greater than 25 cm, only. After October 1991, catheter atherectomy was ran- n ffi 16), but the difference was not significant by domly assigned to two thirds of the patients, with one third analysis of variance. undergoing balloon angioplasty alone. CONCLUSIONS: .An initial change in ABI was most The technique employed for recanalization has been de- l~redictive for patency, whereas no correlation scribed in detail elsewhere, l In this series, only one radi- with tibial run-off was demonstrated. Atherec- ologist (RMC) performed the recanalization. All patients tomy did not increase patency. Short occlusions underwent initial antegrade ipsilateral common femoral artery puncture and placement of a 7F or 8F introducer From the Departmentsof Surgery(ILG, CK, SEW),Radiology (RMC), sheath with a hemostatic valve into the common femoral and Carthology(JMT), Universityof California,Orange, California,and artery. Under fluoroscopic guidance, a stiff straight 0.038- the Veterans Admmistratttn Medical Center, Long Beach, California. inch guidewire was inserted through a 7F plastic Torcon Requests for reprints should be addressed to lan Gordon, MD, PhD, 7 Fr catheter tapered to 5 Fr with a right angle tip (Cook University of Californialrvine Medical Center, 101 City Drive, Orange, Inc., Bloomington, Indiana) and passed to the point of ob- Cahfornia 92668. Presented at the 22nd Annual Meeting of the Society for Clinical struction. The area of obstruction was probed under fluo- Vascular Surgery, Tucson, Arizona,March 2-6, 1994. roscopy, and the catheter and guidewire were advanced THE AMERICAN JOURNAL OF SURGERY® VOLUME168 AUGUST1994 1 ]5 PATENCY OF OCCLUDED SUPERFICIAL FEMORAL ARTERIES/GORDON ET AlL progressively through the arterial obstruction by the oper- ator applying graded force. In cases in which the wire could TABLE I not be passed completely through the occlusion, a prelim- Patency Data for Different Subgroups inary 6-mm balloon angioplasty of the portion of the oc- Percent Patency" clusion already penetrated by the wire was usually per- Subgroup No. 3 Months 6 Months 12 Months formed. This tends to create a dissection that assists in AlP 40 82 50 40 penetrating the atheroma and positioning the guidewire in Balloon~: 23 78 47 43 the true lumen distally. In a few cases in which either long TEC§ 17 88 52 35 occlusions (greater than 15 cm) or occlusion of the SFA Length _<5 cm'i 8 87 62 62 flush with its origin were present, the antegrade approach Length _<10 cm~ 16 81 50 50 was supplemented by a popliteal puncture and retrograde Length >25 cm'" 16 87 43 37 passage of wires and catheters through the occlusion. AABI <0.1 ri 15 66 26 26 Once a guidewire had been passed through the occlusion z~BI >0.3=t 9 88 77 55 into the true lumen proximally and distally, angioplasty "Percentage of entire subgroup sbll patent at specified interval was performed using 6- or 7-mm diameter balloon tPabents who underwent 6- or 7-mm balloon angioplasty alone. tPatients who had supplemental TEC catheter atherectomy. catheters. In patients undergoing supplemental catheter §Percentage of original group w=th conbnued SFA patency. atherectomy, a 2.7-ram diameter (or larger) transcutaneous ~Patient subgroup with 5 cm or shorter occlusion. extraction catheter (TEC)2 was passed through the occlu- JPat=ent subgroup w=th 10 cm or shorter occlusion. sion, and the cutting mechanism was engaged. During the "'Pabent subgroup with occlusions longer than 25 cm. atherectomy, a suction bottle was connected to the central ttPabent subgroup w=th in=hal change in ABI less than 0.1. IiPabent subgroup with inibal change in ABI of 0 3 or more. lumen of the catheter to aspirate debris. Systemic antico- TEC = transcutaneous extract=on catheter; ABI = ankle.brach~al index. agulation with heparin (5,000 units intravenous bolus fol- lowed by 1,000 units per hour intravenously) was routinely instituted after the initial arterial puncture, but discontin- tion of blood flow through the previous occlusion at the ued at the conclusion of the procedure. Completion an- end of the procedure. Table I shows the patency data fol giograms were obtained in every case if fluoroscopy the 40 patients with adequate 1-year follow-up. The pa- demonstrated blood flow connecting the distal and proxi- tency at 1 year was 40% (16 of 40) for the entire groul~ mal SFA lumens. Patients were observed 48 hours in hos- who had successful initial recanalization with adequate pital after the procedure and discharged on aspirin with- follow-up. This corresponds to an aggregate patency o] out other anticoagulation therapy. ABI measurements 29% (16 of 55) in patients undergoing attempted re- made prior to hospital discharge were compared with pre- canalization. In the 23 patients undergoing balloon an- procedure ABIs to calculate the net change. gioplasty after successful recanalization, 1-year patenc) The length of the SFA occlusion was determined by di- was 43% (10 of 23) compared with 35% 1-year patenc) rect measurement of the angiogram obtained immediately in the patients undergoing supplemental TEC atherectom) prior to recanalization. Completion angiograms were (6 of 17). This difference in patency was not significant quantitated to assess the tibial run-off according to the by Mantel-Haenszel life-table analysis. scoring system proposed by the Ad Hoc Committee on As shown in Table I, as the length of occlusion increased. Reporting Standards for the Society for Vascular Surgery patency decreased. For short occlusions of 5 cm or less. and the International Society for Cardiovascular Surgery 1-year patency was 62%, compared with 50% 1-year pa- (SVS-ISCVS). 3 With this system, each tibial vessel is tency for occlusions 10 cm or less, and 37% for long oc- scored from 0 to 3; 0 represents little or no disease, and clusions of 25 cm or more; these differences were not, 3 represents 50% or more occlusion of the entire vessel however, statistically significant. When initial AABI wa~ length. The overall score assigned was the sum of the val- used to identify two groups, patients with an increase in ues obtained for each tibial vessel (no scoring of the pedal ABI less than 0.1, and patients with a AABI of greater than arch was performed, since this was not uniformly evalu- or equal to 0.3, 1-year patencies were 26% and 55%, re- able on each angiogram).
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