CLINICAL STUDY
Retrograde Pedal Access Technique for Revascularization of Infrainguinal Arterial Occlusive Disease Saher S. Sabri, MD, Nicholas Hendricks, MD, James Stone, MD, PhD, Megan C. Tracci, MD, Alan H. Matsumoto, MD, and John F. Angle, MD
ABSTRACT Purpose: To evaluate limb salvage after recanalization of lower extremity arteries using retrograde pedal access in patients with critical limb ischemia (CLI). Materials and Methods: A retrospective review was performed of all patients in whom retrograde pedal arterial access was used for recanalization of infrainguinal occlusive disease between September 2002 and January 2013. Treatment was performed in 99 limbs in 92 patients (64 men and 28 women; median age, 71.6 y; range, 44–91 y) with CLI and no appropriate venous conduit for surgical bypass. Treated limbs were classified as Rutherford class 5 or 6 in 88% and class 4 in 12%. Retrograde and antegrade accesses were combined when occlusions could not be crossed from the antegrade direction. The treated occlusive segments were limited to the femoropopliteal arteries in 22% of procedures, runoff arteries in 32%, or both segments in 46%. Technical success was defined as successful crossing of the lesion and achievement of inline flow to the pedal vessel. KaplanMeier analysis was performed to determine limb salvage rate. Results: Technical success was achieved in 88 of 99 (89%) treated limbs. Stents were placed for suboptimal angioplasty results in 41 of 88 (47%) successfully treated limbs. Major complications occurred in 8 of 99 (8%) procedures, 3 of which resulted in periprocedural mortality. Median follow-up was 8 months (mean, 17 mo; range, 1–98 mo). The limb salvage rate for technically successful cases was 74% at 6 months, 64% at 12 months, and 55% at 24 months. Conclusions: Retrograde pedal access is a viable revascularization technique for achieving limb salvage in patients with CLI.
ABBREVIATIONS ACT = activated clotting time, CLI = critical limb ischemia
Endovascular revascularization of occlusive arterial disease in patients with critical limb ischemia (CLI) has been shown to be an effective approach to achieve limb salvage (1,2). However, conventional techniques of antegrade recanalization may be associated with technical and clinical failure (2–13). The expected technical success for infrainguinal interventions including stenotic and occlusive disease ranges from 56%–97%. Limb salvage rates at 2 years also range from 63%–97% From the Departments of Radiology (S.S.S., N.H., J.S., A.H.M., J.F.A.) and Vascular Surgery (M.C.T.), University of Virginia Health System, 1215 Lee Street, Charlottesville, VA 22908. Received June 27, 2014; final revision received October 7, 2014; accepted October 10, 2014. Address correspondence to S.S.S.; E-mail: [email protected] None of the authors have identified a conflict of interest. & SIR, 2015 J Vasc Interv Radiol 2015; 26:29–38 http://dx.doi.org/10.1016/j.jvir.2014.10.008
(2–13). We aimed to evaluate limb salvage after recanalization of lower extremity artery occlusive disease using a retrograde pedal access approach for intervention in patients with CLI after failed antegrade recanalization.
MATERIALS AND METHODS We retrospectively reviewed all cases in which retrograde pedal arterial access was used between September 2002 and January 2013. Institutional human investigation review board exemption was obtained for this retrospective review. There were 99 limbs treated in 92 patients (64 men and 28 women; median age, 71.6 y; range, 44–91 y). Treated limbs were classified as Rutherford class 5 or 6 in 88% and class 4 in 12%. The patients were deemed not to have a suitable venous conduit or to be at high risk for a surgical distal bypass. The most common comorbidities present were coronary
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artery disease (72%) and diabetes (70%). Other patient characteristics are listed in Table 1. Antegrade recanalization of the occluded femoropopliteal or tibial segment was attempted initially. If intraluminal crossing of the occlusion failed, subintimal recanalization was attempted. For cases in which reentry into a true lumen was unsuccessful despite the use of a reentry device, retrograde access was obtained through a pedal artery. Retrograde pedal access was attempted in the following arteries: anterior tibial/dorsalis pedis (n ¼ 54), posterior tibial (n ¼ 45), and peroneal (n ¼ 1) (one limb had both posterior tibial and dorsalis pedis accesses). The treated occlusive segments were limited to the femoropopliteal arteries in 22 of 99 (22%) limbs, runoff arteries in 32 of 99 (32%) limbs, or both the femoropopliteal and the runoff arteries in 46 of 99 (46%). All occlusions isolated to the femoropopliteal artery segments (22%) involved the popliteal arteries and were classified as Trans-Atlantic Society Consensus on Peripheral Arterial Disease D lesions and not considered to be candidates for an above-knee femoropopliteal bypass. The average lesion length for all limbs in this study was 24 cm (range, 10–50 cm). The target vessel was studied with ultrasound to evaluate its patency. Ultrasound-guided access was performed into the most disease-free segment of the pedal or peroneal artery. If the vessel was heavily calcified and no disease-free segments were available, fluoroscopic-guided puncture of the calcified segment was performed. Access was performed only if the pedal artery was patent on angiography and exhibited a suitable segment for access on angiography or ultrasound. Access was obtained with a 4-cm or 7-cm 21gauge needle (Cook, Inc., Bloomington, Indiana, or AngioDynamics, Latham, New York) and an 0.018-inch micropuncture guide wire. The 3-F inner transition dilator of the micropuncture access set (Cook, Inc, or AngioDynamics) was advanced over the guide wire. Contrast medium was injected to confirm an intraluminal location of the catheter. Retrograde recanalization was attempted using a variety of 0.014-inch and
Table 1 . Patient Characteristics No. limbs Patients
99 92
Mean age, y (range)
71.6 (44–91)
Men/women Hypertension
64/28 87 (95%)
Hyperlipidemia
74 (80%)
Coronary artery disease Diabetes
66 (72%) 64 (70%)
Chronic kidney disease
52 (56%)
Smoking Rest pain (Rutherford class 4)
49 (53%) 12 (12%)
Tissue loss (Rutherford class 5 or 6)
87 (88%)
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0.018-inch guide wires (most common wires used were V14 and V18 [Boston Scientific, Marlborough, Massachusetts]). If attempts at intraluminal crossing of the occlusion were unsuccessful, subintimal recanalization was performed in a retrograde fashion. The crossing was classified as subintimal or intraluminal based on the pattern wire tip advancement in the occluded segment. When additional support was needed, a longer microcatheter (CXI Support Catheter [Cook, Inc] or QuickCross [Spectranetics, Colorado Springs, Colorado]) was used to aid in crossing the occlusion. Through-andthrough access was established as previously described (19) after both antegrade and retrograde access wires were located in luminal or subintimal space by either snaring the retrograde wire through the femoral access sheath or by advancing the retrograde wire into an end hole 4-F or 5-F catheter using an antegrade approach (Fig 1a–d). Balloon angioplasty was used to treat the occlusions. If there was 4 30% residual stenosis or a flow-limiting dissection, self-expanding metallic stents were used to treat the specific areas of residual stenosis or flow-limiting dissections. Various bare metal and covered self-expanding stents were used. The type of stent placed was at the operator’s discretion. Intravenous or intraarterial heparin was used throughout the procedure with a target activated clotting time (ACT) 4 250 seconds. Glycoprotein IIb/IIIa inhibitors were administered intravenously during the procedure based on operators’ discretion. To minimize the risk for access vessel thrombosis, the retrograde catheter was removed as soon as in-line antegrade flow was established. Hemostasis was achieved by light manual compression of the puncture site for a maximum of 5 minutes. Intraarterial vasodilators, such as nitroglycerin or verapamil were administered per operator judgment to minimize vasospasm. All patients undergoing angioplasty alone received antiplatelet monotherapy with aspirin 81–325 mg daily after the procedure, whereas patients undergoing stent placement received clopidogrel 75 mg daily for at least 3 months after procedure in addition to aspirin. All procedural outcomes were recorded. Technical success was defined as successful crossing of the occlusive segment and achievement of in-line flow to the pedal vessel. Clinical success was defined as healing of tissue loss and an improvement of at least one class in Rutherford classification. Procedural complications were defined according to the Society of Interventional Radiology (SIR) Clinical Practice Guidelines (14). KaplanMeier analysis was performed to determine the overall rate of survival, amputation-free survival (time interval from procedure to major amputation or death), and limb salvage (time interval from procedure to major amputation). These distributions were compared between the patients who received angioplasty versus a stent and based on the segment treated: femoropopliteal segment cases versus runoff vessels versus both. The log-rank χ2
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Figure 1. (a) Digital subtraction angiography shows occlusion of the distal popliteal artery (black arrow) and reconstitution of the anterior tibial artery (white arrow). (b) Retrograde access is obtained using a micropuncture needle (arrow). (c) A through-and-through flossing guide wire is established by advancing the retrograde wire (white arrow) through the end hole of the antegrade catheter (black arrow) via a retrograde 3-F catheter (arrowheads) as a support catheter. (d) Completion angiogram after angioplasty shows in-line patency of and to the anterior tibial artery (arrows).
test was the statistical test that was used to make these comparisons.
RESULTS Technical success was achieved in 88 of 99 (89%) treated limbs. Technical failures were due to failed pedal artery access (n ¼ 3), an inability to traverse the occlusive segment in a retrograde fashion or establish a retrograde subintimal access to connect with the antegrade subintimal access because of heavily calcified plaque (n ¼ 4), preexisting surgical ligation of the superficial femoral art or popliteal artery that prevented recanalization and was not known at the time of intervention (n ¼ 2), or a failure to establish in-line arterial patency to the foot despite successfully traversing the occlusion (n ¼ 2). Clinical success was achieved in 77 of 99 (78%) procedures. Angioplasty alone was performed in 47 of 88 (53%) patients. Stents were placed in 41 of 88 (47%) treated limbs, of which 31 of 41 (76%) were placed in the femoropopliteal segment only, 4 of 41 (9%) were placed in the runoff vessels only, and 14 of 41 (15%) were placed in both segments. Stents crossed the knee joint in 23 of 41 (56%) treated limbs. Two patients had stents placed from a femoropopliteal bypass into the popliteal artery. The type and size of stents placed are summarized in Table 2. Of 88 occlusions, 78 (89%) were traversed in a subintimal plane, and 10 of 88 (11%) were believed to be intraluminal. All intraluminal crossings were for lesions involving the runoff vessels only.
Major complications occurred in 8 of 99 (8%) procedures, 3 of which resulted in periprocedural mortality. Two patients developed hemorrhagic complications immediately after the procedure that resulted in multiorgan failure. These two cases were early in the experience, and these patients received glycoprotein IIb/IIIa inhibitors in addition to heparin during the procedure. A third patient experienced multiorgan failure and died 24 hours after a failed procedure without signs of bleeding. The cause of the multiorgan failure was unclear and was presumed to be secondary to sepsis. Three patients experienced a non–ST segment elevation myocardial infarction after the procedure and were treated medically. Minor complications occurred in 2 of 99 (2%) procedures and included groin hematomas that did not require treatment. Median follow-up was 8 months (mean, 17 mo; range, 1–98 mo). The 30-day mortality was 5%. Cumulative survival rate was 76% at 6 months, 71% at 12 months, and 59% at 24 months. The amputation-free survival rate for technically successful cases was 62% at 6 months, 52% at 12 months, and 44% at 24 months. The limb salvage rate for technically successful cases was 74% at 6 months, 64% at 12 months, and 55% at 24 months. There was no difference in outcome for patients receiving intervention on the femoropopliteal segment versus runoff vessels versus both in regard to overall survival (P ¼ .0857), amputation-free survival (P ¼ .643), or limb salvage (P ¼ .973) rates. The type of intervention performed (angioplasty vs stent) did not
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Table 2 . Patients with Stents Placed Arterial Segment with Stent
Stent Type
Diameter Length (Number)
1
Pop
S.M.A.R.T.
7 mm 40 mm
2
AT
Xpert
4 mm 60 mm
3
SFA PT
S.M.A.R.T. Xpert
6 mm 100 mm 4 mm 60 mm
4
SFA
S.M.A.R.T.
7 mm 100 mm
5
Pop SFA
EverFlex S.M.A.R.T
6 mm 150 mm 6 mm 100 mm
6
Pop
S.M.A.R.T.
4 mm 60 mm (2)
7
SFA
S.M.A.R.T.
6 mm 100 mm (2) 7 mm 100 mm (2)
Patient
8
Pop
IntraCoil
4 mm 60 mm
9
SFA Pop
S.M.A.R.T.
6 mm 100 mm (3)
10 11
SFA SFA
S.M.A.R.T. S.M.A.R.T.
6 mm 100 mm (4) 7 mm 10 mm (3)
12
Pop
S.M.A.R.T.
6 mm 20 mm
Peroneal
IntraCoil S.M.A.R.T.
4 mm 40 mm 6 mm 20 mm
13
Pop
Xpert
5 mm 60 mm (2)
14
PT SFA
EverFlex
5 mm 150 mm (3)
15
SFA
S.M.A.R.T.
6 mm 100 mm (4)
Pop AT
Xpert
TPT
4 mm 60 mm 4 mm 40 mm (4)
16 17
PT Femoropopliteal bypass and Pop
Xpert GORE VIABAHN
4 mm 40mm 6 mm 150 mm
18
SFA
EverFlex
6 mm 150 mm
19
Pop AT
Xpert
4 mm 60 mm 4 mm 40 mm
20
SFA
EverFlex
3 mm 40 mm (2) 6 mm 40 mm 6 mm 60 mm
Pop TPT/PT
Xpert
5 mm 40 mm 4 mm 40 mm
21
Femoropopliteal bypass and Pop
GORE VIABAHN
6 mm 150 mm 6 mm 50 mm
22
Pop
GORE VIABAHN
6 mm 50 mm
23
AT SFA
Xpert GORE VIABAHN
4 mm 40 mm (2) 6 mm 150 mm (2)
24 25
SFA SFA
EverFlex EverFlex
6 mm 150 mm (2) 6 mm 150 mm (2)
26
SFA
EverFlex
6 mm 150 mm
Pop TPT/PT
Xpert
6 mm 100 mm 5 mm 60 mm
27
SFA Pop
EverFlex Xpert
6 mm 150 mm 5 mm 60 mm
28
SFA
EverFlex
6 mm 150 mm (2)
3 mm 40 mm
6 mm 100 mm
Pop
4 mm 60 mm (2)
(Continued)
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Table 2. Patients with Stents Placed (continued) Patient
Arterial Segment with Stent
Stent Type
Diameter Length (Number)
SFA
GORE VIABAHN
5 mm 100 mm
Pop
Xpert
4 mm 40 mm 4 mm 60 mm
TPT/PT
Xpert
6 mm 80 mm 29
4 mm 40 mm 3 mm 40 mm 3 mm 20 mm
30
PT
Zilver
5 mm 40 mm
31 32
Pop SFA
Supera EverFlex
4.5 mm 60 mm 6 mm 150 mm (3)
33
SFA
EverFlex
6 mm 150 mm (3)
34
SFA Pop
EverFlex Xpert
6 mm 150 mm (3) 5 mm 60 mm
35
AT
Xpert
4 mm 60 mm (2)
36
SFA Pop
EverFlex Life stent
6 mm 150 mm (2) 6 mm 60 mm
AT
Xpert
4 mm 60 mm (2)
37
SFA
EverFlex
3 mm 40 mm 6 mm 100 mm (3)
38
SFA Pop
Supera
39
SFA
GORE VIABAHN
5 mm 150 mm 5 mm 100 mm 4.5 mm 100 mm
6 mm 40 mm 5.5 mm 100 mm 4.5 mm 100 mm
Pop
Supera
40
Pop
EverFlex
6 mm 60 mm
41
SFA
EverFlex
6 mm 150 mm (2) 6 mm 100 mm
Note.–Stents placed included EverFlex (ev3 Endovascular, Inc, Plymouth, Minnesota), GORE VIABAHN (W. L. Gore & Associates, Flagstaff, Arizona), IntraCoil (ev3 Endovascular, Inc), S.M.A.R.T. (Cordis Corporation, Fremont, California), Supera (Abbott Vascular, Santa Clara, California), Xpert (Abbott Vascular), and Zilver (Cook, Inc). AT ¼ anterior tibial artery; Pop ¼ popliteal artery; PT ¼ posterior tibial artery; SFA ¼ superficial femoral artery; TPT ¼ tibioperoneal trunk.
affect overall survival (P ¼ .162), amputation-free survival (P ¼ .629), or limb salvage rates (P ¼ .579). The results are shown in Figures 2a–c, 3a–c, and 4a–c.
DISCUSSION CLI secondary to infrainguinal arterial occlusive disease is associated with a high amputation rate and a poor survival rate (1). Endovascular revascularization has been increasingly used as a method to treat infrapopliteal disease in patients with CLI even though the BASIL (Bypass versus Angioplasty in Severe Ischemia of the Leg) trial showed equivalent outcomes of surgical bypass and endovascular interventions for recanalization of infrainguinal arterial disease (2). In a meta-analysis performed by Romiti et al (11), the 2-year limb salvage rates for surgical bypass and angioplasty were 85% and 82%, respectively. Soderstrom et al (7) showed similar outcomes when comparing angioplasty and bypass surgery for infrapopliteal disease. Both groups achieved similar
5-year limb salvage (75.3% vs 76%), survival (47.5% vs 43.3%), and amputation-free survival (37.7% vs 37.3%) rates. However, in a review of the literature, there is a wide variation in outcomes after angioplasty among multiple studies for patients with CLI, with 2-year limb salvage rates ranging from 63%–97% (3–12). This variation may be attributed to the heterogeneity of the study populations with differing Rutherford classification, lesion characteristics (stenosis vs occlusion, calcified vs noncalcified), lesion length, and extent of involvement of the infrapopliteal arteries. A study evaluating the outcomes of infrapopliteal interventions for CLI showed a lower technical success rate of 79% for occlusions compared with a 99% technical success rate for stenotic lesions. Limb salvage rates for technically successful procedures performed for occlusive lesions were also lower compared with procedures performed for stenotic lesions (75% vs 92%, respectively, at 1 year) (12). The subintimal arterial flossing with antegraderetrograde intervention technique has been previously
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Figure 2. Limb salvage rates. Overall (a), percutaneous transluminal angioplasty (PTA) versus stent placement (b), and per segment treated (c). Fempop ¼ femoropopliteal segment.
described as a method for recanalization of long occlusions of the femoropopliteal segment and runoff vessels (15). It involves using both antegrade and retrograde accesses to establish through-and-through access, most often in the subintimal space, to achieve in-line flow to the foot when attempts at antegrade recanalization alone fail. In the present study, 89% of the successfully revascularized limbs were accomplished using the subintimal space. In 11% of the cases, intraluminal retrograde recanalization was accomplished. In these intraluminal retrograde recanalization cases, the operators had not created an antegrade subintimal channel. Use of a retrograde pedal approach to traverse an infrainguinal occlusion in patients with CLI is a viable option when 1) antegrade recanalization fails; 2) antegrade recanalization is a suboptimal option because of the occlusion being flush with the origin of a trifurcation artery or a large collateral artery; 3) there is difficulty in establishing a subintimal tract from the antegrade approach because of the presence of a heavily
calcified lesion; or 4) there is an inability to reenter the true lumen below the distalmost portion of the occlusion. In this study, retrograde intraluminal traversal of occlusions was successful only when the occlusions were isolated to the infrapopliteal segments. However, failure of retrograde intraluminal traversal of the lesion did not preclude an attempt at retrograde subintimal recanalization. Pedal access can be performed using either ultrasound or fluoroscopic guidance (15–21). Montero-Baker et al (21) used fluoroscopic guidance to access the pedal arteries by injecting contrast material into the more proximal arteries and using the road map technique to aid in vessel access. We used ultrasound access most often, using fluoroscopic guidance only to access the peroneal artery or heavily calcified arteries. We found ultrasound-guided access to be very easy to employ, while limiting the radiation exposure to the operator and contrast material use. A common technical difficulty in
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Figure 3. Amputation-free survival rates. Overall (a), percutaneous transluminal angioplasty (PTA) versus stent placement (b), and per segment treated (c). Fempop ¼ femoropopliteal segment.
accessing the pedal vessel is the vessel “rolling” away on contact with the tip of the access needle. To address this issue, the target vessel is “pinned” against the underlying bone, which facilitates access. In our experience, the simultaneous real-time ultrasound visualization of the vessel and the needle tip has been critical to successful access to a pedal artery. Access vessel thrombosis has been reported (22), which has created some concerns about the routine use of pedal arteries for access for recanalization procedures. In the present study, two technical failures were due to failure of establishing in-line flow to the foot despite an apparently successful recanalization procedure. These two failures may have been related to access vessel thrombosis or dissection. To minimize the risk for such a complication, several steps were performed. First, a healthy segment of the pedal vessel is chosen for access when possible, and the catheter used is limited to a 3-F catheter. Retrograde sheaths were not used in this study,
and all angioplasty and stent placement procedures were performed from the antegrade access. New lower profile balloons that can be advanced through 4-F catheters may be considered as a potential option for use with retrograde angioplasty to minimize the profile of devices placed into a pedal artery. These lower profile balloons were unavailable at the time of this study. In addition, the retrograde 3-F catheter was removed as soon as retrograde access was no longer needed, and hemostasis was achieved by using light manual pressure for a maximum of 5 minutes regardless of the ACT. Leaving the retrograde access catheter in place until the ACT normalizes may increase the risk of vasospasm and access site thrombosis. The ACT was kept 4 250 seconds for the entire procedure. In addition, intraarterial vasodilators, such as nitroglycerin or verapamil, were administered into the target vessel after each angioplasty and immediately before retrograde catheter removal to limit vasospasm-induced thrombosis. Some
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Figure 4. Survival rates. Overall (a), percutaneous transluminal angioplasty (PTA) versus stent placement (b), and per segment treated (c). Fempop ¼ femoropopliteal segment.
authors have advocated using a surgical cutdown for pedal artery exposure (23). We believe that this technique is unnecessary and may produce further tissue injury in a poorly perfused limb, further compromising tissue healing. The decision to choose the distal target vessel to access was based on the size of the artery and the presence of a relatively healthy segment that extends to or distal to the ankle joint. If more than one healthy segment could potentially be accessed, the artery supplying the skin segment with tissue loss was chosen. Angiosome-directed revascularization is being recognized to have superior limb salvage rates compared with indirect revascularization (24–26). In this retrospective study, it could not be asserted that angiosome-directed revascularization was always performed as a routine practice. Rather, revascularization was directed toward creating any in-line flow to the foot that could most likely be achieved given the underlying anatomy. In addition, small-diameter, long-length, low-profile balloons were not readily available for most of the time period of this study.
Surgical bypass using a vein conduit has been the standard of care for tibial arterial revascularization with 2-year patency rates of 60%–68%. Limb salvage rates have been reported to be 96% at 2 years (2,27–29). However, availability of a suitable venous conduit is a major limiting factor in many patients with CLI. In our study, all patients were deemed not to have a suitable venous conduit by an experienced vascular surgeon. Tibial bypass using a synthetic graft has shown significant lower patency and limb salvage rates compared with venous conduit bypass grafts (30–32). In a metaanalysis by Albers et al (30), patency of femorotibial bypass grafts was 41% at 3 years, with a limb salvage rate of 66%. In a more recent study by Loh et al (33) using a modified polytetrafluoroethylene graft with a distal expanded cuff, the patency rate of the graft was 40% at 3 years, and limb salvage rate was 55%. Cryopreserved vein has also been used as a surgical conduit, with a limb salvage rate of 77% at 2 years (34). In the present study, the limb salvage rate was 55% at 2 years, which is lower than the reported rates of the
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bypass grafts and other angioplasty series. This difference in results can be explained by the superior patency of the venous bypass grafts whenever suitable venous conduits are available. The present study addresses patients with no suitable venous conduit, who were deemed to be poor open surgical risks, and who had a failed attempt at antegrade recanalization of tibial vessels. All lesions included in this study were long segment occlusions and likely had more advanced lesions compared with the lesions in the referenced studies, many of which included patients with both stenoses and occlusions. In addition, our study included a higher percentage of patients classified as Rutherford class 5 and 6 compared with the referenced studies. Another factor to consider is that the decision to proceed to major amputation in our study was not standardized. Some patients underwent amputation within several days of the recanalization procedure, suggesting that the decision to proceed to amputation was already made before the procedure or that not enough time was given to allow for a clinical response to be appreciated. Many patients underwent the procedure with the intent of revascularization to allow for healing of a planned below-knee amputation. This study is limited by its retrospective nature and lack of standardized follow-up. As a result, evaluation of patency of treated vessels was not attainable. The outcomes were limited to limb salvage and patient survival. In the study group, 12% of the patients were classified as Rutherford class 4, meaning they were not at an immediate risk of amputation. A technically failed procedure in this group of patients may not lead to amputation, in contrast to patients classified as Rutherford class 5 and 6. Another limitation of this study is the lack of a standardized decision tree for progressing to major amputation. As noted earlier, some patients had preplanned amputations, and others were not given sufficient time for a clinical response. Choice of stent placed and use of certain medications such as glycoprotein IIb/IIIa inhibitors during the procedure were operator dependent. Lastly, there was no consistent therapy for wound management and healing and inconsistent use of ancillary services such as hyperbaric oxygen. In conclusion, this retrospective study suggests that retrograde pedal access is a viable revascularization technique for achieving limb salvage in patients with CLI in whom antegrade revascularization has failed and surgical bypass is not a viable option.
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3.
4.
5.
6.
7.
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9.
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20.
21.
22. 23.
REFERENCES 24. 1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg 2007; 33(Suppl 1):S1–75. 2. Bradbury AW, Adam DJ, Bell J, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass
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surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg 2010; 51(Suppl 5):5S–17S. Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg 2005; 41:423–435. Soder HK, Manninen HI, Jaakkola P, et al. Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: angiographic and clinical results. J Vasc Interv Radiol 2000; 11:1021–1031. Dorros G, Jaff MR, Dorros AM, et al. Tibioperoneal (outflow lesion) angioplasty can be used as primary treatment in 235 patients with critical limb ischemia: five-year follow-up. Circulation 2001; 104:2057–2062. Bosiers M, Hart JP, Deloose K, et al. Endovascular therapy as the primary approach for limb salvage in patients with critical limb ischemia: experience with 443 infrapopliteal procedures. Vascular 2006; 14:63–69. Soderstrom MI, Arvela EM, Korhonen M, et al. Infrapopliteal surgery as first-line strategies in critical leg ischemia: a propensity score analysis. Ann Surg 2010; 252:765–773. Giles KA, Pomposelli FB, Hamdan AD, et al. Infrapopliteal angioplasty for critical limb ischemia: relation of TransAtlantic InterSociety Consensus class to outcome in 176 limbs. J Vasc Surg 2008; 48:128–136. Ingle H, Nasim A, Bolia A, et al. Subintimal angioplasty of isolated infragenicular vessels in lower limb ischemia: long-term results. J Endovasc Ther 2002; 9:411–416, [Erratum in: J Endovasc Ther 2002; 9:A-6]. Spinosa DJ, Leung DA, Matsumoto AH, et al. Percutaneous intentional extraluminal recanalization in patients with chronic critical limb ischemia. Radiology 2004; 232:499–507. Romiti M, Albers M, Brochado-Neto F, et al. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 2008; 47:975–981. Singh GD, Armstrong EJ, Yeo KK, et al. Endovascular recanalization of infrapopliteal occlusions in patients with critical limb ischemia. J Vasc Surg 2014; 59:1300–1307. Schamp KBC, Meerwaldt R, Reijnen MMPJ, Geelkerken RH, Zeebregts CJ. The ongoing battle between infrapopliteal angioplasty and bypass surgery for critical limb ischemia. Ann Vasc Surg 2012; 26: 1145–1153. Sacks D, McClenny TE, Cardella JF, et al. Society of Interventional Radiology clinical practice guidelines. J Vasc Interv Radiol 2003; 14: 199–202. Spinosa DJ, Harthun NL, Bissonette EA, et al. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) for subintimal recanalization to treat chronic critical limb ischemia. J Vasc Interv Radiol 2005; 16:37–44. Iyer SS, Dorros G, Zaitoun R, et al. Retrograde recanalization of an occluded posterior tibial artery by using a posterior tibial cutdown: two case reports. Cathet Cardiovasc Diagn 1990; 20:251–253. Botti CF, Ansel GM, Silver MJ, et al. Percutaneous retrograde tibial access in limb salvage. J Endovasc Ther 2003; 10:614–618. Fusaro M, Dalla Paola L, Biondi-Zoccai G. Retrograde posterior tibial artery access for below-the-knee percutaneous revascularization by means of sheathless approach and double wire technique. Minerva Cardioangiol 2006; 54:773–777. Fusaro M, Tashani A, Mollichelli N, et al. Retrograde pedal artery access for below-the-knee percutaneous revascularisation. J Cardiovasc Med (Hagerstown) 2007; 8:216–218. Gandini R, Pipitone V, Stefanini M, et al. The “safari” technique to perform difficult subintimal infragenicular vessels. Cardiovasc Intervent Radiol 2007; 30:469–473. Montero-Baker M, Schmidt A, Braunlich S, et al. Retrograde approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther 2008; 15:594–604. Lupattelli T, Clerissi J, Losa S. Regarding the “SAFARI” technique: a word of caution. Cardiovasc Intervent Radiol 2009; 32:197–198. Airoldi F, Vitiello R, Losa S, Tavano D, Faglia E. Retrograde recanalization of the anterior tibial artery following surgical vessel exposure: a combined approach for single remaining infragenicular vessel. J Vasc Interv Radiol 2010; 21:949–950. Rashid H, Slim H, Zayed H, et al. The impact of arterial pedal arch quality and angiosome revascularization on foot tissue loss healing and infrapopliteal bypass outcome. J Vasc Surg 2013; 57:1219–1226. Iida O, Soga Y, Hirano K, et al. Long-term results of direct and indirect endovascular revascularization based on the angiosome concept in patients with critical limb ischemia presenting with isolated below-theknee lesions. J Vasc Surg 2012; 55:363–370.
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26. Biancari F, Juvonen T. Angiosome-targeted lower limb revascularization for ischemic foot wounds: systematic review and meta-analysis. Eur J Vasc Endovasc Surg 2014; 47:517–522. 27. Comparative evaluation of prosthetic, reversed, and in situ vein bypass grafts in distal popliteal and tibial-peroneal revascularization. Veterans Administration Cooperative Study Group 141. Arch Surg 1988; 123:434–438. 28. Twine CP, McLain AD. Graft type for femoro-popliteal bypass surgery. Cochrane Database Syst Rev 2010(5):CD001487. 29. Veith FJ, Gupta SK, Ascer E, et al. Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions. J Vasc Surg 1986; 3:104–114. 30. Albers M, Battistella VM, Romiti M, et al. Meta-analysis of polytetrafluoroethylene bypass grafts to infrapopliteal arteries. J Vasc Surg 2003; 37:1263–1269.
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31. Alcocer F, Jordan WD Jr, Wirthlin DJ, Whitley D. Early results of lower extremity infrageniculate revascularization with a new polytetrafluoroethylene graft. Vascular 2004; 12:318–324. 32. Parsons RE, Suggs WD, Veith FJ, et al. Polytetrafluoroethylene bypasses to infrapopliteal arteries without cuffs or patches: a better option than amputation in patients without autologous vein. J Vasc Surg 1996; 23:347–354; discussion 355–356. 33. Loh SA, Howell BS, Rockman CB, et al. Mid- and long-term results of the treatment of infrainguinal arterial occlusive disease with precuffed expanded polytetrafluoroethylene grafts compared. Ann Vasc Surg 2013; 27:208–217. 34. Randon C, Jacobs B, De Ryck F, et al. Fifteen years of infrapopliteal arterial reconstructions with cryopreserved venous allografts for limb salvage. J Vasc Surg 2010; 51:869–877.
Retrograde Pedal Access Technique for Revascularization of Infrainguinal Arterial Occlusive Disease Saher S. Sabri, MD, Nicholas Hendricks, MD, James Stone, MD, PhD, Megan C. Tracci, MD, Alan H. Matsumoto, MD, and John F. Angle, MD
ABSTRACT Purpose: To evaluate limb salvage after recanalization of lower extremity arteries using retrograde pedal access in patients with critical limb ischemia (CLI). Materials and Methods: A retrospective review was performed of all patients in whom retrograde pedal arterial access was used for recanalization of infrainguinal occlusive disease between September 2002 and January 2013. Treatment was performed in 99 limbs in 92 patients (64 men and 28 women; median age, 71.6 y; range, 44–91 y) with CLI and no appropriate venous conduit for surgical bypass. Treated limbs were classified as Rutherford class 5 or 6 in 88% and class 4 in 12%. Retrograde and antegrade accesses were combined when occlusions could not be crossed from the antegrade direction. The treated occlusive segments were limited to the femoropopliteal arteries in 22% of procedures, runoff arteries in 32%, or both segments in 46%. Technical success was defined as successful crossing of the lesion and achievement of inline flow to the pedal vessel. KaplanMeier analysis was performed to determine limb salvage rate. Results: Technical success was achieved in 88 of 99 (89%) treated limbs. Stents were placed for suboptimal angioplasty results in 41 of 88 (47%) successfully treated limbs. Major complications occurred in 8 of 99 (8%) procedures, 3 of which resulted in periprocedural mortality. Median follow-up was 8 months (mean, 17 mo; range, 1–98 mo). The limb salvage rate for technically successful cases was 74% at 6 months, 64% at 12 months, and 55% at 24 months. Conclusions: Retrograde pedal access is a viable revascularization technique for achieving limb salvage in patients with CLI.
ABBREVIATIONS ACT = activated clotting time, CLI = critical limb ischemia
Endovascular revascularization of occlusive arterial disease in patients with critical limb ischemia (CLI) has been shown to be an effective approach to achieve limb salvage (1,2). However, conventional techniques of antegrade recanalization may be associated with technical and clinical failure (2–13). The expected technical success for infrainguinal interventions including stenotic and occlusive disease ranges from 56%–97%. Limb salvage rates at 2 years also range from 63%–97% From the Departments of Radiology (S.S.S., N.H., J.S., A.H.M., J.F.A.) and Vascular Surgery (M.C.T.), University of Virginia Health System, 1215 Lee Street, Charlottesville, VA 22908. Received June 27, 2014; final revision received October 7, 2014; accepted October 10, 2014. Address correspondence to S.S.S.; E-mail: [email protected] None of the authors have identified a conflict of interest. & SIR, 2015 J Vasc Interv Radiol 2015; 26:29–38 http://dx.doi.org/10.1016/j.jvir.2014.10.008
(2–13). We aimed to evaluate limb salvage after recanalization of lower extremity artery occlusive disease using a retrograde pedal access approach for intervention in patients with CLI after failed antegrade recanalization.
MATERIALS AND METHODS We retrospectively reviewed all cases in which retrograde pedal arterial access was used between September 2002 and January 2013. Institutional human investigation review board exemption was obtained for this retrospective review. There were 99 limbs treated in 92 patients (64 men and 28 women; median age, 71.6 y; range, 44–91 y). Treated limbs were classified as Rutherford class 5 or 6 in 88% and class 4 in 12%. The patients were deemed not to have a suitable venous conduit or to be at high risk for a surgical distal bypass. The most common comorbidities present were coronary
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artery disease (72%) and diabetes (70%). Other patient characteristics are listed in Table 1. Antegrade recanalization of the occluded femoropopliteal or tibial segment was attempted initially. If intraluminal crossing of the occlusion failed, subintimal recanalization was attempted. For cases in which reentry into a true lumen was unsuccessful despite the use of a reentry device, retrograde access was obtained through a pedal artery. Retrograde pedal access was attempted in the following arteries: anterior tibial/dorsalis pedis (n ¼ 54), posterior tibial (n ¼ 45), and peroneal (n ¼ 1) (one limb had both posterior tibial and dorsalis pedis accesses). The treated occlusive segments were limited to the femoropopliteal arteries in 22 of 99 (22%) limbs, runoff arteries in 32 of 99 (32%) limbs, or both the femoropopliteal and the runoff arteries in 46 of 99 (46%). All occlusions isolated to the femoropopliteal artery segments (22%) involved the popliteal arteries and were classified as Trans-Atlantic Society Consensus on Peripheral Arterial Disease D lesions and not considered to be candidates for an above-knee femoropopliteal bypass. The average lesion length for all limbs in this study was 24 cm (range, 10–50 cm). The target vessel was studied with ultrasound to evaluate its patency. Ultrasound-guided access was performed into the most disease-free segment of the pedal or peroneal artery. If the vessel was heavily calcified and no disease-free segments were available, fluoroscopic-guided puncture of the calcified segment was performed. Access was performed only if the pedal artery was patent on angiography and exhibited a suitable segment for access on angiography or ultrasound. Access was obtained with a 4-cm or 7-cm 21gauge needle (Cook, Inc., Bloomington, Indiana, or AngioDynamics, Latham, New York) and an 0.018-inch micropuncture guide wire. The 3-F inner transition dilator of the micropuncture access set (Cook, Inc, or AngioDynamics) was advanced over the guide wire. Contrast medium was injected to confirm an intraluminal location of the catheter. Retrograde recanalization was attempted using a variety of 0.014-inch and
Table 1 . Patient Characteristics No. limbs Patients
99 92
Mean age, y (range)
71.6 (44–91)
Men/women Hypertension
64/28 87 (95%)
Hyperlipidemia
74 (80%)
Coronary artery disease Diabetes
66 (72%) 64 (70%)
Chronic kidney disease
52 (56%)
Smoking Rest pain (Rutherford class 4)
49 (53%) 12 (12%)
Tissue loss (Rutherford class 5 or 6)
87 (88%)
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0.018-inch guide wires (most common wires used were V14 and V18 [Boston Scientific, Marlborough, Massachusetts]). If attempts at intraluminal crossing of the occlusion were unsuccessful, subintimal recanalization was performed in a retrograde fashion. The crossing was classified as subintimal or intraluminal based on the pattern wire tip advancement in the occluded segment. When additional support was needed, a longer microcatheter (CXI Support Catheter [Cook, Inc] or QuickCross [Spectranetics, Colorado Springs, Colorado]) was used to aid in crossing the occlusion. Through-andthrough access was established as previously described (19) after both antegrade and retrograde access wires were located in luminal or subintimal space by either snaring the retrograde wire through the femoral access sheath or by advancing the retrograde wire into an end hole 4-F or 5-F catheter using an antegrade approach (Fig 1a–d). Balloon angioplasty was used to treat the occlusions. If there was 4 30% residual stenosis or a flow-limiting dissection, self-expanding metallic stents were used to treat the specific areas of residual stenosis or flow-limiting dissections. Various bare metal and covered self-expanding stents were used. The type of stent placed was at the operator’s discretion. Intravenous or intraarterial heparin was used throughout the procedure with a target activated clotting time (ACT) 4 250 seconds. Glycoprotein IIb/IIIa inhibitors were administered intravenously during the procedure based on operators’ discretion. To minimize the risk for access vessel thrombosis, the retrograde catheter was removed as soon as in-line antegrade flow was established. Hemostasis was achieved by light manual compression of the puncture site for a maximum of 5 minutes. Intraarterial vasodilators, such as nitroglycerin or verapamil were administered per operator judgment to minimize vasospasm. All patients undergoing angioplasty alone received antiplatelet monotherapy with aspirin 81–325 mg daily after the procedure, whereas patients undergoing stent placement received clopidogrel 75 mg daily for at least 3 months after procedure in addition to aspirin. All procedural outcomes were recorded. Technical success was defined as successful crossing of the occlusive segment and achievement of in-line flow to the pedal vessel. Clinical success was defined as healing of tissue loss and an improvement of at least one class in Rutherford classification. Procedural complications were defined according to the Society of Interventional Radiology (SIR) Clinical Practice Guidelines (14). KaplanMeier analysis was performed to determine the overall rate of survival, amputation-free survival (time interval from procedure to major amputation or death), and limb salvage (time interval from procedure to major amputation). These distributions were compared between the patients who received angioplasty versus a stent and based on the segment treated: femoropopliteal segment cases versus runoff vessels versus both. The log-rank χ2
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Figure 1. (a) Digital subtraction angiography shows occlusion of the distal popliteal artery (black arrow) and reconstitution of the anterior tibial artery (white arrow). (b) Retrograde access is obtained using a micropuncture needle (arrow). (c) A through-and-through flossing guide wire is established by advancing the retrograde wire (white arrow) through the end hole of the antegrade catheter (black arrow) via a retrograde 3-F catheter (arrowheads) as a support catheter. (d) Completion angiogram after angioplasty shows in-line patency of and to the anterior tibial artery (arrows).
test was the statistical test that was used to make these comparisons.
RESULTS Technical success was achieved in 88 of 99 (89%) treated limbs. Technical failures were due to failed pedal artery access (n ¼ 3), an inability to traverse the occlusive segment in a retrograde fashion or establish a retrograde subintimal access to connect with the antegrade subintimal access because of heavily calcified plaque (n ¼ 4), preexisting surgical ligation of the superficial femoral art or popliteal artery that prevented recanalization and was not known at the time of intervention (n ¼ 2), or a failure to establish in-line arterial patency to the foot despite successfully traversing the occlusion (n ¼ 2). Clinical success was achieved in 77 of 99 (78%) procedures. Angioplasty alone was performed in 47 of 88 (53%) patients. Stents were placed in 41 of 88 (47%) treated limbs, of which 31 of 41 (76%) were placed in the femoropopliteal segment only, 4 of 41 (9%) were placed in the runoff vessels only, and 14 of 41 (15%) were placed in both segments. Stents crossed the knee joint in 23 of 41 (56%) treated limbs. Two patients had stents placed from a femoropopliteal bypass into the popliteal artery. The type and size of stents placed are summarized in Table 2. Of 88 occlusions, 78 (89%) were traversed in a subintimal plane, and 10 of 88 (11%) were believed to be intraluminal. All intraluminal crossings were for lesions involving the runoff vessels only.
Major complications occurred in 8 of 99 (8%) procedures, 3 of which resulted in periprocedural mortality. Two patients developed hemorrhagic complications immediately after the procedure that resulted in multiorgan failure. These two cases were early in the experience, and these patients received glycoprotein IIb/IIIa inhibitors in addition to heparin during the procedure. A third patient experienced multiorgan failure and died 24 hours after a failed procedure without signs of bleeding. The cause of the multiorgan failure was unclear and was presumed to be secondary to sepsis. Three patients experienced a non–ST segment elevation myocardial infarction after the procedure and were treated medically. Minor complications occurred in 2 of 99 (2%) procedures and included groin hematomas that did not require treatment. Median follow-up was 8 months (mean, 17 mo; range, 1–98 mo). The 30-day mortality was 5%. Cumulative survival rate was 76% at 6 months, 71% at 12 months, and 59% at 24 months. The amputation-free survival rate for technically successful cases was 62% at 6 months, 52% at 12 months, and 44% at 24 months. The limb salvage rate for technically successful cases was 74% at 6 months, 64% at 12 months, and 55% at 24 months. There was no difference in outcome for patients receiving intervention on the femoropopliteal segment versus runoff vessels versus both in regard to overall survival (P ¼ .0857), amputation-free survival (P ¼ .643), or limb salvage (P ¼ .973) rates. The type of intervention performed (angioplasty vs stent) did not
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Table 2 . Patients with Stents Placed Arterial Segment with Stent
Stent Type
Diameter Length (Number)
1
Pop
S.M.A.R.T.
7 mm 40 mm
2
AT
Xpert
4 mm 60 mm
3
SFA PT
S.M.A.R.T. Xpert
6 mm 100 mm 4 mm 60 mm
4
SFA
S.M.A.R.T.
7 mm 100 mm
5
Pop SFA
EverFlex S.M.A.R.T
6 mm 150 mm 6 mm 100 mm
6
Pop
S.M.A.R.T.
4 mm 60 mm (2)
7
SFA
S.M.A.R.T.
6 mm 100 mm (2) 7 mm 100 mm (2)
Patient
8
Pop
IntraCoil
4 mm 60 mm
9
SFA Pop
S.M.A.R.T.
6 mm 100 mm (3)
10 11
SFA SFA
S.M.A.R.T. S.M.A.R.T.
6 mm 100 mm (4) 7 mm 10 mm (3)
12
Pop
S.M.A.R.T.
6 mm 20 mm
Peroneal
IntraCoil S.M.A.R.T.
4 mm 40 mm 6 mm 20 mm
13
Pop
Xpert
5 mm 60 mm (2)
14
PT SFA
EverFlex
5 mm 150 mm (3)
15
SFA
S.M.A.R.T.
6 mm 100 mm (4)
Pop AT
Xpert
TPT
4 mm 60 mm 4 mm 40 mm (4)
16 17
PT Femoropopliteal bypass and Pop
Xpert GORE VIABAHN
4 mm 40mm 6 mm 150 mm
18
SFA
EverFlex
6 mm 150 mm
19
Pop AT
Xpert
4 mm 60 mm 4 mm 40 mm
20
SFA
EverFlex
3 mm 40 mm (2) 6 mm 40 mm 6 mm 60 mm
Pop TPT/PT
Xpert
5 mm 40 mm 4 mm 40 mm
21
Femoropopliteal bypass and Pop
GORE VIABAHN
6 mm 150 mm 6 mm 50 mm
22
Pop
GORE VIABAHN
6 mm 50 mm
23
AT SFA
Xpert GORE VIABAHN
4 mm 40 mm (2) 6 mm 150 mm (2)
24 25
SFA SFA
EverFlex EverFlex
6 mm 150 mm (2) 6 mm 150 mm (2)
26
SFA
EverFlex
6 mm 150 mm
Pop TPT/PT
Xpert
6 mm 100 mm 5 mm 60 mm
27
SFA Pop
EverFlex Xpert
6 mm 150 mm 5 mm 60 mm
28
SFA
EverFlex
6 mm 150 mm (2)
3 mm 40 mm
6 mm 100 mm
Pop
4 mm 60 mm (2)
(Continued)
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Table 2. Patients with Stents Placed (continued) Patient
Arterial Segment with Stent
Stent Type
Diameter Length (Number)
SFA
GORE VIABAHN
5 mm 100 mm
Pop
Xpert
4 mm 40 mm 4 mm 60 mm
TPT/PT
Xpert
6 mm 80 mm 29
4 mm 40 mm 3 mm 40 mm 3 mm 20 mm
30
PT
Zilver
5 mm 40 mm
31 32
Pop SFA
Supera EverFlex
4.5 mm 60 mm 6 mm 150 mm (3)
33
SFA
EverFlex
6 mm 150 mm (3)
34
SFA Pop
EverFlex Xpert
6 mm 150 mm (3) 5 mm 60 mm
35
AT
Xpert
4 mm 60 mm (2)
36
SFA Pop
EverFlex Life stent
6 mm 150 mm (2) 6 mm 60 mm
AT
Xpert
4 mm 60 mm (2)
37
SFA
EverFlex
3 mm 40 mm 6 mm 100 mm (3)
38
SFA Pop
Supera
39
SFA
GORE VIABAHN
5 mm 150 mm 5 mm 100 mm 4.5 mm 100 mm
6 mm 40 mm 5.5 mm 100 mm 4.5 mm 100 mm
Pop
Supera
40
Pop
EverFlex
6 mm 60 mm
41
SFA
EverFlex
6 mm 150 mm (2) 6 mm 100 mm
Note.–Stents placed included EverFlex (ev3 Endovascular, Inc, Plymouth, Minnesota), GORE VIABAHN (W. L. Gore & Associates, Flagstaff, Arizona), IntraCoil (ev3 Endovascular, Inc), S.M.A.R.T. (Cordis Corporation, Fremont, California), Supera (Abbott Vascular, Santa Clara, California), Xpert (Abbott Vascular), and Zilver (Cook, Inc). AT ¼ anterior tibial artery; Pop ¼ popliteal artery; PT ¼ posterior tibial artery; SFA ¼ superficial femoral artery; TPT ¼ tibioperoneal trunk.
affect overall survival (P ¼ .162), amputation-free survival (P ¼ .629), or limb salvage rates (P ¼ .579). The results are shown in Figures 2a–c, 3a–c, and 4a–c.
DISCUSSION CLI secondary to infrainguinal arterial occlusive disease is associated with a high amputation rate and a poor survival rate (1). Endovascular revascularization has been increasingly used as a method to treat infrapopliteal disease in patients with CLI even though the BASIL (Bypass versus Angioplasty in Severe Ischemia of the Leg) trial showed equivalent outcomes of surgical bypass and endovascular interventions for recanalization of infrainguinal arterial disease (2). In a meta-analysis performed by Romiti et al (11), the 2-year limb salvage rates for surgical bypass and angioplasty were 85% and 82%, respectively. Soderstrom et al (7) showed similar outcomes when comparing angioplasty and bypass surgery for infrapopliteal disease. Both groups achieved similar
5-year limb salvage (75.3% vs 76%), survival (47.5% vs 43.3%), and amputation-free survival (37.7% vs 37.3%) rates. However, in a review of the literature, there is a wide variation in outcomes after angioplasty among multiple studies for patients with CLI, with 2-year limb salvage rates ranging from 63%–97% (3–12). This variation may be attributed to the heterogeneity of the study populations with differing Rutherford classification, lesion characteristics (stenosis vs occlusion, calcified vs noncalcified), lesion length, and extent of involvement of the infrapopliteal arteries. A study evaluating the outcomes of infrapopliteal interventions for CLI showed a lower technical success rate of 79% for occlusions compared with a 99% technical success rate for stenotic lesions. Limb salvage rates for technically successful procedures performed for occlusive lesions were also lower compared with procedures performed for stenotic lesions (75% vs 92%, respectively, at 1 year) (12). The subintimal arterial flossing with antegraderetrograde intervention technique has been previously
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Figure 2. Limb salvage rates. Overall (a), percutaneous transluminal angioplasty (PTA) versus stent placement (b), and per segment treated (c). Fempop ¼ femoropopliteal segment.
described as a method for recanalization of long occlusions of the femoropopliteal segment and runoff vessels (15). It involves using both antegrade and retrograde accesses to establish through-and-through access, most often in the subintimal space, to achieve in-line flow to the foot when attempts at antegrade recanalization alone fail. In the present study, 89% of the successfully revascularized limbs were accomplished using the subintimal space. In 11% of the cases, intraluminal retrograde recanalization was accomplished. In these intraluminal retrograde recanalization cases, the operators had not created an antegrade subintimal channel. Use of a retrograde pedal approach to traverse an infrainguinal occlusion in patients with CLI is a viable option when 1) antegrade recanalization fails; 2) antegrade recanalization is a suboptimal option because of the occlusion being flush with the origin of a trifurcation artery or a large collateral artery; 3) there is difficulty in establishing a subintimal tract from the antegrade approach because of the presence of a heavily
calcified lesion; or 4) there is an inability to reenter the true lumen below the distalmost portion of the occlusion. In this study, retrograde intraluminal traversal of occlusions was successful only when the occlusions were isolated to the infrapopliteal segments. However, failure of retrograde intraluminal traversal of the lesion did not preclude an attempt at retrograde subintimal recanalization. Pedal access can be performed using either ultrasound or fluoroscopic guidance (15–21). Montero-Baker et al (21) used fluoroscopic guidance to access the pedal arteries by injecting contrast material into the more proximal arteries and using the road map technique to aid in vessel access. We used ultrasound access most often, using fluoroscopic guidance only to access the peroneal artery or heavily calcified arteries. We found ultrasound-guided access to be very easy to employ, while limiting the radiation exposure to the operator and contrast material use. A common technical difficulty in
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Figure 3. Amputation-free survival rates. Overall (a), percutaneous transluminal angioplasty (PTA) versus stent placement (b), and per segment treated (c). Fempop ¼ femoropopliteal segment.
accessing the pedal vessel is the vessel “rolling” away on contact with the tip of the access needle. To address this issue, the target vessel is “pinned” against the underlying bone, which facilitates access. In our experience, the simultaneous real-time ultrasound visualization of the vessel and the needle tip has been critical to successful access to a pedal artery. Access vessel thrombosis has been reported (22), which has created some concerns about the routine use of pedal arteries for access for recanalization procedures. In the present study, two technical failures were due to failure of establishing in-line flow to the foot despite an apparently successful recanalization procedure. These two failures may have been related to access vessel thrombosis or dissection. To minimize the risk for such a complication, several steps were performed. First, a healthy segment of the pedal vessel is chosen for access when possible, and the catheter used is limited to a 3-F catheter. Retrograde sheaths were not used in this study,
and all angioplasty and stent placement procedures were performed from the antegrade access. New lower profile balloons that can be advanced through 4-F catheters may be considered as a potential option for use with retrograde angioplasty to minimize the profile of devices placed into a pedal artery. These lower profile balloons were unavailable at the time of this study. In addition, the retrograde 3-F catheter was removed as soon as retrograde access was no longer needed, and hemostasis was achieved by using light manual pressure for a maximum of 5 minutes regardless of the ACT. Leaving the retrograde access catheter in place until the ACT normalizes may increase the risk of vasospasm and access site thrombosis. The ACT was kept 4 250 seconds for the entire procedure. In addition, intraarterial vasodilators, such as nitroglycerin or verapamil, were administered into the target vessel after each angioplasty and immediately before retrograde catheter removal to limit vasospasm-induced thrombosis. Some
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Figure 4. Survival rates. Overall (a), percutaneous transluminal angioplasty (PTA) versus stent placement (b), and per segment treated (c). Fempop ¼ femoropopliteal segment.
authors have advocated using a surgical cutdown for pedal artery exposure (23). We believe that this technique is unnecessary and may produce further tissue injury in a poorly perfused limb, further compromising tissue healing. The decision to choose the distal target vessel to access was based on the size of the artery and the presence of a relatively healthy segment that extends to or distal to the ankle joint. If more than one healthy segment could potentially be accessed, the artery supplying the skin segment with tissue loss was chosen. Angiosome-directed revascularization is being recognized to have superior limb salvage rates compared with indirect revascularization (24–26). In this retrospective study, it could not be asserted that angiosome-directed revascularization was always performed as a routine practice. Rather, revascularization was directed toward creating any in-line flow to the foot that could most likely be achieved given the underlying anatomy. In addition, small-diameter, long-length, low-profile balloons were not readily available for most of the time period of this study.
Surgical bypass using a vein conduit has been the standard of care for tibial arterial revascularization with 2-year patency rates of 60%–68%. Limb salvage rates have been reported to be 96% at 2 years (2,27–29). However, availability of a suitable venous conduit is a major limiting factor in many patients with CLI. In our study, all patients were deemed not to have a suitable venous conduit by an experienced vascular surgeon. Tibial bypass using a synthetic graft has shown significant lower patency and limb salvage rates compared with venous conduit bypass grafts (30–32). In a metaanalysis by Albers et al (30), patency of femorotibial bypass grafts was 41% at 3 years, with a limb salvage rate of 66%. In a more recent study by Loh et al (33) using a modified polytetrafluoroethylene graft with a distal expanded cuff, the patency rate of the graft was 40% at 3 years, and limb salvage rate was 55%. Cryopreserved vein has also been used as a surgical conduit, with a limb salvage rate of 77% at 2 years (34). In the present study, the limb salvage rate was 55% at 2 years, which is lower than the reported rates of the
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bypass grafts and other angioplasty series. This difference in results can be explained by the superior patency of the venous bypass grafts whenever suitable venous conduits are available. The present study addresses patients with no suitable venous conduit, who were deemed to be poor open surgical risks, and who had a failed attempt at antegrade recanalization of tibial vessels. All lesions included in this study were long segment occlusions and likely had more advanced lesions compared with the lesions in the referenced studies, many of which included patients with both stenoses and occlusions. In addition, our study included a higher percentage of patients classified as Rutherford class 5 and 6 compared with the referenced studies. Another factor to consider is that the decision to proceed to major amputation in our study was not standardized. Some patients underwent amputation within several days of the recanalization procedure, suggesting that the decision to proceed to amputation was already made before the procedure or that not enough time was given to allow for a clinical response to be appreciated. Many patients underwent the procedure with the intent of revascularization to allow for healing of a planned below-knee amputation. This study is limited by its retrospective nature and lack of standardized follow-up. As a result, evaluation of patency of treated vessels was not attainable. The outcomes were limited to limb salvage and patient survival. In the study group, 12% of the patients were classified as Rutherford class 4, meaning they were not at an immediate risk of amputation. A technically failed procedure in this group of patients may not lead to amputation, in contrast to patients classified as Rutherford class 5 and 6. Another limitation of this study is the lack of a standardized decision tree for progressing to major amputation. As noted earlier, some patients had preplanned amputations, and others were not given sufficient time for a clinical response. Choice of stent placed and use of certain medications such as glycoprotein IIb/IIIa inhibitors during the procedure were operator dependent. Lastly, there was no consistent therapy for wound management and healing and inconsistent use of ancillary services such as hyperbaric oxygen. In conclusion, this retrospective study suggests that retrograde pedal access is a viable revascularization technique for achieving limb salvage in patients with CLI in whom antegrade revascularization has failed and surgical bypass is not a viable option.
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