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DOI: 10.1148/radiol.2322030729
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(Radiology 2004;232:499-507.)
© RSNA, 2004

Vascular and Interventional Radiology

Percutaneous Intentional Extraluminal Recanalization in Patients with Chronic Critical Limb Ischemia1

David J. Spinosa, MD, Daniel A. Leung, MD, Alan H. Matsumoto, MD, Eric A. Bissonette, MS, Dorothy Cage, RN, MSN, ACNP, Nancy L. Harthun, MD, John A. Kern, MD, John F. Angle, MD, Klaus D. Hagspiel, MD, Ivan K. Crosby, MD, Harry A. Wellons, Jr, MD, Curtis G. Tribble, MD and Gary D. Hartwell, DSc

1 From the Departments of Radiology (D.J.S., D.A.L., A.H.M., D.C., J.F.A., K.D.H., G.D.H.), Surgery (N.L.H., J.A.K., I.K.C., H.A.W., C.G.T.), and Health Evaluation Sciences (E.A.B.), University of Virginia Health Science Center, PO Box 170, Charlottesville, VA 22909. Received May 2, 2003; revision requested July 11; final revision received December 5; accepted January 5, 2004. Address correspondence to D.J.S. (e-mail: djs4m@hscmail.mcc.virginia.edu).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
PURPOSE: To review percutaneous intentional extraluminal recanalization (PIER) for treatment of patients who are poor candidates for infrainguinal arterial bypass surgery (IABS) and have arterial occlusions and chronic critical limb ischemia (CCLI).

MATERIALS AND METHODS: Patients with CCLI who were poor candidates for IABS were candidates for PIER. PIER was performed to create continuous arterial flow to the foot for limb salvage. PIER was attempted in 40 patients (22 men, 18 women; median age, 69 years; age range, 44–87 years). Of these patients, 24 (60%) had diabetes, 17 (42%) had renal disease, and 26 (66%) had coronary artery disease. Wound healing was evaluated at follow-up. Kaplan-Meier curves were constructed to evaluate limb salvage, survival, and amputation-free survival.

RESULTS: Fifty procedures were attempted in 44 limbs. Tissue loss was present in 40 (91%) limbs, and rest pain was present in four (9%); technical success occurred in 38 (86%). Thirty-seven (84%) of 44 limbs treated with PIER involved tibial vessels (tibial vessels only, n = 15; tibial and superior femoral artery [SFA] and/or popliteal vessels, n = 22). Sixty-six infrainguinal arterial vessel segments (SFA, n = 29; tibial, n = 37) in 38 limbs (1.7 segments per limb) were successfully treated with PIER. Thirty-five (95%) of 37 tibial occlusions and 24 (83%) of 29 SFA and/or popliteal occlusions were longer than 10 cm. Median run-off scores were 5.3 (range, 3–8) and 6.6 (range, 3–9) for patients with tibial occlusions and SFA and/or popliteal occlusions, respectively, as scored with modified Rutherford weighting of run-off arteries. Median follow-up was 7.8 months (range, 1–24 months). Twelve months after PIER, Kaplan-Meier analysis showed limb salvage rate was 66%, survival rate was 71%, and amputation-free survival rate was 48% in these patients. The 30-day mortality rate was 2.5%. Major complications occurred in four (10%) patients, and minor complications occurred in an additional four (10%).

CONCLUSION: PIER is a useful percutaneous technique for limb salvage in patients with CCLI.

© RSNA, 2004

Index terms: Arteries, extremities, 928.411 • Arteries, grafts and prostheses, 928.1268, 928.1282 • Arteries, interventional procedures, 928.1268, 928.1282


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
In many hospitals, infrainguinal arterial bypass surgery (IABS) is the preferred treatment for increasing blood flow to the lower limbs of patients with chronic critical limb ischemia (CCLI) who have tissue loss or rest pain at the time of presention. After IABS has been performed, limb salvage rates depend on many factors, including the level and extent of vascular obstruction, availability of a conduit for bypass grafting, ability to create straight-line flow to the foot, severity of the symptoms, and surgical expertise. Importantly, morbidity and mortality rates associated with these procedures are substantial (1,2). In patients who undergo repeat IABS for limb salvage after prior IABS failure, there is an increased rate of graft failure and limb loss, especially in female patients (3).

Percutaneous transluminal angioplasty (PTA) has been proposed as an alternative to IABS. In selected patients with CCLI and focal disease, comparable limb salvage rates and lower complication rates are achieved with PTA. PTA for limb salvage in patients with CCLI, however, is associated with poor outcome when treating diseased vascular segments longer than 5–10 cm (4,5).

Percutaneous intentional extraluminal revascularization (PIER) is emerging as a potential treatment that can be used for limb salvage in patients with CCLI. PIER was described by Bolia et al (6) in 1990 for treatment of long superficial femoral artery (SFA) and popliteal artery occlusions. In 1994, Bolia et al (7) reported the use of PIER in the treatment of tibial occlusions. Since that time, PIER has been used to treat patients with CCLI for the purpose of limb salvage; this technique has been primarily used by European interventionalists. These reports cite technical success and limb salvage rates that are comparable with those of surgical bypass for the treatment of patients with CCLI, with lower complication rates (8–10). Recently, PIER has been advocated as a temporary percutaneous bypass procedure and potentially could be considered the technique of first choice for treatment of patients with arterial occlusions and CCLI (11).

The purpose of our study was to review our experience with PIER in the treatment of patients who are poor candidates for IABS and have arterial occlusions and CCLI.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
This retrospective review of all patients with CCLI who underwent PIER from January 2001 to September 2002 was approved by our institutional review board, and informed consent was obtained. In this study, PIER was performed by one interventionalist with more than 10 years of experience in performing percutaneous interventional procedures. Patients with CCLI due to severe atherosclerotic peripheral vascular disease who had rest pain, tissue loss, or both and had nonreconstructible surgical anatomy at presentation were considered potential candidates for PIER. Patients were not considered for IABS if they had one or more of the following conditions: (a) lack of a suitable native vein conduit for infrapopliteal IABS; (b) poor medical condition at presentation that precluded surgery, as determined by the admitting surgeon or medical consultant; and/or (c) poor infrapopliteal arterial anatomy, which limited IABS options. These patients were not candidates for intraluminal PTA because at least one infrainguinal arterial segment that was needed to create continuous blood flow to the foot was occluded for more than 10 cm in length. The patients treated with PIER in this study were not candidates for IABS and were facing major lower limb amputation.

PIER was attempted in 40 patients; 22 (55%) were men, and 18 (45%) were women. Women and men had median ages of 74 years (range, 46–88 years) and 67 years (range, 29–90 years), respectively.

PIER Procedure and Criteria
Diagnostic bilateral lower extremity angiography was performed in all patients by using an iodinated contrast agent, unless renal insufficiency (serum creatinine level ≥ 2.0 mg/dL [176.8 µmol/L]) was present. In patients with renal insufficiency, a tailored examination limited to the symptomatic extremity was performed by using carbon dioxide and gadolinium as contrast agents to limit the risk of contrast material–induced nephropathy.

Review of the diagnostic angiogram was performed by the interventionalist and consulting vascular surgeon. Requirements for PIER were as follows: (a) there was potential to create continuous arterial flow to the foot, (b) previous surgery resulted in ligation of the ipsilateral SFA origin (a flush occlusion of the native SFA origin was not a contraindication to PIER), (c) angiography revealed a patent arterial vessel (anterior tibial, posterior tibial, or peroneal artery) reconstituting no lower than the level of the ankle mortis to provide a reentry point into the true lumen of the distal target artery, and (d) the patient, surgeon, and interventionalist agreed to proceed with PIER.

PIER was performed by using the technique described by Bolia et al (6,7), with a few modifications. Antegrade access was obtained in the ipsilateral common femoral artery by using a 5-F 21-gauge entry needle and a 0.018- to 0.035-inch transition dilator (Micropuncture system; Cook, Bloomington, Ind). A 0.035-inch steerable guide wire (TerumoGlidewire; Boston Scientific, Natick, Mass) was used to enter the subintimal space (SFA, popliteal artery, and/or infrapopliteal tibial artery, depending on the level of occlusion) and a 5-F angled catheter (Slip Cath; Cook) was advanced into the subintimal space. A loop was created in the leading portion of the guide wire and advanced distally until it reentered the true lumen beyond the occlusion. Balloon angioplasty was then performed in the subintimal space to create an extraluminal channel to allow perfusion of the lower leg. Typically, the tibial arteries were dilated to 3 mm, the popliteal artery to 4 mm, and the SFA to 5–6 mm. When tracking through the subintimal space of the SFA and popliteal artery, a 0.035-inch balloon angioplasty system (Diamond; Boston Scientific) was used successfully. In the tibial vessels, a 0.018-inch balloon angioplasty system (Symmetry; Boston Scientific) was used because the 0.035-inch balloon angioplasty catheters frequently did not track well through the nondilated subintimal space and were oversized relative to the distal tibial and pedal vessels. In calcified vessels, a 0.014-inch coronary balloon system (Quantum Maverick; Boston Scientific) was frequently required to track through the nondilated subintimal space. Because of the relatively compliant nature of coronary angioplasty balloons, however, repeat angioplasty with less compliant 0.018-inch peripheral angioplasty balloon catheters (Symmetry; Boston Scientific) was occasionally necessary to achieve satisfactory subintimal lumen diameters.

Unlike Bolia et al (6,7), who advocate performing balloon dilation of the subintimal space as the guide wire is advanced distally, we pass the guide wire and catheter along the entire subintimal space and reenter the distal true lumen before performing balloon dilation of the subintimal space. We prefer this approach because if the true distal lumen cannot be entered with an antegrade approach, a retrograde approach from the distal target vessel is attempted. By delaying subintimal tract dilation until distal reentry is accomplished, the risk of bleeding into adjacent extravascular tissues is limited, should perforation of the subintimal space occur. The potential for thrombus formation in the dilated subintimal space is also reduced. Limiting thrombus formation in the subintimal space is important because anticoagulation with heparin is typically withheld until the guide wire has reentered the distal vessel lumen. The procedure was considered a technical success when brisk flow was achieved within the subintimal space and the true lumen beyond the distal reentry point to the foot. Flow was considered brisk when 6–8 mL of contrast agent cleared the vessel lumen in 2–3 seconds. Occasionally, self-expanding vascular stents were used in the subintimal space of the SFA and popliteal artery to achieve brisk distal flow.

When reentry into the true lumen of the distal target vessel was not successful, direct retrograde access into the distal target vessel was performed by using the retrograde access via the distal target vessel. We have subsequently called this the subintimal arterial flossing with antegrade-retrograde intervention, or SAFARI, technique (12). Retrograde access was predominantly obtained with ultrasonographic guidance, although occasionally, access was obtained with fluoroscopic guidance with or without the use of a contrast agent. When the proximal true lumen was entered from the retrograde direction, the guide wire was either steered or loop snared into the proximal antegrade sheath. The guide wire was replaced with either a 0.014- or 0.035-inch exchangeable guide wire with tibial PIER or SFA PIER, respectively. When retrograde access was obtained via the popliteal artery, a 35-cm 5-F vascular sheath was placed. If a distal tibial or pedal vessel was accessed, a 3-F dilator was placed over the guide wire to protect the vessel from injury at the access site during PIER. Dilation of the subintimal tract was performed in either the antegrade or retrograde direction for SFA or popliteal artery PIER and in the antegrade direction for tibial PIER.

Once the subintimal space was traversed, 5,000 units of intraarterial heparin were administered, and 100–200-µg boluses of intraarterial nitroglycerine were given periodically during the procedure to minimize vasospasm of the smaller distal run-off vessels. In patients undergoing tibial PIER, administration of the glycoprotein IIb/IIIa platelet inhibitor eptifibatide (Integrilin; COR Therapeutics, South San Francisco, Calif) was also initiated with a loading bolus and followed by weight-adjusted infusion once the subintimal space was traversed to limit small vessel occlusion during the immediate postprocedure period.

At the conclusion of the procedure, hemostasis was obtained with manual compression of the femoral and popliteal access sites once the activated clotting time was less than 180 seconds. Retrograde tibial or pedal artery hemostasis was accomplished at the conclusion of the procedure by using manual compression for about 5–10 minutes, regardless of the activated clotting time.

Patient Follow-up
Patients were discharged with a 3-month supply of warfarin (Coumadin; Bristol-Myers Squibb, New York, NY) if they underwent tibial PIER or received a stent in the SFA or popliteal artery, provided no contraindication to anticoagulant therapy was present. Each patient was instructed to consume one aspirin per day for the remainder of his or her life.

Patient follow-up information was obtained at interventional radiology, vascular surgery, or plastic surgery clinics. Vascular technologists obtained ankle-brachial indexes and pulse volume recordings at our institution. We attempted to obtain ankle-brachial indexes in all patients within 30 days of PIER and at clinical follow-up; however, the presence of calcified tibial vessels limited interpretation in some patients. Pulse volume recordings were obtained and reported in patients with calcified tibial vessels. Clinical evaluation of wound healing was performed at each follow-up visit. Healing was reported if there was a decrease of 50% or more in wound size, as determined by the vascular surgeon.

Statistical Methods
Limb salvage was calculated by using the time from the first procedure in a limb until the time of amputation or last follow-up. This analysis included all limbs in which an intervention was performed. Because four patients underwent treatment of both limbs, variability estimates were adjusted for any correlation of the outcomes in each limb associated with a patient. Amputation-free survival was calculated as the time interval between the first procedure and amputation or death. Similarly, survival was estimated by using death as the failure end point. Kaplan-Meier survival estimates and 95% confidence intervals (CIs) were generated for limb salvage, amputation-free survival, and overall survival. In the case of limb salvage, due to the correlated nature of the data, 95% CIs were obtained by using a cluster bootstrapping technique. This method uses resampling to generate a distribution of estimates sampling all or none of a patient’s records in each sample. Samples were drawn 1,000 times with replacement, and Kaplan-Meier estimates were generated at each distinct failure time. The 2.5th and 97.5th percentile of the bootstrap distributions were obtained for each unique failure time (13).


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Results were reported by using the Recommended Standards for Reports Dealing with Lower Extremity Ischemia: Revised Version (14) and Reporting Standards for Clinical Evaluation of New Peripheral Arterial Revascularization Devices (15). A total of 50 procedures were attempted in 44 limbs in 40 patients (1.14 procedures per limb) (Tables 1, 2). Forty (91%) limbs were treated because of tissue loss (grade III, category 5 or more), and four (9%) were treated because of rest pain (grade II, category 4). In 17 (39%) limbs, a suitable vein for IABS was not available.


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  		TABLE 1. Patient Characteristics

 

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  		TABLE 2. Lesion Characteristics

 
PIER Procedures and Success
PIER was successful in 38 (86%) of the 44 limbs in which it was attempted (Fig 1) and failed in six (14%). All but one of these technical failures occurred before the subintimal arterial flossing with antegrade-retrograde intervention technique was developed (12).



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  		Figure 1. Arteriograms obtained in a 74-year-old woman with a nonhealing ulcer of the left first toe and rest pain. A, Posteroanterior projection shows long left SFA occlusion (arrows). B, Posteroanterior projection shows reconstituted distal SFA below the level of the SFA obstruction and popliteal artery. C, Posteroanterior and, D, lateral projections show long left posterior tibial artery occlusion (straight arrow) and 5-cm occlusion of the peroneal artery (curved arrow). E, Posteroanterior projection shows SFA occlusion before PIER. F, Posteroanterior projection shows successful antegrade SFA PIER. G-J, Successful PIER of long left posterior tibial artery occlusion from origin (curved arrow) to level of the ankle mortis (straight arrow). In G, the posteroanterior projection shows successful PIER of short left peroneal artery occlusion (straight arrow). Note smooth, almost vein graft-like appearance of the PIER lumina. Images H-J were obtained in the lateral projection.

 
A description of the number and type of PIER procedures is included in Table 2. The median run-off score for patients with tibial occlusions was 5.3 (range, 3–8). The median run-off score for patients with SFA and/or popliteal occlusions was 6.6 (range, 3–9) (14,15).

Follow-up
The median clinical follow-up period was 7.6 months (range, 1–24 months). Eleven (25%) major amputations were performed (two above the knee and nine below), and 14 (35%) deaths occurred during the follow-up period. Eleven (79%) of the 14 deaths were cardiovascular in nature. The limb salvage rate was 91% and 66% at 6- and 12-month follow-up, respectively (Fig 2, Table 3). The amputation-free survival rate was 72% and 48% at 6- and 12-month follow-up, respectively (Fig 3a, Table 3). The survival rate was 74% and 71% at 6- and 12-month follow-up, respectively (Fig 3b, Table 3).



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  		Figure 2. Graph shows Kaplan-Meier and 95% CI (dashed lines) estimates for limb salvage (solid line). This figure contains data for 44 limbs in 40 patients and is appropriately corrected for any correlation that exists. Vertical ticks along the survival curve indicate censoring times. Number of patients at risk for failure or those remaining in the risk set are given along the bottom of the graph at corresponding times.

 

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  		TABLE 3. Summary of Kaplan-Meier Estimates and 95% CIs at 6- and 12-month Follow-up

 


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  		Figure 3. Graphs show Kaplan-Meier and 95% CI estimates for amputation-free survival (A) and overall survival (B). Dashed lines represent the 95% CI, and the solid line represents estimated survival. Horizontal ticks along the survival curve indicate censoring times. The number of patients at risk for failure or remaining in the risk set are given along the bottom of the graph at corresponding times.

 
Clinical follow-up data are included in Table 4. Twenty-three of the 40 patients treated for tissue loss either healed (n = 19) or improved (n = 4). Eleven limbs were amputated, and PIER was technically unsuccessful in six patients. Of these six patients, three underwent amputation within 30 days; two died within 60 days, and one underwent successful IABS, which failed within 6 months. This last patient eventually underwent amputation 9 months after IABS. Five of these six patients either underwent major amputation or died within 60 days of the failed procedure, emphasizing the severity of disease in this patient population. In six (55%) of the 11 patients who underwent successful PIER, amputation was performed, despite the presence of improved ankle-brachial indexes and pulse volume recordings, which demonstrated patency at the time of surgery. In these patients, amputation was performed because of infection that could not be controlled, typically due to the presence of osteomyelitis involving the calcaneous or a calcaneal ulcer, typically larger than 4 cm, which failed to demonstrate evidence of healing.


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  		TABLE 4. Outcome Data

 
Hemodynamic follow-up data are included in Table 4. Hemodynamic patency was assessed with ankle-brachial indexes and pulse volume recordings. Pre- and postprocedure ankle-brachial indexes or pulse volume recordings were obtained within 30 days of PIER in all 38 limbs in which this procedure was successful. Ankle-brachial index and pulse volume recording studies were obtained in 23 (60%) of 38 limbs after PIER. Twenty-one (91%) of 23 limbs with a recordable ankle-brachial index showed an improvement of more than 0.10 (mean, 0.38; range, 0.00–0.91) (score ≥ grade 2) (14,15). The tibial vessels in the remainder of the limbs were too calcified to obtain technically satisfactory ankle-brachial indices. Pulse volume recordings without an ankle-brachial index were obtained in 15 (39%) of 38 limbs, and all 15 showed at least a 5-mm increase in peak systolic amplitude at pulse volume recording testing (mean, 10.3 mm; range, 8–15 mm). Thirty-six (95%) of 38 studies showed evidence of hemodynamic patency within 30 days of the procedure.

Mortality and Complications
The 30-day mortality rate was 2%. One patient died 22 days after IABS, which was performed after failed PIER in the right limb and successful PIER in the left limb. Major complications occurred in four (10%) of the 40 patients. One patient had an episode of ventricular fibrillation and required placement of an implantable defibrillator. One patient required emergency IABS after a failed attempt at PIER because of a rupture of the subintimal space, which resulted in bleeding and development of a compartment syndrome. IABS failed in this patient within 6 months. This complication occurred early in our experience, when we performed balloon dilation of the subintimal tract before successfully entering the distal target arterial lumen. One patient with a history of chronic renal failure did not receive IIb/IIIa platlet inhibitors and developed thrombosis of the subintimal tract during the procedure; this patient required overnight thrombolysis and underwent subsequent stent formation. One patient required surgical repair of the common femoral artery access site because an expanding hematoma formed after the patient inadvertently removed the vascular sheath at the bedside.

Minor complications occurred in four (10%) of the 40 patients. All four of these patients developed gastrointestinal bleeding, which was believed to be due to postprocedure anticoagulation with reduced dosages of heparin and concomitant use of a IIb/IIIa antiplatelet agent. Bleeding in these four patients did not require transfusions and was easily controlled by stopping the administration of anticoagulants and eptifibatide. No malignant source for the gastrointestinal bleeding was detected in any of these patients.


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
CCLI is defined as nonhealing ulceration or gangrene of the foot or toes and/or rest pain that requires regular use of analgesics. Typically, patients with CCLI have diffuse multilevel atherosclerotic disease involving the arteries of the lower extremities or isolated infrainguinal occlusion associated with diabetes. Nonoperative management of nonhealing ulcers or gangrene in patients with CCLI usually fails. One-year amputation rates for patients with CCLI have been reported to be between 73% and 95% if IABS is not performed (16). Patients with CCLI also have a high mortality rate. One-, 3-, and 5-year mortality rates for patients with CCLI are 26%, 44%, and 56%, respectively, even in the absence of surgery (2). Mortality rates have been reported to be 8.6 times higher in patients undergoing lower limb amputation than in age-matched patients without diabetes with median survival of only 1.8 years (17). Survival after below-knee amputation is clearly related to medical comorbidities. One-year survival after lower limb amputation has been reported to range from 14% to 81% (18). Additionally, in patients with CCLI that requires amputation, a median 30-day mortality rate of 6.3% has been reported, but the mortality rate can be as high as 18.4% in high-risk patients (18). In comparison, patients with claudication have 5-, 10-, and 15-year mortality rates in the range of 30%, 50%, and 70%, respectively (19,20).

IABS is considered by many physicians to be the treatment of choice for CCLI. Five-year patency rates for IABS have been reported to be as high as 86% for above-knee bypass, in which a native vein is used as a conduit, and as low as 12.5% for arterial bypass to tibial vessels with poor run off, in which prosthetic material is used (21–23). One- and 3-year limb salvage rates are reported to be in the range of 85% and 68%, respectively (2,18,24–26).

The patency rate of infrapopliteal PTA is not well studied, but it is likely to be lower than that of IABS. One-year primary patency rates for PTA are reported to be in the range of 48%–68% (5,27). It is important to note, however, that limb salvage rates in patients treated with successful infrapopliteal PTA to create continuous arterial blood flow to the foot are comparable with those in patients treated with IABS. Limb salvage rates 1 and 3 years after successful infrapopliteal PTA have been reported to be approximately 88% and 68%, respectively (28–33). Soder et al (5) reported an 80% limb salvage rate at 18 months, despite a primary patency rate of only 48% at 10 months. These findings support the benefit of infrapopliteal PTA for limb salvage in patients with CCLI, even if the blood flow to the affected limb is only temporarily improved. These results also emphasize that prolonged primary vessel patency after PTA is not needed for wound healing and limb salvage (28,31,34). Similarly, prolonged graft patency is not needed for improved limb salvage after IABS (35,36).

Despite the similarities in limb salvage and mortality between PTA and IABS in patients with CCLI, limitations of infrainguinal PTA have been reported. Poorer results have been noted in patients with long segments of disease, particularly long occlusions of the infrapopliteal vessels (4,5,31,32,34). In 1998, Parsons et al (37) advocated IABS for all patients with CCLI and infrapopliteal disease, unless the lesions were focal in nature, and reported 1-year patency. They reported limb salvage rates of 13% and 25%, respectively.

PIER is potentially an alternative percutaneous treatment for patients with long arterial occlusions and CCLI. With the PIER technique, the subintimal space is intentionally entered with a guide wire from an antegrade approach. Other investigators have also reported that PIER is a useful technique in the treatment of patients with CCLI and have demonstrated limb salvage rates comparable with those of IABS (8–11,38).

Although many interventionalists in the United States still consider PIER to be an unproven treatment for CCLI, physicians in Europe are promoting PIER as a potential temporary bypass in patients with CCLI (10,11) because of its relatively high technical success, low complication rates, and limb salvage rates that are comparable with those of IABS (6,8,38).

The safety of PIER must be considered. Concern has been expressed that failure to reenter the true lumen will result in acute ischemia because of disruption of vital collateral vessels. Concern has also been raised that if reentry into the true lumen is too distal, it could result in the need for a more complicated surgical procedure if a technically successful PIER procedure should subsequently occlude (39,40); for example, a below-knee femorodistal bypass would be required instead of an above-knee femoropopliteal bypass.

On the basis of the literature and our own experience, we believe that these concerns are unfounded (6–8,10,38,41). Only one patient in our series required emergency surgery. In this patient, the vessel wall was perforated, and successful antegrade PIER could not be performed. During the procedure, balloon dilation of the subintimal tract was used to facilitate advancement of the guide wire and catheter. Since no outflow could be established, blood continued to extravasate into the popliteal fossa, which resulted in substantial pain. It was decided to surgically decompress the popliteal fossa and perform IABS rather than intentionally embolize the subintimal tract or apply a tourniquet to close the subintimal tract and stop bleeding. After IABS, the graft remained patent for 6 months before it failed. The patient subsequently underwent below-knee amputation.

After this complication, we modified our PIER technique. Before balloon dilation of the subintimal tract is performed, access from the proximal true lumen into the distal true lumen is obtained with the guide wire. This ensures that continuous arterial outflow can be achieved without vessel wall perforation. Since using this technique, we have had no further need for emergency surgery. Infrequently, guide wire perforation has occurred before reaching the lumen of the distal outflow artery while trying to create the subintimal tract; however, the subintimal tract was not balloon dilated but rather abandoned, and it sealed without additional treatment. Frequently, a new subintimal tract was then successfully created. Successful creation of a new subintimal tract appears to divert blood away from the initial tract, perforation site, or both, and may also compress and seal the initial tract.

Eighty-six percent of patients underwent hemodynamic patency testing within 30 days of the PIER procedure. We attempted to use ankle-brachial indices to follow vessel patency in these patients; however, ankle-brachial indices could only be obtained in about half of the limbs because of the calcified tibial vessels. Pulse volume recordings were obtained in the remainder of limbs, but the interpretation of pulse volume recordings is more subjective. Evidence of hemodynamic patency after the PIER procedure was identified in 95% of patients. These results are comparable with patency data for IABS after the procedure (36).

Clinical examination was used to determine the extent of wound healing and the absence of rest pain. Seventy-five percent of the limbs with tissue loss in patients who were still alive were healed or deemed improved by both the patient and the vascular or plastic surgeon at the last follow-up visit. Also, both patients treated for rest pain were alive and free of rest pain at the conclusion of this study.

Although the long-term patency rates of PIER are unclear, recent reports suggest that patency may be limited (38,42,43). Rather, the temporary blood flow provided by PIER results in healing of wounds and/or infection, which results in a reduced long-term oxygen demand. Interestingly, in some patients who underwent repeat angiography because of incomplete healing or noninvasive testing that suggested closure of the opening created with PIER, portions of the PIER opening were narrowed but remained open, whereas other portions were closed. Surprisingly, collateral vessels were identified from some areas of the patent portions of the subintimal channel and may have contributed to persistent patency of these subintimal vessel segments. Communication of collateral vessels with the subintimal tract may occur as the subintimal channel is created by the advancing guide wire or balloon inflation, leading to shearing open the entry into the adjacent collaterals in the same way that surgical endarterectomy exposes collaterals when the plaque is lifted from the vessel wall (Fig 4). Communication with these collateral vessels may help to explain the absence or reduction in symptoms long after the PIER has closed.



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  		Figure 4. Arteriogram shows the effect of PIER on collateral vessels. After PIER of the posterior tibial artery, note the following varying effects on vessel collaterals: collateral communication with subintimal lumen created with PIER (straight arrow), communication with subintimal space but narrowed collateral origin due to subintimal flap (curved arrow), and complete occlusion of the collateral branch without communication to subintimal space (box arrow). The effect of PIER on collateral vessels may influence clinical outcome.

 
A technically successful PIER procedure and patent vessel did not always prevent amputation. In six of the 11 patients, patency was demonstrated by the ankle-brachial index and pulse volume recording in the symptomatic extremity just before the patients underwent above- or below-knee amputation. These amputations were performed because of progressive infection or lack of substantial healing. These results are not unlike those in other reports of amputation, despite the presence of a documented patent artery in patients with CCLI (44).

The 30-day mortality and morbidity rate for this group of patients with advanced peripheral vascular disease was lower than that reported for similar patients undergoing IABS (17). The cause of bleeding was believed to be due to the use of a IIb/IIIa platelet inhibitor. IIb/IIIa inhibitors have been shown to improve the outcome in patients with acute coronary syndromes after percutaneous coronary interventions by reducing thrombus formation (45,46). Interventionalists have recently begun using these agents in conjunction with peripheral interventions. The data available for peripheral use at this time, however, are limited to a few small trials in which the benefit of IIb/IIIa inhibitors in conjunction with thrombolysis was evaluated, and there are only a few published reports that demonstrate the efficacy of IIb/IIIa inhibitors for use in peripheral interventions. However, given the ability of these agents to reduce early thrombosis in the coronary arteries after intervention, these agents may have a role in interventions involving the infrapopliteal arteries (47). Only one patient developed evidence of a symptomatic or hemodynamic occlusion within 30 days of the procedure. This patient did not receive a IIb/IIIa inhibitor because of underlying renal failure.

Bleeding and thrombocytopenia are known complications associated with the use of heparin and IIb/IIIa inhibitors. The coronary literature suggests that bleeding complications can be limited with weight-adjusted heparin doses and early removal of vascular sheaths (48); however, bleeding occurred in four patients despite following these recommendations. Whenever possible, we give patients a weight-adjusted bolus of eptifibatide followed by a weight-adjusted infusion of eptifibatide for 18 hours. In one patient who developed a substantial access site hematoma after PIER, surgical repair of the puncture site was required. This patient weighed 120 kg and inadvertently dislodged the arterial sheath while receiving heparin.

Limitations of this study include its retrospective nature, the lack of a surgical control group, reporting of experience that was limited to a single institution, limited anatomic patency data (ie, physiologic data from ankle-brachial indices and pulse volume recordings), and midterm follow-up. Some of these limitations will be overcome as more experience with PIER is gained. Magnetic resonance angiographic findings may prove to be more reliable than ankle-brachial indices and pulse volume recordings in determining vessel patency after PIER. In addition, information about long-term anatomy in patients with CCLI who undergo PIER may help determine how to care for these patients during and after wound healing, as well as clarify the role of PIER in patients with claudication and femoropopliteal disease. Interestingly, the subintimal space may someday provide a route for entirely percutaneous placement of bypass grafts, especially if endoluminal anastomic devices become available.

In conclusion, PIER is a useful percutaneous technique that is used for limb salvage in patients with CCLI who have tissue loss, substantial comorbidities, limited suitable native veins for IABS, previous failed IABS, and/or high surgical risk. On the basis of Kaplan-Meier analysis at 12 months after the PIER procedure was performed, limb salvage was 66% and survival was 71% in this severely symptomatic patient population. Although more experience is needed to determine if PIER should become a first-line treatment for patients with CCLI, we are encouraged by our initial experience, which supports the results of others (6–10).


   ACKNOWLEDGMENTS
 
Special thanks to Sherry Deane for preparation of this manuscript.


   FOOTNOTES
 
Abbreviations: CCLI = chronic critical limb ischemia, CI = confidence interval, IABS = infrainguinal arterial bypass surgery, PIER = percutaneous intentional extraluminal revascularization, PTA = percutaneous transluminal angioplasty, SFA = superficial femoral artery

Author contributions: Guarantor of integrity of entire study, D.J.S.; study concepts, D.J.S., D.A.L., A.H.M., E.A.B.; study design, D.J.S., D.A.L., E.A.B.; literature research, D.J.S.; clinical studies, D.J.S., D.A.L., A.H.M., J.F.A., K.D.H.; data acquisition, D.J.S., D.C., G.D.H., E.A.B.; data analysis/interpretation, D.J.S., E.A.B.; statistical analysis, E.A.B.; manuscript preparation and definition of intellectual content, D.J.S., D.A.L., A.H.M., E.A.B., J.A.K., N.L.H., I.K.C.; manuscript editing and revision/review, all authors; manuscript final version approval, D.J.S., A.H.M., D.A.L., E.A.B.


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TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
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