Analysis of Outcomes Following Failed Endovascular Treatment of Chronic Limb Ischemia

Article Outline

• Abstract
• INTRODUCTION
• MATERIALS AND METHODS
  • Patients
  • Endovascular Technique
  • Outcomes
  • Statistical Methods
• RESULTS
• DISCUSSION
• REFERENCES
• Copyright

Despite recent studies highlighting the advantages of endoluminal intervention in the management of chronic limb ischemia (CLI), outcomes following failed peripheral angioplasty remain less well described. We present a retrospective analysis of failed transluminal infrainguinal percutaneous arterial angioplasty with or without stenting (PTA/S) in patients with CLI. A database of patients undergoing infrainguinal PTA/S between 2002 and 2005 was maintained. Patients underwent duplex scanning follow-up at 2 weeks, 3 months, and every 6 months after the intervention. Angiograms were reviewed in all cases to assess lesion characteristics. Results were standardized to current Transatlantic Inter-Society Consensus (TASC) criteria. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. In total, our analysis involved 246 patients who underwent treatment for CLI using PTA/S. Eighteen percent of procedures (n = 46) were considered an intervention failure secondary to restenosis by duplex ultrasound, returning clinical symptoms, a nonhealing foot lesion, or the absence of a prior palpable pulse. Indications for the original procedure in patients whose PTA/S failed were tissue loss in 44%, claudication in 44%, and rest pain in 12%, while TASC lesion grades were A (0%), B (18%), C (18%), and D (64%). Of patients failing PTA/S, 4% failed in the first 30 days, 78% failed between 1 and 18 months, while 18% failed following 18 months, with a mean time to failure of 8.7 months. Also, 82% of PTA/S failures were candidates for a second endovascular procedure, 11% were suitable for only traditional open bypass, and 4% demonstrated progression of disease necessitating amputation. Of patients undergoing a second endovascular procedure, limb salvage rates were 86% at 12-month follow-up and there was a single periprocedural mortality and complication rate of 6.6%. Of patients requiring open surgical bypass after failed PTA/S, 20% (n = 1) required a major amputation and there were no mortalities. Failure of endoluminal therapy for treatment of lower extremity arterial occlusive disease is amenable to subsequent endovascular intervention for limb salvage with limited morbidity and mortality.

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INTRODUCTION 

Chronic limb ischemia (CLI) is a devastating clinical condition that severely impairs the functional status and quality of life of patients with advanced peripheral vascular disease.¹, ² The treatment of this debilitating disease is associated with substantial morbidity, mortality, and expenditure of healthcare resources.³, ⁴ Surgical bypass with autogenous conduit, the gold standard treatment for CLI, has led to increased limb preservation with reduced rates of lower extremity amputation⁵, ⁶, ⁷ and has proven effective in producing excellent long-term patency and limb salvage. However, this approach is limited in patients with comorbidities such as coronary artery disease, cerebrovascular disease, and chronic obstructive pulmonary disease as well as in patients with unsuitable surgical anatomy. Moreover, conventional surgical bypass in this multiple comorbid population results in complications in up to 25% of patients.⁸, ⁹, ¹⁰

Endovascular therapy, once an adjunct technique reserved for patients unable to tolerate traditional bypass, has now evolved into a primary mode of treatment as a result of its low morbidity and mortality and reduced hospital stay in comparison with conventional bypass surgery. Because of the decreased morbidity and equivalent need for reintervention¹¹ associated with this less invasive form of therapy, percutaneous angioplasty with or without stenting (PTA/S) has been advocated as the primary treatment modality for selected patients with CLI.¹², ¹³, ¹⁴, ¹⁵ While the advantages of successful endoluminal treatment have been increasingly documented, the limb salvage rate and impact of repeat interventions following failed PTA/S remain unclear.

In this study, we examined the consequences of failed PTA/S in the treatment of CLI. We hypothesized that failure of infrainguinal PTA/S would not be associated with significant morbidity and mortality and would remain amenable to subsequent endovascular interventions for limb salvage.

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MATERIALS AND METHODS 

Patients 

Patients undergoing PTA/S for infrainguinal lesions between March 2002 and December 2005 were prospectively entered into a computerized database. The records of 246 patients (251 limbs) with a mean age of 70.4 ± 11 years (range 38–93) were analyzed. All 246 patients were contacted regarding possible procedures at other institutions. Follow-up at 3 months was 93%. Patients who had undergone a previous lower extremity bypass or angioplasty were excluded from analysis. Complete data including demographics, comorbidities, presenting diagnosis, ankle-brachial index, vascular laboratory studies, angiogram results, and outcomes were obtained under a protocol approved by the Institutional Review Board at New York-Presbyterian Hospital. Claudi-cants were offered percutaneous endovascular treatment for lifestyle-limiting claudication or after failure to improve with risk factor modification and active participation in an exercise regimen. Patients with critical ischemia were treated within the same hospitalization. Therapy for individual patients was dictated by individual attending physician preference and was not regulated by unit guidelines. Noninvasive studies were performed initially; however, patients with serious symptoms or signs of severe stenosis/occlusion based on initial noninvasive tests received angiograms. Angiograms were reviewed, and femoropopliteal lesions were morphologically classified according to the Transatlantic Inter-Society Consensus (TASC) stratification.² No iliac lesions were included in this analysis. Angioplasty with or without concomitant stent placement was used as a first-line therapy for all patients with a stenosis±50% or occlusion of an infrainguinal vessel in conjunction with CLI. The criteria for open surgical bypass as the primary treatment were (1) bilateral common iliac occlusion, (2) common femoral artery occlusion, or (3) popliteal occlusion anatomically located behind the knee joint. Proximal iliac lesions were treated with angioplasty prior to undergoing angioplasty of infrainguinal lesions. Patients with lesions involving both proximal (femoropopliteal) and distal (p opliteal or tibial) vessels were treated with angioplasty of both lesions at the same procedure.

Endovascular Technique 

All patients were treated either in the operating room using portable imaging equipment (OEC 9800; GE Medical Systems, Milwaukee, WI) or in the angiography suite using fixed imaging systems (Siemens, Munich, Germany). The majority of procedures were performed under local anesthesia with intravenous sedation; four patients required general anesthesia. Treatment was performed in 70% of patients via a contralateral approach utilizing a 6F Balkin sheath (Cook, Bloomington, IN) and in 30% of patients via an ipsilateral approach utilizing a standard 6F sheath (Brite Tip; Cordis Endovascular Warren, NJ). Intravenous heparin (100 units/kg) was administered to maintain an activated clotting time of±250 sec throughout the procedure. Stenoses were treated via standard transluminal techniques using appropriately sized noncompliant balloons. Superficial femoral artery and popliteal artery occlusions were recanalized utilizing “stiff” angled 0.035-inch guidewires (Terumo, Somerset, NJ). Tibial occlusions were traversed in the subintimal plane utilizing either “floppy” or “stiff” 0.035-inch guidewires. Guide-wires were supported using 4F or 5F angled glide catheters (Angiodynamics, Queensbury, NY). Once confirming reentry into the true lumen, the sub-intimal space was dilated to an appropriate size based on the size of the native vessel above and below the lesion. The decision to use a stent (self-expandable nitinol) was made at the time of angioplasty if there was residual stenosis±30% or a dissection plane. Patency, adequacy of flow, and preservation of runoff were confirmed on completion angiography. Aspirin was administered to all patients postoperatively, unless contraindicated. Patients with stent placement received clopidogrel (75 mg daily) for a minimum of 30 days after the procedure.

Outcomes 

Follow-up clinical assessment was performed at 2 weeks and 3 months postoperatively and then every 6 months thereafter. Peripheral pulses, skin color, and noninvasive hemodynamic evaluation (ankle-brachial index, pulse volume recording, or color Doppler examination) were obtained every 3 months. Angiography was performed for increased velocities (>300 cm/sec) on duplex across the treated lesion. Symptoms and patency were graded according to the Society for Vascular Surgery (SVS)/International Society of Cardiovascular Surgery classification. Success was defined by both clinical and hemodynamic outcomes. Clinical improvement was defined with the SVS standards, with an improvement of at least one clinical category, except in patients with tissue loss, where there needed to be an improvement of at least two categories. Hemodynamic success was defined as patency with <50% residual stenosis measured by duplex scan, angiography, or the presence of a palpable pulse. For patients with multiple treated lesions, all treated vessels had to be patent for hemodynamic success. Limb salvage required (1) no major amputation, (2) an expected toe or transmetatarsal amputation which healed, or (3) ischemic ulcers with complete healing.¹⁶ Procedures were classified as an intervention failure if there was±50% re stenosis on surveillance duplex ultrasound, returning clinical symptoms, a nonhealing foot lesion, or the absence of a prior palpable pulse.

Statistical Methods 

Data were analyzed using standard statistical methods. Kaplan-Meier analysis was used to determine outcomes at specified intervals and reported using current SVS criteria. Univariate analysis was done using the log rank method to determine differences between subgroups generated by Kaplan-Meier. Statistical significance was defined as p < 0.05.

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RESULTS 

There were 251 limbs in 246 patients (55% male, average age 70.4 years) who underwent infrainguinal PTA/S. Mean follow-up was 11.8 months (range 0–51). Indications for treatment included disabling claudication (58%), rest pain (10%), ulcers (20%), and gangrene (12%). Percutaneous intervention was immediately successful in 97% of patients. Failure resulted from inability to cross the lesion or to reenter the true lumen distally. Procedures in 46 patients (18%) failed. Of these unsuccessful interventions, 4.3% (n = 2) failed in the first 30 days, 78.2% (n = 36) failed between 1 and 18 months, and 17.5% (n = 8) failed following 18 months, with a mean time to failure of 8.7 months and a total mean follow-up time of 15.8 months. All of these failures were due to stenosis or occlusion at the site of primary intervention; none of these early failures was due to distal embolization of thrombus.

Lesions were classified by TASC criteria based on angiographic findings. Of patients with favorable outcomes following PTA/S, 44% were characterized as having TASC A/B lesions, 30% C lesions, and 26% D lesions. No TASC A patients failed, while 18% of failures were TASC B patients, 18% TASC C patients, and 64% TASC D patients.

In total, PTA/S was performed in 182 femoral vessels, with concomitant stent placement in 115 (63%) of these vessels. Ninety-seven popliteal lesions underwent PTA/S, with 48 (49%) concomitant stents placed. PTA/S was performed in 40 tibial vessels, with concomitant stents placed in 27 (66%) vessels. In patients failing infrainguinal PTA/S, 38 femoral vessels underwent PTA/S with stent placement in 68% (n = 26), 27 underwent popliteal PTA/S with 59% (n = 16) stented, and 13 tibial vessels were angioplastied with 30% (n = 4) stented. One patient underwent a percutaneous popliteal atherectomy, providing limb salvage at 22 months to date. A comparison of patient characteristics, indications for intervention, and disease characteristics between patients with successful intervention and those failing is summarized in Table I, Table II.

Table I. Characteristics of and indications for intervention for patients having infrainguinal PTA/S

DM, diabetes mellitus; Cr, creatinine; CRI, chronic renal insufficieny.

Table II. Disease characteristics and procedural data

Upon univariate analysis, factors predicting failure were TASC D category (p = 0.019), a prepro-cedural indication of ulcer or gangrene (p = 0.007), and diabetes mellitus (p = 0.001). No other characteristics or events predicted failure, and the number of outcomes was not great enough to reach significance in logistic regression analysis. In patients failing PTA/S, the mean length of stay was 3.4 days, with two patients requiring intensive care monitoring. The overall periprocedural complication rate was 18%, which included hematoma (12%), pseudoaneurysm (4%), and myocardial infarction (2%). Of the two patients with pseudoaneurysms, one was treated with compression and the other with thrombin injection. A single death occurred during the perioperative period, leading to a 30-day mortality of 2.3%. Of patients undergoing a second endovascular procedure following a failed first attempt, the patency following initial failed PTA/S was 84% at 1 year (Fig. 1). Of patients with limb-threatening ischemia who failed their initial endoluminal intervention, the limb-salvage rate was 86% at 12 months (Fig. 2).

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• Fig. 1. 

  Patency following initial failed PTA/S.

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• Fig. 2. 

  Limb salvage in patients with limb-threatening ischemia failing initial PTA/S.

Table III. Morbidity and mortality

*p < 0.05, significant difference between the two groups.

No emergent endovascular intervention, bypass, or unplanned amputation occurred within 30 days of these PTA/S failures. There was no change in the level of amputation or the level of distal anastomosis of a bypass graft as a result of failure. Eighty-three percent of patients failing primary PTA/S underwent a second successful endoluminal intervention, and 11% of patients underwent an ipsilateral bypass. Of patients requiring open surgical bypass after failed PTA/S, only one required a major amputation and there were no mortalities. Four patients (10%) did require a major amputation below or above the knee, and closer review suggested that in these patients intervention had been performed in an attempt to decrease the level of amputation. One patient failing PTA/S was treated conservatively secondary to accompanying terminal illness.

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DISCUSSION 

Severe limb ischemia leads to pronounced morbidity and mortality as well as consumption of many health-care resources.¹⁷ Two treatments are currently available for this expensive and morbid disease, conventional surgical bypass and endo-vascular balloon angioplasty with or without stenting. Those in favor of surgery emphasize its long-term patency and durability.¹⁸, ¹⁹, ²⁰ In contrast, advocates of endovascular intervention point to its low periprocedural morbidity and mortality, reduced costs, and shortened hospital stay.²¹ Despite these differing opinions, increasing numbers of endoluminal interventions are being performed in patients afflicted with CLI. Few attempts, however, have been made to examine the consequences of intervention failure. Our analysis demonstrates that failure of endoluminal therapy for treatment of lower extremity arterial occlusive disease is amenable to subsequent endovascular intervention for limb salvage with limited morbidity and mortality and should be considered a potential first-line intervention for high-risk patients or those lacking an autogenous conduit.

In our study, all PTA/S failures were due to restenosis or occlusion at the site of original intervention and none resulted from distal emboliza-tion. On further analysis of these failures, the initial indication for intervention, the presence of diabetes mellitus, and a TASC D lesion were all associated with intervention failure. Other studies have also attempted to correlate procedural characteristics with the outcome of PTA/S. Most recently, Galaria et al.²² found that a TASC D classification and an advanced preprocedural symptom grade were associated with PTA/S failure. In agreement with those and our findings, Cheng et al.²³ and van der Zagg et al.²⁰ also found that treatment of high-grade lesions with angioplasty and stenting resulted in lower long-term patency rates than those achieved with bypass surgery. However, Clark and colleagues,²⁴ looking at a multicenter registry of patients undergoing percutaneous interventions for the treatment of lower extremity ischemia, did not find lesion severity to predict long-term patency or to identify lesions best treated with surgical bypass but did find diabetes to be a significant predictor of long-term success and that a diabetic patient is more than five times more likely than a nondiabetic patient to suffer reocclusion following infrainguinal angioplasty. Moreover, Hewes and colleagues²⁵ reported that patency was adversely affected in patients with diabetes or with more severe lesion grade. Chronic renal failure, lesion length, poor distal runoff, and occlusion have all been shown to adversely affect the success of percutaneous interventions by others but failed to reach significance in our analysis of successful and failed PTA/S.²⁴, ²⁶, ²⁷

In our series, the use of stent-supported angioplasty did not significantly alter the success or failure of the intervention. At our institution, we use selective stenting based on residual stenosis, with stents used more frequently in longer and more complex lesions. Therefore, in this study, patients most probably failed due to the greater severity of their lesions as opposed to the presence of a stent. The prospective multicenter study of Becquemin et al.²⁶ demonstrated similar findings, suggesting that routine stenting is not justified after balloon angioplasty and may be associated with more local vascular complications. Moreover, Becquemin's group, like ours, also found that acute postoperative stent occlusion occurred infrequently and that intrastent hyperplasia was responsible for most late failures. Other randomized controlled trials have supported similar conclusions.²⁸, ²⁹

It has been postulated that percutaneous treatment used as a primary modality in the treatment of limb ischemia may damage the distal vasculature and therefore interfere with or remove conventional bypass grafting as a viable treatment option.¹⁵, ³⁰, ³¹ Of the five patients undergoing conventional surgical bypass following failed PTA/S in this series, one required a major amputation. Failure of an initial percutaneous intervention for CLI did not appear to impair the ability to perform subsequent bypass surgery if the necessity arose, and no patients required a more distal bypass as a result of instrumentation of vessels. This has also been demonstrated by previous investigations.³², ³³, ³⁴, ³⁵

Recently, the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial,³⁶ a multi-center randomized controlled trial, compared the outcome of initial bypass surgery versus PTA/S in patients presenting with severe limb ischemia due to infrainguinal disease. Its primary finding was that in the medium term, the outcomes for both these treatment modalities were similar with respect to amputation-free survival, all-cause mortality, and health-related quality of life. In the short term, bypass surgery was associated with a significantly higher rate of morbidity, greater hospital stay, and greater use of the intensive care unit. In the long term, surgery was associated with a significantly reduced risk of future amputation, death, or both. This study recorded higher immediate failure and 12-month reintervention rates in the angioplasty group; however, morbidity associated with angioplasty was low, hospital stay was short, and there was no suggestion that a clinically failed angioplasty interfered with subsequent surgery if necessary. In our study, of patients failing infrainguinal angioplasty and undergoing any procedure, the mean length of hospital stay was 3.4 days, with two patients requiring intensive care monitoring. This compares favorably with those patients undergoing successful peripheral angioplasty as well as those included in the BASIL trial. The overall periprocedural complication rate in our failed PTA/S cases was 18%, which included hematoma, pseudoaneurysm, and one perioperative myocardial infarction. One death did occur following reintervention, which led to a 30-day mortality of 2.3%. The mortality for the angioplasty group in the BASIL trial within 30 days after first intervention was 7%. When compared to conventional surgical bypass, the low morbidity and mortality seen with percutaneous intervention may validate it as a primary treatment option for CLI in high-risk patients or those lacking an autogenous conduit. However, as demonstrated by the BASIL trial, patients with a longer life expectancy and who are relatively fit may benefit from the improved durability and reduced reintervention rate of surgery more than the decreased morbidity and cost seen with PTA/S.

Limitations to this study include the limited length of follow-up and potential selection bias of referrals for surgical bypass to patients who did not appear to be potential endovascular candidates by preoperative imaging. Additionally, we elected to utilize clinical change of status and limb salvage instead of angiographic follow-up in an attempt to characterize the success of the reconstruction. This may have limited our ability to discern which vessels failed following percutaneous intervention.

In conclusion, our study indicates that high long-term patency can be achieved with PTA/S for CLI. The initial indication for intervention, the presence of diabetes mellitus, and a TASC D lesion are all predictive variables of lower long-term patency. In this limited cohort of patients, an initial failed endoluminal intervention did not appear to adversely affect the ability to perform a subsequent open surgical bypass. These results support the view that failed endoluminal therapy for lower extremity arterial occlusive disease is amenable to subsequent endovascular intervention without significant morbidity and mortality. However, more studies are needed before a policy of primary endoluminal intervention is adopted for all patients with CLI.

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