Journal of Vascular Surgery
Volume 37, Issue 1 , Pages 72-78, January 2003

Outcome of catheter-directed thrombolysis for lower extremity arterial bypass occlusion☆☆☆★

Presented at the Fiftieth Annual Meeting of the American Association for Vascular Surgery, Boston, Mass, Jun 9-12, 2002.

Denver, Colo; and Springfield, Ill

From the Sections of Vascular Surgerya and Interventional Radiology,b University of Colorado Health Science Center; the Division of Vascular Surgery, Southern Illinois University School of Medicinec; and The Colorado Prevention Center.d

Received 18 June 2002; accepted 3 September 2002.

Article Outline

Abstract 

Objective: The purpose of this study was to determine the clinical outcome of patients undergoing catheter-directed thrombolysis (CDT) for lower extremity arterial bypass (LEAB) occlusion. Methods: A retrospective review was performed of two university-based practices from 1988 to 2001. All patients with LEAB occlusion (<14 days by history) undergoing CDT as initial treatment were included. Technical success, complications, secondary patency, and limb salvage were examined. Additional analysis examined secondary procedures performed for residual lesions or failed CDT and the number of LEABs that were replaced or that became infected. Results: One hundred four patients (77% male; mean age, 65 years) had 109 LEAB occlusions. CDT restored patency in 77%. Of the 25 LEABs that failed initial CDT, 15 underwent surgical thrombectomy/revision, four were replaced, and six underwent no further interventions. Of the 84 LEABs successfully lysed, 51 had residual lesions that underwent revision with interventional (n = 30) or surgical (n = 15) techniques or both (n = 6). Median hospital stay was 8 days with three periprocedural deaths. One quarter of CDT procedures had bleeding or thrombotic complications or both. The mean follow-up period was 45 months. Secondary patency rates on an intention-to-treat basis (attempted thrombolysis) were 32% and 19% at 1 and 5 years, respectively. After successful CDT, the 1-year secondary patency rate was comparable in LEABs with or without residual lesions (42% versus 45%). Overall, the limb salvage rates were 73% and 55% at 1 and 5 years, respectively. The survival rate was 56% at 5 years. Ten of the 54 LEABs (19%) that eventually failed after successful CDT had three or more reocclusive episodes. Seven LEABs (8.3%) salvaged with CDT eventually became infected from recurrent interventions; six of these necessitated major amputation. Twenty LEABs initially salvaged with CDT were replaced (four immediately and 16 after episodes of recurrent ischemia). Two patients died during hospitalization for treatment of recurrent ischemia. Conclusion: Despite relatively high initial technical success for LEAB thrombolysis, eventual failure is the rule rather than the exception. Recurrent LEAB occlusions lead to significant morbidity, including recurrent interventions, eventual graft infection/replacement, and limb loss. However, LEAB replacement has substantial problems associated with limited conduit, reoperative anatomy, and subsequent wound complications. We therefore advocate an initial attempt at CDT with liberal use of graft replacement for early and late failures or as an initial strategy in those with favorable remaining conduit. (J Vasc Surg 2003;37:72-8.)

 

The management of acute lower extremity arterial bypass (LEAB) occlusion has been the subject of much debate among vascular specialists. Catheter-directed thrombolysis (CDT) offers the potential to open the LEAB and expose a possible underlying lesion and offers treatment with either angioplasty or surgical revision. This strategy has been the subject of many reported clinical series1, 2, 3, 4, 5, 6 and encompasses a subgroup of patients involved in several randomized trials.7, 8, 9, 10, 11 In addition, CDT has been one of the recommended initial treatments for LEAB occlusion in the recently reported TransAtlantic Guidelines.12 Proponents of CDT for LEAB occlusion argue that limited intervention in patients with many comorbidities, limited conduit, and potentially abbreviated survival is prudent. If reocclusion occurs, repeat CDT can be performed, reestablishing patency with minimal morbidity.

Proponents of graft replacement argue that the limited early secondary patency rates of CDT for LEAB occlusion are unacceptable. They propose that poor secondary patency is the result of intrinsically damaged LEABs and that despite correction of underlying lesions, reocclusion remains the rule. These reocclusive events may produce major morbidity and increase limb loss.

Confounding data support both approaches. Patency can be reestablished in most LEAB occlusions with CDT.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 Secondary LEAB patency rates are inferior in patients treated with CDT1, 2, 3, 4, 6 compared with primary patency rates reported in series of replacement LEAB grafting.13, 14, 15 However, repeat LEAB is associated with patient morbidity related to wound healing, limb edema, and need for additional surgery from wound or graft surveillance problems.16 Our review assesses the long-term outcome of CDT for treatment of acute LEAB occlusion.

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Materials and methods 

This study was undertaken because two of the authors, Drs Nehler and McLafferty, trained at an institution performing graft replacement for LEAB occlusion and became vascular faculty at institutions performing CDT for LEAB occlusion. Because of these practice patterns, this review does not have a comparable graft replacement arm but will use series from the surgical literature as controls. With vascular surgery databases at the Denver Veterans Affairs Medical Center and Southern Illinois University in Springfield, Ill, all patients undergoing CDT for acute (≤14 days) LEAB occlusion from January 1, 1988, to December 31, 2001, were identified. Patient records were reviewed for demographic variables including age, gender, and the following risk factors: diabetes, hypertension, coronary artery disease, prior coronary artery bypass surgery, congestive heart failure, and dialysis-dependent renal disease. The number of prior lower extremity vascular interventions and the primary indication for the patient's initial lower extremity revascularization were recorded. The duration of LEAB patency before CDT was recorded.

Technique of CDT was intraarterial within the thrombus and consistent with other reports.9, 11 After pulse spray, urokinase was dosed at 150,000 to 200,000 units per hour. Tissue plasminogen activator was dosed 0.3 mg/kg in 75 mL normal saline solution. This volume was pulsed in 2-mL to 3-mL increments, followed by a 0.05-mg/kg drip. Concomittent heparin drip was frequently used with urokinase but not with tissue plasminogen activator. Data regarding CDT for LEAB occlusions included: LEAB conduit (vein or prosthetic), LEAB anatomic configuration (aortofemoral, extraantomic, femoropopliteal above-knee, femoropopliteal below-knee, or femorotibial), duration of CDT; the number of subsequent follow-up angiographic studies per CDT, duration of CDT, success of CDT at achieving LEAB patency, the presence of any residual LEAB lesions identified after CDT, whether any endovascular procedures were performed for residual lesions, and information regarding any bleeding or thromboembolic complications of CDT.

Information recorded after CDT included: hospital stay, subsequent surgical revascularization procedures performed, 30-day mortality, and major nonfatal morbidity. Long-term data included: secondary graft patency, limb salvage, survival, recurrent graft occlusions, management of recurrent graft occlusions, additional hospitalizations for complications related to CDT, incidence of graft infection, and incidence of graft replacement.

Statistical analysis 

Data were collected from record review and entered into a relational database (Microsoft Access, Redmond, Wash). Continuous variables were summarized as mean ± standard deviation or median and range. Categoric variables were summarized as frequency within each category and percent of population. Kaplan-Meier product-limit estimates were used to summarize the time to secondary graft patency, patient survival, and limb salvage. Log-rank tests and univariate logistic regression models were used to examine the relationship between immediate CDT success or secondary LEAB patency in infrainguinal grafts and days of symptoms, gender, graft anatomy, and conduit.

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Results 

One hundred four patients (mean age, 65 ± 13 years; range, 41 to 90 years) underwent CDT for 109 acute LEAB occlusions. Table I shows patient demographics, risk factors, and pertinent surgical history.

Table I. Demographics and risk factors for 107 patients undergoing CDT for LEAB occlusion
Demographic or risk factor%
Male gender77
Diabetes32
Coronary artery disease54
Prior CABG27
Congestive heart failure10
Hypertension46
Dialysis dependence5
Smokers total (current)89 (48)
Contralateral BKA/AKA12
Two or more prior revascularizations60
Three or more prior revascularizations34
Known first revascularization for claudication40
Limb threat on LEAB occlusion presentation88

CABG, Coronary artery bypass grafting; BKA, below-knee amputation; AKA, above-knee amputation.

The anatomic configuration and conduit distribution of 109 occluded LEABs undergoing CDT are presented in Table II.
Table II. Characteristics of 112 LEAB occlusions undergoing CDT
No. (%)
Suprainguinal14 (13)
Aortic6 (6)
Extraanatomic8 (7)
Infrainguinal95 (87)
Above-knee popliteal22 (20)
Prosthetic19
Autogenous3
Below-knee popliteal30 (27)
Prosthetic6
Autogenous24
Tibial43 (39)
Prosthetic8
Autogenous35
In 98 LEABs, the original date of the surgery could be determined. Median patency of these LEABs before CDT was 10 months, with 67% occluding before 2 years and 37% occluding before 6 months.

One hundred seven of 109 CDT procedures (98%) were completed/abandoned within 48 hours. Median number of angiographic studies during CDT was 2.8 (range, 1 to 5). Urokinase was used in 103 CDT procedures (94%) and tissue plasminogen activator was used in the remainder of CDT procedures. CDT was successful in restoring patency in 84 LEABs (77%). Thirty-three LEABs had no demonstrable lesions after successful CDT, but two needed tibial embolectomy for distal embolization and two others were replaced during the same hospitalization. Fifty-one LEABs had residual lesions after CDT. Table III lists the anatomic location of these lesions.

Table III. Anatomic location of lesions in 51 LEABs after successful CDT
Location of lesionNo. (%)
Inflow10 (20)
Outflow27 (53)
Intragraft4 (8)
Inflow and outflow10 (20)
The following interventions were performed for these lesions: percutaneous transluminal angioplasty (n = 30), percutaneous transluminal angioplasty followed by surgical revision to treat additional or refractory outflow lesions (n = 6), and surgical revision or graft replacement of long segment graft or tibial lesions, including embolectomy of distal emboli (n = 15). Twenty-five LEABs (23%) failed CDT. Fifteen underwent surgical thrombectomy and revision, four were replaced, and six underwent no further revision. Of these, 18 limbs were initially salvaged and seven underwent near-term (within 30 days) major amputation.

The median hospital stay was 8 days (range, 2 to 73 days). Complications are described in Table IV.

Table IV. Complications associated with CDT
ComplicationNo. (%)
Death3 (2.8)
Bleeding14 (13)
Thromboembolic15 (14)
Myocardial infarct4 (4)
Renal failure1 (1)
Compartment syndrome1 (1)
There were three periprocedural deaths (2.7%; two fatal myocardial infarctions and one ruptured thoracic aortic aneurysm). Fourteen patients (14%) had bleeding complications, of which 11 were local access site injuries. All needed transfusion, and seven needed surgical evacuation/repair. Three patients had remote hemorrhage necessitating transfusion (two gastrointestinal and one retroperitoneal). Fifteen patients (13%) had thromboembolic complications: two patients had contralateral limb arterial thromboembolism distal to the site of access necessitating emergent arterial thrombectomy/embolectomy (both having acute occlusion of existing contralateral bypasses with severe ischemia). One arterial dissection was treated with angioplasty/stenting. Twelve cases of ipsilateral distal arterial embolization occurred. Four were treated with pulsed spray CDT and five with emergent arterial embolectomy after CDT pulsed spray failure, and three were treated conservatively. Additional major morbidity included compartment syndrome necessitating fasciotomy in one patient, three nonfatal myocardial infarctions, and acute renal failure in one patient from myoglobinuria. In summary, 2.9% of patients treated with CDT died and 6.7% had major amputation.

The mean follow-up period after CDT was 45 ± 36 months. The secondary graft patency rates (± standard error) on an intention-to-treat analysis were 32% (±4.9%), 25% (±4.7%), and 19% (±4.7%), at 1, 3, and 5 years, respectively (Fig 1).

Median secondary graft patency for successfully lysed LEABs was 6 months. After successful CDT, the 1-year secondary patency rate was similar in LEABs with or without residual lesions (42% versus 45%). The relationships between gender, graft anatomy, conduit, days of symptoms, and immediate success CDT and secondary patency were examined in those patients with infrainguinal grafts (Table V).
Table V. Relationships between gender, graft anatomy, conduit, days of symptoms CDT and initial CDT success and secondary patency in those patients with infrainguinal grafts
VariableImmediate successSecondary graft patency
GenderP = .42P = .69
Graft anatomyP = .73P = .25
ConduitP = .85P = .75
Days of symptomsP = .39
No significant associations were detected between immediate success of CDT and gender, graft anatomy, conduit, and days of symptoms before CDT. Similarly, no significant differences in secondary LEAB patency were identified between genders, graft anatomy, or conduit. Only 39% of patients who underwent CDT had a patent LEAB at 6 months without any periprocedural complications. Finally, no learning curve difference was noted between early (before June 1994) and late (after June 1994) periods for secondary patency (P = .37).

One hundred forty-nine additional hospitalizations were necessary for recurrent lower extremity ischemia or complications during the follow-up period. Twenty-five of the 54 LEABs (46%) that eventually failed after initial successful CDT had two or more reocclusive episodes, and 10 (18%) had three or more reocclusive episodes. Thirty-three additional CDT procedures were performed to manage recurrent LEAB occlusion. Thirty-three operative graft thrombectomies with or without revision were used to manage recurrent LEAB occlusion. Twenty-three additional LEAB surgical revisions were performed to manage graft stenoses uncovered after additional CDT or graft surveillance. Seven of 84 LEABs (8.3%) initially salvaged with CDT eventually became infected (six requiring major amputation). Six of these grafts were prosthetic, all had had multiple occlusions with need for repeat surgery, and most had associated wound complications. Twenty of 84 LEABs (24%) initially salvaged with CDT were eventually replaced (four immediately and 16 after episodes of recurrent ischemia). Two patients died during repeat hospitalizations for recurrent lower extremity ischemia and subsequent complications. Limb salvage rates (± standard error) were 73% (±4.6%), 63% (±5.3%), and 55% (±5.9%) at 1, 3, and 5 years, respectively (Fig 2).

Patient survival rates (± standard error) were 92% (±2.7%), 74% (±4.7%), and 56% (±5.8%) at 1, 3, and 5 years, respectively (Fig 3).

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Discussion 

The management of LEAB occlusion represents a clinical enigma for the modern vascular surgeon. Moreover, this problem will increase in the future because of an aging population and the exponential increase of endovascular technology for infrainguinal occlusive disease. Our experience with CDT for LEAB occlusion yields several observations regarding this patient cohort. Ninety percent of patients had limb salvage indications at the time of LEAB occlusion at a mean age (65 years) that was approximately 5 years younger than typical limb salvage series.16, 17, 18, 19 Perhaps because these were younger patients, at least 40% had their first vascular intervention for claudication. Before CDT, 60% and 34% of these patients had undergone at least two and three prior revascularizations, respectively. Finally, these LEABs had early failure before CDT with 20% constructed of nonautogenous conduit in the infrageniculate position. In general, this is a younger vascular population with an escalation in their vascular disease over time.

The immediate success and durability of CDT for LEAB occlusion in our analysis is similar in our report to previous series and randomized trials.2, 7, 8, 9, 10, 11 Three quarters of the LEABs had patency restored. One quarter had bleeding or thromboembolic complications, and roughly half needed surgical therapy, which shows the technical difficulties of catheter-based interventions in patients with multiple prior revascularizations. Approximately two thirds of LEABs salvaged with CDT had residual lesions. Most of these lesions were managed with endovascular methods. The long-term performance of these salvaged LEABs was disappointing. Secondary patency dropped off markedly by 6 months (40%), with a slower attrition rate up to 5 years (20%). No difference was seen in secondary patency rates for any subgroup examined, which may represent a type II error. Limb salvage rate decreased at a fairly steady rate to approximately 50% at 5 years. The amount of morbidity accrued during the follow-up period was concerning. A large number of reocclusions/interventions occurred, with one in 10 salvaged grafts eventually infected and almost one in four of salvaged grafts eventually replaced.

Our data neither prove nor disprove that surgical therapy for LEAB occlusion is preferable to CDT. There is every reason to speculate that the short-term and long-term morbidity in a population undergoing redo LEAB would be substantial owing to perioperative mortality, reoperations for thrombotic, bleeding, and wound complications for open surgery comparable with complications of CDT.16, 20, 21, 22, 23 Long-term morbidity with regards to wound complications, lower extremity edema, graft surveillance/revision, graft failure/replacement, and modest limb loss over time may have been similar.13, 14, 16, 21, 22, 23 Of note, immediate amputation may play a role in a subset of patients as a result of age, comorbidities, minimal arterial outflow for reconstruction, or marginal function.

Given that therapy alternatives for LEAB occlusion appear relatively dismal, can measures be taken to reduce this disadvantaged population of patients? It appears clear that a subset of patients with initial intervention for claudication will eventually progress to limb threat after revascularization failure. Standard clinical patterns of progression would include: 1) patients with iliac angioplasty/stenting followed by failure or aortofemoral bypass followed by limb occlusions, with an eventual crossfemoral reconstruction necessary18; and 2) patients with an above-knee femoral popliteal bypass with failures eventually resulting in a femorotibial reconstruction.24, 25 Although the actual percentage of these difficult cases created with intervention in the claudication population is unknown, it is clear to every vascular surgeon that once this clinical course had started, misery is the rule rather than the exception. Therefore, one of the clear messages of these data is to proceed with caution when intervening for claudication.

Currently, we individualize the management of LEAB occlusion on the basis of patient age/comorbidities, available conduit, and arterial runoff. Younger patients with prior prosthetic infrainguinal grafts for claudication and available saphenous conduit undergo arteriography with or without CDT to define arterial outflow followed by saphenous vein graft replacement. Older patients or those with compromised or limited autogenous conduits available undergo CDT. If successful, lesions are managed with endovascular methods if possible. Although half of CDT salvaged LEABs will reocclude in 6 to 12 months, half will remain patent. Unfortunately, the number of patients in our series was insufficient to provide reliable subset analyses to determine which patients/grafts/lesions/conduits might perform best. Those patients with early reocclusion after CDT should undergo graft replacement or amputation. This strategy takes advantage of the patients who do well with CDT and minimizes the long-term morbidity of repetitive LEAB occlusions.

Modern LEAB occlusions represent a difficult vascular cohort with frequent multiple revascularization failures. Many of these patients are younger, with initial interventions for claudication, and now face limb-threatening ischemia with significant deterioration in their antecedent vascular anatomy. Although no subsequent course appears ideal and some may conclude the poor secondary patency rates are unacceptable, we believe an initial attempt at CDT in many patients with liberal use of graft replacement for failures or as an initial strategy in those with favorable remaining conduit offers the potential to minimize the long-term morbidity in a population with a poor natural history.

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Discussion 

Dr Frank B. Pomposelli. (Boston, Mass). I have a couple of questions.

Did you attempt to stratify your outcomes according to whether or not the patient had a primary graft or a revised graft?

And how many patients got away cleanly, an intervention, and then had no further complications?

Dr Mark R. Nehler. The stratification regarding whether or not patients had had one graft or if they had two grafts or more, or three or more, was not done. We thought about doing that, but the numbers were small enough that I did not think it was going to make a lot of statistical sense to do so; so, that was not done.

In terms of the patients who got away cleanly without any complications, it would be a minority of patients, and I do not have the exact numbers.

Dr George H. Meier III (Norfolk, Va). We are becoming more interested in thrombolysis day by day as we do more distal bypasses with less and less quality vein.

The real question for you is the subgroup analysis. Is there a subgroup, particularly in the venous set, that would benefit from thrombolysis in terms of prolonging graft patency? Our problem is when you have got a very distal bypass with alternative vein already, then it is very difficult for us to reconstruct that patient with autologous conduit a second time. And so the question for you is, is thrombolysis in those autologous grafts beneficial?

Dr Nehler. We did do the univariate analysis looking at conduit as a potential factor in secondary patency, looking at graft anatomy, so above-knee popliteal versus BK, tibial versus popliteal, and did not see any difference and presented the findings that were not significant. But it may very well be that we do not have enough numbers. When you take 112 grafts and then you start dividing them up, it is not uncommon that what you find is that you just do not have enough numbers to make those analyses. So, it may very well be that there is a subgroup that does well, but we were not able to identify it.

Dr John Mosley (United Kingdom). Whenever we see a paper that deals with thrombolysis, there is always a small number that have had renal failure. And this is presumably because of extensive muscle necrosis. Is there a time limit you have developed between the thrombosis occurring and when you would begin thrombolysis?

Dr Nehler. Not per se. I would have to say that we did the usual sorts of things to examine the patient and tried not to lyse the grafts and limbs that had nonsalvageable muscle. But obviously there are some gray areas and mistakes can be made. We had one case of that in this series, so it was not an overwhelming problem, but certainly in that case we made a mistake.

Dr Kenneth Ouriel (Cleveland, Ohio). I think we need to remember that although the results you have shown us are quite dismal for some subcategories of thrombolysis, there is really no comparator group. When evaluating your results, we tend to compare them with first time infrainguinal reconstruction. And certainly they cannot compete with the excellent results of primary infrainguinal bypass that we have become accustomed to. The important issue, however, is whether your thrombolytic results do, indeed, compete favorably with the less satisfactory results of second and third time redo infrainguinal bypass procedures. Do you have any information in this regard?

Dr Nehler. That is an excellent point, and that is a lot of what we did describe in our discussion. I think the majority of these patients would not be first time bypass candidates, based on the demographics I showed you. It would be more of the papers of what happens when you do a redo bypass in somebody with multiple previous failures. And the numbers are not near as well documented and they are not quite as successful as first time infrainguinal reconstruction. There is going to be a lot of wound complication. There is going to be graft surveillance issues. You are going to have to do alternate conduits. And so by no means are we saying that replacement grafting is going to be far superior to these numbers. This was merely a natural history study of what happens when we do this particular method.

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References 

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☆ Competition of interest: nil.

☆☆ Reprint requests: Mark R. Nehler, MD, Vascular Surgery Section, University of Colorado Health Sciences Center, 4200 E 9th Ave #5521, Denver, CO 80262-0312 (e-mail: Mark.Nehler@uchsc.edu).

★ 0741-5214/2003/$30.00 + 0

PII: S0741-5214(02)75183-5

doi:10.1067/mva.2003.42

Journal of Vascular Surgery
Volume 37, Issue 1 , Pages 72-78, January 2003

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