Aortobiiliac bypass to the distal external iliac artery versus aortobifemoral bypass: a matched cohort study.

Vascular bypass has long been the standard surgical treatment for symptomatic aortoiliac occlusive disease (AIOD). Conventional wisdom has been that aortobifemoral bypass (ABF) be performed for AIOD because of the inevitable progression of iliac atherosclerosis leading to bypass thrombosis. However, ABF is prone to significant groin incision complications such as infection and lymphocele. The purpose of this study was to determine if aortobiiliac bypass (ABI) to the distal external iliac artery performs similarly to ABF in cases in which minimal atherosclerosis is present in the distal iliac arteries. Of patients undergoing aortic reconstruction for symptomatic AIOD between July 1998 and December 2008, 37 were found to have minimal atherosclerosis in the distal external iliac arteries and underwent ABI. These were compared with patients undergoing ABF using a retrospective matched cohort design. The indication for ABI was claudication in 86.5 per cent and critical limb ischemia in 13.5 per cent. There was no difference found in overall bypass patency. The 1-, 3-, and, 5-year patencies were 97, 92, and 79 per cent in the ABI group and 93, 85, and 76 per cent in the ABF group, respectively (P = 0.8). The incidence of groin wound complications in the ABF group was 14.6 per cent. ABI to the distal external iliac artery achieves equivalent graft patencies to ABF without added risk of associated groin wound complications. These data suggest that ABI be preferentially considered to ABF in situations when the very distal external iliac arteries are patent and free of significant atherosclerotic disease.

Contemporary management of diabetic neuropathic foot ulceration: a study of 917 consecutively treated limbs.

BACKGROUND: For patients with diabetic neuropathic foot ulceration, the current treatment paradigm is heavily weighted toward limb revascularization; aligning incentives to perform more surgery and less ulcer management/prevention. Our purpose was to perform an analysis of functional outcomes to assess this current treatment paradigm. STUDY DESIGN: Nine hundred and seventeen neuropathic ulcerated feet in 706 patients with diabetes were analyzed. Four hundred and sixty limbs (50.2%) had concomitant ischemia, 219 of which were revascularized (137 angioplasty and 82 open surgery). Outcomes measured included ulcer healing, survival, limb salvage, amputation-free survival, maintenance of ambulation, and independence. Independent predictors of outcomes were measured using an Extended Cox Model. RESULTS: Overall outcomes (n = 917) were: ulcer healed, n = 250 (27%; mean time to healing 33 weeks); functionally healed, n = 488 (53%; mean time to functional healing 29 weeks); 5-year limb salvage, 68%; survival, 38%; amputation-free survival, 30%; maintenance of ambulation, 64%; and maintenance of independence, 74%. There was little difference in ulcer healing rates for patients with or without ischemia (28.5% versus 26%; p = 0.4). However, ischemia was a significant marker of poor outcomes (nonischemic ulcer, ischemic ulcer revascularized, and ischemic ulcer not revascularized: 5-year limb salvage of 80%, 61%, and 51%; p < 0.001); survival (47%, 37%, and 24%; p = 0.03); amputation-free survival (37%, 28%, and 17%; p < 0.001); maintenance of ambulation (74%, 55%, and 55%; p < 0.001); and maintenance of independence (82%, 72%, and 58%; p = 0.01). Wound healing was an independent predictor of survival and amputation-free survival (survival: hazard ratio = 0.58; 95% CI,0.46-0.73; amputation-free survival: hazard ratio = 0.42; 95% CI, 0.33-0.53). CONCLUSIONS: The current treatment paradigm is associated with relatively poor healing rates and substantial late morbidity and mortality. Although revascularization is effective treatment for ischemia, it is probably overvalued when compared with the potential improvement afforded by better medical foot wound management.

Clinical success using patient-oriented outcome measures after lower extremity bypass and endovascular intervention for ischemic tissue loss.

INTRODUCTION: Successful outcome after lower extremity revascularization is usually measured by physician-oriented terms such as graft patency and amputation-free survival. It has been increasingly appreciated that these criteria do not necessarily translate into success from the prospective of the patient. The purpose of this study, therefore, is to retrospectively examine success after lower extremity revascularization for tissue loss using patient-oriented measures and to include patients who underwent both open surgical bypass and endovascular therapy. METHODS: Between 1998 and 2005, 677 patients (316 endovascular and 361 open surgery) underwent revascularization for ischemic tissue loss. The method of revascularization (endovascular or open surgery) was left to the discretion of the surgeon. Revascularization was considered to be clinically successful if each of the following occurred: reconstruction patency until wound healing, limb salvage for 1 year, maintenance of ambulation for 1 year, and survival for 6 months. The influence of 20 intrinsic patient factors, including type of revascularization (open vs endo) was examined using the chi(2) test. Significant factors in bivariate analysis were included in a logistic regression model to determine independent predictors and probability of failure. RESULTS: Overall clinical success was achieved in 277 (40.9%) patients. Success for open surgical and endovascular cohorts was 44.3% and 37.0%, respectively (P = .06). Type of intervention was not a significant factor in either bivariate or logistic regression analysis. Independent predictors of failure (odds ratio [OR]; 95% confidence interval [CI]) regardless of treatment type included impaired ambulatory status at the time of presentation (OR 3.24; CI 2.14, 4.90), diabetes (OR 1.62; CI 1.14, 2.32), endstage renal disease (ESRD) (OR 1.55; CI 1.07, 2.23), presence of gangrene (OR 2.0; CI 1.42, 2.82), and prior vascular intervention (OR 1.46; CI 1.02, 2.10). Paradoxically, hyperlipidemia (OR 0.70; CI 0.50, 0.98) was a predictor for success. Probability of failure was 35.4% (OR 1.0) if no independent predictors were present and increased with the addition of each adverse predictor. For instance, diabetic patients with impaired ambulatory status and gangrene had an 85.2% (OR 10.5) probability of failure. In the worst case scenario, a diabetic patient with ESRD, impaired ambulatory status, gangrene, and a prior vascular intervention was considered, probability of failure was a dismal 92.8% (OR 23.7). CONCLUSION: Clinical success after lower extremity revascularization for ischemic tissue loss is determined by intrinsic patient factors and not by method of revascularization. These data reiterate that future investigation efforts should be focused less on the method of revascularization and more on identification of patient cohorts at risk for failure regardless of treatment.

Comparison of interventional outcomes according to preoperative indication: a single center analysis of 2,240 limb revascularizations.

BACKGROUND: Outcomes after lower extremity revascularization are usually reported according to the level of peripheral arterial disease (PAD, aortoiliac or infrainguinal) or the method of treatment (open or endovascular surgery). Outcomes stratified by indication, ie, claudication or critical limb ischemia (rest pain and tissue loss), have not been well studied. The purpose of this study was to compare postoperative outcomes according to the preoperative indications. STUDY DESIGN: Outcomes of 2,240 consecutive limb revascularizations in 1,732 patients from January 1998 through December 2005 were stratified and examined according to preoperative indication: claudication (n=999 limbs), ischemic rest pain (n=464 limbs), or tissue loss (n=777 limbs). End points measured included primary and secondary interventional or operative patency, limb salvage, survival, amputation-free survival, maintenance of ambulation, maintenance of independence, and resolution of presenting symptoms. RESULTS: The proportion of medical comorbidities and the severity of disease increased significantly by cohort from claudication to rest pain to tissue loss. With a mean followup of 1,089 days (range 0 to 3,689 days), overall outcomes performance declined consistently according to indication for all end points measured at 5 years (claudication, rest pain, tissue loss, p value): secondary reconstruction patency (93%, 80%, 66%, respectively; p < 0.001), limb salvage (99%, 81%, 68%, respectively; p < 0.001), survival (78%, 46%, 30%, respectively; p < 0.001), amputation-free survival (78%, 42%, 25%, respectively; p < 0.001), maintenance of ambulation (96%, 78%, 68%, respectively; p < 0.001), maintenance of independence (98%, 85%, 75%, respectively; p < 0.001), and resolution of presenting symptoms (79%, 61%, 42%, respectively; p < 0.001). CONCLUSIONS: There is a declining spectrum of outcomes performance from claudication to rest pain to tissue loss. These findings question the accuracy of all previously published data for critical limb ischemia, for which rest pain and tissue loss are usually blended and reported as a single outcomes value.

The reverse J arteriovenous graft configuration for hemodialysis access: rationale, technique, and outcomes.

The long-term survival of patients on hemodialysis is often limited by the exhaustion of vascular access sites. A fundamental principle of vascular access surgery is that the arteriovenous (AV) access be placed as far distally in the arm as possible. This principle enhances the secondary patency of the AV grafts by preserving the proximal veins for AV graft revision and provides venous outflow for a new AV access to be placed more proximally in the extremity. The standard straight and looped AV graft configurations violate this principle by bypassing long segments of vein in the extremity that could be used for AV graft revision or new AV graft placement. We have developed a novel AV graft configuration that preserves venous outflow and enhances the longevity of each AV access site. The purpose of this review is to describe the reverse J AV graft technique and to report our outcomes with the procedure. Between February 2004 and April 2007, 26 AV grafts were placed using the reverse J configuration. Eighteen (69%) AV grafts were placed in the upper arm, 7 (27%) were placed in the forearm, and 1 (4%) was placed in the thigh. Median follow-up was 320 days. The secondary AV graft patency was 90 per cent at 6 months, 84 per cent at 12 months, and 84 per cent at 18 months. Five AV grafts were subsequently revised to a loop configuration. Overall patient survival was 85 per cent at 6 months, 68 per cent at 12 months, and 62 per cent at 18 months. Compared with the standard straight and looped AV graft configurations, the reverse J AV graft configuration preserves the length of venous outflow in the extremity for AV graft revision or new AV graft placement. Therefore, the reverse J configuration enhances the secondary patency of AV graft patency and AV access site longevity.

Contemporary outcomes of iliofemoral bypass grafting for unilateral aortoiliac occlusive disease: a 10-year experience.

Current treatment of complex aortoiliac occlusive disease (AIOD) includes the aortobifemoral bypass or the femoral-femoral bypass. However, because of bilateral groin exposure and associated risks, there is a significant morbidity associated with these procedures. In appropriate patients with unilateral AIOD, the iliofemoral bypass graft (IFBPG) via a lower abdominal retroperitoneal incision can be an acceptable alternative. The purpose of this study is to review the safety and efficacy as well as long-term outcomes of IFBPG in patients with unilateral AIOD. From July 1997 through June 2006, 40 patients (64.3 +/- 11.2-years-old, range 41-89-years-old, 57.5% critical limb ischemia, 70% male, 95% smokers) with unilateral AIOD were treated with IFBPG. Perioperative complications and symptom resolution were measured and Kaplan-Meier life table analysis was used to analyze outcomes of primary and secondary patency, survival, limb salvage, contralateral intervention, and maintenance of ambulation and independent living status. The perioperative complication rate was 12.5 per cent (n = 5) including one patient who developed atrial-fibrillation and one who developed acute renal failure. Both patients experienced resolution of these symptoms before discharge. Other complications included one limb thrombosis and two wound infections. There were no perioperative deaths. Secondary patency was 97.5 per cent and 93.3 per cent at 1 and 5 years. Limb salvage in patients with critical limb ischemia (CLI) was 85.1 per cent and 79.1 per cent at 1 and 5 years. Limb amputation occurred due to infection (n = 2), or failed IFBPG (n = 2). Thirty-one patients (77.5%) experienced symptom resolution including 15 (88.2%) of the patients treated for claudication. Two patients (5%) required contralateral iliac intervention. Patient survival was 97.5 per cent and 64.5 per cent at 1 and 5 years. Greater than 90 per cent of patients maintained their functional independence at 5 years. IFBPG achieved excellent technical and functional outcomes, particularly in patients treated for vasculogenic claudication. This procedure is relatively safe and efficacious in a population of patients with complex unilateral AIOD and can be an acceptable alternative to the aortobifemoral bypass or fem-fem procedure.

Do current outcomes justify more liberal use of revascularization for vasculogenic claudication? A single center experience of 1,000 consecutively treated limbs.

BACKGROUND: The purpose of this study was to reconsider current recommended treatment guidelines for vasculogenic claudication by examining the contemporary results of surgical intervention. STUDY DESIGN: We performed a retrospective review of 1,000 consecutive limbs in 669 patients treated for medically refractory vasculogenic claudication and prospectively followed. Outcomes measured included procedural complication rates, reconstruction patency, limb salvage, maintenance of ambulatory status, maintenance of independent living status, survival, symptom resolution, and symptom recurrence. RESULTS: Of the 1,000 limbs treated, endovascular therapy was used in 64.3% and open surgery in 35.7% of patients; aortoiliac occlusive disease was treated in 70.1% and infrainguinal disease in 29.9% of patients. The overall 30-day periprocedural complication rate was 7.5%, with no notable difference in complication rates when comparing types of treatment or levels of disease. Overall reconstruction primary patency rates were 87.7% and 70.8%; secondary patencies were 97.8% and 93.9%; limb salvage, 100% and 98.8%; and survivals, 95.4% and 76.9%, at 1 and 5 years, respectively. More than 96% of patients maintained independence and ambulatory ability at 5 years. Overall symptom resolution occurred in 78.8%, and symptom recurrence occurred in 18.1% of limbs treated, with slightly higher resolution and recurrence noted in patients treated with endovascular therapy. CONCLUSIONS: Contemporary treatment of vasculogenic claudication is safe, effective, and predominantly endovascular. These data support a more liberal use of revascularization for patients with claudication and suggest that current nonoperative treatment guidelines may be based more on surgical dogma than on achievable outcomes.

Surgical implications of early failed endovascular intervention of the superficial femoral artery.

BACKGROUND: It is generally accepted that failed infrainguinal bypass with prosthetic material significantly compromises arterial run off, which may limit future revascularization. It is well known that the negative consequences of early vein graft thrombosis are limited, but the effect of failed peripheral angioplasty on the distal vasculature is poorly studied. The purpose of this study was to determine whether early failure after superficial femoral artery intervention influences subsequent revascularization options. METHODS: Between July 1, 1998, and June 30, 2006, 276 patients underwent endovascular intervention of the superficial femoral artery. A prospective analysis of angiograms done before the intervention and after early failure (

The mid-thigh loop arteriovenous graft: patient selection, technique, and results.

As patient longevity on hemodialysis has increased, surgeons are increasingly challenged to provide vascular access to patients who have exhausted options for access in the upper extremity. A common operation performed on these patients has been the loop thigh arteriovenous (AV) graft based off the common femoral vessels. However, there are several disadvantages of placing prosthetic grafts in proximity to the groin. Our group has modified the thigh loop AV graft procedure by moving the anastomoses to the mid-superficial femoral artery and vein. The advantage of this location is that it preserves the proximal femoral vessels for graft revision and avoids the node-bearing tissue and overhanging panniculus of the groin. The purpose of this study was to review our technique, patient selection, and experience with the mid-thigh loop AV graft procedure. Between 2001 and 2003, 46 mid-thigh loop AV grafts were placed in 38 patients. Patient hospital, office, and dialysis clinic records were reviewed. The primary and secondary patency for AV grafts in this study by life-table was 40 per cent and 68 per cent at 1 year and 18 per cent and 43 per cent at 2 years. There were 10 infections (21%) requiring graft removal. Four patients underwent subsequent placement of a proximal loop thigh AV graft after mid-thigh graft failure. Patient survival was 86 per cent at 1 year and 82 per cent at 2 years. There were no patient deaths related to thigh graft placement. Our results with the mid-thigh loop AV graft compare favorably with published results for thigh loop AV grafts. The procedure preserves the proximal vasculature, permitting graft revision or subsequent proximal graft placement, and may be associated with fewer infectious complications. The mid-thigh loop AV graft procedure should be considered before placement of a thigh loop AV graft based off the common femoral artery and vein.

Does obesity predict functional outcome in the dysvascular amputee?

Limited information is available concerning the effects of obesity on the functional outcomes of patients requiring major lower limb amputation because of peripheral arterial disease (PAD). The purpose of this study was to examine the predictive ability of body mass index (BMI) to determine functional outcome in the dysvascular amputee. To do this, 434 consecutive patients (mean age, 65.8 +/- 13.3, 59% male, 71.4% diabetic) undergoing major limb amputation (225 below-knee amputation, 27 through-knee amputation, 132 above-knee amputation, and 50 bilateral) as a complication of PAD from January 1998 through May 2004 were analyzed according to preoperative BMI. BMI was classified according to the four-group Center for Disease Control system: underweight, 0 to 18.4 kg/m2; normal, 18.5 to 24.9 kg/m2; overweight, 25 to 29.9 kg/m2; and obese, > or = 30 kg/m2. Outcome parameters measured included prosthetic usage, maintenance of ambulation, survival, and maintenance of independent living status. The chi2 test for association was used to examine prosthesis wear. Kaplan-Meier curves were constructed to assess maintenance of ambulation, survival, and maintenance of independent living status. Multivariate analysis using the multiple logistic regression model and a Cox proportional hazards model were used to predict variables independently associated with prosthetic use and ambulation, survival, and independence, respectively. Overall prosthetic usage and 36-month ambulation, survival, and independent living status for the entire cohort was 48.6 per cent, 42.8 per cent, 48.1 per cent, 72.3 per cent, and for patients with normal BMI was 41.5 per cent, 37.4 per cent, 45.6 per cent, and 69.5 per cent, respectively. There was no statistically significant difference in outcomes for overweight patients (59.2%, 50.7%, 52.5%, and 75%) or obese patients (51.8%, 46.2%, 49.7%, and 75%) when compared with normal patients. Although there were significantly poorer outcomes for underweight patients for the parameters of prosthetic usage when compared with the remaining cohort (25%, P = 0.001) and maintenance of ambulation when compared with overweight patients (20.8%, P = 0.026), multivariate analysis adjusting for medical comorbidities and level of amputation showed that BMI was not a significant independent predictor of failure for any outcome parameter measured. In conclusion, BMI failed to correlate with functional outcome and, specifically, obesity did not predict a poorer prognosis.

Is surgical thrombectomy to salvage failed autogenous arteriovenous fistulae worthwhile?

The Dialysis Outcomes Quality Initiatives guidelines emphasize placement of autogenous arteriovenous (AV) fistulae for patients on hemodialysis. This recommendation is based on studies that demonstrate enhanced patency for AV fistulae compared with grafts. However, closer review of the data demonstrates that although primary patency of AV fistulae is superior to grafts, the secondary patency rates are equivalent. This suggests that secondary procedures to maintain fistula patency are inferior to those performed on arteriovenous grafts. Surgical thrombectomy of AV fistulae can be challenging. It is often difficult to completely remove thrombus adjacent to the anastomosis of the fistula, and pseudoaneurysms within the fistula can prevent passage of the thrombectomy catheter and complete removal of thrombus from the fistula. Consequently, some surgeons simply abandon thrombosed AV fistulae and place a new access. We have developed a method for completely clearing thrombus from failed AV fistulae by locating the fistulotomy close to the arterial anastomosis and using a technique to manually extract thrombus from the fistula before passing a thrombectomy catheter. The purpose of this study was to review our results with this procedure. Between 2001 and 2004, 10 patients with a previously functioning AV fistula presented with thrombosis. There were seven brachiocephalic fistulae and three radiocephalic fistulae. All patients underwent surgical thrombectomy and fistulography. Five patients underwent balloon angioplasty of a venous stenosis and one patient underwent surgical revision of an arterial stenosis. Technical success, defined as being able to completely clear thrombus from the fistula and treat the cause for fistula failure, was achieved in 70 per cent (7/10) of cases. Technical failure was caused by vein rupture during the balloon angioplasty in two cases and a central venous occlusion that could not be treated in one case. The 6-month primary and secondary patency for cases that were technically successful was 51 and 69 per cent, respectively. Our conclusion was that surgical thrombectomy can significantly extend fistula functionality in patients who present with thrombosis.

Postoperative outcomes according to preoperative medical and functional status after infrainguinal revascularization for critical limb ischemia in patients 80 years and older.

The purpose of this study was to provide outcomes after intervention for critical limb ischemia (CLI) in elderly patients (> or =80 years) according to medical and functional status at presentation. From January 1998 to September 2003, 140 limbs/122 patients (age range 80-97 years) were treated (57 patients/66 limbs, infrainguinal bypass; 65 patients/74 limbs, infrainguinal angioplasty) for CLI. At presentation, 71 (58.2%) patients were functionally ambulatory, 41 (33.6%) were homebound ambulators, and 10 (8.2%) were transfer-only ambulators. Overall end points after treatment as well as outcomes according to type of treatment and preoperative medical and functional status were determined. End points included reconstruction patency, limb salvage, survival, amputation-free survival, and maintenance of ambulatory and independent living status. Results for the 140 limbs/122 patients at 3 years (Kaplan-Meier curves) include primary patency, 55.3%; secondary patency, 73.2%; limb salvage, 78.3%; survival, 62.5%; amputation-free survival, 49.7%; maintenance of ambulation, 77.8%; and maintenance of independent living status, 82.9%. There was essentially no difference in outcomes based on type of treatment (endovascular vs open operation). When analyzing 2-year outcomes by functional status (ambulatory vs homebound vs transfer), there was deterioration in outcomes according to declining functional status at presentation for mortality (84.7% vs 66.4% vs 42%; P < 0.001), amputation-free survival (73.3% vs 48.2% vs 36.9%; P < 0.001), limb salvage (86% vs 66.5% vs 71.9%; P = 0.022), and secondary patency (84.3% vs 61.5% vs 69.2%; P = 0.005) regardless of treatment. Homebound ambulators were two times and transfer-only patients five times more likely to experience death (Cox hazard model); diabetics were four times more likely to lose a limb and experience a decline in ambulation and living status. Overall medical and functional status at presentation predicts postoperative functional outcomes. These data support a policy of aggressive vascular intervention in the functional elderly and clinical restraint in the functionally impaired patient with CLI.

Preoperative clinical factors predict postoperative functional outcomes after major lower limb amputation: an analysis of 553 consecutive patients.

BACKGROUND: Despite being a major determinant of functional independence, ambulation after major limb amputation has not been well studied. The purpose, therefore, of this study was to investigate the relationship between a variety of preoperative clinical characteristics and postoperative functional outcomes in order to formulate treatment recommendations for patients requiring major lower limb amputation. METHODS: From January 1998 through December 2003, 627 major limb amputations (37.6% below knee amputations, 4.3% through knee amputations, 34.5% above knee amputations, and 23.6% bilateral amputations) were performed on 553 patients. Their mean age was 63.7 years; 55% were men, 70.2% had diabetes mellitus, and 91.5% had peripheral vascular disease. A retrospective review was performed correlating various preoperative presenting factors such as age at presentation, race, medical comorbidities, preoperative ambulatory status, and preoperative independent living status, with postoperative functional endpoints of prosthetic usage, survival, maintenance of ambulation, and maintenance of independent living status. Kaplan-Meier survival curves were constructed and compared by using the log-rank test. Odds ratios (OR) and hazard ratios (HR) with 95% confidence intervals were constructed by using multiple logistic regressions and Cox proportional hazards models. RESULTS: Statistically significant preoperative factors independently associated with not wearing a prosthesis in order of greatest to least risk were nonambulatory before amputation (OR, 9.5), above knee amputation (OR, 4.4), age > 60 years (OR, 2.7), homebound but ambulatory status (OR, 3.0), presence of dementia (OR, 2.4), end-stage renal disease (OR, 2.3), and coronary artery disease (OR, 2.0). Statistically significant preoperative factors independently associated with death in decreasing order of influence included age > or = 70 years (HR, 3.1), age 60 to 69 (HR, 2.5), and the presence of coronary artery disease (HR, 1.5). Statistically significant preoperative factors independently associated with failure of ambulation in decreasing order of influence included age > or = 70 years (HR, 2.3), age 60 to 69 (HR, 1.6), bilateral amputation (HR, 1.8), and end-stage renal disease (HR, 1.4). Statistically significant preoperative factors independently associated with failure to maintain independent living status in decreasing order of influence included age > or = 70 years (HR, 4.0), age 60 to 69 (HR, 2.7), level of amputation (HR, 1.8), homebound ambulatory status (HR, 1.6), and the presence of dementia (HR, 1.6). CONCLUSIONS: Patients with limited preoperative ambulatory ability, age > or = 70, dementia, end-stage renal disease, and advanced coronary artery disease perform poorly and should probably be grouped with bedridden patients, who traditionally have been best served with a palliative above knee amputation. Conversely, younger healthy patients with below knee amputations achieved functional outcomes similar to what might be expected after successful lower extremity revascularization. Amputation in these instances should probably not be considered a failure of therapy but another treatment option capable of extending functionality and independent living.

Does a standardization tool to direct invasive therapy for symptomatic lower extremity peripheral arterial disease improve outcomes?

OBJECTIVES: While decision analysis and treatment algorithms have repeatedly been shown to improve quality of care in many areas of medicine, no such algorithm has emerged for the invasive management of lower extremity peripheral arterial disease. Using the best available evidence-based outcomes data, our group designed a standardization tool, the Lower Extremity Grading System (LEGS) score, which consistently directs limbs to a specific treatment on the basis of presentation. The purpose of this study was to examine whether use of such a tool improves outcomes by directing treatment of lower extremity peripheral arterial disease. METHODS: Over 18 months (July 2001-December 2002) our group intervened in 673 limbs (angioplasty, open surgery, primary limb amputation) with lower extremity peripheral arterial disease. During this time we developed the LEGS score, and implemented its prospective use for the final 362 limbs. For the purpose of this study, all 673 limbs were retrospectively scored with the LEGS score to determine the LEGS recommended best treatment. Of the 673 limbs, 551 (81.9%) received the same treatment as recommended with LEGS and 122 (18.1%) received treatment contrary to LEGS. Limbs treated contrary to LEGS (cases) were then compared with matched control limbs (treated according to LEGS), with similar angiographic findings, clinical presentation, preoperative functional status, comorbid conditions and operative technical factors. Outcomes measured at 6 months included arterial reconstruction patency, limb salvage, survival, and maintenance of ambulatory status and independent living status. Kaplan-Meier curves were used to assess patency, limb salvage, and survival; associated survival curves were compared with the log-rank test. Functional outcomes were compared with the Fisher exact test. RESULTS: After matching case limbs with control limbs, 9 limbs had no control match. Thus 113 limbs in 100 patients treated contrary to LEGS were compared with 113 limbs in 100 patients treated according to LEGS. Limbs treated contrary to LEGS resulted in significantly inferior outcomes at 6 months for measures of primary patency (57.5% vs 84.3%; P < .001), secondary patency (73.2% vs 96.2%; P < .001), limb salvage (89.7% vs 97.2%; P = .04), and maintenance of ambulatory status (78% vs 92%; P = .02). As an additional finding, 29.6% (92 of 311) of interventions performed before implementation of the algorithm were treated contrary to LEGS, and thus contrary to objectively determined best therapy, compared with 8.3% (30 of 362) after LEGS implementation (P < .001). CONCLUSIONS: Limbs treated according to our standardization tool resulted in better outcomes compared with limbs treated contrary to the algorithm. These data suggest that routine use of an appropriately validated treatment standardization algorithm is capable of improving overall results for invasive treatment of lower extremity peripheral arterial disease.

Invasive treatment of chronic limb ischemia according to the Lower Extremity Grading System (LEGS) score: a 6-month report.

BACKGROUND: The invasive treatment of chronic lower extremity peripheral arterial disease (PAD) has become inconsistent. To standardize treatment at our institution, the Lower Extremity Grading System (LEGS) score was devised, based on arteriographic findings, symptoms, functional status, comorbid conditions, and technical factors. The scoring system was used to direct the invasive treatment approach in patients with lower extremity PAD. The purpose of this study was to prospectively assess outcomes of invasive treatment of lower extremity ischemia as directed by LEGS. METHODS: From March 2002 through December 2002, 332 limbs in 227 patients with indications for intervention were scored and treated according to the LEGS score and followed for 6 months. Of the 227 patients, 66.1% were male; median age was 65 years. Diabetes mellitus was present in 44.9% of patients, claudication in 48.5%, and limb-threatening ischemia in 51.5%. Results of treatment as directed by LEGS were judged with the treatment outcome measures of reconstruction patency, limb salvage, mortality, change in ambulatory status, change in independent living status, and change in the short-form health survey (SF-36). RESULTS: Of 332 limbs, 61.5% with a score of 10 to 19 underwent endovascular therapy; 34% with a score of 0 to 9 underwent open revascularization; and 4.5% with a score greater than 20 underwent primary limb amputation. Interventions for the entire cohort as directed by LEGS resulted in 6-month primary reconstruction patency of 82.4%; secondary reconstruction patency, 92.6%; limb salvage, 90%; survival, 89.1%; maintenance of ambulatory status, 85.6%; maintenance of independent living, 88.4%; and statistically significant improvement in health assessment, regardless of treatment type, as determined with the SF-36. There was no statistically significant variability when comparing results according to treatment (open surgery, 0-9 vs endovascular therapy, 10-19) or smaller score group categories (0-5, 6-9, 10-13, 14-19). CONCLUSIONS: At 6 months, treatment as directed by LEGS score resulted in acceptable outcomes. This project is the first reported prospectively confirmed standardization tool for treatment of lower extremity PAD, and, pending independent confirmation by others, provides a comparative baseline against which other standardization efforts can be measured.

Trends in aortic aneurysm surgical training for general and vascular surgery residents in the era of endovascular abdominal aortic aneurysm repair.

HYPOTHESIS: The emergence of endovascular abdominal aortic aneurysm (AAA) repair may negatively impact the open AAA experience of general surgery residents. METHODS: Prospectively collected data on general and vascular surgery resident training in AAA repair for a 5-year period (1997 to 2001) at a single institution were retrospectively reviewed. Five general surgery residents and one vascular resident completed training yearly. Institutional volume of open and endovascular repair of AAA was also assessed. RESULTS: The cumulative mean general surgical resident experience with open AAA repair fell significantly over a 5-year period; 9.5 +/- 2.5 cases were performed per general surgical resident finishing in 1997, 7.5 +/- 0.3 cases in 1998, 4.6 +/- 0.4 cases in 1999, 4.0 +/- 1.3 cases in 2000, and 4.2 +/- 1.0 cases in 2001 (P =.03). The vascular resident experience with open AAA repair did not change significantly over the 5-year period. However, the active development of an endovascular AAA program increased total AAA exposure of the vascular resident from 26 cases in 1997 to a mean of 70 cases in 2000 and 2001. The institution volume of open nonsuprarenal AAA repairs fell 38% during the 5-year period (P =.33) during a period when endovascular AAA repair increased from 9 (1996) to 55 (2000) cases (P <.001). The complexity of open AAA surgery also increased: 23.3% of open cases (7/30) in 2000 were juxta/pararenal versus 2.9% (1/35) in 1996 (P =.05). CONCLUSION: The introduction of endovascular AAA repair may have negatively impacted general surgical resident training in open AAA repair. The number of open AAA cases declined, and their complexity significantly increased. Many uncomplicated AAAs were managed with endovascular means. At programs with such a paradigm shift in AAA treatment, expectation that general surgery residents gain the proficiency necessary to safely perform AAA repair without additional training may be unrealistic.

Endovascular exclusion of saccular AAAs using "stacked" AneuRx aortic cuffs.

PURPOSE: To show that AneuRx aortic cuffs might be used in a "stacked" configuration to effectively treat saccular abdominal aortic aneurysm (AAA). METHODS: In a recent 1-year period, 147 patients underwent endovascular AAA repair. Of these, 5 (4 men; mean age 61.6 years, range 55-69) had saccular AAAs with a mean diameter of 3.7 +/- 0.2 cm (range 3.0-4.7). AneuRx aortic cuff prostheses (3.75-cm length) were deployed sequentially in these 5 patients via a right femoral approach; the devices were overlapped approximately 1.5 to 2.0 cm until complete exclusion of the aneurysm was achieved. Endograft surveillance was performed using computed tomography at 4 weeks postoperatively and then every 6 months. RESULTS: Successful exclusion of the saccular infrarenal aortic aneurysms was achieved in all 5 patients using 2 or 3 "stacked" stent-graft extensions. Four of the 5 procedures were performed under spinal anesthesia; the average procedural time was 96 +/- 41 minutes. The average hospital length of stay was 1.6 days; no major morbidity or mortality was encountered. There were no early or late endoleaks, aneurysm expansion, or device migration over a follow-up that ranged to 12 months. CONCLUSIONS: Saccular AAA provides ideal anatomy for endovascular repair with a "tube" endograft. "Stacked" aortic cuffs create a customized stent-graft that is not otherwise commercially available.

Aortic neck angulation predicts adverse outcome with endovascular abdominal aortic aneurysm repair.

BACKGROUND: Significant aortic neck angulation may predispose to suboptimal outcome after endovascular abdominal aortic aneurysm (EAAA) repair. However, the definition of "significant" neck angulation and its correlation with adverse outcome are poorly characterized. METHODS: Prospectively collected data on 148 consecutive EAAA repairs performed between December 1995 and January 2001 were supplemented with retrospective review of charts and radiographs. Aortic neck angulation was measured from arteriograms or three-dimensional computed tomography scanning reconstructions. Patients were excluded (n = 24) if radiographs were unavailable for review. Because of a paucity of severe aortic neck angulation in other endograft groups, only patients treated with a modular bifurcated device (Medtronic) (n = 81) were included in the final analysis. Mean time from implantation was 26.6 +/- 9.2 months. RESULTS: The risk of a patient experiencing one or more adverse events was 70%, 54.5%, and 16.6% in those with severe (>or=60 degrees, n = 10), moderate (40 to 59 degrees, n = 11), and mild (<40 degrees, n = 60) aortic neck angulation, respectively (P =.0003). Adverse events included death within 30 days (20% vs 0%, P =.0007), acute conversion to open repair (20% vs 0%, P =.0007), aneurysm expansion (9.1% to 20% vs 1.7%, P =.034), device migration (20% to 30% vs 3.3%, P =.013), and type I endoleak (23.8% vs 8.3%, P =.033), all occurring with significantly greater incidence in patients with moderate or severe aortic neck angulation when compared with those with mild angulation, respectively. Aortic neck length and diameter, age, and medical comorbidities were not significantly different between groups. CONCLUSION: Aortic neck angulation appears to be an important determinant of outcome after EAAA repair. Although patients with mild angulation (<40 degrees) had favorable outcomes in this series, those with moderate (40 to 59 degrees) or severe angulation (>or=60 degrees) had a 54% to 70% risk of one or more adverse events. Importantly, these outcomes occurred in spite of an adequate length (>2 cm) of proximal aortic neck. On the basis of these data, great caution should be exercised in recommending EAAA repair for patients with aortic neck angulation >or=40 degrees.

A decade of decline: an analysis of Medicare reimbursement for vascular surgical procedures.

Despite inflation and a robust economy, standard Medicare reimbursements for vascular surgical procedures have progressively declined. The objective of this analysis was to quantitatively and objectively evaluate the decline of vascular surgical reimbursement over the past decade. In this study, data for the analysis of specific vascular surgical procedures was obtained from the National Center for Health Statistics-National Hospital Discharge Survey (NCHS-NHDS) for all vascular procedures as reported by ICD-9-CM codes. The average Medicare reimbursement for each of the specified procedures for 1990 was compared to that of 2001 and the percent change in average reimbursement over this period was calculated. Comparisons between 1990 and 2001 dollar amounts were made after correction for inflation using the consumer price index. This correction factor allows for the calculation of the actual percentage reduction in "real dollars" that is reflected in buying power. We found significant decreases in Medicare reimbursement for each of the vascular procedures included in this analysis. Despite national economic prosperity, there was an average 41% decrease in the buying power per case for vascular surgical procedures over the past decade. We feel that these reductions in reimbursement are overzealous and need to be reexamined.