Dennis F. Bandyk

Rupture rate of large abdominal aortic aneurysms in patients refusing or unfit for elective repair

CONTEXT Among patients with abdominal aortic aneurysm (AAA) who have high operative risk, repair is usually deferred until the AAA reaches a diameter at which rupture risk is thought to outweigh operative risk, but few data exist on rupture risk of large AAA. OBJECTIVE To determine the incidence of rupture in patients with large AAA. DESIGN AND SETTING Prospective cohort study in 47 Veterans Affairs medical centers. PATIENTS Veterans (n = 198) with AAA of at least 5.5 cm for whom elective AAA repair was not planned because of medical contraindication or patient refusal. Patients were enrolled between April 1995 and April 2000 and followed up through July 2000 (mean, 1.52 years). MAIN OUTCOME MEASURE Incidence of AAA rupture by strata of initial and attained diameter. RESULTS Outcome ascertainment was complete for all patients. There were 112 deaths (57%) and the autopsy rate was 46%. Forty-five patients had probable AAA rupture. The 1-year incidence of probable rupture by initial AAA diameter was 9.4% for AAA of 5.5 to 5.9 cm, 10.2% for AAA of 6.0 to 6.9 cm (19.1% for the subgroup of 6.5-6.9 cm), and 32.5% for AAA of 7.0 cm or more. Much of the increased risk of rupture associated with initial AAA diameters of 6.5-7.9 cm was related to the likelihood that the AAA diameter would reach 8.0 cm during follow-up, after which 25.7% ruptured within 6 months. CONCLUSION The rupture rate is substantial in high-operative-risk patients with AAA of at least 5.5 cm in diameter and increases with larger diameter.

Monitoring functional patency of in situ saphenous vein bypasses: The impact of a surveillance protocol and elective revision

Implementation of a protocol that monitored in situ saphenous vein bypass hemodynamics for low-flow states provided insight into the pathophysiologic characteristics and time course of graft failure. From 1981 to 1988, 250 in situ bypasses to popliteal (n = 83) or tibial (n = 167) arteries were performed in 231 patients. Indications for operation included critical limb ischemia in 232 cases (93%), popliteal aneurysm in 11 cases (4%), and disabling claudication in seven cases (3%). Arterial pressure measurements, continuous-wave Doppler spectral analysis, and duplex ultrasonography were used to assess patency, detect hemodynamic changes indicative of graft stenosis, and localize anatomic hemodynamic changes indicative of graft stenosis. Seventy grafts with correctable anatomic lesions (retained venous valves, graft stenosis, arteriovenous fistula, native vessel atherosclerosis) that decreased graft blood flow or ankle arterial pressure or both were identified. Correction of vein conduit or anastomotic lesions comprised 73 (77%) of the 95 revisions performed. Vein-patch angioplasty of a stenosis was the most common secondary operation performed. Graft revision was highest in the perioperative period (10% at 30 days), decreased to 7% per 6-month interval until 18 months, and was 3% per year thereafter. The primary patency rate of grafts not identified to have a correctable lesion was 86% at 4 years, a level similar to the secondary patency of 81% for grafts requiring one or multiple revisions. The surveillance protocol identified grafts with correctable lesions before thrombosis thereby permitting elective revision of patent grafts. Hemodynamic studies confirmed that a frequent mechanism of late failure of grafts was the development of a low-flow state produced by lesions not amenable to revision.

Experience with in situ saphenous vein bypasses during 1981 to 1989: Determinant factors of long-term patency

From 1981 to 1989, 361 consecutive in situ saphenous vein bypasses were performed. Indications for revascularization were critical limb ischemia (n = 335, 93%), popliteal aneurysm (n = 15, 4%), and claudication (n = 11, 3%). Outflow tract was the popliteal artery in 116 (32%) and tibial artery in 245 (68%) of bypasses. At 6 years primary patency was 63% and secondary patency was 81%. During the performance of the in situ bypass procedure, 86 (24%) venous conduits were modified because of a technical failure (n = 49, 13%) or an inadequate vein segment (n = 37, 10%). Secondary patency at 4 years for bypasses requiring modification was 72% compared to 84% for bypasses not modified (p less than 0.05). Atherosclerotic disease of the inflow artery necessitating endarterectomy, patch angioplasty, or replacement lowered primary patency at 3 years (69%) compared to the inflow artery not requiring reconstruction (46%, p less than 0.02). In the follow-up period, 95 (26%) bypasses were revised because of thrombosis or hemodynamic failure. Bypasses requiring revision had a 4-year secondary patency of 68% compared to 88% for bypasses not revised (p less than 0.02). The first 179 cases (1981 to 1985) were compared to the subsequent 182 cases (1986 to 1989). The secondary patency at 3 years for the latter half (92%) compared to the first half (80%) of the experience was significantly improved (p less than 0.02). The secondary patency for bypasses not requiring revision was significantly improved (p less than 0.02) for the latter half (n = 142, 97%) compared to the first half (n = 124, 83%) of the series. Long-term patency with the in situ saphenous vein bypass is dependent on surgical experience, quality of the venous conduit, and atherosclerotic disease of the inflow artery that necessitates reconstruction. Meticulous surgical technique and compulsive bypass surveillance results in superior long-term patency.

Relationship of age, gender, race, and body size to infrarenal aortic diameter

PURPOSE To assess the effects of age, gender, race, and body size on infrarenal aortic diameter (IAD) and to determine expected values for IAD on the basis of these factors. METHODS Veterans aged 50 to 79 years at 15 Department of Veterans Affairs medical centers were invited to undergo ultrasound measurement of IAD and complete a pre-screening questionnaire. We report here on 69,905 subjects who had no previous history of abdominal aortic aneurysm (AAA) and no ultrasound evidence of AAA (defined as IAD > or = 3.0 cm). RESULTS Although age, gender, black race, height, weight, body mass index, and body surface area were associated with IAD by multivariate linear regression (all p < 0.001), the effects were small. Female sex was associated with a 0.14 cm reduction in IAD and black race with a 0.01 cm increase in IAD. A 0.1 cm change in IAD was associated with large changes in the independent variables: 29 years in age, 19 cm or 40 cm in height, 35 kg in weight, 11 kg/m2 in body mass index, and 0.35 m2 in body surface area. Nearly all height-weight groups were within 0.1 cm of the gender means, and the unadjusted gender means differed by only 0.23 cm. The variation among medical centers had more influence on IAD than did the combination of age, gender, race, and body size. CONCLUSIONS Age, gender, race, and body size have statistically significant but small effects on IAD. Use of these parameters to define AAA may not offer sufficient advantage over simpler definitions (such as an IAD > or = 3.0 cm) to be warranted.

Failure of foot salvage in patients with end-stage renal disease after surgical revascularization ☆ ☆☆

PURPOSE This report ascertained factors responsible for for failure of foot salvage in patients with end-stage renal disease (ESRD) after undergoing infrainguinal bypass for critical ischemia. METHODS A retrospective review of 69 distal arterial reconstructions performed in 53 patients with ESRD (hemodialysis [n = 37], kidney transplantation [n = 10], peritoneal dialysis [n = 6]) for foot gangrene (n = 28), nonhealing ulcer (n = 25), or ischemic rest pain (n = 16) was conducted. Endpoints of surgical morbidity, limb loss, and graft patency were correlated with extent of preoperative tissue loss and presence of diabetes mellitus. RESULTS The 30-day operative mortality rate was 10%, and the patient survival rate at 2 years was 38%. The primary graft patency rate was 96% at 30 days, 72% at 1 year, and 68% at 2 years. Eleven of 22 foot amputations performed during the mean follow-up period of 14 months (range 3 to 96 months) occurred within 2 months of revascularization. Mechanisms responsible for limb loss included graft failure (n = 9), foot ischemia despite a patent bypass (n = 8), and uncontrolled infection (n = 5). Overall, 59% of amputations were performed in limbs with a patent bypass to popliteal or tibial arteries. Healing of forefoot amputations was prolonged, but all limb loss beyond 9 months of revascularization was due to graft failure. The limb salvage rate at 1 year decreased (p = 0.13) from 74% to 51% in patients admitted with gangrene. Only two of seven patients admitted with forefoot gangrene experienced foot salvage. CONCLUSION Failure of foot salvage in patients with ESRD and critical ischemia was due to wound healing problems rather than graft thrombosis. Earlier referral for revascularization, before development of extensive tissue ischemia and infection, is recommended. Primary amputation should be considered in patients admitted with forefoot gangrene, particularly if it is complicated by infection.

Durability of the in situ saphenous vein arterial bypass: A comparison of primary and secondary patency *

The use of the saphenous vein in situ is associated with unique problems that decrease primary graft patency (patency uninterrupted by revision). During the past 5 years, we have performed 192 in situ saphenous vein bypasses in 182 patients, including 61 to the popliteal artery, 128 to infrapopliteal arteries, and three to isolated popliteal artery segments. The operative indications were critical limb ischemia in 178 cases (93%), popliteal aneurysm in eight cases (4%), and disabling claudication in six cases (3%). A progressive decline in primary patency occurred after operation. The primary patency rate at 36 months was only 48% for femoropopliteal bypasses and was 58% for femorotibial bypasses. In contrast, the secondary patency rate (patency maintained by thrombectomy, thrombolysis, or revision) at 36 months was 89% and 80% for femoropopliteal and femorotibial bypasses, respectively. The improved secondary patency was due to postoperative surveillance of graft hemodynamics and the success of graft revision. Problems unique to the in situ technique (incomplete valve incision, residual arteriovenous fistula, graft torsion and entrapment) accounted for 58% of early (less than 30 days) graft revisions and 52% of late revisions. The use of Doppler spectral analysis at operation and duplex scanning after operation can locate unsuspected technical errors and identify grafts with low flow at increased risk for failure. The primary patency of the in situ bypass mandates objective assessment of valve incision sites at operation and a protocol of postoperative surveillance to identify grafts that require revision. Early surgical intervention of hemodynamically abnormal but patent in situ bypasses is rewarded by excellent secondary patency.

Bacterial adherence to vascular prostheses: A determinant of graft infectivity

An in vitro model was developed to quantitatively measure bacterial adherence to the surface of prosthetic vascular graft material. Four strains of bacteria (Staphylococcus aureus, nonmucin-producing S. epidermidis [SP-2], mucin-producing S. epidermidis [RP-12], and Escherichia coli) were used to inoculate expanded polytetrafluoroethylene (ePTFE), woven Dacron, and velour knitted Dacron graft material. After graft specimens were incubated in a 10(7) suspension of bacteria, they were washed to remove nonadherent organisms and ultrasonically oscillated to dislodge adherent organisms. Quantitative culture of the sonication effluent was used to calculate bacterial adherence, expressed as the number of colony-forming units found in each square centimeter of graft material per 10(7) inoculum. All bacterial strains had a greater affinity to velour knitted Dacron graft than to ePTFE (p less than 0.025). E. coli and S. aureus adhered to velour knitted Dacron in greater numbers than to woven Dacron (p less than 0.04). The production of extracellular polysaccharide (mucin) by the RP-12 strain significantly increased adherence to both EPTFE and Dacron grafts compared with the other three bacterial strains tested (p less than 0.04). Although E. coli was less adherent to ePTFE than nonmucin-producing staphylococcal strains (S. aureus and SP-2), no difference in adherence to knitted or woven Dacron graft material was demonstrated. The differential adherence of bacteria to prosthetic vascular grafts pays an important role in the pathogenesis of graft sepsis and determines relative graft infectivity. The in vitro model developed is well suited for further study of the mechanisms by which bacteria adhere to and colonize vascular grafts.

Disparity in outcomes of surgical revascularization for limb salvage: Race and gender are synergistic determinants of vein graft failure and limb loss

Background— Vein bypass surgery is an effective therapy for atherosclerotic occlusive disease in the coronary and peripheral circulations; however, long-term results are limited by progressive attrition of graft patency. Failure of vein bypass grafts in patients with critical limb ischemia results in morbidity, limb loss, and additional resource use. Although technical factors are known to be critical to the success of surgical revascularization, patient-specific risk factors are not well defined. In particular, the relationship of race/ethnicity and gender to the outcomes of peripheral bypass surgery has been controversial. Methods and Results— We analyzed the Project of Ex Vivo Vein Graft Engineering via Transfection III (PREVENT III) randomized trial database, which included 1404 lower extremity vein graft operations performed exclusively for critical limb ischemia at 83 North American centers. Trial design included intensive ultrasound surveillance of the bypass graft and clinical follow-up to 1 year. Multivariable modeling (Cox proportional hazards and propensity score) was used to examine the relationships of demographic variables to clinical end points, including perioperative (30-day) events and 1-year outcomes (vein graft patency, limb salvage, and patient survival). Final propensity score models adjusted for 16 covariates (including type of institution, technical factors, selected comorbidities, and adjunctive medications) to examine the associations between race, gender, and outcomes. Among the 249 black patients enrolled in PREVENT III, 118 were women and 131 were men. Black men were at increased risk for early graft failure (hazard ratio [HR], 2.832 for 30-day failure; 95% confidence interval [CI], 1.393 to 5.759; P=0.0004), even when the analysis was restricted to exclude high-risk venous conduits. Black patients experienced reduced secondary patency (HR, 1.49; 95% CI, 1.08 to 2.06; P=0.016) and limb salvage (HR, 2.02; 95% CI, 1.27 to 3.20; P=0.003) at 1 year. Propensity score models demonstrate that black women were the most disadvantaged, with an increased risk for loss of graft patency (HR, 2.02 for secondary patency; 95% CI, 1.27 to 3.20; P=0.003) and major amputation (HR, 2.38; 95% CI, 1.18 to 4.83; P=0.016) at 1 year. Perioperative mortality and 1-year mortality were similar across race/gender groups. Conclusions— Black race and female gender are risk factors for adverse outcomes after vein bypass surgery for limb salvage. Graft failure and limb loss are more common events in black patients, with black women being a particularly high-risk group. These data suggest the possibility of an altered biological response to vein grafting in this population; however, further studies are needed to determine the mechanisms underlying these observed disparities in outcome.

The origin of infrainguinal vein graft stenosis: A prospective study based on duplex surveillance ☆ ☆☆

PURPOSE The purpose of this study was to determine the origin of vein graft lesions and their propensity for progression based on prospective duplex surveillance of 135 infrainguinal vein bypasses. METHODS One hundred sixteen greater saphenous, 13 spliced, five cephalic, and one superficial femoral vein grafts were evaluated by color duplex imaging at surgical procedure, 1 and 6 weeks, 3 and 6 months, and every 3 to 6 months thereafter. Duplex-identified lesions were graded by peak systolic velocity and velocity ratio criteria and were either followed or subjected to revision. RESULTS Early postoperative duplex surveillance allowed stratification of infrainguinal grafts into two subsets. Of 91 (67%) grafts with normal early scans (at 3 months), only two (2.2%) developed de novo stenoses (at 6 and 8 months) that required revision. Forty-four grafts with abnormal duplex scans had a focal flow abnormality (peak systolic velocity > 150 cm/sec, velocity ratio > 1.5) in the graft body (n = 24) or anastomotic region (n = 20). In 14 grafts the flow abnormality (mean peak systolic velocity = 217 cm/sec, velocity ratio = 2.3) normalized. Ten additional grafts exhibited a moderate, persistent graft stenosis (mean peak systolic velocity 248 cm/sec, velocity ratio = 3.3) that was not repaired. All 20 grafts with lesions that progressed to high-grade stenosis (mean peak systolic velocity = 362 cm/sec, velocity ratio = 7.2) and were revised had a residual flow abnormality confirmed at operation, or it appeared by 6 weeks. In the entire series six (4.4%) grafts failed during the mean 12-month follow-up interval (range 3 to 30 months), 4 with unrepaired defects and two after revision. CONCLUSIONS Prospective duplex surveillance verified that de novo graft stenosis was uncommon (< 2.2%) after reversed and in situ saphenous vein bypass grafting. Graft stenoses developed at sites of unrepaired defects or early appearing conduit abnormalities. An early appearing duplex focal flow abnormality warranted careful surveillance, because one half of such sites progressed to a high-grade stenosis. Grafts with normal early duplex scans exhibited a low incidence of stenosis development or occlusion, and thus less intense postoperative surveillance can be recommended.

In situ replacement of vascular prostheses infected by bacterial biofilms

Late prosthetic graft infections are commonly the result of coagulase-negative staphylococci that survive within a biofilm on prosthetic surfaces and provoke perigraft inflammation. The indolent nature and microbiologic characteristics of bacterial biofilm infections coupled with the morbidity of graft excision and extraanatomic bypass grafting prompted us to use in situ graft replacement in 15 patients admitted to the hospital with 17 infected graft segments at a mean (+/- SEM) time interval of 70 +/- 16 months after graft implantation (n = 6) or revision (n = 9). Since 1986, 17 grafts (14 aortofemoral, 2 axillofemoral, and 1 femoropopliteal) infected by bacterial biofilms have been treated. Signs on admission included femoral pseudoaneurysm (n = 7), perigraft abscess (n = 6), or graft-cutaneous sinus tract (n = 4). No patient exhibited septicemia. At operation graft incorporation was absent and Grams stain of perigraft exudate showed polymorphonuclear leukocytes but no bacteria. Culture of explanted graft material isolated coagulase-negative staphylococci (n = 12), Staphylococcus aureus (n = 1), and no growth (n = 2). All patients were successfully treated by a regimen that included parenteral antibiotics, removal of involved graft material, excision of inflamed perigraft tissue, and in situ replacement with an expanded polytetrafluoroethylene prosthesis. No deaths, graft thromboses, or deep wound infections occurred after operation. Recurrent graft infection did not develop during a follow-up interval that ranged from 5 to 50 months (mean, 21 months). Diagnosis of vascular prosthesis infection caused by bacterial biofilms can be based on signs at admission and operative findings. Complications of this perigraft infection can be eradicated by antibiotic administration, local debridement, and in situ graft replacement.