The current management of isolated degenerative femoral artery aneurysms is too aggressive for their natural history.

BACKGROUND: Previous studies have combined anastomotic, catheter-induced, and atherosclerotic isolated femoral artery aneurysms (FAAs) to achieve adequate numbers for analysis and have recommended repair of asymptomatic FAAs with diameters ≥2.5 cm and all symptomatic FAAs. This study evaluated the contemporary management of isolated FAAs. METHODS: Patients with FAAs were evaluated using a standardized, prospectively maintained database by a research consortium. RESULTS: From 2002 to 2012, 236 FAAs were identified in 182 patients (mean age, 72 years; male-to-female ratio, 16:1) at eight institutions. The mean nonoperative mean diameter was 2.8 ± 0.7 cm, and the operative diameter was 3.3 ± 1.5 cm. FAA location was the common femoral artery in 191, superficial femoral artery (SFA) in 34, and profunda femoris artery in 11. Synchronous aneurysms (mean, 1.7 per patient) occurred in the aorta (n = 113), in the iliac (n = 109), popliteal (n = 86), and hypogastric (n = 56) arteries, and in the contralateral common femoral artery (n = 34), SFA (n = 9), and profunda femoris artery (n = 2). Of the aneurysms repaired, 66% were asymptomatic; other indications for repair were claudication (18%), local pain (8%), nerve compression (3%), rupture (2%), acute thrombosis (1%), and rest pain (0.5%). Acute aneurysm-related complications (rupture, thrombosis, embolus) were associated (P < .05) with FAA diameter >4 cm and intraluminal thrombus, but not location. Mean diameter of asymptomatic aneurysms that developed acute complications was 5.7 ± 1.3 cm for rupture, 4 ± 1.1 cm for thrombosis, and 3.5 cm for embolus. Repair was by interposition or bypass graft in 177 FAAs and by endovascular repair in three SFA aneurysms. Two perioperative deaths, of myocardial infarction and multisystem organ failure, occurred at 30 days. Operative complications included wound infection (6%), seroma (3%), and bleeding (2%). No amputations occurred through 5 years in the operative or nonoperative groups. Survival in operated-on patients was 99% (n = 138) at 3 months, 92% at 1 year, and 81% (n = 20) at 5 years. CONCLUSIONS: This largest study of isolated FAAs demonstrates that (1) acute complications did not occur in FAAs ≤3.5 cm, repair criteria of asymptomatic FAAs should be changed to >3.5 cm, and chronic intraluminal thrombus should reduce the threshold for repair, and that (2) current indications for symptomatic FAA repair result in low morbidity and should remain unchanged.

Anterior thoracolumbar spine exposure: critical review and analysis.

BACKGROUND: Indications for anterior thoracolumbar spine interbody fusion have expanded because of safe and expeditious surgical exposure that can be provided by the approach surgeon. In our practice, previous anterior interbody instrumentation, multiple disc level exposure, patient age, and body habitus are not surgical deterrents despite the potential for increased complications. The arterial and venous complications of anterior spine exposure have been well documented; however, the purpose of this study is to document the incidence of other complications, such as deep vein thrombosis (DVT), lymphedema, seroma/hematoma, wound infection, and hospital readmission and to determine whether outcome is influenced by the factors mentioned above. METHODS: Six hundred seventeen consecutive patients had anterior thoracolumbar spine exposure performed by a single vascular surgeon between January 2007 and June 2012. Office and hospital records were reviewed with institutional review board approval. RESULTS: The mean patient age was 56 years, and 16% were >69 years of age. The mean body mass index (BMI) was 29.27 kg/m(2) (range: 16-53 kg/m(2)); 39% were considered obese, with BMI measurements of >30 kg/m(2). The overwhelming majority of cases were performed for varying grades of spondylolisthesis and/or degenerative disc disease; in 8 cases (1.3%), the indication for disc exposure was diskitis/osteomyelitis. One disc level was exposed in 36% of cases, 2 in 43%, and ≥3 in 21%. Six percent of patients had previous anterior spine exposure, 42% had previous posterior laminectomy and/or diskectomy, and 3% required anterior disc reexposure to remove hardware or an artificial disc. There was 1 major arterial dissection and 3 major venous injuries. Other complications included extensive DVT (2%), debilitating lymphedema (0.5%), wound seroma/hematoma requiring treatment (2%), wound infection (3%), and readmission within 60 days (8%). Multilevel (>2 levels) disc exposure was associated with an increased rate of lymphedema, posterior lumbar wound infection, and hospital readmission (all P values ≤ 0.01; chi-squared analysis). A BMI >30 kg/m(2) was associated with an increased rate of DVT, posterior lumbar wound infection, and hospital readmission (all P values ≤ 0.018; chi-squared analysis). Age >69 years was associated with an increased rate of wound hematoma (P = 0.002; chi-squared analysis). Logistic regression analysis revealed that BMI >30, multilevel disc exposure, and removal of an artificial disc or hardware were all associated with an increased rate of any nonvessel complication (P values < 0.001); however, no specific variable was associated with an increased rate of a major vessel complication, including those cases where the surgical indication was diskitis/osteomyelitis. CONCLUSIONS: The overall incidence of nonvessel injury complications after anterior thoracolumbar spine exposure is low. Redo anterior spine exposure and redo disc exposure cases, including those that require hardware or artificial disc removal, can be performed safely. Multidisc level exposure is, however, associated with an increased incidence of lymphedema, wound infection, and hospital readmission. Patients with BMI >30 kg/m(2) should be approached with caution because there is a significantly increased rate of DVT, wound infection, and hospital readmission.

Immunogenicity and safety of re-exposure to recombinant human thrombin in surgical hemostasis.

BACKGROUND: This Phase 4, open-label study evaluated the immunogenicity and safety of a second exposure to recombinant human thrombin (rThrombin) in adult patients with previous exposure to rThrombin. STUDY DESIGN: Topical rThrombin was applied as a hemostatic aid during a surgical procedure (day 1). Adverse events and clinical laboratory abnormalities were monitored to day 29 (study end). Immunogenicity samples were collected on days 1 and 29. Thirty-one patients were treated at 9 study sites; 30 patients completed the study. RESULTS: Mean age was 59.5 years; 61.3% of patients were male. Study operations types included spinal (n = 23 of 31; 74.2%), arterial reconstruction or peripheral arterial bypass (n = 4; 12.9%), arteriovenous vascular access procedure (n = 3; 9.7%), and other (n = 1; 3.2%). A median of 10 mL rThrombin (1,000 IU/mL; range 5 to 60 mL) was prepared per patient. Median elapsed time since previous rThrombin exposure was 1.3 years (range 19 days to 3.3 years). Recombinant human thrombin was not observed to be immunogenic; no patients (n = 0 of 30, 0%; 95% CI 0.0%, 11.6%) became positive for anti-rThrombin product antibodies at day 29, approximately 1 month after the second exposure to rThrombin. The most commonly reported adverse events were procedural pain (n = 23 of 31, 74.2%), constipation (n = 8, 25.8%), and nausea (n = 8, 25.8%) All adverse events and clinical laboratory abnormalities were considered unrelated to treatment. For the majority of patients, maximal severity of any adverse event was mild or moderate. CONCLUSIONS: The immunogenicity and safety results of this Phase 4 rThrombin trial suggest that patients with known previous exposure may be safely re-exposed to topical rThrombin.

Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin.

BACKGROUND: We evaluated safety and immunogenicity observations pooled from 8 clinical trials of recombinant human thrombin (rThrombin), an active topical hemostatic agent. STUDY DESIGN: Recombinant thrombin was applied with an absorbable gelatin sponge or spray applicator during a surgical procedure (day 1). Adverse events and laboratory parameters were monitored until study end (day 29). Immunogenicity was evaluated after study completion on plasma samples collected at baseline and on day 29. RESULTS: Studies included 583 rThrombin-treated patients (median age, 59 years; 54% men). Surgical procedures included: spinal, 33% of patients; hepatic resection, 14%; peripheral arterial bypass, 23%; arteriovenous graft formation for hemodialysis access, 18%; and skin graft after burn wound excision, 12%. Adverse events reported for >or= 10% patients included incision site pain, procedural pain, nausea, constipation, pyrexia, anemia, insomnia, vomiting, and pruritus. Five of 552 patients developed antibodies to rThrombin (0.9%; 95% CI, 0.3 to 2.1; day 29); antibodies did not neutralize the biologic activity of native human thrombin. At baseline, 12 patients had pre-existing, antibodies recognizing rThrombin (12 of 552; 2.2%; 95% CI, 1.1 to 3.8); these patients had no previous exposure to rThrombin and their antibody titer did not increase >or= 1.0 unit (>or= 10-fold) at day 29. CONCLUSIONS: Results from 8 clinical trials collectively demonstrated that rThrombin is well tolerated in numerous surgical settings when used as a topical adjunct to hemostasis. Adverse events and changes in laboratory parameters were consistent with commonly reported postoperative events. Less than 1% of patients developed antibodies to rThrombin; the antibodies did not neutralize native human thrombin.

A phase 3b, open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis.

BACKGROUND: The immunogenicity and safety of recombinant human thrombin (rThrombin) were evaluated in this phase 3b, open-label, single-group, multisite study of 209 adult vascular and spinal operation patients at high risk for preexisting anti-bovine thrombin product antibodies. STUDY DESIGN: Patients received rThrombin applied as a topical hemostat during a surgical procedure (day 1). Immunogenicity samples were collected at baseline and approximately 1 month after operation (day 29) and were analyzed after study participation. RESULTS: Mean patient age was 61.5 years; median number of previous surgical procedures was 5.0 (range, 1 to 25). Operation types included spinal (n = 89 of 209 [43%]), arterial reconstruction (including peripheral arterial bypass; n = 75 of 209 [36%]), and arteriovenous vascular access procedures (n = 45 of 209 [22%]). All patients had confirmed or highly likely previous bovine thrombin exposure; at baseline, 15.6% of patients (n = 32 of 205) had preexisting anti-bovine thrombin antibodies. Of 200 patients with complete immunogenicity evaluations, 31 had preexisting anti-bovine thrombin antibodies (15.5%), and 4 had preexisting anti-rThrombin product antibodies (2.0%). None of the 200 patients became antibody positive for rThrombin antibodies on day 29 (seroconversion or > or = 10-fold increase in titer). Adverse events and laboratory results were consistent with a surgical population with substantial comorbidities. Patients with preexisting antibodies to bovine thrombin were older (p = 0.04) and had undergone more surgical procedures previously (p < 0.001) than patients without preexisting antibodies. CONCLUSIONS: Results of this study confirm the low immunogenicity of rThrombin and suggest that rThrombin can be used safely as an aid to hemostasis in patients with or without preexisting anti-bovine thrombin antibodies. A sizeable proportion of this vascular and spinal operation patient population (15.6%) had preexisting anti-bovine thrombin antibodies; these patients are at risk for immune responses after reexposure to bovine thrombin.

Duplex ultrasound of the superficial femoral artery is a better screening tool than ankle-brachial index to identify at risk patients with lower extremity atherosclerosis.

OBJECTIVES: The purpose of vascular disease screening is early identification of atherosclerotic disease and the aim of an ankle-brachial index (ABI) is to identify lower extremity (LE) atherosclerosis as a marker for coronary artery disease (CAD). However, early evidence of atherosclerosis may be present in the superficial femoral artery (SFA) with a normal resting ABI. This study was performed to determine if SFA duplex ultrasound (DUS) could detect more patients with LE atherosclerosis than an ABI; be performed in the same or less time as the ABI measurement; and be associated with similar vascular disease markers as the ABI. METHODS: From January through November 2006, 585 patients were screened for peripheral arterial disease. SFA DUS was included in this Institutional Review Board approved program and demographic/ultrasound data were collected prospectively. SFA DUS findings were divided into six categories. Plaque w/o color change or worse and ABI <0.90 or >1.20 were considered to be abnormal. Data were evaluated using decision matrix and logistical regression analysis. RESULTS: Sensitivity and specificity of SFA DUS using the ABI as the benchmark was 100% and 88%, respectively. Sensitivity and specificity of ABI was 17% and 100%, respectively, using DUS as the standard. DUS detected atherosclerotic disease in 143 SFAs (93 patients) in which the ipsilateral ABI was normal, and there were no false negative SFA DUS studies. Multivariate logistic regression analysis demonstrated the following variables to be significantly and independently associated with an abnormal SFA DUS as well as an abnormal ABI: history of claudication, history of myocardial infarction, and an abnormal carotid DUS. Additional variables (current or past smoker and age >55) were also independently associated with an abnormal SFA DUS but not with an abnormal ABI. Mean time to complete bilateral testing was essentially the same for both tests. CONCLUSIONS: SFA DUS is an accurate screening tool and can be utilized in screening protocols in place of the time-honored ABI without prolonging the examination. Traditional vascular disease markers that are found in patients with an abnormal ABI are also associated with an abnormal SFA DUS. SFA DUS identifies more patients with early LE atherosclerosis than does ABI without missing significant popliteal/tibial artery occlusive disease. Finally, an abnormal SFA DUS can be used as an indirect marker to identify more potentially at risk patients with CAD.

Visceral/renal artery debranching for complex thoracoabdominal hybrid procedures via retroperitoneal abdominal aortic exposure: a preliminary report.

Visceral/renal artery debranching can lengthen the distal landing zone in patients with complex thoracoabdominal aortic disease, thus enabling endograft repair. Initial reports of "hybrid" procedures are promising, but they usually describe transperitoneal visceral/renal artery exposure. This clinical series describes four complex thoracoabdominal aortic aneurysm/dissection cases in which the visceral and renal artery debranching procedure was accomplished via a retroperitoneal approach.

Long-term results of 442 consecutive, standardized carotid endarterectomy procedures in standard-risk and high-risk patients.

OBJECTIVES: The objectives of this study were to determine the results of a specific technique in the performance of carotid endarterectomy (CEA) and to compare results using this technique between standard-risk and high-risk patients eligible for Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) and between asymptomatic and symptomatic patients. METHODS: A total of 391 patients underwent 442 consecutive CEA procedures under general anesthesia with the intent to shunt, patch, and perform intraoperative completion duplex ultrasound imaging. Indications included 272 asymptomatic patients (61.5%) with carotid stenoses > or =60% and 170 symptomatic patients (38.5%) with carotid stenosis > or =50%. Data were analyzed to determine the early (< or =30 days) and long-term morbidity and mortality overall in standard-risk and high-risk procedures and in asymptomatic and symptomatic patients. The primary end points were the occurrence of all strokes or death or myocardial infarction (MI) in the first 30 postoperative days (100% follow-up) and the occurrence by life-table analysis of ipsilateral stroke or death or MI (SDMI) out to 93 months (mean, 31.4 months). RESULTS: A total of 441 (99.7%) procedures included shunting, 440 (99.5%) included patching, and 442 (100%) had completion duplex ultrasound imaging. Of these, 235 procedures were standard risk and 207 procedures were high risk. At the 30-day follow-up, there were two ipsilateral central neurologic deficits (1 major stroke, 1 minor stroke), no death, and one MI (0.45% for all strokes or death; 0.68% for all strokes or death or MI). After 30 days of follow-up, an additional 16 strokes (9 ipsilateral, 7 contralateral), eight MIs, and 38 deaths had occurred. No statistically significant difference was found between standard-risk and high-risk groups or between asymptomatic and symptomatic groups for stroke, death, MI, stroke or death, or stroke or death or MI at 30 days or during long-term follow-up at any interval up to 93 months. CONCLUSION: CEA performed with intent to treat using general anesthesia, shunting, patching, and completion duplex scanning results in extremely low 30-day and long-term morbidity and mortality in asymptomatic, symptomatic, standard-risk and high-risk patients. These results are substantially superior to those reported in carotid stenting trials for both carotid stenting and CEA and do not support the contention that there is a high-risk group for CEA.

Medical benefits of a peripheral vascular screening program.

We present preliminary results and analysis of a screening program that has been offered at a community-based hospital since July 2004. The program includes a quick carotid ultrasound study, abdominal aortic ultrasound imaging, and measurement of bilateral ankle/brachial indices (ABI). From July 2004 through January 2006, 1,719 patients were screened, including 1,094 (64%) women and 652 (36%) men. The majority of carotid screens were normal; however, 28.9% (497 patients) had 15-40% stenosis, 1.4% (24 patients) had 40-60% stenosis, and 0.3% (six patients) had >60% stenosis. Sixteen patients (1%) had infrarenal aortic dilation (>3 cm), and an abnormal ABI (<0.90) was detected in at least one limb in 100 patients (5.8%). No procedures resulted from carotid screening; however, two patients underwent urgent repair for 9.3 and 7.5 cm diameter abdominal aortic aneurysms. Abnormal ABI in conjunction with symptoms led to arteriography in three patients, one of whom had iliac stent deployment. This nonselective vascular screening program attracted many new patients into the health-care system. The open/endovascular procedure yield was low, but early disease detection was significant, causing numerous patients to be referred for additional testing and risk factor modification programs. These preliminary data suggest that community-based vascular screening programs play a key role in early vascular disease detection and provide the potential for prevention of disease progression while, at the same time, building sustainable business for hospitals and physicians.