Comparative Effectiveness of Carotid Artery Stenting Versus Carotid Endarterectomy Among Medicare Beneficiaries.

BACKGROUND: Effectiveness of carotid artery stenting (CAS) relative to carotid endarterectomy (CEA) among Medicare patients has not been established. We compared effectiveness of CAS versus CEA among Medicare beneficiaries. METHODS AND RESULTS: We linked Medicare data (2000-2009) to the Society for Vascular Surgery's Vascular Registry (2005-2008) and the National Cardiovascular Data Registry's (NCDR) Carotid Artery Revascularization and Endarterectomy Registry (2006-2008/2009). Medicare patients were followed up from procedure date until death, stroke/transient ischemic attack, periprocedural myocardial infarction, or a composite end point for these outcomes. We derived high-dimensional propensity scores using registry and Medicare data to control for patient factors and adjusted for provider factors in a Cox regression model comparing CAS with CEA. Among 5254 Society for Vascular Surgery's Vascular Registry (1999 CAS; 3255 CEA) and 4055 Carotid Artery Revascularization and Endarterectomy Registry (2824 CAS; 1231 CEA) Medicare patients, CAS patients had a higher comorbidity burden and were more likely to be at high surgical risk (Society for Vascular Surgery's Vascular Registry: 96.7% versus 44.5%; Carotid Artery Revascularization and Endarterectomy Registry: 71.3% versus 44.7%). Unadjusted outcome risks were higher for CAS. Mortality risks remained elevated for CAS after adjusting for patient-level factors (hazard ratio, 1.24; 95% confidence interval, 1.06-1.46). After further adjustment for provider factors, differences between CAS and CEA were attenuated or no longer present (hazard ratio for mortality, 1.13; 95% confidence interval, 0.94-1.37). Performance was comparable across subgroups defined by sex and degree of carotid stenosis, but there was a nonsignificant trend suggesting a higher risk of adverse outcomes in older (>80) and symptomatic patients undergoing CAS. CONCLUSIONS: Outcomes after CAS and CEA among Medicare beneficiaries were comparable after adjusting for both patient- and provider-level factors.

Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease.

BACKGROUND: The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis. METHODS: In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention. RESULTS: The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention. CONCLUSIONS: Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).

Percutaneous Large Arterial Access Closure Techniques.

Endovascular repair has replaced open surgical repair as the standard of care for treatment of abdominal and thoracic aortic aneurysms in appropriately selected patients owing to its decreased morbidity and length of stay and excellent clinical outcomes. Similarly, there is a progressive trend toward total percutaneous repair of the femoral artery using percutaneous suture-mediated closure devices over open surgical repair due to decreased complications and procedure time. This article describes the techniques of closure for large-bore vascular access most commonly used in endovascular treatment of abdominal and thoracic aortic aneurysms, but could similarly be applied to any procedure requiring large-bore arterial access, such as transcatheter aortic valve replacement.

The Effect of Realtime Monitoring on Dose Exposure to Staff Within an Interventional Radiology Setting.

PURPOSE: The purpose of this study is to evaluate a new device providing real-time monitoring on radiation exposure during fluoroscopy procedures intending to reduce radiation in an interventional radiology setting. MATERIALS AND METHODS: In one interventional suite, a new system providing a real-time radiation dose display and five individual wireless dosimeters were installed. The five dosimeters were worn by the attending, fellow, nurse, technician, and anesthesiologist for every procedure taking place in that suite. During the first 6-week interval the dose display was off (closed phase) and activated thereafter, for a 6-week learning phase (learning phase) and a 10-week open phase (open phase). During these phases, the staff dose and the individual dose for each procedure were recorded from the wireless dosimeter and correlated with the fluoroscopy time. Further subanalysis for dose exposure included diagnostic versus interventional as well as short (<10 min) versus long (>10 min) procedures. RESULTS: A total of 252 procedures were performed (n = 88 closed phase, n = 50 learning phase, n = 114 open phase). The overall mean staff dose per fluoroscopic minute was 42.79 versus 19.81 µSv/min (p < 0.05) comparing the closed and open phase. Thereby, anesthesiologists were the only individuals attaining a significant dose reduction during open phase 16.9 versus 8.86 µSv/min (p < 0.05). Furthermore, a significant reduction of total staff dose was observed for short 51 % and interventional procedures 45 % (p < 0.05, for both). CONCLUSION: A real-time qualitative display of radiation exposure may reduce team radiation dose. The process may take a few weeks during the learning phase but appears sustained, thereafter.

Evaluation of novel disposable, light-weight radiation protection devices in an interventional radiology setting: a randomized controlled trial.

OBJECTIVE: Radiation exposure to interventionalists is increasing. The currently available standard radiation protection devices are heavy and do not protect the head of the operator. The aim of this study was to evaluate the effectiveness and comfort of caps and thyroid collars made of a disposable, light-weight, lead-free material (XPF) for occupational radiation protection in a clinical setting. SUBJECTS AND METHODS: Up to two interventional operators were randomized to wear a XPF or standard 0.5-mm lead-equivalent thyroid collars in 60 consecutive endovascular procedures requiring fluoroscopy. Simultaneously a XPF cap was worn by all operators. Radiation doses were measured using dosimeters placed outside and underneath the caps and thyroid collars. Wearing comfort was assessed at the end of each procedure on a visual analog scale (0-100 [100 = optimal]). RESULTS: Patient and procedure data did not differ between the XPF and standard protection groups. The cumulative radiation dose measured outside the cap was 15,700 µSv and outside the thyroid collars 21,240 µSv. Measured radiation attenuation provided by the XPF caps (n = 70), XPF thyroid collars (n = 40), and standard thyroid collars (n = 38) was 85.4% ± 25.6%, 79.7% ± 25.8% and 71.9% ± 34.2%, respectively (mean difference XPF vs standard thyroid collars, 7.8% [95% CI, -5.9% to 21.6%]; p = 0.258). The median XPF cap weight was 144 g (interquartile range, 128-170 g), and the XPF thyroid collars were 27% lighter than the standard thyroid collars (p < 0.0001). Operators rated the comfort of all devices as high (mean scores for XPF caps and XPF thyroid collars 83.4 ± 12.7 (SD) and 88.5 ± 14.6, respectively; mean scores for standard thyroid collars 89.6 ± 9.9) (p = 0.648). CONCLUSION: Light-weight disposable caps and thyroid collars made of XPF were assessed as being comfortable to wear, and they provide radiation protection similar to that of standard 0.5-mm lead-equivalent thyroid collars.

Direct percutaneous sac injection for postoperative endoleak treatment after endovascular aortic aneurysm repair.

BACKGROUND: This study presents the short-term and midterm results of direct percutaneous sac injection (DPSI) for postoperative endoleak treatment after endovascular aortic aneurysm repair (EVAR). METHODS: Between March 1994 and November 2011, EVAR was performed in 986 patients. The median follow-up was 63 ± 45 months (range, 0-211 months). A retrospective analysis was performed. DPSI was used in 21 patients for 19 type II endoleaks and two endoleaks of undefined origin (EOUO), of which 12 (57%) were after failure of a previous endovascular treatment attempt. RESULTS: DPSI using thrombin (n = 16), coils (n = 7), gelfoam (n = 6), or glue (n = 3), or a combination, was technically feasible in all patients. Saccography during DPSI revealed a previously undetected type I endoleak in three patients. Immediate DPSI success was achieved in 16 of 18 procedures (88.9%), with two complications. Glue incidentally intravasated in the inferior vena cava, causing a clinically nonsignificant subsegmental pulmonary artery embolism in one patient, and the temporary development of a type III endoleak, possibly from graft puncture, in another. During a median follow-up of 39 months (interquartile range, 13-88 months) after DPSI, recurrent endoleaks were observed in nine patients (50.0%), one type I endoleak due to graft migration, five type II endoleaks, and three EOUO. The occurrence of a re-endoleak during follow-up was significantly associated with dual-antiplatelet medication (0% in patients without re-endoleak vs 44.4% in patients with re-endoleak; P = .023) and with a nonsignificant trend for the use of aspirin alone (33.3% in patients without re-endoleak vs 80% in patients with re-endoleak; P = .094). Re-endoleak occurred in 33.3% of the patients without antiplatelet medication and in 100% of patients with dual-antiplatelet medication (P = .026). Thrombin was used as the sole embolic agent during the initial DPSI in all patients with dual-antiplatelet therapy. No other factor was significantly associated with re-endoleaks. Reintervention was deemed necessary in six patients within a median of 10 months (interquartile range, 4-16 months) after DPSI, including six additional DPSI treatments in four patients with type II re-endoleaks, cuff placements in one type I endoleak, and endograft relining in one EOUO. CONCLUSIONS: This initial experience suggests that DPSI is feasible as a technique for endoleak treatment after EVAR. However, complications and endoleak recurrence remain a concern. The role of antiplatelet therapy and different embolic agents on long-term embolization success needs to be studied in more detail.

Transapical endovascular aortic repair to treat complex aortic pathologies.

Clinical condition, hostile anatomy, and previous heart/aortic surgery may preclude standard open surgery and standard endovascular interventions in patients with complex aortic pathologies. We report our initial experience using the transapical endovascular approach to treat a type IA endoleak after transfemoral endovascular graft repair for a contained rupture of a penetrating descending aortic ulcer; an ascending aortic anastomotic pseudoaneurysm after open surgical repair of an ascending aortic dissection; and a type A aortic dissection after minimally invasive mitral valve repair. There were no neurologic or cardiovascular complications, and the 30-day mortality was 0%.

Retrievable inferior vena cava filters: factors that affect retrieval success.

PURPOSE: To report and analyze the indications, procedural success, and complications of retrievable inferior vena cava filters (rIVCF) placement and to identify parameters that influence retrieval attempt and failure. METHODS: Between January 2005 and December 2010, a total of 200 patients (80 men, median age 67 years, range 11-95 years) received a rIVCF with the clinical possibility that it could be removed. All patients with rIVCF were prospectively entered into a database and followed until retrieval or a decision not to retrieve the filter was made. A retrospective analysis of this database was performed. RESULTS: Sixty-one percent of patients had an accepted indication for filter placement; 39% of patients had a relative indication. There was a tendency toward a higher retrieval rate in patients with relative indications (40% vs. 55%, P = 0.076). Filter placement was technically successful in all patients, with no procedure-related mortality. The retrieval rate was 53%. Patient age of >80 years (odds ratio [OR] 0.056, P > 0.0001) and presence of malignancy (OR 0.303, P = 0.003) was associated with a significantly reduced probability for attempted retrieval. Retrieval failure occurred in 7% (6 of 91) of all retrieval attempts. A time interval of > 90 days between implantation and attempted retrieval was associated with retrieval failure (OR 19.8, P = 0.009). CONCLUSIONS: Patient age >80 years and a history of malignancy are predictors of a reduced probability for retrieval attempt. The rate of retrieval failure is low and seems to be associated with a time interval of >90 days between filter placement and retrieval.

Endovascular repair of infrarenal aortic aneurysms in octogenarians and nonagenarians.

OBJECTIVE: The purpose of this report was to present short and midterm results of endovascular aortic aneurysm repair (EVAR) of infrarenal aortic aneurysms in octogenarians and nonagenarians. METHODS: Between March 1994 and March 2011, elective EVAR was performed in 967 patients in our institution. This includes 279 patients older than 80 years at the time of the procedure (octogenarians: n = 252, nonagenarians: n = 27). Mean follow-up was 48.4 ± 34.5 months. A retrospective analysis was performed. Survival was calculated using Kaplan-Meier analysis and a survival comparison to patients who underwent EVAR <80 years old (n = 688) was performed. Cox hazard regression analysis was used to assess parameters that influence survival. RESULTS: Technical success was 96% in octogenarians and 85% in nonagenarians. Technical failure in 15 of 279 patients includes primary type I endoleak (n = 6), procedure abortion due to inability to pass the iliac vessels (n = 6), and emergency conversion (n = 3). Thirty-day mortality was significantly higher for patients >80 years old (2.8% vs 1.0%; P = .044). Morbidity rates were 11.5% for octogenarians and 7.4% for nonagenarians with predominately cardiopulmonary complications. High-risk patients >80 years old showed a comparable perioperative mortality rate to low-/medium-risk patients >80 years old (2.9% vs 2.5%;P = .717), but a significantly higher complication rate (22.5% vs 9.2%; P = .0275) and reduced midterm survival with 1-, 3-, and 5-year survival rates of 79% ± SE 7%, 55% ± SE 8%, and 38% ± SE 9% (log-rank test P = .03). In high-risk patients age >80 years old, their age did not influence 30-day mortality (2.5% vs 2.7%; P = .978) and midterm survival. Survival in octogenarians at 1, 3, and 5 years was 87.9 ± SE 2.1%, 70.9 ± SE 3.0%, and 55.6% ± SE 3.5%, respectively. Survival in nonagenarians at 1 and 3 years was 96.3% ± SE 4% and 60.6% ± SE 10.4%. Higher cardiac (hazard ratio [HR], 1.22; P = .038) and renal risk scores (HR, 1.59; P = .0016), chronic obstructive pulmonary disease (HR, 1.56; P = .032), and anemia (HR, 2.1; P < .001) influenced midterm survival. CONCLUSION: EVAR in octogenarians and nonagenarians is associated with a significantly higher but still low perioperative mortality compared to younger patients. Midterm survival in octogenarians and nonagenarians, although significantly lower than in younger patients, is still acceptable, indicating that age >80 years should not be an exclusion criteria for EVAR. Even high-risk patients >80 years can be treated safely with a low perioperative mortality and comparable midterm outcome to younger high-risk patients.

Retroperitoneal versus direct femoral artery approach for thoracic endovascular aortic repair access: a case-control study.

BACKGROUND: Many individuals who are candidates for thoracic endovascular aortic repair (TEVAR) are found to have iliac artery anatomy and/or disease that preclude transfemoral endovascular access and require retroperitoneal surgical approach through more proximal arteries. This relatively more invasive technique could potentially affect the procedural outcomes. This study compares the retroperitoneal with transfemoral access used for TEVAR in a single center. METHOD: In this study, 133 consecutive patients (96 men; mean age ± SD: 69.5 ± 14.7 years) who underwent TEVAR between 1994 and 2009 in a single center were retrospectively evaluated. The type of endovascular access was identified in all the patients. The basic demographics, access method, endograft type, 30-day morbidity and mortality rates, as well as procedure recordings including fluoroscopic and procedure duration, estimated blood loss, and duration of hospitalization were compared between the TEVAR procedures performed using a surgical retroperitoneal approach and those using the standard femoral access. RESULTS: Retroperitoneal access was used in 19 (14.3%; 13 women; mean age ± SD: 71 ± 12.2 years) and direct femoral access in 114 (85.7%; 24 women; mean age ± SD: 69 ± 15.4 years) patients. Two of the retroperitoneal accesses were obtained after failure of femoral approach. Techniques that were used included iliac artery conduit (seven patients), aortic artery conduit (eight patients), aortobifemoral artery graft conduit (one patient), and direct sheath introduction through the distal aorta (two patients) or common iliac artery (one patient). Retroperitoneal approach was used more frequently in women (35%) as compared with men (6%) (p = 0.0001). In all, 79% of the retroperitoneal approaches were associated with use of delivery sheath sizes larger than 24F (p = 0.049). TEVAR technical success was 100% with retroperitoneal and 97.3% with femoral access (p > 0.05). Thirty-day mortality rates were 0% and 8.8% and the rates of access artery injury were 5.3% and 4.4% in retroperitoneal and femoral access groups, respectively (p > 0.05). The incidence of retroperitoneal hematoma was significantly higher with retroperitoneal access (21% vs. 2.6%, p = 0.008). Additionally, retroperitoneal access was associated with significant increase in estimated blood loss and duration of hospitalization (p < 0.05). CONCLUSIONS: Type of access does not affect TEVAR success and the early mortality rate. Retroperitoneal approach is a valuable alternative technique in cases involving failed or impossible femoral access. However, this approach is associated with higher chances of retroperitoneal bleeding and longer procedural time and duration of hospitalization. Thoracic endografts with smaller delivery systems could minimize the need for this approach in the future.

Percutaneous suture-mediated closure versus surgical arteriotomy in endovascular aortic aneurysm repair.

PURPOSE: To compare percutaneous suture-mediated closure (PSMC) with surgical closure in endovascular aortic aneurysm repair and examine the influence of obesity, sheath size, and vessel calcification on the effectiveness of percutaneous closure. MATERIALS AND METHODS: A total of 445 patients (mean age, 75.9 ± 7.6 years) undergoing aortic aneurysm repair from 2003 to 2010 were retrospectively reviewed. A total of 100 PSMC and 557 surgical closures for arteriotomies with sheath sizes between 12 F and 18 F were compared in terms of failure, complications, and operating room time. Additionally, effects of arterial calcification, body mass index, and sheath size on PSMC were evaluated. RESULTS: Eighty-five percent of PSMCs were successful. Failure was attributed to lack of hemostasis in 11 and difficulty in device positioning in four cases. Complication rate after successful PSMC (9.4%) was significantly less than surgery (19.4%) (P = .02).When failed PSMC cases were considered as complication, the complication rate was not different between the two groups (P = .4). Seroma occurred more after surgical closures (11.4% vs 1.2%; P = .001). Pseudoaneurysm occurred more after PSMC (3.5% vs 0.18%; P = .008).Average PSMC procedure time was less than that of surgical closure (P = .0001). PSMC success rate was 89.7% for < 16-F sheaths and 80.4% for ≥ 16-F sheaths (P = .15). PSMC success was not different between obese and nonobese patients (P = .22). PSMC success in calcified and noncalcified arteries was not different (P = .37). CONCLUSIONS: PSMC is an effective arterial closure method. It is faster and associated with less postprocedure morbidity than surgery. Appropriate technique and meticulous vascular exposure affect PSMC success. Obesity, vascular calcification, and sheath size did not change PSMC outcome in this study.

Fenestrated and branched endografts: why we need them now.

Standard endovascular repair of abdominal aortic aneurysm (AAA) has been shown to be associated with significant advantages compared with conventional surgery in the perioperative time frame related to the minimally invasive nature of the procedure. Given the encouraging long-term results of endovascular AAA repair, this method is increasingly applied to patients with complex AAA anatomies. The present article reviews the indications for branched and fenestrated endografts in various aortic pathologic processes.

Ultrasound-accelerated thrombolysis for the treatment of deep vein thrombosis: initial clinical experience.

PURPOSE: To evaluate the success of lysis and clinical outcomes in patients treated with ultrasound (US)-accelerated thrombolysis for deep vein thrombosis (DVT). MATERIALS AND METHODS: Forty-seven patients with 53 cases of DVT were treated with US-accelerated thrombolysis at eight centers in the United States. Sixty percent of the occlusions were in the lower extremity, 36% were in the upper extremity, and 4% were hepatic. The clot was acute (< or =14 days) in 47% of cases, subacute (15-28 d) in 8%, chronic (>28 d) in 17%, acute-on-chronic in 17%, and not specified in 11%. Patients were treated with urokinase (UK), tissue plasminogen activator (tPA), recombinant plasminogen activator (rPA), or tenecteplase. RESULTS: Complete lysis (> or =90%) was seen in 37 of 53 cases (70%) and overall lysis (complete plus partial) was seen in 48 (91%). No lysis occurred in five cases (9%), four of which were chronic. The median thrombolysis infusion time was 22.0 hours. Major complications (hematoma at site of earlier surgery) occurred in only two patients (3.8%), with no incidence of intracranial or retroperitoneal hemorrhage. US-accelerated thrombolysis exhibited comparable or better lysis with a lower average drug dose and shorter median treatment times than reported in the National Venous Registry and a more recently published study of standard catheter-directed thrombolysis. CONCLUSIONS: US-accelerated thrombolysis was shown to be a safe and efficacious treatment for DVT in this multicenter experience. The addition of US reduces total infusion time and provides a greater incidence of complete lysis with a reduction in bleeding rates.

Matched-pair analysis of endovascular versus open surgical repair of abdominal aortic aneurysms in young patients at low risk.

PURPOSE: To compare clinical outcomes of endovascular and open aortic repair of abdominal aortic aneurysms (AAAs) in young patients at low risk. It was hypothesized that endovascular aneurysm repair (EVAR) compares favorably with open aneurysm repair (OAR) in these patients. MATERIALS AND METHODS: Twenty-five patients aged 65 years or younger with a low perioperative surgical risk profile underwent EVAR at a single institution between April 1994 and May 2007 (23 men; mean age, 62 years+/-2.8). A sex- and risk-matched control group of 25 consecutive patients aged 65 years or younger who underwent OAR was used as a control group (23 men; mean age, 59 years+/-3.9). Patient outcomes and complications were classified according to Society of Vascular Surgery/International Society for Cardiovascular Surgery reporting standards. RESULTS: Mean follow-up times were 7.1 years+/-3.2 after EVAR and 5.9 years+/-1.8 after OAR (P=.1020). Total complication rates were 20% after EVAR and 52% after OAR (P=.0378), and all complications were mild or moderate. Mean intensive care unit times were 0.2 days+/-0.4 after EVAR and 1.1 days+/-0.4 after OAR (P<.0001) and mean lengths of hospital stay were 2.3 days+/-1.0 after EVAR and 5.0 days+/-2.1 after OAR (P<.0001). Cumulative rates of long-term patient survival did not differ between EVAR and OAR (P=.144). No AAA-related deaths or aortoiliac ruptures occurred during follow-up for EVAR and OAR. In addition, no surgical conversions were necessary in EVAR recipients. Cumulative rates of freedom from secondary procedures were not significantly different between the EVAR and OAR groups (P=.418). Within a multivariable Cox proportional-hazards analysis adjusted for patient age, maximum AAA diameter, and cardiac risk score, all-cause mortality rates (odds ratio [OR], 0.125; 95% CI, 0.010-1.493; P=.100) and need for secondary procedures (OR, 5.014; 95% CI, 0.325-77.410; P=.537) were not different between EVAR and OAR. CONCLUSIONS: Results from this observational study indicate that EVAR offers a favorable alternative to OAR in young patients at low risk.

Adequacy of an early arterial phase low-volume contrast protocol in 64-detector computed tomography angiography for aortoiliac aneurysms.

PURPOSE: This retrospective study was conducted to determine whether a low-volume contrast medium protocol provides sufficient enhancement for 64-detector computed tomography angiography (CTA) in patients with aortoiliac aneurysms. METHODS: Evaluated were 45 consecutive patients (6 women; mean age, 72 +/- 6 years) who were referred for aortoiliac computed tomography angiography between October 2005 and January 2007. Group A (22 patients; creatinine clearance, 64.2 +/- 8.1 mL/min) received 50 mL of the contrast agent. Group B (23 patients; creatinine clearance, 89.4 +/- 7.3 mL/min) received 100 mL of the contrast agent. The injection rate was 3.5 mL/s, followed by 30 mL of saline at 3.5 mL/s. Studies were performed on the same 64-detector computed tomography scanner using a real-time bolus-tracking technique. Quantitative analysis was performed by determination of mean vascular attenuation at 10 regions of interest from the suprarenal aorta to the common femoral artery by one reader blinded to type and amount of contrast agent and compared using the Student t test. Image quality according to a 4-point scale was assessed in consensus by two readers blinded to type and amount of contrast medium and compared using the Mann-Whitney test. Multivariable adjustments were performed using ordinal regression analysis. RESULTS: Mean total attenuation did not differ significantly between both groups (196.5 +/- 33.0 Hounsfield unit [HU] in group A and 203.1 +/- 44.2 HU in group B; P = .57 by univariate and P > .05 by multivariable analysis). Accordingly, attenuation at each region of interest was not significantly different (P > .35). Image quality was excellent or good in all patients. No significant differences in visual assessment were found comparing both contrast medium protocols (P > .05 by univariate and by multivariable analysis). CONCLUSIONS: Aortoiliac aneurysm imaging can be performed with substantially reduced amounts of contrast medium using 64-detector computed tomography angiography technology.

Anemia is associated with abdominal aortic aneurysm (AAA) size and decreased long-term survival after endovascular AAA repair.

OBJECTIVE: Anemia is a common comorbid condition in various inflammatory states and an established predictor of mortality in patients with chronic heart failure, ischemic heart disease, and end-stage renal disease. The present study of patients with abdominal aortic aneurysm (AAA) undergoing endovascular repair (EVAR) assessed the relationships between baseline hemoglobin concentration and AAA size, as well as anemia and long-term survival. METHODS: Between March 1994 and November 2006, 711 patients (65 women, mean age 75.8 +/- 7.8 years) underwent elective EVAR. Anemia was defined as a hemoglobin level <13 g/dL in men and <12 g/dL in women. Post-EVAR mean follow-up was 48.3 +/- 32.0 months. Association of hemoglobin level with AAA size was assessed with multiple linear regression. Mortality was determined with use of the internet-based Social Security Death Index and the electronic hospital record. Kaplan-Meier survival curves of anemic and nonanemic patient groups were compared by the log-rank method. Multivariable logistic regression models were used to determine the influence of anemia on vital status after EVAR. RESULTS: A total of 218/711 (30.7%) of AAA patients undergoing EVAR had anemia at baseline. After adjustment for various risk factors, hemoglobin level was inversely related to maximum AAA diameter (beta: - .144, 95%-CI: -1.482 - .322, P = .002). Post-EVAR survival was 65.5% at 5 years and 44.4% at 10 years. In long-term follow-up, survival was significantly lower in patients with anemia as compared to patients without anemia (P < .0001 by log-rank). Baseline hemoglobin levels were independently related to long-term mortality in multivariable Cox regression analysis adjusted for various risk factors (adjusted HR: 0.866, 95% CI: .783 to .958, P = .005). Within this model, statin use (adjusted HR: .517, 95% CI: .308 to .868, P = .013) was independently related to long-term survival, whereas baseline AAA diameter (adjusted HR: 1.022, 95% CI: 1.009 to 1.036, P = .001) was an independently associated with increased mortality. CONCLUSIONS: Baseline hemoglobin concentration is independently associated with AAA size and reduced long-term survival following EVAR. Thus, the presence or absence of anemia offers a potential refinement of existing risk stratification instruments.

Long-term outcome from uterine fibroid embolization with tris-acryl gelatin microspheres: results of a multicenter study.

PURPOSE: To determine the long-term outcome of uterine fibroid therapy (UFE) using tris-acryl gelatin microspheres (TAGM). MATERIALS: This was a multicenter prospective study of patients undergoing UFE with TAGM, and during this phase of the study, the clinical outcomes 3 years after treatment were assessed. Measures of outcome included the Ruta Menorrhagia Questionnaire, patient self-assessments of symptoms and impact on activities, patient satisfaction and health-related quality of life as measured by the SF-12. Long-term re-intervention rates were also assessed. The data were analyzed at each interval compared to baseline using appropriate statistical tests. RESULTS: Of the 102 patients enrolled, 96 patients had complete baseline data and of these, 69 (72%) had known outcomes at 3 years after treatment. Sixty-one patients (64%) completed long-term follow-up without major intervention. An additional 8 patients (8.3%) underwent fibroid surgery (7 hysterectomies and 1 myomectomy). Among those without intervention, at 3 years after treatment, the mean Ruta Questionnaire Score was 19.3, compared to 47.9 at baseline and 24.5 at 3 months (P <.01). At baseline, 57% of patients had extremely heavy bleeding, while only 2% had that complaint at 36 months. At 36 months, much or moderate improvement in pelvic pain occurred in 83% of patients, pelvic discomfort in 83%, and urinary problems in 69% and 84% were moderately or very satisfied with their outcome. CONCLUSIONS: Over the long-term, UFE using TAGM is effective and safe, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction.

Bivalirudin as an anticoagulation agent: safety and efficacy in peripheral interventions.

PURPOSE: Traditionally, unfractionated heparin is used to prevent thrombotic complications in peripheral interventions. The purpose of this study is to evaluate the use of bivalirudin as the anticoagulant agent for peripheral interventions. MATERIALS AND METHODS: A retrospective analysis of 108 patients who underwent 110 peripheral interventions between January 2002 and January 2004 and received bivalirudin as the sole anticoagulation agent was conducted at Baptist Cardiac and Vascular Institute. Interventions were performed in the following areas: iliac, femoropopliteal, and distal (n = 55), carotid (n = 31), vertebral (n = 1), renal (n = 14), aorta (n = 7), and subclavian (n = 2). The following procedural and clinical endpoints were examined: death, requirement of urgent surgery or surgery during the same admission, urgent percutaneous revascularization in the same treated vessel, thrombotic or embolic events, bleeding events, and groin complications. RESULTS: A total of 266 lesions were dilated in 185 arteries. There were no procedural mortalities, procedural success was 99.1%, and the complication rate was 3.6%. There was one embolic stroke (0.9%), one thrombosis (0.9%), and two groin hematomas (1.8%). No patient required urgent surgery or reintervention in the same treated vessel. No complications were noted at 7 days after the procedure. There were two interventions by postprocedure day 30: toe amputation and groin debridement. CONCLUSION: Bivalirudin is a safe alternative to unfractionated heparin as the anticoagulation agent in peripheral interventions. This study shows that the complication profile is comparable to other bivalirudin studies. Bivalirudin is effective, easy to use, and is associated with few bleeding complications.