Outcomes over Time in Patients with Hostile Neck Anatomy Undergoing Endovascular Repair of Abdominal Aortic Aneurysm.

PURPOSE: To assess differences in outcome in an early and later time period in patients with hostile neck anatomy who underwent endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: This single-center, institutional review board-approved retrospective study assessed patients who underwent EVAR between 2004 and 2013, divided into 2 time periods: 2004-2008 and 2009-2013. One hundred twenty-five patients had at least 1 hostile neck parameter that met inclusion criteria: 61 of 216 (28%) patients in the early period and 64 of 144 (44%) patients in the late period. Patients in the late group were younger compared to patients in the early group (late group, 74.5 ± 8.8 years vs early group, 77.5 ± 7.5 years; P = .046). No significant differences were observed in hostile neck anatomic factors between the early and late periods. RESULTS: No statistical difference was observed in periprocedural factors or outcome measures, except for abdominal aortic aneurysm (AAA) sac regression in the late period compared to the early period (late period, 73.5% vs early period, 55.7%; P = .038). A statistically significant increase was observed in type 1a endoleaks in patients in the late group with suprarenal fixation compared to patients with infrarenal fixation (suprarenal, 27.0% vs infrarenal, 7.9%; P = .025) and in the overall time studied (suprarenal, 20.3% vs infrarenal, 7.6%; P = .045). CONCLUSIONS: Except for AAA sac regression, no changes were observed in periprocedural factors and outcome measures over time in patients with hostile neck who underwent EVAR.

Multicenter Trial of the VenaTech Convertible Vena Cava Filter.

PURPOSE: To demonstrate rates of successful filter conversion and 6-month major device-related adverse events in subjects with converted caval filters. MATERIALS AND METHODS: An investigational device exemption multicenter, prospective, single-arm study was performed at 11 sites enrolling 149 patients. The VenaTech Convertible Vena Cava Filter (B. Braun Interventional Systems, Inc, Bethlehem, Pennsylvania) was implanted in 149 patients with venous thromboembolism and contraindication to or failure of anticoagulation (n = 119), with high-risk trauma (n = 14), and for surgical prophylaxis (n = 16). When the patient was no longer at risk for pulmonary embolism as determined by clinical assessment, an attempt at filter conversion was made. Follow-up of converted patients (n = 93) was conducted at 30 days, 3 months, and 6 months after conversion. Patients who did not undergo a conversion attempt (n = 53) had follow-up at 6 months after implant. RESULTS: All implants were successful. One 7-day migration to the right atrium required surgical removal. Technical success rate for filter conversion was 92.7% (89/96). Mean time from placement to conversion was 130.7 days (range, 15-391 d). No major conversion-related events were reported. The mean conversion procedure time was 30.7 minutes (range, 7-135 min). There were 89 converted and 32 unconverted patients who completed 6-month follow-up with no delayed complications. CONCLUSIONS: The VenaTech Convertible filter has a high conversion rate and low 6-month device-related adverse event rate. Further studies are necessary to determine long-term safety and efficacy in both converted and unconverted patients.

Technical Results of Vacuum-Assisted Thrombectomy for Arterial Clot Removal in Patients with Acute Limb Ischemia.

PURPOSE: To assess the efficacy and safety of a vacuum-assisted thrombectomy (VAT) catheter system for treating patients with acute limb ischemia (ALI). MATERIALS AND METHODS: A retrospective study evaluated VAT systems (Penumbra, Alameda, California) in a consecutive series of 30 patients with ALI. ALI was defined as clinical symptoms within 2 weeks of presentation. The primary endpoint was improvement in blood flow across a lesion by improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures. Target lesions were grouped anatomically into above-the-knee (ATK) or below-the-knee (BTK) lesions. RESULTS: In 30 patients, 33 lesions (ATK, n = 13; BTK, n = 20) were treated. No complications were attributed to the VAT systems. The primary endpoint was obtained in 24/33 (72.7%) lesions (BTK, 17/20 [85.0%]; ATK, 7/13 [53.9%]; P = .050 by χ(2) test). TIMI scores were similar at baseline but differed after VAT between the ATK and BTK groups (P < .025 by t test). ATK lesions required more concomitant angioplasty or stent placement, or both (P < .015 by χ(2) test). CONCLUSIONS: VAT is a safe, technically successful short-term therapeutic option for thrombus removal in patients with ALI.

Endovascular coil embolization of a pancreatic pseudoaneurysm in a child with pancreatitis.

Pancreatic pseudoaneurysm is a rare but potentially fatal complication in pancreatitis; however, the incidence in children is not well established. Surgery has been the mainstay of treatment; however, we report a case of PSA associated with pancreatitis in a 6-year-old boy, which was successfully managed endovascularly.

Ultrasound-accelerated versus standard catheter-directed thrombolysis in 102 patients with acute and subacute limb ischemia.

PURPOSE: To compare the safety and efficacy of ultrasound-accelerated thrombolysis (UAT) and standard catheter-directed thrombolysis (CDT) in patients with acute and subacute limb ischemia. MATERIALS AND METHODS: Medical records of all patients treated with thrombolysis for acute and subacute limb ischemia between August 2005 and January 2012 were reviewed. Coprimary (increase in ankle-brachial index, degree of lysis) and secondary endpoints (technical success, distal embolization, bleeding complications, need for additional interventions) were assessed. UAT was performed in 75 patients, and CDT was performed in 27 patients. Patients' baseline demographic and clinical parameters and procedure details, including lytic drug infusion rate (P = .704 and P = .987), total infusion time (P = .787 and P = .377), and use of adjunctive procedures (P = .457), did not differ significantly between the two groups. RESULTS: Complete lysis was achieved in 72.0% (UAT) and 63.0% (CDT) of patients (P = .542); hemodynamic success was achieved in 91.8% (UAT) and 92.3% (CDT) (P = .956). Overall major and minor bleeding complications were observed in 6.9% (UAT) and 3.9% (CDT) of patients. Major (P = .075) and minor (P = .276) bleeding independently did not differ between UAT and CDT. Major and minor bleeding combined was lower: 6.7% (UAT) versus 22.2% (CDT) (P = .025). Overall target vessel patency after 8.0 months (range, 1.5-20.5 mo) was 73.5%; target vessel patency for UAT was 75.9% versus 64.3% for CDT (P = .379). Median long-term survival was not significantly different between UAT and CDT: 3.6 years (range, 2.42-5.33 y) versus 1.8 years (range, 1.33-4.92 y) (P = .061). CONCLUSIONS: Both UAT and CDT are safe and efficient treatment modalities for patients with acute and subacute limb ischemia. The observed lower risk of total bleeding for UAT versus CDT may warrant prospective comparative trials.

Ultrasound-accelerated vs standard catheter-directed thrombolysis--a comparative study in patients with iliofemoral deep vein thrombosis.

PURPOSE: To compare the thrombolytic efficacy and safety of standard catheter-directed thrombolysis (CDT) and ultrasound (US)-accelerated thrombolysis (UAT) for the treatment of iliofemoral deep vein thrombosis (DVT). MATERIALS AND METHODS: All medical records of patients who underwent CDT or UAT for DVT between June 2004 and October 2011 at a single tertiary care center were reviewed. Target vein patency was graded according to a reporting standard by an independent interventional radiologist. RESULTS: CDT was performed in 19 patients and UAT in 64 patients. The baseline parameters and DVT characteristics, including the duration of symptoms, the location, and the extension did not differ significantly between groups. Both treatment modalities were associated with a similar substantial resolution of thrombus load (CDT = 89%; interquartile range [IQR], 70%-100%; UAT = 82%; IQR, 55%-92% (P = .560). No significant differences in the lytic drug infusion rates, the total lytic doses, the total infusion time, and the use of adjunctive procedures were observed between groups. Major and minor bleeding complications were observed in 8.4% and 4.8% of the patients, with no difference between the treatment groups (P = .709 and P = .918, respectively). During a median follow-up of 35 months (20-55 months), three deaths and 16 cases of repeated thrombosis were observed. The estimated mean event-free survival time was longer after CDT (69 mo) compared with UAT (33 mo) (log-rank test P = .310). CONCLUSIONS: The present study failed to prove any substantial clinical benefit provided by UAT with regard to effectiveness or safety compared with standard CDT. Given the added costs of the US delivery device, prospective randomized data are needed to justify its widespread use for DVT treatment.

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.

Sixty-four-detector CT angiography of infrarenal aortic neck length and angulation: prospective analysis of interobserver variability.

PURPOSE: To quantify the interobserver variability of abdominal aortic aneurysm (AAA) neck length and angulation measurements. MATERIALS AND METHODS: A total of 25 consecutive patients scheduled for endovascular AAA repair underwent follow-up 64-row computed tomographic (CT) angiography in 0.625-mm collimation. AAA neck length and angulation were determined by four blinded, independent readers. AAA neck length was defined as the longitudinal distance between the first transverse CT slice directly distal to the lowermost renal artery and the first transverse CT slice that showed at least a 15% larger outer aortic wall diameter versus the diameter measured directly below the lowermost renal artery. Infrarenal AAA neck angulation was defined as the true angle between the longitudinal axis of the proximal AAA neck and the longitudinal axis of the AAA lumen as analyzed on three-dimensional CT reconstructions. RESULTS: Mean deviation in aortic neck length determination was 32.3% and that in aortic neck angulation was 32.1%. Interobserver variability of aortic neck length and angulation measurements was considerable: in any reader combination, at least one measurement difference was outside the predefined limits of agreement. CONCLUSIONS: Assessment of the longitudinal extension and angulation of the infrarenal aortic neck is associated with substantial observer variability, even if measurement is carried out according to a standardized protocol. Further studies are mandatory to assess dedicated technical approaches to minimize variance in the determination of the longitudinal extension and angulation of the infrarenal aortic neck.

Influence of stent type on hemodynamic depression after carotid artery stent placement.

PURPOSE: To assess the effect of stent type on hypotension and bradycardia after carotid artery stent placement. MATERIALS AND METHODS: A retrospective analysis on a prospectively maintained database was conducted in 256 patients (126 men; mean age, 71.8 years +/- 8.6; 194 de novo lesions) undergoing carotid artery stent placement between January 1996 and January 2007 by using self-expanding stents. Braided Elgiloy stents (Wallstents) were used in 44 of the 256 patients (17.2%) and slotted-tube nitinol stents were deployed in 212 (82.8%). Bivariate and multivariable logistic regression models were used to determine the influence of stent design on procedural and 24-hour hypotension and bradycardia. RESULTS: Procedural hemodynamic depression (HD) was encountered in 73 of the 256 patients (28.5%) due to hypotension in 24 (9.4%), bradycardia in 12 (4.7%), or both in 37 (14.5%) patients. Rates of procedural hypotension were 11.3% with nitinol stents and 0% with braided Elgiloy stents (P = .0188). Persistent postprocedural HD occurred in 91 of the 256 patients (35.5%) due to hypotension in 40 patients (15.6%), bradycardia in 23 (9.0%), or both in 28 (10.9%). Within a multivariable analysis adjusted for clinically relevant factors affecting rates of HD, the use of braided Elgiloy stents was associated with a decreased rate of procedural hypotension (odds ratio: 0.165; 95% confidence interval: 0.038, 0.721; P = .017). Procedural hypotension and bradycardia were not correlated to incidence of major adverse events but were associated with an increased duration of hospital stay (P = .0059 and P = .0335, respectively). CONCLUSIONS: Nitinol stents are associated with a higher risk of hypotension as compared to braided Elgiloy stents during carotid artery stent placement.

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.

Dr. Gary J. Becker Young Investigator Award: intraarterial adenovirus for metastatic gastrointestinal cancer: activity, radiographic response, and survival.

PURPOSE: To determine the antitumoral activity and radiographic response pattern of intraarterial administration of a selective replication-competent adenovirus in patients with hepatic metastases from gastrointestinal carcinomas. MATERIALS AND METHODS: Thirty-five patients were treated, seven in the dose-escalation phase and 28 at high doses. Inclusion criteria allowed mild laboratory value and performance status abnormalities and as much as 50% replacement of hepatic volume by tumor. An attenuated adenovirus that selectively replicates in p53-deficient cells (Onyx-015) was administered by hepatic arterial infusion at doses as high as 2 x 10(12) particles for two cycles. Subsequent cycles (maximum of eight total) were administered in combination with intravenous 5-fluorouracil (5-FU) and leucovorin. RESULTS: Tumor responses were demonstrated in combination with chemotherapy, even in 5-FU-resistant patients. The 15 patients who responded radiographically showed a pattern of acute tumor enlargement despite normalization of laboratory and clinical parameters, followed by very slow regression of tumor size. Radiographic response did not correlate with p53 status. Median survival of radiographic responders (475 days) was significantly longer than that of nonresponders (143 days). CONCLUSIONS: Hepatic arterial infusion of the replication-selective adenovirus Onyx-015 in combination with chemotherapy resulted in tumor regressions in select patients, including some in whom previous chemotherapy had failed. A biphasic radiographic response pattern was demonstrated. The mechanism of action appears to be more complex than that seen in vitro.

Treatment of abdominal aortic anastomotic pseudoaneurysm with percutaneous coil embolization.

Intraabdominal anastomotic pseudoaneurysms continue to be a late complication of aortic reconstructive procedures. Early surgical repair is critical but is associated with high operative mortality rates. We present a patient who was diagnosed with a distal anastomotic pseudoaneurysm 13 months after transabdominal repair of a symptomatic abdominal aortic aneurysm. Because of the poor operative risk, the patient was considered for a less invasive approach and underwent coil embolization of the abdominal aortic anastomotic pseudoaneurysm. The patient remains without recurrence of pseudoaneurysm 3.5 years later.