Safety and Long-Term Survival Outcome in Patients With Unresectable Barcelona Clinic Liver Cancer (BCLC) Stages C and D Advanced Hepatocellular Carcinoma Treated With 40 µm Drug-Eluting Bead Transcatheter Arterial Chemoembolization.

Background To evaluate the safety, treatment response, and overall survival (OS) following drug-eluting bead transarterial chemoembolization (DEB-TACE) using doxorubicin-loaded 40 µm microspheres in patients with advanced hepatocellular carcinoma (HCC). Methods This was a single-center retrospective evaluation of patients with unresectable HCC without extrahepatic spread and Barcelona Clinic Liver Cancer (BCLC) stages C and D disease who underwent DEB-TACE between August 2015 and January 2018. Pre-treatment data included demographics, medical history, cancer staging, tumor size, laboratory results, and prior treatments for HCC. Follow-up data included the date of DEB-TACE treatments or microwave ablation (MWA) procedures, laboratory test results, adverse events, treatment response, and the date and cause of death. Results Thirty-two patients met the study inclusion criteria. Eighteen patients (56.3%) underwent a single DEB-TACE and 14 patients (43.8%) had two to five DEB-TACE procedures. Five patients (15.6%) had MWA following initial DEB-TACE. Mild postembolization syndrome occurred in six patients (18.8%) during a 30-day period following initial DEB-TACE. Seven patients (21.9%) experienced worsening ascites, pleural fluid, or encephalopathy during the study observation period. Three patients had moderate to severe worsening liver function tests 90 days post-procedure. Seventeen patients (53.1%) had a complete or partial response and nine patients (28.1%) had disease progression. Median OS was 15.0±14.4 months from the time of initial DEB-TACE, with 63% and 33% of patients still alive at 12 and 24 months. Multivariate analyses identified that Okuda Stage (P=0.03) and Cancer of the Liver Italian Programme (CLIP) score (P=0.05) were significantly associated with overall survival after adjusting for other covariates. There were four HCC-related deaths during the 30-day post-procedure period. Conclusion DEB-TACE with small 40 µm doxorubicin-loaded microspheres is a safe and effective treatment for unresectable patients with BCLC stages C and D advanced HCC. Patients with advanced, high-risk unresectable HCC should be considered for DEB-TACE as opposed to supportive or palliative care alone.

Novel approach in using ultrasound in treating acute limb ischemia.

BACKGROUND: It is imperative to gain safe access into the occluded targeted vessel and begin treating acute extremity limb ischemia. Often the origin of the targeted native artery or bypass graft will have a flush occlusion making it difficult to cannulate. This paper looks at the novel use of portable ultrasound to evaluate the origin of the artery or bypass graft to help facilitate the start of thrombolysis. METHODS: We reviewed our last 2 years of acute limb ischemia in our patients with high risk factors and comorbidities. We reviewed the use of ultrasound in these cases from the initial use of gaining femoral access to real time ultrasound and fluoroscopic guidance into the targeted native artery or bypass graft to begin needed thrombolysis. RESULTS: We had 26 acute limb ischemia in 10 patients with native arterial circulation and in 16 patients with either saphenous or prosthetic bypass grafts. Ultrasound was used in gaining safe access with no complications in 22 contralateral and 2 antegrade femoral and 4 direct-graft accesses. Ultrasound was used in 6 of these cases to help gain access in the occluded graft (4 cases) and saphenous veins (2 cases). It was successful in all cases but one case which had bleeding. CONCLUSIONS: Ultrasound is increasing in its application including acute limb ischemia with flush occlusions of native arteries and bypass grafts.

First Clinical Experience With Targeted REnal Nerve Demodulation (TREND-1) Using a Neurotropic Agent for the Treatment of Sympathetic Hypertension.

AIMS: To evaluate the feasibility and safety of a novel targeted neuromodulatory treatment for sympathetic hypertension involving a one-time local injection of neurotropic agents near renal nerves. METHODS AND RESULTS: Seven patients suffering from uncontrolled hypertension per ESH-ESC guidelines were treated using a single dose of NW2013, a neurotropic Na+/K+ ATPase antagonist. A microneedle catheter was used to administer 1.2 mL of NW2013 (0.6 mL per artery) to the perivascular space surrounding renal arteries using percutaneous endovascular procedures under fluoroscopic guidance. All patients were successfully treated without any procedural complications. Patients were followed for 12 months post procedure, and office and 24-hour ambulatory blood pressure measurements were made. Both office and ambulatory blood pressures were lower at 24 hours, 1 month, and 3 months after treatment. The decrease in office blood pressure was greater than the decrease in ambulatory blood pressure. A reduction in medication regimen was also observed in 2 patients. One patient suffered a cerebrovascular event after 6-month follow-up and died from stroke, unrelated to the treatment. Overall, the reduction in office and ambulatory blood pressure was sustained over the course of 12 months. CONCLUSIONS: Treatment of hypertension using local administration of NW2013 near renal nerves appears to be feasible and safe. Large, controlled, randomized, and blinded clinical studies with monitoring of patient compliance to daily oral medication are recommended to further establish the efficacy of this novel treatment.

Segmental liver ischemia/infarction after elective transjugular intrahepatic portosystemic shunt creation: clinical outcomes in 10 patients.

PURPOSE: To determine the clinical significance and potential mechanisms of segmental liver ischemia and infarction following elective creation of a transjugular intrahepatic portosystemic shunt (TIPS). MATERIALS AND METHODS: A retrospective review of 374 elective TIPS creations between March 2006 and September 2014 was performed, yielding 77 contrast-enhanced scans for review. Patients with imaging evidence of segmental perfusion defects were identified. Model for End-stage Liver Disease scores, liver volume, and percentage of liver ischemia/infarct were calculated. Clinical outcomes after TIPS creation were reviewed. RESULTS: Ten patients showed segmental liver ischemia/infarction on contrast-enhanced imaging after elective TIPS creation. Associated imaging findings included thrombosis of the posterior division (n = 7) and anterior division (n = 3) of the right portal vein (PV). The right hepatic vein was thrombosed in 5 patients, as was the middle hepatic vein in 3 and the left hepatic vein in 1. One patient had acute thrombosis of the shunt and main PV. Three patients developed acute liver failure: 2 died within 30 days and 1 required emergent liver transplantation. One patient died of acute renal failure 20 days after TIPS creation. A large infarct in a transplant recipient resulted in biloma formation. Five patients survived without additional interventions with follow-up times ranging from 3 months to 5 years. CONCLUSIONS: Segmental perfusion defects are not an uncommon imaging finding after elective TIPS creation. Segmental ischemia was associated with thrombosis of major branches of the PVs and often of the hepatic veins. Clinical outcomes varied significantly, from transient problems to acute liver failure with high mortality rates.

The role of embolic protection in peripheral arterial atherectomy.

Embolic protection devices were initially developed for use in the treatment of saphenous vein aortocoronary bypass graft stenosis as well as in carotid artery stenting because of the significant risk of atheroembolism and their use is well accepted. The use of these devices for lower-extremity arterial interventions is becoming well accepted because of the significant consequences of embolization in patients with limited circulatory runoff. This is especially true in the use of mechanical atherectomy devices for femoropopliteal arterial lesions.

Wall apposition assessment and performance comparison of distal protection filters.

PURPOSE: To assess the wall apposition of 3 distal protection filters used in carotid artery stenting (CAS) for cerebral protection and quantify the effect on the in vitro capture efficiency of the filters under simulated physiological flow conditions. METHODS: The 3 distal protection filters (Angioguard XP, FilterWire EZ, and RX Accunet) were deployed in silicone flow models of 5.0-, 5.5-, and 6.0-mm inner diameter and were tested at a mean flow rate characteristic of the human internal carotid artery while injecting polydispersed microspheres simulating plaque emboli. The injected microspheres had a diameter larger than the pore size of the devices tested, so it was conjectured that any microspheres missed by the device traveled between the device basket and the vessel wall. Varying the diameter of the vessel phantom within the recommended vessel diameter treatment range for each device simulated the variability of vessel diameter in vivo, allowing the quantification of device wall apposition. RESULTS: None of the devices tested completely prevented distal embolization in the flow model. The RX Accunet device has the best overall wall apposition, yielding gaps of 0.075% of the vessel cross-sectional area. The FilterWire EZ device had the best overall average filtration rate, failing to capture only 0.8% of plaque particles. There were no statistically significant differences in the wall apposition assessment or the capture efficiency of the RX Accunet and FilterWire EZ devices. CONCLUSION: Several complications related to apposition of the filter basket on the vessel wall and device retrieval were detected in all the devices. It is inferred that the adaptability of the filter basket to conform to the vessel cross section at the site of deployment is the primary design variable responsible for distal embolization during CAS with cerebral protection.

Expanding use of embolic protection devices.

Embolic protection devices were initially developed for the treatment of saphenous vein aorto-coronary bypass graft stenosis due to the significant risk of atheroembolism, and their use is well accepted. The use of these devices for carotid arterial interventions is also well accepted due to the significant consequences of embolization in the cerebral circulation. The use of these devices is extending to other vascular beds to include the renal arteries and lower extremities. We review the basic principles of these devices and their uses in various vascular beds based on our own experience as well as that in the literature.

Type 2 endoleaks after abdominal aortic aneurysm stent grafting with systematic mesenteric and lumbar coil embolization.

We evaluated the results of our policy of systematic coil embolization of the inferior mesenteric artery (IMA) and/or lumbar arteries (LAs) prior to endovascular abdominal aortic aneurysm (AAA) repair (EVAR). We retrospectively reviewed all patients undergoing EVAR over a 4-year period at one hospital. Results were analyzed using uni- and multivariate analyses. Fifty-five male patients with an average age of 71 years were evaluated. Follow-up averaged 15 +/- 13 months. The IMA was either coiled or occluded in 30 cases. One or more LAs were coiled in 29 patients. An average of 1.3 LAs per patients were coiled (range 0-6). There were no immediate or late complications from coiling. At last follow-up, 14 AAAs showed no change in diameter, one increased by 2 mm, and the remainder (n = 40) decreased by 7.5 +/- 6 mm in maximal diameter. Only five (9%) type 2 endoleaks were detected during follow-up. Three were associated with AAA size increase. Four of the five were treated with additional coiling, with good results. By logistic regression, neither endoleak occurrence nor AAA shrinkage correlated with LA or IMA coiling. However, by multivariate analysis, completeness of lumbar coiling correlated negatively with aneurysm shrinkage (p = 0.04) and IMA coiling correlated positively with aneurysm shrinkage (p = 0.04). Coil embolization of the IMA and/or LAs prior to EVAR can be safely accomplished in a large number of cases and is associated with a low incidence of type 2 endoleaks. We cannot at present demonstrate a benefit to LA embolization in terms of endoleak prevention or AAA shrinkage. However, IMA embolization may be of benefit in terms of AAA shrinkage.

Distal embolic protection during femoropopliteal atherectomy.

We report on a series of 10 consecutive cases of superficial femoral and popliteal artery atherectomy with the SilverHawk device, carried out for the treatment of peripheral vascular atherosclerosis. All cases were done with the use of a distal embolic protection device. Debris were retrieved in the filter in each case. Implications are discussed, along with a review of the available literature on this device.

Early experience in the application of distal protection devices in treatment of peripheral vascular disease of the lower extremities.

The objectives of this study were to reduce the risk of showering distal vessels with thromboemboli created during percutaneous interventions of the arteries in the lower extremities. Distal protection devices have been used in coronary and carotid interventions. Hence, using similar techniques, these filters and occlusion balloons were advanced past the targeted lesions and distally into femoral and popliteal arteries. Once opened, these devices allowed standard angioplasty and stent placement and captured the dislodged thromboemboli. Five cases were performed with the distal protection devices. One case used the distal occlusion balloon and four with the filter system. All five passed the lesion and were deployed. All five devices were retrieved without incident and were retrieved with substantial debris. There were no adverse events. The use of distal protection to treat high-risk or unstable lesions in the lower extremities shows great promise. Further case will be needed to evaluate the device for feasibility and safety.

Blunt splenic injuries: high nonoperative management rate can be achieved with selective embolization.

BACKGROUND: This retrospective review tests the hypothesis that including selective splenic arteriography and embolization in the algorithm of a previously existing nonoperative management (NOM) strategy will result in higher rates of successful NOM in patients with blunt splenic injury. METHODS: All patients with blunt splenic injuries documented by computed tomographic scan and/or operative findings over a 24-month period at a Level I trauma center were reviewed. A previously published series from this institution of 251 patients with splenic injury (Group 1) was then compared with the patients that constitute this current review (Group 2). Group 2 was then compared with patients described in a previous publication advocating nonselective arteriography in blunt splenic injuries. RESULTS: Thirteen patients with blunt splenic injury in Group 2 underwent 14 splenic embolization procedures, with 12 (93%) being successfully treated without operation. Group 2 had a significantly higher NOM rate (82% vs. 65%, p < 0.01) than Group 1. These results are similar to the series published by Sclafani et al. (82.1% vs. 83.1%) in which every patient with splenic injury that was managed non-operatively underwent arteriography with or without embolization. CONCLUSION: A high rate of NOM can be achieved with observation and selective use of arteriography with or without embolization in the management of blunt splenic injuries.

History and current status of endovascular management for the extracranial carotid and supra-aortic vessels.

Few procedures in the history of medicine have been more controversial than carotid artery stenting (CAS) for the management of carotid artery occlusive disease. Introduced just as the randomized trials were establishing carotid endarterectomy as the gold standard for carotid interventions, CAS has finally reached the point in its development when dedicated stenting systems are being tested in randomized clinical trials. Assisted by the concomitant use of distal protection devices, CAS has shown equipoise with endarterectomy in terms of safety at 30 days. This review summarizes the completed and ongoing CAS trials and the applications of endovascular techniques in the supra-aortic vessels.

Updated review of the global carotid artery stent registry.

The purpose of this article was to review and update the current status of carotid artery stent placement in the world. Surveys of major interventional centers in Europe, North and South America, and Asia were initially completed in June 1997. Subsequent updates from these 24 centers in addition to 29 new centers have been obtained to bring up to date the information. The survey asked the various questions regarding the patients enrolled, procedure techniques, and results of carotid stenting, including complications and restenosis. The total number of endovascular carotid stent procedures that have been performed worldwide to date included 12392 procedures involving 11243 patients. There was a technical success of 98.9% with 12254 carotid arteries treated. Complications that occurred during the carotid stent placement or within a 30-day period following placement were recorded. Overall, there was transient ischemic attack rate of 3.07%, minor strokes of 2.14%, major strokes of 1.20%, and procedure-related deaths of 0.64%. The combined minor and major strokes and procedure-related death rate was 3.98% based on procedure number. With nonprocedure-related death rate of 0.77%, the total stroke and death rate was 4.75%. Subsets of questions were directed at the new use of distal embolic protection devices; there were 6753 cases done without protection and which incurred a 5.29% rate of strokes and procedure-related deaths. In the 4221 cases with cerebral protection, there was a 2.23% rate of strokes and procedure-related deaths. Restenosis rates of carotid stenting have been 2.7%, 2.6%, and 2.4% at 1, 2, and 3 years, respectively. The rate of neurologic events after stent placement has been 1.2%, 1.3%, and 1.7% at 1, 2, and 3 years, respectively. Endovascular stent treatment of carotid artery atherosclerotic disease is growing as an alternative for vascular surgery, especially for patients who are high risk for standard carotid endarterectomy. The periprocedure risks for major and minor strokes and death are generally acceptable at this early stage of development and have shown an improvement with technological developments, including distal embolic protection.

Endovascular treatment of innominate artery stenosis in a bovine aortic arch--a case report.

Recent reports have established the feasibility and safety of percutaneous transluminal angioplasty and stent placement in the treatment of innominate artery occlusive disease. Although the long-term durability of these endovascular approaches has not been clearly established, they are particularly attractive in patients who are not considered good candidates for surgical reconstruction. The authors present a case involving a morbidly obese Hispanic woman who had undergone previous coronary artery bypass and complained of right visual symptoms, dizziness, and right upper extremity claudication. Because of her unusual bovine anatomy and the desire to avoid reoperating in her chest, a unique approach with a left subclavian-to-carotid bypass and innominate artery angioplasty and stenting was used.

A comparison of balloon-mounted and self-expanding stents in the carotid arteries: immediate and long-term results of more than 500 patients.

PURPOSE: To compare the rates of neurological complications and restenosis for balloon-mounted (BM) versus self-expanding (SE) stents deployed in the extracranial carotid arteries. METHODS: Among 513 patients (312 men; mean age 71.3 years, range 27-91) who underwent carotid artery stent placement, 496 received 520 stents. The patients were followed with periodic duplex ultrasound examinations; angiography was performed whenever the duplex scan identified a >50% stenosis or symptoms warranted investigation. Periprocedural data on complications were analyzed on an intention-to-treat basis, while intermediate-term neurological complications were compared in stented patients. RESULTS: In the periprocedural period, there were 19 (3.7%) transient ischemic attacks, 10 (1.9%) minor strokes, 6 (1.2%) major strokes, and 8 (1.6%) deaths among the 513 patients. Five (1.0%) of the deaths were related to neurological complications (3.9% all stroke/neurological death rate). Among the 496 patients receiving 247 (48%) BM stents and 273 (52%) SE stents in 518 arteries, the all stroke/neurological death rates were 3.6% and 4.0%, respectively (p>0.05). During a mean follow-up of 20.6 months (range to 5.6 years), the 3-year freedom from all fatal and ipsilateral nonfatal strokes excluding the 30-day periprocedural period was 95.0% for BM stents and 95.2% for SE devices. Vessel patency (>50%) at 3 years was 92.0% in the population: 96.3% for BM stents and 83.7% for SE stents (p=0.0422). CONCLUSIONS: The rate of neurological complications following carotid stenting has been relatively low overall, and no differences were found relative to the type of stent deployed. Vessel patency was excellent at 3 years, with slightly better patency in BM stents, but because of their vulnerability to compression, they will not replace SE stents.

Evaluation of glycoprotein IIb/IIIa inhibitors in carotid angioplasty and stenting.

PURPOSE: To review the immediate neurological and bleeding complications associated with the use of glycoprotein (GP) IIb/IIIa inhibitors in patients undergoing extracranial carotid artery stent placement. METHODS: A retrospective review was performed of 550 patients (321 men; mean age 71.1 years, range 28-91) who underwent carotid artery angioplasty and stent placement. Glycoprotein IIb/IIIa inhibitors were given prophylactically along with heparin to 216 patients, whose outcomes were compared to a control group of 334 patients who received intravenous heparin alone. Primary endpoints were the immediate and 30-day neurological complications, including transient ischemic attacks (TIAs), minor and major strokes, and neurologically-related deaths. The secondary endpoint was any abnormal bleeding. RESULTS: The all stroke/neurological death rate in 216 patients treated with heparin and GP IIb/IIIa inhibitors was 6.0% (13 events) compared 2.4% (8 events) in the 334 patients in the heparin-only control group (p=0.0430). Two of the 4 neurologically-related deaths in the GP IIb/IIIa inhibitor group resulted from intracranial hemorrhages; there were no intracranial hemorrhages in the heparin-only group. There was 1 episode of extracranial bleeding in the GP IIb/IIIa inhibitor group treated with embolization. The incidences of significant puncture-site bleeding requiring transfusion were similar in the groups. CONCLUSIONS: Neurological complications following percutaneous carotid artery interventions have been relatively few. The neurological sequelae in carotid stent patients receiving glycoprotein IIb/IIIa inhibitors were more numerous and consequential, which suggests that the use of GP IIb/IIIa inhibitors in carotid stenting should be discouraged.