Episodic overt hepatic encephalopathy after transjugular intrahepatic portosystemic shunt does not increase mortality in patients with cirrhosis.

BACKGROUND & AIMS: Overt hepatic encephalopathy (OHE) is a major complication of transjugular intrahepatic portosystemic shunt (TIPS) placement, given its high incidence and possibility of refractoriness to medical treatment. Nevertheless, the impact of post-TIPS OHE on mortality has not been investigated in a large population. METHODS: We designed a multicenter, non-inferiority, observational study to evaluate the mortality rate at 30 months in patients with and without OHE after TIPS. We analyzed a database of 614 patients who underwent TIPS in three Italian centers and estimated the cumulative incidence of OHE and mortality with competitive risk analyses, setting the non-inferiority limit at 0.12. RESULTS: During a median follow-up of 30 months (IQR 12-30), 293 patients developed at least one episode of OHE. Twenty-seven (9.2%) of them experienced recurrent/persistent OHE. Patients with OHE were older (64 [57-71] vs. 59 [50-67] years, p <0.001), had lower albumin (3.1 [2.8-3.5] vs. 3.25 [2.9-3.6] g/dl, p = 0.023), and had a higher prevalence of pre-TIPS OHE (15.4% vs. 9.0%, p = 0.023). Child-Pugh and MELD scores were similar. The 30-month difference in mortality between patients with and without post-TIPS OHE was 0.03 (95% CI -0.042 to 0.102). Multivariable analysis showed that age (subdistribution hazard ratio 1.04, 95% CI 1.02-1.05, p <0.001) and MELD score (subdistribution hazard ratio 1.09, 95% CI 1.05-1.13, p <0.001), but not post-TIPS OHE, were associated with a higher mortality rate. Similar results were obtained when patients undergoing TIPS for variceal re-bleeding prophylaxis (n = 356) or refractory ascites (n = 258) were analyzed separately. The proportion of patients with persistent OHE after TIPS was significantly higher in the group of patients who died. The robustness of these results was increased following propensity score matching. CONCLUSION: Episodic OHE after TIPS is not associated with mortality in patients undergoing TIPS, regardless of the indication. IMPACT AND IMPLICATIONS: Overt hepatic encephalopathy (OHE) is a common complication in patients with advanced liver disease and it is particularly frequent following transjugular intrahepatic portosystemic shunt (TIPS) placement. In patients with cirrhosis outside the setting of TIPS, the development of OHE negatively impacts survival, regardless of the severity of cirrhosis or the presence of acute-on-chronic liver failure. In this multicenter, non-inferiority, observational study we demonstrated that post-TIPS OHE does not increase the risk of mortality in patients undergoing TIPS, irrespective of the indication. This finding alleviates concerns regarding the weight of this complication after TIPS. Intensive research to improve patient selection and risk stratification remains crucial to enhance the quality of life of patients and caregivers and to avoid undermining the positive effects of TIPS on survival.

Mortality after transjugular intrahepatic portosystemic shunt in older adult patients with cirrhosis: A validated prediction model.

BACKGROUND AND AIMS: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) improves survival in patients with cirrhosis with refractory ascites and portal hypertensive bleeding. However, the indication for TIPS in older adult patients (greater than or equal to 70 years) is debated, and a specific prediction model developed in this particular setting is lacking. The aim of this study was to develop and validate a multivariable model for an accurate prediction of mortality in older adults. APPROACH AND RESULTS: We prospectively enrolled 411 consecutive patients observed at four referral centers with de novo TIPS implantation for refractory ascites or secondary prophylaxis of variceal bleeding (derivation cohort) and an external cohort of 415 patients with similar indications for TIPS (validation cohort). Older adult patients in the two cohorts were 99 and 76, respectively. A cause-specific Cox competing risks model was used to predict liver-related mortality, with orthotopic liver transplant and death for extrahepatic causes as competing events. Age, alcoholic etiology, creatinine levels, and international normalized ratio in the overall cohort, and creatinine and sodium levels in older adults were independent risk factors for liver-related death by multivariable analysis. CONCLUSIONS: After TIPS implantation, mortality is increased by aging, but TIPS placement should not be precluded in patients older than 70 years. In older adults, creatinine and sodium levels are useful predictors for decision making. Further efforts to update the prediction model with larger sample size are warranted.

Rivaroxaban in Peripheral Artery Disease after Revascularization.

BACKGROUND: Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain. METHODS: In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome. RESULTS: A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007). CONCLUSIONS: In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

BACKGROUND: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER. METHODS: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee. RESULTS: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (P-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; P=0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (P-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (P-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; P=0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (P=0.95) and postprocedural bleeding requiring intervention (P=0.93) was not significantly increased. CONCLUSIONS: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.

Portosystemic shunt is an effective treatment for complications of portal hypertension in hepatic myeloid metaplasia and improves nutritional status.

In patients affected by myelofibrosis with hepatic myeloid metaplasia (HMM), portal hypertension (PHT) complications may develop. In this case series, we analysed the efficacy and safety of transjugular portosystemic shunt (TIPS) in the treatment of PHT-related complications and its effects on the nutritional status. Six patients were evaluated and the average follow-up period after TIPS was 33 (IQR 5) months. None of the patients developed hepatic failure, nor any recurrence of variceal bleeding was recorded. No additional paracentesis or endoscopic prophylactic treatment for PHT-related complications were required. In all subjects, the average dose of diuretics was almost halved three months after TIPS. Three patients died during the follow-up, but none for liver-related causes. All patients showed an improvement in the global nutritional status. In conclusion, TIPS represent an effective and safe treatment option for patients affected by complications of PHT secondary to HMM and drives to an improvement of the nutritional status.

Direct percutaneous embolization of aneurysm sac: a safe and effective procedure to treat post-EVAR type II endoleaks.

PURPOSE: To report safety and effectiveness of type II endoleak embolization, with percutaneous direct aneurysm sac puncture. MATERIALS AND METHODS: Fifty patients, 31 male (mean age 55 ± 5), with post-EVAR type-II endoleak underwent direct percutaneous sac puncture for embolization. Procedures were performed, under local anesthesia. Sac puncture was done using a 20G needle under rotational angiography guidance. A coaxial system (4 Fr catheter + 2.7 microcatheter) was used to navigate the sac. During the follow-up period, all patients underwent contrast-enhanced ultrasound (CEUS) at 6 and 12 months. RESULTS: Technical success, with complete exclusion of the aneurysm sac, was achieved in all cases. Time of procedure varied between 36 and 68 min (mean 51.36 min). Mean fluoroscopy time was 16.7 min. A posterior left access was used in 41 cases, posterior right access in 6 cases, and an anterior approach in 3. In 19 cases (38%), one or more feeding vessels were visualized and embolized. Sac embolization was done using Onyx plus micro-coils in 31 cases (62%) and Onyx alone in 19 cases (38%). Mean amount of Onyx was 6 ml. No complications, correlated with the direct percutaneous sac puncture, or to Onyx injection occurred. After 1-year follow-up, sac shrinkage occurred in 34 cases (68%), while in 16 patients (32%) sac size remained stable without evidence of sac perfusion. CONCLUSION: Percutaneous direct sac embolization using Onyx in combination or not with microcoils represents a safe and valid technique to solve post-EVAR type II endoleaks.

Provisional Stenting Using the Zilver PTX Drug-Eluting Stent After Drug-Coated Balloon Angioplasty: Initial Experience From the Double Drug Dose "3D" Study.

Purpose: To explore the provisional use of a drug-eluting stent (DES) after suboptimal drug-coated balloon (DCB) angioplasty in complex, calcified femoropopliteal lesions. Materials and Methods: A prospective, single-center, investigator-initiated pilot study enrolled 15 patients (mean age 71.3 years; 9 men) with symptomatic stenosis (n=6) or occlusion (n=9) of the native superficial femoral and/or proximal popliteal arteries who experienced suboptimal DCB dilation despite postdilation. Lesion characteristics were evaluated with computed tomography angiography and duplex ultrasound confirmed by intravascular ultrasound. Follow-up included clinical and imaging evaluations as well as blood tests to monitor inflammatory markers. Endpoints included systemic inflammation, acute/chronic thrombosis, aneurysm formation, and mortality. Results: Provisional stenting was required for residual stenosis >50% in 4 cases and flow-limiting dissection in 11. Provisional spot stenting was done using the Zilver PTX DES. Clinical improvement was observed in all cases. After 24-month follow-up all patients were alive and in good clinical condition. One- and 2-year primary patency rates were 93.3% and 92.9%, respectively; secondary patency was 100%. Restenosis required reintervention in 2 cases. No local or systemic complications or toxicity were observed due to the use of a double dose of paclitaxel. No significant increase in any inflammation marker was observed in the perioperative period, and no aneurysm formation was seen over 24 months of follow-up. Conclusion: Combined DCB plus DES therapy seems to be safe and correlated with high primary patency following suboptimal angioplasty. Larger studies are required to confirm the safety and efficacy of this approach.

Updated Clinical and Radiological Classification of Lower Limb Atherosclerotic Disease.

Lower limb atherosclerotic disease has classically been classified as acute or chronic; however, this is an evolving process that has a wide spectrum of clinical and imaging aspects. Owing to the evolvement of endovascular and imaging techniques, we have now garnered new information regarding the pathophysiology and behavior of atherosclerotic disease, also in response to endovascular and surgical techniques. Clinical presentation can actually be classified according to the time of presentation, ranging from acute (<2 weeks) and subacute (from 2 weeks to 3 months) to chronic (over 3 months) and acute/subacute on underlying chronic disease. Imaging characteristics such as the presence of thrombus, number of collaterals, and target vessel wall features may help in defining the correct type of atherosclerotic lesion, triggering the appropriate treatment strategy. Clinical and imaging characteristics of those different stages are complex and not systematically addressed by current guidelines, that do not show any specific recommendations for imaging pathways/characteristics or treatment. This review illustrates the clinical and imaging characteristics of the different stages of lower limb atherosclerotic disease and related treatment options.

Under-dilated TIPS Associate With Efficacy and Reduced Encephalopathy in a Prospective, Non-randomized Study of Patients With Cirrhosis.

BACKGROUND & AIMS: Portosystemic encephalopathy (PSE) is a major complication of trans-jugular intrahepatic porto-systemic shunt (TIPS) placement. Most devices are self-expandable polytetrafluoroethylene-covered stent grafts (PTFE-SGs) that are dilated to their nominal diameter (8 or 10 mm). We investigated whether PTFE-SGs dilated to a smaller caliber (under-dilated TIPS) reduce PSE yet maintain clinical and hemodynamic efficacy. We also studied whether under-dilated TIPS self-expand to nominal diameter over time. METHODS: We performed a prospective, non-randomized study of 42 unselected patients with cirrhosis who received under-dilated TIPS (7 and 6 mm) and 53 patients who received PTFE-SGs of 8 mm or more (controls) at referral centers in Italy. After completion of this study, dilation to 6 mm became the standard and 47 patients were included in a validation study. All patients were followed for 6 months; Doppler ultrasonography was performed 2 weeks and 3 months after TIPS placement and every 6 months thereafter. Stability of PTFE-SG diameter was evaluated by computed tomography analysis of 226 patients with cirrhosis whose stent grafts increased to 6, 7, 8, 9, or 10 mm. The primary outcomes were incidence of at least 1 episode of PSE grade 2 or higher during follow up, incidence of recurrent variceal hemorrhage or ascites, incidence of shunt dysfunction requiring TIPS recanalization, and reduction in porto-caval pressure gradient. RESULTS: PSE developed in a significantly lower proportion of patients with under-dilated TIPS (27%) than controls (54%) during the first year after the procedure (P = .015), but the proportions of patients with recurrent variceal hemorrhage or ascites did not differ significantly between groups. No TIPS occlusions were observed. These results were confirmed in the validation cohort. In an analysis of self-expansion of stent grafts, during a mean follow-up period of 252 days after placement, none of the PTFE-SGs self-expanded to the nominal diameter in hemodynamically relevant sites (such as portal and hepatic vein vascular walls). CONCLUSIONS: In prospective, non-randomized study of patients with cirrhosis, we found under-dilation of PTFE-SGs during TIPS placement to be feasible, associated with lower rates of PSE, and effective.

Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD).

BACKGROUND: Patients with peripheral artery disease (PAD) undergoing a lower-extremity revascularization are at heightened risk for ischemic cardiac and limb events. Although intensification of antithrombotic therapy after revascularization has demonstrated benefit in coronary disease populations, this approach has not been well studied or shown consistent benefit in PAD. Recent trial evidence demonstrated that a treatment strategy of rivaroxaban added to background antiplatelet therapy reduced ischemic risk in patients following recent acute coronary syndromes, as well as in patients with stable atherosclerotic vascular disease. Whether these benefits extend to the population of patients with symptomatic lower-extremity PAD undergoing revascularization is the objective of the VOYAGER PAD trial. STUDY DESIGN: VOYAGER PAD is an international randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of rivaroxaban in symptomatic PAD patients undergoing a peripheral surgical and/or endovascular revascularization. Patients are randomized in a 1:1 ratio to either rivaroxaban 2.5 mg twice daily or placebo, on a background of low-dose aspirin (100 mg daily). In addition, the use of a limited course of P2Y12 inhibition is allowed at the discretion of the site investigator. The primary efficacy end point is a novel composite of myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, and major amputation of vascular etiology. The primary safety end point is major bleeding according to the Thrombolysis in Myocardial Infarction definition. Enrolment began in August 2015 and will complete randomization of at least 6,500 patients by January 2018. This event-driven trial is expected to observe outcomes over a mean patient follow-up of 30 months. CONCLUSIONS: VOYAGER PAD is evaluating the efficacy of rivaroxaban added to background antiplatelet therapy to reduce major cardiovascular and limb ischemic vascular outcomes in the high-risk population of PAD patients undergoing peripheral revascularization.

Comparison of Image Quality and Diagnostic Performance of Cone-Beam CT during Drug-Eluting Embolic Transarterial Chemoembolization and Multidetector CT in the Detection of Hepatocellular Carcinoma.

PURPOSE: To compare image quality and diagnostic performance of cone-beam computed tomography (CT) and multidetector CT in the detection of hypervascular hepatocellular carcinoma (HCC) in patients with cirrhosis undergoing transarterial chemoembolization with drug-eluting embolic agents. MATERIALS AND METHODS: Fifty-five consecutive patients referred for chemoembolization of hypervascular HCC were prospectively enrolled. Imaging included preprocedural multidetector CT within 1 month before planned treatment, intraprocedural cone-beam CT, and 1-month follow-up multidetector CT. Analysis of image quality was performed with calculations of lesion-to-liver contrast-to-noise ratio (LLCNR) and lesion-to-liver signal-to-noise-ratio (LLSNR). One-month follow-up multidetector CT was considered the reference standard for the detection of HCC nodules. RESULTS: Median LLCNR values were 3.94 (95% confidence interval [CI], 3.06-5.05) for preprocedural multidetector CT and 6.90 (95% CI, 5.17-7.77) for intraprocedural cone-beam CT (P < .0001). Median LLSNR values were 11.53 (95% CI, 9.51-12.44) for preprocedural multidetector CT and 9.36 (95% CI, 8.12-10.39) for intraprocedural cone-beam CT (P < .0104). Preprocedural multidetector CT detected 115 hypervascular nodules with typical HCC behavior, and cone-beam CT detected 15 additional hypervascular nodules that were also visible on 1-month follow-up multidetector CT. CONCLUSIONS: Cone-beam CT has a significantly higher diagnostic performance compared with preprocedural multidetector CT in the detection of HCCs and can influence management of patients with cirrhosis by identifying particularly aggressive tumors.

True Aneurysm of the Inferior Thyroid Artery: A Case Report and Literature Review.

Aneurysms of the inferior thyroid artery (ITA) are extremely rare and potentially determine severe sequelae. We report a case of true ITA aneurysm in a 45-year-old Caucasian woman treated with endovascular embolization; postoperative course was uneventful and, at 6-month follow-up, the aneurysm is completely thrombized. A systematic review of the literature has been also performed to identify the epidemiologic and clinical characteristics and diagnostic and operative options of this disease. Size alone is not able to predict the fate of the aneurysm and an aggressive treatment seems to be justified because of the high risk of complications in case of rupture. In an emergency setting, the endovascular procedures associated to hematoma evacuation or open surgery should be rapidly performed to save patient life.

Endovascular Solution of Acute Limb Ischemia Engendered by Persistent Sciatic Artery Pseudoaneurysm due to Stent Fracture.

We report a case of acute limb ischemia (ALI) due to a thromboembolism from a persistent sciatic artery (PSA) pseudoaneurysm precipitated by a fractured stent. Patient, previously treated for ALI by fibrinolysis and stent implantation, presented with a PSA pseudoaneurysm (undetected during first hospitalization), stent fracture (SF), and occlusion of vessels below the knee. Fibrinolysis was performed, restoring direct flow to the foot. A week later, an endovascular procedure was attempted to reline SF and exclude the PSA pseudoaneurysm by deployment of two 13 × 100-mm peripheral endografts (Viabahn; W.L. Gore & Associates, Flagstaff, AZ). At 1-year follow-up, patient was asymptomatic without further clinical events.

Color Doppler Ultrasound with Superb Microvascular Imaging Compared to Contrast-enhanced Ultrasound and Computed Tomography Angiography to Identify and Classify Endoleaks in Patients Undergoing EVAR.

BACKGROUND: The aim of the study was to evaluate the diagnostic effectiveness of color Doppler ultrasound (CDUS) with superb microvascular imaging (SMI) compared to contrast-enhanced ultrasound (CEUS), computed tomography (CT) multislice angiography (64 slices), and angiography required for therapeutic reasons, for follow-up after endovascular aneurysm repair (EVAR). METHODS: From March 2014 to May 2015, 57 patients treated with EVAR were evaluated with CT, CEUS, CDUS, SMI, and angiography in cases requiring treatment. Evaluation included sac diameter, stent-graft integrity, identification, and classification of endoleaks. Sensitivity, specificity, accuracy, and negative and positive predictive values were evaluated for each modality of endoleak identification. RESULTS: Eight endoleaks (16.3%), all type II, were documented. Sensitivity of CT, CEUS, CDUS and SMI was 88%, 100%, 63%, and 75%, respectively. Specificity of CT, CEUS, CDUS, and SMI was 100%, 100%, 96%, and 98%, respectively With SMI, CDUS sensitivity significantly increased, whereas specificity did not register great differences. CONCLUSIONS: SMI was more accurate than CDUS but less accurate than CEUS and CT to identify endoleaks after EVAR. SMI could be concretely used in the follow-up phase to increase CDUS accuracy especially in patients who cannot be studied with CEUS or CT.

Updated Management of Malignant Biliary Tract Tumors: An Illustrative Review.

The management of malignant biliary tumors (MBTs) is complex and requires a multidisciplinary approach. Guidelines and methods of staging for biliary tumors have recently been released by main international societies, altering the clinical and radiologic approach to this pathologic condition. The aim of the present review is to detail the updated role of imaging in preoperative staging and follow-up and to illustrate clinical/therapeutic pathways. In addition, future perspectives on imaging and targeted/embolization therapies are outlined.

Use of ultrasound in the insertion of a vascular closure device: a comparative retrospective study with the standard blind technique.

PURPOSE: To evaluate whether ultrasound (US) assistance can decrease the rate of complications related to the use of vascular closure devices (VCDs). MATERIALS AND METHODS: A retrospective comparative study was done on 150 consecutive patients who had a VCD inserted under US guidance after retrograde common-femoral-artery (CFA) puncture. This group was compared to a historical control group of 150 consecutive patients who had the same VCDs inserted with the standard blind technique. After the procedures, patients were placed at bedrest for at least 6 h. Technical success, defined as correct deployment without adjunctive manual compression, blood count and US evaluation of the arterial puncture site was done at 24 h and at 3 months. Differences in terms of efficacy and safety were statistically evaluated using US guidance as a predictor for a lower complication rate. RESULTS: Technical success was achieved in 147/150 patients (98 %) in the study group vs. 141/150 cases (94 %) of the control group (p = 0.038). In three cases (2 %) adjunctive manual compression (≤5 min) was required. One pseudoaneurysm (0.65 %) occurred after 24 h, solved with manual compression. Six minor complications (4 %)--haematoma (n = 5; 3.35 %), recurrent wound bleeding (n = 1; 0.65 %)--were reported. In the control group four (2.65 %) major complications occurred: CFA occlusion managed with surgical bypass, CFA dissection solved by surgical bypass, two pseudoaneurysms solved with manual compression. Thirteen (8.65 %) minor complications were observed with haematoma (n = 10; 6.65 %), and recurrent wound bleeding (n = 3; 2.0 %). The comparative analysis of the total complication rate and major complication rate between the study group and the control group was statistically significant (p = 0.016 and p = 0.049, respectively). A 24-h evaluation showed a triphasic flow within the CFA in 150/150 patients (100 %) of the study group and in 146/150 cases (97.35 %) of the control group. CONCLUSION: VCD inserted under US guidance increases the success rate reducing the number of complications.

Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era.

UNLABELLED: To analyse data comparing drug-eluting devices versus non-coated devices in the treatment of vascular disease in the infrapopliteal region. All data available in the literature (16 studies were included) comparing drug-eluting stents (DESs) and drug-eluting balloons (DEBs) versus bare-metal stents (BMSs) and conventional balloons were analysed. For each single study, primary and secondary endpoints were reported. As comparative studies between DEBs and DESs were not available, a technical evaluation of the advantages and disadvantages of both were also included. Besides the limitations of the published studies, all of them were reporting interesting results for the new generation devices (DEB and DES). DES: primary patency at 1 year comprised between 75.0 % and 86 %; target lesion revascularisation between 8.7 % and 13.8 %. DEB: primary patency comprised between 71 % and 84.6 % at 12 months; target lesion revascularisation between 15.3 % and 17.6 %. However, limb salvage rates were not always higher using a DEB rather than a standard percutaneous transluminal angioplasty (PTA); a clinical improvement for patients treated with DEB was demonstrated only in the Leipzig registry. On the basis of the results available, the drug-eluting devices produced better results. DEB can be considered the leading approach in below-the-knee disease. A comparative evaluation with DES is mandatory in the future. KEY POINTS: •We present data about advanced endovascular treatment of peripheral artery disease. •This provides an update on drug-eluting devices in infrapopliteal vascular disease. •Drug-eluting devices (DEB/DES) show promising results compared with traditional ones.