INTRODUCTION:Portal hypertension characterizes decompensated cirrhosis and its complications. It may trigger acute-on-chronic liver failure (ACLF), which carries a high mortality. Transjugular intrahepatic portosystemic shunt (TIPS) is the most efficient therapy for most portal hypertension-related complications including fluid overload (FO) defined as refractory or recurrent ascites, hepatorenal syndrome, and/or hydrothorax. However, TIPS for FO in ACLF is questioned. METHODS:In this case-control study, patients from the prospective cohorts CANONIC (n = 1,324) and German TIPS-Registry (n = 724) were screened for cases of FO and matched 1:1 by sex, age, Model for End-Stage Liver Disease (MELD) score, and presence and grade of ACLF. Clinical outcomes, ACLF status, and mortality were assessed. RESULTS:The total population was 118 patients with ACLF of whom 59 received TIPS and 59 did not. The main indication for TIPS was hepatorenal syndrome (61.0%). Patients with ACLF who did not receive TIPS had a higher 28-day cumulative mortality rate (22.0% vs 5.1%, P = 0.009). At 28 days, TIPS insertion in ACLF was associated with a 78% mortality reduction (hazard ratio 0.22 [0.06-0.77]). It further led to improvement of hepatic encephalopathy and the MELD score. In addition, ACLF resolution occurred in 61% of TIPS patients with ACLF. The presence of coagulation and circulatory organ failures, and increased bilirubin, INR, MELD score, and CLIF-C OF were associated with 28-day mortality. The survival benefit of TIPS was no longer observed after 90 days. DISCUSSION:TIPS decreased the 28-day mortality of patients with FO and ACLF. Thus, TIPS should be regarded as a bridging strategy-ideally for liver transplantation.

So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies. The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 μg/mm2 and different coating technologies for femoropopliteal interventions from the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial. Procedural characteristics of clinically driven (CD) target lesion revascularization (TLR) were analyzed. Within a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes. At 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups. The 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543)

BACKGROUND:So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies.OBJECTIVES:The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 μg/mm2 and different coating technologies for femoropopliteal interventions from the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial. Procedural characteristics of clinically driven (CD) target lesion revascularization (TLR) were analyzed.METHODS:Within a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes.RESULTS:At 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups.CONCLUSIONS:The 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543).

AIMS:Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 μg/mm2. METHODS AND RESULTS:Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. CONCLUSION:Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. CLINICAL TRIAL REGISTRATION:The trial is registered with ClinicalTrials.gov (NCT02701543).

BACKGROUND & AIMS: We studied the effects of diameter of covered, self-expandable, nitinol stents on survival times of patients with a transjugular intrahepatic portosystemic shunt (TIPS). METHODS: We collected data from 185 patients (median age, 55 y; 30% female) who received a covered nitinol stent, from February 2006 through September 2010, using the online multicenter German TIPS registry. TIPS were given to 107 patients for refractory ascites and to 78 patients for variceal bleeding. Patients at risk of hepatic encephalopathy (owing to advanced age, prior episodes) or liver failure (bilirubin level, >3 mg/dL), and bleeding patients receiving variceal embolization at TIPS, received 8-mm stents (n = 53). The remaining patients received 10-mm stents (n = 132). Eighty-one of the 10-mm stents were underdilated using 8-mm dilation balloons. Clinical and biochemical data were collected after TIPS placement at 1 month, 3 months, 6 months, 9 months, 1 year, and thereafter every 3 to 6 months. Groups were compared using propensity score analysis. RESULTS: Patients who received 8-mm stents survived significantly longer (34 +/- 26 mo) than patients who received 10-mm stents (18 +/- 19 mo), regardless of whether they were fully dilated or underdilated. When we compared 10-mm stents with or without underdilation, we found that a significantly higher proportion of patients who received underdilated stents survived for 1 month after TIPS placement (95% vs 84%; P = .03), but not for 3 months (P = .10). In multivariate analysis, 1-year mortality correlated with full dilation of the stent to 10 mm (hazard ratio [HR], 2.0; 95% CI, 1.1-3.5) and with serum creatinine concentration at baseline (HR, 1.5; 95% CI, 1.0-1.7). Five-year mortality was associated with use of the 10-mm stents (HR, 1.8; 95% CI, 1.4-2.7) and baseline concentration of creatinine (HR, 1.3; 95% CI, 1.1-1.6). CONCLUSIONS: A smaller stent (nominal diameter of 8 mm, but not underdilation of a 10-mm stent) is associated with a prolonged survival compared with 10-mm stents, independent of liver-specific prognostic criteria.

To assess changes in portal and splanchnic arterial haemodynamics in patients undergoing transjugular intrahepatic portosystemic shunt (TIPS) using four-dimensional (4D) flow MRI, a non-invasive, non-contrast imaging technique.

BACKGROUND:Portal hypertension and hepatocellular carcinoma (HCC) are major complications of advanced liver cirrhosis. Thus, patients are often affected by both complications. Transjugular intrahepatic portosystemic shunt (TIPSS) is an effective treatment for portal hypertension and its complications. However, no established guidelines for the treatment of symptomatic portal hypertension in HCC patients are currently available. In addition, only limited information exists about the consequence of TIPSS implantation in patients with HCC.AIM:To evaluate the efficacy, safety and overall survival in HCC patients who underwent TIPSS implantation.METHODS:Forty HCC patients with portal hypertension who were treated with TIPSS between 1995 and 2012 were included in the analysis. Medical records and imaging studies were analysed. The indication for TIPSS implantation, procedure-related complications, treatment success and overall survival were assessed.RESULTS:TIPSS implantation was performed in 23 patients (57.5%) due to treatment refractory ascites, in 14 patients (35.0%) due to recurrent variceal bleeding and in three patients (7.5%) due to ascites and variceal bleeding. Primary technical success was assessed in all patients. After TIPSS implantation, no variceal bleeding reoccurred and ascites was controlled in 74.1%. No severe procedure-related complications and no deterioration of liver function were observed. Post-TIPSS hepatic encephalopathy occurred in 40.0% of all patients. 30-day, 90-day-, 1-year- and 5-year survival rates were 97.5%, 75.0%, 42.5% and 7.5%, respectively. Median overall survival after TIPSS implantation was 180 days.CONCLUSION:Transjugular intrahepatic portosystemic shunt implantation is an effective and safe treatment for portal hypertension in patients with HCC.

Die Bestimmung des portosystemischen Druckgradienten als Differenz zwischen dem Lebervenenverschlussdruck und dem Druck in der freien Lebervene ist ein gängiges Verfahren, um das Ausmaß der portalen Hypertension und den Strömungswiderstand der Leber festzustellen. Das Verfahren wird auch eingesetzt, um Therapieeffekte von Medikamenten (z.B. ß-Blocker) zu quantifizieren. Da diese sich in einem Bereich zwischen 1 und 4 mm Hg bewegen, ist zu fordern, dass die Technik reproduzierbare Ergebnisse mit geringer Abweichung liefert. Da die Bestimmung des freien Lebervenendruckes gelegentlich nicht reproduzierbare Ergebnisse liefert, wurde empfohlen, den Druck in der V. cava inferior (VCI) auf Höhe der Einmündung der Lebervenen ebenfalls zu bestimmen und, bei einer Abweichung > 2 mm Hg diesen, und nicht den freien Lebervenendruck zur Berechnung des Gradienten zu verwenden (Groszmann RJ, Hepatology 2004;39:280).

Background and aims: Portal hypertension and hepatocellular carcinoma (HCC) are major complications of advanced liver cirrhosis. As HCC typically represents a late-stage complication of liver cirrhosis, most of these patients are also affected by symptomatic portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment for portal hypertension and its complications. However, no established guidelines for the treatment of portal hypertension in HCC patients are currently available and only limited information exists about the consequence of TIPS implantation in patients with HCC. Therefore, we evaluated the efficacy, safety and overall survival (OS) in HCC patients who underwent TIPS implantation.

OBJECTIVESAortic dissection DeBakey type I and II may require distal reinterventions after initial proximal repair. We evaluated outcomes following open versus endovascular approaches to distal aortic pathologies after surgery for acute dissection.METHODSOne hundred and forty-one consecutive patients underwent 152 distal reinterventions after previous type I or II dissection repair [63 (first quartile, 55; third quartile, 72) years old; initially 86% DeBakey type I; 54% hemiarch, 39% isolated ascending, 7% total arch replacement] at two tertiary centres in the USA and Europe over the last 14 years. Among them, 56 and 85 required reintervention for the aortic arch and the descending aorta, respectively. The median follow-up was 2.1 (first quartile, 0.8; third quartile, 5.8) years (439 patient-years).RESULTSThe median time between acute aortic dissection repair and descending aortic reintervention was longer in the open group (2.7 (first quartile, 0.8; third quartile, 6.7) vs 0.6 (first quartile, 0.1; third quartile, 3.5) years, P < 0.01). There was one irreversible spinal ischaemia in the open and one stroke in the endovascular group. Two patients in the open and none in the endovascular group required re-exploration for bleeding. Two open and 4 endovascular patients required more than 1 distal reintervention (6 vs 8%, P = 1). Descending aortic open-repair patients experienced higher in-hospital mortality (23 vs 0%, P < 0.01) and lower survival at 1 and 5 years (74 ± 8% vs 96 ± 3%, 65 ± 9% vs 92 ± 5%, P < 0.01, respectively).CONCLUSIONSEndovascular intervention for descending aortic pathologies after DeBakey type I or II dissection surgical repair is associated with lower in-hospital mortality and better survival, and does not raise the likelihood of later reinterventions at the mid-term follow-up.

Hintergrund: Die hepatische Enzephalopathie (HE) ist, ebenso wie der Child- und MELD-score bei Patienten mit Leberzirrhose ein zuverlässiger Prädiktor der Mortalität. Dies trifft insbesondere auch für Patienten zu, die einen TIPS erhalten haben. In der vorliegenden Studie wird an einer großen Zahl von Patienten überprüft, inwieweit diese Aussage auch für einzelne Untergruppen mit verschiedenen TIPS-Indikationen (Blutung, therapie-refraktärer Aszites, hepatorenales Syndrom) zutrifft. Die Studie zeigt, dass eine sehr viel differenziertere Betrachtung erforderlich ist und lenkt die Indikationsstellung zur TIPS-Anlage in eine neue Richtung.

PurposeTo evaluate influence of variation in spatio‐temporal resolution and scan‐rescan reproducibility on three‐dimensional (3D) visualization and quantification of arterial and portal venous (PV) liver hemodynamics at four‐dimensional (4D) flow MRI.MethodsScan‐rescan reproducibility of 3D hemodynamic analysis of the liver was evaluated in 10 healthy volunteers using 4D flow MRI at 3T with three different spatio‐temporal resolutions (2.4 × 2.0 × 2.4 mm3, 61.2 ms; 2.5 × 2.0 × 2.4 mm3, 81.6 ms; 2.6 × 2.5 × 2.6 mm3, 80 ms) and thus different total scan times. Qualitative flow analysis used 3D streamlines and time‐resolved particle traces. Quantitative evaluation was based on maximum and mean velocities, flow volume, and vessel lumen area in the hepatic arterial and PV systems.Results4D flow MRI showed good interobserver variability for assessment of arterial and PV liver hemodynamics. 3D flow visualization revealed limitations for the left intrahepatic PV branch. Lower spatio‐temporal resolution resulted in underestimation of arterial velocities (mean 15%, P < 0.05). For the PV system, hemodynamic analyses showed significant differences in the velocities for intrahepatic portal vein vessels (P < 0.05). Scan‐rescan reproducibility was good except for flow volumes in the arterial system.Conclusion4D flow MRI for assessment of liver hemodynamics can be performed with low interobserver variability and good reproducibility. Higher spatio‐temporal resolution is necessary for complete assessment of the hepatic blood flow required for clinical applications. Magn Reson Med 72:477–484, 2014. © 2013 Wiley Periodicals, Inc.

OBJECTIVES:To investigate mid-term outcome in patients undergoing thoracic endovascular aortic repair (TEVAR) for non-dissected aortic pathology with favourable and unfavourable landing zone and aortic anatomy. METHODS:Between 2000 and 2011, TEVAR was performed in 208 patients with descending thoracic aortic disease. Of 105 patients with non-dissected thoracic aortic pathology, 69 presented with unfavourable anatomy as defined by short length (<15 mm), large diameter (>42 mm), angulation of >60° of the proximal or distal landing zone or extreme aortic tortuosity. The endpoints perioperative mortality, 1-year survival, endoleak occurrence and incidence of secondary intervention were compared with the remaining 36 patients with favourable anatomy. RESULTS:Median follow-up was 18 months. TEVAR was performed emergently in 24 of 69 (35%) patients with unfavourable anatomy and in 11 of 36 (31%) of those with favourable anatomy (P = 0.68). No patients underwent conversion to open surgery, no periinterventional rupture was observed. Perioperative mortality did not differ between cohorts (1/69 vs 1/36, P = 0.78). Postoperative permanent spinal cord ischaemia occurred in patients with unfavourable anatomy only (2/69 vs 0/36, P = 0.78). Early endoleak and secondary intervention were more frequent in patients with unfavourable anatomy (19/69 vs 7/36 and 13/69 vs 1/36), but not statistically significant (P = 0.5 and P = 0.13, respectively). One-year aorta-related survival rates were similar in both groups (66/69 vs 33/36, P = 0.45). CONCLUSIONS:Mid-term outcome after TEVAR does not differ between patients with favourable and unfavourable landing zone anatomy in terms of aorta-related survival. However, the more frequent need for secondary intervention warrants a more rigorous follow-up after TEVAR in patients with unfavourable anatomy.

Purpose To evaluate the feasibility of time-resolved flow-sensitive four-dimensional (4D) MRI for the visualization and quantification of splanchnic arterial and portal venous hemodynamics in patients with cirrhosis and in controls. Materials and methods We applied flow-sensitive 4D MRI to evaluate arterial and portal venous three-dimensional blood flow in patients with advanced liver cirrhosis (n=5) and in healthy controls (n=10) using 3T MRI (spatial resolution=1.7×2.1×2.4 mm3, temporal resolution=62.4 ms). The qualitative flow was analyzed using three-dimensional streamlines and time-resolved particle traces. Retrospective flow was quantified in nine predefined anatomic regions evaluating maximum and mean velocities, the flow volume, the vessel lumen area, pulsatility indices, and resistance indices. Doppler ultrasound (US) was our reference standard. Results Flow-sensitive 4D MRI visualized liver hemodynamics successfully in 91% of patients and 96% of volunteers with limitations for the patients’ extrahepatic vessels (one case of splenic and superior mesenteric veins each) and intrahepatic portal vein branches (in five vessels). Healthy control individuals revealed reduced velocities and larger vessel areas in MRI than in Doppler US. We found no significant differences in the flow volume, pulsatility indices, and resistance indices on comparing MRI with US. Regional flow quantification within the splanchnic system of healthy volunteers and liver cirrhosis patients revealed an increase in the inflow (up to 65%), but a decrease in the patients’ outflow (up to 37%). Conclusion Flow-sensitive 4D MRI is feasible for profound evaluation of arterial and portal venous hemodynamics in liver cirrhosis patients, providing additional information on the pathophysiology of the altered splanchnic system.

The study was to test the hypothesis that mesenteric and renal arteries may be occluded by intra-aortic balloon pumps (IABPs), despite correct positioning. Computed tomography scans of 107 patients (34.6% women and 65.4% men) were evaluated for diameter and distance measurements of the descending aorta. Renal perfusion was examined with duplex sonography. Mean distances between left subclavian artery and celiac trunk, between the left subclavian and superior mesenteric artery, and between the left subclavian and renal artery were 214.5 ± 22.3, 229.5 ± 22.3, and 242.9 ± 22.1 mm, respectively. Statistical assessment of aortic distances in patient population showed no correlation between the length of the descending aorta and body mass index (BMI) and height (men: R2 < 0.13; women: R2 < 0.3). An impaired arterial perfusion of the renal parenchyma existed in three of the 12 patients; three of the 12 demonstrated diastolic oscillatory flow over the renal arteries; two of the 12 patients presented both during IABP support. Autopsy observation was used to observe the position of the IABP catheter. The correlation between patient height/BMI and the distances between subclavian artery and renal/visceral branches is weak. Therefore, even if positioned correctly, intra-aortic balloon catheters may be too long and could potentially cause occlusion of aortic branches.