Algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection in the Netherlands: an open-label, nationwide, stepped-wedge cluster-randomised trial.

BACKGROUND: Early recognition and management of postoperative complications, before they become clinically relevant, can improve postoperative outcomes for patients, especially for high-risk procedures such as pancreatic resection. METHODS: We did an open-label, nationwide, stepped-wedge cluster-randomised trial that included all patients having pancreatic resection during a 22-month period in the Netherlands. In this trial design, all 17 centres that did pancreatic surgery were randomly allocated for the timing of the crossover from usual care (the control group) to treatment given in accordance with a multimodal, multidisciplinary algorithm for the early recognition and minimally invasive management of postoperative complications (the intervention group). Randomisation was done by an independent statistician using a computer-generated scheme, stratified to ensure that low-medium-volume centres alternated with high-volume centres. Patients and investigators were not masked to treatment. A smartphone app was designed that incorporated the algorithm and included the daily evaluation of clinical and biochemical markers. The algorithm determined when to do abdominal CT, radiological drainage, start antibiotic treatment, and remove abdominal drains. After crossover, clinicians were trained in how to use the algorithm during a 4-week wash-in period; analyses comparing outcomes between the control group and the intervention group included all patients other than those having pancreatic resection during this wash-in period. The primary outcome was a composite of bleeding that required invasive intervention, organ failure, and 90-day mortality, and was assessed by a masked adjudication committee. This trial was registered in the Netherlands Trial Register, NL6671. FINDINGS: From Jan 8, 2018, to Nov 9, 2019, all 1805 patients who had pancreatic resection in the Netherlands were eligible for and included in this study. 57 patients who underwent resection during the wash-in phase were excluded from the primary analysis. 1748 patients (885 receiving usual care and 863 receiving algorithm-centred care) were included. The primary outcome occurred in fewer patients in the algorithm-centred care group than in the usual care group (73 [8%] of 863 patients vs 124 [14%] of 885 patients; adjusted risk ratio [RR] 0·48, 95% CI 0·38-0·61; p<0·0001). Among patients treated according to the algorithm, compared with patients who received usual care there was a decrease in bleeding that required intervention (47 [5%] patients vs 51 [6%] patients; RR 0·65, 0·42-0·99; p=0·046), organ failure (39 [5%] patients vs 92 [10%] patients; 0·35, 0·20-0·60; p=0·0001), and 90-day mortality (23 [3%] patients vs 44 [5%] patients; 0·42, 0·19-0·92; p=0·029). INTERPRETATION: The algorithm for the early recognition and minimally invasive management of complications after pancreatic resection considerably improved clinical outcomes compared with usual care. This difference included an approximate 50% reduction in mortality at 90 days. FUNDING: The Dutch Cancer Society and UMC Utrecht.

Twelve-Month Outcomes of Intravascular Lithotripsy for Treatment of Calcified Popliteal and Infrapopliteal Lesions in Patients With Chronic Limb-Threatening Ischemia.

PURPOSE: Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. METHODS: This prospective, multicenter cohort study included all patients treated with IVL in the popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method. RESULTS: Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC. CONCLUSIONS: This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting. CLINICAL IMPACT: Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted.

Endovascular and Surgical Venous Arterialization for No-Option Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is known for its high rates of major amputation and mortality. Conventional revascularization techniques often fail in CLTI patients due to the heavily diseased arteries. Foot vein arterialization (FVA) has been proposed as an alternative technique to provide arterial blood to the foot by using the disease-free venous bed. OBJECTIVES: This systematic review and meta-analysis aimed to determine outcomes of surgical FVA (sFVA) and percutaneous FVA (pFVA) at 6 and 12 months post-procedure. DATA SOURCES: PubMed, Scopus, Web of Science, and the Cochrane Library databases were searched to identify papers reporting clinical outcomes of sFVA and pFVA published between January 1966 and March 2023. METHODS: Databases were searched for eligible studies. A meta-analysis was performed to evaluate the limb salvage rate, overall survival rate, and wound healing rate at 6 and 12 months. RESULTS: A total of 27 studies were included, with 753 patients and 793 limbs. Of the included studies, 16 analyzed the sFVA technique and 11 the pFVA technique. Of the included patients, 86.3% were Rutherford 5/6 in the sFVA group versus 98.4% in the pFVA group. The pooled limb salvage rate at 6 and 12 months was 78.1% and 74.1% in the sFVA group and 81.7% and 78.6% in the pFVA group, respectively. Wound healing rates were not reported in the sFVA group. In the pFVA group, the pooled wound healing rates were 48.1% and 64.5% at 6 and 12 months, respectively. CONCLUSION: This study showed promising results after FVA among a large population of CLTI patients. In high-risk patients, pFVA is a feasible option with favorable limb salvage and wound healing rates.

Biliopancreatic and biliary leak after pancreatoduodenectomy treated by percutaneous transhepatic biliary drainage.

BACKGROUND: Complementary to percutaneous intra-abdominal drainage, percutaneous transhepatic biliary drainage (PTBD) might ameliorate healing of pancreatic fistula and biliary leakage after pancreatoduodenectomy by diversion of bile from the site of leakage. This study evaluated technical and clinical outcomes of PTBD for this indication. METHODS: All patients undergoing PTBD for leakage after pancreatoduodenectomy were retrospectively evaluated in two tertiary pancreatic centers (2014-2019). Technical success was defined as external biliary drainage. Clinical success was defined as discharge with a resolved leak, without additional surgical interventions for anastomotic leakage other than percutaneous intra-abdominal drainage. RESULTS: Following 822 pancreatoduodenectomies, 65 patients (8%) underwent PTBD. Indications were leakage of the pancreaticojejunostomy (n = 25; 38%), hepaticojejunostomy (n = 15; 23%) and of both (n = 25; 38%). PTBD was technically successful in 64 patients (98%) with drain revision in 40 patients (63%). Clinical success occurred in 60 patients (94%). Leakage resolved after median 33 days (IQR 21-60). PTBD related complications occurred in 23 patients (35%), including cholangitis (n = 14; 21%), hemobilia (n = 7; 11%) and PTBD related bleeding requiring re-intervention (n = 4; 6%). In hospital mortality was 3% (n = 2). CONCLUSION: Although drain revisions and complications are common, PTBD is highly feasible and appears to be effective in the treatment of biliopancreatic leakage after pancreatoduodenectomy.

Repeatability, and Intra-Observer and Interobserver Agreement of Two Dimensional Perfusion Angiography in Patients with Chronic Limb Threatening Ischaemia.

OBJECTIVE: Two dimensional (2D) perfusion angiography is a method that provides quantitative foot perfusion information from standard digital subtraction angiography acquisitions. The aim of this study was to test the reliability of this method in patients with chronic limb threatening ischaemia (CLTI) by investigating repeatability, and intra-observer and interobserver agreement. METHODS: Twenty patients with CLTI and a below the knee endovascular revascularisation were included in a prospective clinical study. Prior to treatment two perfusion angiography runs were acquired with a five minute interval without performing an intervention. In these recordings, regions of interest were selected and time density curves and perfusion parameters were determined. To investigate intra-observer agreement one observer performed five measurements on the same acquisition for each patient. To investigate interobserver agreement three observers performed measurements on the same acquisition for each patient. Results were presented in Bland-Altman plots and as the intraclass correlation coefficient per parameter. RESULTS: Two patients were excluded from repeatability analyses because of major motion artefacts. Repeatability analyses of the 18 remaining patients showed excellent correlation for every parameter (> .96). Intra-observer and interobserver agreement for all 20 patients were excellent for all parameters (1.00). CONCLUSION: Repeatability and intra-observer and interobserver agreement of 2D perfusion angiography in patients with CLTI were found to be excellent. It is therefore a reliable tool when used according to the standardised methods described in this study.

Midterm Single-Center Results of Endovascular Aneurysm Repair With Additional EndoAnchors.

PURPOSE: To review midterm clinical outcomes of EndoAnchor placement during or after endovascular aneurysm repair (EVAR) or chimney EVAR (ch-EVAR). MATERIALS AND METHODS: A retrospective analysis was conducted of 51 consecutive patients [median age 75 years; 38 men] who underwent EVAR/ch-EVAR with EndoAnchor placement between June 2010 and December 2016 to prevent seal failures (31, 61%) or to treat type Ia endoleak and/or migration (20, 39%). Median aortic neck diameter was 27.7 mm and median neck length was 9.0 mm. Thirty-three (65%) had a conical neck; 48 (94%) had at least 1 hostile neck characteristic. Thirty-two (63%) patients had severe comorbidities (ASA score ⩾III). Eight patients had a single ch-EVAR procedure. Baseline patient characteristics, anatomic variables, procedure details, early and late complications, reinterventions, and aneurysm-related and all-cause mortality rates were recorded. Follow-up imaging was performed with computed tomography angiography (CTA) or duplex ultrasonography. RESULTS: Median procedure time was 100 minutes; a median of 6 EndoAnchors were implanted. There were 10 (10%) residual type Ia endoleaks at the end of the procedure; 9 had resolved by the first postoperative CTA. One residual and 2 new type Ia endoleaks were identified at the first postoperative imaging. Median follow-up for the entire cohort was 24.0 months, during which 3 new type Ia endoleaks were identified. Five of the 6 type Ia endoleaks were treated, 1 resolved spontaneously. There was 1 endograft limb occlusion without clinical consequences, 1 chimney graft occlusion without possibilities for a reintervention, 1 rupture after type IV endoleak (a Nellix device was successfully deployed within the main device), and 1 complete graft explantation for infection. There was no new-onset hemodialysis. Kaplan-Meier estimates of freedom from type Ia endoleak, proximal neck-related reinterventions, and aneurysm-related mortality at 2 years were 87.3%, 92.2%, and 94.0%, respectively. CONCLUSION: EndoAnchors are helpful in the endovascular treatment of unfavorable proximal aortic necks, with fair midterm results.

A comparative study of geometry-based methods and intra-arterial pressure measurements to assess the hemodynamic significance of equivocal iliac artery stenoses.

OBJECTIVES: To date, the ultimate decision to treat iliac artery stenoses in patients suffering from symptomatic peripheral arterial disease is based on the patient's symptoms and on visual inspection of angiographical images. The primary aim of this study was to investigate the accuracy of geometry-based methods (i.e. visual inspection and quantitative vascular analysis (Viewforum version R7.2v1 Advanced vessel analysis, Philips Healthcare, Best, The Netherlands) of 3D rotational angiography) to identify the severity of equivocal iliac artery stenosis in peripheral arterial disease patients with intra-arterial hyperemic pressure measurements (gold standard) as a reference. METHODS: Twenty patients with symptomatic iliac artery stenoses were subjected to 3D rotational angiography. Intra-arterial pressure measurements under hyperemic conditions were performed across 24 visually identified iliac artery stenoses. Three experienced interventional-radiologists retrospectively estimated the lumen diameter reduction by visual inspection. Furthermore, quantitative vascular analysis was performed on the 3D rotational angiography data. Geometry-based estimates were classified into two groups: lumen diameter reduction of <50% (non-significant) and diameter reduction ≥ 50% (significant), and compared to the intra-arterial hyperemic pressure gradients. A stenosis causing a pressure gradient (Δp) ≥10 mmHg was considered hemodynamically significant. RESULTS: Visual inspection and quantitative vascular analysis correctly identified hemodynamically significant stenoses in, respectively, 83% and 67% of the 24 iliac artery stenoses. Quantitative vascular analysis-based identification of hemodynamic significant stenoses (Δp ≥ 10 mmHg) could be optimized by lowering the threshold to a 42% lumen diameter reduction which improved the accuracy from 67% to 83%. CONCLUSIONS: Visual inspection of 3D rotational angiography by experienced interventional-radiologists has an 83% accuracy to identify hemodynamic significant iliac artery stenoses (Δ p ≥10 mmHg). The use of quantitative vascular analysis software did not improve accuracy.

Diagnosis and management of postpancreatectomy hemorrhage: a systematic review and meta-analysis.

BACKGROUND: Postpancreatectomy hemorrhage is a potentially lethal complication after pancreatic resection. The objective of this systematic review is to provide insight in the current status of incidence, detection, management and clinical outcomes of late postpancreatectomy hemorrhage. METHODS: A systematic search was conducted on the literature from February 2007 to July 2018 in PubMed, Embase and the Cochrane library. Included were clinical studies with clinical outcomes on late postpancreatectomy hemorrhage defined according to the International Study Group of Pancreatic Surgery definition (i.e. occurring >24 h after pancreatic resection). RESULTS: A total of 14 studies on 467 patients with late postpancreatectomy hemorrhage were included. The incidence of late postpancreatectomy hemorrhage ranged from 3% to 16% (weighted mean: 5%). Seventy-four patients received conservative treatment; 252 patients underwent primary endovascular intervention; 82 patients underwent primary relaparotomy; 56 patients underwent primary endoscopic intervention; and three patients died before any intervention could be performed. CT-scan and diagnostic angiography were able to identify the source of hemorrhage in 67% (66/98) and 69% (114/166) of patients, respectively. The most frequent origin of the hemorrhage was the gastroduodenal artery stump (79/275; 29%), followed by the common hepatic artery (51/275; 19%) and splenic artery (32/275; 12%). Overall mortality was 21% (98/464 patients; range 0%-38%). Mortality was lower after primary interventional angiography as compared to primary relaparotomy (16% vs 37% respectively). CONCLUSIONS: This systematic review provides a comprehensive overview of the current literature for severe late postpancreatectomy hemorrhages. CT-scan and diagnostic angiography are equally sensitive in detecting the bleeding source. Interventional angiography appears to be associated to lower mortality as compared to relaparotomy and endoscopy as first intervention for postpancreatectomy hemorrhage.

Subtraction computed tomography imaging to detect endoleaks after endovascular aneurysm sealing with sac anchoring.

Background Early detection of small type I endoleaks after endovascular aneurysm sealing is mandatory because they can rapidly progress and lead to severe complications. Recognition of endoleaks can be challenging due to the appearances on computed tomography unique to endovascular aneurysm sealing. We aimed to validate the accuracy and added value of subtraction computed tomography imaging using a post-processing software algorithm to improve detection of endovascular aneurysm sealing-associated endoleaks on postoperative surveillance imaging. Methods The computed tomography scans of 17 patients (16 males; median age: 78, range: 72-84) who underwent a post-endovascular aneurysm sealing computed tomography including both non-contrast and arterial phase series were used to validate the post processing software algorithm. Subtraction images are produced after segmentation and alignment. Initial alignment of the stent segmentations is automatically performed by registering the geometric centers of the 3D coordinates of both computed tomography series. Accurate alignment is then performed by translation with an iterative closest point algorithm. Accuracy of alignment was determined by calculating the root mean square error between matched 3D coordinates of stent segmentations. Results The median root mean square error after initial center of gravity alignment was 0.62 mm (IQR: 0.55-0.80 mm), which improved to 0.53 mm (IQR: 0.47-0.69 mm) after the ICP alignment. Visual inspection showed good alignment and no manual adjustment was necessary. Conclusions The possible merit of subtraction computed tomography imaging for the detection of small endoleaks during surveillance after endovascular aneurysm sealing was illustrated. Alignment of different computed tomography phases using a software algorithm was very accurate. Further studies are needed to establish the exact role of this technique during surveillance after endovascular aneurysm sealing compared to less invasive techniques like contrast-enhanced ultrasound.

Surgical and endovascular venous arterialization for treatment of critical limb ischaemia.

Patients with critical limb ischaemia have a poor life expectancy. Aggressive revascularization is accepted in order to preserve their independence in the final phase of their lives. Bypass surgery and more recently endovascular interventions with angioplasty and stenting have become the treatment of choice to prevent amputation and to resolve pain. However, as many as 20 % of patients with critical limb ischaemia are unsuitable candidates for a vascular intervention because of extensive occlusions of outflow in the crural and pedal vessels. Such "no-option critical limb ischaemia" may be treated with venous arterialization. In the present review, we discuss the history of the venous arterialization procedure, the mechanisms, the different techniques, and complications of venous arterialization.

Randomized comparison of femoropopliteal artery drug-eluting balloons and drug-eluting stents (FOREST trial): Study protocol for a randomized controlled trial.

The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates after uncoated balloon angioplasty are disappointing. Although stents have better outcomes, they also have limitations. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis. In the past decade, drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have been introduced, and both have been proven to possess antirestenotic features compared with conventional techniques. The objective of this study is to perform a noninferiority analysis of DEBs with provisional bare-metal stenting and primary stenting with DESs in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional bare-metal stenting proves to be noninferior to primary stenting with DESs, DEBs may be the favorable technique because the postoperative long-term limitations of stents will be restricted. This is a prospective, randomized, controlled, single-blind, multicenter trial. The study population consists of volunteers aged ≥18 years, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford-Baker classification 2 to 5) caused by de novo stenotic or occlusive atherosclerotic lesions of the superficial femoral artery or of the popliteal artery (only segment P1). Subjects will be treated with a DEB and provisional bare-metal stenting (if a stenosis >30% or a flow-limiting dissection persists after prolonged inflation with an uncoated balloon) or with primary stenting with a DES. The study will include 254 patients (ratio 1:1). The primary end point is 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound imaging (peak systolic velocity ratio <2.5). Secondary end points are technical success, target lesion revascularization, target vessel revascularization, improvement in ankle-brachial index, improvement in Rutherford classification, amputation rate, and mortality rate.

Pros and Cons of 3D Image Fusion in Endovascular Aortic Repair: A Systematic Review and Meta-analysis.

PURPOSE: To systematically review and meta-analyze the added value of 3-dimensional (3D) image fusion technology in endovascular aortic repair for its potential to reduce contrast media volume, radiation dose, procedure time, and fluoroscopy time. METHODS: Electronic databases were systematically searched for studies published between January 2010 and March 2016 that included a control group describing 3D fusion imaging in endovascular aortic procedures. Two independent reviewers assessed the methodological quality of the included studies and extracted data on iodinated contrast volume, radiation dose, procedure time, and fluoroscopy time. The contrast use for standard and complex endovascular aortic repairs (fenestrated, branched, and chimney) were pooled using a random-effects model; outcomes are reported as the mean difference with 95% confidence intervals (CIs). RESULTS: Seven studies, 5 retrospective and 2 prospective, involving 921 patients were selected for analysis. The methodological quality of the studies was moderate (median 17, range 15-18). The use of fusion imaging led to an estimated mean reduction in iodinated contrast of 40.1 mL (95% CI 16.4 to 63.7, p=0.002) for standard procedures and a mean 70.7 mL (95% CI 44.8 to 96.6, p<0.001) for complex repairs. Secondary outcome measures were not pooled because of potential bias in nonrandomized data, but radiation doses, procedure times, and fluoroscopy times were lower, although not always significantly, in the fusion group in 6 of the 7 studies. CONCLUSION: Compared with the control group, 3D fusion imaging is associated with a significant reduction in the volume of contrast employed for standard and complex endovascular aortic procedures, which can be particularly important in patients with renal failure. Radiation doses, procedure times, and fluoroscopy times were reduced when 3D fusion was used.

Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions.

PURPOSE: To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions. METHODS: The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography. RESULTS: Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively. CONCLUSION: The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.

Long-Term Outcomes of Catheter-Directed Thrombolysis for Acute Lower Extremity Occlusions of Native Arteries and Prosthetic Bypass Grafts.

BACKGROUND: Catheter-directed thrombolysis is a well-accepted treatment for acute lower extremity occlusions of native arteries and bypass grafts. Several variables that affect outcomes of thrombolysis have been identified. The hypothesis of this study was that the long-term outcome after catheter-directed thrombolysis would be better for acute lower extremity occlusions of native arteries compared with prosthetic bypass grafts. METHODS: This observational study retrospectively analyzed 159 consecutive patients (114 men), median age, 65 years (range 57-73 years), with 89 native artery (56%), and 70 prosthetic bypass graft (44%) occlusions of the lower extremity. All patients were treated with catheter-directed thrombolysis between 2006 and 2009 in 2 vascular referral centers in the Netherlands. The severity of ischemia was Rutherford class I (52%), class IIa (27%), class IIb (12%) and unknown (9%) in native arteries and class I (64%), class IIa (19%), class IIb (1%), and unknown (16%) in bypass grafts. Median (range) duration of symptoms before the start of thrombolysis was 3.5 (1-14) days in native arteries and 3 (1-9) days in bypass grafts. All patients were treated with a continuous dosage of urokinase (100,000 IU/h). Amputation-free survival was estimated by conduit type using the Kaplan-Meier method and compared using the log-rank test. Univariate and multivariate analyses were performed using a Cox proportional hazards model. RESULTS: Complete (>95%) lysis was achieved in 69% of native arteries and bypass grafts (P = 1.00). Major hemorrhagic complications occurred in 12% (4% hemorrhagic strokes, of which 2% were fatal) of native arteries and in 7% (0% hemorrhagic stroke) of bypass grafts (P = 0.28). The 30-day mortality rate was 6% in native arteries and 1% in bypass grafts (P = 0.17), and the 30-day amputation rate was 10% in native arteries and 13% in bypass grafts (P = 0.45). Mean follow-up was 27 ± 19 months. Amputation-free survival at 1 year was 76% for native arteries and 78% for bypass grafts and at 5 years was 65% for native arteries and 51% for bypass grafts (P = 0.32). Multivariate analysis showed 2 negative predictors for amputation-free survival: age >65 years and cerebrovascular disease. Conduit type was not an independent predictor for amputation-free survival (P = 0.78). CONCLUSIONS: Despite initial promising results, long-term follow-up of catheter-directed thrombolysis for acute lower extremity occlusions showed a disappointing amputation-free survival. In multivariate analysis, no significant differences in amputation-free survival between native arteries and prosthetic bypass grafts were determined.

Endovascular treatment of complex abdominal aortic aneurysms by combining different types of endoprostheses.

PURPOSE: To describe an off-the-shelf method for the treatment of abdominal aortic aneurysms with hostile (large, >30 mm) neck and/or small (<20 mm) aortic bifurcation. CASE REPORT: We describe five patients with large aortic necks and/or small aortic bifurcations, which were treated by combining an AFX endoprosthesis with a Valiant Captiva endograft, and additional proximal endoanchors when deemed necessary. Initial technical success was 100%. Follow-up ranged from 228 to 875 days. One patient suffered a type 1A and 1B endoleak at 446 days follow-up, which were successfully treated by endovascular means. CONCLUSION: Combining the AFX and Valiant Captiva endografts is an off-the-shelf solution for treatment of large diameter aortic necks and small aortic bifurcations in patients deemed unfit for open repair or declined for fenestrated endografts. Longer follow-up is required to assess the long-term safety with special focus on aortic neck dilation.

Complications of Balloon Pulmonary Angioplasty: A Comprehensive Analysis Based on the Latest ESC Consensus Statement.

Background/Objectives: The literature reports high complication rates in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who undergo balloon pulmonary angioplasty (BPA), especially in patients with poor pulmonary hemodynamics. Here, we describe the complications of BPA based on the new definitions. Methods: All patients with CTEPH who completed BPA treatment before 15 September 2023 were selected from the CTEPH database. Peri-procedural complications were collected and classified according to the 2023 consensus paper on BPA treatment. Complications were analyzed in subgroups of patients with pulmonary vascular resistance (PVR), ≤ or >6.6 WU, and mean pulmonary artery pressure (mPAP), ≤ or >45 mmHg, at first BPA. Results: In this analysis, 87 patients (63% women; mean age 61.1 ± 14.0 years; 62% on dual PH targeted medical therapy) underwent 426 (mean 4.9 ± 1.6 per patient) BPAs. Only non-severe complications occurred in 14% of BPA treatments and in 47% of the patients; 31% patients had a thoracic complication. The thoracic complications were mild (71%) or moderate (29%). Patients with a PVR > 6.6 WU (n = 8) underwent more BPA treatments (6.6 ± 1.5 versus 4.6 ± 1.5, p = 0.002), had more complications (88% versus 41% of patients, p = 0.020), and had more thoracic complications (17% vs. 7% of BPAs, p = 0.013) than patients with PVR ≤ 6.6 WU. Patients with mPAP > 45 mmHg (n = 13) also had more BPA treatments (6.5 ± 1.7 versus 4.6 ± 1.4, p < 0.001), more complications (77% versus 44% of patients, p = 0.027) and more thoracic complications (14% versus 8% of BPAs, p = 0.039) than patients with mPAP ≤ 45 mmHg. Conclusions: Complications occurred in 14% of BPAs and were mostly mild. Patients with severe pulmonary hemodynamics suffered more (thoracic) complications.

Covered versus bare-metal stenting of the mesenteric arteries in patients with chronic mesenteric ischaemia (CoBaGI): a multicentre, patient-blinded and investigator-blinded, randomised controlled trial.

BACKGROUND: Mesenteric artery stenting with a bare-metal stent is the current treatment for atherosclerotic chronic mesenteric ischaemia. Long-term patency of bare-metal stents is unsatisfactory due to in-stent intimal hyperplasia. Use of covered stents might improve long-term patency. We aimed to compare the patency of covered stents and bare-metal stents in patients with chronic mesenteric ischaemia. METHODS: We conducted a multicentre, patient-blinded and investigator-blinded, randomised controlled trial including patients with chronic mesenteric ischaemia undergoing mesenteric artery stenting. Six centres in the Netherlands participated in this study, including two national chronic mesenteric ischaemia expert centres. Patients aged 18 years or older were eligible for inclusion when an endovascular mesenteric artery revascularisation was scheduled and a consensus diagnosis of chronic mesenteric ischaemia was made by a multidisciplinary team of gastroenterologists, interventional radiologists, and vascular surgeons. Exclusion criteria were stenosis length of 25 mm or greater, stenosis caused by median arcuate ligament syndrome or vasculitis, contraindication for CT angiography, or previous target vessel revascularisation. Digital 1:1 block randomisation with block sizes of four or six and stratification by inclusion centre was used to allocate patients to undergo stenting with bare-metal stents or covered stents at the start of the procedure. Patients, physicians performing follow-up, investigators, and radiologists were masked to treatment allocation. Interventionalists performing the procedure were not masked. The primary study outcome was the primary patency of covered stents and bare-metal stents at 24 months of follow-up, evaluated in the modified intention-to-treat population, in which stents with missing data for the outcome were excluded. Loss of primary patency was defined as the performance of a re-intervention to preserve patency, or 75% or greater luminal surface area reduction of the target vessel. CT angiography was performed at 6 months, 12 months, and 24 months post intervention to assess patency. The study is registered with ClinicalTrials.gov (NCT02428582) and is complete. FINDINGS: Between April 6, 2015, and March 11, 2019, 158 eligible patients underwent mesenteric artery stenting procedures, of whom 94 patients (with 128 stents) provided consent and were included in the study. 47 patients (62 stents) were assigned to the covered stents group (median age 69·0 years [IQR 63·0-76·5], 28 [60%] female) and 47 patients (66 stents) were assigned to the bare-metal stents group (median age 70·0 years [63·5-76·5], 33 [70%] female). At 24 months, the primary patency of covered stents (42 [81%] of 52 stents) was superior to that of bare-metal stents (26 [49%] of 53; odds ratio [OR] 4·4 [95% CI 1·8-10·5]; p<0·0001). A procedure-related adverse event occurred in 17 (36%) of 47 patients in the covered stents group versus nine (19%) of 47 in the bare-metal stent group (OR 2·4 [95% CI 0·9-6·3]; p=0·065). Most adverse events were related to the access site, including haematoma (five [11%] in the covered stents group vs six [13%] in the bare-metal stents group), pseudoaneurysm (five [11%] vs two [4%]), radial artery thrombosis (one [2%] vs none), and intravascular closure device (none vs one [2%]). Six (13%) patients in the covered stent group versus one (2%) in the bare-metal stent group had procedure-related adverse events not related to the access site, including stent luxation (three [6%] vs none), major bleeding (two (4%) vs none), mesenteric artery perforation (one [2%] vs one [2%]), mesenteric artery dissection (one [2%] vs one [2%]), and death (one [2%] vs none). INTERPRETATION: The findings of this trial support the use of covered stents for mesenteric artery stenting in patients with chronic mesenteric ischaemia. FUNDING: Atrium Maquet Getinge Group.

Imaging the inflammatory activity of sarcoidosis.

Accurate assessment of pulmonary and extrapulmonary organ involvement in sarcoidosis is one of the great challenges for clinicians. This assessment includes the evaluation of symptoms and of sarcoidosis activity in a specific organ and its functional consequences. In this review, radiological and nuclear techniques to image the inflammatory activity of sarcoidosis are described, in particular (18)F-FDG positron emission tomography/computed tomography. The current use of this technique in clinical practice is explained, particularly in patients with persistent symptoms, stage IV disease and cardiac sarcoidosis.

The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and infrapopliteal endovascular interventions.

INTRODUCTION: Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions. METHODS: THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal. DISCUSSION: Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.