Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.

BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

Multi-Operational Selective Computer-Assisted Targeting of hepatocellular carcinoma-Evaluation of a novel approach for navigated tumor ablation.

OBJECTIVE: To facilitate precise local ablation of hepatocellular carcinoma (HCC) in a setting of combined ablation and transarterial chemoembolization (TACE), we evaluated accuracy and efficiency of a novel technique for navigated positioning of ablation probes using intrahepatic tumor referencing and electromagnetic (EM) guidance, in a porcine model. METHODS: An angiographic wire with integrated EM reference sensor at its tip was inserted via a transarterial femoral access and positioned in the vicinity of artificial liver tumors. The resulting offset distance between the tumor center and the intrahepatic endovascular EM reference was calculated. Subsequently, EM tracked ablation probes were inserted percutaneously and navigated toward the tumor center, relying on continuous EM guidance via the intrahepatic reference. Targeting accuracy was assessed as the Euclidean distance between the tip of the ablation probe and the tumor center (Target Positioning Error, TPE). Procedural efficiency was assessed as time efforts for tumor referencing and tumor targeting. RESULTS: In 6 animals, 124 targeting measurements were performed with an offset distance < 30 mm (clinically most feasible position), resulting in a mean TPE of 2.9 ± 1.6 mm. No significant correlation between the TPE and different intrahepatic offset distances (range 21 to 61 mm, n = 365) was shown as long as the EM reference was placed within the liver. However, the mean TPE increased when placing the EM reference externally on the animal skin (p < 0.01). TPE was similar when targeting under continuous ventilation or in apnea (p = 0.50). Mean time for tumor referencing and navigated targeting was 6.5 ± 3.8 minutes and 14 ± 8 seconds, respectively. CONCLUSION: The proposed technique allows precise and efficient navigated positioning of ablation probes into liver tumors in the animal model. We introduce a simple approach suitable for combined ablation and TACE of HCC in a single treatment session.

Patency of the arterial pedal-plantar arch in patients with chronic kidney disease or diabetes mellitus.

BACKGROUND: Patency of the pedal-plantar arch limits risk of amputation in peripheral artery disease (PAD). We examined patients without chronic kidney disease (CKD)/diabetes mellits (DM) [PAD-control], those with DM without CKD, and those with CKD without DM. METHOD: Uni- and multivariate logistic regression was used to assess association of CKD with loss of patency of the pedal-plantar arch and presence of tibial or peroneal vessel occlusion. Multivariate models adjusted for age, sex, hypertension, hyperlipidemia and smoking. RESULTS: A total of 419 patients were included [age 75.2 ± 10.3 years, 288 (69%) male]. CKD nearly doubled the unadjusted odds ratio (OR) for loss of patency of the pedal-plantar arch. After adjustment, association remained significant for severe CKD [estimated glomerular filtration rate (eGFR) ≤ 29 ml/min compared with eGFR ≥ 60 ml/min, adjusted (adj.) OR 8.24 (95% confidence interval {CI} 0.99-68.36, p = 0.05)]. CKD was not related to risk of tibial or peroneal artery occlusion [PAD-control versus CKD, adj. OR 1.09 (95% CI 0.49-2.44, p = 0.83)] in contrast to DM [PAD-control versus DM, adj. OR 2.41 (95% CI 1.23-4.72, p = 0.01), CKD versus DM, adj. OR 2.21 (95% CI 0.93-5.22); p = 0.07)]. CONCLUSIONS: Below the knee (BTK) vascular pattern differs in patients with either DM or CKD alone. Severe CKD is a risk factor for loss of patency of the pedal-plantar arch.

Efficacy Outcomes of Endovascular Versus Surgical Revascularization in Critical Limb Ischemia: Results From a Prospective Cohort Study.

Data on efficacy outcomes of endovascular versus surgical revascularization in patients with critical limb ischemia (CLI) in contemporary practice are limited. In this prospective cohort study, 353 consecutive patients with CLI were enrolled and allocated to endovascular (PTA [percutaneous transluminal angioplasty]), surgical (SURG), or no revascularization (No REVASC) after interdisciplinary consensus. Outcome measures were sustained primary clinical success (sPCS; survival without major amputation, repeated target extremity revascularization, and freedom from CLI), limb salvage, and amputation-free survival. Propensity-matched Kaplan-Meier analyses and stratified log-rank tests were performed. The PTA, SURG, and No REVASC groups consisted of 264, 62, and 27 patients, respectively. Compared to SURG patients, PTA patients were significantly older, had more risk factors, and more often had ischemic lesions. Propensity score-adjusted analyses showed no significant differences: sPCS was 51.3%/52.2%, limb salvage rate 91.5%/93.7%, and major amputation-free survival 90.5%/87.2% at 12 months for PTA and SURG, respectively. Amputation-free survival for the No REVASC group was 69% at 12 months. In conclusion, endovascular and surgical revascularization in CLI has comparable efficacy outcomes after 12 months. Contemporary overall outcome of patients with CLI is considerably better compared to earlier studies.

Haemostaseological complication management in caval and iliac venous stenting.

Antiplatelet and anticoagulation therapy after venous stenting is still not standardized, data from randomized-controlled trials are missing. Rare prothrombotic disorders and nonresponsiveness to drugs must be taken into account. This case report demonstrates successful haemostaselogical complication management in recurrent rethromboses due to underlying clopidogrel resistance and low responsiveness to anticoagulation with dabigatran after endovascular stent reconstruction of chronic pelvic and caval vein occlusion in a patient with severe postthrombotic syndrome.

A concept for electromagnetic navigated targeting of liver tumors using an angiographic approach.

BACKGROUND: The benefits of using navigation technology for percutaneous local ablation of selected hepatocellular carcinoma (HCC) have been shown. Due to additional efforts in the procedural workflow, barriers to introducing navigation systems on a broad clinical level remain high. In this work, initial steps toward a novel concept for simple and precise targeting of HCC are evaluated. MATERIAL AND METHODS: The proposed technique is based on an angiographic approach using an intrahepatic electromagnetic (EM) reference, for consecutive percutaneous navigated positioning of ablation probes. We evaluated the environmental influence of the angiography suite on EM tracking accuracy, the measurement of a 3 D offset from two 2 D fluoroscopy images, and the accuracy and efficiency of the proposed approach in a porcine liver model. RESULTS: The C-arm had a major influence on EM tracking accuracy, with an error up to 3.8 mm. The methodology applied for measurement of a 3 D offset from 2 D fluoroscopy images was confirmed to be feasible with a mean error of 0.76 mm. In the porcine liver model experiment, the overall target positioning error (TPE) was 2.0 mm and time for navigated targeting was 17.9 seconds, when using a tracked ablation probe. CONCLUSIONS: The initial methodology of the proposed technique was confirmed to be feasible, introducing a novel concept for simple and precise navigated targeting of HCC.

A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) - one-year results of a pre-maturely terminated study.

BACKGROUND: The indications for conservative "best medical treatment" (BMT) versus additional renal artery stenting are a matter of ongoing debate. The RADAR study aimed to evaluate the impact of percutaneous renal artery stenting on the impaired renal function in patients with hemodynamically significant atherosclerotic renal artery stenosis (RAS). METHODS: RADAR is an international, prospective, randomized (1:1) controlled study comparing BMT alone versus BMT plus renal artery stenting in patients with duplex sonographic hemodynamically relevant RAS. Follow-up assessments were at 2, 6, and 12 months and at 3 years. The primary endpoint was change in estimated glomerular filtration rate (eGFR) at 12 months. RESULTS: Due to slow enrollment, RADAR was terminated early after inclusion of 86 of the scheduled 300 patients (28.7%). Change in eGFR between baseline and 12 months was 4.3 ± 15.4 ml/min/1.73 m2 (stent group) and 3.0 ± 14.9 ml/min/1.73 m2 (BMT group), p > 0.999. Clinical event rates were low with a 12-month composite of cardiac death, stroke, myocardial infarction, and hospitalization for congestive heart failure of 2.9% in the stent and 5.3% in the BMT group, p = 0.526, and a 3-year composite of 14.8% and 12.0%, p = 0.982. At 3 years, target vessel (re-)vascularization occurred in one patient (3.0%) in the stent group and in 8 patients (29.4%) in the BMT group. CONCLUSION: In RADAR, outcomes of renal artery stenting were similar to BMT. These results have to be interpreted with the caveat that the study did not reach its statistically based sample size. TRIAL REGISTRATION: Clinicaltrials.gov, NCT00640406. Registered on 17 March 2008.

Feasibility of stereotactic MRI-based image guidance for the treatment of vascular malformations: a phantom study.

PURPOSE: Treatment of vascular malformations requires the placement of a needle within vessels which may be as small as 1 mm, with the current state of the art relying exclusively on two-dimensional fluoroscopy images for guidance. We hypothesize that the combination of stereotactic image guidance with existing targeting methods will result in faster and more reproducible needle placements, as well as reduced radiationexposure, when compared to standard methods based on fluoroscopy alone. METHODS: The proposed navigation approach was evaluated in a phantom experiment designed to allow direct comparison with the conventional method. An anatomical phantom of the left forearm was constructed, including an independent control mechanism to indicate the attainment of the target position. Three interventionalists (one inexperienced, two of them frequently practice the conventional fluoroscopic technique) performed 45 targeting attempts utilizing the combined and 45 targeting attempts utilizing the standard approaches. RESULTS: In all 45 attempts, the users were able to reach the target when utilizing the combined approach. In two cases, targeting was stopped after 15 min without reaching the target when utilizing only the C-arm. The inexperienced user was faster when utilizing the combined approach and applied significantly less radiation than when utilizing the conventional approach. Conversely, both experienced users were faster when using the conventional approach, in one case significantly so, with no significant difference in radiation dose when compared to the combined approach. CONCLUSIONS: This work presents an initial evaluation of a combined navigation fluoroscopy targeting technique in a phantom study. The results suggest that, especially for inexperienced interventionalists, navigation may help to reduce the time and the radiation dose. Future work will focus on the improvement and clinical evaluation of the proposed method.