[Suture Aneurysms - Aetiopathogenesis, Symptomatology, Diagnostic Testing, Treatment, Outcome and Influencing Factors after Open Vascular Surgical and Image-guided Interventional Reconstruction]. / Nahtaneurysmen - Ätiopathogenese, Symptomatologie, Diagnostik, Therapie, Outcome und Einflussfaktoren nach offen gefäßchirurgischer und interventioneller Rekonstruktion.

AIM: To illustrate incidence, aetiopathogenesis, symptomatology, diagnostic testing, peri-interventional/-surgical management and outcome of SA based on selective references from the scientific medical literature and our own clinical experiences in diagnostic and therapeutic care. METHODS: Narrative overview RESULTS: CONCLUSION: SA as relevant quantity of care has become a substantial part of basic vascular surgical or image-guided radiology treatment. The vascular surgeon or radiologist (for image-guided interventions) needs to be adequately focused on the demanding diagnostic and therapeutic management, demanding her/his complete competence and expertise.

First clinical experience with the Multi-LOC multiple stent delivery system for focal stenting in long femoro-popliteal lesions.

Background: The purpose of this observational study is to report the six-month clinical outcomes with a new multiple stent delivery system in patients with femoro-popliteal lesions. Patients and methods: The LOCOMOTIVE study is an observational multicentre study with a primary endpoint target lesion revascularization (TLR) rate at six months. Femoro-popliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow limiting dissections, elastic recoil or recoil due to calcification required stenting, up to six short stents per delivery device, each 13 mm in length, were implanted. Sonographic follow-ups and clinical assessments were scheduled at six months. Results: For this first analysis, a total of 75 patients 72.9 ± 9.2 years of age were enrolled. The majority of the 176 individually treated lesions were in the superficial femoral artery (76.2 %, 134/176) whereas the rate of TASC C/D amounted to 51.1 % (90/176). The total lesion length was 14.5 ± 9.0 cm with reference vessel diameters of 5.6 ± 0.7 mm. Overall 47 ± 18 % of lesion lengths could be saved from stenting. At six months, the patency was 90.7 % (68/75) and all-cause TLR rates were 5.3 % (4/75) in the overall cohort. Conclusions: The first clinical experience at six months suggests that the MSDS strategy was safe and effective to treat femoro-popliteal lesions of considerable length (14.5 ± 9.0 cm). Almost half of the lesion length could be saved from stenting while patency was high and TLR rates were acceptably low.

[Loss of image quality due to the image output of a digital radiographic system]. / Bildqualitätseinbussen bei der Bildausgabe eines digitalen Röntgenaufnahmesystems.

Not all digital radiography systems allow an unrestricted image postprocessing for the radiologist. Depending on the X-ray system there are restrictions in varying brightness and contrast of the image. We compared grey level information that are given to the radiologist by various digital radiography systems. Histograms of differently postprocessed X-ray images were calculated, which were acquired by three different X-ray systems. We found that every modality has its own way of saving and converting the images into DICOM data. The processed image is either sent into PACS with the initial grey level range (10 or 12 bit) or the image is sent with a reduced grey level range due to windowing. The grey level range is associated with the ability of unrestricted windowing in PACS. So, taking an image with a reduced grey level range, the radiologist will face limited potential to optimise the window setting individually afterwards. The loss of image quality due to image transfer from the modality to PACS can lead to an information loss in the diagnostic relevant range.

Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound?

PURPOSE: The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel-resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment. The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany. MATERIALS AND METHODS: Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to drug-coated balloon (DCB, n = 78) or plain old balloon angioplasty (POBA, n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency and increase in walking distance were recorded. Based on the Kaplan-Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system. RESULTS: There were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the treatment groups (DCB: 19.1 vs. POBA 40.6%, p = 0.007). At 2 years, the patency rate was significantly higher in the DCB group (72.3 vs. 48.4%, p = 0.006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 vs. 52 ± 136 m, p = 0.001). We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA. CONCLUSIONS: The use of paclitaxel-resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency and substantial cost savings at 2 years. ClinicalTrials.gov Identifier NCT01970579.

Surrogate and clinical endpoints for studies in peripheral artery occlusive disease: Are statistics the brakes?

BACKGROUND: The aim of this review is to present the available clinical and surrogate endpoints that may be used in future studies performed in patients with peripheral artery occlusive disease (PAOD). Importantly, we describe statistical limitations of the most commonly used endpoints and offer some guidance with respect to study design for a given sample size. The proposed endpoints may be used in studies using surgical or interventional revascularization and/or drug treatments. METHODS: Considering recently published study endpoints and designs, the usefulness of these endpoints for reimbursement is evaluated. Based on these potential study endpoints and patient sample size estimates with different non-inferiority or tests for difference hypotheses, a rating relative to their corresponding reimbursement values is attempted. RESULTS: As regards the benefit for the patients and for the payers, walking distance and the ankle brachial index (ABI) are the most feasible endpoints in a relatively small study samples given that other non-vascular impact factors can be controlled. Angiographic endpoints such as minimal lumen diameter (MLD) do not seem useful from a reimbursement standpoint despite their intuitiveness. Other surrogate endpoints, such as transcutaneous oxygen tension measurements, have yet to be established as useful endpoints in reasonably sized studies with patients with critical limb ischemia (CLI). CONCLUSIONS: From a reimbursement standpoint, WD and ABI are effective endpoints for a moderate study sample size given that non-vascular confounding factors can be controlled.

Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter.

OBJECTIVES: Based on a novel paclitaxel-resveratrol drug matrix, the safety and efficacy to inhibit intimal hyperplasia were studied in symptomatic claudicants with morphologically challenging lesions. BACKGROUND: The treatment of peripheral artery occlusive disease (PAOD) with percutaneous transluminal angioplasty is limited by occurrence of vessel recoil and neointimal hyperplasia. Drug-coated balloons (DCB) deliver drugs to the arterial wall to potentially reduce the restenosis rate. A number of paclitaxel-coated balloon technologies are available to treat peripheral lesions. METHODS: In this randomized controlled trial, a total of 153 patients with symptomatic PAOD in femoro-popliteal lesions were randomized either to DCB or plain old balloon angioplasty (POBA). RESULTS: The mean lesion length was 13.2 ± 10.4 cm with target lesion total occlusions in 26.1% of all patients (40/153). The primary endpoint of in-lesion late lumen loss (LLL) at 6 months was significantly reduced in the DCB group as compared to the POBA group (0.35 mm CI [0.19; 0.79 mm] vs. 0.72 mm CI [0.68; 1.22 mm], p = 0.006). At 12 months, the TLR rate in the DCB group was significantly lower as compared to the POBA group (17.8 vs. 37.7% p = 0.008). The censored walking distance increase suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (12 months 165 ± 105 vs. 94 ± 136 m, p = 0.012). CONCLUSION: The use of paclitaxel-resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates. ClinicalTrials.gov identifier NCT01970579.

Superiority of transcutaneous oxygen tension measurements in predicting limb salvage after below-the-knee angioplasty: a prospective trial in diabetic patients with critical limb ischemia.

PURPOSE: To assess postprocedural angiograms, the ankle-brachial index (ABI), and transcutaneous oxygen tension (TcPO2) to predict outcome after infrageniculate angioplasty (PTA) in diabetic patients with critical limb ischemia (CLI) scheduled for amputation. MATERIALS AND METHODS: PTA was performed in 28 diabetic patients with CLI confined to infrapopliteal vessels. We recorded patency of crural vessels, including the vascular supply of the foot as well as the ABI and TcPO2 of the foot. RESULTS: Technical success rate was 92.9% (n = 26), and limb-salvage rate at 12 months was 60.7% (n = 17). The number of patent straight vessels above and below the level of the malleoli increased significantly in patients avoiding amputation. Amputation was unnecessary in 88.2% (n = 15) patients when patency of at least one tibial artery was achieved. In 72.7% (n = 8) of patients, patency of the peroneal artery alone was not sufficient for limb salvage. ABI was of no predictive value for limb salvage. TcPO2 values increased significantly only in patients not requiring amputation (P = 0.015). In patients with only one tibial artery supplying the foot or only a patent peroneal artery in postprocedural angiograms, TcPO2 was capable of reliably predicting the outcome. CONCLUSION: Below-the-knee PTA as an isolated part of therapy was effective to prevent major amputation in more than a half of diabetic patients with CLI. TcPO2 was a valid predictor for limb salvage, even when angiographic outcome criteria failed.

Embolization of the gastroduodenal artery before selective internal radiotherapy: a prospectively randomized trial comparing platinum-fibered microcoils with the Amplatzer Vascular Plug II.

The Amplatzer Vascular Plug II (AVP II) is a novel device for transcatheter vessel occlusion, for which only limited comparative data exist. Embolotherapy of the gastroduodenal artery (GDA) is essential before internal radiotherapy (SIRT) in order to prevent radiation-induced peptic ulcerations due to migration of yttrium-90 microspheres. The purpose of this study was to compare the vascular anatomical limitations, procedure time, effectiveness, and safety of embolization of the GDA with coils versus the AVP II. Fifty patients stratified for SIRT were prospectively randomized for embolization of the GDA with either coils or the AVP II. The angle between the aorta and the celiac trunk, diameter of the GDA, fluoroscopy time and total time for embolization, number of embolization devices, complications, and durability of vessel occlusion at follow-up angiography for SIRT were recorded. A t-test was used for statistical analysis. Embolizations with either coils or the AVP II were technically feasible in all but two patients scheduled for embolization of the GDA with the AVP II. In both cases the plug could not be positioned due to the small celiac trunk outlet angles of 17 degrees and 21 degrees. The mean diameter of the GDA was 3.7 mm (range, 2.2-4.8 mm) for both groups. The procedures differed significantly in fluoroscopy time (7.8 min for coils vs. 2.6 min for the AVP II; P < 0.001) and embolization time (23.1 min for coils vs. 8.8 min for the AVP II; P < 0.001). A mean of 6.0 +/- 3.2 coils were used for GDA embolization, while no more than one AVP II was needed for successful vessel occlusion (P < 0.001). One coil migration occurred during coil embolization, whereas no procedural complication was encountered with the use of the AVP II. Vessel reperfusion was noted in only one patient, in whom coil embolization was performed. In conclusion, embolization of the GDA with the AVP II is safe, easy, rapid, and highly effective; only an extremely sharp-angled celiac trunk outlet represented an anatomical limitation for device deployment.

CT-guided brachytherapy (CTGB) versus interstitial laser ablation (ILT) of colorectal liver metastases: an intraindividual matched-pair analysis.

PURPOSE: To compare local tumor control after percutaneous tumor ablation by interstitial laser therapy (ILT) or CT-guided brachytherapy (CTGB). PATIENTS AND METHODS: In a matched pair analysis including 18 patients with 36 liver metastases of colorectal primary, both ILT and CTGB were performed in different lesions. The following matching factors were considered: (i) tumor size < or = 5 cm, and (ii) execution of chemotherapy after tumor ablation. Primary endpoint was local tumor control. RESULTS: Treated lesions were identical in terms of tumor size and all matching criteria were fulfilled in all patients except for the performance of adjuvant chemotherapy. Median follow-up was 14 months (3-24 months) for both groups. Only five of 18 patients (28%) demonstrated local tumor progression after CTGB, whereas in ten of 18 patients (56%) tumor progression was found after ILT. Differences encountered were significant for all patients (p = 0.04), whereas in those who fulfilled all matching criteria (n = 14) the level of statistical significance was not reached (p = 0.23). CONCLUSION: CTGB demonstrated superior local tumor control compared to ILT in long-term follow-up.