Radiation Exposure During Uterine Fibroid Embolization (UFE): A Confounder-Controlled Comparison Between a State-of-the-Art Angiography Unit and a Conventional Angiography unit.

PURPOSE: To compare radiation exposure of a state-of-the-art and a conventional angiography unit in patients undergoing uterine fibroid embolization (UFE). MATERIALS AND METHODS: Between January 2009 and December 2016, 286 patients underwent UFE in our Interdisciplinary Fibroid Center. The inclusion criteria for this retrospective analysis were first-time transarterial embolization for symptomatic fibroids, bilateral embolization, procedures applying a state-of-the-art (Group 1) or a conventional angiography unit (Group 2), and bilateral technical success with an adequate embolization endpoint after the injection of microspheres. Study endpoints included radiation exposure, major complications, morphological success (MRI), and clinical success (questionnaire on quality-of-life). Propensity score matching controlled for confounders. RESULTS: The inclusion criteria were met by 58 (Group 1) and 177 (Group 2) patients. After propensity score matching, there was no significant difference between Group 1 (n = 46) and Group 2 (n = 92) regarding age, body-mass index, volume of the dominant fibroid and the uterus, fluoroscopy time, and amount of embolic agent (p ≥ 0.10 each). The dose-area product was significantly lower in Group 1 than in Group 2 (1159.0 cGycm2 vs. 3123.5 cGycm2; p < 0.001), while major complication rates (both groups 0 %) and dominant fibroid devascularization (both groups 100 %) were equal (p > 0.99). There were no significant differences between both groups regarding shrinkage of the dominant fibroid and the uterus and no relevant differences regarding patient-reported quality-of-life. CONCLUSION: A state-of-the-art angiography unit has the potential to reduce radiation exposure in patients undergoing UFE without increasing the risk of major complications and with comparably high morphological and clinical success. KEY POINTS: · A state-of-the-art angiography unit potentially reduces radiation exposure in patients undergoing UFE.. · Reduced radiation exposure does not seem to negatively influence the rate of major complications.. · Reduced exposure does not seem to negatively affect morphological and clinical success.. CITATION FORMAT: · Sommer C, Voigt W, Oliger MK et al. Radiation Exposure During Uterine Fibroid Embolization (UFE): A Confounder-Controlled Comparison Between a State-of-the-Art Angiography Unit and a Conventional Angiography unit. Fortschr Röntgenstr 2018; 190: 250 - 258.

Bone marrow concentrate and bovine bone mineral for sinus floor augmentation: a controlled, randomized, single-blinded clinical and histological trial--per-protocol analysis.

PURPOSE: The purpose of this work was to evaluate the potential of substituting autogenous bone (AB) by bone marrow aspirate concentrate (BMAC). Both AB and BMAC were tested in combination with a bovine bone mineral (BBM) for their ability of new bone formation (NBF) in a multicentric, randomized, controlled, clinical and histological noninferiority trial. MATERIALS AND METHODS: Forty-five severely atrophied maxillary sinus from 26 patients were evaluated in a partial cross-over design. As test arm, 34 sinus of 25 patients were augmented with BBM and BMAC containing mesenchymal stem cells. Eleven control sinus from 11 patients were augmented with a mixture of 70% BBM and 30% AB. Biopsies were obtained after a 3-4-month healing period at time of implant placement and histomorphometrically analyzed for NBF. RESULTS: NBF was 14.3%±1.8% for the control and nonsignificantly lower (12.6%±1.7%) for the test (90% confidence interval: -4.6 to 1.2). Values for BBM (31.3%±2.7%) were significantly higher for the test compared with control (19.3%±2.5%) (p<0.0001). Nonmineralized tissue was lower by 3.3% in the test compared with control (57.6%; p=0.137). CONCLUSIONS: NBF after 3-4 months is equivalent in sinus, augmented with BMAC and BBM or a mixture of AB and BBM. This technique could be an alternative for using autografts to stimulate bone formation.

Paclitaxel-induced arterial wall toxicity and inflammation: part 2--long-term tissue response in a minipig model.

PURPOSE: In part 1 of the present study, the authors demonstrated that coronary paclitaxel uptake from drug eluting stents (DESs) was not dependent on exposure time and dose. In this second part, the effect of the different paclitaxel dose densities on long-term biologic behavior was evaluated. MATERIALS AND METHODS: In 40 minipigs, (with 4- and 12-week follow-up), identical stents with the same three paclitaxel dose densities as in part 1 were implanted in the right coronary artery. Minipigs implanted with Polyzene-F nanocoated stents served as the control group. Quantitative angiography measuring average luminal diameter (from three in-stent reference points), minimal luminal diameter (from the point of maximum in-stent stenosis), average late loss, maximum late loss, and binary stenosis rate was performed, as was microscopy to determine neointimal thickening, injury score, and inflammation. RESULTS: All three DESs were associated with a high average late loss, binary stenosis rate, and neointimal thickening, without significant differences. Drug-free stents had significantly less late in-stent stenosis: there was an average late loss of 0.3 mm +/- 0.3 in drug-free stents versus 0.8 mm +/- 0.2 in intermediate-dose stents and 1.5 mm +/- 0.6 in high-dose stents (P = .04). DES-associated inflammation was high in all DESs and six times higher as in the drug-free stents (Kornowski scores of 0.2 +/- 0.1 in drug-free stents, 1.3 +/- 0.9 in low-dose stents, 1.7 +/- 0.8 in intermediate-dose stents, and 1.3 +/- 1.0 in high-dose stents; P = .04). It worsened with time in all DESs, as did late in-stent stenosis. CONCLUSIONS: The extensive and long-term retention of paclitaxel even in a low-dose formulation, at least according to the present labeling of DESs, might be associated with negative long-term results with regard to inflammation and late in-stent stenosis.

Comparison of a microporous thermoplastic polyurethane-covered stent with a self-expanding bare nitinol stent in a porcine iliac artery model.

PURPOSE: To compare outcomes with a thermoplastic polyurethane (TPU)-covered self-expanding nitinol stent-graft (TPU graft) with those of a bare self-expanding nitinol stent in a porcine model. MATERIALS AND METHODS: Fourteen TPU grafts and 14 commercially available bare nitinol stents were implanted, one each, in the iliac arteries of 14 minipigs. Follow-up was performed at 1 week (six animals), 4 weeks (four animals), and 12 weeks (four animals). The primary study endpoint was in-stent stenosis assessed with quantitative angiography and microscopy. Secondary endpoints were injury, inflammation, and endothelialization. RESULTS: After 1 week, the maximum percentage luminal loss was significantly greater in TPU grafts (average, 16.2%; range, 0.0%-35.8%) than in bare nitinol stents (8.2%; 0.0%-17.3%) (P = .04). Three of the four TPU grafts were occluded after 4 weeks, and all four TPU grafts were occluded after 12 weeks. Binary stenosis was seen in three of four bare nitinol stents after both 4 and 12 weeks. At 4-week follow-up, the average percentage luminal loss was significantly greater in TPU grafts (85.2%; 40.8%-100%) than in bare nitinol stents (49.5%; 37.9%-62.4%) (P = .003). The difference in neointimal height and percentage average stenosis between TPU grafts (1,028.7 microm and 68.4%) and bare nitinol stents (1,033.6 microm [918.0-1,118.40 microm] and 68.1% [60.44%-71.99%]) was not statistically significant. After 12 weeks, the average percentage luminal loss was 100% in TPU grafts due to occlusion of all stent-grafts and 24.9% (8.0%-63.9%) in bare nitinol stents (P = .011). CONCLUSIONS: TPU grafts failed to provide improved patency compared with the bare nitinol stents because of excessive neointimal growth and subsequent occlusion. In addition, the bare nitinol stents showed considerable in-stent stenosis at angiography and microscopy.

Long-term results of balloon-expandable LifePath endografts in abdominal aortic aneurysm: a single-center experience.

OBJECTIVE: This retrospective single-center study analyzed long-term results after LifePath (Edwards Lifesciences LLC, Irvine, Calif) endoprosthesis implantation for abdominal aortic aneurysm (AAA), primarily focusing on the wire form fracture issue and consecutive endoleak rate. METHODS: Between 1999 and 2004, all consecutive patients with LifePath AAA devices in our institution were included in the retrospective analysis. All patients had computed tomography angiography (CTA) imaging preoperatively and image postprocessing. The follow-up using CTA imaging specifically addressed material fatigue (wire form fractures) resulting in migrations and type I endoleaks. RESULTS: During the 6-year study period, which included the 1-year withdrawal and redesign of the device, 51 patients were treated with LifePath AAA endografts. The 30-day mortality was 0%. The perioperative 30-day morbidity was 9.8%. One patient required a primary conversion due to misdeployment of the iliac limbs within the graft main body. The primary endoleak rate was 20.56% (type I, 2%; type II, 19.6%). During the mean follow-up of 40.7 months, 12 patients died, six were lost to follow-up, and 32 underwent subsequent CTA imaging. Eight patients (25%) demonstrated a proximal type I endoleak, seven (22%) had a type II endoleak, and three had a type III endoleak (9%). In nine patients (28.1%), wire form fractures could be detected at image postprocessing. Four patients required a secondary conversion due to endoleak and aneurysm growth (2 type I endoleaks and 2 type III endoleaks). CONCLUSION: Wire form fracture is the major structural problem in the LifePath balloon-expandable endograft device, resulting in a significant endoleak rate. We must caution those patients with a LifePath device in-situ that careful follow-up must be performed due to material fatigue and they should consider secondary conversion.

Efficacy of a polyphosphazene nanocoat in reducing thrombogenicity, in-stent stenosis, and inflammatory response in porcine renal and iliac artery stents.

PURPOSE: It is hypothesized that the inorganic polymer poly[bis(trifluoroethoxy)phosphazene] (PTFEP) reduces stent-associated thrombosis, in-stent stenosis, and inflammatory response and stimulates reendothelialization in a porcine model. MATERIALS AND METHODS: PTFEP-nanocoated and bare stainless-steel stents (316 L) were implanted bilaterally in renal and iliac arteries of 16 minipigs (1, 4, and 12 weeks follow-up durations). Primary study endpoints were thrombogenicity determined by filling defects on angiography and in-stent stenosis assessed by lumen loss on quantitative angiography (ie, percentage stenosis) and light microscopy (ie, neointimal thickness, neointimal area, area stenosis). Secondary endpoints were inflammatory response and reendothelialization evaluated by light microscopy and scanning electron microscopy (SEM), respectively. RESULTS: Stent placement was successful in 32 renal and 26 iliac arteries. At follow-up, there were no thrombus depositions on PTFEP-coated renal and iliac stents. Thrombus depositions were found on two of six bare metal iliac stents after 4 weeks (P = .0651). PTFEP-coated stents showed a trend toward reduced in-stent stenosis in all renal and iliac arteries at all intervals: in iliac stents, neointimal area was significantly smaller in coated stents than in bare metal stents after 1 week and 4 weeks (P = .03 and P = .001, respectively). In renal arteries, inflammation scores indicated lower inflammatory response in PTFEP-coated stents than in bare metal stents after 1 week (P = .01). After 1 week, coated and bare metal stents exhibited complete reendothelialization on SEM. CONCLUSIONS: PTFEP-coated stents exhibited reduced thrombus deposition and a trend toward less in-stent stenosis and inflammatory response than bare metal stents.

The efficacy of nanoscale poly[bis(trifluoroethoxy) phosphazene] (PTFEP) coatings in reducing thrombogenicity and late in-stent stenosis in a porcine coronary artery model.

OBJECTIVES: Previous experimental studies have demonstrated that poly[bis(trifluoroethoxy)phosphazene] (PTFEP) nanocoated stents have antithrombotic characteristics, reduce in-stent stenosis, prevent wall inflammation, and do not hamper endothelialization. This study was designed to validate these findings in a porcine coronary artery model. MATERIALS AND METHODS: PTFEP-coated (n = 15) and bare stents (n= 13) were implanted in coronary arteries of 18 mini-pigs (4- and 12-week follow-up). Primary study endpoints were thrombogenicity and in-stent stenosis, secondary study endpoints were inflammatory response and re-endothelialization evaluated by quantitative angiography and light microscopy. RESULTS: No thrombus deposition occurred on any stent. At 4 weeks follow-up, the bare stents (n = 4) had a significantly smaller neointimal area (1.93 vs. 3.20 mm(2), P = 0.009). At 12 weeks, PTFEP-coated stents (n = 11) had significantly superior results in almost all parameters: neointimal area (2.25 vs. 2.65 mm(2), P = 0.034), neointimal height (204.46 vs. 299.41 microm, P = 0.048), percentage stenosis (38.25 vs. 50.42%, P = 0.019), and inflammation score (0.12 vs. 0.30, P = 0.029). Complete re-endothelialization was seen in both stent types at both intervals. CONCLUSION: At long-term follow-up, the superior results of PTFEP-coated stents were characterized by a noteworthy reduction of neointimal growth and inflammatory response.