Terapia endovascular en trauma periférico: una alternativa a la cirugía abierta tradicional / Endovascular therapy in peripheral trauma: our experience

Resumen Introducción: La terapia endovascular ha demostrado ser una buena alternativa de tratamiento en las enfermedades arteriales y venosas. Asimismo, en trauma vascular periférico constituye una excelente opción, especialmente en sitios anatómicos difíciles de acceder y con lesiones complejas como seudoaneurismas, fístulas arteriovenosas (FAV) o la combinación de ambos, con numerosas ventajas. Objetivo: Evaluar los resultados del tratamiento endovascular en trauma vascular penetrante por agresiones y iatrogenias. Materiales y Método: Revisión retrospectiva de todos los pacientes con trauma vascular periférico sometidos a terapia endovascular. Resultados: Entre abril de 2011 y mayo de 2020 se trataron 30 pacientes, 28 hombres y 2 mujeres. Con edades fluctuantes entre 17 y 84 años. La causa del trauma fue 20 penetrantes y 10 iatrogenias. Los vasos afectados fueron arteria femoral superficial 6, femoral profunda 2, subclavia 9, axilar 1, poplítea 4, ilíacas 1, peronea 1, tibial anterior 5, tronco venoso braquiocefálico 1. Diecisiete pacientes fueron tratados con endoprótesis, 9 con embolización y 4 con cierre percutáneo en relación con catéteres arteriales en subclavia. No hubo mortalidad, pero dos pacientes requirieron reparación abierta: un seudoaneurisma poplíteo gigante y un seudoaneurisma de tibial anterior, en ambos se constató sección completa de ambas arterias. El seguimiento clínico ha sido entre 30 días y 3 años. Conclusiones: En esta serie de casos, la terapia endovascular en lesiones de trauma vascular periférico ofrece excelentes resultados con baja morbimortalidad y permeabilidad aceptable a corto y mediano plazo.

Introduction: Endovascular therapy has proven to be a good treatment alternative in arterial and venous diseases. Likewise, in peripheral vascular trauma it is an excellent option, especially in anatomical sites that are difficult to access and with complex lesions such as pseudoaneurysms, arteriovenous fistulas (AVFs) or the combination of both, with numerous advantages. Aim: To evaluate the results of endovascular treatment in trauma Penetrating vascular injury and iatrogenesis. Materials and Method: Retrospective review of all patients with peripheral vascular trauma undergoing endovascular therapy. Results: Between April 2011 and May 2020, 30 patients were treated, 28 men and 2 women. With fluctuating ages between 17 and 84 years. The cause of the trauma was 20 penetrating and 10 iatrogenic. The affected vessels were superficial femoral artery 6, deep femoral 2, subclavian 9, axillary 1, popliteal 4, iliac 1, peroneal 1, anterior tibial 5, brachiocephalic venous trunk 1. Seventeen patients were treated with endoprosthesis, 9 with embolization and 4 with percutaneous closure in relation to arterial catheters in the subclavian. There was no mortality but two patients required open repair: a giant popliteal pseudoaneurysm and an anterior tibial pseudoaneurysm in which both sections of both arteries were found to be complete. Clinical follow-up was between 30 days and 3 years. Conclusión: In this serie, endovascular therapy in peripheral vascular trauma lesions offers excellent results with low morbidity and mortality and acceptable patency in the short and medium term.

Zoledronate alters natural progression of tissue-engineered vascular grafts.

Macrophages are a critical driver of neovessel formation in tissue-engineered vascular grafts (TEVGs), but also contribute to graft stenosis, a leading clinical trial complication. Macrophage depletion via liposomal delivery of clodronate, a first-generation bisphosphonate, mitigates stenosis, but simultaneously leads to a complete lack of tissue development in TEVGs. This result and the associated difficulty of utilizing liposomal delivery means that clodronate may not be an ideal means of preventing graft stenosis. Newer generation bisphosphonates, such as zoledronate, may have differential effects on graft development with more facile drug delivery. We sought to examine the effect of zoledronate on TEVG neotissue formation and its potential application for mitigating TEVG stenosis. Thus, mice implanted with TEVGs received zoledronate or no treatment and were monitored by serial ultrasound for graft dilation and stenosis. After two weeks, TEVGs were explanted for histological examination. The overall graft area and remaining graft material (polyglycolic-acid) were higher in the zoledronate treatment group. These effects were associated with a corresponding decrease in macrophage infiltration. In addition, zoledronate affected the deposition of collagen in TEVGs, specifically, total and mature collagen. These differences may be, in part, explained by a depletion of leukocytes within the bone marrow that subsequently led to a decrease in the number of tissue-infiltrating macrophages. TEVGs from zoledronate-treated mice demonstrated a significantly greater degree of smooth muscle cell presence. There was no statistical difference in graft patency between treatment and control groups. While zoledronate led to a decrease in the number of macrophages in the TEVGs, the severity of stenosis appears to have increased significantly. Zoledronate treatment demonstrates that the process of smooth muscle cell-mediated neointimal hyperplasia may occur separately from a macrophage-mediated mechanism.

Histologic Analysis with the Newly Designed Exoskeleton Seal® Stent-Graft in the Porcine Abdominal Aorta.

PURPOSE: To investigate the technical feasibility of a novel exoskeleton Seal® stent-graft and analyze early histologic changes in the porcine abdominal aorta. MATERIALS AND METHODS: Six pigs received an abdominal stent-graft (Group I), and six received an iliac branch stent-graft (Group II). Groups were subdivided as follows: Group Ia, which received three bifurcated main-body stent-grafts; Group Ib, which received three bifurcated main-body stent-grafts with both iliac graft-stents; Group IIa, which received three simple uni-iliac tapered stent-grafts; and Group IIb, which received three uni-iliac tapered tapered stent-grafts with right straight limb and left branched limb. Statistical analyses were performed with the Wilcoxon signed-rank test and mixed-model regression analysis. RESULTS: The primary technical success rate (< 24 h) was 83% because of two acute thromboses in the lumen of the stented abdominal aorta immediately after stent-graft placement. At 4 weeks, late thrombosis occurred in two pigs. Higher mean neointimal hyperplasia areas (23.5% vs. 16.2%; P = .047), neointimal hyperplasia thicknesses (545.5 µm vs. 422.2 µm; P = .001), and degrees of collagen deposition (2.71 vs. 2.33; P = .002) were observed at the bare-metal stent-graft compared with the proximal exoskeleton portion of the stent-graft, with no significant differences between the patent and occluded groups or among the four types of stent-grafts. CONCLUSIONS: The exoskeleton stent-graft demonstrates 66% of patency rate during 1-month follow-up due to four cases of thromboses; however, the endothelialization on the junction of proximal graft showed no significant differences between the patent and occluded groups. Further studies should investigate long-term outcomes with prolonged neointimal hyperplasia.

Stent implantation for ostial left anterior descending coronary artery stenosis: clinical particularities, therapeutic strategies, and medium-term outcomes.

BACKGROUND: The stenosis of the ostial left anterior descending artery represents one of the challenges for the interventional cardiologist. The aim of our study was to define the characteristics of this population and to analyze their results in medium term. METHODS: We had undertaken a retrospective study of 76 patients treated in the Cardiology Department of the Military Hospital of Tunis, between January 2014 and March 2017. Percutaneous coronary revascularizations of de novo ostial lesions of the left anterior descending artery were included. RESULTS: The mean age was 59.8 years with a male predominance. Two dilation strategies were adopted: 39% of patients had a "provisional-T-stenting" of the left main coronary artery versus 61% of patients who had a floating stent technic. The main immediate complication was acute occlusion of the circumflex artery ostium. After 12 months, the thrombosis and restenosis rates were 5,2% and 6,5%. Predictors of MACE were: Insulin-requiring diabetes(p=0.05), chronic renal failure(p=0.02), a low-pressure stent deployment(p=0.01), or the presence of signs of left ventricular failure (p<10-3). The predictive factors for stent thrombosis were the alteration of the left ventricular ejection fraction (p<0.01) and the eccentricity of the lesion (p<10-3). Finally, the predictive factors of restenosis were: acute per procedural occlusion of the ostial circumflex artery (p=0.01) or the presence of an associated lesion of distal IVA (p<0,001). CONCLUSION: Ostial lesions of the interventricular artery can be re-vascularized by percutaneous angioplasty with acceptable rates of major cardiovascular events. However, the risk of iterative revascularization remains significant.

Twenty-year experience with cryopreserved arterial allografts for vascular infections.

OBJECTIVES: The aim of this study was to analyse outcomes over 2 decades using cryopreserved vascular allografts to treat vascular infection. METHODS: We conducted a retrospective study of patients identified from our institutional database who were treated for primary or secondary vascular infection using implanted allografts. RESULTS: Between October 1992 and May 2014, 54 patients underwent surgery for vascular infection out of 118 patients implanted with cryopreserved vascular allografts. The 52 patients for whom we had full information form the basis of the study with a 96% follow-up. The average age was 64 ± 11 years; 87% were men; 65% had previous vascular surgery; 19% had emergency operations. A total of 75% of the patients had aortoiliofemoral infections. Five patients underwent surgery with cardiopulmonary bypass. Fifty percent required more than 1 allograft and 15% had concomitant procedures. Seventy-three percent (38/52) of specimen cultures yielded positive results with polymicrobial flora in 29%. Surgical specimens most frequently grew coagulase-negative staphylococci. The early postoperative reoperation rate was 15% for allograft-related complications. There were 20 (38%) early deaths, including deaths of acute myocardial infarction, anastomosis rupture and persistent sepsis and shock. Uncontrolled infection leading to septic shock and multiple organ failure was the cause of death in 50% of the cases. The mean duration of freedom from allograft reintervention was 12.2 years. The mean duration of freedom from allograft occlusion or limb loss was 12.1 years [95% confidence interval (CI) 9.9-14.4]. Of the 32 surviving patients, we had patency information for 66% obtained by angiography or computed tomography. The mean survival for the cohort was 5.9 years (95% CI 3.9-7.8). Mean freedom from cardiovascular infection-related death was 9.3 years (95% CI 7.2-11.4). CONCLUSIONS: Allografts can be indicated for treatment of primary/secondary infection and have remarkable results in multimorbid patients. Patients with vascular infection have a high-risk profile, around 40% mortality during the first 6 months, with reduction in overall mortality thereafter. We believe that allografts may play a role in the surgical treatment of vascular infection.

Utilization, patency, and complications associated with vascular access for hemodialysis in the United States.

BACKGROUND: This study examines the utilization and outcomes of vascular access for long-term hemodialysis in the United States and describes the impact of temporizing catheter use on outcomes. We aimed to evaluate the prevalence, patency, and associated patient survival for pre-emptively placed autogenous fistulas and prosthetic grafts; for autogenous fistulas and prosthetic grafts placed after a temporizing catheter; and for hemodialysis catheters that remained in use. METHODS: We performed a retrospective study of all patients who initiated hemodialysis in the United States during a 5-year period (2007-2011). The United States Renal Data System-Medicare matched national database was used to compare outcomes after pre-emptive autogenous fistulas, preemptive prosthetic grafts, autogenous fistula after temporizing catheter, prosthetic graft after temporizing catheter, and persistent catheter use. Outcomes were primary patency, primary assisted patency, secondary patency, maturation, catheter-free dialysis, severe access infection, and mortality. RESULTS: There were 73,884 (16%) patients who initiated hemodialysis with autogenous fistula, 16,533 (3%) who initiated hemodialysis with prosthetic grafts, 106,797 (22%) who temporized with hemodialysis catheter prior to autogenous fistula use, 32,890 (7%) who temporized with catheter prior to prosthetic graft use, and 246,822 (52%) patients who remained on the catheter. Maturation rate and median time to maturation were 79% vs 84% and 47 days vs 29 days for pre-emptively placed autogenous fistulas vs prosthetic grafts. Primary patency (adjusted hazard ratio [aHR], 1.26; 95% confidence interval [CI], 1.25-1.28; P < .001) and primary assisted patency (aHR, 1.36; 95% CI, 1.35-1.38; P < .001) were significantly higher for autogenous fistula compared with prosthetic grafts. Secondary patency was higher for autogenous fistulas beyond 2 months (aHR, 1.36; 95% CI, 1.32-1.40; P < .001). Severe infection (aHR, 9.6; 95% CI, 8.86-10.36; P < .001) and mortality (aHR, 1.29; 95% CI, 1.27-1.31; P < .001) were higher for prosthetic grafts compared with autogenous fistulas. Temporizing with a catheter was associated with a 51% increase in mortality (aHR, 1.51; 95% CI, 1.48-1.53; P < .001), 69% decrease in primary patency (aHR, 0.31; 95% CI, 0.31-0.32; P < .001), and 130% increase in severe infection (aHR, 2.3; 95% CI, 2.2-2.5; P < .001) compared to initiation with autogenous fistulas or prosthetic grafts. Mortality was 2.2 times higher for patients who remained on catheters compared to those who initiated hemodialysis with autogenous fistulas (aHR, 2.25; 95% CI, 2.21-2.28; P < .001). CONCLUSIONS: Temporizing catheter use was associated with higher mortality, higher infection, and lower patency, thus undermining the highly prevalent approach of electively using catheters as a bridge to permanent access. Autogenous fistulas are associated with longer time to catheter-free dialysis but better patency, lower infection risk, and lower mortality compared with prosthetic grafts in the general population.

Multicenter Assessment of Grafts in Coronaries: Midterm Evaluation of the C-Port Device (the MAGIC Study).

OBJECTIVE: The commercially available C-Port distal anastomotic device (Food and Drug Administration cleared in 2007) is an automated miniature vascular stapler that performs the coronary anastomosis. This prospective multicenter registry sought to evaluate midterm patency using this device compared with hand-sewn grafts. METHODS: Patients receiving at least one C-Port anastomosis during coronary artery bypass grafting surgery were enrolled at eight sites. Of the 117 patients enrolled, 78 patients (67%) with 104 C-Port vein grafts completed the study to patency assessment via computed tomography angiography. Clinical follow-up and index graft patency (Gated 64-slice computed tomography scan) were performed at least 12 months postoperatively. The primary efficacy endpoint was patency compared with the peer-reviewed results from the PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) trial. RESULTS: The patient population was consistent with the PREVENT IV placebo cohort. The mortality at 12 months was 0.85% (1/117). The major cardiac morbidity rate was 3.4% (4/117). The C-Port vein graft occlusion rate was 16.3% (17/104) compared with 26.6% (597/2242) in the PREVENT IV trial (P = 0.011). Within this study, C-Port graft occlusion rates were not significantly different from the hand-sewn grafts (P = 0.821). CONCLUSIONS: The C-Port device is safe and effective in creating the distal anastomosis with equivalent patency rates to hand-sewn grafts at 12 months. When compared with hand-sewn anastomoses from a recent large prospective trial, the C-Port device demonstrated a statistically significant reduction in midterm graft occlusion. Further studies are required to evaluate its effect in less invasive coronary surgery.

Practice Patterns of Fenestrated Aortic Aneurysm Repair: Nationwide Comparison of Z-Fen Adoption at Academic and Community Centers Since Commercial Availability.

CONTEXT: Over the past decade, a number of endovascular approaches have evolved to treat aortic aneurysms with anatomy that is not amenable to traditional endovascular repair, although the optimal practice and referral patterns remain in question. The Zenith fenestrated (Z-Fen) endograft (Cook Medical) represents the first commercially available fenestrated graft product in the United States. OBJECTIVE: We aim to quantify practice patterns in Z-Fen use during the first 5 years of commercial availability, and we identify predictors of high and low uptake. DESIGN, SETTING, AND PATIENTS: This is a retrospective review of complete order records for Z-Fen endografts since June 2012. We performed univariate and multivariate regressions of predictors that surgeons and centers would be in the top and bottom quartiles of annual Z-Fen use. RESULTS: Since June 15, 2012, 744 surgeons have been trained to use Z-Fen, and 4133 cases have been performed at 409 trained centers. The average annual number of cases per trained surgeon was 4.46 [95% confidence interval (CI), 3.58-5.70]; however, many surgeons performed few or no cases following training, and there was a skew toward users with low average annual volumes (25th percentile 1.23, 50th percentile 2.35, 75th percentile 4.93, and 99th percentile 33.29). Predictors of high annual use in the years following training included academic center (aOR 5.87, P = .001) and training within the first 2 years of availability (aOR 46.23, P < .001). CONCLUSION: While there is literature supporting the safety and efficacy of Z-Fen, adoption has been relatively slow in an era when the vast majority of vascular surgeons have advanced endovascular skills. Given the training and resources required to use fenestrated or branched aortic endovascular devices, referral patterns should be determined and training should be focused on centers with high expected volumes.

Endovascular treatment of abdominal aortic aneurysms with narrow aortic bifurcation using Excluder bifurcated stent grafts.

OBJECTIVE: This study investigated the influence of the aortic bifurcation anatomy on the endovascular treatment of abdominal aortic aneurysms using Excluder (W. L. Gore & Associates, Flagstaff, Ariz) bifurcated stent grafts. METHODS: This was a retrospective single-center study of patients treated with the Excluder stent graft. Analysis included anatomical factors of the aortic bifurcation (aortic bifurcation diameter [ABD], calcification, thrombus), characteristics of the stent graft limbs (sum of stent graft limbs diameters [SLD]), and the SLD/ABD ratio. Narrow bifurcation was defined as ABD <20 mm. Primary outcomes were intraoperative stenosis, need for additional intraoperative measures, limb stenosis, and occlusion during follow-up. RESULTS: The study included 232 patients. Mean ABD was 24.6 ± 6 mm, with 53 patients (23%) presenting with narrow bifurcation (range, 12.5-19.5 mm). Median SLD in these patients was 28 mm, and the SLD/ABD ratio was 1.64. Calcification involving >50% of the bifurcation circumference was present in 32% of the patients, with 17% presenting thrombus in this area. Of 53 patients with narrow bifurcation, intraoperative stenosis >50% occurred in three (5.7%), which required adjunctive treatment. Computed tomography at 1 month showed limb stenosis >50% in nine patients (17%). No limb occlusions were recorded with a median follow-up of 34 months. Multivariate analysis of the overall series showed a higher risk of limb stenosis on the computed tomography at 1 month in patients with peripheral artery disease (hazard ratio [HR], 5.3; 95% confidence interval [CI], 1.2-24.4; P = .032), narrow bifurcation (HR, 5.7; 95% CI, 2-15.8; P = .001), higher SLD/ABD ratio (HR, 29.3; 95% CI, 4-215.2; P = .001), and calcium >50% (HR, 3; 95% CI, 1.1-8; P = .03), and lower in bifurcations with thrombus (HR, 0.3; 95% CI, 0.1-0.8; P = .017). CONCLUSIONS: Abdominal aortic aneurysms with narrow bifurcation can be treated with the bifurcated Excluder device without additional adjunctive measures. The presence of limb stenosis during follow-up is not associated with occlusion. Long-term follow-up studies are needed to confirm these results.

Long-segment pulmonary artery resection to avoid pneumonectomy: long-term results after prosthetic replacement.

OBJECTIVES: Resection of a long pulmonary artery (PA) segment infiltrated by tumour and reconstruction by conduit interposition or wide patch is a challenging but feasible option to avoid pneumonectomy. Our goal was to report the long-term results of our experience with this type of operation using various techniques and materials. METHODS: Between 1991 and 2015, 24 patients underwent sleeve resection of a long PA segment or extended resection (>2.5 cm) of 1 aspect of the circumference of the PA associated with lobectomy for centrally located lung cancer. Materials used for conduit reconstruction (20 patients) included pulmonary vein in 12 patients, autologous pericardium in 4, porcine pericardium in 3 and bovine pericardium in 1. Patches used in 4 patients consisted of porcine pericardium (2 patients) and pulmonary vein (2 patients). RESULTS: Twenty-three patients underwent left upper lobectomy without associated bronchoplasty. One patient underwent bronchovascular left upper sleeve lobectomy. The postoperative morbidity rate was 29.1%. No complications related to the reconstructive procedure occurred. There were no postoperative deaths. Complete patency of the reconstructed PA was shown in all patients by postoperative contrast computed tomography performed every 6 months. Pathological tumour stage ranged from I to IIIA. Five-year overall survival and disease-free survival rates were 69.9% and 52.7%, respectively, at a median follow-up of 41 months. CONCLUSIONS: Resection of the long PA segment followed by conduit or wide patch reconstruction is a feasible, safe and effective option to avoid pneumonectomy. Different biological materials can be used to provide adequate tissue characteristics; the choice is made on a case-by-case basis. Long-term results confirm the oncological reliability of this operation.

Long term follow-up of bifurcation aneurysms treated with braided stent assisted coiling and complex T- and Y- stent constructs.

BACKGROUND: Stent assisted coil embolization (SACE) of bifurcation aneurysms is challenging. Heterogeneous results have been achieved to date, but largely for laser cut stents. While braided stents offer multiple technical advantages, their long term efficacy has yet to be validated. OBJECTIVE: To report the first long term 18 month results for the durability of bifurcation aneurysms treated with braided stents. MATERIALS AND METHODS: Over a 4 year period, 59 consecutive patients with 60 bifurcation aneurysms underwent elective braided SACE across three Australian neurovascular centers. 17 of these aneurysms underwent T- or Y-shaped stent constructs. All patients had immediate, 6 month and 18 month clinical and radiological follow-up. Radiological assessment was made on modified Raymond-Roy occlusion scores while clinical assessment was based on the modified Rankin Scale. Subgroup analysis of 17 aneurysms treated with multi-stent constructs was conducted. RESULTS: 6 month follow-up data were available for 59 aneurysms and 18 month follow-up data for 58 aneurysms. Satisfactory aneurysm occlusion was achieved in 97% at inception and at 6 months, and 98% at 18 months. Good neurological outcomes were achieved in 95% at 18 months. Similar satisfactory results were achieved with the multi-stent construct cohort. Intraprocedural thromboembolic events were recorded in 5% and delayed events in 2%. Technical complications were found in 5%. All complication rate was 13%. CONCLUSION: Braided SACE was safe, efficacious, and durable at the long term 18 month follow-up, including for multi-stent constructs. Preliminary results indicate favorable clinical and radiological outcomes compared with laser cut stents.

Quantity and quality of graft flow in coronary artery bypass grafting is associated with cardiac computed tomography study-based anatomical and functional parameters.

OBJECTIVES: Graft flow in coronary artery bypass grafting (CABG) may be determined by the anatomical and pathological characteristics of the coronary artery and target myocardium. Our goal was to explore the relationships between graft flow and the cardiac/coronary parameters in CABG. METHODS: We enrolled 63 patients who underwent isolated CABG and were examined by cardiac computed tomography. We statistically analysed the correlation between the intraoperative graft flow, such as the mean graft flow (MGF) or the pulsatile index (PI), and the computed tomography scan-based anatomy of the coronary artery tree and the left ventricle in 104 individually bypassed grafts. RESULTS: The MGF displayed a significantly positive correlation with the perfused left ventricle mass volume (r = 0.3583, P = 0.0002), and the percentage of stenosis and the diameter of the coronary artery (r = 0.2396, P = 0.0148 and r = 0.2972, P = 0.0022). The PI displayed a negative correlation with the percentage of stenosis and the diameter of the coronary artery (r = -0.2826, P = 0.0038 and r = -0.2796, P = 0.0040). Abnormal graft flow (PI >5.0, and MGF <20 ml/min in arterial graft and MGF <40 ml/min in vein graft) was found in 9 grafts. The internal diameter of the coronary artery at the distal anastomosis site was significantly smaller [1.35 (1.15-1.64) mm vs 1.71 (1.5-2.1) mm, P = 0.0065], and the distal calcium score of the target coronary artery was significantly higher [40 (4-61) vs 0.4 (0-10), P = 0.014] in the abnormal grafts. CONCLUSIONS: Intraoperatively measured MGF and PI in CABG were associated with cardiac anatomical parameters, such as the percentage of stenosis, internal diameter or calcium score of the target coronary artery or perfused left ventricle mass volume.

Endocarditis infecciosa protésica precoz en el anciano: cambios a lo largo de un periodo de 28 años (1987-2014) / Early prosthetic valve infective endocarditis in the elderly: changes over a 28-year period (1987-2014)

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Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States.

BACKGROUND: Fenestrated endografts are customized, patient-specific, endovascular devices with potential to significantly reduce morbidity and mortality of short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair. The Zenith fenestrated endovascular graft (ZFEN) for abdominal aortic aneurysms (Cook Medical, Bloomington, Ind), Food and Drug Administration-approved in 2012, remains the only fenestrated device available in the United States. This technology is among the most technically complex catheter-based procedures and, therefore, inherently associated with serious risk for device-related complications. We sought to define patterns of physician and hospital adoption of ZFEN. METHODS: Deidentified datasets containing numbers of physicians trained, orders by physicians and hospitals, and designs (fenestration/scallop configuration) was provided for U.S. ZFEN devices ordered (April 2012-August 2015). We evaluated the number of physicians trained, the number of devices ordered, hospital characteristics, and fenestration/scallop design configurations. Cook Medical assembled the datasets but played no role in study design, analysis, or interpretation of data. RESULTS: Between April 2012 and August 2015, 553 physicians attended formal ZFEN training sessions, 388 (70%) of whom ordered a total of 2669 devices. An increase in orders per month (nine in June 2012 and 91 in August 2015, 911% growth; P < .001) and in number of physicians ordering per month (eight in June 2012 and 62 in August 2015, 675% growth; P < .001) was observed. Teaching hospitals, representing all U.S. regions (Midwest 927, 35%; South 799, 30%; Northeast 547, 20%; West 396, 15%), accounted for 1703 (64%) ZFEN orders. Of 553 trained physicians, 165 (30%) ordered no devices, 116 (21%) ordered 1 device, 144 (26%) ordered 2-5 devices, 61 (11%) ordered 6-10 devices, 39 (7%) ordered 11-20, and 28 (5%) ordered >20 devices. For physicians contributing >6 months of data (n = 336), the average number of devices ordered per year was three (standard deviation, 4); 272 (81%) ordered ≤ 5 devices/year, 15 (4.5%) ordered 11-20 devices/year, and 3 (0.9%) ordered >20 devices/year. Of devices with design details available (2618 of 2669; 98%), most common designs were 2 small fenestrations/1 scallop (1443; 55%), 2 small fenestrations/1 large fenestration (568; 22%), 1 small fenestration/1 scallop (173, 6.6%), and 2 small fenestrations (169; 6.5%). The average number of target vessels incorporated in each design was 2.7/device; 2071 (79%) incorporated three, 398 (15%) incorporated two. CONCLUSIONS: Since 2012, ZFEN has demonstrated a ninefold increase in monthly orders, with 553 physicians trained. Unlike the experience of rapid dissemination seen with infrarenal endografts, only 28 (5%) physicians have ordered >20, whereas 165 (30%) have ordered none, and 272 (81%) ordered ≤ 5 devices/year. Assuming that volume, in general, correlates with outcomes, this adoption pattern raises questions whether fenestrated technology should be regionalized to high-volume centers.

Stent Implantation for Superior Vena Cava Syndrome of Malignant Cause.

Purpose The purpose of this paper is the retrospective analysis of endovascular therapy for the treatment of superior vena cava syndrome (SVCS) of malignant cause. This study focuses on the effectiveness of the therapy regarding the duration of remission, symptom control and practicability. Materials and Methods From January 2003 to November 2012, therapeutic implantation of one or more stents was performed in 141 patients suffering from SVCS. The medical history was retrospectively researched using digitalized patient files. If those were incomplete, secondary research was conducted using the cancer registry of the General Hospital Nuremberg, the cancer registry of the tumor center at Friedrich-Alexander-University Erlangen-Nuremberg (FAU) or information given by physicians in private practice. This data was collected using Microsoft Office Excel® and statistically analyzed using IBM SPSS Statistics 22®. Results 168 stents were implanted in 141 patients (median age: 64.6 years; range: 36 - 84), 86 being male and 55 being female. In 121 patients, SVCS was caused by lung cancer (85.8 %), in 9 patients by mediastinal metastasis of an extrathoracic carcinoma (6.4 %), in 3 patients by mesothelioma of the pleura (2.1 %) and in 1 patient by Hodgkin's disease (0.7 %). There was no histological diagnosis in 7 cases (4.9 %). The primary intervention was successful in 138 patients (97.9 %). Immediate thrombosis in the stent occurred in the remaining 3 cases. Recurrence of SVCS was observed in 22 patients (15.6 %), including 5 early and 17 late occlusions. Stent dislocation or breakage was not observed. As expected, the survival after implantation was poor. The median survival was 101 days, and the median occlusion-free survival was 80 days. Conclusion The symptomatic therapy of SVCS with endovascular stents is effective and safe. Despite effective symptom control and a low rate of recurrence, the patients' prognosis is poor. Key Points: · Patients with SVCS of malignant cause have a poor prognosis.. · Lung cancer is the most common cause for SVCS.. · Endovascular therapy is safe and effective.. Citation Format · Büstgens FA, Loose R, Ficker JH et al. Stent Implantation for Superior Vena Cava Syndrome of Malignant Cause. Fortschr Röntgenstr 2017; 189: 423 - 430.

Flow Diverter Stents for the Treatment of Anterior Cerebral Artery Aneurysms: Safety and Effectiveness.

BACKGROUND AND PURPOSE: Flow diverter stents (FDSs) are increasingly used for the treatment of intracranial aneurysms. Initially developed for the management of giant and large aneurysms, their indications have progressively expanded. The purpose of our study was to evaluate the safety and effectiveness of FDSs for the treatment of anterior cerebral artery (ACA) aneurysms. MATERIALS AND METHODS: Among the 94 consecutive patients treated for 100 intracranial aneurysms by means of FDSs in our institution from October 2010 to January 2015, eight aneurysms (8 %) in seven patients were located on the ACA. Three aneurysms were located on the A1 segment, three aneurysms on the anterior communicating artery (ACom) and two on the A2-A3 junction. In three cases, FDS was used for angiographic recurrence after coiling. Five patients were treated with a Pipeline embolization device, one with a NeuroEndograft and the last one with a Silk FDS. RESULTS: Treatment was feasible in all cases. No technical difficulty was reported. No acute or delayed clinical complication was recorded. Modified Rankin Scale was 0 for six patients and one for one patient. Mean angiographic follow-up was 9.7 ± 3.9 months (range 6-15). Total exclusion was observed in five aneurysms (71.4 %) and neck remnant in two (28.6 %) cases. One patient refused the control DSA. CONCLUSION: Our series shows the safety and effectiveness of FDSs for the treatment of ACA aneurysms.

First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis.

AIMS: In preclinical studies, a bare metal cobalt-chromium stent with an active surface oxide layer modification (BMSmod) has been shown to inhibit neointimal hyperplasia effectively. We sought to assess both the clinical safety and feasibility of the BMSmod. METHODS AND RESULTS: In this prospective, non-randomised, first-in-man multicentre study, a total of 31 patients with de novo coronary lesions, reference lumen diameters of 2.5-3.5 mm and lesion length ≤16 mm, were enrolled. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at baseline and six-month follow-up. Primary angiographic and OCT endpoints included in-stent late lumen loss (LLL) and mean neointimal thickness at six months. The device-oriented composite endpoint (DoCE), defined as cardiac death, myocardial infarction not clearly attributable to a non-intervention vessel, and clinically indicated target lesion revascularisation (CI-TLR), was analysed according to the intention-to-treat principle. In 31 patients (33 lesions), the procedural success rate was 93.5%. At six months, angiographic LLL was 0.91±0.45 mm and binary angiographic restenosis occurred in 23.3% of lesions. Out of 33 lesions, OCT was performed in 27 lesions at both time points. Mean neointimal thickness amounted to 348±116 µm. At six months, the DoCE was 19.4% due to the occurrence of CI-TLR in five patients (including one late definite stent thrombosis of a non-study stent). CONCLUSIONS: In contrast to previous preclinical pathophysiological work, the BMSmod did not prevent neointimal hyperplasia in a first-in-man clinical setting.

Computational fluid dynamics of cerebral aneurysm coiling using high-resolution and high-energy synchrotron X-ray microtomography: comparison with the homogeneous porous medium approach.

BACKGROUND: Computational modeling of intracranial aneurysms provides insights into the influence of hemodynamics on aneurysm growth, rupture, and treatment outcome. Standard modeling of coiled aneurysms simplifies the complex geometry of the coil mass into a homogeneous porous medium that fills the aneurysmal sac. We compare hemodynamics of coiled aneurysms modeled from high-resolution imaging with those from the same aneurysms modeled following the standard technique, in an effort to characterize sources of error from the simplified model. MATERIALS: Physical models of two unruptured aneurysms were created using three-dimensional printing. The models were treated with coil embolization using the same coils as those used in actual patient treatment and then scanned by synchrotron X-ray microtomography to obtain high-resolution imaging of the coil mass. Computational modeling of each aneurysm was performed using patient-specific boundary conditions. The coils were modeled using the simplified porous medium or by incorporating the X-ray imaged coil surface, and the differences in hemodynamic variables were assessed. RESULTS: X-ray microtomographic imaging of coils and incorporation into computational models were successful for both aneurysms. Porous medium calculations of coiled aneurysm hemodynamics overestimated intra-aneurysmal flow, underestimated oscillatory shear index and viscous dissipation, and over- or underpredicted wall shear stress (WSS) and WSS gradient compared with X-ray-based coiled computational fluid dynamics models. CONCLUSIONS: Computational modeling of coiled intracranial aneurysms using the porous medium approach may inaccurately estimate key hemodynamic variables compared with models incorporating high-resolution synchrotron X-ray microtomographic imaging of complex aneurysm coil geometry.

Current practices of Asia-Pacific cardiologists in the utilization of bioresorbable scaffolds.

BACKGROUND & AIMS: Although Absorb Bioresorbable Vascular Scaffolds (A-BVS) are routinely used in the Asia-Pacific, there is little information on patient selection or deployment technique here. This document investigates the experiences of leading interventional cardiologists from the Asia-Pacific region with a focus on patient characteristics, deployment techniques and management. METHODS AND RESULTS: A detailed questionnaire was distributed to 28 highly-experienced interventional cardiologists ('Authors') from 13 Asia-Pacific countries. The results were discussed at a meeting on patient selection, technical consideration, deployment practices and patient management. Potential patient benefits of Absorb compared to metallic DES, the learning curve for patient selection and preparation, device deployment, and subsequent patient management approaches are presented. CONCLUSIONS: Current practices are derived from guidelines optimized for European patients. Differences in approach exist in the Asia-Pacific context, including limited access to imaging and frequency of occurrence of complex lesions. Nevertheless, the use of the Absorb BVS ('Absorb') in certain Asia-Pacific countries has flourished and practices here are continuing to mature.