Insulin-transferrin-selenium promote formation of tissue-engineered vascular grafts in early stage of culture.

To create tissue-engineered vascular grafts (TEVGs) in vitro, vascular smooth muscle cells (VSMCs) must function effectively and produce sufficient extracellular matrix (ECM) in a three-dimensional space. In this study, we investigated whether the addition of insulin-transferrin-selenium (ITS), a medium supplement, could enhance TEVG formation. PGA fabric was used as the scaffold, and 1% ITS was added to the medium. After two weeks, the tissues were examined using electron microscopy and staining. The ITS group exhibited a denser structure and increased collagen production. VSMCs were cultured in two dimensions with ITS and assessed for collagen production, cell growth, and glucose metabolism. The results showed that ITS supplementation increased collagen production, cell growth, glucose utilization, lactate production, and ATP levels. Furthermore, reducing the amount of fetal bovine serum (FBS) in the medium did not affect the TEVGs or VSMCs when ITS was present. In conclusion, ITS improves TEVG construction by promoting VSMCs growth and reducing the need for FBS.

Treatment with a flow diverter-assisted coil embolization for ruptured blood blister-like aneurysms of the internal carotid artery: a technical note and analysis of single-center experience with pooled data.

Treatment of blood blister-like aneurysms (BBAs) of the supraclinoid internal carotid artery (ICA) with flow diverters (FDs) has become widespread in recent years. However, ruptured blood blister-like aneurysm (BBA) of ICA treatment with flow diverter-assisted coil embolization (FDAC) remains controversial. Moreover, limited direct comparative studies have been conducted between the two treatment modalities, FDs and FDAC, for BBAs. The purpose of this study was to document our experience and evaluate the effectiveness and safety of FDAC. We conducted a retrospective analysis of clinical and radiological information from ten patients who experienced ruptured BBAs of the supraclinoid ICA at our center from January 2021 to February 2023. The technical details of FDAC for ruptured BBAs were described, and the technical steps were named "pipeline embolization device (PED)-Individualized shaping(microcatheter)-Semi deploying-Rivet(coils)-Massage(microwire)" as the PEISSERM technique. Clinical outcomes were assessed using the modified Rankin Scale (mRS), whereas radiological results were determined through angiography. A pooled analysis was implemented, incorporating data from literature sources that reported perioperative and long-term clinical and angiographic outcomes of ruptured BBAs treated with FD and FDAC strategies, along with our data. Data in our analysis pool were categorized into FD and FDAC strategy groups to explore the preferred treatment modalities for BBAs. The PEISSERM technique was utilized to treat ten patients, seven males, and three females, with an average age of 41.7 years. A single PED was deployed in conjunction with coils in all ten patients. All PEDs were documented to have good wall apposition. The immediate postoperative angiograms demonstrated Raymond grade I in ten aneurysms. Angiographic follow-up of nine patients at 4-25 months showed total occlusion of the aneurysms. At the most recent follow-up, the mRS scores of nine patients hinted at a good prognosis. Pooled analysis of 233 ICA-BBA cases of FD revealed a technical success rate of 91% [95% confidence interval (CI), 0.88 to 0.95], a rate of complete occlusion of 79% (95% CI, 0.73 to 0.84), a recurrence rate of 2% (95% CI, 0.00 to 0.04), a rebleed rate of 2% (95% CI, 0.00 to 0.04), and the perioperative stroke rate was 8% (95% CI, 0.04 to 0.11). The perioperative mortality was 4% (95% CI, 0.01 to 0.07). The long-term good clinical outcome rate was 85% (95% CI, 0.80 to 0.90). The mortality rate was 6% (95% CI, 0.03 to 0.09). Results from the subgroup analysis illustrated that the FDAC strategy for BBAs had a significantly higher immediate postoperative complete occlusion rate (P < 0.001), total occlusion rate (P = 0.016), and a good outcome rate (P = 0.041) compared with the FD strategy. The FDAC strategy can yield a higher rate of good outcomes than the FD strategy. The PEISSERM technique employed by the FDAC is a reliable and effective treatment approach as it can minimize the hemodynamic burden of BBA's fragile dome, thereby achieving an excellent occlusion rate. The PEISSERM technique in the FDAC strategy contributes to understanding the BBA's treatment and offers a potentially optimal treatment for BBA.

Clinical Study on the Management of Aortic Dissection Involving the Aortic Arch through Endovascular Isolation and In Situ Fenestration with Covered Stent.

Objective: This study aimed to investigate the clinical effectiveness of the SilverFlow branch stent through endovascular isolation and in situ fenestration (ISF) for the treatment of aortic dissection (AD) involving the aortic arch. Methods: A total of 21 patients with AD involving the aortic arch, admitted to our hospital between September 2021 and January 2023, were selected for this prospective study. All patients underwent treatment with an endoluminal isolated ISF-covered stent, with the branch stent being the SilverFlow, developed by Shenzhen Xianjian Company. We assessed the success rate of the ISF procedure stent-related complications and compared the volumes of the true and false cavities before and after treatment. Follow-up evaluations were conducted 1, 3, and 6 months post-operation, focusing on neurological complications, mortality, and the need for secondary interventional treatment. Results: Among the 21 AD patients with aortic arch involvement, 20 (95.23%) underwent non-emergency surgery, while 1 (4.76%) required emergency surgery due to cardiac ischemia and signs of dissection rupture. All surgeries were successfully completed. After treatment, the average volume of the true lumen significantly decreased compared to pre-treatment levels, while the volume of the false lumen significantly increased (P < .05). The success rate was 100%, with only one case (4.76%) experiencing type I internal leakage. There were no cases of stent displacement, distortion, or fenestration vessel occlusion. One patient (4.76%) succumbed to acute pericardial tamponade, resulting in a mortality rate of 4.76%. Another patient (4.76%) suffered from upper limb ischemia, significantly improving with antithrombotic drug treatment. No occurrences of stroke, visceral ischemia, or other complications were reported, and no secondary interventional treatments were required. Conclusions: The application of the SilverFlow branch stent for endovascular isolation of ISF in AD cases involving the aortic arch demonstrates a high success rate, low complication and mortality rates, and significant clinical feasibility and value.

Impact of patient demographics and intraoperative characteristics on abdominal aortic aneurysm sac following endovascular repair.

BACKGROUND: Endovascular aortic repair (EVAR) has become the preferred treatment for abdominal aortic aneurysm (AAA). Its main aim is to seal the perfusion of the aneurysmal sac and, thus, induce sac regression and subsequent aortic remodelling. Aneurysmal sac regression has been linked to the short- and long-term clinical outcomes post-EVAR. It has also been shown to be influenced by endograft device choice, with several of these available commercially. This review summarises and discusses current evidence on the influence of pre- and intraoperative factors on sac regression. Additionally, this review aims to highlight the device-specific variations in sac regression to provide an overall holistic approach to treating AAAs with EVAR. METHODS: A comprehensive literature search was conducted using multiple electronic databases to identify and extract relevant data. RESULTS: Female sex, >70 mm original sac diameters, higher pre-procedural fibrinogen levels, smoking and low intra-aneurysmal pressure were found to positively impact sac regression. Whereas renal impairment, ischemic heart disease, high intra-aneurysmal pressure and aneurysm neck thrombus negatively influenced sac regression. Patent lumbar arteries, age, statins and hypercholesterolaemia displayed conflicting evidence regarding sac regression. Regarding the EVAR endografts compared, newer generation devices such as the Anaconda mainly showed the most optimal results. CONCLUSION: Sac regression following EVAR in AAA is an important prognostic factor for morbidity and mortality. Nevertheless, several pre- and intraoperative factors can have an influence on sac regression. Therefore, it is necessary to take them into account when assessing AAA patients for EVAR to optimise outcomes. The choice of EVAR stent-graft can also affect sac regression, with evidence suggesting that the Fenestrated Anaconda is associated with the most favourable results.

Treatment of a Delayed Type IIIb Endoleak 20 Years Post EVAR With Inverted Contralateral Limb Custom-Made Device: A Case Report.

PURPOSE: Type III endoleak can be difficult to distinguish from Type I endoleak. Depending on the stent graft anatomy, the use of standard bifurcated endografts may not be technically feasible, and patients may have to be subject to an aorto-uni-iliac repair with femoral-femoral bypass or open surgery. CASE REPORT: We report a case of an 86-year-old male who had a Type IIIb endoleak 20 years post EVAR which was characterized on angiography to be from a hole close to the bifurcation limb origin. The initial Talent (Medtronic, Santa Rosa, California) device had a 50 mm main body common trunk, which was not amenable to treatment with standard devices. He was successfully treated with a custom-made device with an inverted contralateral limb. CONCLUSIONS: Our case highlights the need for lifelong surveillance post EVAR as endoleak may present decades post initial EVAR. It also demonstrates that many Type III endoleak which were otherwise deemed unsuitable for treatment with standard devices may potentially be treatable with custom-made device (CMD). This solution preserves a percutaneous option in a now older person which avoids surgical bypass. Further studies are required to establish the durability of this treatment and survey for recurrence.

Virtual Reality to Ease Endovascular Repair of Thoracoabdominal Aneurysms Under Local Anesthesia.

Purpose: Virtual reality (VR) has both a non-pharmacological analgesic and anxiolytic action that can be used as an alternative to general anesthesia for very high-risk patients. Case report: We present here the case of a patient treated for a complex endovascular thoracoabdominal aortic aneurysm exclusion using a 4-fenestrated aortic endograft using VR. The patient had no postoperative complications and was safely discharged from the hospital on postoperative day 6. Conclusion: This case demonstrates that the use of VR in addition to local anesthesia can be a safe alternative to general anesthesia.

Decreasing trends in reintervention and readmission after endovascular aneurysm repair in a multiregional implant registry.

OBJECTIVE: As endovascular aortic aneurysm repair (EVAR) matures into its third decade, measures such as long-term reintervention and readmission have become a focus of quality improvement efforts. Within a large United States integrated health care system, we describe time trends in the rates of long-term reinterventions utilization measures. METHODS: Data from a United States multiregional EVAR registry was used to perform a descriptive study of 3891 adults who underwent conventional infrarenal EVAR for infrarenal abdominal aortic aneurysm between 2010 and 2019. Three-year follow-up was 96.7%. Outcomes included 1-, 3-, and 5-year graft revision (defined as a procedure involving placement of a new endograft component), secondary interventions (defined as a procedure necessary for maintenance of EVAR integrity [eg, coil embolization and balloon angioplasty/stenting]), conversion to open, interventions for type II endoleaks alone, and 90-day readmission. Crude cause-specific reintervention probabilities were calculated by operative year using the Aalen-Johansen estimator, with death as a competing risk and December 31, 2020 as the study end date. RESULTS: Excluding interventions for type II endoleak alone, 1-year secondary intervention incidence decreased from 5.9% for EVARs in 2010 to 2.0% in 2019 (P < .001) and 3-year incidence decreased from 7.2% to 3.6% from 2010 to 2017 (P = .03). The 3-year incidences of graft revision (mean incidence, 3.4%) and conversion to open remained fairly stable (mean incidence, 0.6%) over time. The 3-year incidence of interventions for type II endoleak alone also decreased from 3.4% in 2010 to 0.7% in 2017 (P = .01). Ninety-day readmission rates decreased from 19.3% for index EVAR in 2010 to 9.2% in 2019 (P = .03). CONCLUSIONS: Comprehensive data from a multiregional health care system demonstrates decreasing long-term secondary intervention and readmission rates over time in patients undergoing EVAR. These trends are not explained by evolving management of type II endoleaks and suggest improving graft durability, patient selection, or surgical technique. Further study is needed to define implant and anatomic predictors of different types of long-term reintervention.

Hierarchical-structured bacterial cellulose/potato starch tubes as potential small-diameter vascular grafts.

To achieve long-term patent small-diameter (<6 mm) vascular implants, biomimetic vascular grafts have gained much attention in promoting in situ blood vessel regeneration. In this study, hierarchical-structured bacterial cellulose/potato starch (BC/PS) composites were biosynthesized by the addition of swollen PS. Investigations on the physicochemical properties of BC/PS composites showed that the properties could be improved and tailored by the addition of swollen PS. The composites displayed a morphology, water content, thermal properties, mechanical properties, and biocompatibility appropriate for vascular tissue engineering. Most importantly, the BC/PS grafts, with a dense inner surface and a circumferential macroporous outer layer, possessed 75% patency and promoted rapid blood vessel regeneration in in vivo assessment on rabbits, with complete endothelium monolayer, organized smooth muscle cells, rich new capillaries, and deposited extracellular matrix. Collectively, these findings demonstrate that hierarchical-structured BC/PS tubes hold great promise as artificial small-diameter vascular grafts.

Percutaneous EVAR for Ruptured Abdominal Aortic Aneurysms Using the Cordis INCRAFT Endograft.

OBJECTIVES: Low profile endovascular aneurysm repair (EVAR) devices such as the Cordis INCRAFT AAA Stent Graft System may expand the category of patients suitable for endovascular repair. We report our experience with the INCRAFT system in treating ruptured abdominal aortic aneurysms (rAAA). METHODS: We included all patients presenting with rAAA from 2015 to 2019 in our hospital who were treated by percutaneous EVAR with the INCRAFT system. The primary outcome was technical success, referring to adequate stent graft placement. Secondary outcomes included completion of the procedure under local anesthesia and mortality at 30-days, one year and long-term follow-up. RESULTS: Fifteen male patients (mean age: 74 years, SD 6.7) were treated for rAAA with a median aneurysm diameter of 8.25 cm (SD 1.66). The device was successfully delivered and deployed in all subjects. Per-procedurally one type I endoleak required additional stent placement and one patient developed an acute thrombosis of the device main body and iliac limbs requiring thrombectomy. 80.0% of patients were successfully treated under local anesthesia only. The 30 day and one year mortality were 26.6% and 33.3% respectively. Long-term survival was 60.0% at a median follow-up period of 57 months, with two patients requiring late reintervention for an endoleak. CONCLUSIONS: The INCRAFT system can be used to percutaneously treat rAAA with a high technical success rate and mortality similar to reported in the literature for other devices. The large majority of procedures can be completed with only local anesthesia.

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.

"Awake" Spinal Cord Monitoring Under Local Anesthesia and Conscious Sedation in Fenestrated and Branched Endovascular Aortic Repair.

INTRODUCTION: Endovascular repair of thoracoabdominal aortic aneurysms carries a risk of spinal cord ischemia, the causes of which remain uncertain. We hypothesized that local anesthesia (LA) with conscious sedation could abrogate the potential suppressive cardiovascular effects of general anesthesia (GA) and facilitate intraoperative monitoring of neurological function. Here, we examine the feasibility of this technique during fenestrated (FEVAR) or branched endovascular aortic repair (BEVAR). MATERIALS AND METHODS: Consecutive patients undergoing FEVAR or BEVAR under LA and conscious sedation by a team at a single center were analyzed. Patients received conscious sedation using intravenous remifentanil and propofol infusions in conjunction with a local anesthetic agent. No patient had a prophylactic spinal drain inserted. Outcome measures included conversion to GA, need for vasopressors and/or spinal drainage, length of stay, complications, and patient survival. RESULTS: A total of 44 patients underwent FEVAR or BEVAR under LA and conscious sedation. The cohort included thoracoabdominal aortic aneurysms (n=41) and pararenal aneurysms treated with endografts covering the supraceliac segment (n=3). Four patients (9%) required conversion to GA at a median operative duration of 198 minutes (range 97-495 minutes). Vasopressors were required intraoperatively in 3 of the cases that were converted to GA. No patient developed spinal cord ischemia and none had insertion of a spinal drain. The median hospital length of stay was 4 days (range 2-41 days). Postoperative delirium and hospital-acquired pneumonia was seen in 7% of patients. All patients survived to 30 days, with 95% alive at a median follow-up of 15 months (range 3-26 months). CONCLUSION: LA and conscious sedation is a feasible anesthetic technique for the endovascular repair of thoracoabdominal aortic aneurysms.

Does washing medical devices before and after use decrease bacterial contamination?: An in vitro study.

ABSTRACT: Surface treatment of medical devices may be a way of avoiding the need for replacement of these devices and the comorbidities associated with infection. The aim of this study was to evaluate whether pre- and postcontamination washing of 2 prostheses with different textures can decrease bacterial contamination.The following microorganisms were evaluated: Staphylococcus aureus, Staphylococcus epidermidis, Proteus mirabilis and Enterococcus faecalis. Silicone and expanded polytetrafluoroethylene vascular prostheses were used and divided into 3 groups: prostheses contaminated; prostheses contaminated and treated before contamination; and prostheses contaminated and treated after contamination. Treatments were performed with antibiotic solution, chlorhexidine and lidocaine. After one week of incubation, the prostheses were sown in culture medium, which was incubated for 48 hours. The area of colony formation was evaluated by fractal dimension, an image analysis tool.The antibiotic solution inhibited the growth of S epidermidis and chlorhexidine decrease in 53% the colonization density for S aureus in for both prostheses in the pre-washing. In postcontamination washing, the antibiotic solution inhibited the growth of all bacteria evaluated; there was a 60% decrease in the colonization density of S aureus and absence of colonization for E faecalis with chlorhexidine; and lidocaine inhibited the growth of S aureus in both prostheses.Antibiotic solution showed the highest efficiency in inhibiting bacterial growth, especially for S epidermidis, in both washings. Lidocaine was able to reduce colonization by S aureus in post-contamination washing, showing that it can be used as an alternative adjuvant treatment in these cases.

Treatment Results of Endovascular Aneurysm Repair Using the Parallel Stent-Graft Double D Technique for Distal Saccular Abdominal Aortic Aneurysms and Common Iliac Aneurysms.

BACKGROUND: Endovascular aneurysm repair (EVAR) using a bifurcated stent graft may involve technical challenges when aortic disease (aneurysm or dissection) consists of a length <70 mm between the inferior renal artery and aortic bifurcation or narrow aortic bifurcation that is common in asymmetric distal abdominal aortic aneurysms (AAAs) or iliac artery aneurysms (IAAs). We use EVAR with the double D technique (DDT-EVAR) for such cases, which involves straight type of stent grafts with same diameter in left and right that are deployed parallel to an aortic cuff that has been previously placed. In addition, DDT-EVAR can preserve the inferior mesenteric artery (IMA) for IAA. METHODS: DDT-EVAR was performed for 21 of 910 (2%) cases from April 2007 to April 2019 at our institution. The median patient age was 74 years (range, 52-85). Nineteen patients (90%) were men. Six patients (all saccular; 1 rupture) had AAAs, 12 had IAAs, and 3 had chronic type B aortic dissociation (TBAD) for re-entry closure. AAA and IAA had diameters of 45 mm (range, 34-71) and 34 mm (range, 25-58), respectively. An aortic cuff was used for 19 (90%) cases. Endurant II (Medtronic, Santa Rosa, CA) was used for 12 cases. The Excluder (W.L. Gore & Associates, Inc, Flagstaff, AZ) was used for 7 cases. Endurant II was used for 20 cases, and the VBX (W.L. Gore & Associates, Inc) was used for 1 case as stent-graft limbs. RESULTS: The procedural success rate was 100%. The median operative time was 146 min (range, 88-324). IMA planned for preservation was successful for all 12 cases. Type I and type III endoleaks were not observed. With TBAD, flow to the false lumen decreased or disappeared, and no complications during the hospital stay were associated with the procedure. For 2 patients whose procedure involved Endurant II stent-graft limb, limb occlusions were observed postoperatively, and reintervention was required. No other patients required additional treatment at a median follow-up of 18 months (range, 4-50). CONCLUSIONS: DDT-EVAR is a safe and straightforward technique for the treatment of distal AAA, common iliac artery aneurysm, and TBAD. It may help preserve the IMA and internal iliac artery, even when it is impossible to preserve them with a bifurcated stent graft.

Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system.

BACKGROUND: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. STUDY DESIGN: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. RESULTS: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). CONCLUSIONS: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.

Cost-effectiveness analysis of immediate access arteriovenous grafts versus standard grafts for hemodialysis.

OBJECTIVE: Immediate-access arteriovenous grafts (IAAVGs), or early cannulation arteriovenous grafts (AVGs), are more expensive than standard grafts (sAVGs) but can be used immediately after placement, reducing the need for a tunneled dialysis catheter (TDC). We hypothesized that a decrease in TDC-related complications would make IAAVGs a cost-effective alternative to sAVGs. METHODS: We constructed a Markov state-transition model in which patients initially received either an IAAVG or an sAVG and a TDC until graft usability; patients were followed through multiple subsequent access procedures for a 60-month time horizon. The model simulated mortality and typical graft- and TDC-related complications, with parameter estimates including probabilities, costs, and utilities derived from previous literature. A key parameter was median time to TDC removal after graft placement, which was studied under both real-world (7 days for IAAVG and 70 days for sAVG) and ideal (no TDC placed with IAAVG and 1 month for sAVG) conditions. Costs were based on current Medicare reimbursement rates and reflect a payer perspective. Both microsimulation (10,000 trials) and probabilistic sensitivity analysis (10,000 samples) were performed. The willingness-to-pay threshold was set at $100,000 per quality-adjusted life-year (QALY). RESULTS: IAAVG placement is a dominant strategy under both real-world ($1201.16 less expensive and 0.03 QALY more effective) and ideal ($1457.97 less expensive and 0.03 QALY more effective) conditions. Under real-world parameters, the result was most sensitive to the time to TDC removal; IAAVGs are cost-effective if a TDC is maintained for ≥23 days after sAVG placement. The mean catheter time was lower with IAAVG (3.9 vs 8.7 months; P < .0001), as was the mean number of access-related infections (0.55 vs 0.74; P < .0001). Median survival in the model was 29 months. Overall mortality was similar between groups (76.3% vs 76.7% at 5 years; P = .33), but access-related mortality trended toward improvement with IAAVG (6.1% vs 6.8% at 5 years; P = .052). CONCLUSIONS: The Markov decision analysis model supported our hypothesis that IAAVGs come with added initial cost but are ultimately cost-saving and more effective. This apparent benefit is due to our prediction that a decreased number of catheter days per patient would lead to a decreased number of access-related infections.

Safety and efficacy of endovascular implantation of a portal vein stent combined with iodine-125 seed-strips followed by transcatheter arterial chemoembolization with sorafenib for the treatment of hepatocellular carcinoma with portal vein tumor thrombosis.

OBJECTIVE: To assess the safety and efficacy of endovascular implantation of a portal vein stent combined with iodine-125 seed-strips followed by transcatheter arterial chemoembolization with sorafenib (PVS-125I-TACE-S) for the treatment of hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT). METHODS: Between January 2015 and July 2017, 18 patients with PVTT caused by HCC that were treated with PVS-125I-TACE-S were reviewed. The technical success, complications, changes in liver function from baseline values due to subsequent endovascular implantation of a portal vein stent combined with iodine-125 seed-strips (PVS-125I), time-to-tumor progression (TTP) and overall survival (OS) were observed. RESULTS: The technical success rate was 100%. Adverse events (AEs) were managed successfully, with no occurrence of procedure-related deaths. Liver function test values after PVS-125I were not significantly different than baseline values (P＞0.05). The median TTP was 7.0 months (range: 4.2-9.9 months). In Vp3 PVTT, the TTP was 9.7 months (range: 8.8-10.5 months), and in Vp4 PVTT, the TTP was 4.2 months (range: 2.8-5.6 months). The median OS was 10.0 months (range: 7.0-13.1 months). In Vp3 PVTT, OS was 11.9 months (range: 9.2-14.5 months), and in Vp4 PVTT, OS was 7.2 months (range: 3.8-10.7 months). CONCLUSIONS: PVS-125I-TACE-S is safe for patients with HCC with PVTT and may extend the TTP and survival of patients with Vp4 PVTT. ADVANCES IN KNOWLEDGE: PVS implantation promptly restored flow in the obstructed portal vein, which can reduce the risk of hepatic failure and upper gastrointestinal bleeding. Implantation of iodine-125 seed-strips may directly expose the portal tumor thrombus to radiation and kill cancer cells. Their combined use with TACE-S has a strong scientific rationale.