Abstract:
OBJECTIVE:Peripheral artery disease is the second most common cardiovascular disease. It can often occur in complex form when there is a presence of long, diffuse, and multiple lesions. Current treatments use either single long drug-coated balloons (DCBs) or multiple DCBs; however, treatment success is limited. The purpose of this study was to investigate the preclinical feasibility of our multiple-release Tailored Medical Devices DCB (MR-TMD-DCB) to treat multiple arterial segments using a single DCB. METHODS:The MR-TMD-DCBs were developed using a two-layer coating approach. The DCBs were developed in a certified Current Good Manufacturing Practices facility using presterilized materials and reagent and then characterized for coating morphology, thermal and chemical changes, and in vitro particulate shedding. The drug loss, tissue uptake, and undelivered drug amounts were analyzed using an in vitro peripheral artery flow model and explanted pig arteries. Then, an in vivo survival study was performed using a healthy porcine model to measure the short-term drug uptake (seven swine; 14 treatments at day 1) and retention (seven swine; 14 treatments at day 7) in two different arterial segments after treatment with a single MR-TMD-DCB. RESULTS:The coating on the MR-TMD-DCB was smooth and homogeneous with paclitaxel molecularly dispersed in its amorphous state. A negligible number of particulates were shed from the MR-TMD-DCB coating. A similar amount of drug was accurately delivered into two separate explanted arteries using a single MR-TMD-DCB during the in vitro flow model testing (707 ± 109 ng/mg in the first explanted artery and 783 ± 306 ng/mg in the second explanted artery). The MR-TMD-DCB treatment resulted in equivalent drug amounts in the two arterial segments at day 1 (63 ± 19 ng/mg in the first treatment site and 59 ±19 ng/mg in the second treatment site) and at day 7 (9 ± 6 ng/mg in the first treatment site and 10 ± 6 ng/mg in the second treatment site). In addition, the drug levels at each time point were in the clinically relevant range to prevent neointimal hyperplasia. CONCLUSIONS:The MR-TMD-DCBs provided equivalent and clinically relevant drug retention levels into two different arterial segments. Thus, MR-TMD-DCBs can be used to accurately deliver drug into multiple arterial segments with the use of a single DCB. The clinical outcomes of these findings need further investigation. Future long-term pharmacokinetics and safety studies will be performed to evaluate the safety and efficacy of the MR-TMD-DCB.
journal_name
J Vasc Surgjournal_title
Journal of vascular surgeryauthors
Anderson JA,Lamichhane S,Fuglsby K,Remund T,Pohlson K,Evans R,Engebretson D,Kelly Pdoi
10.1016/j.jvs.2019.04.494subject
Has Abstractpub_date
2020-05-01 00:00:00pages
1750-1757.e7issue
5eissn
0741-5214issn
1097-6809pii
S0741-5214(19)31815-4journal_volume
71pub_type
杂志文章abstract:OBJECTIVE:Lingual arteriovenous malformations (AVMs) are extremely rare in clinical practice, which has limited comprehensive research to find standard treatment protocols. This study summarizes the clinical features of lingual AVMs and assesses the safety and efficacy of ethanol embolotherapy in the management of thes...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2019.08.286
更新日期:2020-08-01 00:00:00
abstract:OBJECTIVE:The goal of this study was to select branched endograft designs that could fit most aortic arch anatomies. Such off-the-shelf endografts, once available, would be an endovascular therapeutic option to consider in the acute setting and would shorten the design and manufacturing process. METHODS:We retrospecti...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jvs.2019.11.046
更新日期:2020-09-01 00:00:00
abstract:OBJECTIVE:This study investigated the prevalence and distribution of deep vein thrombosis (DVT) in patients with symptomatic pulmonary embolism (PE) to establish a screening protocol to reduce unnecessary venous duplex scanning using different D-dimer level rather than single cutoff point of 0.5 microg/mL in patients w...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2007.05.026
更新日期:2007-09-01 00:00:00
abstract:PURPOSE:Treatment of aortoiliac prosthetic graft infections includes the removal of the infected material and repeat revascularization if necessary. The risk of infection of the graft material used for the repeat revascularization has been the drawback of its use in situ except with autografts. Good results were obtain...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/s0741-5214(96)80013-9
更新日期:1996-03-01 00:00:00
abstract:OBJECTIVE:This study was performed for the determination of the expansion rates and outcomes and for recommendations for the surveillance of the 3.0-cm to 3.9-cm abdominal aortic aneurysm (AAA). DESIGN:The study was observational with data from patients screened with ultrasound scanning for AAA at five Veterans Affair...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,多中心研究
doi:10.1067/mva.2002.121572
更新日期:2002-04-01 00:00:00
abstract:OBJECTIVE:Aortic arch aneurysmal disease remains a therapeutic challenge. For patients unsuitable for standard open surgery, hybrid repair with debranching of the supra-aortic arteries followed by thoracic endovascular grafting has been shown to be an effective solution. The aim of this study was to report the clinical...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2019.11.033
更新日期:2020-09-01 00:00:00
abstract:OBJECTIVE:To compare the safety and efficacy of coil embolization (COIL) to Amplatzer vascular plug embolization (PLUG) to achieve internal iliac artery (IIA) occlusion prior to endovascular aortiliac aneurysm repair (EVAR). METHODS:Data from consecutive patients who underwent IIA embolization prior to EVAR over a 6-y...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2012.05.001
更新日期:2012-11-01 00:00:00
abstract:PURPOSE:Though the peroneal artery (PA) often remains patent despite disease or occlusion of other infrapopliteal arteries, there is skepticism about using the terminal PA as the outflow tract in distal revascularizations for limb salvage, especially when a patent inframalleolar artery is available. We analyzed our exp...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2008.01.002
更新日期:2008-05-01 00:00:00
abstract::Paper-based information systems are cumbersome and inefficient. The microcomputer is an attractive, affordable, and powerful alternative to traditional paper-based record keeping. This article reviews fundamentals of data base management and microcomputer technology for the surgeon interested in microcomputer-based in...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.1984.avs0010585
更新日期:1984-07-01 00:00:00
abstract::Bacillus Calmette-Guérin (BCG) is a live attenuated strain of Mycobacterium bovis that has proven effective in the treatment of early-stage bladder cancer. Although intravesical therapy with BCG is generally considered safe, serious complications including hematuria, granulomatous pneumonitis, hepatitis, and life-thre...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,评审
doi:10.1016/j.jvs.2007.01.054
更新日期:2007-07-01 00:00:00
abstract:PURPOSE:We evaluated the day-to-day variability of transcutaneous oxygen tension (tcPO2) in patients with diabetes mellitus and peripheral arterial occlusive disease who were at risk for chronic foot ulceration. METHODS:The tcPO2 was measured in the morning once daily for 3 consecutive days in 10 male patients with di...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.2001.115799
更新日期:2001-08-01 00:00:00
abstract::Revascularization of the lower extremities may require an axillofemoral bypass when an aortobifemoral bypass is contraindicated. Thirty-one patients underwent axillounifemoral and 59 had an axillobifemoral bypass, with a mortality rate of 9%. The indication for operation was limb salvage in 67%, intra-abdominal sepsis...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:
更新日期:1987-06-01 00:00:00
abstract::Heavily calcified aortic and iliac arteries are occasionally encountered that will not yield to currently available needles and sutures. The use of the Hall drill to penetrate such arterial walls, stopping short of the adventitial layer, and Teflon strips to buttress the anastomosis, is an effective means of dealing w...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:
更新日期:1988-08-01 00:00:00
abstract::Vascular cells are an important target for gene transfer because of their potential to deliver gene products both locally and systemically. Direct retroviral gene transfer to vascular cells in vivo has been limited by inefficient rates of transduction. We hypothesized that vascular cell transduction efficiency (TE), d...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/s0741-5214(97)70155-1
更新日期:1997-07-01 00:00:00
abstract::This article is a report on a case of a giant pseudoaneurysm of the inferior gluteal artery where important features of the diagnosis, with special mention of magnetic resonance imaging and arteriography, are discussed. Surgical therapy is the treatment of choice for these lesions. Historically, proximal arterial cont...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.1988.avs0080716
更新日期:1988-12-01 00:00:00
abstract:OBJECTIVE:Transcarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting. However, outcome comparisons between TCAR and carotid endarter...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jvs.2018.11.029
更新日期:2020-01-01 00:00:00
abstract::Despite significant progress in elucidating the pathogenesis of aneurysmal disease, the precise etiology of arterial wall degradation remains unclear. Numerous etiologies have been implicated, including stress-strain factors, structural wall abnormalities, and enzyme imbalance. We have previously shown that collagenas...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.1985.avs0020393
更新日期:1985-05-01 00:00:00
abstract:OBJECTIVE:The outcomes for common vascular operations, such as carotid endarterectomy (CEA), are associated with surgeon volume. However, the number of operations associated with an improved stroke or death rate for CEA is not known. The objective of the current study was to define the annual surgeon volume of CEAs tha...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jvs.2019.10.057
更新日期:2020-07-01 00:00:00
abstract::Vascular smooth muscle cells exhibit varied responses after vessel injury and surgical interventions, including phenotypic switching, migration, proliferation, protein synthesis, and apoptosis. Although the source of the smooth muscle cells that accumulate in the vascular wall is controversial, possibly reflecting mig...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,评审
doi:10.1016/j.jvs.2007.02.061
更新日期:2007-06-01 00:00:00
abstract:INTRODUCTION:Recent evidence suggests disparities exist among racial groups with peripheral arterial disease (PAD). Hispanics (HI) are the fastest growing demographic in the United States, but little outcome data is available for this population. Therefore, we undertook this study to compare the results of autogenous i...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2009.02.010
更新日期:2009-06-01 00:00:00
abstract::Visceral artery aneurysms are rare in infants and children. The majority of cases are caused by genetic syndromes, trauma, or infection. Although the majority of aneurysms are asymptomatic, visceral artery aneurysms can present with abdominal pain, nausea/vomiting, or rupture. Aneurysm rupture can manifest as hemodyna...
journal_title:Journal of vascular surgery
pub_type:
doi:10.1016/j.jvs.2019.06.106
更新日期:2020-04-01 00:00:00
abstract:OBJECTIVE:Outcomes of open (OR) and endovascular revascularization (ER) for chronic mesenteric ischemia (CMI) were analyzed with respect to clinical risk stratification. METHODS:The data of 229 consecutive patients treated for CMI with OR (146 patients/265 vessels) or ER (83 patients/105 vessels) between 1991 and 2005...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2009.02.006
更新日期:2009-06-01 00:00:00
abstract:BACKGROUND:The objective of this study is to provide an up-to-date meta-analysis on the short- and long-term mortality rates of elective repair of abdominal aortic aneurysms (AAAs) via the open and endovascular approaches. METHODS:MEDLINE, EMBASE, and Cochrane Central Register of Controlled trials, conference proceedi...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,评审
doi:10.1016/j.jvs.2013.02.013
更新日期:2013-06-01 00:00:00
abstract::Peripheral artery disease is growing in global prevalence and is estimated to afflict between 8 and 12 million Americans. Its most severe form, critical limb ischemia (CLI), is associated with high rates of limb loss, morbidity, and mortality. Revascularization is the cornerstone of limb preservation in CLI, and has t...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,评审
doi:10.1016/j.jvs.2012.05.114
更新日期:2013-02-01 00:00:00
abstract:PURPOSE:Although anticoagulation therapy for iliofemoral venous thrombosis prevents pulmonary embolism, it is not designed to avoid the postthrombotic syndrome. Mechanical removal of the thrombus in the form of venous thrombectomy should yield better long-term results. The purpose of our study was to analyze the clinic...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/s0741-5214(97)70249-0
更新日期:1997-03-01 00:00:00
abstract:OBJECTIVE:The optimal role for bare metal stents (BMS) or stent grafts (SG) in femoropopliteal occlusive disease (FPOD) is as of yet undefined. Understanding the clinical consequences of failure can help guide initial treatment decisions. The goal of this study was to define the nature, frequency, and risk factors for ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2013.05.094
更新日期:2013-12-01 00:00:00
abstract::Giant splenic artery aneurysms are extremely rare entities that have important clinical implications. The size and the natural history pose unique challenges in the management of these lesions. We present one such case that was associated with a primary arteriovenous malformation in the splenic hilum. This is the thir...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,评审
doi:10.1016/j.jvs.2006.06.049
更新日期:2006-12-01 00:00:00
abstract:BACKGROUND:Venous valves are still discussed controversially, mainly because it is still uncertain whether primarily missing or insufficient valves or the weakness of the venous walls cause varices. Furthermore, the distribution and frequencies of major superficial tributary veins (MSTVs), which should discharge the gr...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2009.02.241
更新日期:2009-06-01 00:00:00
abstract::Peripheral arterial disease (PAD) is well recognized as a marker for systemic atherosclerosis. Platelets play an essential role in all stages of the disease, contributing to both thrombosis and the development of atherosclerosis. Medication regimens to optimize outcomes in both patients who are to undergo revasculariz...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,评审
doi:10.1016/j.jvs.2014.07.006
更新日期:2014-10-01 00:00:00
abstract:OBJECTIVE:Diabetes and peripheral arterial disease (PAD) are independently associated with increased risk of amputation. However, the effect of poor glycemic control on adverse limb events has not been studied. We examined the effects of poor glycemic control (high hemoglobin A1c level) on the risk of amputation and mo...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2017.06.101
更新日期:2018-01-01 00:00:00