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https://www.readbyqxmd.com/read/28749100/medical-devices-cardiovascular-devices-classification-of-the-balloon-aortic-valvuloplasty-catheter-final-order
#1
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
July 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28749083/evidence-of-bone-marrow-downregulation-in-brain-dead-rats
#2
Laura Menegat, Rafael Simas, Julia M Caliman, Fernando L Zanoni, Jacqueline F Jacysyn, Luiz Fernando F da Silva, Primavera Borelli, Luiz Felipe P Moreira, Paulina Sannomiya
Experimental findings support the evidence of a persistent leucopenia triggered by brain death (BD). This study aimed to investigate leucocyte behaviour in bone marrow and blood after BD in rats. BD was induced using intracranial balloon catheter inflation. Sham-operated (SH) rats were trepanned only. Thereafter bone marrow cells were harvested every six hours from the femoral cavity and used for total and differential counts. They were analysed further by flow cytometry to characterize lymphocyte subsets, granulocyte adhesion molecules expression and apoptosis/necrosis [annexin V/propidium iodide (PI) protocol]...
July 27, 2017: International Journal of Experimental Pathology
https://www.readbyqxmd.com/read/28748694/bilayered-nanoparticles-with-sequential-release-of-vegf-gene-and-paclitaxel-for-restenosis-inhibition-in-atherosclerosis
#3
Xiaowei Zhu, Hongzhi Xie, Xiaoyu Liang, Xuanling Li, Jianwei Duan, Yongxia Chen, Ziying Yang, Chao Liu, Cuiwei Wang, Hailing Zhang, Quan Fang, Hongfan Sun, Chen Li, Yongjun Li, Chun Wang, Cunxian Song, Yong Zeng, Jing Yang
Complete re-endothelialization followed by inhibition of smooth muscle cell proliferation is considered an effective therapeutic option to prevent restenosis. We have designed poly(lactide-co-glycolide)-loaded bilayered nanoparticles (NPs) with the ability to sequentially release VEGF-encoding plasmids from the outer layer and paclitaxel (PTX) from the core to promote endothelial regeneration while also prevent restenosis. Comparing with conventional NPs, which release VEGF plasmid and PTX simultaneously, we expect that the bilayered NPs could release the VEGF plasmid more rapidly followed by a delayed release of PTX, resulting in efficient VEGF gene transfection, which ideally could promote re-endothelialization while inhibit excessive smooth muscle cell growth...
July 27, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28748354/pressure-directed-embolization-of-hepatic-arteries-in-a-porcine-model-using-a-temporary-occlusion-balloon-microcatheter-proof-of-concept
#4
Steven C Rose, Gregory D Halstead, Kazim H Narsinh
PURPOSE: The purpose of this project was to test the hypothesis that temporary hepatic artery balloon occlusion would favorably alter the distribution of particle emboli within the targeted and nontargeted downstream vascular compartments. MATERIALS AND METHODS: Five Yorkshire pigs underwent transfemoral placement of balloon microcatheters into selected segmental hepatic arteries. A collection catheter was surgically introduced into a downstream hepatic artery branch...
July 26, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28748148/shifting-paradigms-for-treatment-of-symptomatic-aortic-stenosis-in-lower-risk-populations-role-of-a-newer-generation-balloon-expandable-transcatheter-aortic-valve-implantation-device
#5
EDITORIAL
Erik Walter Holy, Mohamed Abdel-Wahab
No abstract text is available yet for this article.
June 2017: Cardiovascular Diagnosis and Therapy
https://www.readbyqxmd.com/read/28745529/sleepiness-and-behavioral-risk-taking-do-sleepy-people-take-more-or-less-risk
#6
Garrett Hisler, Zlatan Krizan
BACKGROUND: Although sleep loss has been implicated in risk-taking behavior, it is unclear how individuals' current propensity to fall asleep, known as sleepiness, influences risk-taking. Because sleepiness is not only driven by recent sleep but also by factors such as circadian rhythm and current stimulation, it may be an important contributor to risk-taking as it reflects the more immediate sleep-wake state. PARTICIPANTS: 130 participants were recruited from a large Midwestern U...
July 26, 2017: Behavioral Sleep Medicine
https://www.readbyqxmd.com/read/28745145/magnetic-compression-stricturoplasty-for-treatment-of-refractory-esophageal-strictures-in-children-technique-and-lessons-learned
#7
Russell Woo, Christopher Marc Wong, Zachary Trimble, Devin Puapong, Shannon Koehler, Scott Miller, Sidney Johnson
INTRODUCTION: Esophageal stricture is the most common complication following repair of esophageal atresia (EA). In general, these strictures are successfully managed using endoscopic techniques including bougie and balloon dilation, stenting, and chemotherapeutic agent application. If these techniques are unsuccessful, patients require segmental esophageal resection and reanastomosis or esophageal replacement. Magnetic compression anastomosis has been described in children. Herein we report our experience with magnetic compression stricturoplasty to treat refractory strictures after EA repair...
July 1, 2017: Surgical Innovation
https://www.readbyqxmd.com/read/28743787/isar-pebis-paclitaxel-eluting-balloon-versus-conventional-balloon-angioplasty-for-in-stent-restenosis-of-superficial-femoral-artery-a%C3%A2-randomized-trial
#8
Ilka Ott, Salvatore Cassese, Philipp Groha, Birgit Steppich, Felix Voll, Martin Hadamitzky, Tareq Ibrahim, Sebastian Kufner, Karl Dewitz, Theresa Wittmann, Albert Markus Kasel, Karl-Ludwig Laugwitz, Heribert Schunkert, Adnan Kastrati, Massimiliano Fusaro
BACKGROUND: Paclitaxel-eluting balloon (PEB) angioplasty has superior efficacy compared with conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB angioplasty versus BA for in-stent restenosis of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for in-stent restenosis of SFA. METHODS AND RESULTS: Patients with symptomatic in-stent restenosis of SFA were randomly assigned to either PEB or BA at 2 centers in Munich, Germany...
July 25, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28743786/outcomes-of-patients-presenting-with-clinical-indices-of-spontaneous-reperfusion-in-st-elevation-acute-coronary-syndrome-undergoing-deferred-angiography
#9
Paul Fefer, Roy Beigel, Shaul Atar, Doron Aronson, Arthur Pollak, Doron Zahger, Elad Asher, Zaza Iakobishvili, Nir Shlomo, Ronny Alcalai, Michal Einhorn-Cohen, Amit Segev, Ilan Goldenberg, Shlomi Matetzky
BACKGROUND: Few data are available regarding the optimal management of ST-elevation myocardial infarction patients with clinically defined spontaneous reperfusion (SR). We report on the characteristics and outcomes of patients with SR in the primary percutaneous coronary intervention era, and assess whether immediate reperfusion can be deferred. METHODS AND RESULTS: Data were drawn from a prospective nationwide survey, ACSIS (Acute Coronary Syndrome Israeli Survey)...
July 25, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28743481/prevalence-and-prognostic-relevance-of-atrial-fibrillation-in-patients-with-takotsubo-syndrome
#10
Thomas Stiermaier, Francesco Santoro, Charlotte Eitel, Tobias Graf, Christian Möller, Nicola Tarantino, Francesca Guastafierro, Matteo Di Biase, Holger Thiele, Natale D Brunetti, Ingo Eitel
BACKGROUND: Takotsubo syndrome (TTS) is associated with a considerable risk of complications during the acute phase and substantial long-term mortality rates. Concomitant atrial fibrillation may have an impact on outcome in these patients. Aim of this study was to assess the prevalence and prognostic relevance of atrial fibrillation in TTS. METHODS: We performed an international, multicenter study including 387 TTS patients consecutively enrolled at 3 centers. Atrial fibrillation was defined as known history before admission or documented episodes during hospital stay...
July 18, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28743219/use-of-a-thoracic-endograft-in-an-acute-abdominal-aortic-setting-case-report-and-literature-review
#11
Sebastiano Tasselli, Paolo Perini, Elisa Paini, Luca Milan, Stefano Bonvini
PURPOSE: We report the case of a thoracic endograft used to achieve exclusion of a ruptured proximal paranastomotic abdominal aortic aneurysm (PAAA) as a consequence of aortic ballooning. CASE REPORT: A type I proximal endoleak was evidenced following endovascular repair of a PAAA with an aortic cuff. The leak was treated with ballooning, which caused distal aortic rupture. A thoracic endograft was deployed inside the cuff, achieving complete exclusion. At 1 year, there are no signs of migration or endoleak with complete PAAA thrombosis, according to computed tomographic angiography...
January 1, 2017: Vascular and Endovascular Surgery
https://www.readbyqxmd.com/read/28742797/a-comparison-of-selective-aortic-arch-perfusion-and-resuscitative-endovascular-balloon-occlusion-of-the-aorta-for-the-management-of-hemorrhage-induced-traumatic-cardiac-arrest-a-translational-model-in-large-swine
#12
Ed B G Barnard, James E Manning, Jason E Smith, Jason M Rall, Jennifer M Cox, James D Ross
BACKGROUND: Survival rates remain low after hemorrhage-induced traumatic cardiac arrest (TCA). Noncompressible torso hemorrhage (NCTH) is a major cause of potentially survivable trauma death. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) at the thoracic aorta (Zone 1) can limit subdiaphragmatic blood loss and allow for IV fluid resuscitation when intrinsic cardiac activity is still present. Selective Aortic Arch Perfusion (SAAP) combines thoracic aortic balloon hemorrhage control with intra-aortic oxygenated perfusion to achieve return of spontaneous circulation (ROSC) when cardiac arrest has occurred...
July 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28741848/pharmacologic-considerations-in-the-management-of-patients-receiving-left-ventricular-percutaneous-mechanical-circulatory-support
#13
J Erin Allender, Brent N Reed, Jenna L Foster, Jeremy D Moretz, Carrie S Oliphant, Douglas L Jennings, Robert J DiDomenico, James C Coons
Percutaneous mechanical circulatory support (MCS) devices, including the intra-aortic balloon pump, Impella, and TandemHeart, are often used for hemodynamic support in the setting of refractory cardiogenic shock. The thrombotic and bleeding complications associated with these devices is well recognized, and the Impella and TandemHeart devices have unique anticoagulation considerations that may influence patient outcomes. Both devices typically require use of a heparinized purge solution in combination with intravenous unfractionated heparin, thereby providing multiple sources of heparin exposure...
July 25, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28740414/the-role-of-endoscopic-therapy-in-obesity-management-intragastric-balloons-and-aspiration-therapy
#14
REVIEW
Nitin Kumar, Shelby Sullivan, Christopher C Thompson
Weight management is increasingly incorporating endoscopic bariatric therapy (EBT). As the global burden of obesity and its comorbidities has increased, it is evident that novel therapeutic approaches will be necessary to address the obesity epidemic. EBTs offer greater efficacy than diet and lifestyle modification and lower invasiveness than bariatric surgery. The US Food and Drug Administration has approved two intragastric balloons and aspiration therapy for the treatment of obesity: Apollo Orbera is indicated for the treatment of Class I and Class II obesity, Re Shape Integrated Dual Balloon system is indicated for the same range with a comorbidity, and Aspire Bariatrics AspireAssist is approved for patients with a body mass index of 35-55 kg/m(2)...
2017: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
https://www.readbyqxmd.com/read/28739614/apical-ballooning-takotsubo-syndrome-with-concurrent-st-segment-elevation-myocardial-infarction
#15
Mohsin A Hussain, Andrew T Cox, Rachel Bastiaenen, Abhiram Prasad
We present the case of a 61-year-old woman admitted with chest pain and an ECG demonstrating ST-segment elevation in the lateral leads. Emergency coronary angiography demonstrated an occluded obtuse marginal branch. Percutaneous intervention was unsuccessful as the lesion could not be crossed with a wire. Left ventriculography and transthoracic echocardiography demonstrated hypokinesis of the entire apex but preserved contractility of the basal segments, consistent with a diagnosis of apical ballooning syndrome (ABS)...
July 24, 2017: BMJ Case Reports
https://www.readbyqxmd.com/read/28739456/acute-type-b-dissection-causing-collapse-of-evar-endograft-and-iliac-limb-occlusion
#16
Nathan K Itoga, Tiffany Wu, Michael D Dake, Ronald L Dalman, Jason T Lee
We describe a rare case of acute type B dissection causing collapse of a previously placed infrarenal stent-graft, resulting in acute limb ischemia due to left iliac limb thrombosis in a 59-year-old male. The patient presented with acute back and abdominal discomfort radiating to his back, bilateral buttock stabbing discomfort, and left> right thigh and calf rest pain. CTA showed a spiral type B dissection with collapse of the proximal portion of the EVAR device and left limb occlusion. Urgent treatment with TEVAR distal to the left subclavian covered the entry tear and redirected the majority of the flow to the true lumen leading to near immediate expansion of the proximal portion of the EVAR device...
July 21, 2017: Annals of Vascular Surgery
https://www.readbyqxmd.com/read/28738537/phosphodiesterase-inhibitor-ameliorates-neuronal-injury-in-spinal-cord-ischemia-reperfusion-injured-rat-model
#17
Xiao-Gang Chen, Fu Hua, Shou-Guo Wang, Yong-Yi Xu, Hai-Tao Yue
This study investigated the mechanisms responsible for the neuroprotective effect of sildenafil citrate (SFC) on ischemia-reperfusion spinal cord (SC) injuries. Balloon occlusion of the thoracic aorta was used to induce SC ischemia. The animals (n=30) were separated into three groups: sham, SC injury with saline, and SC injury with 5mg/kg i.p. SFC treatment (SFC). The Basso, Beattie, and Bresnahan (BBB) score was determined to assess neurological function at different time intervals after reperfusion. After 48h, histopathology of the SC was assessed by triphenyltetrazolium chloride (TTC) and Nissl staining...
July 20, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28738485/-impact-and-clinical-outcome-of-intra-aortic-balloon-pump-use-during-percutaneous-coronary-intervention
#18
J J Xu, Z Gao, Y Song, Y L Ma, X F Tang, Y Yao, C He, H H Wang, Y J Yang, R L Gao, S B Qiao, B Xu, J Q Yuan
Objective: To observe the impact and clinical outcome of intra-aortic balloon pump(IABP) use in patients underwent percutaneous coronary intervention (PCI). Methods: From January 2013 to December 2013, 10 724 consecutive patients undergoing PCI were enrolled.After 2 years' follow-up, the incidence of major adverse cardiovascular and cerebrovascular events such as death, myocardial infarction, stent thrombosis, revascularization, recurrent stroke were recorded, propensity score was used to match baseline data, and the clinical outcomes in patients with IABP and non-IABP were compared...
July 24, 2017: Zhonghua Xin Xue Guan Bing za Zhi
https://www.readbyqxmd.com/read/28738452/prediction-of-delayed-colonic-transit-using-bristol-stool-form-and-stool-frequency-in-eastern-constipated-patients-a-difference-from-the-west
#19
Veeravich Jaruvongvanich, Tanisa Patcharatrakul, Sutep Gonlachanvit
Background/Aims: The correlation between the Bristol stool form scale (BSFS) and colonic transit time (CTT) has been reported in Western populations. Our study aims to study the relationship between BSFS, stool frequency, and CTT in Eastern patients with chronic constipation. Methods: A total of 144 chronic primary constipation patients underwent colonic transit study by using radio-opaque markers, anorectal manometry, and balloon expulsion test. Stool diary including stool forms and frequency was recorded...
July 21, 2017: Journal of Neurogastroenterology and Motility
https://www.readbyqxmd.com/read/28737592/dilation-time-in-endoscopic-papillary-balloon-dilation-for-common-bile-duct-stones
#20
Yong-Hua Shen, Liu-Qing Yang, Yu-Ling Yao, Lei Wang, Yi-Yang Zhang, Jun Cao, Qi-Bin He, Xiao-Ping Zou, Yun-Hong Li
BACKGROUND: To assess the short-term outcomes after endoscopic sphincterotomy (EST) plus endoscopic papillary balloon dilation (EPBD) versus EPBD alone and appropriate balloon dilation time in EPBD alone. MATERIALS AND METHODS: A total of 413 patients with common bile duct stones (CBDSs) were included in the EST plus EPBD group and 84 were in the EPBD alone group. We retrospectively evaluated the safety and efficacy between EST plus EPBD and EPBD alone group. The patients in EPBD alone group were assigned to dilation time ≥5 minutes group (n=35) and time <5 minutes group (n=49)...
July 21, 2017: Surgical Laparoscopy, Endoscopy & Percutaneous Techniques
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