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Results for “Protective Devices”

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At least 163 records · Page 9Linked to original sources
PubMed2005

A randomized, controlled trial of saphenous vein graft intervention with a filter-based distal embolic protection device: TRAP trial.

The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recruitment once another distal protection device was approved for clinical use. The primary study endpoint, major adverse cardiac events at 30 days, occurred in 17.3% of control patients and 12.7% of patients treated with the TRAP device (P = 0.24). There was a trend toward a lower incidence of myocardial infarction in the TRAP group compared with the control group (16.2% vs 10.5%, P = 0.12). This difference was predominantly due to a lower incidence of moderate-large infarction (CKMB >5x) in the TRAP group. Use of the TRAP VFS during SVG intervention was safe and was associated with a trend toward a lower incidence of adverse events, however, due to low enrollment the study lacked sufficient power to detect a significant benefit with the device.

Aged↗
PubMed2005

Comparison of the effects of a distal embolic protection device and an aspiration catheter during percutaneous coronary intervention in patients with acute myocardial infarction.

BACKGROUND: The beneficial effect of percutaneous coronary intervention (PCI) using stents for acute myocardial infarction (AMI) has already been demonstrated, but there is the problem that mechanical microvascular occlusion can occur because of thrombus/atheroma embolization when the PCI was performed. The aim of the present study was to retrospectively test and compare the effects of an aspiration catheter or distal embolic protection with a distal occlusion balloon catheter to prevent peripheral vascular embolization. METHODS AND RESULTS: The subjects consisted of 135 patients who underwent PCI with stenting within 12 h of the onset of chest pain caused by their first AMI. They were divided into 2 groups; the aspiration group, consisted of 81 consecutively seen patients who underwent aspiration catheter treatment between January 2001 and May 2002, and the distal protection group was the next group of 54 consecutively seen patients treated with a distal protection device between June 2002 and February 2003. The results were as follows. Thrombolysis in Myocardial Infarction (TIMI) score of 3 was obtained significantly more frequently in the distal protection group (94.4%) than in the aspiration group (79.0%). Additionally, the intensity of the cardiac muscle stain (blush score) was evaluated on coronary angiography and the rate of cases showing a blush score of 3, which indicates favorable blood perfusion at the tissue level, in the distal protection group (56.6%) was significantly greater than in the aspiration group (33.3%, p<0.01). The time to peak blood concentration of creatinine kinase was also significantly shorter in the distal protection group. CONCLUSIONS: The distal embolism protection method is superior to the aspiration method for prevention of embolization after PCI with stenting for AMI, in terms of tissue level reperfusion in myocardial recanalization therapy.

Cardiac Catheterization↗
PubMed2005

Bivalirudin versus heparin as an antithrombotic agent in patients who undergo percutaneous saphenous vein graft intervention with a distal protection device.

Bivalirudin (Angiomax) is increasingly used as a substitute for heparin in a variety of percutaneous coronary interventions, and data on its usage in saphenous vein graft interventions are limited. This retrospective, observational study evaluated the efficacy and safety of bivalirudin compared with heparin as an antithrombotic regimen in patients who underwent saphenous vein graft intervention with distal protection devices. We found that bivalirudin use is clinically safe and feasible, with fewer vascular and ischemic complications compared with heparin.

Aged↗
PubMed2002

Significant atheromatous debris following uncomplicated vein graft direct stenting: evidence supporting routine use of distal protection devices.

We present the case of an angiographically uncomplicated direct stent vein graft intervention in which the Percusurge embolization containment device was used. We performed histological examination of the resulting debris and observed massive particulate atheromatous material. This case illustrates the severity of distal embolization that can go clinically unnoticed after direct stenting and also supports the routine use of distal protection devices for vein graft intervention.

Aged↗
PubMed2004

Differences in number, size and location of intracranial microembolic lesions after surgical versus endovascular treatment without protection device of carotid artery stenosis.

BACKGROUND AND PURPOSE: The benefit of carotid endarterectomy in symptomatic high-grade stenosis has long been proven. The role of angioplasty as an alternative is still a matter of debate. We compared the occurrence of intraprocedural microembolic signals and ischemic lesions between carotid endarterectomy (CEA) and carotid angioplasty with stent placement (CAS) without a protection device. METHODS: 88 patients who underwent a CEA and 41 patients who underwent CAS were prospectively investigated. One day before and after the intervention diffusion weighted MRI-studies were obtained. In 21 CEA and 18 CAS patients transcranial Doppler (TCD) monitoring was performed during the procedure to detect microembolic signals (MES). RESULTS: DWI-lesions could be detected after intervention in 17% of the CEA patients compared with 54% of the CAS patients (p<0.005). The median lesion volume was 0.08 cm(3) in the CEA group and 0.02 cm(3) in the CAS group (p<0.001). Ischemic complications consisted of 2 strokes (2.3%) with symptoms lasting more than seven days in the CEA group and 1 stroke (2.4 %) in the CAS group. The median number of MES in the CEA group was 17 versus 61 in the CAS group (p<0.001). No significant correlation was found between the total number of MES and ischemic lesions in either group. CONCLUSION: A larger number of emboligenic particles with smaller volume is detached during CAS. Additionally DWI lesions were observed in different territories after CAS but not after CEA. Conventional TCD emboli detection is not useful to compare interventional therapies of the carotid arteries.

Aged↗
PubMed2003

Carotid stent angioplasty: the role of cerebral protection devices.

Carotid endarterectomy has been validated with results of several randomized controlled trials in which its effectiveness has been demonstrated over that of the best nonsurgical therapy. However, in the past several years, carotid angioplasty with stent placement has emerged as a potential safe and effective alternative to carotid endarterectomy. In this article we examine the current status of carotid angioplasty with the recent introduction of innovative cerebral protection devices and improved endovascular devices. We present a brief description of the current randomized trials evaluating carotid endarterectomy compared to carotid angioplasty as well as our combined experience in 262 patients.

Angioplasty↗
PubMed1992

The effects of powered air supply to the respiratory protective device on respiration parameters during rest and exercise.

The common chemical warfare protective masks impose an excessive respiratory load on the wearer due to elevated breathing resistance and increased dead space. For patients with severe respiratory disease, the excessive respiratory effort may be intolerable. Besides, the substantial negative pressure created within the mask during inspiration may result in an inward leakage in individuals having difficulties with proper facial fitting of the mask. The purpose of the current investigation was to evaluate the effects of a blower, actively driving air, through the mask's filter, at a flow (mean +/- SD) of 42 +/- 2 L/min, on respiratory parameters during rest and moderate exercise. Ten healthy subjects of either sex participated in two experimental sessions, wearing the mask with and without the blower. Each session included 6 min of sitting at rest and 6 min of walking on a treadmill (3.2 mph, and 10 percent grade). In nine of the subjects, the active air supply produced a positive inspiratory pressure at rest (5 +/- 4 vs -24 +/- 9 mm H2O peak inspiratory pressure with and without the blower, respectively, p < 0.0001). Inspiratory carbon dioxide concentration (FICO2) at rest was diminished (0.4 +/- 0.4 vs 1.3 +/- 0.7 percent with and without the blower, respectively; p < 0.01) while FIO2 increased from 19.5 +/- 0.7 percent to 20.6 +/- 0.4 percent with the device (p < 0.01). These changes were associated with a significant decrease in respiratory rate (15 +/- 2 vs 18 +/- 3 per minute, p < 0.01). During exercise the blower barely decreased the negative inspiratory pressures, had no effect on other respiratory parameters measured, but significantly shortened the inspiratory/cycle-length time ratio (0.46 +/- 0.03 vs 0.53 +/- 0.03, p < 0.005). The effects of active air supply were not different between male and female subjects. We conclude that the blower is expected to be a useful accessory to respiratory protective devices for patients with pulmonary disease.

Adult↗
PubMed1996

Assessment of human exposure to pesticides in greenhouses and effectiveness of personal protective devices.

The exposure to pesticides in a group of workers growing vegetables in greenhouses in farms near Rimini in Italy was evaluated. The pesticides used were organophosphorus compounds, organochlorine compounds, carbamates, pyrethroids, amide and anilide derivatives. Measurements were carried out in seven greenhouses randomly selected. The environment was free of atmospheric agents which could have influenced the pesticide concentrations in the indoor air. Two types of chemical sampling were performed: environmental and personal. The latter was done in the liquid for washing hands and by means of pads applied directly to the worker's skin and to the clothes. The aim of the determination of airborne pesticide concentrations was to evaluate mean environmental exposure to pesticides in the sprayed areas. The sampling went on from a fixed point during the entire spraying period. The aim of individual sampling was to determine the active ingredients as contaminants. The values obtained showed a risk of exposure for the greenhouse personnel working without using personal protective devices (masks, gloves and waterproof clothes), considering that pesticides could be absorbed through the skin in between the spraying intervals.

Agricultural Workers' Diseases↗