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Controversies in carotid stenting.

Endovascular therapies are now commonly used in many vascular sites. However, the role for carotid angioplasty and stenting (CAS) remains an unproven therapy with some potential benefits. Initial results of CAS were worse than the surgical standard of carotid endarterectomy (CEA) and did not meet American Heart Association guidelines. However, recent improvements have resulted in improved stroke morbidity rate that may approach that of CEA. Specifically, the embolic problem associated with CAS has been reduced with embolic protection devices, but the ultimate effect of these protection devices remains uncertain. Initial comparison studies of CAS to CEA showed an unacceptably high stroke morbidity rate in the CAS group. As a result, multiple randomized clinical trials have been initiated to compare the results of CAS with embolic protection to that of CEA. While these studies are underway, the authors advocate a careful application of CAS to be used as a complementary tool for the carotid surgeon to use in special circumstances when CEA cannot be undertaken with acceptable morbidity. Furthermore, since the reported stroke morbidity rate of CAS exceeds the AHA recommendation for treatment of asymptomatic patients, most nonsurgical patients with asymptomatic disease should be treated with medical therapy.

Angioplasty↗

The 'double bag': a device for protection against blood spray in the management of epistaxis.

Nasal bleeding is one of the commonest emergencies that place medical staff at risk of blood contamination during management. A sizeable proportion of incidents have been reported where blood splashes in the facial area caused such contamination, and the exposed conjunctivae are potential sites for transmission of human immunodeficiency viruses (HIV). We present a simple self-made device named the 'Double Bag', which is highly effective in preventing blood spraying during the management of epistaxis. It was designed to be used while treating epistaxis or removing nasal packing after surgery, when transient bleeding is expected.

Blood-Borne Pathogens↗

Role of an intramammary device in protection against experimentally induced staphylococcal mastitis in ewes.

An intramammary device (IMD) was adapted for use in ewes; this device was made of abraded polyethylene material (1.7 mm in diameter, 47 mm long) and formed a 15-mm-diameter loop in the gland cistern. The IMD was inserted in 1 gland in each of 43 ewes. A significant (P < 0.0001) increase in milk somatic cell count (SCC) was observed in glands provided with an IMD. This increase was attributable to an increase in neutrophil numbers and was observed during the first 12 weeks after insertion. The IMD had a protective effect against experimentally induced staphylococcal mastitis (Staphylococcus aureus and S epidermidis), although different milk SCC were required for protection from each bacterial species in most ewes (10(6) and 2 x 10(5) cells/ml, respectively). Histologic studies revealed that the IMD induced local squamous metaplasia in the glandular part of the lactiferous sinus. Erythrocytes were found in milk from glands provided with an IMD throughout the studied period (35 days of the 45-day lactation) and, in some cases, blood clots were observed during the first 2 weeks of lactation. Glands with IMD also had lower milk production and quality at 30 and 32 days of lactation. Eight ewes with IMD were studied throughout a subsequent lactation. Milk from the IMD-containing glands had an increase in SCC, as in the previous lactation period; did not contain blood clots or erythrocytes; and had normal composition (similar to that in glands without the IMD).

Animals↗

A new multipurpose CO2 laser therapy instrument.

A new multipurpose CO2 laser therapy instrument has been developed. It is a highly efficient medical instrument. By use of high laser power density to coagulate, evaporate, and cut body tissue on the nidus, the operation can be controlled and has obvious curative effects. Unlike other kinds of CO2 laser therapy instruments, this device has an advanced switching power supply (SPS) and red guiding light system. With an overcurrent protective device, an overvoltage protective device, and a high-voltage shield device, it provides efficiency, stability, reliability, and low loss. The plastic casing does not leak electricity and the film switches are designed for clinical practice convenience. Additionally, the laser power is numerically displayed and can be set prior to the procedure. The distinct visible guiding light of the laser output makes the operation more convenient and accurate. Because of this unique design and properties, it is a leading model in China. The instrument can be widely used for surgery, gynecology, dermatology, and otolaryngology. The radiation therapy of low laser power density has the effect of being antiinflamatory, analgesic, and antipruritic, and promotes cure of the epithelium. Moreover, it is effective to treat all sorts of sprains, scapulohumeral periarthritis, arthritis, sciatica, and surface ulcers.

Carbon Dioxide↗

Nonsurgical carotid revascularization.

Carotid endarterectomy is a well-established treatment of improving the carotid luminal diameter and preventing strokes, and the indications and complications are well-defined. Carotid angioplasty and stent placements are relatively newer ways of treating carotid artery stenosis. In certain contexts, they may have some advantages over carotid endarterectomy. However, the success rates, morbidity, and mortality associated with these procedures are less well characterized. In earlier comparative studies, the incidence of ipsilateral stroke rate was higher with angioplasty, but in later studies, this trend is reversing. Angioplasty may also have an edge in specific situations like patients with coexisting significant coronary arterial disease, contralateral carotid artery occlusion, and in instances when the narrowing is long and at multiple sites. Protective devices like distal occlusion balloon and filter protection devices may reduce the incidence of stroke. We are still awaiting the results of some major randomized head-to-head trials comparing carotid endarterectomy and stenting.

Angioplasty↗

Technical aspects and current results of carotid stenting.

PURPOSE: We reviewed our experience with carotid stenting (CS), focusing on technical evolution and results. METHODS: From September 1995 to February 2000, 77 patients with 83 internal (n = 68) and common carotid artery lesions (n = 15) were selected for CS. This patient population was categorized into three consecutive periods based on patient selection, material, and technical skills. For internal carotid artery lesions, period I included 11 patients treated by means of direct carotid puncture with balloon expandable stents; period II included 42 patients treated by means of a femoral approach with self-expandable stents; and period III included 15 patients in whom monorail system and cerebral protection devices were used. Common carotid artery lesions were treated by means of carotid puncture in five patients and by means of a femoral approach in 10 patients. In only two of the latter cases, cerebral protection devices were used. RESULTS: The overall immediate success rate, defined as successfully treated stenosis with no neurological events, was 89.7% for internal carotid artery lesions and 100% for common carotid artery lesions. All neurological events, which consisted of reversible events (4.4%), minor stroke (1.5%), and major stroke (2.9%), occurred during periods I and II. In periods I, II, and III, the rate of surgical conversion was 18%, 9.5%, and 0%, respectively, the rate of transient ischemic attack and reversible ischemic neurologic deficit was 0%, 7%, and 0%, respectively, and the rate of minor and major stroke was 0%, 7%, and 0%, respectively. All major strokes were cleared with intra-arterial thrombolysis. At discharge, the success rates defined by means of the absence of conversion and neurological events were 82% during period I, 76% during period II, and 100% during period III. The freedom from neurological deficits rates were 100%, 97.6%, and 100%, respectively. During follow-up, six significant asymptomatic restenoses were detected with duplex scanning; however, only one patient required reintervention. CONCLUSION: Technical skills and technological improvement, including low-profile balloon and catheter, cerebral protection device, and intra-arterial rescue techniques, may reduce the rate of neurological events associated with CS. Technical improvements should be given careful consideration before the initiation of randomized trials comparing CS and carotid endarterectomy.

Adult↗

Respirators, recommendations, and regulations: the controversy surrounding protection of health care workers from tuberculosis.

Recent nosocomial outbreaks of tuberculosis have increased concern about the occupational acquisition of tuberculosis by health care workers. The Centers for Disease Control and Prevention (CDC), Department of Health and Human Services, and the Occupational Safety and Health Administration, Department of Labor, have issued recommendations and regulations in an effort to decrease health care workers' risk for exposure to patients with infectious tuberculosis. Within the CDC, the National Center for Infectious Diseases, the National Center for Prevention Services, and the National Institute for Occupational Safety and Health collaborated to produce the 1994 Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Facilities. As stated in the Draft Guidelines, the major components of health care worker protection from Mycobacterium tuberculosis infection include administration or source controls, engineering controls, and respiratory protective devices. We review the evolution of the seemingly conflicting recommendations for respiratory protective devices made by these Centers of the CDC and explain how the recommendations in the current CDC Guidelines were reached.

Centers for Disease Control and Prevention, U.S.↗

Effectiveness of the sirolimus-eluting stent in the treatment of saphenous vein graft disease.

The use of bare stents for the percutaneous intervention of saphenous vein bypass grafts (SVGs) is associated with a high subsequent rate of restenosis. To assess the impact of the sirolimus-eluting stent (SES), we studied 19 consecutive patients who underwent de novo SVG intervention treated solely with SES. Mean graft age was 10 years. Clinical presentation was an acute coronary syndrome in 68%. In total, twenty-two de novo lesions were treated with 35 SESs (mean=1.6 stents per lesion). Use of glycoprotein IIb/IIIa inhibitor therapy and distal embolization protection device were at operator discretion and were 42% and 32%, respectively. The rate of in-hospital major adverse cardiac events (MACE) was 11%, related to 2 patients with a creatine kinase rise consistent with peri-procedural acute myocardial infarction (AMI); a distal protection device was not utilized in either. Over a mean 12.5+/-2.6 month follow-up, one patient died from a non-cardiac cause, and there were no further AMIs. Target lesion revascularization was undertaken in 1 patient (5%); survival free of MACE was 84%. In conclusion, utilizing SESs for percutaneous intervention of degenerate SVGs is associated with a low rate of target vessel revascularization. Increased utilization of distal protection devices might reduce the peri-procedural rate of AMI.

Acute Disease↗

Is there evidence that cerebral protection is beneficial? Clinical data.

Advances in angioplasty techniques and the development of low-profile, flexible, tapered nitinol stents designed specifically for carotid applications have made carotid artery stenting a viable alternative to carotid endarterectomy for treatment of occlusive disease of the carotid arteries. During the stenting process, however, debris may be released and cause distal embolization that can lead to stroke or death. Thus, several embolic protection devices have been developed for use in carotid stenting, two of which are available in the United States. In the past 5 years, data from several large trials, series, and registries of carotid artery stenting-reflecting the experience in thousands of patients-have become available. These investigations include the CAVATAS study, the Global Carotid Artery Stent Registry, the SAPPHIRE study, the ARCHeR trials, the CABERNET registry, the BEACH registry, the SECuRITY registry, the German Registry, and the EVA-3S trial. The studies have provided considerable evidence that use of an embolic protection device decreases the incidence of cerebral embolic events during carotid stenting in both symptomatic and asymptomatic patients. They have also shown that increased experience with angioplasty in the carotid artery decreases complication rates associated with the procedure, even when a protection device is not employed. Although the benefits of routine use of cerebral protection have not been confirmed by level 1 evidence, a consensus supports such use.

Angioplasty↗

[The determination of the criteria for selecting and using personal means of acoustic protection].

The most frequent occupational disease in Italy is noise-induced hearing loss. Not only is this disease invalidating and irreversible, it also involves extremely high direct and indirect costs for both the injured worker and the employer. Appropriate preventive measures are therefore essential and include personal protection devices. Recent Italian legislation (DL 277 15/8/91) assigns an important role to personal acoustic protection devices, raising, in certain situations, serious problems in terms of fitness for specific jobs. On the basis of an analysis of the characteristics of the various types of hearing protection aids, including efficacy, capacity of attenuation, influence on intelligibility of speech and perception of danger signals, guidelines are supplied for their best possible use.

Auditory Perception↗

Carotid artery stenting in surgical high-risk patients.

Recent studies have shown that carotid artery angioplasty and stenting may offer a viable alternative for symptomatic and asymptomatic patients with carotid artery stenosis, especially in high-risk patients. We report the results of a prospective single-center registry designed to evaluate the feasibility and safety of carotid artery angioplasty and stenting with and without distal protection devices in high-risk patients. A total of 116 consecutive patients underwent 126 procedures and 127 stents were deployed successfully in 130 lesions. The majority of patients (63%) had restenosis after a prior carotid endarterectomy; 31% were considered to be ineligible for carotid endarterectomy by both the vascular surgeons and the interventional cardiologist and 9% were considered ineligible for surgery due to hostile neck anatomy. Periprocedural and follow-up evaluation included a thorough independent clinical and neurological assessment. Distal embolic protection devices were used in 44% of all cases. Procedural success was achieved in 122 procedures (97%). The overall rate of in-hospital major adverse cerebrovascular events (death, stroke, and myocardial infarction) was 2.6%. Event rates in patients with prior carotid endarterectomy were comparable to patients with de novo lesions with 5.2% vs. 2.4% death/stroke at 30 days and 8.3% and 6.6% stroke/death rates at 1 year, respectively. When distal protection devices were used, death/stroke rates were 0% as compared to 4.5% when distal protection was not used (P = NS). However, minor embolic phenomena were observed in both primary and secondary lesions independent of the use of distal protection. These results support the use of carotid artery angioplasty and stenting in high-risk patients with significant primary or secondary carotid artery stenosis. In both types of lesions, acceptable results justify its use as a valid revascularization method. While clinical embolic events occur in a minority of patients in both lesion types, they are not entirely prevented by distal protection.

Aged↗

Continuity in the treatment of carotid artery disease: results of a carotid stenting program initiated by vascular surgeons.

The treatment of carotid artery stenosis currently constitutes a major component of vascular surgical practice. Carotid angioplasty and stenting (CAS), however, is mainly performed by nonvascular surgeon interventionalists with cerebral protection devices available only through investigational protocols. This study reports the initial results of a CAS program initiated and performed by vascular surgeons using commercially available cerebral protection devices. Fifty-seven patients were enrolled in the study over a 14-month period. All patients were at high risk for conventional endarterectomy (7 resentosis, 4 irradiation, and 46 medically high-risk ASA III). Mean age was 75.7 years (range, 45-93 years). High-grade stenosis of the carotid artery was present in all cases (mean stenosis, 85%; range, 80-99%). Twenty-four percent of patients were symptomatic. Cerebral protection was performed with an occlusion balloon-wire in 32 cases and with a filter-wire device in 24; no cerebral protection was used in 1 patient with restenosis after endarterectomy. Initially in the study, atropine was administered selectively for the development of bradycardia. Currently atropine is administered routinely prior to the initial balloon angioplasty of the carotid bulb. Clopidogrel (75 mg/day) was administered for 5 days prior to CAS and for 30 days after CAS. All 57 patients underwent successful dilatation of their carotid stenoses without occlusion or dissection. Ten of 32 patients in whom balloon occlusion was used for cerebral protection exhibited transient evidence of cerebral ischemia during protection balloon occlusion. These symptoms resolved completely without permanent neurological deficit in all cases. Development of bradycardia with a heart rate <50 bpm was significantly reduced by routine administration of atropine prior to the initial dilatation within the carotid bulb (p = 0.01). Mean hospital length of stay was 1.33 days (range, 1-5 days). There were two periprocedure myocardial infarctions, two postprocedure transient ischemic attacks, and one reversible ischemic neurologic deficit. There was no 30-day mortality. There have been no instances of hemodynamically significant restenosis during a mean follow-up period of 5.4 months. From these results we have concluded that CAS can be performed effectively and safely using commercially available cerebral protection devices. A program initiated and performed exclusively by vascular surgeons is effective and should be the standard model used in the endovascular treatment of carotid artery stenosis.

Aged↗

Analysis of radiation scatter during angiographic procedures: evaluation of a phantom model and a modified radiation protection system.

PURPOSE: To study the radiation scattering associated with the digital subtraction angiography (DSA) unit in angiographic procedures and to design an effective radiation protection shield based on these data. MATERIALS AND METHODS: The number of scattered photons was measured at three points relative to the operator's position. Anteroposterior abdominal and lateral cranial fluoroscopy were evaluated. As protective devices, a lead curtain, sliding shields, and a brim-shaped image intensifier (II) hood were designed. RESULTS: In abdominal fluoroscopy, radiation was found to scatter to the operator's lower limbs from the underside of the catheter table, to the abdomen from the side of the patient's body, and to the head and neck from the table surface adjacent to the patient. The use of protective devices reduced exposure from 2.89 to 0.058 mR/min for the operator's lower limbs, from 0.987 to 0.069 mR/min for the operator's abdomen, and from 0.696 to 0.139 mR/ min for the operator's head and neck area. With lateral cranial fluoroscopy, radiation was detected to scatter to the operator's lower limbs from the underside of the catheter table, to the abdomen from the patient's temporal area, and to the head and neck from the patient's face. The use of protective devices reduced exposure from 0.248 to 0.010 mR/min for the operator's lower limbs, from 0.129 to 0.010 mR/min for the operator's abdomen, and from 0.162 to 0.018 mR/min for the operator's head and neck area. CONCLUSIONS: The characteristic directions of scattering to the operator were identified. An effective modified radiation protection system was designed based on this information.

Abdomen↗

[Stenting for carotid artery stenosis of 55 cases].

OBJECTIVE: To introduce the procedure of carotid stenting, and to summary experiences of 55 cases. To study the theory and clinical significance of carotid stenting for carotid artery stenosis. METHODS: Fifty-five patients with severe carotid atheromatous stenoses were treated by stent implantation. Fifty-eight stents were implanted. Forty-one of these stents were Wallstent, 14 were Smart stents and 3 were OptiMed stents. Cerebral protection device was furnished for 18 patients. RESULTS: During operation, there were 2 cases of small stroke and 2 cases of major stroke. One patient suffered from left eye area deficit, who had a little signs after 3 months. Another patient had consciousness loss and right-side paralysis and had a recovery in consciousness after salvage. The incidence of nervous system complications was 6.9%. Serious stroke rate was 3.5%. The incidence of circulatory system complications was 10.3%. Those patients who received cerebral protection device did not have nervous complication. CONCLUSION: Carotid stenting is effective for the treatment of carotid artery stenosis. The experienced surgeon can make this procedure safe. The procedure's safety is enhanced by using cerebral protection device.

Aged↗

The need for a participatory conservation programme for the reduction of noise exposure to Thai female workers.

Hearing loss induced in thirty female workers because of exposure to continuous noise was studied in a plastic bag plant in Samutprakarn Province, the largest industrial zone in Thailand. The sound level in this plant was 98.5 dBA., 94.0 dBA. and 93.0 dBA. in the weaving, winding and warping sections, respectively. Results of an audiometric test showed a significant relationship between high noise level and hearing loss at frequency 4,000 Hz. A questionnaire survey found that a relatively high number of workers had various symptoms such as: 76.7% general fatigue, 70% headache, 63.3% ear distension and 56.7% vertigo. Concerning the usage of ear protective devices, it was found that 80% of the workers have never used such devices, 16.7% occasionally used them, and 3.3% have always used cotton wool to reduce the high noise level. Their reasons for non-use of ear protective devices were 1) not provided by the employer (86.7%), 2) not necessary (83.3%), 3) accustomed to the noise (63.3%), 4) nobody uses (56.7%), and 5) no loud noise (16.7%). These results point to the need for improving the work conditions and welfare services of the workers at this plant. Also, hearing conservation programmes can be instituted in developing countries through cooperation among the safety inspectorate, the employer and the workers.

Adult↗

Evaluation of comfort and seal leakages of several respirators used in agricultural work.

Certain aspects in the use of some respiratory protective devices were studied under laboratory and field conditions. The face seal leakages of these devices were measured and volunteers were interviewed about their subjective opinions on the use of the devices. Twelve men and five women participated in the study. The models tested were Silner 12, Siltox, Sundstrom SR 62/80, Airstream Breath Easy 2, Pirelli, and 3M (8810 P2, disposable) which are used in agricultural work in Finland. According to the study's results, these four models significantly differed from each other regarding the facial seal leakage (p less than 0.01). The Silner 12 had the greatest seal leakage (5.9% with men and 5.2% with women). The subjects felt that these respiratory protective devices were not cumbersome in their agricultural work or in the laboratory tests. The comfort of these devices in practical work was about the same for all models. Powered filtering hoods were more pleasant to use than mechanical ones because they offered less breathing resistance. The volunteers complained that with the Breath Easy 2 they felt drafts on the backs of their heads, especially while working in cool weather.

Adult↗

MO.MA -- a new cerebral stroke protection system during carotid artery stenting.

BACKGROUND: Carotid angioplasty and stenting (CAS) has been introduced as an alternative to carotid endarterectomy for the treatment of carotid atherosclerosis. Due to the risk of embolisation during CAS, the usage of cerebral protection devices is obligatory. AIM: To assess the safety and efficacy of the novel cerebral protection device -- the MO.MA system. METHODS: Twenty one patients selected for carotid stenting were included into the study. We estimated the deliverability of the device to the target site, procedural success rate and the incidence of adverse events. RESULTS: All performed procedures were successful without major cerebro-vascular complications during both 30-day and 6-month follow-up periods. CONCLUSIONS: The MO.MA system is safe and effective in preventing stroke during CAS.

Adult↗