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At least 19 recordsLinked to original sources
PubMed2000

Carotid stenting with and without protection devices: should protection be used in all patients?

Embolic events that result in neurological deficits have been the most significant concern regarding carotid bifurcation stenting. Ex vivo carotid angioplasty studies using human carotid plaques have shown that embolic particles were released from all specimens. In addition, transcranial Doppler studies have confirmed the presence of multiple emboli in the middle cerebral artery during carotid stenting. Preliminary experience with the use of brain protection devices for carotid stenting have shown encouraging results in terms of safety and efficacy. Moreover, embolic particles have been recovered from all cases in which protection devices have been used. We provide the rationale for routine use of these protection devices and also review the various protection devices on the horizon.

Carotid Stenosis↗
PubMed1990

Thermal discomfort of respiratory protective devices.

Respiratory protective devices which would protect the wearer against noxious material and gases are not worn in many of the appropriate circumstances. They have been said to feel uncomfortable and hot. In the present study, six men and six women in a 25 degrees C room reported on facial discomfort, thermal sensation, and sweating while wearing three different types of half-facepiece respirators requiring tidal airflow. Skin temperature of the face was measured using a thermocouple taped to the nasolabial fold. The subjects reported that the face felt comfortable when the skin temperature was 34 degrees C or below. However, at skin temperatures above 34.5 degrees C, the face felt increasingly warm, uncomfortable, and sweaty. This finding is similar to that reported previously when subjects wore a half-facepiece respirator supplied continuously with warm, humid air. The conclusion is that thermal conditions of the face contributed to, and may possibly dominate, the discomfort of wearing respiratory protective devices.

Adult↗
PubMed2006

Bifurcating saphenous vein aorto-coronary bypass graft lesions: treatment of left main equivalent using two Filterwire EX distal protection devices.

Distal protection devices for the prevention of embolization during saphenous venous aorto-coronary bypass graft intervention are currently considered standard of care. Branching or Y-type saphenous vein grafts present a unique and challenging problem when a distal protection device is anticipated. We present a case in which two Filterwires were used simultaneously through two separate guiding catheters in a left main equivalent bifurcating saphenous vein graft (SVG) with significant ostial and proximal atherosclerotic lesions of both limbs, which supplied left anterior descending artery and circumflex artery territories.

Aged↗
PubMed2004

Favorable early outcome of carotid artery stenting without protection devices.

BACKGROUND AND PURPOSE: Protection devices are increasingly used in carotid artery stenting. However, no randomized trial has been conducted to evaluate the efficacy of such devices, and arguments have also been formulated against their routine use. We set out to investigate the complication rates associated with carotid artery stenting performed without protection devices. Applicability of covered stents in the carotid system was also evaluated. METHODS: Between January 2001 and July 2003, 245 consecutive patients (260 hemispheres) underwent carotid artery stenting. No protection devices were applied. Covered stents were implanted in 31 (12.1%) cases. The incidence of complications during the intervention and the subsequent 30-day follow-up period was recorded. RESULTS: The technical success rate was 98.8%. One postprocedural nonneurological death (0.4%) occurred. Neurological complications (inclusive of transient ischemic attacks) were observed in 14 cases (5.4%). The rate of major complications (death, major stroke, and myocardial infarction) was 1.6% among the symptomatic and 1.5% among the asymptomatic cases. The rate of minor strokes was 3.2% in the symptomatic and 1.5% in the asymptomatic group. Of the neurological complications, 64.3% occurred postprocedurally. No ipsilateral neurological complications were detected in the subgroup treated with covered stents. CONCLUSIONS: Carotid artery stenting without protection devices appears to be safe. Most of the neurological complications could not have been prevented with protection devices, because they occurred after the intervention. The application of covered stents may reduce the rate of embolization-related complications in the periprocedural period.

Aged↗
PubMed2006

Comparison of performance of three different types of respiratory protection devices.

Respiratory protection is offered to American workers in a variety of ways to guard against potential inhalation hazards. Two of the most common ways are elastomeric N95 respirators and N95 filtering-facepiece respirators. Some in the health care industry feel that surgical masks provide an acceptable level of protection in certain situations against particular hazards. This study compared the performance of these types of respiratory protection during a simulated workplace test that measured both filter penetration and face-seal leakage. A panel of 25 test subjects with varying face sizes tested 15 models of elastomeric N95 respirators, 15 models of N95 filtering-facepiece respirators, and 6 models of surgical masks. Simulated workplace testing was conducted using a TSI PORTACOUNT Plus model 8020, and consisted of a series of seven exercises. Six simulated workplace tests were performed with redonning of the respirator/mask occurring between each test. The results of these tests produced a simulated workplace protection factor (SWPF). The geometric mean (GM) and the 5th percentile values of the SWPFs were computed by category of respiratory protection using the six overall SWPF values. The level of protection provided by each of the three respiratory protection types was compared. The GM and 5th percentile SWPF values without fit testing were used for the comparison, as surgical masks were not intended to be fit tested. The GM values were 36 for elastomeric N95 respirators, 21 for N95 filtering-facepiece respirators, and 3 for surgical masks. An analysis of variance demonstrated a statistically significant difference between all three. Elastomeric N95 respirators had the highest 5th percentile SWPF of 7. N95 filtering-facepiece respirators and surgical masks had 5th percentile SWPFs of 3 and 1, respectively. A Fisher Exact Test revealed that the 5th percentile SWPFs for all three types of respiratory protection were statistically different. In addition, both qualitative (Bitrex and saccharin) and quantitative (N95-Companion) fit testing were performed on the N95 filtering- and elastomeric-facepiece respirators. It was found that passing a fit test generally improves the protection afforded the wearer. Passing the Bitrex fit test resulted in 5th percentile SWPFs of 11.1 and 7.9 for elastomeric and filtering-facepiece respirators, respectively. After passing the saccharin tests, the elastomeric respirators provided a 5th percentile of 11.7, and the filtering-facepiece respirators provided a 5th percentile of 11.0. The 5th percentiles after passing the N95-Companion were 13.0 for the elastomeric respirators and 20.5 for the filtering-facepiece respirators. The data supports fit testing as an essential element of a complete respiratory protection program.

Adult↗
PubMed2005

Filter no reflow during percutaneous coronary interventions using the Filterwire distal protection device.

BACKGROUND: Distal protection devices are increasingly used to prevent embolization during percutaneous coronary interventions (PCI) in saphenous vein grafts (SVG) and native coronary arteries (NV). During interventions with the Filterwire device we have observed reduced flow that is reversible following removal of the filter (filter no reflow, FNR), which might be erroneously interpreted as true no reflow and might be associated with reduced capture efficiency of the basket. METHODS: We analyzed the incidence of FNR in 58 patients (60 lesions) at high risk of embolization undergoing PCI of either a SVG or a NV using the Filterwire (Boston Scientific, Natick, MA). Qualitative and quantitative angiographic analysis was performed, and the volume of collected debris was estimated using a photographic technique. RESULTS: In our population, about 1/3 of the cases showed FNR, which was associated with angiographically visible filling defects within the basket, indicating macroembolism. However some patients (especially those undergoing vein graft interventions) showed filling defects without FNR, and some others FNR without filling defects. Thus we tried to understand the predictors of FNR: FNR was associated with higher amount of collected debris (36.97 +/- 42.98 mm(3) vs. 11.31 +/- 18.47 mm(3), p = 0.005), was neither prevented by abciximab, nor predicted by high thrombotic burden, increasing stent volume or need for predilatation. When patient with and without angiographically evident macroembolisation were separately analyzed, a linear correlation of FNR with the quantity of debris was only apparent in the macroembolization group. CONCLUSIONS: Interventionalists should be aware of the "Filter No Reflow", a common but reversible angiographic complication when the Filterwire device is used. Reduced flow seen during these procedures should be treated conservatively. Mechanical obstruction of the filter, but also other mechanisms (pharmacologically active debris? platelet aggregates?) play a role in this phenomenon.

Abciximab↗
PubMed2005

Thrombectomy and distal protection devices.

Visible distal embolization is a relatively rare complication during percutaneous coronary interventions but it may occur in 15-20% of angioplasties in saphenous vein grafts (SVG) and in thrombus containing lesions of native coronary arteries, especially in the setting of acute myocardial infarction (AMI). Mechanical thrombectomy devices and distal protection devices have been introduced to reduce the incidence of distal embolisation. Angiojet thrombectomy has shown positive outcomes in thrombus containing lesions when compared with intracoronary thrombolysis but a randomised trial failed to show benefit in the context of AMI. The X-Sizer, Excimer LASER and various simple aspiration thrombectomy catheters show promise in treatment of AMI with improvement shown in surrogate end-points such as resolution of ST-elevation but there have been no randomised trials large enough to demonstrate changes in hard clinical end-points. Distal protection devices have come to be routinely used during SVG treatment and, after the results of the SAFER and FIRE trials; they became a treatment recommendation in the recently issued European Society of Cardiology (ESC) guidelines. For AMI, these devices showed great promise in early single-centre studies which have been offset by the lack of clinical benefit in the multi-centre EMERALD trial. Proximal occlusion devices may further decrease the incidence of distal embolisation, especially in the treatment of totally occluded SVGs or native arteries, by reversing the blood flow and offering protection at a very early stage of the procedure before wire passage. Despite continuous technical improvement and a growing number of miniaturised thrombectomy devices and filters, because of the paucity of controlled large studies, it remains unclear whether these devices will remain limited to niche' applications or will become a regular companion to balloons and stents in mainstream angioplasty procedures.

Angioplasty, Balloon, Coronary↗
PubMed2006

Coronary interventional devices: balloon, atherectomy, thrombectomy and distal protection devices.

With increased operator experience and improved device technology, there has been a constant growth in the number of complex lesions (ie, thrombotic lesions, diffuse lesions,calcified lesions, nondilatable rigid lesions, ostial lesions, bifurcations, and chronic total occlusions) attempted by interventionalists with the use of drug-eluting stents. Although coronary stent implantation remains the mainstay and ultimate step for the treatment of most coronary lesions, adjunctive devices may be essential for lesion preparation in some cases (5%-10%) to allow stent deployment and expansion and prevent distal embolization. Thrombectomy and distal protection devices have shown to be effective in the interventions of saphenous vein graft lesions, although their use remains unproven in acute myocardial infarctions.

Angioplasty, Balloon, Coronary↗
PubMed1980

A new respiratory protective device.

This paper describes a new respiratory protective device for use in dangerous environments. The new system provides a lightweight alternative to present compressed air systems and a safe alternative to present pure oxygen respirator systems. The new system utilizes electronically controlled valves, two breathing bags, and a small, compressed supply of oxygen-rich air to achieve these goals. A prototype backpack system very adequately demonstrated the feasibility of such a system as a useable device for respiratory protection.

Environmental Exposure↗
PubMed2005

Cerebral protection devices for use during carotid artery stenting.

(1) Cerebral protection devices offer a new approach to reducing the risk of stroke and death in patients undergoing carotid angioplasty with stenting (CAS). (2) Nine studies have examined the efficacy of cerebral protection devices, by comparing the incidence of procedure related stroke and death to that of CAS without protection, and to surgical endarterectomy. Few of the studies were of high quality. (3) Overall, the differences in the incidence of procedure-related stroke and death were not statistically significant among patients who underwent CAS without protection, compared to those who received CAS with protection, or to those who underwent endarterectomy. (4) Complications reported with the use of cerebral protection devices are minor and transient. (5) CAS with cerebral protection may offer a safe and efficacious alternative to endartectomy in symptomatic, high risk patients with severe carotid artery disease. Evidence to support the use of CAS with cerebral protection devices in asymptomatic patients who have severe carotid artery stenosis, is unavailable.

Angioplasty, Balloon, Coronary↗
PubMed1993

Assessment of comfort of various hearing protection devices (HPD).

To evaluate the comfort of hearing protection devices, two models of ear plugs and five models of ear muffs were tested. The psychophysical method of 'single stimuli' was applied on a group of 30 subjects with or without wearing the devices for a short duration of 15 min under noise condition of 100 dBa in the acoustic chamber as also on a group of 10 weavers with the protection devices worn for longer durations of 1 h, 4 h and 8 h under noise exposure of 102-104 dBA in the weaving shed. Each subject performed 8 trials with each type of device on different days. Application force and tightness of spring were also evaluated. The results yielded a comfort grading for hearing protection devices. The comfort grading, however, depended on several factors in addition to application force and tightness of spring, which has been discussed.

Adult↗
PubMed2003

Critical analysis of distal protection devices.

There is considerable evidence that embolization takes place universally during all carotid stenting procedures. In addition, the development of sophisticated distal protection devices and their availability made the concept of cerebral protection widely acceptable, and currently there is a consensus among specialists that protection devices need to be used routinely. The results of the SAFER trial as well as the SAPPHIRE trial have further increased the enthusiasm for routine use of protection devices. However, each additional step to an existing procedure adds potential risks to the procedure. This is true for cerebral protection devices. The problems associated with the use of a distal protection device relate to (1) difficulties in introducing and deploying the device, (2) effectiveness of emboli capture, (3) protection device induced vessel injury, and (4) difficulties in retrieving the device. This article reviews the early clinical experience with various protection devices and summarizes some of the disadvantages of these devices.

Angiography↗
PubMed1994

Noise exposure, noise annoyance, use of hearing protection devices and distress among blue-collar workers.

OBJECTIVES: This study tested the hypotheses that, in high noise levels [> or = 85 dB(A)], hearing protection devices are used largely by workers sensitive to noise, as reflected by reports of noise annoyance, and that the usage would reduce distress symptoms. METHODS: Data collected from 1587 healthy male blue-collar workers included noise exposure level, noise annoyance, use of hearing protection devices, distress symptoms (somatic complaints and poststress irritability), and possible confounding by age, education and ethnic origin. RESULTS: Multiple logistic regression results indicated that the use of hearing protection devices was related to noise exposure level [odds ratio (OR) 2.94, 95% confidence interval (95% CI) 2.58--3.30], but more so to high noise annoyance (OR 3.03, 95% CI 2.77--3.29), even after control for age, education, and ethnic origin. No interaction was found between noise level and noise annoyance. These findings highlight the contribution of noise annoyance to the use of hearing protection devices. Of the 42.6% of workers using hearing protection devices in the presence of high ambient noise, 60% were highly annoyed. Noise-annoyed workers also tended to wear hearing protection devices even in low noise levels. The use of hearing protection devices was associated with lower distress symptoms among the low and moderately annoyed workers, but among the highly annoyed workers the reverse was true. CONCLUSIONS: Thus, for the highly annoyed workers, the use of hearing protection devices was perhaps an additional source of stress. One immediate implication of this study is that future intervention procedures should focus on unannoyed workers who tend to use hearing protection devices less.

Adult↗
PubMed2005

Embolic protection devices for carotid artery stenting: is there a difference between filter and distal occlusive devices?

OBJECTIVES: We sought to compare the efficacy of a filter embolic protection device (F-EPD) and a distal occlusive embolic protection device (DO-EPD) in patients undergoing carotid artery stenting (CAS). BACKGROUND: The embolic protection device (EPD) may lower the periprocedural rate of cerebral ischemic events during CAS. However, it is unclear whether there is a difference in effectiveness between the different types of EPD. METHODS: We analyzed data from the Carotid Artery Stent (CAS) Registry. RESULTS: From July 1996 to July 2003, 1,734 patients were included in the prospective CAS Registry. Of these patients, 729 patients were treated with an EPD, 553 (75.9%) with F-EPD, and 176 (24.1%) with DO-EPD. Patients treated with DO-EPD were more likely to be treated for symptomatic stenosis (64.5% vs. 53.4%, p = 0.011). The carotid lesions in patients treated under DO-EPD seemed to be more complicated, as expressed by a higher proportion of ulcers (p = 0.035), severe calcification (p = 0.039), a longer lesion length (p = 0.025), and a higher pre-interventional grade of stenosis (p < 0.001). The median duration of the CAS intervention was 30 min in the DO-EPD group, compared with 48 min in the filter group (p < 0.001). No differences in clinical events rate between the two groups of protection devices were observed. Multivariate analysis on the occurrence of the combined end point of in-hospital death or stroke found no difference between filter- and DO-EPD (4 of 176 [2.3%] for DO-EPD vs. 10 of 551 [1.8%] for F-EPD; adjusted odds ratio = 1.04, 95% confidence interval 0.24 to 4.44; p = 0.958). CONCLUSIONS: Filter EPD is the currently preferred method of EPD in clinical practice. Both F-EPD and DO-EPD seem to be equally effective during CAS.

Brain Ischemia↗
PubMedDate not supplied

[The energy cost and the use of individual protective devices in firefighters].

Firefighters are required to wear fire-protection devices when involved in hazardous work situations. To determine whether fire protective clothing and self-contained breathing apparatus (SCBA) affect maximal physical work performance and to assess their additional energy requirement, we studied a cohort of Italian firemen while performing a rapid air-stair climbing (Mt. 29). Heart rate (HR) and maximal speed (time/distance) were measured in 23 firemen during the exercises, performed either wearing fire protection clothing and SCBA (p2) and service dress (p1). We also measured maximal oxygen consumption (VO2 max, indirect determination), WBGT and the speed/HR ratio (iR) as an arbitrary index of physical work performance. The participant reached the sub-maximal HR in both exercises (p1 87.01%; p2 88.84%). Fire protection devices significantly reduced the exercise maximal speed (p < 0.001) and increased the maximal HR (p < 0.01). IR index was significantly (p < 0.001) lower for p2, indicating a reduction of physical work performance (-26.9%); VO2 max was inversely related with mean and maximal HR (p < 0.001). These results suggest that only well trained firefighters should be employed in emergency actions requiring fire protection devices and SCBA.

Adult↗
PubMed2005

Embolic protection during saphenous vein graft intervention using a second-generation balloon protection device: results from the combined US and European pilot study of the TriActiv Balloon Protected Flush Extraction System.

BACKGROUND: Stent placement in saphenous vein bypass grafts is associated with a high incidence of myonecrosis usually resulting from embolization of thrombus and friable atheroma. Embolic protection devices reduce the incidence of adverse events after vein graft stenting. However, first-generation balloon occlusion systems are still associated with a 10% incidence of periprocedural adverse events. We report the first experience with a new second-generation balloon occlusion embolic protection device, the TriActiv Balloon Protected Flush Extraction System. METHODS: Ninety-six lesions in 78 saphenous vein grafts were treated in 74 patients. The primary end point was major adverse cardiovascular events at 30 days. RESULTS: Device success was achieved in 92% of patients, and atheromatous debris was recovered in 69% of analyzed aspirates. By 30 days, major adverse cardiovascular events, which were limited to non-Q-wave myocardial infarctions, occurred in 16.2%. Per protocol analysis in patients with device success revealed a rate of adverse events of only 5.7%. CONCLUSIONS: The initial experience with the TriActiv Balloon Protected Flush Extraction System demonstrated a high success rate and recovery of embolic debris with an acceptable rate of adverse events. A large randomized trial will compare this device to other embolic protection systems.

Adult↗