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Comparison of 4 cerebral protection filters for carotid angioplasty: an in vitro experiment focusing on carotid anatomy.

PURPOSE: To assess the influence of internal carotid artery (ICA) tortuosity on the effectiveness of 4 cerebral protection filters in an in vitro bench-top model. METHODS: To simulate the anatomical arterial variants, 3 open flow models were constructed: one with normal carotid anatomy, 1 representing a mildly tortuous ICA, and a third imitating a severely tortuous ICA. Polyvinyl alcohol particles (150-1000 microm) served as the embolic material; the emboli were divided into 3 groups according to size: small (150-250 microm), medium (355-500 microm), and large (710-1000 microm). Five milligrams of each size group were injected separately into the ICA proximal to each of 4 protection filters: AngioGuard, FilterWire EX, TRAP, and NeuroShield. Emboli that were not caught by the protection system or were washed into the external carotid artery (ECA) ran into an effluent filter and were weighed and classified according to size. RESULTS: In 240 test runs, the FilterWire EX presented the lowest weight of emboli in the ICA effluent under all anatomical conditions: normal anatomy 0.39 mg (2.58%), mild tortuosity 0.45 mg (2.99%), and severe tortuosity 0.50 mg (3.33%) (p>0.05). The Angioguard system showed the worst results: normal 1.21 mg (98.03%), mild tortuosity 2.54 mg (16.84%), and severe tortuosity 3.14 mg (20.91%) (p<0.001) compared to the FilterWire EX and the NeuroShield systems. The only protection device displaying no significant differences in all of the 3 emboli sizes was the FilterWire EX (p>0.05). Relevant differences in effectiveness in mildly and severely tortuous ICAs were apparent among the other devices. For all emboli sizes, the differences of the AngioGuard and TRAP systems were highly significant (p<0.001). There was no significant difference between the FilterWire EX and the NeuroShield. CONCLUSIONS: The only protection device showing no significant decrease in efficacy in the tortuous ICA models was the FilterWire EX. In both tested anatomical variants, the protection systems ranked in the same order of effectiveness. None of the tested devices prevented embolization completely.

Balloon Occlusion↗

Distal embolic protection for SVG interventions: can we afford not to use it?

The development of atherosclerosis in saphenous vein grafts (SVGs) is one of the limiting factors in coronary artery bypass surgery. Approximately one half of vein conduits are significantly diseased or occluded at 10 years. A surgical revascularization strategy is often not pursued secondary to the incremental risks associated with a repeat bypass procedure. For this reason, percutaneous treatment of SVG disease is often the first option for a majority of patients. However, catheter-based treatment of SVG disease is associated with increased morbidity and mortality compared with native coronary arterial percutaneous intervention. This is often the result of distal embolization of atherothrombotic disease, leading to the phenomenon of "no-reflow." Intraprocedural pharmacological therapy has historically been the mainstay of treatment for these patients. However, more recently, the development of a mechanical embolic protection device has shown to be beneficial for the prevention of these complications. This article will review the types of embolic protection devices and the clinical studies that have proven their necessity in percutaneous SVG intervention.

Angioplasty, Balloon, Coronary↗

Novel delivery of pancreatic islet cells to treat insulin-dependent diabetes mellitus.

Immune protective devices containing pancreatic islets are designed to treat insulin-dependent diabetes mellitus by providing glycaemic control without immunosuppression. The immune protection is achieved by separating allogeneic or xenogeneic islets from the host by semipermeable membranes that allow only small molecules such as glucose, insulin and nutrients to pass through. Lymphocytes and immunoglobulins are excluded by the membrane and unable to cause rejection of the islets. Three types of immune protective devices, i.e. microcapsules, diffusion chambers and perfusion devices (vascularised artificial pancreas), have been studied. Microcapsules injected into the abdominal cavity in a large quantity achieved glycaemic control, but required a small amount of immunosuppression to prevent fibrosis around the the capsules. A clinical attempt to use microcapsulated human islets in a diabetic patient who has maintained functional kidney allografts has been reported. Intra-abdominal placement of diffusion chambers containing allogeneic islets achieved excellent glycaemic control without immunosuppression in diabetic dogs. However, their use was limited by the eventual breakage of tubular chambers. We have extensively used the vascularized artificial pancreas for treatment of experimental diabetes mellitus. Excellent biocompatibility of the device was evidenced by the extraordinary longevity of the patency of the device in healthy dogs. Long term control of severe diabetes mellitus was achieved in totally pancreatectomised dogs without immunosuppression by devices seeded with allogeneic (canine) and xenogeneic (porcine) islets. The vascularised artificial pancreas could be an excellent alternative to Diabetes Control and Complication Trial (DCCT)-type intensive insulin therapy or pancreatic transplantation by providing tight glycaemic control with minimal exogenous insulin therapy without immunosuppression.

Animals↗

The effects of protective equipment on styrene exposure in workers in the reinforced plastics industry.

This study was designed to determine whether styrene absorption through the skin results in measurable changes in biologic indicators of styrene exposure using a group of workers engaged in hand lay-up operations during which extensive styrene skin contact occurs. Serial measurements of expired breath and blood styrene and urinary excretion of mandelic and phenylglyoxylic acid were made in eight female workers during 4 consecutive days using different experimental conditions including either (1) gloves/protective clothing alone, (2) respirator alone, (3) both gloves/protective clothing and respirator, or (4) neither respirator nor gloves/protective clothing. A two-by-two factorial design imbedded in a Latin square design allowed estimation of the effects of the two types of protection (i.e., gloves/clothing and respiratory) and any interaction. Levels of styrene in venous blood and expired breath and urine mandelic and phenylglyoxylic acid excretion were no different when gloves/clothes were used as protection compared to no protection at all. Significant reduction in all biologic indices occurred when respiratory protection was used. The results of the study suggest that percutaneous absorption of styrene is not a significant exposure source and does not significantly contribute to the body burden of styrene of workers in the reinforced plastic industry engaged in hand lay-up operations. Respiratory protective devices were the most effective means for reducing styrene absorption. Even though skin absorption of styrene is limited, skin protection is necessary because of the risk of dermatitis.

Air Pollutants, Occupational↗

Focal ischemia of the brain after neuroprotected carotid artery stenting.

OBJECTIVES: This study sought to assess the incidence of cerebral ischemia in nonselected patients undergoing neuroprotected carotid angioplasty and stenting (CAS) without preceding multiple-vessel diagnostic angiography. BACKGROUND: Protection devices to prevent distal embolization during CAS are presently under clinical investigation. Diffusion-weighted magnetic resonance imaging (MRI) visualizes recent ischemia of the brain and may aid in assessing the efficacy of protection devices. METHODS: Elective CAS was performed in 42 consecutive patients (15 female, 27 male; mean age, 67 +/- 9 years) using six different types of cerebral protection systems. All patients underwent MRI of the brain before and after a total of 44 interventions. RESULTS: Placement and retrieval of the devices and stent deployment was achieved in all procedures. New ischemic foci were seen on postinterventional MRI in 10 cases (22.7%). One patient had sustained a major stroke, whereas no adverse neurological sequelae were associated with the other nine procedures. In the latter, one to three foci (maximum area 43.0 mm(2)) were detected in cerebral regions subtended by the ipsilateral carotid artery in eight cases and by the contralateral carotid artery in one case. In the stroke patient, 12 ischemic foci (maximum area 84.5 mm(2)) were exclusively located in the contralateral hemisphere. Follow-up MRI at 4.1 months (median, n = 7) identified residuals of cerebral ischemia only in this patient. CONCLUSIONS: Neuroprotected CAS is associated in about 25% of cases with predominantly silent cerebral ischemia. Our findings suggest manipulation of endoluminal equipment in the supraaortic vessels to be a major risk factor for cerebral embolism during neuroprotected CAS.

Aged↗

Carotid angioplasty under cerebral protection with the PercuSurge GuardWire System.

The purpose of this study was to examine the possible beneficial effect of the PercuSurge GuardWire cerebral protection device based on balloon occlusion of the distal internal carotid artery and debris aspiration for patients undergoing carotid artery stenting (CAS). A total of 268 CAS procedures were attempted under cerebral protection using the PercuSurge GuardWire system in 242 patients (194 men; mean age, 71.2 +/- 9.4 years; range, 40-91). The lesions were mainly atherosclerotic; 64% were symptomatic. Technical success was 99.3%. All lesions were stented except three postangioplasty restenoses. Prophylactic occlusion during balloon dilatation and stenting was well tolerated in 255 patients (95.9%). Microscopic analysis of the aspirated blood showed different types of particles numbering between 7 and 145 per procedure, with a mean diameter of 250 microm (mean, 56-2,652 microm). The 30-day stroke and death rate was 2.3%, with four periprocedural complications at < 48 hr (one retinal embolism and three transient ischemic attacks), one intracerebral hemorrhage at 3 days, and one death of cardiac failure at 3 weeks. This technique appears safe and efficient with a low rate of periprocedural embolic events. Protection devices seem indispensable to perform CAS and expand the applicability of the procedure. Randomized studies (surgery vs. CAS with and without cerebral protection) are awaited.

Aged↗

Protected stent-assisted angioplasty in radiation-induced carotid artery stenosis.

OBJECTIVE: The surgical treatment of radiation-induced carotid stenosis is challenging and presents a high rate of complications. This has led several investigators to propose stent-assisted angioplasty as the treatment of choice for this condition. The aim of this study is to evaluate the potential risks of intra-procedural embolic stroke in this setting using cerebral protection devices. METHODS: We describe our recent experience in the endovascular treatment by means of stent-assisted angioplasty with the aid of a filter cerebral protection device of eight patients presenting with radiation-induced carotid stenosis. RESULTS: Procedural success, defined as residual stenosis of less than 30% was obtained in all cases. The mean percentage stenosis was reduced from mean 80+/-6.3% (range 70-90%) to 13+/-4% (range 10-20%). Predilation was performed in five cases, post-dilation in all the cases. Mild-to-moderate bradycardia while inflating the balloon was present in three cases and was severe in one case. No patient sustained myocardial infarction, stroke or TIA during the procedure or hospital stay. During a mean clinical follow-up of 16+/-7.3 months (range 5-25) there were no neurological events. On sonographic follow-up, no patient presented in-stent de novo stenosis. DISCUSSION: Carotid angioplasty with cerebral protection can be performed safely in radiation-induced carotid stenosis with a high technical success rate. With the recent innovations and improvements in angioplasty technique, its indications and results will have to be redefined. Given the complexity and complications of surgical approaches for this condition, and the encouraging results obtained with endovascular techniques, carotid angioplasty emerges as the preferred treatment option.

Adult↗

Preventing heel breakdown.

The prevalence of heel pressure ulcers is a major health care problem. Heel ulcers develop as a result of pressure, shear, or friction concentrated on a small area over a bony prominence that lacks subcutaneous tissue. Significant risk factors for development of heel breakdown include immobility, age, mental status, nutrition, chronic illness, and orthopaedic surgical procedures, especially hip pinning and hip replacement surgeries. It is important for nurses to identify patients at risk for heel pressure ulcers and to initiate appropriate preventive interventions. This article discusses the etiology of heel pressure ulcers, risk factors, heel assessment, and choice of heel protection devices.

Heel↗

Peripheral light focusing by the anterior eye and the ophthalmohelioses.

Peripheral focusing of light by the anterior eye may provide a unifying concept to explain the location and etiology of sun-related eye conditions (ophthalmohelioses). Using a bovine eye model, along with computer-assisted ray-tracing techniques to model limbal focusing, we demonstrated a correlation between the locations of the foci of scattered incident light (resulting in a 20-fold concentration of light at the limbus) and the usual locations of pterygium and cortical cataract. These findings suggest the need for improved ocular protective devices, particularly ones that provide lateral protection of the eye against the increased ultraviolet insolation resulting from thinning of the ozone layer.

Animals↗

Is there any evidence that cerebral protection is beneficial? Experimental data.

This article presents the available experimental data from the world literature on the use of cerebral protection devices during carotid artery stenting (CAS). Clinical studies relying on surrogate markers of cerebral embolisation in place of neurological event rate as primary outcome measures are evaluated alongside bench-top and animal studies. These surrogate markers include evaluations of outcomes using procedural transcranial Doppler (TCD) and diffusion-weighted magnetic resonance imaging of brain (DWI). Pathological analyses of debris retrieved from in-vivo analyses of protection devices are also included in this review because although the focus of these studies was primarily clinical, the laboratory data will be preferentially presented and it provides interesting insights. It can be shown that each of the three philosophies of cerebral protection, namely flow arrest (proximal or distal), flow reversal and distal filtration is capable of the entrapment of sizeable debris that would logically threaten devastating stroke if it embolized to the brain. Whilst balloon occlusion significantly reduces the procedural microembolic load (particles less than 60 mm) and flow reversal may be the first means to entirely eliminate it, filters may be associated with increased microembolization. This has been described by some workers as controlled embolization. Certainly, particles smaller than the pore size of currently available filters (60-140 mm) will readily evade capture due to filter periflow and through-flow. There is evidence to suggest that tens of thousands of particles of this size may be released during CAS and there is some evidence that this may be associated with more new white lesions on DWI of brain. The clinical consequences of this controlled embolization however, remain unclear and sophisticated neuropsychometric test batteries may need to be applied at later time points to detect subtle injury that may be compounded by a late inflammatory response around cerebral emboli. Devices relying on placement in the distal internal carotid artery (ICA) for establishment of protection risk intimal damage and the release of microemboli due largely to device deployment and retrieval. Although devices effecting flow arrest and flow reversal will limit all embolization, they do so at the expense of constant procedural cerebral perfusion and may not be tolerated in patients with precarious cerebral reserve capacity, loss of integrity of the Circle of Willis and/or high-grade stenosis of the contralateral ICA. Advances in the concept of cerebral protection will require technical refinements to existing devices, alternative mechanical strategies and/or pharmacological plaque stabilization.

Angioplasty↗

An outbreak of severe acute respiratory syndrome among hospital workers in a community hospital in Hong Kong.

BACKGROUND: During outbreaks, hospital workers are at high risk for nosocomial infection with severe acute respiratory syndrome (SARS)-associated coronavirus. OBJECTIVE: To examine how hospital workers became infected and whether they transmit the virus to their families. DESIGN: Retrospective descriptive study. SETTING: 529-bed community hospital in Hong Kong. PATIENTS: 40 hospital workers infected with SARS-associated coronavirus over a 6-week period (25 March through 5 May 2003). MEASUREMENTS: Percentage of infected hospital workers according to job category. RESULTS: The cumulative incidence was highest among health care assistants, followed by physicians and nurses (8%, 5%, and 4%, respectively). Most hospital workers were infected from direct contact with patients with SARS, who primarily were in general wards and had unsuspected infection. At the time of contact, all hospital workers had used masks but not necessarily other protective devices. Affected hospital workers did not infect their families. CONCLUSION: Before isolation of all patients with clinically confirmed or suspected SARS, routine use of several protective devices, and training of staff in infection control, many health care workers were infected with SARS from patients with unsuspected cases.

Adult↗

Cobalt exposure in wet grinding of hard metal tools for wood manufacture.

The authors examined exposure to cobalt during the wet grinding of hard metal tools (Widia tools) used in the wood industry, usually in small specialized workshop which can produce exposure to cobalt > TLV-TWA (50 micrograms/m3) if carried out with no protective devices. Local exhausts near the grinding wheel can reduce the exposure to cobalt by as much as 20 times. Nevertheless, some technical problems often hamper the effectiveness of these protective devices, so that the plant situation, examined by the forecasting OTL test as proposed by Tuggle (Am. Ind. Hyg. Assoc. J., 43 (1982) 338), does not appear to be completely acceptable. Other technical solutions are therefore necessary for a complete control of the exposure to cobalt. A more effective water stream, a greater air velocity near the grinding wheel and a protective shield between the wheel and the worker are some suggestions.

Air Pollutants, Occupational↗

Use of platelet glycoprotein IIb/IIIa inhibitors in saphenous vein graft percutaneous coronary intervention and clinical outcomes.

Platelet glycoprotein (GP) IIb/IIIa inhibitors are widely used in percutaneous coronary intervention (PCI). Previous studies have suggested that they do not offer benefit in saphenous vein graft PCI. Nonetheless, their use remains widespread during vein graft angioplasty. We retrospectively analyzed 1,537 patients who underwent saphenous vein graft PCI. Patients who received a GP IIb/IIIa inhibitor (n = 941) were compared with those who did not receive any GP IIb/IIIa inhibitor (n = 596). The primary end point was myonecrosis after PCI (creatine kinase-MB level >3 times the upper reference limit). The incidence of myonecrosis after PCI was similar between the group that received GP IIb/IIIa and the group that did not (odds ratio for GP IIb/IIIa use 1.39, 95% confidence interval 0.97 to 2.00, p = 0.07). Propensity-adjusted analysis demonstrated no significant difference in myonecrosis after PCI, in-hospital mortality, Q-wave myocardial infarction, or bleeding (blood transfusion, retroperitoneal bleed, or hematoma) between the 2 groups. In an analysis restricted to patients who were treated with an emboli protection device, GP IIb/IIIa use was not associated with decreased myonecrosis after PCI (this was also the case for patients who were not treated with an emboli protection device). Unadjusted survival (mean follow-up 5.5 +/- 0.1 years) was similar between the group that received GP IIb/IIIa and the group that did not (log-rank test, p = 0.89). There was no difference in survival after adjusting for the propensity to receive a GP IIb/IIIa inhibitor (adjusted odds ratio for GP IIb/IIIa use 0.92, 95% confidence interval 0.69 to 1.23, p = 0.59). In conclusion, adjunctive use of platelet GP IIb/IIIa inhibitors in saphenous vein graft PCI does not appear to be associated with less myonecrosis or improved survival.

Aged↗

Benefits of cerebral protection during carotid stenting with the PercuSurge GuardWire system: midterm results.

PURPOSE: To examine the possible beneficial effect of a new cerebral protection device based on balloon occlusion of the distal internal carotid artery (ICA) and debris aspiration for patients undergoing carotid artery stenting (CAS). METHODS: One hundred and eighty-four CAS procedures were attempted under cerebral protection using the PercuSurge GuardWire system in 167 patients (129 men; mean age 70.5 +/- 9.2 years, range 40-91)). The lesions were mainly atherosclerotic, and half (n = 93) were asymptomatic. Eighteen restenotic and 7 post-radiation stenoses were also treated. RESULTS: Technical success was 99.5%. All lesions were stented except 3 postangioplasty restenoses. Prophylactic occlusion during balloon dilation and stenting was well tolerated in 176 (95.7%) patients. Microscopic analysis of the aspirated blood showed different types of particles numbering between 7 and 145 per procedure with a mean diameter of 250 microm (56-2652 microm). The 30-day stroke and death rate was 2.7%: 3 periprocedural complications at <48 hours (1 major stroke and 2 transient ischemic attacks), 1 intracerebral hemorrhage at 3 days, and 1 death of cardiac failure at 3 weeks. CONCLUSIONS: This study yielded a favorably low rate of periprocedural embolic events comparable with standard CAS series. Protection devices may play an important role in future carotid interventions and expand the applicability of the procedure. Randomized studies (surgery versus CAS with and without cerebral protection) are awaited.

Adult↗

[Biomechanical examinations of the efficacy of wrist guards in inline skating].

INTRODUCTION: Fractures of the wrist and forearm are the most frequent injuries in Inline-Skating. Clinical experience has shown that these injuries can be prevented the use of wrist protectors. But various authors have shown that fractures can also occur despite the use of wrist protectors. Aim of this study was to examine different wrist protectors in a biomechanical set up. METHOD: A standardized trauma was simulated using an artificial hand with a certain weight. The forces with or without protective devices have been recorded by a force moment sensor. The results of different protectors have been compared. RESULTS: A mean force of 956 N was measured without the use of a protective device. With the application of a wrist protector these forces were reduced between 4 and 20 %. The best values have been reached with models with a strong base plate. CONCLUSIONS: The results of the present study may explain the clinical observation that wrist and forearm fractures can occur despite the use of a wrist guard. The protective effect of a wrist protector depends highly on the model that is used.

Athletic Injuries↗

[Predictive elements and prevention of myocardial damage during angioplasty/stenting].

Cardiac enzyme elevation is observed in 5-30% of patients after percutaneous intervention and appears associated with higher subsequent cardiac events and mortality. The cause of myocardial enzyme release could be an obvious angiographic complication of the procedure but, most frequently, is neither clinically nor angiographically clear. Different clinical series have identified clinical, angiographic and procedural risk factors for CK-MB elevation after otherwise successful coronary intervention, including unstable angina, diffuse atherosclerosis and aggressive procedures such as atheroablation. Microembolization of atherothrombotic plaque material appears to be the pathogenetic mechanism. Periprocedural administration of platelet glycoprotein IIb/IIIa inhibitors has been shown to reduce subsequent myocardial infarction and long-term mortality. Beta-blockers may also have a protective effect against post-procedural CK-MB elevations and follow-up cardiac events. New distal protection devices are under investigation and appear promising. The risk of inducing myocardial damage during percutaneous intervention should be considered before attempting the procedure. The use of platelet IIb/IIIa inhibitors and protection devices should be considered in high-risk patients.

Adrenergic beta-Antagonists↗

Protected stent-assisted carotid angioplasty in the management of late post-endarterectomy restenosis.

OBJECTIVES: The high complication rate associated with the surgical treatment of post-carotid endarterectomy restenosis has led several investigators to propose stent-assisted angioplasty as the treatment of choice for this condition. Late restenosis is very infrequent and mainly due to atherosclerotic progression. The aim of this study is to evaluate the potential risk of intraprocedural embolic stroke during stent-assisted angioplasty with cerebral protection devices in these patients. METHODS: We describe our recent experience in the endovascular treatment of 10 patients presenting late carotid restenosis by means of stent-assisted angioplasty with the aid of a filter cerebral protection device. Mean elapsed time from surgery to angioplasty was 92+/-31 months (range 48-144 months). RESULTS: Procedural success was obtained in all the cases. Pre-dilation was performed in six cases, post-dilation in all the cases. The mean percentage stenosis was reduced from mean 77+/-12% (range 60-95%) to 6.3+/-6.7% (range 0-17%). Bradycardia while inflating the balloon was mild-to-moderate in seven cases and severe in two. No patient sustained stroke or transient ischemic attack (TIA) during the procedure or during hospital stay. On follow-up, two patients presented with moderate asymptomatic restenosis and were managed conservatively. DISCUSSION: Carotid angioplasty with cerebral protection can be performed safely in late carotid restenosis with a high technical success rate. No clinical embolic complications occurred in this subset of patients. With recent innovations and improvements in angioplasty technique, previous indications for angioplasty in these patients will have to be redefined. Carotid angioplasty seems to be a valuable treatment alternative to conventional surgery in this subset of patients.

Aged↗