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Protection Devices (protection + device)

Distribution by Scientific Domains

Medical Sciences	96%

Kinds of Protection Devices

distal protection device

embolic protection device

Selected Abstracts

Safety and effectiveness of the INVATEC MO.MA® proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial,

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2010
Gary M. Ansel MD
Abstract Objective: The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA® Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Background: Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis. Methods: This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. Results: For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0,5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. Conclusions: The ARMOUR trial demonstrated that the MO.MA® Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. © 2010 Wiley-Liss, Inc. [source]

Optical Power Limiters Based on Colorless Di-, Oligo-, and Polymetallaynes: Highly Transparent Materials for Eye Protection Devices,

ADVANCED FUNCTIONAL MATERIALS, Issue 6 2007
G.-J. Zhou
Abstract The synthesis, characterization, and photophysics of a series of solution-processable and tractable di-, oligo-, and polymetallaynes of some group 10,12 transition metals are presented. Most of these materials are colorless with very good optical transparencies in the visible spectral region and exhibit excellent optical power limiting (OPL) for nanosecond laser pulse. Their OPL responses outweigh those of the state-of-the-art reverse saturable absorption dyes such as C60, metalloporphyrins, and metallophthalocyanines that are all associated with very poor optical transparencies. On the basis of the results from photophysical studies and theoretical calculations, both the absorption of triplet and intramolecular charge-transfer states can contribute to the enhancement of the OPL properties for these materials. Electronic influence of the type, spatial arrangement, and geometry of metal groups on the optical transparency/nonlinearity optimization is evaluated and discussed in detail. The positive contribution of transition metal ions to the OPL of these compounds generally follows the order: Pt,>,Au,>,Hg,>,Pd. The optical-limiting thresholds for these polymetallaynes can be as low as 0.07,J,cm,2 at 92,% linear transmittance and these highly transparent materials manifest very impressive figure of merit ,ex/,o values (up to 22.48), which are remarkably higher than those of the benchmark C60 and metal phthalocyanine complexes. The present work demonstrates an attractive approach to developing materials offering superior OPL/optical transparency trade-offs and these metallopolyynes are thus very promising candidates for use in practical OPL devices for the protection of human eyes and other delicate optical sensors. [source]

New distal embolic protection device the FiberNet® 3 dimensional filter: First carotid human study

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2007
Michel Henry
Abstract Objective: Evaluate the performance and safety of the FiberNet® Embolic Protection System during carotid artery intervention. Background: Carotid Angioplasty and Stenting (CAS) can be proposed to treat the majority of carotid stenoses. Brain embolization takes place and routine use of Embolic Protection Devices (EPD) is warranted. Many EPDs have significant limitations, which may be addressed by a new EPD, the FiberNet® (Lumen Biomedical, Plymouth, MN). Methods: The system consists of a 3-dimensional expandable filter made of fibers, which expand radially, mounted onto a 0.014, wire and retrieval catheter. FiberNet can capture particles as small as 40 ,m without compromising flow. Results: 35 lesions treated in 34 patients. Male 67.6%. Age: 71.4 ± 8.8 (50,85). Average stenosis 84.5% ± 7.9 (70,99). 29.4% were symptomatic. Technical success: 34/35 (97%). No stroke or death within 30 days. Neurological events: two permanent amaurosis, one amaurosis fugax. All samples visually contained significant amounts of emboli. The mean surface area of debris caught was 63.8 mm2 (37.7,107.5). Comparisons were made with other EPDs. The mean surface area of debris caught was 12.2 mm2 (2.7,34.3). No changes were noted in CT/MRI at 30-day post procedure. Conclusion: The first human use of this new novel EPD in carotid artery stenting is encouraging. The FiberNet was easy to use and confirmed the ability to capture particles less than 100 ,m. The feasibility of the FiberNet has been demonstrated. Additional patients will demonstrate the overall safety and efficacy of this new EPD device. © 2007 Wiley-Liss, Inc. [source]

European Carotid PROCAR Trial: Prospective Multicenter Trial to Evaluate the Safety and Performance of the ev3 ProtégéÔ Stent in the Treatment of Carotid Artery Stenosis,1- and 6-Month Follow-Up

JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2006
JENNIFER SUGITA
Background: The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device. Method: The Protégé® GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018, (6,9 mm stent) or 7 Fr 0.035, (10 mm stent) over-the-wire delivery system. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. A total of 77 patients have been enrolled in the trial. Results: In the 77 lesions treated (31 symptomatic, 46 asymptomatic), the procedure was technically successful in 76 (99%), with an average residual stenosis of less than 30%. One procedure failed because the embolic protection device could not be retrieved and the patient was sent to surgery. Within 30 days, there were four (5.2%) major adverse neurological events (MANEs). Three of the MANEs were major strokes (3.9%), one a minor stroke. The fifth MANE occurred prior to the 6-month follow-up visit; this patient had a major stroke 75 days after the procedure and died 36 days later. One additional death occurred because of urosepsis. Conclusions: The PROCAR trial shows that the Protégé stent with adjuvant use of a filter embolic protection device satisfies safety and performance criteria for the treatment of carotid artery stenosis. The incidence of MANEs for the Protégé stent is comparable to the incidence of these events in other recent carotid stent studies and standard carotid endarterectomy (CEA). [source]

Cohort study for the effect of chronic noise exposure on blood pressure among male workers in Busan, Korea

AMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 6 2009
Ji Ho Lee MD
Abstract Objective It has not yet been established whether exposure to chronic noise induces an increase in blood pressure or an increase in the development of hypertension. Therefore, a cohort study was performed to identify the effects of chronic noise exposure on blood pressure. Methods Five hundred thirty male workers at a metal manufacturing factory in Busan, Korea, were enrolled in the study. They were monitored with an annual health check-ups for nine consecutive years from 1991 to 1999. The subjects were divided into four groups which were determined by noise level categories (NLCs) according to the exposure of noise intensity; NLC-I: office workers who were exposed to <60 dBA at work; NLC-II: worksite technical supporters or inspectors who were intermittently exposed to noise and were not using hearing protection devices; NLC-III: worksite workers exposed to a noise below 85 dBA (TWA) and used one type of hearing protection device, earplug or earmuff; NLC-IV: worksite workers who were exposed to a noise level of 85 dBA or higher in average and used both earplug and earmuff. Results After controlling the possible confounders, such as baseline age, smoking, alcohol intake, exercise, family history of hypertension, systolic blood pressure (SBP), or diastolic blood pressure (DBP), and changes in body mass index (BMI), we determined that the mean values for the SBP over the duration of this study were 3.8, 2.0, and 1.7 mmHg higher in groups NLC-IV, NLC-III, and NLC-II, respectively, in comparison to that of the NLC-I group. There was no significant difference in DBP among the groups. Conclusion This study suggests that chronic noise exposure increases SBP independently, among male workers. Am. J. Ind. Med. 52:509,517, 2009. © 2009 Wiley-Liss, Inc. [source]

Noise exposures aboard catcher/processor fishing vessels

AMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 8 2006
Richard L. Neitzel MS
Abstract Background Commercial fishing workers have extended work shifts and potential for 24 hr exposures to high noise. However, exposures in this industry have not been adequately characterized. Methods Noise exposures aboard two catcher/processors (C/P) were assessed using dosimetry, sound-level mapping, and self-reported activities and hearing protection device (HPD) use. These data were combined to estimate work shift, non-work, and 24 hr overall exposure levels using several metrics. The length of time during which HPDs were worn was also used to calculate the effective protection received by crew members. Results Nearly all workers had work shift and 24 hr noise levels that exceeded the relevant limits. After HPD use was accounted for, half of the 24 hr exposures remained above relevant limits. Non-work-shift noise contributed nothing to 24 hr exposure levels. HPDs reduced the average exposure by about 10 dBA, but not all workers wore them consistently. Conclusions The primary risk of hearing loss aboard the monitored vessels comes from work shift noise. Smaller vessels or vessels with different layouts may present more risk of hearing damage from non-work periods. Additional efforts are needed to increase use of HPDs or implement noise controls. Am. J. Ind. Med. 2006. © 2006 Wiley-Liss, Inc. [source]

Airways inflammation after exposure in a swine confinement building during cleaning procedure

AMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 4 2002
Britt-Marie Larsson PhD
Abstract Background Healthy volunteers exposed for 3 hr during weighing of pigs develop an airway inflammation characterized by a massive influx of neutrophilic granulocytes in the upper and lower airways and increased bronchial responsiveness to methacholine. The purpose of the present study was to investigate health effects from exposure during cleaning of the swine confinement building and to evaluate the effect of a respiratory protection device. Methods Sixteen subjects were exposed for 3 hr during cleaning of a swine confinement room with a high-pressure cleaner. Seven out of sixteen subjects were equipped with a mask during exposure. Results The bronchial responsiveness increased in all subjects following exposure, significantly more in the group exposed without a mask (P,<,0.05). The cell concentration (mainly neutrophilic granulocytes) in nasal lavage fluid as well as the concentration of interleukin-8, increased significantly only in those subjects exposed without a respiratory protection device. In peripheral blood, an increase of neutrophilic granulocytes was observed in both groups, although it was significantly higher in the group without mask (P,<,0.05). The inhalable dust level was 0.94 (0.74 , 1.55) mg/m3 and respirable dust 0.56 (0.51,0.63) mg/m3. Conclusion Exposure to dust aerosols during the cleaning of the interior of a swine confinement building induces increased bronchial responsiveness and an acute inflammatory reaction in the upper airways. The use of a mask attenuated but did not abolish the inflammatory response. This suggests that gases and/or ultrafine particles in this environment could be important factors in the development of increased bronchial responsiveness. Am. J. Ind. Med. 41:250,258, 2002. © 2002 Wiley-Liss, Inc. [source]

Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stenting of saphenous vein grafts trial,

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2010
Neeraj Badhey MD
Abstract Background: We sought to evaluate the contemporary use of embolic protection devices (EPDs) in saphenous vein graft (SVG) interventions. Methods: We examined EPD use in the stenting of saphenous vein grafts (SOS) trial, in which 80 patients with 112 lesions in 88 SVGs were randomized to a bare metal stent (39 patients, 43 grafts, and 55 lesions) or paclitaxel-eluting stent (41 patients, 45 grafts, and 57 lesions). Results: An EPD was used in 60 of 112 lesions (54%). A Filterwire (Boston Scientific) was used in 70% of EPD-treated lesions, Spider (ev3, Plymouth, Minnesota) in 12%, Proxis (St. Jude, Minneapolis, Minnesota) in 12%, and Guardwire (Medtronic, Santa Rosa, California) in 7%. Of the remaining 52 lesions, an EPD was not utilized in 13 lesions (25%) because the lesion was near the distal anastomosis, in 14 lesions (27%) because of an ostial location, in one lesion (2%) because of small SVG size, in two in-stent restenosis lesions (4%) because of low distal embolization risk, and in 22 lesions (42%) because of operator's preference even though use of an EPD was feasible. Procedural success was achieved in 77 patients (96%); in one patient a Filterwire was entrapped requiring emergency coronary bypass graft surgery and two patients had acute stent thrombosis. Conclusion: In spite of their proven efficacy, EPDs were utilized in approximately half of SVG interventions in the SOS trial. Availability of a proximal protection device could allow protection of ,25% of unprotected lesions, yet operator discretion appears to be the major determinant of EPD use. © 2010 Wiley-Liss, Inc. [source]

Safety and effectiveness of the INVATEC MO.MA® proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial,

Percutaneous saphenous vein graft intervention with sequential embolic protection devices: Complementing lesion anatomy with embolic protection device

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2008
Parker Grow MD
Abstract Saphenous vein graft (SVG) percutaneous coronary intervention (PCI) carries unique technical challenges requiring the utilization of embolic protection devices (EPDs) to reduce the adverse events associated with distal embolization. Distal embolization is a common and almost ubiquitous consequence of SVG PCI due to the soft and friable nature of the SVG lesions. We describe a case of revascularizing a SVG with tandem stenoses employing the use of two different EPDs that complemented their respective lesion's location within the SVG. © 2008 Wiley-Liss, Inc. [source]

New distal embolic protection device the FiberNet® 3 dimensional filter: First carotid human study

Efficacy of Sirolimus-Eluting Stents as Compared to Paclitaxel-Eluting Stents for Saphenous Vein Graft Intervention

JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2006
Ph.D., WILLIAM W. CHU M.D.
Background: Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. In the contemporary drug-eluting stent (DES) era, the comparison of the efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) in SVG interventions is currently unknown. We conducted this retrospective analysis to investigate this issue. Methods and Results: Forty-seven patients with 50 SVG lesions who underwent standard percutaneous coronary intervention (PCI) with SES (SES group) were compared with 42 patients with 45 SVG lesions with PES (PES group). All patients received distal protection devices (DPDs) during the interventions. The in-hospital, 30-day, and 6-month clinical outcomes in both groups were compared. Baseline clinical and procedural characteristics were balanced between both groups except for the proximal and mid lesions. There were no deaths or Q-wave myocardial infarctions (MIs) during the index hospitalization. Non-Q-wave MI was similar between the two groups (SES vs PES, 4.3% vs 7.1%, P = 0.55). At 30-day and 6-month follow-ups, all the clinical outcomes were similar between the two groups. There was no subacute thrombosis (SAT) or late thrombosis in either group. The event-free survival at 6 months was also similar between both groups (P = 0.75). Conclusions: The use of DES in patients undergoing SVG intervention with a DPD is clinically safe and feasible. As compared to SES, PES have the same efficacy and clinical outcomes in SVG interventions up to 6 months. [source]

Flow-Reversal Device for Cerebral Protection During Carotid Artery Stenting,Acute and Long-Term Results

JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2006
KASJA RABE M.D.
Objective: Several types of cerebral (embolic) protection devices have been used in patients undergoing carotid stenting. This study assessed results achieved with a flow-reversal system. Method: Carotid stenting was performed in 56 patients (mean age, 68 ± 9 years). The mean percentage of stenosis was 77%± 10%. During the procedure, cerebral protection was achieved by means of balloon occlusion of the common and external carotid artery with use of a Parodi Anti-Emboli System. The patients' neurologic status was assessed during the intervention; at discharge; 1, 6, and 12 months after the procedure; and yearly thereafter. Results: The procedure was technically successful in all cases. One patient had a minor stroke 6 hours after the intervention. No major strokes, deaths, or myocardial infarctions occurred. During long-term follow-up (to 40 months), 2 patients died of a secondary complication after intracerebral bleeding and stroke and 1 died as a result of ventricular fibrillation. Restenosis did not exceed 50% of vessel diameter in any patient. Conclusions: The acute results indicate that proximal occlusion and flow reversal for cerebral protection during carotid stenting is a safe and effective method. The low restenosis and complication rate during long-term follow-up is in accordance with other series of carotid angioplasty and shows that the occlusion balloons do not cause any long-term side effects. [source]

Cohort study for the effect of chronic noise exposure on blood pressure among male workers in Busan, Korea

Exposure to hazardous workplace noise and use of hearing protection devices among US workers,NHANES, 1999,2004,,

AMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 5 2009
SangWoo Tak ScD
Abstract Background To estimate the prevalence of workplace noise exposure and use of hearing protection devices (HPDs) at noisy work, NIOSH analyzed 1999,2004 data from the National Health and Nutrition Examination Survey (NHANES). Methods A total of 9,275 currently employed workers aged ,16 years were included in the weighted analysis. Hazardous workplace noise exposure was defined as self-reported exposure to noise at their current job that was so loud that the respondent had to speak in a raised voice to be heard. Industry and occupation were determined based on the respondent's current place and type of work. Results Twenty-two million US workers (17%) reported exposure to hazardous workplace noise. The weighted prevalence of workplace noise exposure was highest for mining (76%, SE,=,7.0) followed by lumber/wood product manufacturing (55%, SE,=,2.5). High-risk occupations included repair and maintenance, motor vehicle operators, and construction trades. Overall, 34% of the estimated 22 million US workers reporting hazardous workplace exposure reported non-use of HPDs. The proportion of noise-exposed workers who reported non-use of HPDs was highest for healthcare and social services (73.7%, SE,=,8.1), followed by educational services (55.5%). Discussion Hearing loss prevention and intervention programs should be targeted at those industries and occupations identified to have a high prevalence of workplace noise exposure and those industries with the highest proportion of noise-exposed workers who reported non-use of HPDs. Am. J. Ind. Med. 52:358,371, 2009. Published 2009 Wiley-Liss, Inc. [source]

Comparison of the original and revised structures of the health promotion model in predicting construction workers' use of hearing protection,

RESEARCH IN NURSING & HEALTH, Issue 1 2006
David L. Ronis
Abstract Pender's health promotion model (HPM) has been revised, including substantial changes in its structure. The purpose of this study was to compare the fit and predictive usefulness of the original and revised structures of the HPM as applied to the use of hearing protection devices by 703 construction workers. Structural equation modeling was used to evaluate the two alternative forms of the model. Both forms of the model fit well, with the revised structure having a better fit and explaining more of the variance in use of hearing protection (28% vs. 18%). Results support the revised structure of the health promotion model (HPM) over the original form, and indicate it may be useful in understanding and predicting use of hearing protection. © 2006 Wiley Periodicals, Inc. Res Nurs Health 29:3,17, 2006 [source]

Guidelines for patient selection and performance of carotid artery stenting

ANZ JOURNAL OF SURGERY, Issue 6 2010
The Carotid Stenting Guidelines Committee
Abstract Background:, The endovascular treatment of carotid atherosclerosis with carotid artery stenting (CAS) remains controversial. Carotid endarterectomy remains the benchmark in terms of procedural mortality and morbidity. At present, there are no consensus Australasian guidelines for the safe performance of CAS. Methods:, We applied a modified Delphi consensus method of iterative consultation between the College representatives on the Carotid Stenting Guidelines Committee (CSGC). Results:, Selection of patients suitable for CAS needs careful consideration of clinical and patho-anatomical criteria and cannot be directly extrapolated from clinical indicators for carotid endarterectomy (CEA). Randomized controlled trials (including pooled analyses of results) comparing CAS with CEA for treatment of symptomatic stenosis have demonstrated that CAS is more hazardous than CEA. On current evidence, the CGSC therefore recommends that CAS should not be performed in the majority of patients requiring carotid revascularisation. The evidence for CAS in patients with symptomatic severe carotid stenosis who are considered medically high risk is weak, and there is currently no evidence to support CAS as a treatment for asymptomatic carotid stenosis. The use of distal protection devices during CAS remains controversial with increased risk of clinically silent stroke. The knowledge requirements for the safe performance of CAS include an understanding of the evidence base from randomized controlled trials, carotid and aortic arch anatomy and pathology, clinical stroke syndromes, the differing treatment options for stroke and carotid atherosclerosis, and recognition and management of periprocedural complications. It is critical that all patients being considered for a carotid intervention have adequate pre-procedural neuro-imaging and an independent, standardized neurological assessment before and after the procedure. Maintenance of proficiency in CAS requires active involvement in surgical/endovascular audit and continuing medical education programs. These standards should apply in the public and private health care settings. Conclusion:, These guidelines represent the consensus of an inter-collegiate committee in order to direct appropriate patient selection and the range of cognitive and technical requirements to perform CAS. Advances in endovascular technologies and the results of randomized controlled trials will guide future revisions of these guidelines. [source]

Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stenting of saphenous vein grafts trial,

Safety and effectiveness of the INVATEC MO.MA® proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial,

Selective use of embolic protection devices during saphenous vein grafts interventions: A single-center experience,

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2010
Shahar Lavi MD
Abstract Objectives: To report on outcomes with selective use of embolic protection devices (EPD) during percutaneous coronary intervention (PCI) to saphenous vein grafts (SVG). Background: PCI to SVG is associated with increased risk and the use of EPD is recommended in this setting. Methods: Angiographic and clinical outcomes were prospectively obtained from 534 consecutive patients who underwent PCI to SVG with or without EPD at a tertiary cardiac centre. Long-term outcomes were obtained by linkage to a provincial registry. Results: EPD, deployed in 198 of 373 SVGs (53%) suitable for deployment of a distal EPD, were used more often in ectatic (33% vs. 19%, P = 0.003), ulcerated (17% vs. 9%, P = 0.03), thrombotic (26% vs. 10%, P < 0.0001) vein grafts, with longer degenerated segments (P = 0.002), and in lesions involving the body of the graft (85% vs. 66%, P < 0.0001), and less with lesions involving the graft ostium (29% vs. 44%, P = 0.003). Patients suitable for but not receiving EPD tended to be more likely to have a periprocedural myocardial infarction. During 3 years of follow-up, 49% of the patients had a cardiovascular event. Cumulative mortality was 8.4%, 18.8% and 14.7% in patients unsuitable for distal EPD, suitable but without EPD, and with EPD (p = 0.11). Nonuse of EPD was an independent predictor of MACE at 3 years. (P = 0.02). Conclusions: Selective use of EPD is associated with low in-hospital cardiovascular event rates. Long-term outcomes are manifested by a high rate of events, especially in patients with SVG's suitable for but not receiving EPD. This suggests that routine use of distal EPD may be warranted in unselected patients with suitable SVG anatomy. © 2010 Wiley-Liss, Inc. [source]

"Over-and-under" pericardial covered stent with paclitaxel balloon in a saphenous vein graft,

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2010
Joanna J. Wykrzykowska MD
Abstract Treatment of vein graft disease remains a challenge in interventional cardiology because of the risk of embolization and no-reflow phenomenon. Currently available distal protection devices have their limitations. The PTFE-covered stents may be well suited for venous graft lesion treatment, but those available commercially to date have poor crossing profiles, and deliverability and high rates of restenosis. We report the first use of over-and-under pericardium-covered stent in combination with drug-eluting balloon to treat venous graft disease. © 2009 Wiley-Liss, Inc. [source]

Safety and efficacy of carotid stenting in the very elderly,

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2010
Arthur Grant MD
Abstract Background: Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA) in patients at high risk for complications from surgery. The very elderly (,80-year-old) are one subgroup of patients identified as being at increased risk for carotid surgery. However, there is concern that the very elderly are also at increased risk for complications of CAS. A stroke and death rate of 12% was reported in very elderly patients during the roll-in phase of Carotid Revascularization Endarterectomy versus Stent Trial (CREST). We are reporting on a large clinical series of CAS with independent neurological assessment in the very elderly. Methods: Between 1994 and 2008, a consecutive series of 418 CAS patients (,80-year-old) were treated at four high-volume centers with extensive CAS experience. Independent neurologic assessment was performed after CAS procedures. Thirty-day follow-up information was available in 389 patients. Results: The average age was 83.2 ± 2.8 years. Most patients were male (63.2%), and the target lesion carotid stenosis was asymptomatic in two-thirds (68.2%) of patients. The majority of patients treated with CAS had a history of coronary artery disease (74.4%), hypertension (87.8%), and dyslipidemia (71.1%). One third (30.1%) were diabetic and more than half (56.5%) were current or former smokers. Embolic protection devices (EPD) were used in 78.7% of cases with the CAS procedure being performed before EPD availability being the most common reason for not using them. The overall 30-day incidence of stroke and death was 2.8% (11/389). The cumulative incidence of major cardiovascular events (stroke, death, or myocardial infarction) during that time period was 3.3% (13/389). Conclusions: This large series of CAS with independent neurologic assessment is convincing evidence that the very elderly (,80 years) can safely undergo CAS with stroke and death rates comparable to younger patients. The key to obtaining these excellent results is that CAS be performed by high volume, experienced operators who exercise restraint regarding patient selection. © 2009 Wiley-Liss, Inc. [source]

Coronary no-reflow phenomenon: From the experimental laboratory to the cardiac catheterization laboratory,

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2008
Shereif H. Rezkalla MD
Abstract Coronary no-reflow occurs commonly during acute percutaneous coronary intervention, particularly in patients with acute myocardial infarction and those with degenerated vein grafts. It is associated with a guarded prognosis, and thus needs to be recognized and treated promptly. The pathophysiology originates during the ischemic phase and is characterized by localized and diffuse capillary swelling and arteriolar endothelial dysfunction. In addition, leukocytes become activated and are attracted to the lumen of the capillaries, exhibit diapedesis and may contribute to cellular and intracellular edema and clogging of vessels. At the moment of perfusion, the sudden rush of leukocytes and distal atheroemboli further contributes to impaired tissue perfusion. Shortening the door-to-balloon time, use of glycoprotein IIb/IIIa platelet receptor inhibitors and distal protection devices are predicted to limit the development of no-reflow during percutaneous interventions. Distal intracoronary injection of verapamil, nicardipine, adenosine, and nitroprusside may improve coronary flow in the majority of patients. Hemodynamic support of the patient may be needed in some cases until coronary flow improves. © 2008 Wiley-Liss, Inc. [source]

Percutaneous saphenous vein graft intervention with sequential embolic protection devices: Complementing lesion anatomy with embolic protection device

Carotid angioplasty and stenting in octogenarians: Is it safe?

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2008
M. Henry MD
Abstract Purpose: Elderly patients have a higher risk of complications in carotid endarterectomy. The aim of the study was to evaluate whether carotid artery stenting (CAS) performed in octogenarians also increases the procedure related risk. Methods: 870 patients (male 626) mean age 70.9 ± 9.3 years underwent 930 CAS for de novo lesions (n = 851) restenoses (n = 54) post radiation (n = 14) inflammatory arteritis (n = 9) post trauma aneurysms (n = 2). Indications for treatment: symptomatic carotid stenosis , 70% (n = 577) or asymptomatic stenosis , 80%. Patients were separated into two age groups: <80 years (749 patients, 806 CAS) and >80 years (121 patients, 124 CAS). 187 CAS performed without protection (N.P,) 6 patients >80 years, 743 with protection (NP+) (occlusion balloon: 334, filters: 404, reversal flow: 6) 118 patients >80 years. Data analysis included neurological complications, death and myocardial infarction (MI) rate at 30 days, anatomical particularities. Technical points will be described depending on the age of the patient. Results: Technical success 804/806 in patients <80 years, 123/124 in patients >80 years (NS). 30 days outcomes: in the patient group <80 years we observed 9 TIA (1.1%) 3 without NP (1.7%) 6 with NP (0.9%), 5 minor strokes (0.6%) 2 without NP (1.1%) 3 with NP (0.5%), 3 major strokes: 2 without NP (1.1%) 1 with NP (0.2%), 5 deaths (0.6%) 2 without NP (1.1%) 3 with NP (0.5%). Death/stroke/MI: 14 (1.8%) 6 without NP (3.3%), 8 with NP (1.3%). In the group >80 years, we observed 2 TIA (1.7%) 1 without NP 1 with NP (0.92%) 1 minor stroke without NP (17%) no major stroke, no death. Death/stroke/MI 1 without NP (17%). Conclusion: CAS can be performed in elderly patients without higher risk than in younger patients. But good indications, a meticulous technique, protection devices are mandatory and some technical points must be pointed out to avoid neurological complications and failures. © 2008 Wiley-Liss, Inc. [source]

Thrombectomy during PCI for acute myocardial infarction

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2008
Are the randomized controlled trial data relevant to the patients who really need this technique?
Abstract Macro and microembolization during percutaneous coronary intervention (PCI) in ST elevation acute myocardial infarction (STEAMI) is frequent and may result in obstruction of the microvascular network with subsequent reduction in efficacy of reperfusion. Numerous mechanistic studies have shown that the presence and size of the culprit thrombus is the most powerful predictor of incidence of embolization and slow flow/no reflow. Techniques that have been used to reduce the incidence of these events include thrombectomy devices and embolic protection devices. Although numerous prospective randomized clinical trials have been performed to evaluate the role of thrombectomy devices in patients with STEAMI, the results of these trials are conflicting and they speak to both sides of the controversy. The Achilles heal of the majority of these trials is the premise that thrombectomy devices should be routinely used in all patients presenting with STEAMI even irrespective of the presence and size of the thrombus. Such a hypothesis is naively optimistic and it ignores the basic knowledge available to us regarding the relationship between thrombus burden and embolization. Nonetheless, clinicians are faced every day with the reality of making difficult decisions on how to best treat patients presenting with STEAMI and large thrombus burden. The current available "evidence-based medicine" cannot and should not be generalized to these patients because only a minority of these patients was included in these randomized clinical trials. In these patients, thrombectomy devices should be strongly considered as an integral part of the armamentarium available to reduce thrombus burden prior to definitive treatment. Whether a future clinical trial will provide a definitive answer in terms of clinical outcome difference is doubtful because such a trial will need to include large number of selected patients with STEAMI who both have large amount of myocardium at jeopardy and large thrombus burden, a difficult and possibly undoable study. © 2008 Wiley-Liss, Inc. [source]

Inadvertent dilation of a saphenous vein graft stenosis by the PercuSurge GuardWire distal protection balloon

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2003
Naveen Sharma MD
Abstract Distal embolization protection devices are fast becoming an integral part of percutaneous vein graft interventions. The distal elastomeric balloon of the PercuSurge GuardWire system is supposed to be atraumatic to the vessel wall. We report the inadvertent dilation of a moderate distal stenosis at the site of GuardWire balloon inflation while intervening on a critical proximal saphenous vein graft stenosis. This case illustrates that plaque compression and potential vessel wall trauma might occur during the inflation of the PercuSurge GuardWire distal protection balloon. Cathet Cardiovasc Intervent 2003;59:346,349. © 2003 Wiley-Liss, Inc. [source]

Initial clinical experience with distal protection using the FilterWire in patients undergoing coronary artery and saphenous vein graft percutaneous intervention

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2002
Jeffrey J. Popma MD
Abstract Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and native coronary arteries may be associated with embolization of particulate debris into the distal microcirculation. The FilterWire uses a polyurethane filter bag contained on a radiopaque loop to trap embolic debris during native vessel and SVG intervention. The objectives of this study were to assess the feasibility and safety of the FilterWire during PCI and to examine the size and content of the particulate debris captured during SVG and native vessel intervention. Early angiographic, in-hospital, and 30-day clinical outcomes were reviewed in 35 patients with 36 lesions treated with the FilterWire during PCI. Lesions were located in 22 (61%) native coronary arteries and in 14 (39%) SVGs. Multivessel coronary artery disease was present in 75% of patients. Lesions were complex (ACC/AHA complexity B2 or C) in 81% of cases. The FilterWire was successfully delivered and deployed distal to the site of coronary intervention in 92% of lesions, including 95% of native vessels and 82% of SVG lesions. Embolic debris was entrapped in 82% of these cases. The average particulate debris had a mean major axis of 490 ,m (range, 45,3,302 ,m) and minor axis of 226 ,m (range, 33,1,677 ,m). Although reduced flow was common (36.1%) when the FilterWire was in place, there were no sustained episodes of abrupt closure and only one (2.8%) patient developed sustained no-reflow after FilterWire removal. Distal branch vessel embolization was found in four (11.1%) cases. Major adverse cardiac events occurred in 5 (14%) of 35 patients treated with the device, although 2 of these patients were evolving an acute myocardial infarction at the time of the procedure; in patients meeting the prospectively defined inclusion criteria, the major adverse cardiac event was 6%. These results suggest that the FilterWire is a feasible and safe method of collecting particulate debris released during SVG and native vessel coronary intervention. Its benefit over conventional therapy and other distal protection devices is currently under study. Cathet Cardiovasc Intervent 2002;57:125,134. © 2002 Wiley-Liss, Inc. [source]

Laser-facilitated thrombectomy: A new therapeutic option for treatment of thrombus-laden coronary lesions

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2002
Johannes B. Dahm MD
Abstract To overcome the adverse complications of balloon angioplasty in thrombus burden lesions (i.e., distal embolization, platelet activation, no-reflow phenomenon with persistent myocardial hypoxemia), mechanical removal of the thrombus or distal embolization protection devices is required. Pulsed ultraviolet excimer laser light at 308 nm can vaporize thrombus and suppress platelet aggregation. Clinical experience has already shown its efficacy in acute ischemic-thrombotic acute coronary syndromes. Unlike other thrombectomy devices, a 308 nm excimer laser can ablate thrombi as well as the underlying plaque, speed up thrombus clearing, and enhance thrombolytic and GP IIb/IIIa activity. It can also be employed in patients with contraindications for systemic thrombolytic agents or GP IIb/IIIa antagonists. Our report covers clinical data and technical aspects concerning three patients with acute myocardial infarction who presented with a large thrombus burden. After successful laser-transmitted vaporization of the thrombus mass in these patients, the remaining thrombus burden was evacuated, and normal antegrade coronary flow was successfully restored. This approach can be useful for selective patients with acute coronary syndromes. Cathet Cardiovasc Intervent 2002;56:365,372. © 2002 Wiley-Liss, Inc. [source]