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Particulate and histopathologic examination of atherosclerotic material collected during carotid artery stenting is presented, illustrating the limitations of current knowledge regarding the use of distal protection devices (DPD) during this novel vascular intervention.
OBJECTIVE: Transfemoral carotid artery stenting (CAS), with or without distal protection, is associated with risk for cerebral and peripheral embolism and access site complications. To establish cerebral protection before crossing the carotid lesion and to avert transfemoral access complications, the present study was undertaken to evaluate a transcervical approach for CAS with carotid flow reversal for cerebral protection. METHODS: Fifty patients underwent CAS through a transcervical approach. All patients with symptoms had greater than 60% internal carotid artery (ICA) stenosis, and all patients without symptoms had greater than 80% ICA stenosis. Twenty-one patients (42%) had symptomatic disease or ipsilateral stroke, and 8 patients (16%) had contralateral stroke. Four patients (8%) had recurrent stenosis, 7 patients (14%) had contralateral ICA occlusion, and 1 patient (2%) had undergone previous neck radiation. Twenty-seven procedures (54%) were performed with local anesthesia, and 23 (46%) with general anesthesia. Using a cervical cutdown, flow was reversed in the ICA by occluding the common carotid artery and establishing a carotid-jugular vein fistula. Pre-dilation was selective, and 8-mm to 10-mm self-expanding stents were deployed and post-dilated with 5-mm to 6-mm balloons in all cases. RESULTS: The procedure was technically successful in all patients, without significant residual stenoses. No strokes or deaths occurred. There was 1 wound complication (2%). All patients were discharged within 2 days of surgery. Mean flow reversal time was 21.4 minutes (range, 9-50 minutes). Carotid flow reversal was not tolerated in 2 patients (4%). Early in the experience, carotid flow reversal was not possible in 1 patient, and there were 1 major and 3 minor common carotid artery dissections, which resolved after stent placement. One intraoperative transient ischemic attack (2%) occurred in 1 patient in whom carotid flow was not reversed, and 1 patient with a contralateral ICA occlusion had a contralateral transient ischemic attack. At 1 to 12 months of follow-up, all patients remained asymptomatic, and all but 1 stent remained patent. CONCLUSION: Transcervical CAS with carotid flow reversal is feasible and safe. It can be done with the patient under local anesthesia, averts the complications of the transfemoral approach, and eliminates the increased complexity and cost of cerebral protection devices. Transcervical CAS is feasible when the transfemoral route is impossible or contraindicated, and may be the procedure of choice in a subset of patients in whom carotid stenting is indicated.
PURPOSE: Carotid angioplasty and stenting (CAS) is being evaluated as an alternative to carotid endarterectomy (CEA) for treatment of severe carotid artery stenosis. Because CAS does not require general anesthesia and is less traumatic, it might be especially advantageous in older patients, but data comparing these 2 treatment methods in older patients are scarce. METHODS: The periprocedural complication rates in 53 patients aged 75 years or older who had undergone protected CAS between June 2001 and April 2004 were compared with those in a group of 110 patients aged 75 years or older who had undergone CEA between January 1997 and December 2001, before widespread introduction of CAS procedures at our institution. All patients were evaluated by a neurologist both before and after surgery. According to the criteria set forth by the large trials the occurrence of minor, major, or fatal stroke, and myocardial infarction within 30 days was determined. RESULTS: The demographic characteristics and indications for an intervention were similar in both treatment groups. Thirty patients (57%) in the CAS group had symptomatic carotid stenosis, compared with 69 patients (63%) in the CEA group. In neither group was there any fatal stroke or myocardial infarction. The 30-day stroke rate was significantly higher in the CAS group (4 minor, 2 major strokes; 11.3%) than in the CEA group (no minor, 2 major strokes; 1.8%; P < .05). Although the 30-day major stroke rate between CAS and CEA groups was comparable (3.8% vs 1.8%; P = 0.6), this effect was mainly attributable to a significantly higher rate of minor stroke in the CAS group (7.5% vs 0%; P < .05). CONCLUSION: Despite the use of cerebral protection devices the neurologic complication rate in patients aged 75 years and older associated with CAS was significantly higher than with CEA performed by highly skilled surgeons at our academic institution. Although this finding is mainly based on a significantly higher rate of minor stroke in the CAS group, the common practice of preferentially submitting older patients to CAS is questionable, and should be abandoned until the results of further randomized trials are available.
BACKGROUND: Carotid artery balloon angioplasty and stenting (CBAS) is emerging as an acceptable alternative to carotid endarterectomy in selected high-risk patients. Conversely, patients with pre-existing renal impairment, diabetes, or both may be harmed by the nephrotoxic contrast agents required during CBAS. We attempted to limit or eliminate the use of contrast material during CBAS. METHODS: Eighteen patients with severe carotid stenoses (>70%) underwent CBAS at our institution over the last 12 months with duplex scan-assisted CBAS. Of these, 12 were primary procedures, and 6 were performed for carotid re-stenosis. Fourteen patients (78%) were neurologically asymptomatic. The average age of these patients was 75 +/- 11 years (range, 44-92 years). Hypertension, chronic renal insufficiency (serum creatinine level > or =1.5 mg/dL), coronary artery disease, diabetes, and smoking were present in 89%, 67%, 59%, 33%, and 28% of patients, respectively. Preoperative duplex carotid mapping was performed in all cases. All procedures were performed with patients under local anesthesia and light sedation. RESULTS: An ATL HDI 5000 scanner with the SonoCT feature was used. The common femoral artery was cannulated with a single-entry needle under direct ultrasound visualization. Fluoroscopy was used to assist passage of the guidewire into the aorta and the common carotid artery. In only four cases (22%) was an aortic arch angiogram obtained. Selective catheterization of the internal and external carotid arteries was performed under ultrasound guidance. The distal cerebral protection device (17 cases) was placed under fluoroscopic guidance. Balloon width and length were chosen according to ultrasound measurements. Balloon and stent deployment were successfully achieved with ultrasound guidance alone in all cases. Appropriate stent apposition and resolution of the stenosis was confirmed by duplex scanning in all cases. Five patients (28%) were noted to have low (<100 mL/min) internal carotid artery volume flow after stent deployment (range, 20-88 mL/min; mean +/- SD, 50 +/- 25 mL/min). The internal carotid artery volume flow increased immediately after Filterwire retrieval in all cases and ranged from 136 to 400 mL/min (mean, 245 +/- 107 mL/min). This increase was statistically significant ( P < .02). No ipsilateral strokes or deaths occurred during follow-up from 1 to 12 months (mean follow-up, 5 months). CONCLUSIONS: Duplex scan-assisted CBAS is feasible and may reduce the need for intra-arterial contrast injection in selected patients deemed at high risk for renal failure from nephrotoxic contrast material. Additional advantages include direct visualization of the puncture site, precise position of the balloon and stent, and B-mode and hemodynamic confirmation of the adequacy of the technique.
OBJECTIVE: Current clinical trials evaluating carotid stenting have focused on high-risk patients and may not reflect the broad population of patients with carotid stenosis who undergo treatment to prevent stroke. The Carotid Revascularization Using Endarterectomy or Stenting Systems (CaRESS) phase I study is a multicenter, prospective, nonrandomized trial designed to address the question of whether carotid stenting (CAS) with cerebral protection is comparable to carotid endarterectomy (CEA) in patients with symptomatic and asymptomatic carotid stenosis. METHODS: Patients with symptomatic (with >50% stenosis) or asymptomatic (with >75% stenosis) carotid stenosis were entered into the study in a 2:1 ratio of carotid stent and GuardWire Plus distal protection device. This unique trial model was developed through collaboration with the International Society of Endovascular Specialists, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the National Institutes of Health, and industry representatives. The primary end points included death and stroke at 30 days and a composite 1-year end point of death, stroke, or myocardial infarction (MI) from 0 to 30 days and death or stroke from 31 days to 1 year. The secondary end points included residual stenosis, restenosis, repeat angiography, and carotid revascularization at 30 days and 1 year and quality-of-life changes at 1 year. RESULTS: A total of 397 patients (254 CEA and 143 CAS) were enrolled in the study: 32% were symptomatic and 68% were asymptomatic. There were no significant differences in patient characteristics, symptoms, or surgical risk profiles between groups at baseline. Kaplan-Meier analysis revealed no significant differences in combined death/stroke rates at 30 days (3.6% CEA vs 2.1% CAS) or at 1 year (13.6% CEA vs 10.0% CAS). Similarly, there was no significant difference in the combined end point of death, stroke, or MI at 30 days (4.4% CEA vs 2.1% CAS) or at 1 year (14.3% CEA vs 10.9% CAS). There were no significant differences between CEA and CAS in the secondary end points of residual stenosis (0% CEA vs 0.9% CAS), restenosis (3.6% CEA vs 6.3% CAS), repeat angiography (2.1% CEA vs 3.6% CAS), carotid revascularization (1.0% CEA vs 1.8% CAS), or change in quality of life (-1.56 points CEA vs -4.22 points CAS). CONCLUSIONS: The CaRESS phase I study suggests that the 30-day and 1-year risk of death, stroke, or MI with CAS is equivalent to that with CEA in symptomatic and asymptomatic patients with carotid stenosis.
This Clinical Update summarizes the results of larger case series, industry-sponsored registries, and randomized trials of carotid artery stenting (CAS). In >20 case series that studied >24,000 patients undergoing CAS, 51% of patients were symptomatic, most procedures (97%) resulted in successful stent deployment, and 30-day stroke rates varied from 1% to 8%, with a trend toward lower rates as experience and embolic protection device (EPD) use increased. In 12 industry-sponsored registries (none were published in peer-reviewed journals), 30-day stroke rates varied from 2% to 7%, and 30-day combined adverse events, including stroke, death, and myocardial infarction, were 3% to 9%. More than 12 randomized trials comparing CAS and carotid endarterectomy (CEA) have been initiated since 1998. Results have varied over time, depending on the population studied and the technology used. However, the largest and most recent results of the completed SAPPHIRE trial in high-risk patients undergoing CAS with the use of EPDs demonstrated that CAS is at least not inferior to CEA, with a 1-year combined adverse event rate of 12% for CAS and 20% for CEA (P = .05). Other ongoing trials will address not only whether CAS could be superior to CEA in high-risk patients but also, more importantly, whether CAS is beneficial in other subgroups, such as low-risk and asymptomatic patients.
BACKGROUND: The role of carotid angioplasty and stenting (CAS) in the treatment of asymptomatic patients with carotid disease remains controversial. The purpose of this report is to compare outcomes in asymptomatic patients treated with CAS and carotid endarterectomy (CEA). This was the initial experience performing CAS for most of the surgeons. For comparison, we also report our outcomes in standard-risk patients treated concurrently with CEA during the same period of time. METHODS: A retrospective, nonrandomized review of asymptomatic patients undergoing CEA or CAS at Washington University Medical Center in St. Louis was done. Patients with >70% asymptomatic carotid stenosis treated between September 2003 and April 2005 were identified. CEA was the first therapeutic consideration in all patients. CAS was reserved for high-risk patients. Thirty-day outcomes of stroke or death were recorded. During this time interval, 248 patients were treated including with 93 CAS and with 145 CEA. Symptomatic or clinically detected adverse outcomes such as myocardial infarction (MI), arrhythmia, renal failure, or pulmonary complications were noted but were not the primary end points of this review. This study addresses only the periprocedural outcomes of CEA and CAS in asymptomatic patients. No data >30-day follow-up are included. RESULTS: During this period, 93 CAS and 145 CEA procedures were done in asymptomatic patients. Patient characteristics in both groups were similar. Carotid protection devices were used in 91.4% of CAS patients. The results in the CAS group showed one death (1.1%) and one stroke (1.1%). In the CEA group, three strokes occurred (2.1%, P = 0.9999), one associated with death (0.7%, P = 0.9999). The CAS group had 1.34 +/- 0.83 risk factors vs 0.39 +/- 0.58 in the CEA group (P < .0001). Median CAS and CEA length of stay was 1 day. CONCLUSIONS: CAS for asymptomatic carotid stenosis demonstrated equivalent outcomes compared with CEA, despite CAS being reserved for use in a disadvantaged subset of high-risk patients owing to anatomic risk factors or medical comorbidities. These results suggest CAS should be considered a reasonable treatment option in the high-risk but asymptomatic patient. Enthusiasm for CAS should be tempered by the recognition that long-term outcomes in CAS-treated asymptomatic patients remain unknown.
The recent advances in stent technology and renal endovascular management have provided a technically reproducible method of percutaneously treating atherosclerotic renal artery stenosis (RAS). In many centers, this has resulted in endovascular management being the primary therapy for atherosclerotic RAS. Although still controversial, it appears that endovascular management of RAS by primay stent deployment provides better blood pressure control than that afforded by best medical management. The impact on renal function is less than that found for hypertension, but there is evidence to suggest that the use of protection devices and primary stenting may enhance renal function outcomes. Whether the ultimate benefit of enhanced survival follows remains an important question and should be the subject of future prospective studies.
Atherosclerotic plaque rupture is a key event in the pathogenesis of acute coronary syndromes and during coronary interventions. Atherosclerotic plaque rupture does not always result in complete thrombotic occlusion of the entire epicardial coronary artery with subsequent acute myocardial infarction, but may in milder forms result in the embolization of atherosclerotic and thrombotic debris into the coronary microcirculation. This review summarizes the available morphological evidence for coronary microembolization in patients who died from coronary artery disease, most notably from sudden death. Then the experimental pathophysiology of coronary microembolization in animal models of acute coronary syndromes is detailed. Finally, the review presents the available clinical evidence for coronary microembolization in patients, highlights its key features--arrhythmias, contractile dysfunction, microinfarcts and reduced coronary reserve--, compares these features to those of the experimental model and addresses its prevention by mechanical protection devices and glycoprotein IIb/IIIa antagonism.
Asymptomatic carotid lesions treatment techniques have not greatly evolved over the last 15 years. Although there seems to be a consensus to apply only medical treatment for lesions less than 60-70%, there is still debate with regards to patient cohort suffering from high-grade stenosis (between 70% and 90%). Very high-grade lesions seem, however, to benefit from surgery. The most significant improvements come from Duplex scan and non-invasive radiology (TDM with injection and MRI) allowing a more accurate stenosis measurement and above all, detection of potential high-risk lesion (inhomogeneous plaque, haematoma under plaque). Medical treatment as well as risk factor balancing is always complementary to surgery. The most significant improvement is probably the anaesthesiology technique with the wide use of local analgesia allowing an ideal cerebral protection. The various surgical techniques: simple endarterectomy or with patch, eversion endarterectomy, venous or prosthetic by-pass show no significant difference either in the immediate results or in restenosis. These techniques enabled a mortality rate of less than 1% (due to a better cardiac check-up) and morbidity rate of less than 2%. The development of percutaneous transluminal angioplasty with stenting (secured by protection devices) has made indications slightly more difficult by adding a non-validated technique which has not proven its merits compared to surgery. One of the dangers from this technique is that it may lead to abusive indications. In summary, surgery is the most adequate treatment for high-grade asymptomatic carotid lesions after a precise locoregional check-up, especially a cardiac one. Medico legal implications in this asymptomatic situation call for precise and honest patient information.
OBJECTIVE: To assess the sustainable benefits of a professional, multidisciplinary training program for patients with rheumatoid arthritis. DESIGN: Two studies with different observation periods. Study I was a prospective, randomized trial for 1 year. Study II was a noncontrolled observation over 5 years. SETTING: The 9-day program for eight patient groups encompassed a multidisciplinary cooperation between rheumatologists, orthopedists, physicotherapists, psychologists and social workers. PATIENTS: Sixty-eight consecutive patients with rheumatoid arthritis participated in an arthritis training program either immediately after enrollment in the program or after 1 year. INTERVENTIONS: The program covered the following fields: pathogenesis of rheumatoid arthritis, drug therapy, physicotherapy, practical exercise in remedial gymnastics, use of joint protection devices, orthopedic perspectives, psychological counseling, dietetics, information about unproven cures and social assistance. MAIN OUTCOME MEASURES: Clinical outcome was assessed by self-report questionnaires: (1) Stanford Health Assessment Questionnaire, (2) Freiburg Questionnaire of Coping with Illness, (3) Beck Depression Inventory, and (4) a 21-point scale to evaluate cognitive-behavioral and environmental impact. RESULTS: A significant and persistent improvement of all investigated parameters was demonstrated in the 1-year controlled trial. Between the end-point of the 1-year study and the 5-year evaluation, this improvement increased even more for functional status and coping with illness, whereas depression returned to baseline values. These effects were seen even without reinforcement of the training. CONCLUSION: A professional, multidisciplinary approach to educate patients with rheumatoid arthritis leads to a significant and sustained improvement of the clinical outcome and is an approach that should be established as a part of conventional therapy.
The loss of viability of isolated rat hepatocytes exposed to either 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) or its toxic metabolite 1-methyl-4-phenylpyridinium ion (MPP+) was prevented by addition of fructose to the incubation medium. This protection was dependent on fructose concentration, being complete at 10 mM. Addition of fructose dramatically delayed MPTP- and MPP+-induced depletion of ATP and was accompanied by a significant accumulation of lactate, indicating the occurrence of enhanced glycolytic production of ATP. Glucose was much less effective against MPTP and MPP+ toxicity, probably because it is a relatively poor substrate for glycolysis in liver cells. We conclude that depletion of ATP is a critical event in MPTP cytotoxicity in our in vitro model system, and that the use of alternative sources of ATP production may represent an important protective device against the effects of this toxic agent.
OBJECTIVE: To determine the incidence of remote testicular trauma and of possible related permanent hormonal and seminal changes in infertile men. DESIGN: Retrospective clinical study of hormonal and seminal parameters in a subpopulation of infertile men. SETTING: Andrology Clinic in an academic research environment. PARTICIPANTS: Infertile men, with and without history of remote testicular trauma, and fertile volunteers. MAIN OUTCOME MEASURES: Percentage of infertile men with history of blunt testicular trauma, concentrations of reproductive hormones, and semen parameters. RESULTS: Significant remote blunt testicular trauma was reported by 16.8% of infertile men. This had occurred 2 to 17 years (mean, 16.4 years) before evaluation, mostly with contact sports at adolescent age. Estradiol concentrations after testicular trauma were 19% and 25% higher than in infertile men without history of testicular injury and in fertile controls. Elevated E2 levels did not correlate with T. Infertile men with and without history of testicular trauma showed changes in seminal parameters. CONCLUSION: The incidence of remote blunt testicular trauma in infertile men is unexpectedly high. After injury, FSH-stimulated aromatization of T may increase testicular E2 production, interfere with spermatogenesis, and cause infertility. Consistent use of protective devices in contact sports is recommended.
D-Amino acid containing peptides have been found to be responsible for sawfly larvae poisoning in many parts of the world. These compounds, unique in the animal kingdom, were isolated from three different species of sawfly indigenous to Australia, Denmark and South America. The octapeptide, lophyrotomin, is the major toxin in the Australian and Danish species and is present in small amounts in the South American sawfly. Pergidin, the main toxin in the South American sawfly, is a heptapeptide containing a phosphoseryl residue. This, as far as we are aware, is the first example of such a peptide to be isolated from an animal source. Small amounts of pergidin have been found in the other two species. All available evidence suggests that both peptides are biosynthesised 'de novo' possibly as a protective device, however it cannot be excluded that microorganisms may be responsible. These compounds are stable to enzymatic breakdown because of their configuration and their strong chemical bonding and lipophilic character provide a potential for residues to remain in the host animal and cause significant changes.
OBJECTIVES: To assess patient-reported prostate cancer-specific quality of life 2 and 3 years after radiotherapy to the prostate in a randomized dose-escalation trial of 70 versus 78 Gy conducted from 1993 to 1998. METHODS: Two years after completing radiotherapy, a questionnaire that assessed bladder, rectal, and sexual function was sent to 301 patients in the study. Three years after treatment, a second questionnaire was sent to the 175 patients with adequate follow-up. RESULTS: Three years after radiotherapy, urinary incontinence was reported by 35% of patients, but only 6% required the use of a pad or other protective device. Patients reported increased leakage with a full bladder (urge incontinence) between the 2 and 3-year questionnaires (42% versus 50%; P = 0.03). At 3 years, 33% of patients reported rectal bleeding compared with 47% at 2 years (P = 0.006). Patients in the 78-Gy arm reported more frequent bowel movements at 3 years and less change in bowel function at 2 years than patients in the 70-Gy arm. Before radiotherapy, 84% of patients reported erections adequate for intercourse at least a few times during the previous year. After 2 and 3 years, this had decreased to 49% and 41%, respectively (P <0.02). CONCLUSIONS: By patient-reported questionnaire, 78 Gy produced an increase in bowel movement frequency and no increase in bladder or sexual side effects at 3 years compared with 70 Gy. Comparing the results 2 and 3 years after radiotherapy, the symptoms of rectal bleeding had improved, erectile function had decreased, and urinary urge incontinence had increased.
Approximately one third of laboratory animal workers have occupational allergy to animal danders, and a third of these have symptomatic asthma. Sensitization generally occurs with the first 3 years of employment, and risk factors include atopic background, as well as job description as it relates to the intensity of exposure. A symptomatic worker can reduce allergen exposure with personal protective devices. A laboratory can further reduce exposure with generally available equipment, such as laminar flow caging, and procedures, such as frequent wet washing of vivaria and careful maintenance of ventilation systems. It is advisable to institute periodic medical screening of all laboratory animal workers with questionnaires and allergy skin testing in addition to providing them with training programs to reduce personal exposure.
Atherosclerosis is a process in which lipid and factors are mixed. When LDL are oxydized, they are catabolized by the macrophage's pathway, leading to foam cells which constitute the fatty streak, the earliest lesion in atherogenesis, and they have cytotoxic, chemotactic effects. Many protective devices against free radicals and oxydation mechanisms exist, particularly antioxydant vitamins and other natural dietary antioxydants. After a brief recall of their mechanisms, epidemiological, experimental and clinical data are reviewed. To day it seems necessary to take into consideration these factors in prevention and therapeutic of atherosclerosis and dylipidaemia. Many inquiries keep going, particularly about susceptible of LDL to oxydation. One is waiting for intervention surveys in order to conclude about nutritional and medical treatments.
PURPOSE: In a retrospective analysis, we evaluated the Gustave-Roussy Institute's experience of locoregional control, survival, and complications of low-dose rate brachytherapy for carcinoma of the floor of the mouth. METHODS AND MATERIALS: Between 1970 and 1985, 160 patients with previously untreated carcinoma of the floor of the mouth received interstitial brachytherapy as definitive treatment. Of the 160 patients, 79 (49%) had T1 and 81 (51%) had T2 lesions, and 127 (79%) had N0 and 33 (21%) had N1; 84% of tumors arose from the anterior floor of the mouth. Brachytherapy was performed with 192Ir wires, according to the Paris system rules, followed by neck dissection (T2 or N1) or follow-up (T1N0). RESULTS: With a follow-up period of 9-19 years, the observed survival rates were 89% at 2 years and 76% at 5 years, and the local control rates were 93% in T1 and 88% in T2 tumors. A low rate of distant metastases was noticed (5%); 31% of patients developed a second primary cancer. Severe mucosal necrosis was observed in <10% of patients. Any grade of bone necrosis was seen in 18% of cases (only 2.5% had G3 necrosis). This complication occurred more frequently in patients with poor dental status and in those treated without dental protection during implantation (p <0.001). CONCLUSION: Radical brachytherapy offers excellent local control (89%) and an acceptable rate of complications (<10% severe necrosis) that may be significantly decreased with dental care and the use of protective devices. The high incidence of second malignancies remains a major concern in these patients.