Initial experience with larger laser sheaths for the removal of transvenous pacemaker and implantable defibrillator leads.
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BACKGROUND: In a previous randomized trial, the 12F laser sheath removed pacing leads via the implant vein more successfully than traditional mechanical tools alone. Two larger sizes of laser sheath, the 14F and 16F models, were developed to extract defibrillator leads and large-diameter pacing leads implanted for the chronic. These devices use pulsed ultraviolet laser light to core though fibrotic tissue grown over the lead body to free the lead from the vasculature. A mandatory prospective registry studied the safety and effectiveness profiles of the larger laser sheaths vis-a-vis the 12F laser sheath. METHODS AND RESULTS: In this study, 863 patients underwent extraction of 1285 leads at 52 sites. Patients treated with the 14F device tended to have older leads than the 12F population; the 16F population, which comprised mostly defibrillator patients, were younger, had younger leads, and were more often male than the 12F population. Clinical success (extracting the entire lead or the lead body minus the distal electrode) was observed in 91% to 92% of cases for all device sizes. The overall complication rate was 3.6%, with 0.8% perioperative mortality. Incidence of complications was independent of laser sheath size. CONCLUSIONS: The 14F and 16F laser sheaths offer an extraction option for larger long-term transvenous pacemaker and defibrillator leads that is as safe and effective as the 12F laser sheath. (+info)
Health and safety practices among farmers and other workers: a needs assessment.
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The development of appropriate health and safety interventions for farmers and agri-workers is important world-wide but data on present practices and attitudes to change are lacking. A representative quota sample (n = 1,938) of the Irish population was surveyed on lifestyle practices and workplace risk assessment and control measures, in relation to chemical exposure, manual handling and machinery. Focus group discussions were conducted also with 47 representatives of national farming organizations. As compared with the general workforce, farmers had a significantly (p < 0.01) lower level of assessment of risk hazards associated with manual handling and machinery. Both farmers and employees in workplaces with less than 20 employees reported a significantly lower level of safety training. Male farmers had a particularly negative health profile with only 18% reporting regular dental checks, 26% practising skin protection and 29% taking regular exercise. Discussions indicated that barriers to change included low perceived susceptibility, lack of time and resources. Mental health issues were particularly highlighted. We conclude farmers differ significantly in many instances from the rest of the workforce in regard to occupational health and safety issues and specific interventions in key areas are required for the agri-sector. (+info)
Utility, safety, and accuracy of intraoperative angiography in the surgical treatment of aneurysms and arteriovenous malformations.
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BACKGROUND AND PURPOSE: The role of intraoperative angiography in the treatment of neurovascular lesions has remained extremely controversial. We retrospectively reviewed the utility, safety, and accuracy of intraoperative angiography to ascertain its effect on the treatment of patients with neurovascular lesions. METHODS: We reviewed the results of intraoperative angiography in 91 patients treated surgically for intracranial aneurysms and in 98 patients treated surgically for arteriovenous malformations (AVMs). All treatments were completed at two major teaching hospitals between October 1987 and March 1995. RESULTS: The initial angiographic findings caused the surgical procedure to be modified in 24 (26%) of the patients with aneurysms and in 28 (29%) of the patients with AVMs. Analysis of the final angiographic sequence showed residual lesions in nine (10%) of the aneurysm cases and in eight (8%) of the AVM cases. The imperfect angiographic results were deemed acceptable because there was either evidence of collateral flow when the parent vessel was occluded or the risk of further surgical modification was considered more dangerous than the abnormality itself. Seven patients suffered complications, of which only one had permanent neurologic sequelae: a CNS complication rate of 0.5%. Comparison of the intraoperative angiographic findings with those of postoperative studies revealed four false-negative results (5.2%). CONCLUSION: Intraoperative angiography is an important component in the treatment of patients with intracranial vascular lesions. It is effective and can be carried out with low risk in this patient population. (+info)
Total laparoscopic hysterectomy using the harmonic scalpel.
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Total laparoscopic hysterectomy (TLH) is the complete hysterectomy including transection of the uterine vessels and opening/closure of the vaginal vault performed laparoscopically. This procedure can be performed as an alternative to total abdominal hysterectomy in many cases. We previously found use of the harmonic scalpel to be extremely helpful in performing laparoscopically assisted vaginal hysterectomies. In this series, the harmonic scalpel was used to facilitate performing TLH. Our experience has shown this can be performed without major complications in a cost-effective manner. (+info)
The Food and Drug Administration and atrial defibrillation devices.
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CONTEXT: Atrial fibrillation is a common arrhythmia. It leads to significant morbidity and mortality, primarily from the increased incidence of stroke. The implantable atrial defibrillator, a new therapeutic option for the management of atrial fibrillation, is currently undergoing Food and Drug Administration (FDA) scrutiny for approval to market in the United States. DATA SOURCES: A review of the basic epidemiology of atrial fibrillation, as well as the current status of accepted treatment options in light of the development of the implantable atrial defibrillator, was conducted. A literature search using the terms atrial fibrillation, implantable defibrillator, Food and Drug Administration, medical devices, and medical device regulatory law was conducted using the MEDLINE and Current Contents databases. RESULTS: Currently, there is no consensus on the optimal treatment of atrial fibrillation. Despite the lack of definitive studies showing overall benefit associated with maintaining sinus rhythm in patients in atrial fibrillation, the implantable atrial defibrillator may soon reach the general market. We examine the FDA process for the evaluation of this new medical device and discuss implications for the patient, physician, industry, and health insurers. CONCLUSIONS: Current FDA approval processes for new devices are a compromise between (a) the needs for expediency and encouraging innovation by the medical device industry and (b) the need to ensure that new devices will contribute to improved patient outcomes. We suggest alternative FDA-approval processes that address these issues. (+info)
Totally implantable venous access ports systems for patients receiving chemotherapy for solid tissue malignancies: A randomized controlled clinical trial examining the safety, efficacy, costs, and impact on quality of life.
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PURPOSE: To examine the safety, efficacy, costs, and impact on quality of life of venous access ports implanted at the outset of a course of intravenous cancer chemotherapy. PATIENTS AND METHODS: Adults beginning a course of intravenous chemotherapy at two university-affiliated hospitals were randomly allocated to have venous access using a surgically implanted venous access port (Port-a-Cath; Pharmacia, Canada Inc, Montreal, Quebec, Canada) or using standard peripheral venous access. All accesses were documented by number, route, purpose, and procedure duration. Outcome measurements included port complications, access strategy failure, access-related anxiety and pain, quality of life (Functional Living Index-Cancer [FLI-C]), and costs. RESULTS: Port complication rates were low (0.23/1,000 days). Failure occurred in two (3.4%) of 59 port subjects and 16 (26.7%) of 60 controls (P =. 0004) at a median period of 26 days after randomization (95% confidence interval, 8 to 92). Peripheral accesses in port subjects took less time, had less access-related anxiety and pain, and were less costly to perform than in controls. Allocation had no effect on FLI-C scores. Peripheral access failure correlated with allocation to the control group (P =.007), higher pain scores with intravenous (IV) starts (P =.003), and anxiety with IV starts (P =.01). Venous accessing overall in port patients was four times more costly than that in controls ($2,178/patient v $530/patient, respectively). CONCLUSION: Ports were safe and effective but had no detectable impact on functional quality of life, despite less access-related anxiety, pain, and discomfort. Because only approximately one quarter of control patients ultimately required central venous access, economic considerations suggest that port-use policies should be based upon defined criteria of need. (+info)
Effect of mouth leak on effectiveness of nasal bilevel ventilatory assistance and sleep architecture.
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Mouth leak is common during nasal ventilatory assistance, but its effects on ventilatory support and on sleep architecture are unknown. The acute effect of sealing the mouth on sleep architecture and transcutaneous carbon dioxide tension (Ptc,CO2) was tested in 9 patients (7 hypercapnic) on longterm nasal bilevel ventilation with symptomatic mouth leak. Patients slept with nasal bilevel ventilation at their usual settings on two nights in random order. On one night, the mouth was taped closed. Leak was measured with a pneumotachograph. Median leak fell from 0.35+/-0.07 (mean +/- SEM) L x s(-1) untaped to 0.06+/-0.03 L x s(-1) taped. Ptc,CO2 fell in 8/9, including all hypercapnic patients. Across all patients, the mean Ptc,CO2 fell by 1.02+/-0.28 kPa (7.7+/-2.1 mm Hg) with taping (p = 0.007). Arousal index fell in every patient. Mean arousal index fell from 35.0+/-3.0 to 13.9+/-1.2 h(-1) (p<0.0001), and rapid eye movement (REM) sleep increased from 12.9+/-1.5% to 21.1+/-1.8% sleep time (p = 0.0016). Slow wave sleep changed inconsistently, from a mean of 13.1+/-1.6% to 19.5+/-2.2% of sleep (p = 0.09). Sleep latency and efficiency were unchanged. In four healthy volunteers ventilator-induced awake hypopharyngeal pressure swing during timed bilevel ventilation fell by 35+/-5% L(-1) x s(-1) of voluntary mouth leak (p<0.0001). Mouth leak reduces effective nasal bilevel ventilatory support, increases transcutaneous carbon dioxide tension, and disrupts sleep architecture. (+info)
Adult-worn child carriers: a potential risk for injury.
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OBJECTIVES: To examine and describe types of injuries associated with adult-worn child carriers and illustrate the need for careful use of these products by parents. METHODS: A literature search for the terms infant carriers, backpack carriers, infant slings, baby carriers, and baby slings was conducted. Information was also obtained and tabulated from the three Consumer Product Safety Commission databases: the National Electronic Injury Surveillance System (NEISS), the In-Depth Investigations File, and the Injury/Potential Injury Incident File. RESULTS: No reports of injuries were found in the medical literature. In the NEISS database, 51 injuries were reported between January 1990 and September 1998. Of these injuries, 38 (74.5%) were head traumas and eight (15.7%) were facial trauma. Of the 51 injuries, 11 (22%) required hospitalization. CONCLUSIONS: Based on the data presented in this paper, injuries associated with the use of adult-worn child carriers appear to come from three general sources: product appropriateness and design, product condition, and product use. It is important for health care providers to assist in the dissemination of information regarding the safe use of these products to parents in an effort to prevent injuries. (+info)