Sex and risk of hip implant failure: assessing total hip arthroplasty outcomes in the United States.

IMPORTANCE: The role of sex in relationship to implant failure after total hip arthroplasty (THA) is important for patient management and device innovation. OBJECTIVE: To evaluate the association of sex with short-term risk of THA revision after adjusting for patient, implant, surgery, surgeon, and hospital confounders. DESIGN AND SETTING: A prospective cohort of patients enrolled in a total joint replacement registry from April 1, 2001, through December 31, 2010. PARTICIPANTS: Patients undergoing primary, elective, unilateral THA. MAIN OUTCOME MEASURES: Failure of THA, defined as revision procedure for (1) any reason, (2) septic reason, or (3) aseptic reason after the index procedure. RESULTS: A total of 35,140 THAs with 3.0 years of median follow-up were identified. Women constituted 57.5% of the study sample, and the mean (SD) patient age was 65.7 (11.6) years. A higher proportion of women received 28-mm femoral heads (28.2% vs 13.1%) and had metal on highly cross-linked polyethylene-bearing surfaces (60.6% vs 53.7%) than men. Men had a higher proportion of 36-mm or larger heads (55.4% vs 32.8%) and metal on metal-bearing surfaces (19.4% vs 9.6%). At 5-year follow-up, implant survival was 97.4% (95% CI, 97.2%-97.6%). Device survival for men (97.7%; 95% CI, 97.4%-98.0%) vs women (97.1%; 95% CI, 96.8%-97.4%) was significantly different (P = .01). After adjustments, the hazards ratios for women were 1.29 (95% CI, 1.11-1.51) for all-cause revision, 1.32 (95% CI, 1.10-1.58) for aseptic revision, and 1.17 (95% CI, 0.81-1.68) for septic revision. CONCLUSIONS: After considering patient-, surgery-, surgeon-, volume-, and implant-specific risk factors, women had a 29% higher risk of implant failure than men after THA in this community-based sample.

Medical device surveillance: gender differences in pulmonary artery rupture after pulmonary artery catheterization.

BACKGROUND: Pulmonary artery (PA) rupture is a rare but often fatal complication of PA catheterization. METHODS: An analysis was performed of all the case reports of PA rupture after PA catheterization that were submitted to the Food and Drug Administration's Medical Device Reporting (MDR) system between the years 1991 and 2001. The MDR system is a national passive surveillance system that includes adverse event reports from such sources as manufacturers and healthcare professionals. The Nationwide Inpatient Sample (NIS), a massive, nationally representative database maintained by the Agency for Healthcare Research and Quality, was examined to study patterns of PA catheter use. RESULTS: A total of 71 PA rupture cases were identified from the MDR data. The most likely outcome following PA rupture was death. These PA ruptures were associated with 47 deaths and 24 injuries. The range of reported ages of the cases was between 40 and 91 years, with a mean age of 74 years. Of the 71 PA rupture cases, 52 were in women and 10 were in men, with gender not reported in 9 of the cases. There were significantly more cases in women than expected (Mantel-Haenszel common odds ratio estimate = 5.84, 95% confidence interval = 2.97 - 11.46, p < 0.001). CONCLUSIONS: These data suggest that women may be at significantly greater risk of PA rupture after PA catheterization than men. Clinicians must be aware of the potential for this complication of PA catheterization.

From controlled trials to clinical practice: monitoring transmyocardial revascularization use and outcomes.

OBJECTIVES: We sought to examine trends in the use and outcomes of transmyocardial revascularization (TMR) in community practice. We also identified important risk factors for TMR and compared outcomes of TMR combined with coronary artery bypass graft surgery (TMR + CABG) versus bypass alone in patients receiving incomplete revascularization. BACKGROUND: Although it is approved for use as a stand-alone procedure, there are limited data on the outcomes of (TMR + CABG). METHODS: We identified 3,717 patients receiving TMR at 173 U.S. hospitals participating in the Society of Thoracic Surgeons (STS) National Cardiac Database. Baseline characteristics and outcomes in these patients were compared with those from six published randomized TMR trials. Multivariable logistic regression was used to identify clinical risk factors for mortality with TMR. Risk-adjusted mortality was also compared for TMR + CABG relative to CABG only in patients not amenable to complete traditional revascularization. RESULTS: Between January 1998 and December 2001, the number of STS hospitals performing TMR and total procedural counts increased markedly, driven predominately by more TMR + CABG cases. Overall mortality rates for TMR-alone and TMR + CABG were 6.4% and 4.2%, respectively. Operative risks were significantly higher in those patients with recent myocardial infarction, unstable angina, and depressed ventricular function. Among patients receiving incomplete revascularization, TMR + CABG was not associated with decreased mortality risk compared with CABG alone, adjusted odds ratio 1.11 (95% confidence interval 0.74 to 1.67). CONCLUSIONS: The use of TMR, and in particular, TMR + CABG, is expanding in community practice. Although procedural risks are high, there is room for optimization through improved patient selection and timing of the procedure. Further studies of TMR + CABG are needed given its growing use and unclear benefits.

Health effects associated with medical glove use.

Adverse reactions to medical gloves represent an important public health issue. Accordingly, there is increasing interest in understanding the information reported to the US Food and Drug Administration (FDA) describing health effects associated with the use of medical gloves. This article provides a retrospective analysis and summary of health effects associated with medical glove use reported to the FDA. The FDA's medical device adverse event databases were searched via computer using keywords to identify reports of reactions associated with any type of medical glove. Demographic and clinical information abstracted from these reports was used to perform frequency and trend analyses. The reported medical glove-related events, including the noted trends in reporting, suggest the need for further study and continued monitoring of such reports.

The role of the veterinarian in hurricanes and other natural disasters

Hurricanes create a multiplicity of complicated problems and hazards ranging from outbreaks of infectious disease to animal control problems precipitated by destruction of property. A multidisciplinary response is required to solve such problems. The pool of knowledge derived from various professionals interacting with multiple levels of government agencies (federal, state, and local) will provide the expertise needed. Because the veterinarian is trined to deal with disease involving populations of animals (e.g. herds of flocks) as well as individuals, and because of his/her intensive clinical training, the veterinarian is uniquely qualified to deal with the disaster situation. The veterinarian possesses extensive knowledge in disease and disease processes and has the capability of disease and injury management in affected populations, which qualifies him/her for an essential role, with unlimited potential as a member of any disaster relief team. There is considerable potential for veterinarians to play a role in responding to natural disasters. The areas of disease control, animal care, animal control, protection of the food supply, disinfection/sterilization, and planning are all areas where veterinarians can take an active part. Inclusion of the veterinarian in the process of planning for and responding to natural disasters will yield significant public health benefits(AU)