Patient-Centered Standards for Medically Integrated Dispensing: ASCO/NCODA Standards.

PURPOSE: To provide standards for medically integrated dispensing of oral anticancer drugs and supportive care medications. METHODS: An Expert Panel was formed, and a systematic review of the literature on patient-centered best practices for the delivery of oral anticancer and supportive care drugs was performed to April 2019 using PubMed and Google Scholar. Available patient-centered standards, including one previously developed by the National Community Oncology Dispensing Association (NCODA), were considered for endorsement. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: A high-quality systematic review that was current to May 2016 was adopted into the evidence base. Five additional primary studies of multifaceted interventions met the inclusion criteria. These studies generally included a multicomponent intervention, often led by an oncology pharmacist, and also included patient education and regular follow-up and monitoring. These interventions resulted in significant improvements to patient quality and safety and demonstrated improvements in adherence and other patient outcomes. CONCLUSION: The findings of the systematic review were consistent with the NCODA patient-centered standards for patient relationships and education, adherence, safety, collection of data, documentation, and other areas. NCODA standards were adopted and used as basis for these American Society of Clinical Oncology/NCODA standards. Additional information is available at www.asco.org/mid-standards.

Ultraviolet Radiation-Induced Production of Nitric Oxide:A multi-cell and multi-donor analysis.

Increasing evidence regarding positive effects of exposure to sunlight has led to suggestions that current advice may be overly weighted in favour of avoidance. UV-A has been reported to lower blood pressure, possibly through nitric oxide (NO) production in skin. Here, we set out to investigate effects of UV-A and solar-simulated radiation on the potential source of dermal NO, the effective doses and wavelengths, the responsiveness of different human skin cells, the magnitude of inter-individual differences and the potential influence of age. We utilised isogenic keratinocytes, microvascular endothelial cells, melanocytes and fibroblasts isolated from 36 human skins ranging from neonates to 86 years old. We show that keratinocytes and microvascular endothelial cells show greatest NO release following biologically relevant doses of UV-A. This was consistent across multiple neonatal donors and the effect is maintained in adult keratinocytes. Our observations are consistent with a bi-phasic mechanism by which UV-A can trigger vasodilatory effects. Analyses of NO-production spectra adds further evidence that nitrites in skin cells are the source of UV-mediated NO release. These potentially positive effects of ultraviolet radiation lend support for objective assessment of environmental influence on human health and the idea of "healthy sun exposure".

Establishing Clinically Relevant Severity Levels for the Central Sensitization Inventory.

OBJECTIVES: The aim of this study was to create and validate severity levels for the central sensitization inventory (CSI), a valid and reliable patient-reported outcome instrument designed to identify patients whose presenting symptoms may be related to a central sensitivity syndrome (CSS; eg, fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome), with a proposed common etiology of central sensitization (CS). METHODS: Based on CSI score means and standard deviations from previously published subject samples, the following CSI severity levels were established: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100. The concurrent validity of the CSI severity levels was then confirmed in a separate chronic pain patient sample (58% with a CSS diagnosis and 42% without) by demonstrating associations between CSI scores and (1) the number of physician-diagnosed CSSs; (2) CSI score distributions in both CSS and non-CSS patient samples; (3) patient-reported history of CSSs; and (4) patient-reported psychosocial measures, which are known to be associated with CSSs. RESULTS: Compared to the non-CSS patient subsample, the score distribution of the CSS patient subsample was skewed toward the higher severity ranges. CSI mean scores moved into higher severity levels as the number of individual CSS diagnoses increased. Patients who scored in the extreme CSI severity level were more likely to report previous diagnoses of fibromyalgia, chronic fatigue syndrome, temporomandibular joint disorder, tension/migraine headaches, and anxiety or panic attacks (P < 0.01). CSI severity levels were also associated with patient-reported depressive symptoms, perceived disability, sleep disturbance, and pain intensity (P ≤ 0.02). CONCLUSION: This study provides support for these CSI severity levels as a guideline for healthcare providers and researchers in interpreting CSI scores and evaluating treatment responsiveness.

Pericardiocentesis Under Continuous Ultrasonographic Guidance Using a 7 cm Micropuncture Needle.

OBJECTIVES: To compare procedural success and safety of pericardiocentesis using continuous ultrasonographic visualization of a long (7 cm) micropuncture needle to standard access with an 18 gauge needle without continuous ultrasound guidance. BACKGROUND: Current approaches to pericardiocentesis commonly utilize a large-bore 18 gauge needle for access without allowing for continuous visualization of needle entry into the pericardial space. METHODS: We included all consecutive patients at our institution who underwent pericardiocentesis between November 1, 2011 and March 3, 2016. A total of 21 patients (group 1) underwent pericardiocentesis using a 7 cm micropuncture needle inserted under continuous ultrasonographic guidance, while 51 patients (group 2) underwent pericardiocentesis, mostly with an 18 gauge needle (92%), following preprocedural echocardiography only. The primary endpoint was successful placement of a drain into the pericardial space. RESULTS: The primary endpoint was similar between group 1 and group 2 (100% vs 94%, respectively; P=.26). Successful drainage of pericardial fluid was achieved in 95% of patients in group 1 and in 98% in group 2 (P=.88). The amount of pericardial fluid drained in each group was similar (640 mL vs 557 mL, respectively; P=.26). No procedure-related complications occurred in group 1, compared with 2 cases of right ventricular perforation that occurred in group 2. In-hospital mortality and length of stay were similar. CONCLUSION: This study suggests that an ultrasound-mounted micropuncture needle allows for safe and effective pericardiocentesis. This technique may provide a safer alternative to the standard use of an 18 gauge needle.

Study design and rationale of the heterotopic implantation of the Edwards-Sapien XT transcatheter valve in the inferior VEna cava for the treatment of severe tricuspid regurgitation (HOVER) trial.

BACKGROUND: Tricuspid regurgitation (TR) is an under treated disease. Although surgery for TR remains an effective therapy, many patients are considered to be at a high risk or otherwise inoperable. Caval valve implant (CAVI) offers an alternative to surgery in these patients. Trials assessing the safety and efficacy of caval valve implant are lacking. METHODS: The Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna cava for the treatment of severe Tricuspid Regurgitation (HOVER) trial is an FDA approved, physician initiated, prospective, non-blinded (open label), non-randomized safety and feasibility study to determine the safety and efficacy of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe TR in patients who are at high risk or inoperable. Patients with severe TR in the absence of severe pulmonary hypertension will be recruited. They will be evaluated by a multi-disciplinary team who will agree by consensus that the patients' symptoms are from TR. They will undergo imaging to assess the size of the inferior vena cava (IVC) to determine feasibility of the procedure. If patients meet the inclusion criteria and are free from exclusion criteria, after informed consent they will be eligible for enrollment in the study. A total of 30 patients will be enrolled. The primary objective of the study will be to demonstrate procedural success at 30-days and patient success at 1-year. CONCLUSION: Caval valve implant may present an alternative for patients who are at high risk or inoperable for tricuspid valve surgery (TVS) for TR. © 2016 Wiley Periodicals, Inc.

Radial artery avulsion--a rare complication of transradial catheterization.

Transradial access is becoming the default mode of catheterization in a growing number of centers in the United States. The increasing utilization of transradial access has led to significant reduction in access site complications especially bleeding complications. We report a rare complication of transradial catheterization of radial artery avulsion, which was successfully treated in an endovascular fashion during the index procedure. © 2014 Wiley Periodicals, Inc.

Trends in major entry site complications from percutaneous coronary intervention (from the Dynamic Registry).

Several factors contribute to the risk of percutaneous coronary intervention-related major entry site (MES) complications. We sought to examine the trends in MES among unselected patients during the stent era. Data from the Dynamic Registry including 5 distinct recruitment waves from 1997 to 2006 (n = 10,932) were used to assess baseline characteristics and MES among consecutive patients undergoing percutaneous coronary intervention. MES was defined as bleeding requiring transfusion, pseudoaneurysm, arterial thrombosis or dissection, vascular complication requiring surgery, or retroperitoneal bleed. Uncomplicated hematomas were not included. Several trends were observed in baseline characteristics including an increase from wave 1 to wave 5 in body mass index >30 kg/m(2) (30.2% to 40.4%), renal disease (3.5% to 9.1%), diabetes (28.0% to 34.1%), and hypertension (59.4% to 78%; ptrend <0.001 for all). The use of a thienopyridine increased significantly from wave 1 (49.7%) to wave 5 (84%), whereas glycoprotein IIb/IIIa inhibitor use peaked in wave 3 (53.1%) and then decreased (p <0.001). Access site was predominately femoral, but radial access increased over time (0.3% wave 1, 6.6% wave 5, p ≤0.0001). The rates of MES (2.8% to 2.2%, ptrend = 0.01) and MES requiring transfusion (2.0% to 0.74%, ptrend <0.001) were low and decreased with time. The trend in less risk for MES in later time periods remained after adjustment. In conclusion, MES has decreased over time; however, opportunity for bleeding avoidance strategies still exists.

The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample.

UNLABELLED: Central sensitization (CS) is a proposed physiological phenomenon in which central nervous system neurons become hyperexcitable, resulting in hypersensitivity to both noxious and non-noxious stimuli. The term central sensitivity syndrome (CSS) describes a group of medically indistinct (or nonspecific) disorders, such as fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome, for which CS may be a common etiology. In a previous study, the Central Sensitization Inventory (CSI) was introduced as a screening instrument for clinicians to help identify patients with a CSS. It was found to have high reliability and validity (test-retest reliability = .82; Cronbach's alpha = .88). The present study investigated a cohort of 121 patients who were referred to a multidisciplinary pain center, which specializes in the assessment and treatment of complex pain and psychophysiological disorders, including CSSs. A large percentage of patients (n = 89, 74%) met clinical criteria for one or more CSSs, and CSI scores were positively correlated with the number of diagnosed CSSs. A receiver operating characteristic analysis determined that a CSI score of 40 out of 100 best distinguished between the CSS patient group and a nonpatient comparison sample (N = 129) (area under the curve = .86, sensitivity = 81%, specificity = 75%). PERSPECTIVE: The CSI is a new self-report screening instrument to help identify patients with CSSs, including fibromyalgia. The present study investigated CSI scores in a heterogeneous pain population with a large percentage of CSSs, and a normative nonclinical sample to determine a clinically relevant cutoff value.

The development and psychometric validation of the central sensitization inventory.

Central sensitization (CS) has been proposed as a common pathophysiological mechanism to explain related syndromes for which no specific organic cause can be found. The term "central sensitivity syndrome (CSS)" has been proposed to describe these poorly understood disorders related to CS. The goal of this investigation was to develop the Central Sensitization Inventory (CSI), which identifies key symptoms associated with CSSs and quantifies the degree of these symptoms. The utility of the CSI, to differentiate among different types of chronic pain patients who presumably have different levels of CS impairment, was then evaluated. Study 1 demonstrated strong psychometric properties (test-retest reliability = 0.817; Cronbach's alpha = 0.879) of the CSI in a cohort of normative subjects. A factor analysis (including both normative and chronic pain subjects) yielded 4 major factors (all related to somatic and emotional symptoms), accounting for 53.4% of the variance in the dataset. In Study 2, the CSI was administered to 4 groups: fibromyalgia (FM); chronic widespread pain without FM; work-related regional chronic low back pain (CLBP); and normative control group. Analyses revealed that the patients with FM reported the highest CSI scores and the normative population the lowest (P < 0.05). Analyses also demonstrated that the prevalence of previously diagnosed CSSs and related disorders was highest in the FM group and lowest in the normative group (P < 0.001). Taken together, these 2 studies demonstrate the psychometric strength, clinical utility, and the initial construct validity of the CSI in evaluating CS-related clinical symptoms in chronic pain populations.

Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks.

OBJECTIVES: The purpose of this study was to evaluate the feasibility and efficacy of the percutaneous device closure of a consecutive series of patients with periprosthetic paravalvular leaks referred to our structural heart disease center with congestive heart failure and hemolytic anemia. BACKGROUND: Clinically significant periprosthetic paravalvular leak is an uncommon but serious complication after surgical valve replacement. Percutaneous closure has been utilized as an alternative to surgical repair of this defect in high-risk surgical patients. METHODS: This is a retrospective review of 57 percutaneous paravalvular leak closures that were performed in 43 patients (67% male, mean age 69.4 ± 11.7 years) between April 2006 and September 2010. Integrated imaging modalities were used for the evaluation, planning, and guidance of the interventions. RESULTS: Closure was successful in 86% of leaks and in 86% of patients. Twenty-eight of 35 patients improved by at least 1 New York Heart Association functional class. The percentage of patients requiring blood transfusions and/or erythropoietin injections post-procedure decreased from 56% to 5%. Clinical success was achieved in 89% of the patients in whom procedure was successful. The survival rates for patients at 6, 12, and 18 months after paravalvular leak closures were 91.9%, 89.2%, and 86.5%, respectively. Freedom from cardiac-related death at 42 months post-procedure was 91.9%. CONCLUSIONS: Percutaneous closure of symptomatic paravalvular leaks, facilitated by integrated imaging modalities has a high rate of acute and long-term success and appears to be effective in managing symptoms of heart failure and hemolytic anemia.

Percutaneous closure of left ventricular pseudoaneurysm.

BACKGROUND: Left ventricular pseudoaneurysm is a rare but serious complication from myocardial infarction and cardiac surgery. Although standard treatment is surgical intervention, percutaneous closure of left ventricular pseudoaneurysm has become an option for high-risk surgical candidates. Experience with percutaneous treatment is limited to a few single case reports. This is the first series of percutaneous treatment of the left ventricular pseudoaneurysms. METHODS AND RESULTS: This is a retrospective analysis of 9 procedures of percutaneous repair of left ventricular pseudoaneurysm in 7 consecutive patients (ages 51 to 83 years, 6 men) completed in our Structural Heart Disease center from June 2008 to December 2010. All patients were considered as a high risk for surgery because of multiple comorbidities. Multiple imaging modalities were used before, during, and after the procedures to improve success and efficacy. The left ventricular pseudoaneurysms of all 7 patients were successfully repaired. Fluoroscopy time on average was 36.5±24.0 minutes (range, 12.4 to 75.7 minutes). All patients were followed up for a period ranging from 3 to 32 months after the procedure. Each patient improved by at least 1 New York Heart Association functional class, and 4 patients improved by 2 classes. CONCLUSIONS: Transcatheter closure of the left ventricular pseudoaneurysm is a feasible alternative for high-risk surgical candidates. The use of multiple imaging modalities is required for a detail planning and execution of the procedure.

Simultaneous aortic and mitral metallic paravalvular leaks repaired through one delivery sheath.

Paravalvular leaks (PVL) are a well-known complication after prosthetic valve surgery. Effective non-surgical repair techniques are being developed using several off-label transcatheter occlusive devices given that there is no unique technique applicable to repair each paravalvular leak. We describe a technique used to simultaneously repair several PVL percutaneously, in a patient with double mechanical prosthesis using a single delivery system, by taking advantage of specific anatomical factors and selecting the best applicable devices.

Fibromyalgia syndrome in chronic disabling occupational musculoskeletal disorders: prevalence, risk factors, and posttreatment outcomes.

OBJECTIVE: To identify the prevalence, risk factors, and treatment outcomes of patients with chronic disabling occupational musculoskeletal disorders (CDOMD) who met criteria for fibromyalgia. METHODS: This was a prospective prognostic study of a consecutive cohort of CDOMD patients (n = 449) admitted for treatment. Patients were assessed for chronic widespread pain and fibromyalgia. The measures included demographic, injury-related and occupational information, psychosocial measures, and 1-year work status follow-up. RESULTS: The CDOMD patients with fibromyalgia reported higher-level psychosocial distress. Women with fibromyalgia were 9.6 times less likely to return to work 1-year posttreatment and, of those who did, were 4.3 times less likely to retain work. CONCLUSIONS: Of this cohort, 23.2% patients met criteria for fibromyalgia. Patients with fibromyalgia were found to show greater psychosocial distress and significantly poorer rates of work return and work retention 1-year postrehabilitation.

Temporal trends in patient-reported angina at 1 year after percutaneous coronary revascularization in the stent era: a report from the National Heart, Lung, and Blood Institute-sponsored 1997-2006 dynamic registry.

BACKGROUND: Percutaneous coronary intervention (PCI) has witnessed rapid technological advancements, resulting in improved safety and effectiveness over time. Little, however, is known about the temporal impact on patient-reported symptoms and quality of life after PCI. METHODS AND RESULTS: Temporal trends in post-PCI symptoms were analyzed using 8879 consecutive patients enrolled in the National Heart, Lung, and Blood Institute-sponsored Dynamic Registry (wave 1: 1997 [bare metal stents], wave 2: 1999 [uniform use of stents], wave 3: 2001 [brachytherapy], wave 4, 5: 2004, 2006 [drug eluting stents]). Patients undergoing PCI in the recent waves were older and more often reported comorbidities. However, fewer patients across the waves reported post-PCI angina at one year (wave 1 to 5: 24%, 23%, 18%, 20%, 20%; P(trend)<0.001). The lower risk of angina in recent waves was explained by patient characteristics including use of antianginal medications at discharge (relative risk [95% CI] for waves 2, 3, 4 versus 1: 1.0 [0.9 to 1.2], 0.9 [0.7 to 1.1], 1.0 [0.8 to 1.3], 0.9 [0.7 to 1.1]). Similar trend was seen in the average quality of life scores over time (adjusted mean score for waves 1 to 5: 6.2, 6.5, 6.6 and 6.6; P(trend)=0.01). Other factors associated with angina at 1 year included younger age, female gender, prior revascularization, need for repeat PCI, and hospitalization for myocardial infarction over 1 year. CONCLUSIONS: Favorable temporal trends are seen in patient-reported symptoms after PCI in routine clinical practice. Specific subgroups, however, remain at risk for symptoms at 1 year and thus warrant closer attention.

The decline in PCI complication rate: 2003-2006 versus 1999-2002.

INTRODUCTION: Technical improvements permit the performance of percutaneous coronary interventions (PCI) reliably and safely. However, adverse events during such procedures have still not been eliminated. The purpose of this study was to assess the current rates of complications from PCI, as well as any changes from 1999 to 2006. METHODS: Prospectively collected Lenox Hill Hospital data were abstracted from the New York State PCI Report forms and a review of the Quality Improvement office database. The reported complications from 23,399 consecutive PCIs performed during an eight-year period (January 1999 to December 2006) were recorded. The one-month composite endpoint (CEP: death, myocardial infarction, stent thrombosis, stroke, or emergent cardiac surgery within one month of the PCI) and the one-month composite endpoint excluding stent thrombosis (CEPnoST) were evaluated. RESULTS: Complications occurred in 3.36% of PCIs. The following complication rates were found: one month death rate 0.6%, death in the catheterization suite 0.047%, stent thrombosis (one month) 0.53%, presumed stent thrombosis (one month) 0.82%, myocardial infarction (MI: either Q or non-Q wave) 0.74%, emergent cardiac surgery 0.15%, stroke 0.29%, cardiac perforation 0.29%, retroperitoneal bleeding 0.18%, acute renal failure 0.28%, need for hemodialysis 0.17%, CEP 1.8% and CEPnoST 1.58%. When the complication rates from the most recent period (2003-2006) were compared with those from the earlier period (1999-2002), a statistically significant difference was found in total complications, CEP, CEPnoST, stroke, MI, and vascular complications. CONCLUSIONS: Current rates of PCI complications remain low. The overall PCI complication rate was lower during the last four years of the study.

Asbestos exposures of mechanics performing clutch service on motor vehicles.

A study was conducted to assess historical asbestos exposures of mechanics performing clutch service on motor vehicles. For most of the 20th century, friction components used in brakes and manual transmission clutches contained approximately 25-60% chrysotile asbestos. Since the late 1960s, asbestos exposure assessment studies conducted on mechanics performing brake service have frequently reported levels below the current OSHA permissible exposure limit (PEL) of 0.1 fiber/cc (flcc). Although there is a robust asbestos exposure data set for mechanics performing brake service, there are almost no data for mechanics removing and replacing clutches in manual transmission vehicles. Personal and area airborne asbestos samples were collected during the removal of asbestos-containing clutches from 15 manual transmissions obtained from salvage facilities by an experienced mechanic. Clutch plates and debris were analyzed for asbestos using EPA and ISO published analytical methods. More than 100 personal and area air samples were collected and analyzed for asbestos fibers using NIOSH methods 7400 and 7402. A separate study involved a telephone survey of 16 automotive mechanics who began work prior to 1975. The mechanics were asked about the duration, frequency, and methods used to perform clutch service. Wear debris in the bell housing surrounding clutches had an average of 0.1% chrysotile asbestos by weight, a value consistent with similar reports of brake debris. Asbestos air sampling data collected averaged 0.047 flcc. Mechanics participating in the telephone survey indicated that clutch service was performed infrequently, the entire clutch assembly was normally replaced, and there was no need to otherwise handle the asbestos-containing clutch plates. These mechanics also confirmed that wet methods were most frequently used to clean debris from the bell housing. Combining the asbestos exposure that occurred when mechanics performed clutch service, along with the duration and frequency of this task, the incremental contribution of this task to mechanics' 8-hr time-weighted average (TWA) asbestos exposures was 0.0016 flcc. Using the range of data inputs that were obtained, the authors calculated a range of TWA exposures of 3.75 x 10(-5) flcc to 0.03 flcc. The mean value of 0.0016 flcc is below background levels of asbestos that have been reported in garages during this time and below the current OSHA PEL of 0.1 flcc.

Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry.

OBJECTIVES: We investigated the effectiveness and safety of drug-eluting stents (DES) as used in routine clinical practice. BACKGROUND: Randomized trials have shown that DES prevent target vessel revascularization in selected patients, but whether this translates into superior outcomes, compared with bare-metal stents (BMS), for the full spectrum of patients treated with DES in North America is unknown. METHODS: Patients in the National Heart, Lung, and Blood Institute Dynamic Registry enrolled in 2004 who received at least 1 DES (n = 1,460) were compared with 1,763 patients enrolled in the recruitment period immediately preceding the approval of DES (2001 to 2002) who received at least 1 BMS. RESULTS: Patients receiving DES more often had diabetes mellitus and less often presented with an acute myocardial infarction (MI). At 1 year, cumulative death and MI was 7.6% in DES- and 8.7% in BMS-treated patients (adjusted hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.68 to 1.15; p = 0.34). The 1-year rate of target vessel revascularization was 5.0% in DES and 9.2% in BMS patients (p < 0.001), and the risk of any repeat revascularization by percutaneous coronary intervention or coronary bypass was lower in DES patients (adjusted HR 0.38, 95% CI 0.25 to 0.60; p < 0.001). Patients with both simple and complex lesion characteristics benefited from DES with lower risk of repeat target vessel revascularization by percutaneous coronary intervention compared with BMS (any complex lesion: adjusted HR 0.57, 95% CI 0.39 to 0.83; absence of any complex lesion: adjusted HR 0.44, 95% CI 0.28 to 0.71). The 1-year incidence of stent thrombosis was 1.0% in DES patients. CONCLUSIONS: The generalized use of DES resulted in better outcomes than BMS, with fewer clinically driven revascularization procedures and similar rates of death and MI at 1 year.

Completeness of revascularization for multivessel coronary artery disease and its effect on one-year outcome: a report from the NHLBI Dynamic Registry.

When percutaneous coronary intervention (PCI) is performed in patients with multivessel coronary disease, a targeted revascularization (TR) of diseased vessels is performed more often than complete revascularization (CR). We compared baseline characteristics and 1-year outcomes of patients undergoing TR by operator choice (n = 1,091), TR because CR was unachievable (n = 375), and CR (n = 315) in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry. Patients receiving TR because CR was unachievable were older, had more comorbidities, worse ejection fraction, less often received 2b/3a inhibitors and stents, and less frequently achieved complete angiographic success than either patients receiving TR by choice or CR. Despite these considerable differences, cumulative rates of 1-year mortality, the need for repeat PCI, or coronary bypass surgery were similar in patients who received CR, TR by choice, or TR because CR was unachievable. In multivariable models, after adjustment for clinical characteristics and propensity to receive CR, the hazard ratio for CR versus TR was 1.10 (95% CI: 0.58-2.10) for 1-year mortality; 0.89 (0.60-1.32) for repeat PCI, and 0.92 (0.66-1.29) for repeat PCI or coronary bypass surgery. In conclusion, despite the presence of more unfavorable characteristics, patients undergoing TR demonstrate 1-year outcomes equivalent to those having CR, supporting its continued use in selected patients.

Metalworking fluid mist occupational exposure limits: a discussion of alternative methods.

NIOSH published a recommended exposure limit (REL) for metalworking fluids (MWF) in 1998 that was designed to prevent respiratory disorders associated with these industrial lubricants. The REL of 0.4 mg/m(3) (as a time-weighted average for up to 10 hours) was for the fraction of aerosol corresponding to deposition in the thoracic region of the lungs. This nonregulatory occupational exposure limit (OEL) corresponded to approximately 0.5 mg/m(3) for total particulate mass. Although this REL was designed to prevent respiratory disorders from MWF exposures, NIOSH acknowledged that exposures below the REL may still result in occupational asthma and hypersensitivity pneumonitis--two of the most significant respiratory illnesses associated with MWF. In the 8 years since the publication of the NIOSH MWF REL, neither the Occupational Safety and Health Administration (OSHA) nor the American Conference of Governmental Industrial Hygienists (ACGIH) has recommended an exposure limit for water-soluble MWF specifically, other than their previous exposure limits for mineral oil. An informal effort to benchmark companies involved in the manufacture of automobiles and automotive parts in North America indicated that most companies are using the NIOSH MWF REL as a guide for the purchase of new equipment. Furthermore, most companies have adopted a goal to limit exposures to below 1.0 mg/m3. We failed to find any company that has strictly enforced an OEL of 1.0 mg/m(3) through the use of either administrative controls or personal protective equipment, when engineering controls failed to bring the exposures to below this limit. We also found that most companies have failed to implement specific medical surveillance programs for those employees exposed to MWF mist above 1.0 mg/m(3). Organization Resources Counselors (ORC) published in 1999 (on their website) a "best practices" manual for maintaining MWF systems and reducing the likelihood of MWF-related illnesses. The emphasis of this approach was on control techniques, and there was no assignment of a specific OEL for MWF due to the wide variety of fluids that exist. The ORC did suggest that maintaining exposure levels to below 2.0 mg/m(3) would assist in minimizing upper respiratory complaints associated with MWF. Although the ORC manual indicated that MWF vary in composition and no single OEL is likely to be appropriate for all such fluids, it adopted a very similar concept to control banding, placing all MWF operations into a single band using similar (if not identical) controls. OSHA, in lieu of adopting a 6B health standard for MWF, has also published a voluntary "best practices" manual on their website. Their document drew heavily from the work of ORC and also incorporated information from the 1998 NIOSH MWF criteria document. Industrial users of MWF need to have guidance, such as an OEL, to determine when either engineering, administrative controls, or personal protective equipment must be implemented to protect their employees. The purpose of this article is to explore various approaches that might be taken to result in a single or multiple limits for exposures to MWF and its components. Approaches such as control banding are discussed in terms of an alternative to the use of an OEL.

Clinical outcomes following percutaneous coronary intervention with drug-eluting vs. bare-metal stents in dialysis patients.

BACKGROUND: Late mortality among dialysis patients undergoing PCI with bare-metal stents is high. The impact of drug-eluting stent use on outcomes in such patients is unclear. OBJECTIVE: To compare the clinical outcomes of dialysis patients undergoing coronary stenting with versus without the use of drug-eluting stents. METHODS: Baseline features and outcomes were compared in dialysis patients undergoing coronary stent implantation using either bare-metal devices only (n = 41) or drug-eluting stents (n = 33), in recruitment waves 3 (2001-2002; n = 2,047) and 4 (2004; n = 2,112) of the National Heart Lung, and Blood Institute Dynamic Registry. The primary study endpoint was the composite of major adverse cardiac events (MACE), defined as death, myocardial infarction (MI) or any repeat revascularization procedure at 1-year follow up. RESULTS: Baseline and procedural features and in-hospital MACE rates were similar in both groups. Cumulative 1-year rates of the composite MACE endpoint and all-cause mortality were lower in patients treated with drug-eluting versus bare-metal stents (25.2% vs. 57.3%; p = 0.01, and 18.4% and 36.8%, respectively; p = 0.09). By multivariable analysis, drug-eluting versus bare-metal stent use was independently associated with freedom from the composite MACE endpoint (hazard ratio = 0.24, 95% CI [0.10-0.60]; p = 0.002) and with a trend to lower all-cause mortality (HR = 0.40 [0.15-1.05]; p = 0.06) at 1 year. CONCLUSION: In this cohort of dialysis patients undergoing percutaneous coronary intervention (PCI), drug-eluting versus bare-metal stent implantation was associated with enhanced freedom from 1-year MACE. Given previous bare-metal stent data indicating worse outcomes after PCI than after bypass surgery in dialysis patients, randomized trials comparing these strategies in the drug-eluting stent era are needed.