Incidence and clinical outcome of minor surgery in the year after drug-eluting stent implantation: results from the Evaluation of Drug-Eluting Stents and Ischemic Events Registry.

BACKGROUND: The aim of the study was to describe the incidence and consequences of minor surgery after drug-eluting stent (DES) implantation. METHODS: The Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) Registry prospectively enrolled unselected patients undergoing percutaneous coronary intervention at 47 US centers between July 2004 and December 2007. We examined 8,323 patients who received a DES in EVENT to determine the frequencies of minor surgery and postoperative adverse events. RESULTS: Minor surgery (defined as procedures not requiring a major surgical incision) was performed in 164 (2.0%) of 8,323 patients <1 year after stenting, as follows: pacemaker/defibrillator implantation (46%), eye surgery (17%), orthopedic (9%), dermatologic (8%), endovascular (6%), and gastrointestinal procedures (5%). Compared with patients who did not undergo minor surgery, those who did were older, had more comorbidities, had more extensive coronary disease, and were more likely to have received warfarin after stenting. Only 1 (0.6%, 95% CI 0.0%-3.4%) of 164 patients had an event (stent thrombosis causing myocardial infarction) during the first week after minor surgery; this rate was slightly higher than the background rate of ischemic events in the study population (exact mid P = .01). Clopidogrel use at 12 months was similar between patients who did and those who did not undergo minor surgery (65.2% vs 65.5%, P = .95). CONCLUSIONS: In the EVENT Registry, minor surgery was performed in 2% of patients in the first year after DES implantation. The risk of stent thrombosis during the first week after surgery was increased slightly compared with background rates, but the absolute event rate was low (0.6%).

Prevalence and prognostic significance of preprocedural cardiac troponin elevation among patients with stable coronary artery disease undergoing percutaneous coronary intervention: results from the evaluation of drug eluting stents and ischemic events registry.

BACKGROUND: Although cardiac troponin (cTn) elevation is associated with periprocedural complications during percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes, the prevalence and prognostic significance of preprocedural cTn elevation among patients with stable coronary artery disease undergoing PCI are unknown. METHODS AND RESULTS: Between July 2004 and September 2006, 7592 consecutive patients who underwent attempted stent placement at 47 hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed the frequency of an elevated cTn immediately before PCI and its relationship to in-hospital and 1-year outcomes among patients who underwent PCI for either stable angina or a positive stress test. Among the stable coronary artery disease population (n=2382, 31.4%), 142 (6.0%) had a cTn level above the upper limit of normal before the procedure. Compared with patients who had normal baseline cTn, patients with elevated cTn had a higher rate of in-hospital death or myocardial infarction (13.4% versus 5.6%; P<0.001) and a trend toward higher rates of urgent repeat PCI (1.4% versus 0.2%; P=0.06). In multivariable analyses adjusted for demographic, clinical, angiographic, and procedural factors, baseline cTn elevation remained independently associated with the composite of death or myocardial infarction at hospital discharge (odds ratio, 2.1; 95% confidence interval, 1.2 to 3.8; P=0.01) and at the 1-year follow-up (odds ratio, 2.0; 95% confidence interval, 1.2 to 3.3; P=0.005). CONCLUSIONS: Baseline elevation of cTn is relatively common among patients with stable coronary artery disease undergoing PCI and is an independent prognostic indicator of ischemic complications. If these data are confirmed in future studies, consideration should be given to routine testing of cTn before performance of PCI in this patient population.

Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents.

CONTEXT: Clinical trials that have excluded patients at high risk for cardiac events have led to commercial labeling approval of drug-eluting stents; nevertheless, such high-risk patients commonly undergo stent placement in clinical practice. The degree to which they experience cardiac events at a higher rate than non-high-risk patients is unclear. OBJECTIVE: To assess the rates of major adverse cardiac events during the index admission and 1 year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features. DESIGN, SETTING, AND PATIENTS: From July 2004 to September 2005, consecutive patients who underwent attempted stent placement at 42 different hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed outcomes of 3323 patients who received at least 1 drug-eluting stent for a reason other than acute ST-segment elevation myocardial infarction. The study population was divided into 2 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food and Drug Administration-approved indications for sirolimus- and paclitaxel-eluting stents. MAIN OUTCOME MEASURES: The composite clinical outcomes of death, myocardial infarction, or target vessel revascularization during the index admission and death, myocardial infarction, or target lesion revascularization at 1 year were evaluated. RESULTS: Of the 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic. During the index hospitalization, the composite clinical outcome occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-label group (adjusted odds ratio, 2.32; 95% confidence interval [CI], 1.75-3.07; P<.001). At 1 year, the composite clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (17.5%) vs 131 (8.9%) (adjusted hazard ratio [HR], 2.16; 95% CI, 1.74-2.67; P<.001). Stent thrombosis also occurred more frequently among patients in the off-label group during the initial hospitalization (8 [0.4%] vs 0) and at 1 year: 29 (1.6%) vs 13 (0.9%), adjusted HR, 2.29 (95% CI, 1.02-5.16; P = .05). CONCLUSIONS: Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes during the index admission and at 1 year. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drug-eluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed.

The Pediatric Vision Screener III: detection of strabismus in children.

OBJECTIVE: To evaluate the clinical performance of the Pediatric Vision Screener (PVS) in children in a pediatric ophthalmology office setting. METHODS: Seventy-seven subjects between 2 and 18 years of age received gold-standard orthoptic examinations and were classified as at risk for amblyopia if strabismus or anisometropia (>1.50 diopters) was present. Strabismus was subclassified as variable or constant. The subjects were then tested with the PVS, which produced a pass or refer recommendation based on a binocularity score. The PVS also produced a yield score to indicate the subject's interest in the target. Sensitivity and specificity for amblyopia risk detection were calculated. RESULTS: Binocularity as determined by the PVS was greater than 65% for all controls and less than 20% for all subjects with constant strabismus. Binocularity ranged from 0% to 52% in subjects with variable strabismus. All subjects with anisometropia and no strabismus had binocularity scores less than 10%. CONCLUSIONS: The PVS identified strabismus, when present, in all subjects and identified 3 subjects with anisometropia as well. The PVS shows potential to address a lack of screening instrumentation appropriate for use with preschool-aged children.

Pediatric Vision Screener 2: pilot study in adults.

Amblyopia is a form of visual impairment caused by ocular misalignment (strabismus) or defocus in an otherwise healthy eye. If detected early, the condition can be fully treated, yet over half of all children with amblyopia under age 5 escape detection. We developed a Pediatric Vision Screener (PVS) to detect amblyopia risk factors. This instrument produces a binocularity score to indicate alignment and a focus score to indicate focus. The purpose of this study is to assess the performance of the PVS by testing adults who were fully cooperative for testing. The study group includes 40 subjects (20 controls, 20 patients) aged 22 to 79 years. 12 patients had constant strabismus (8 to 50Delta), and eight had variable strabismus (12 to 55Delta). All controls had binocularity scores >50%. Binocularity was <50% in 11/12 patients. The patient with binocularity >50% had a well-controlled intermittent exotropia and was not at risk for amblyopia. Focus scores were highly sensitive for good focus but not specific. The PVS shows high sensitivity and specificity for detection of strabismus in adults. Future studies will determine whether this performance can be achieved in preschool children, who are at greatest risk for vision loss.

Pediatric Vision Screener 1: instrument design and operation.

We develop the Pediatric Vision Screener (PVS) to automatically detect ocular misalignment (strabismus) and defocus in human subjects. The PVS utilizes binocular retinal birefringence scanning to determine when both eyes are aligned, with a theoretical accuracy of <1 deg. The device employs an autoconjugate, bull's-eye detector-based system to detect focus. The focus and alignment pathways are separated by both wavelength and data acquisition timing. Binocular focus and alignment are detected in rapid alternating sequence, measuring both parameters in both eyes in <0.5 sec. In this work, the theory and design of the PVS are described in detail. With objective, automated measurement of both alignment and focus, the PVS represents a new approach to screening children for treatable eye disease such as amblyopia.

Practice-based evidence to evidence-based practice: building the National Radiation Oncology Registry.

The National Radiation Oncology Registry (NROR), sponsored by the Radiation Oncology Institute and the American Society for Radiation Oncology, is designed to collect standardized information on cancer care delivery among patients treated with radiotherapy in the United States and will focus on patients with prostate cancer. Stakeholders were engaged through a forum that emphasized the need for patient-centered outcomes, minimal data burden, and maximal connectivity to existing registries and databases. An electronic infrastructure is under development to provide connectivity across radiation oncology and hospital information systems. The NROR Gateway features automatic abstraction as well as aggregation of treatment and outcome data. The prostate cancer data dictionary provides standardized elements in four domains: facility, physician, patient, and treatment. The pilot phase will consist of clinical centers chosen to provide a representative mix of radiation treatment modalities, facility types, population-based settings, and regional locations. The initial set of radiation practice metrics includes physician board certification and maintenance, ordering of staging scans, active surveillance discussion, dose prescriptions for low-risk/high-risk disease, radiation fields for low-risk/high-risk disease, image-guided radiation therapy use, androgen deprivation therapy use, post-brachytherapy implant computed tomography dosimetry, collection of toxicity assessments, and longitudinal patient follow-up. The NROR pilot study will provide the framework for expansion to a nationwide electronic registry for radiation oncology.

Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner.

Purpose. The Pediatric Vision Scanner (PVS) detects strabismus by identifying ocular fixation in both eyes simultaneously. This study was undertaken to assess the ability of the PVS to identify patients with amblyopia or strabismus, particularly anisometropic amblyopia with no measurable strabismus. Methods. The PVS test, administered from 40 cm and requiring 2.5 seconds of attention, generated a binocularity score (BIN, 0%-100%). We tested 154 patients and 48 controls between the ages of 2 and 18 years. BIN scores of amblyopic children and controls were measured, and 21 children received sequential PVS measurements to detect any changes in BIN resulting from amblyopia treatment. Results. With the pass/refer threshold set at BIN 60%, sensitivity and specificity were 96% for the detection of amblyopia or strabismus. Assuming a 5% prevalence of amblyopia or strabismus, the inferred positive and negative predictive values of the PVS were 56% and 100%, respectively. Fixation accuracy was significantly reduced in amblyopic eyes. In anisometropic amblyopia patients treated successfully, the BIN improved to 100%. Conclusions. The PVS identified children with amblyopia or strabismus with high sensitivity and specificity, while successful treatment restored normal BIN scores in amblyopic patients without strabismus. The results support the hypothesis that the PVS detects strabismus and amblyopia directly. Future strategies for screening by nonspecialists may thus be based on diagnostic detection of amblyopia and strabismus rather than the estimation of risk factors, allowing for rapid, accurate identification of children with amblyopia early in life when it is most amenable to treatment.

In-hospital and 1-year outcomes among percutaneous coronary intervention patients with chronic kidney disease in the era of drug-eluting stents: a report from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry.

OBJECTIVES: This study sought to evaluate ischemic and bleeding outcomes in patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). BACKGROUND: Previous studies have shown that CKD is associated with poor outcomes after PCI. However, these studies were largely conducted before the introduction of DES and aggressive antithrombotic therapy or were performed in the setting of randomized trials. With data from a contemporary registry, we evaluated the influence of CKD on major cardiovascular events and bleeding complications in unselected "real-world" patients undergoing PCI. METHODS: Data from 4,791 patients enrolled in the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) Registry between July 2004 and September 2005 were analyzed. Patients were stratified into 4 groups: creatinine clearance (CrCl) >75, 50 to 75, 30 to 49 and <30 ml/min. RESULTS: During the index hospital stay, there was a step-wise increase in bleeding complications with decreasing CrCl (3.3%, 5.0%, 8.8%, and 14.3%; p < 0.0001 for trend). Lower CrCl was also associated with more frequent death or myocardial infarction (MI) during the initial hospital stay (p = 0.001) and at 1 year (p < 0.001). These findings were confirmed in multivariate analyses that adjusted for baseline differences in demographic, clinical, and angiographic factors. Use of guideline-recommended medications at 1 year, including aspirin, clopidogrel, angiotensin-converting enzyme inhibitors, and statins, also decreased with declining renal function. CONCLUSIONS: Renal function is an independent and powerful predictor of bleeding and ischemic complications in the era of DES and contemporary antithrombotic therapy in patients undergoing PCI. The low use of guideline-recommended drugs among patients with CKD undergoing PCI might contribute to these adverse outcomes and warrants further evaluation.

Laser-generated spark morphology and temperature records from emission and Rayleigh scattering studies.

Using both Rayleigh scattering and time-resolved emission spectroscopy, we have recorded the spatial and temporal evolution of laser-generated sparks in argon from changes during the first ten of nano-seconds to complete dissipation, which occurs in a time span of approximately 5 ms. Maps of either emission intensity or argon density spanning the entire region affected by the energy deposited by the laser show the dissipation of the spark in detail. Immediately after ignition, the argon plasma occupies an ellipsoidal volume of roughly 3-mm vertical (axial) length. After approximately 20-40 micros, the spark region has transformed into a toroidal shape in a plane perpendicular to the vertical axis, with a radius of approximately 1.5 mm. The torus rises slowly up and expands noticeably in the radial direction. A record of peak temperatures of the spark ranging from approximately 10,000 K at 60-micros delay time to approximately 450 K at 4-ms delay time indicate cooling rates from approximately 100 to 1 K/micros at these times.

Automated detection of ocular alignment with binocular retinal birefringence scanning.

We previously developed a retinal birefingence scanning (RBS) device to detect eye fixation. The purpose of this study was to determine whether a new binocular RBS (BRBS) instrument can detect simultaneous fixation of both eyes. Control (nonmyopic and myopic) and strabismic subjects were studied by use of BRBS at a fixation distance of 45 cm. Binocularity (the percentage of measurements with bilateral fixation) was determined from the BRBS output. All nonstrabismic subjects with good quality signals had binocularity >75%. Binocularity averaged 5% in four subjects with strabismus (range of 0-20%). BRBS may potentially be used to screen individuals for abnormal eye alignment.