Objectives This study sought to ascertain causes of death and the incidence of percutaneous coronary intervention (PCI)-related mortality within 30 days. Background Public reporting of 30-day ...mortality after PCI without clearly identifying the cause may result in operator risk avoidance and affect hospital reputation and reimbursements. Death certificates, utilized by previous reports, have poor correlation with actual cause of death and may be inadequate for public reporting. Methods All patients who died within 30 days of a PCI from January 2009 to April 2011 at a tertiary care center were included. Causes of death were identified through detailed chart review using Academic Research Consortium consensus guidelines and compared with reported death certificates. The causes of death were divided into cardiac and noncardiac and PCI and non–PCI-related categories. Results Of the 4,078 PCI, 81 deaths (2%) occurred within 30 days. Of these, 58% died of cardiac and 42% of noncardiac causes. However, only 42% of 30-day deaths were attributed to PCI-related complications. Patients with non–PCI-related, compared with PCI-related, death presented with a higher incidence of cardiogenic shock (15 of 47 32% vs. 2 of 34 6%; p < 0.01) and cardiac arrest (19 of 47 40% vs. 1 of 34 3%; p < 0.01). Death certificates had only 58% accuracy (95% confidence interval: 45% to 72%) for classifying patients as experiencing cardiac versus noncardiac death. Conclusions Less than one-half of 30-day deaths are attributed to a PCI-related complication. Death certificates are inaccurate and do not report PCI-related deaths, which may represent a better marker of PCI quality.
ViziLite Plus with TBlue system (Zila Pharmaceuticals; now Zila, a division of Tolmar, Fort Collins, Colo.) and VELscope (LED Dental, White Rock, British Columbia, Canada) are oral cancer screening ...aids that have been developed to assist dentists in identifying precancerous and cancerous oral lesions.
The authors screened patients with an overhead examination light and then with VELscope or ViziLite. Patients with a clinically innocuous lesion underwent a biopsy, and the authors compared the results of tissue pathological analysis with findings from the screening aid tests to determine the sensitivity and specificity of each device. The authors tested these devices to determine their ability to aid in the decision-making process regarding whether further evaluation of a clinically innocuous lesion was required.
The authors examined 102 lesions with ViziLite and then biopsied them corrected. They found three dysplasias and one malignancy, none of which were detected with the ViziLite (sensitivity = 0 percent, confidence interval CI = 0-60.2 percent; specificity = 75.5 percent, CI = 66.7-82.8 percent). The authors examined another 156 lesions with VELscope and then biopsied them corrected.They found 11 dysplasias and one malignancy, six of which were detected with VELscope (sensitivity = 50 percent, CI = 21.1-78.9 percent; specificity = 38.9 percent, CI = 30.8-46.9 percent).
The study results indicate that use of ViziLite or VELscope along with a conventional screening examination for lesions deemed clinically innocuous was not beneficial in identifying dysplasia or cancer. Additional clinical studies are needed before these devices can be recommended.
Clinicians and patients could have a false sense of security after obtaining a negative ViziLite or VELscope examination result because potentially large numbers of precancerous and cancerous lesions will be missed by both devices.
Abstract Objectives The aim of this study was to develop a hybrid approach–specific model to predict chronic total coronary artery occlusion (CTO) percutaneous coronary intervention success, useful ...for experienced but not ultra-high-volume operators. Background CTO percutaneous coronary intervention success rates vary widely and have improved with the “hybrid approach,” but current predictive models for success have major limitations. Methods Data were obtained from consecutively attempted patients from 7 clinical sites (9 operators, mean annual CTO volume 61 ± 17 cases). Angiographic analysis of 21 lesion variables was performed centrally. Statistical modeling was performed on a randomly designated training group and tested in a separate validation cohort. The primary outcome of interest was technical success. Results A total of 436 patients (456 lesions) met entry criteria. Twenty-five percent of lesions had prior failed percutaneous coronary interventions at the site. The right coronary artery was the most common location (56.4%), and mean occlusion length was 24 ± 20 mm. The initial approach was most often antegrade wire escalation (70%), followed by retrograde (22%). Success was achieved in 79.4%. Failure was most closely correlated with presence of an ambiguous proximal cap, and in the presence of an ambiguous proximal cap, specifically defined collateral score (combination of Werner and tortuosity scores) and retrograde tortuosity. Without an ambiguous proximal cap, poor distal target, occlusion length >10 mm, ostial location, and 1 operator variable contributed. Prior failure, and Werner and tortuosity scores alone, were only weakly correlated with outcomes. The basic 7-item model predicted success, with C statistics of 0.753 in the training cohort and 0.738 in the validation cohort, the later superior (p < 0.05) to that of the J-CTO (Multicenter CTO Registry of Japan) (0.55) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (0.61) scores. Conclusions Success can be reasonably well predicted, but that prediction requires modification and combination of angiographic variables. Differences in operator skill sets may make it challenging to create a powerful, generalizable, predictive tool.
Objectives This study sought to improve methodology for predicting post–percutaneous coronary intervention (PCI) mortality. Background Recently, an increased proportion of post-PCI deaths caused by ...noncardiac causes has been suggested, often in rapidly triaged patients resuscitated from sudden cardiac death or presenting with cardiogenic shock. Older risk adjustment algorithms may not adequately reflect these issues. Methods Consecutive patients undergoing PCI from 2000 to 2009 were randomly divided into training (n = 8,966) and validation (n = 8,891) cohorts. The 2010 ACC-NCDR (American College of Cardiology–National Cardiovascular Data Registry) mortality algorithm was applied to the training cohort and its highest risk decile, separately. Variables describing general and neurological status at admission were then tested for their additional predictive capability and new algorithms developed. These were tested in the validation cohort, using receiver-operator characteristic curve, Hosmer-Lemeshow, and reclassification measures as principal outcome measures. Results In-hospital mortality was 1.0%, of which 52.2% had noncardiac causes or major contributions. Baseline model C-statistics for the total and upper decile training cohorts were 0.904 and 0.830. The Aldrete score (addressing consciousness, respiration, skin color, muscle function, and circulation) and neurology scores added incremental information, resulting in improved validation cohort C-statistics (entire group: 0.883 to 0.914, p < 0.001; high-risk decile: 0.829 to 0.874, p < 0.001). Reclassification of the ACC-NCDR <90th and ≥90th risk percentiles by the new score yielded improved mortality prediction (p < 0.001 and p = 0.033, respectively). Conclusions Half of in-hospital deaths in this series were of noncardiac causation. Prediction of in-hospital mortality after PCI can be considerably improved over conventional models by the inclusion of variables describing general and neurological status.
Left main coronary artery (LMCA) percutaneous coronary intervention (PCI) has emerged as an appealing alternative to bypass surgery for significant LMCA disease, especially in high-risk candidates. ...PCI for unprotected LMCA stenosis is currently designated a class IIb indication. Direct comparisons between unprotected LMCA PCI and multivessel PCI are lacking. We aimed to determine the incremental risk associated with unprotected LMCA PCI compared to multivessel PCI. We queried the Cleveland Clinic PCI database to identify patients who underwent unprotected LMCA PCI from 2003 through 2009 and compared these to patients undergoing multivessel PCI in the same period. Patients undergoing PCI for acute myocardial infarction were excluded. Mortality was derived using the Social Security Death Index. Short-term (≤30-day) mortality rates in the LMCA PCI group (n = 468, 1.9%) were similar to the death rate in the multivessel PCI group (n = 1,973, 1.3%, p = 0.3). There was no significant difference in adjusted mortality between the 2 study groups. Stratifying LMCA PCI by the number of concomitant vessel territories treated, there was no significant difference in mortality in any LMCA PCI category (LMCA only, LMCA + 1-vessel PCI, LMCA + multivessel PCI) compared to multivessel PCI. In conclusion, there was comparable short-term and long-term mortality in the LMCA PCI and multivessel PCI groups. LMCA stenting did not appear to incur incremental risk compared to multivessel PCI.
Objectives This trial compared the performance of a novel bioabsorbable vascular closure device (VCD) versus manual compression (MC) for access site hemostasis in patients undergoing percutaneous ...trans-femoral coronary or peripheral procedures. Background From a patient's perspective, access site management after percutaneous procedures remains challenging. Methods Patients enrolled in this multicenter, nonblinded trial underwent 6-F diagnostic or interventional procedures were randomly assigned 2:1 to VCD versus MC. The primary efficacy end points were time to hemostasis (TTH) and time to ambulation (TTA), and the primary safety end points were periprocedural and 30-day incidence of arterial access-related complications. Results The trial assigned 401 patients (mean age 62.7 ± 10.9 years, 66.1% men) to VCD (n = 267) versus MC (n = 134) after 87 “roll-in” patients treated at 17 participating institutions. The baseline characteristics of the groups were similar. Procedural success was 91.8% in the VCD versus 91.0% in the MC group (p = NS). Mean TTH was 4.4 ± 11.6 min in the VCD versus 20.1 ± 22.5 min in the MC group (95% confidence interval: 19.0 to 12.3; p < 0.0001). Likewise, TTA was significantly shorter in the VCD (2.5 ± 5.0 h) than in the MC (6.2 ± 13.3 h) group (95% confidence interval: 5.5 to 1.9; p = 0.0028). No patient died or suffered a major access-site-related adverse event. Minor adverse events were few among all study groups. Conclusions After 6-F percutaneous invasive procedures, TTH and TTA were both significantly shorter in patients assigned to VCD than in patients managed with MC. The 30-day rates of access-site-related complications were remarkably low in all groups. (Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device; NCT00345631 )
In Malaysia, two-thirds of reported workplace-related fatal and serious injury incidents are the result of commuting crashes (especially those involving motorcyclists), however, little is known about ...the contributing factors to these collisions. A telephone survey of 1,750 motorcyclists (1,004 adults who had been involved in a motorcycle commuting crash in the last 2 years and 746 adult motorcyclists who had not been involved in a motorcycle crash in the last 2 years) was undertaken. The contributions of a range of behavioural, attitudinal, employment and travel pattern factors to collision involvement were examined. The findings revealed that the majority of participants were licensed riders, rode substantial distances (most often for work purposes), and reported adopting safe riding practices (helmet wearing and buckling). However, there were some concerning findings regarding speeding behaviour, use of mobile phones while riding, and engaging in other risky behaviours. Participants who had been involved in a collision were younger (aged 25-29 years), had higher exposure (measured by distances travelled, frequency of riding, and riding on high volume and higher speed roads), reported higher rates of riding for work purposes, worked more shift hours and had a higher likelihood of riding at relatively high speeds compared with participants who had not been involved in a collision. Collisions generally occurred during morning and early evening hours, striking another vehicles, and during normal traffic flow. The implications of these findings for policy decisions and development of evidence-based behavioural/training interventions addressing key contributing factors are discussed.
Recent work has demonstrated that two archaic human groups (Neanderthals and Denisovans) interbred with modern humans and contributed to the contemporary human gene pool. These findings relied on the ...availability of high-coverage genomes from both Neanderthals and Denisovans. Here we search for evidence of archaic admixture from a worldwide panel of 1,667 individuals using an approach that does not require the presence of an archaic human reference genome. We find no evidence for archaic admixture in the Andaman Islands, as previously claimed, or on the island of Flores, where Homo floresiensis fossils have been found. However, we do find evidence for at least one archaic admixture event in sub-Saharan Africa, with the strongest signal in Khoesan and Pygmy individuals from Southern and Central Africa. The locations of these putative archaic admixture tracts are weighted against functional regions of the genome, consistent with the long-term effects of purifying selection against introgressed genetic material.
The underrepresentation of non-Europeans in human genetic studies so far has limited the diversity of individuals in genomic datasets and led to reduced medical relevance for a large proportion of ...the world's population. Population-specific reference genome datasets as well as genome-wide association studies in diverse populations are needed to address this issue. Here we describe the pilot phase of the GenomeAsia 100K Project. This includes a whole-genome sequencing reference dataset from 1,739 individuals of 219 population groups and 64 countries across Asia. We catalogue genetic variation, population structure, disease associations and founder effects. We also explore the use of this dataset in imputation, to facilitate genetic studies in populations across Asia and worldwide.
Purpose The goal of the current study was to examine primary care and public health activities among federally funded health centers, to better understand their successes, barriers encountered, and ...lessons learned. Methods Qualitative and quantitative methods were used to collect data from nine health centers, stratified by administrative division, urban–rural location, and race/ethnicity of patients served. Descriptive data on patient and institutional characteristics came from the Uniform Data System, which collects data from all health centers annually. Questionnaires were administered and phone interviews were conducted with key informants. Results Health centers performed well on primary care coordination and community orientation scales and reported conducting many essential public health activities. Specific needs were identified for integrating primary care and public health: (1) more funding for collaborations and for addressing the social determinants of health, (2) strong leadership to champion collaborations, (3) trust-building among partners, with shared missions and clear expectations of responsibilities, and (4) alignment and standardization of data collection, analysis, and exchange. Conclusions Lessons learned from health centers should inform strategies to better integrate public health with primary care.
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