Coronary Artery Disease: Brindis RG

Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA, Masoudi FA, Brindis RG, Beckman KJ, Chambers CE, Ferguson TB, Garcia MJ, Grover FL, Holmes DR, Klein LW, Limacher M, Mack MJ, Malenka DJ, Park MH, Ragosta M, Ritchie JL, Rose GA, Rosenberg AB, Shemin RJ, Weintraub WS, Wolk MJ, Allen JM, Douglas PS, Hendel RC, Peterson ED. · Division of Cardiology, Duke University Medical Center, Durham, NC, USA. · Catheter Cardiovasc Interv. · Pubmed #19127535 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF), Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and the American Association for Thoracic Surgery, along with key specialty and subspecialty societies, conducted an appropriateness review of common clinical scenarios in which coronary revascularization is frequently considered. The clinical scenarios were developed to mimic common situations encountered in everyday practice and included information on symptom status, extent of medical therapy, risk level as assessed by noninvasive testing, and coronary anatomy. Approximately 180 clinical scenarios were developed by a writing committee and scored by a separate technical panel on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization was considered appropriate and likely to improve health outcomes or survival. Scores of 1 to 3 indicate revascularization was considered inappropriate and unlikely to improve health outcomes or survival. The mid range (4 to 6) indicates a clinical scenario for which the likelihood that coronary revascularization would improve health outcomes or survival was considered uncertain. For the majority of the clinical scenarios, the panel only considered the appropriateness of revascularization irrespective of whether this was accomplished by percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). In a select subgroup of clinical scenarios in which revascularization is generally considered appropriate, the appropriateness of PCI and CABG individually as the primary mode of revascularization was considered. In general, the use of coronary revascularization for patients with acute coronary syndromes and combinations of significant symptoms and/or ischemia was viewed favorably. In contrast, revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy were viewed less favorably. It is anticipated that these results will have an impact on physician decision making and patient education regarding expected benefits from revascularization and will help guide future research.

Douglas PS, Khandheria B, Stainback RF, Weissman NJ, Peterson ED, Hendel RC, Stainback RF, Blaivas M, Des Prez RD, Gillam LD, Golash T, Hiratzka LF, Kussmaul WG, Labovitz AJ, Lindenfeld J, Masoudi FA, Mayo PH, Porembka D, Spertus JA, Wann LS, Wiegers SE, Brindis RG, Douglas PS, Hendel RC, Patel MR, Peterson ED, Wolk MJ, Allen JM, Anonymous00094, Anonymous00095, Anonymous00096, Anonymous00097, Anonymous00098, Anonymous00099, Anonymous00100, Anonymous00101. · No affiliation provided · J Am Coll Cardiol. · Pubmed #18342240 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

Douglas PS, Khandheria B, Stainback RF, Weissman NJ, Peterson ED, Hendel RC, Stainback RF, Blaivas M, Des Prez RD, Gillam LD, Golash T, Hiratzka LF, Kussmaul WG, Labovitz AJ, Lindenfeld J, Masoudi FA, Mayo PH, Porembka D, Spertus JA, Wann LS, Wiegers SE, Brindis RG, Douglas PS, Patel MR, Wolk MJ, Allen JM, Anonymous00125, Anonymous00126, Anonymous00127, Anonymous00128, Anonymous00129, Anonymous00130, Anonymous00131, Anonymous00132. · Duke University Medical Center, Durham, NC, USA. · Circulation. · Pubmed #18316491 links to  free full text

Abstract: The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

Douglas PS, Khandheria B, Stainback RF, Weissman NJ, Peterson ED, Hendel RC, Stainback RF, Blaivas M, Des Prez RD, Gillam LD, Golash T, Hiratzka LF, Kussmaul WG, Labovitz AJ, Lindenfeld J, Masoudi FA, Mayo PH, Porembka D, Spertus JA, Wann LS, Wiegers SE, Brindis RG, Douglas PS, Hendel RC, Patel MR, Peterson ED, Wolk MJ, Allen JM, Anonymous00137, Anonymous00138, Anonymous00139, Anonymous00140, Anonymous00141, Anonymous00142, Anonymous00143, Anonymous00144, Anonymous00145, Anonymous00146. · Duke University Medical Center, Durham, NC, USA. · Catheter Cardiovasc Interv. · Pubmed #18314889 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain.The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

Brindis RG, Kloner RA. · Division of Cardiology, San Francisco Kaiser Hospital, San Francisco, California 94115, USA. · Am J Cardiol. · Pubmed #14609621 No free full text.

Abstract: Cardiologists are seeing increasing numbers of patients with erectile dysfunction (ED), which frequently coexists with cardiovascular disease. The pharmacologic profile of the new class of phosphodiesterase (PDE) inhibitors-specifically PDE5 inhibitors-and their potential effects on hemodynamic variables have therefore become significant factors in therapeutic decision making. Most of the published data linking PDE5 inhibitor effects and cardiovascular disease relate to sildenafil, although >or=2 new agents are in various stages of development and clinical trials. Sildenafil and other PDE5 inhibitors act on vascular smooth muscle, predominantly in the corpus cavernosum. PDE5 is not found in cardiomyocytes, and no effect of PDE5 inhibition on cardiac contractility has been demonstrated. On the basis of a safety database comprising thousands of men with ED, sildenafil has demonstrated minimal adverse effects in men with stable ischemia, hypertension, and/or severe coronary artery disease. Sildenafil has modest effects on hemodynamic variables and has been shown to increase coronary artery flow reserve. Alone or combined with >or=1 antihypertensive medication, sildenafil did not increase the incidence of adverse events or hypotensive episodes. Sildenafil-associated decreases in systolic and diastolic blood pressure, the result of its vasodilator activity, have been modest. Sildenafil has decreased both elevated pulmonary vascular resistance and elevated pulmonary artery pressures in patients with pulmonary vascular disease. Beneficial changes in hemodynamics have been observed with the use of sildenafil in patients with congestive heart failure with underlying ischemic and other dilated cardiomyopathies. No association between sildenafil and increased cardiovascular morbidity or mortality has emerged in analyses of clinical trial data.

Hendel RC, Berman DS, Di Carli MF, Heidenreich PA, Henkin RE, Pellikka PA, Pohost GM, Williams KA, Wolk MJ, Alagona P, Bateman TM, Cerqueira MD, Corbett JR, Dean AJ, Dehmer GJ, Goldbach P, Gordon L, Kushner FG, Kwong RY, Min J, Quinones MA, Ward RP, Yang SH, Allen J, Brindis RG, Douglas PS, Patel M, Peterson E. · Appropriate Use Criteria for Radionuclide Imaging Writing Group-Midwest Heart Specialists, Winfield, IL, USA. · Circulation. · Pubmed #19451357 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF), along with key specialty and subspecialty societies, conducted an appropriate use review of common clinical scenarios where cardiac radionuclide imaging (RNI) is frequently considered. This document is a revision of the original Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT MPI) Appropriateness Criteria, published 4 years earlier, written to reflect changes in test utilization and new clinical data, and to clarify RNI use where omissions or lack of clarity existed in the original criteria. This is in keeping with the commitment to revise and refine appropriate use criteria (AUC) on a frequent basis. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Sixty-seven clinical scenarios were developed by a writing group and scored by a separate technical panel on a scale of 1 to 9 to designate appropriate use, inappropriate use, or uncertain use. In general, use of cardiac RNI for diagnosis and risk assessment in intermediate- and high-risk patients with coronary artery disease (CAD) was viewed favorably, while testing in low-risk patients, routine repeat testing, and general screening in certain clinical scenarios were viewed less favorably. Additionally, use for perioperative testing was found to be inappropriate except for high selected groups of patients. It is anticipated that these results will have a significant impact on physician decision making, test performance, and reimbursement policy, and will help guide future research.

Bhatt DL, Peterson ED, Harrington RA, Ou FS, Cannon CP, Gibson CM, Kleiman NS, Brindis RG, Peacock WF, Brener SJ, Menon V, Smith SC, Pollack CV, Gibler WB, Ohman EM, Roe MT, Anonymous00072. · VA Boston Healthcare System and Brigham and Women's Hospital, Boston, MA, USA. · Eur Heart J. · Pubmed #19339264 No free full text.

Abstract: AIMS: The presence of peripheral arterial disease (PAD) or cerebrovascular disease (CVD) is associated with higher likelihood of significant coronary artery disease (CAD). We sought to assess the prevalence of PAD, CVD, prior CAD, or pre-existent disease in multiple arterial territories ('polyvascular' disease) in patients presenting with non-ST-segment elevation acute coronary syndrome and its impact on adverse events. METHODS AND RESULTS: Data from 95 749 patients enrolled from February 2003 to September 2006 at 484 sites in the CRUSADE registry were analysed. Patients were categorized as having prior 0, 1, 2, or 3 affected arterial beds. The rates of in-hospital mortality, myocardial infarction, stroke, and congestive heart failure were analysed, as were the rates of non-bypass surgery-related red blood cell transfusion and major bleeding. On presentation, 11,345 (11.9%) patients had established PAD, 9973 (10.4%) had documented CVD, and 41,404 (43.2%) had prior CAD. In this cohort, 0, 1, 2, and 3 arterial bed disease before presentation was present in 46 814 (48.9%, 95% CI 48.6-49.2%), 36 704 (38.3%, 95% CI 37.8-39.0%), 10 675 (11.2%, 95% CI 10.9-11.9%), and 1556 (1.6%, 95% CI 1.5-1.8%) patients, respectively. The rates of ischaemic events increased with the number of affected vascular beds. The adjusted odds ratio for the composite of in-hospital ischaemic events for pre-existent disease in 1, 2, or 3 arterial beds (compared with 0 arterial bed involvement) increased from 1.07 to 1.26 to 1.31 (P < 0.001). Similarly, the adjusted odds ratio for transfusion increased with greater disease burden from 1.11 to 1.28 to 1.30 (P < 0.001), although the adjusted rates of protocol-defined non-bypass surgery-related major bleeding did not. CONCLUSION: Prior polyvascular disease increases the risk of in-hospital adverse events, including mortality. Identification of these patients in clinical trial and real world populations may provide an opportunity to reduce their excess risk with intensive secondary prevention efforts.

Li Z, Kravitz RL, Marcin JP, Romano PS, Rocke DM, Denton TA, Brindis RG, Dai J, Amsterdam EA. · Division of General Internal Medicine and Center for Healthcare Policy and Research, University of California, Davis, Sacramento, CA, USA. · BMC Health Serv Res. · Pubmed #19087305 links to  free full text

Abstract: BACKGROUND: Coronary artery bypass graft (CABG) surgery is performed because of anticipated survival benefit, improvement in quality of life, or both. We performed this study to explore variations in clinical indications for CABG surgery among California hospitals and surgeons. METHODS: Using California CABG Outcomes Reporting Program data, we classified all isolated CABG cases in 2003-2004 as having "probable survival enhancing indications (SEIs)", "possible SEIs" or "non-SEIs." Patient and hospital characteristics associated with SEIs were examined. RESULTS: While 82.9% of CABG were performed for probable SEIs, the range extended from 68% to 96% among hospitals and 51% to 100% among surgeons. SEI rates were higher among patients aged >or= 65 compared with those aged 18-64 (Adjusted Odds Ratio [AOR] > 1.29 for age groups 65-69, 70-74 and >or= 75; all p < 0.001), among Asians and Native Americans compared with Caucasians (AOR 1.22 and 1.15, p < 0.001); and among patients with hypertension, peripheral vascular disease, diabetes, cerebrovascular disease and congestive heart failure compared to patients without these conditions (AOR > 1.09, all p < 0.001). Variations in indications for surgery were more strongly related to patient mix than to surgeon or hospital effects (intraclass correlation [ICC] = 0.04 for hospital; ICC = 0.01 for surgeon). CONCLUSION: California hospitals and surgeons vary in their distribution of indications for CABG surgery. Further research is required to identify the roles of market factors, referral patterns, patient preferences, and local clinical culture in producing the observed variations.

Shaw LJ, Shaw RE, Merz CN, Brindis RG, Klein LW, Nallamothu B, Douglas PS, Krone RJ, McKay CR, Block PC, Hewitt K, Weintraub WS, Peterson ED, Anonymous00293. · Emory Program in Cardiovascular Outcomes Research and Epidemiology, 1256 Briarcliff Rd NE, Suite 1-N, Emory University School of Medicine, Atlanta, GA 30306, USA. · Circulation. · Pubmed #18378615 links to  free full text

Abstract: BACKGROUND: Although populations referred for coronary angiography are increasingly diverse, there is limited information on coronary artery disease (CAD) prevalence and in-hospital mortality other than for predominately white male patients. METHODS AND RESULTS: We examined gender and ethnic differences in CAD prevalence and in-hospital mortality in a prospective cohort of patients referred for angiographic evaluation of stable angina (n=375,886) or acute coronary syndromes (ACS; unstable angina or myocardial infarction, n=450,329) at 388 US hospitals participating in the American College of Cardiology-National Cardiovascular Data Registry, an angiographic registry. Univariable and multivariable (with covariates that included risk factors, symptoms, and comorbidities) logistic regression models were used to estimate significant CAD, defined as > or = 70% stenosis, and in-hospital mortality. Within stable angina and ACS cohorts, 7% of patients were black, 2% were Hispanic, 0.3% were Native American, 1% were Asian, and 90% were white, respectively. In stable angina, the risk-adjusted OR for significant CAD was 0.34 for women compared with men (P<0.0001), with black women having the lowest risk-adjusted odds (P<0.0001) compared with other females. Among ACS patients, the risk-adjusted OR of significant CAD was 0.47 for women compared with men (P<0.0001); similarly, black women had the lowest risk-adjusted odds (P<0.0001) compared with other females. Higher in-hospital mortality was reported for white women presenting with stable angina (P<0.00001). White women had a 1.34-fold (95% CI 1.21 to 1.48) higher risk-adjusted odds ratio for mortality than white men with stable angina (P<0.0001), with higher rates noted for white women who were older or had significant CAD (both P<0.0001). Lower utilization of elective coronary revascularization, aspirin, and glycoprotein IIb/IIIa inhibitors (all P<0.0001) may have contributed to higher in-hospital mortality for white women. In ACS, higher in-hospital mortality was reported for Hispanic (P=0.015) and white (P<0.0001) women; however, neither white (P=0.51) or Hispanic (P=0.13) women had higher in-hospital risk-adjusted mortality. CONCLUSIONS: The likelihood for significant CAD at coronary angiography and for in-hospital mortality varied significantly by ethnicity and gender. Future clinical practice guidelines should be tailored to gender subsets of the population, in particular for black women, to improve the efficient use of angiographic laboratories and to target at-risk populations of women and men.

Brener SJ, Milford-Beland S, Roe MT, Bhatt DL, Weintraub WS, Brindis RG, Anonymous00074. · Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44195, USA. · Am Heart J. · Pubmed #18082505 No free full text.

Abstract: BACKGROUND: Multivessel (MV) coronary artery disease (CAD) frequently exists in patients presenting with non-ST-elevation (NSTE) acute coronary syndromes (ACSs). Although an early invasive strategy improves outcome in these patients, there are limited data on culprit-only, single-vessel (SV) percutaneous coronary intervention (PCI) or MV PCI in the NSTE ACS setting. METHODS: To identify the predictors of SV versus MV PCI in patients with ACS and compare their outcomes up to hospital discharge, we analyzed the records of 105,866 patients undergoing PCI with ACS and MV CAD from 402 centers reported to the American College of Cardiology National Cardiovascular Database Registry between 2000 and 2004. Demographic, clinical, and angiographic characteristics of the patients were used to create a propensity score for SV versus MV PCI. RESULTS: Single-vessel PCI was performed in 68% (72,048 patients), whereas the remaining 32% (33,818 patients) had MV PCI. Factors independently associated with the performance of SV versus MV PCI were presentation with NSTE infarction (vs unstable angina), adjusted odds ratio (OR) of 1.29 (95% CI 1.24-1.34); being older, adjusted OR of 1.09 (95% CI 1.08-1.11) per decade; and presence of total occlusion, adjusted OR of 1.25 (95% CI 1.16-1.36). The c-statistic for the model was 0.70. Procedural success was achieved in 91% of SV PCI and 88% of MV PCI (P < .001). Inhospital mortality was 1.3% and 1.2%, respectively (P = .09; adjusted OR 1.11 [95% CI 0.97-1.27], P = .13). Rates of morbidity, such as bleeding, development of renal failure, or nonfatal cardiogenic shock, were similar for both groups. CONCLUSIONS: In patients with MV CAD, presenting with ACS and selected for PCI, performance of MV PCI appears to be associated with at least as successful an inhospital outcome as SV PCI.

Patel MR, Chen AY, Peterson ED, Newby LK, Pollack CV, Brindis RG, Gibson CM, Kleiman NS, Saucedo JF, Bhatt DL, Gibler WB, Ohman EM, Harrington RA, Roe MT. · Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. · Am Heart J. · Pubmed #16996828 No free full text.

Abstract: BACKGROUND: Unlike ST-segment elevation myocardial infarction, the degree of stenosis and physiology of ischemia varies in patients with non-ST-segment elevation myocardial infarction (NSTEMI). The prevalence, predictors, and outcomes of patients with NSTEMI who lack significant epicardial coronary artery disease (CAD) in routine clinical practice remain poorly characterized. We sought to determine the prevalence, predictors, and outcomes of patients with NSTEMI and insignificant CAD. METHODS: We analyzed 38301 patients with NSTEMI in the CRUSADE quality improvement initiative who underwent cardiac catheterization to determine the prevalence and factors associated with insignificant CAD (all coronary stenoses <50%) and inhospital outcomes for patients with and without CAD. A multivariable model was used to determine the factors associated with insignificant CAD. RESULTS: A total of 3306 (8.6%) of 38301 patients had insignificant CAD. The strongest multivariable predictors of insignificant CAD were female sex (odds ratio 2.8, 95% CI 2.6-3.1), younger age (odds ratio per 10-year decrease 1.5, 95% CI 1.5-1.6), and lack of current/recent smoking (odds ratio 1.9, 95% CI 1.7-2.0). Inhospital rates of death were 0.65% for patients with insignificant CAD compared with 2.36% for patients with CAD (P < .0001). CONCLUSION: Insignificant CAD is present in 9% of patients with NSTEMI and is associated with a low incidence of adverse outcomes. The strongest predictors of insignificant CAD are female sex and younger age. These findings underscore the need for research to understand the pathophysiology of myocardial infarction in this population.

Yang X, Alexander KP, Chen AY, Roe MT, Brindis RG, Rao SV, Gibler WB, Ohman EM, Peterson ED, Anonymous00083. · Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27715, USA. · J Am Coll Cardiol. · Pubmed #16226173 No free full text.

Abstract: OBJECTIVES: In a large contemporary population of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS), we sought to describe blood transfusion rates (overall and in patients who did not undergo coronary artery bypass grafting [CABG]), patient characteristics and practices associated with transfusion, variation among hospitals, and in-hospital outcomes in patients receiving transfusions. BACKGROUND: The use of antithrombotic agents and invasive procedures reduces ischemic complications but increases risks for bleeding and need for blood transfusion in patients with NSTE ACS. METHODS: We evaluated patient characteristics and transfusion rates in the overall population (n = 85,111) and determined outcomes and factors associated with need for transfusion in a subpopulation of patients who did not undergo CABG (n = 74,271) from 478 U.S. hospitals between January 1, 2001, and March 31, 2004. RESULTS: A total of 14.9% of the overall and 10.3% of the non-CABG population underwent transfusion during their hospitalization. Renal insufficiency and advanced age were strongly associated with the likelihood of transfusion. Interhospital transfusion rates varied significantly. Non-CABG patients who received transfusions had a greater risk of death (11.5% vs. 3.8%) and death or reinfarction (13.4% vs. 5.8%) than patients who did not undergo transfusion. CONCLUSIONS: Transfusion is common in the setting of NSTE ACS, and patients who undergo transfusion are sicker at baseline and experience a higher risk of adverse outcomes than their nontransfused counterparts. Given the wide variation in transfusion practice, further efforts to understand patient and process factors that result in bleeding and need for transfusion in NSTE ACS are needed.

Foody JM, Roe MT, Chen AY, Smith SC, Brindis RG, Peterson ED, Gibler WB, Ohman EM, Anonymous00154. · Section of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USA. · Am J Cardiol. · Pubmed #15695133 No free full text.

Abstract: We sought to characterize current patterns of care for lipid testing and management in a sample of patients in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines Quality Improvement Initiative and to determine the most important predictors of lipid testing and management at discharge. We evaluated data from >40,000 patients who had been hospitalized in United States hospitals from March 2000 to March 2003 and had a principal discharge diagnosis of unstable angina pectoris or non-ST-segment elevation acute myocardial infarction as part of the initiative.

Tavris DR, Gallauresi BA, Lin B, Rich SE, Shaw RE, Weintraub WS, Brindis RG, Hewitt K. · Food and Drug Administration, Center for Devices and Radiological Health, Division of Postmarket Surveilance, USA. · J Invasive Cardiol. · Pubmed #15353824 No free full text.

Abstract: Hemostasis devices are primarily used to stop bleeding from the femoral artery catheterization site after cardiac diagnostic or interventional procedures. Studies assessing the effectiveness of hemostatic devices compared to manual compression have produced mixed results regarding the relative risk of serious adverse events, such as hemorrhage. This study assessed the relative risk of serious complications following the use of the two main types of hemostasis devices (as compared with manual compression), and assessed the relative rates of these complications by gender.

Anderson HV, Shaw RE, Brindis RG, Hewitt K, Krone RJ, Block PC, McKay CR, Weintraub WS. · Texas Heart Institute and the University of Texas, Houston 77030, USA. · J Am Coll Cardiol. · Pubmed #11923031 No free full text.

Abstract: The American College of Cardiology (ACC) established the National Cardiovascular Data Registry (ACC-NCDR) to provide a uniform and comprehensive database for analysis of cardiovascular procedures across the country. The initial focus has been the high-volume, high-profile procedures of diagnostic cardiac catheterization and percutaneous coronary intervention (PCI).Several large-scale multicenter efforts have evaluated diagnostic catheterization and PCI, but these have been limited by lack of standard definitions and relatively nonuniform data collection and reporting methods.Both clinical and procedural data, and adverse events occurring up to hospital discharge, were collected and reported according to uniform guidelines using a standard set of 143 data elements. Datasets were transmitted quarterly to a central facility for quality-control screening, storage and analysis. This report is based on PCI data collected from January 1, 1998, through September 30, 2000.A total of 139 hospitals submitted data on 146,907 PCI procedures. Of these, 32% (46,615 procedures) were excluded because data did not pass quality-control screening. The remaining 100,292 procedures (68%) were included in the analysis set. Average age was 64 +/- 12 years; 34% were women, 26% had diabetes mellitus, 29% had histories of prior myocardial infarction (MI), 32% had prior PCI and 19% had prior coronary bypass surgery. In 10% the indication for PCI was acute MI < or =6 h from onset, while in 52% it was class II to IV or unstable angina. Only 5% of procedures did not have a class I indication by ACC criteria, but this varied by hospital from a low of 0 to a high of 38%. A coronary stent was placed in 77% of procedures, but this varied by hospital from a low of 0 to a high of 97%. The frequencies of in-hospital Q-wave MI, coronary artery bypass graft surgery and death were 0.4%, 1.9% and 1.4%, respectively. Mortality varied by hospital from a low of 0 to a high of 4.2%.This report presents the first data collected and analyzed by the ACC-NCDR. It portrays a contemporary overview of coronary interventional practices and outcomes, using uniform data collection and reporting standards. These data reconfirm overall acceptable results that are consistent with other reported data, but also confirm large variations between individual institutions.