PubMed Health⌕ Search

Biomedical subjects

Ralph G Brindis

Publications and source records attributed to Ralph G Brindis.

At least 37 records · Page 2Linked to original sources
PubMed2005

Mortality after emergent percutaneous coronary intervention in cardiogenic shock secondary to acute myocardial infarction and usefulness of a mortality prediction model.

Although percutaneous coronary intervention (PCI) in the setting of cardiogenic shock has a high in-hospital mortality rate, it has been shown to decrease the mortality rate in certain subgroups. The identity and relative importance of variables that are predictive of in-hospital mortality rate after PCI for cardiogenic shock are uncertain. Accordingly, we examined data of >300,000 patients in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) that were collected from 1998 to 2002 and evaluated the outcomes in 483 consecutive patients who underwent emergency PCI for cardiogenic shock. Patients' mean age was 65 +/- 13 years, with men predominating (61%). All underwent emergency/salvage PCI in the setting of cardiogenic shock after acute myocardial infarction. Mean left ventricular ejection fraction was 30 +/- 16%. Stents were placed in 64% of patients, and thrombolytic agents were administered in 26%. Although PCI was angiographically successful in 79% of patients, the in-hospital mortality rate was 59.4%. Length of stay after PCI was 7.2 +/- 8 days. Logistic regression using all available variables identified 6 multivariate predictors of death: age (odds ratio [OR] 2.34, 95% confidence interval [CI] 1.68 to 3.28, p <0.001) for each 10-year increment, female gender (OR 1.55, 95% CI 1.00 to 2.41, p <0.001), baseline renal insufficiency (creatinine >2.0 mg/dl; OR 4.69, 95% CI 1.96 to 11.23, p <0.001), total occlusion in the left anterior descending artery (OR 1.99, 95% confidence interval 1.28 to 3.09, p <0.01), no stent used (OR 2.55, 95% CI 1.63 to 3.96, p <0.01), and no glycoprotein IIb/IIIa inhibitor used during PCI (OR 1.96, 95% CI 1.30 to 2.98, p <0.01). In a second analysis using only variables known to the clinician at the time of initial presentation, gender, age, renal insufficiency, and total occlusion of the left anterior descending coronary artery were significant. In conclusion, analysis of patients from the ACC-NCDR who underwent emergency PCI for acute myocardial infarction in the presence of cardiogenic shock shows an in-hospital mortality rate of approximately 60% when PCI is attempted.

Age Factors↗
PubMed2005

Lipid management in patients with unstable angina pectoris and non-ST-segment elevation acute myocardial infarction (from CRUSADE).

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.

Academic Medical Centers↗
PubMed2005

Risk of local adverse events following cardiac catheterization by hemostasis device use - phase II.

OBJECTIVES: To assess the relative risks of serious local adverse events following cardiac catheterization by type of hemostasis device (versus manual compression controls) and gender. BACKGROUND: Reports to the FDA (U.S. Food and Drug Administration) of local vascular complications associated with the use of hemostasis devices following cardiac catheterization and resulting in serious injuries, raised concerns about the safety of these devices. Review of the medical literature also posed cause for concern. METHODS: Data were obtained from the American College of Cardiology-National Cardiovascular Data Registry, modified to suit the needs of this research. It included information from 59 institutions and 13,878 cardiac catheterizations performed during the last quarter of 2003. Multiple logistic regression, using 10 different outcomes, was used to assess the risk associated with type of device and gender, while controlling for demographic and physiologic variables, type of procedure, and several indices of comorbidity. RESULTS: Serious adverse events were reported in 3.37% of patients, the most common being bleeding with hematoma (2.00%). The adjusted odds ratio for women (compared to men) was 1.73 for any vascular complication. Only one hemostasis device, VasoSeal, demonstrated a high risk of any vascular complication compared to manual compression controls (OR = 2.38 [1.47-3.85; p = 0.0004]). This risk was mainly associated with diagnostic cardiac catheterization (OR = 3.36). CONCLUSIONS: VasoSeal appears to pose a greater risk for serious local vascular complications following cardiac catheterization than either manual compression controls or other hemostasis devices. Women have almost twice the risk of men for most local complications.

Cardiac Catheterization↗
PubMed2004

Utilization of early invasive management strategies for high-risk patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE Quality Improvement Initiative.

CONTEXT: The American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of non-ST-segment elevation acute coronary syndromes (NSTE ACS) recommend early invasive management for high-risk patients, given the benefits with this approach demonstrated in randomized clinical trials. OBJECTIVES: To determine the use and predictors of early invasive management strategies (cardiac catheterization <48 hours following presentation) in high-risk patients with NSTE ACS and to examine the association of early invasive management with mortality. DESIGN, SETTING, AND PATIENTS: The CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) Quality Improvement Initiative evaluated care patterns and outcomes for 17,926 high-risk NSTE ACS patients (positive cardiac markers and/or ischemic electrocardiographic changes) based on ACC/AHA guidelines recommendations at 248 US hospitals with catheterization and revascularization facilities between March 2000 and September 2002. MAIN OUTCOME MEASURES: Use of early invasive management within 48 hours of presentation, predictors of early invasive management, and in-hospital mortality. Results Of the 17,926 patients analyzed, 8037 (44.8%) underwent early cardiac catheterization less than 48 hours following presentation. Predictors of early invasive management included cardiology care, younger age, lack of prior or current congestive heart failure, lack of renal insufficiency, ischemic electrocardiographic changes, positive cardiac markers, white race, and male sex. Patients treated with early invasive management were more likely to be treated with medications and interventions recommended by the ACC/AHA guidelines and had a lower risk of in-hospital mortality after adjusting for differences in clinical characteristics and after comparing propensity-matched pairs (2.5% vs 3.7%, P<.001). Conclusions An early invasive management strategy is not utilized in the majority of high-risk patients with NSTE ACS. This strategy appears to be reserved for patients without significant comorbidities and those cared for by cardiologists and is associated with a lower risk of in-hospital mortality.

Aged↗
PubMed2004

Care of non-ST-segment elevation patients: insights from the CRUSADE national quality improvement initiative.

Acute coronary syndromes (ACS), including non-ST-segment elevation (NSTE) ACS, represent a significant source of morbidity and mortality in the United States. To address this widespread, serious health problem, the American College of Cardiology and the American Heart Association (ACC/AHA) published guidelines for the treatment of NSTE ACS, which include unstable angina (UA) and NSTE myocardial infarction (NSTEMI). These ACC/AHA guidelines are intended to help physicians make appropriate decisions when diagnosing and treating patients with NSTE ACS.

Aged↗
PubMed2004

Risk of local adverse events following cardiac catheterization by hemostasis device use and gender.

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.

Analysis of Variance↗
PubMed2003

Sildenafil in patients with cardiovascular disease.

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.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2003

Evaluation of the American College of Cardiology/American Heart Association and the Society for Coronary Angiography and Interventions lesion classification system in the current "stent era" of coronary interventions (from the ACC-National Cardiovascular Data Registry).

In 1988 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for Coronary Angioplasty proposed a lesion classification system to stratify lesions by difficulty and risk to better understand the outcomes of coronary interventions. It was a 3-level (A, B, and C) classification based on 11 lesion characteristics. A modification, dividing the intermediate B category into B1 and B2, is also in common use. Recently, a simplification of this classification was evaluated using the large Society for Cardiac Angiography and Interventions (SCAI) Registry (SCAI I = non-C/patent; SCAI II = C/patent; SCAI III = non-C/occluded; SCAI IV = C/occluded). The lesion classification systems were evaluated in 61,926 patients from the ACC National Cardiovascular Data Registry who underwent single-vessel percutaneous coronary intervention between January 1998 and September 2000. Stents were placed in 74.5% of patients. Logistic models for lesion success and complications were constructed and compared. The c statistic for success using the ACC/AHA original classification system was 0.69, 0.71 for the modified ACC/AHA system, and 0.75 for the SCAI classification. The range of complication and success rates was greater using the SCAI models, and the logistic models for success and complication were more robust for the SCAI system. Thus, in the large ACC-National Cardiovascular Data Registry, with a high percentage of stent usage, the simpler SCAI lesion classification provided better discrimination for success and complications than the more complex ACC/AHA lesion classification system-original or modified.

Angioplasty, Balloon, Coronary↗
PubMed2003

Changing the model of care for patients with acute coronary syndromes.

Acute coronary syndromes (ACS) represent a major cause of morbidity and mortality for patients with cardiovascular disease, but evidence-based therapies shown to improve outcomes for ACS are often underused in clinically eligible patients. Although clinical practice guidelines have been developed to provide standards for the diagnosis and treatment of patients with ACS and to provide physicians with a framework for clinical decision-making, multiple obstacles have hindered their implementation and questions remain about the applicability of guidelines for diverse clinical situations. Systematic reviews of quality-improvement studies have shown that multifaceted approaches using targeted educational interventions, creation of quality standards, and regular performance feedback are needed to ensure sustained improvements in care. Approaches to quality improvement thus are being redirected to focus on multidisciplinary collaborations designed to improve the entire process of care for patients with ACS. Multiple large observational registries and quality-improvement initiatives now are capturing data regarding adherence to practice guidelines and contemporary patterns of care for ACS. This comprehensive evaluation of ACS treatment will help guide efforts designed to promote evidence-based care and ultimately determine the effect of widespread implementation of practice guidelines on clinical outcomes. The shifting model of care for ACS therefore suggests that quality improvement and monitoring of adherence to practice guidelines should be considered components of optimal clinical practice.

Angina, Unstable↗
PubMed2003

Updated risk adjustment mortality model using the complete 1.1 dataset from the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR).

OBJECTIVES: To revise and update a risk adjustment model for in-hospital mortality following percutaneous coronary intervention (PCI) procedures using all data from the 1.1 version of the American College of Cardiology National Cardiovascular Data Registry (ACC-NCR). BACKGROUND: A model based on data received at the ACC-NCDR from 1998-2000 was previously reported. The revision of this mortality model reflects all of the data submitted using 1.1 data specifications and collected through the second quarter of 2001. The model was applied to selected high-risk subgroups from a sample of data collected during the year 2001 from version 2.0 of the NCDR. METHODS: Data on 173,743 PCI procedures collected at the ACC-NCDR between January 1, 1998 and March 31, 2001 were analyzed. A mortality model was generated as well as separate models for presentation with and without acute myocardial infarction within 24 hours. The model was used to generate predicted mortalities that were compared to observed mortalities in more current high-risk patient subgroups in the NCDR. RESULTS: The same factors that were previously found to be associated with increased risk of PCI mortality were re-verified in the current analysis. Inclusion of the complete 1.1 dataset produced some changes in the regression weights and the constant value. Excellent discrimination was achieved in the revised model (C-Index = 0.89). The model was applied to high-risk patient groups from data collected on 76,249 during the calendar year 2001 using the 2.0 NCDR data elements and definitions. These analyses showed a high level of agreement between observed mortality of each subgroup and the predicted mortality rates generated from the revised 1.1 PCI mortality model. CONCLUSIONS: Risk adjustment models for in-hospital mortality following PCI for all patients and for those with and without recent MI were regenerated using all data collected from the 1.1 data specifications of the ACC-NCDR and validated on high-risk groups from data collected during 2001 under data version 2.0 of the NCDR. These models reflect the most up-to-date analysis of mortality prediction from this large, multi-center national database.

Aged↗
PubMed2002

Integrating quality into the cycle of therapeutic development.

The quality of healthcare, particularly as reflected in current practice versus the available evidence, has become a major focus of national health policy discussions. Key components needed to provide quality care include: 1) development of quality indicators and performance measures from specific practice guidelines, 2) better ways to disseminate such guidelines and measures, and 3) development of support tools to promote standardized practice. Although rational decision-making and development of practice guidelines have relied upon results of randomized trials and outcomes studies, not all questions can be answered by randomized trials, and many treatment decisions necessarily reflect physiology, intuition, and experience when treating individuals. Debate about the role of "evidence-based medicine" also has raised questions about the value of applying trial results in practice, and some skepticism has arisen about whether advocated measures of clinical effectiveness, the basic definition of quality, truly reflect a worthwhile approach to improving medical practice. We provide a perspective on this issue by describing a model that integrates quantitative measurements of quality and performance into the development cycle of existing and future therapeutics. Such a model would serve as a basic approach to cardiovascular medicine that is necessary, but not sufficient, to those wishing to provide the best care for their patients.

Clinical Trials as Topic↗
PubMed2002

Percutaneous coronary interventions in octogenarians in the American College of Cardiology-National Cardiovascular Data Registry: development of a nomogram predictive of in-hospital mortality.

OBJECTIVES: We sought to evaluate the results of percutaneous coronary intervention (PCI) in elderly patients in contemporary practice. BACKGROUND: Prior studies of PCI in the elderly population demonstrate increased in-hospital mortality, but these studies are limited by small population size. METHODS: Using the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) of 100,253 patients, the in-hospital outcomes in all 8,828 PCI procedures performed on octogenarians were evaluated. Patients underwent PCI between 1998 and 2000 at over 145 participating centers. RESULTS: The mean age was 83.72 +/- 3.02 years, with female preponderance (53%). The PCI was considered angiographically successful in 93%, stents were placed in 75%, and the post-PCI length of stay was 3.3 +/- 5.1 days. Overall in-hospital mortality was 3.77% but was only 1.35% in PCI without recent myocardial infarction (MI) within one week (p < 0.0001). Patients having PCI within 6 h of the onset of their MI had an increase in mortality tenfold (13.79%) compared with patients without a recent MI (p < 0.0001). All groups that were defined based on time of PCI after MI onset up to seven days had increased mortality (all p < 0.0001). Older age (odds ratio [OR] of 1.03 per incremental year), depressed ejection fraction (EF) (OR 0.69 per 10 points for EF <60%), and time of PCI after MI onset (<6 h, OR 6.87; 6 to 24 h, OR 5.66; 24 h to one week, OR 2.93) were most strongly predictive of outcome by multivariate analysis. The predicted mortality from the multivariate model correlated well with the observed in-hospital mortality up to 20% mortality. A 254-point nomogram was constructed employing the logistic model using a weighted point system. CONCLUSIONS: In patients > or = 80 years old, PCI has good success and acceptable mortality. The presence of an acute or recent MI substantially increases the risk of in-hospital death.

Age Factors↗
PubMed2002

Development of a risk adjustment mortality model using the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) experience: 1998-2000.

OBJECTIVES: We sought to develop and evaluate a risk adjustment model for in-hospital mortality following percutaneous coronary intervention (PCI) procedures using data from a large, multi-center registry. BACKGROUND: The 1998-2000 American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) dataset was used to overcome limitations of prior risk-adjustment analyses. METHODS: Data on 100,253 PCI procedures collected at the ACC-NCDR between January 1, 1998, and September 30, 2000, were analyzed. A training set/test set approach was used. Separate models were developed for presentation with and without acute myocardial infarction (MI) within 24 h. RESULTS: Factors associated with increased risk of PCI mortality (with odds ratios in parentheses) included cardiogenic shock (8.49), increasing age (2.61 to 11.25), salvage (13.38) urgent (1.78) or emergent PCI (5.75), pre-procedure intra-aortic balloon pump insertion (1.68), decreasing left ventricular ejection fraction (0.87 to 3.93), presentation with acute MI (1.31), diabetes (1.41), renal failure (3.04), chronic lung disease (1.33); treatment approaches including thrombolytic therapy (1.39) and non-stent devices (1.64); and lesion characteristics including left main (2.04), proximal left anterior descending disease (1.97) and Society for Cardiac Angiography and Interventions lesion classification (1.64 to 2.11). Overall, excellent discrimination was achieved (C-index = 0.89) and application of the model to high-risk patient groups demonstrated C-indexes exceeding 0.80. Patient factors were more predictive in the MI model, while lesion and procedural factors were more predictive in the analysis of non-MI patients. CONCLUSIONS: A risk adjustment model for in-hospital mortality after PCI was successfully developed using a contemporary multi-center registry. This model is an important tool for valid comparison of in-hospital mortality after PCI.

Aged↗
PubMed2002

A contemporary overview of percutaneous coronary interventions. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR).

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.

Angioplasty, Balloon, Coronary↗