Charles R. McKay

Guidelines for the Management of Patients With Valvular Heart Disease Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients With Valvular Heart Disease)

This executive summary and recommendations appears in the November 3, 1998, issue of Circulation . The guidelines in their entirety, including the ACC/AHA Class I, II, and III recommendations, are published in the November 1, 1998, issue of the Journal of the American College of Cardiology . Reprints of both the full text and the executive summary and recommendations are available from both organizations. During the past 2 decades, major advances have occurred in diagnostic techniques, the understanding of natural history, and interventional cardiological and surgical procedures for patients with valvular heart disease. The information base from which to make clinical management decisions has greatly expanded in recent years, yet in many situations, management issues remain controversial or uncertain. Unlike many other forms of cardiovascular disease, there is a scarcity of large-scale multicenter trials addressing the diagnosis and treatment of valvular disease from which to derive definitive conclusions, and the literature represents primarily the experiences reported by single institutions in relatively small numbers of patients. The Committee on Management of Patients With Valvular Disease was given the task of reviewing and compiling this information base and making recommendations for diagnostic testing, treatment, and physical activity. These guidelines follow the format established in previous American College of Cardiology/American Heart Association (ACC/AHA) guidelines for classifying indications for diagnostic and therapeutic procedures: Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment IIa. Weight of evidence/opinion is in favor of usefulness/efficacy IIb. Usefulness/efficacy is less well established by evidence/opinion. Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful and in some cases …

Comparative Effectiveness of Revascularization Strategies

BACKGROUND Questions persist concerning the comparative effectiveness of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG). The American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) collaborated to compare the rates of long-term survival after PCI and CABG. METHODS We linked the ACCF National Cardiovascular Data Registry and the STS Adult Cardiac Surgery Database to claims data from the Centers for Medicare and Medicaid Services for the years 2004 through 2008. Outcomes were compared with the use of propensity scores and inverse-probability-weighting adjustment to reduce treatment-selection bias. RESULTS Among patients 65 years of age or older who had two-vessel or three-vessel coronary artery disease without acute myocardial infarction, 86,244 underwent CABG and 103,549 underwent PCI. The median follow-up period was 2.67 years. At 1 year, there was no significant difference in adjusted mortality between the groups (6.24% in the CABG group as compared with 6.55% in the PCI group; risk ratio, 0.95; 95% confidence interval [CI], 0.90 to 1.00). At 4 years, there was lower mortality with CABG than with PCI (16.4% vs. 20.8%; risk ratio, 0.79; 95% CI, 0.76 to 0.82). Similar results were noted in multiple subgroups and with the use of several different analytic methods. Residual confounding was assessed by means of a sensitivity analysis. CONCLUSIONS In this observational study, we found that, among older patients with multivessel coronary disease that did not require emergency treatment, there was a long-term survival advantage among patients who underwent CABG as compared with patients who underwent PCI. (Funded by the National Heart, Lung, and Blood Institute.).

Treatments, trends, and outcomes of acute myocardial infarction and percutaneous coronary intervention.

Coronary artery disease remains a major public health problem in the U.S. as many Americans experience an acute myocardial infarction (MI) and/or undergo percutaneous coronary intervention (PCI) each year. Given the attendant risks of mortality and morbidity, acute MI remains a principal focus of

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.

Impact of ethnicity and gender differences on angiographic coronary artery disease prevalence and in-hospital mortality in the American College of Cardiology-National Cardiovascular Data Registry.

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 ≥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.

ACCF 2012 Expert Consensus Document on Practical Clinical Considerations in the Interpretation of Troponin Elevations: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents

This document has been developed as an Expert Consensus Document (ECD) by the American College of Cardiology Foundation (ACCF), American Association for Clinical Chemistry (AACC), American College of Chest Physicians (ACCP), American College of Emergency Physicians (ACEP), American College of

Segmentation of intravascular ultrasound images: a knowledge-based approach

Intravascular ultrasound imaging of coronary arteries provides important information about coronary lumen, wall, and plaque characteristics. Quantitative studies of coronary atherosclerosis using intravascular ultrasound and manual identification of wall and plaque borders are limited by the need for observers with substantial experience and the tedious nature of manual border detection. We have developed a method for segmentation of intravascular ultrasound images that identifies the internal and external elastic laminae and the plaque-lumen interface. The border detection algorithm was evaluated in a set of 38 intravascular ultrasound images acquired from fresh cadaveric hearts using a 30 MHz imaging catheter. To assess the performance of our border detection method we compared five quantitative measures of arterial anatomy derived from computer-detected borders with measures derived from borders manually defined by expert observers. Computer-detected and observer-defined lumen areas correlated very well (r=0.96, y=1.02x+0.52), as did plaque areas (r=0.95, y=1.07x-0.48), and percent area stenosis (r=0.93, y=0.99x-1.34.) Computer-derived segmental plaque thickness measurements were highly accurate. Our knowledge-based intravascular ultrasound segmentation method shows substantial promise for the quantitative analysis of in vivo intravascular ultrasound image data.

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.

Tissue characterization in intravascular ultrasound images

Intravascular ultrasound (IVUS) imaging permits direct visualization of vascular pathology. It has been used to evaluate lumen and plaque in coronary arteries and its clinical significance for guidance of coronary interventions is increasingly recognized. Conventional manual evaluation is tedious and time consuming. This paper describes a highly automated approach to segmentation of coronary wall and plaque, and determination of plaque composition in individual IVUS images and pullback image sequences. The determined regions of plaque were classified in one of three classes: soft plaque, hard plaque, or hard plaque shadow. The methods performance was assessed in vitro and in vivo in comparison with observer-defined independent standards. In the analyzed images and image sequences, the mean border positioning error of the wall and plaque borders ranged from 0.13-0.17 mm. Plaque classification correctness was 90%,.

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.