Abstract Background Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. ...Operator volume patterns and associated outcomes since this change are unknown. Objectives The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample. Methods Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality. Results The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding. Conclusions Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses.
Abstract Cardiovascular disease (CVD) is a leading cause of death and disability in the United States. National quality programs such as the National Cardiovascular Data Registry (NCDR®) permit ...assessments of the quality of care and outcomes for broad populations of patients with CVD. This report provides data from 2014 from four NCDR® hospital quality programs: 1) CathPCI® for coronary angiography and percutaneous coronary intervention (667,424 procedures performed in 1,612 hospitals) ICD™ for implantable cardioverter defibrillators (158,649 procedures performed in 1,715 hospitals); 3) ACTION®-GWTG™ for acute coronary syndromes (182,903 patients admitted to 907 hospitals); and 4) IMPACT® for cardiac catheterization and intervention for pediatric and adult congenital heart disease (20,169 procedures in 76 hospitals). The report provides perspectives on the demographic and clinical characteristics of enrolled patients; characteristics of participating centers; selected measures of processes and outcomes of care.
Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of ...IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs.
Cardiovascular Drug Development Fordyce, Christopher B., MD, MSc; Roe, Matthew T., MD, MHS; Ahmad, Tariq, MD, MPH ...
Journal of the American College of Cardiology,
04/2015, Letnik:
65, Številka:
15
Journal Article
Recenzirano
Odprti dostop
Abstract Despite the global burden of cardiovascular disease, investment in cardiovascular drug development has stagnated over the past 2 decades, with relative underinvestment compared with other ...therapeutic areas. The reasons for this trend are multifactorial, but of primary concern is the high cost of conducting cardiovascular outcome trials in the current regulatory environment that demands a direct assessment of risks and benefits, using clinically-evident cardiovascular endpoints. To work toward consensus on improving the environment for cardiovascular drug development, stakeholders from academia, industry, regulatory bodies, and government agencies convened for a think tank meeting in July 2014 in Washington, DC. This paper summarizes the proceedings of the meeting and aims to delineate the current adverse trends in cardiovascular drug development, understand the key issues that underlie these trends within the context of a recognized need for a rigorous regulatory review process, and provide potential solutions to the problems identified.
Objectives This study sought to provide a report to the public of data from the CathPCI Registry of the National Cardiovascular Data Registry. Background The CathPCI Registry collects data from ...approximately 85% of the cardiac catheterization laboratories in the United States. Methods Data were summarized for 6 consecutive calendar quarters beginning January 1, 2010, and ending June 30, 2011. This report includes 1,110,150 patients undergoing only diagnostic cardiac catheterization and 941,248 undergoing percutaneous coronary intervention (PCI). Results Some notable findings include, for example, that on-site cardiac surgery was not available in 83% of facilities performing fewer than 200 PCIs annually, with these facilities representing 32.6% of the facilities reporting, but performing only 12.4% of the PCIs in this data sample. Patients 65 years of age or older represented 38.7% of those undergoing PCI, with 12.3% being 80 years of age or older. Almost 80% of PCI patients were overweight (body mass index ≥25 kg/m2 ), 80% had dyslipidemia, and 27.6% were current or recent smokers. Among patients undergoing elective PCI, 52% underwent a stress study before the procedure, with stress myocardial perfusion being used most frequently. Calcium scores and coronary computed tomography angiography were used very infrequently (<3%) before diagnostic or PCI procedures. Radial artery access was used in 8.3% of diagnostic and 6.9% of PCI procedures. Primary PCI was performed with a median door-to-balloon time of 64.5 min for nontransfer patients and 121 min for transfer patients. In-hospital risk-adjusted mortality in ST-segment elevation myocardial infarction patients was 5.2% in this sample. Conclusions Data from the CathPCI Registry provide a contemporary view of the current practice of invasive cardiology in the United States.
Given the attendant risks of mortality and morbidity, acute MI remains a principal focus of cardiovascular therapeutics. ...30-day mortality and rehospitalization rates for acute MI are publicly ...reported in an effort to promote optimal acute MI care, and aspects of MI care delivery are the focus of local, regional, and national quality initiatives (1-3). Updates or revisions to the American College of Cardiology (ACC)/American Heart Association (AHA) practice guidelines for PCI, ST-segment elevation myocardial infarction (STEMI), and unstable angina (UA)/non-ST-segment elevation myocardial infarction (NSTEMI) have been published within the last 3 years, building upon prior versions published earlier in the decade (5-7).
Background Guidelines recommend noninvasive tests (NITs) to risk stratify and identify patients with higher likelihood of coronary artery disease (CAD) prior to elective coronary angiography. ...However, a high percentage of patients are found to have nonobstructive CAD. We aimed to understand the relationship between patient characteristics, NIT findings, and the likelihood of nonobstructive CAD. Methods Patients undergoing elective catheterization without history of CAD were identified from 1,128 hospitals in National Cardiovascular Data Registry's CathPCI Registry between July 2009 and December 2011. Noninvasive tests included stress electrocardiogram, stress echocardiogram, stress radionuclide, stress cardiac magnetic resonance, and computed tomographic angiography. Patient demographics, risk factors, symptoms, and NIT results were correlated with the presence of nonobstructive CAD , defined as all native coronary stenoses <50%. Results Of 661,063 patients undergoing elective angiography, 386,003 (58.4%) had nonobstructive CAD. Preprocedure NIT was performed in 64% of patients; 51.9% were reported to be abnormal, but only 9% had high-risk findings. Independent factors associated with nonobstructive CAD were younger age, female sex, atypical chest pain, and a low-risk NIT. Patients with high-risk findings on NIT were more likely to have obstructive CAD (adjusted odds ratio 3.03 2.86-3.22). Noninvasive test findings had minimal incremental value beyond clinical factors for predicting obstructive disease ( C index = 0.75 for clinical factors vs 0.74 for NIT findings). Conclusion In current practice, about two-thirds of patients undergo NIT prior to elective cardiac catheterization, yet most patients have nonobstructive CAD. The weak correlation between most NIT results and the likelihood of obstructive CAD provides further impetus for improving preangiography assessment of likelihood of disease.
Abstract Background Rates of referral to cardiac rehabilitation after percutaneous coronary intervention (PCI) have been historically low despite the evidence that rehabilitation is associated with ...lower mortality in PCI patients. Objectives This study sought to determine the prevalence of and factors associated with referral to cardiac rehabilitation in a national PCI cohort, and to assess the association between insurance status and referral patterns. Methods Consecutive patients who underwent PCI and survived to hospital discharge in the National Cardiovascular Data Registry between July 1, 2009 and March 31, 2012 were analyzed. Cardiac rehabilitation referral rates, and patient and institutional factors associated with referral were evaluated for the total study population and for a subset of Medicare patients presenting with acute myocardial infarction. Results Patients who underwent PCI (n = 1,432,399) at 1,310 participating hospitals were assessed. Cardiac rehabilitation referral rates were 59.2% and 66.0% for the overall population and the AMI/Medicare subgroup, respectively. In multivariable analyses, presentation with ST-segment elevation myocardial infarction (odds ratio 2.99; 95% confidence interval: 2.92 to 3.06) and non–ST-segment elevation myocardial infarction (odds ratio: 1.99; 95% confidence interval: 1.94 to 2.03) were associated with increased odds of referral to cardiac rehabilitation. Models adjusted for insurance status showed significant site-specific variability in referral rates, with more than one-quarter of all hospitals referring <20% of patients. Conclusions Approximately 60% of patients undergoing PCI in the United States are referred for cardiac rehabilitation. Site-specific variation in referral rates is significant and is unexplained by insurance coverage. These findings highlight the potential need for hospital-level interventions to improve cardiac rehabilitation referral rates after PCI.
Abstract Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these ...advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements. This review will examine the current landscape of cardiovascular clinical trials in the United States, highlight recently conducted registry-based clinical trials, and discuss the potential attributes of the recently launched pragmatic clinical trial by the Patient-Centered Outcomes Research Institute’s National Patient-Centered Clinical Research Network, called the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing the Benefits and Long-term Effectiveness) trial.
Guidelines support percutaneous coronary intervention (PCI) of the noninfarct-related artery during primary PCI for ST-segment elevation myocardial infarction (STEMI) in patients with hemodynamic ...compromise; however, in patients without hemodynamic compromise, PCI of the noninfarct-related artery is given a class III recommendation. We analyzed the National Cardiovascular Data Registry (n = 708,481 admissions, 638 sites) to determine the prevalence, predictors, and in-hospital outcomes of primary multivessel PCI from 2004 to 2007. Patients with STEMI and multivessel coronary artery disease who were undergoing primary PCI were identified (n = 31,681). After excluding the patients treated with staged PCI (n = 2,745), 10.8% (n = 3,134) of the remaining population (n = 28,936) were treated with multivessel PCI. Patients undergoing multivessel PCI were at higher risk and were more likely to be in cardiogenic shock. The overall in-hospital mortality rates were greater in patients undergoing multivessel PCI (7.9% vs 5.1%, p <0.01). Among patients with STEMI and cardiogenic shock (n = 3,087), those receiving multivessel PCI had greater in-hospital mortality (36.5% vs 27.8%; adjusted odds ratio 1.54, 95% confidence interval 1.22 to 1.95). In conclusion, these data suggest that performing multivessel PCI during primary PCI for STEMI does not improve short-term survival even for patients with cardiogenic shock. These findings suggest the need for definitive studies to evaluate the utility of noninfarct-related artery PCI among patients with STEMI.
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