Medical Device Innovation: Prospective Solutions for an Ecosystem in Crisis Adding a Professional Society Perspective

Barriers to medical device innovation compromise timelines and costs from bench to bedside. Fragmented strategies by individual competitors are no longer sustainable. Pragmatically focused pre-competitive collaboration across stakeholders approaches innovation as an ecosystem. Desiloing experience and expertise encourages high-impact infrastructure efficiencies unique to pre-competitive constructs. Alignment of processes and objectives across the regulatory, reimbursement, clinical research, and clinical practice enterprises, with particular attention to the total product life cycle and continuous accrual of safety information, promotes more predictable equipoise for speed of access relative to residual safety concerns. Professional societies are well positioned to convene pre-competitive dialogue, facilitate alignment, and add perspective to equipoise within the innovation ecosystem

The clinical and cost burden of coronary calcification in a Medicare cohort: An economic model to address under-reporting and misclassification

AbstractBackgroundCoronary artery calcification (CAC) is a well-established risk factor for the occurrence of adverse ischemic events. However, the economic impact of the presence of CAC is unknown.ObjectivesThrough an economic model analysis, we sought to estimate the incremental impact of CAC on medical care costs and patient mortality for de novo percutaneous coronary intervention (PCI) patients in the 2012 cohort of the Medicare elderly (≥65) population.MethodsThis aggregate burden-of-illness study is incidence-based, focusing on cost and survival outcomes for an annual Medicare cohort based on the recently introduced ICD9 code for CAC. The cost analysis uses a one-year horizon, and the survival analysis considers lost life years and their economic value.ResultsFor calendar year 2012, an estimated 200,945 index (de novo) PCI procedures were performed in this cohort. An estimated 16,000 Medicare beneficiaries (7.9%) were projected to have had severe CAC, generating an additional cost in the first year following their PCI of $3500, on average, or$56 million in total. In terms of mortality, the model projects that an additional 397 deaths would be attributable to severe CAC in 2012, resulting in 3770 lost life years, representing an estimated loss of about $377 million, when valuing lost life years at$100,000 each.ConclusionsThese model-based CAC estimates, considering both moderate and severe CAC patients, suggest an annual burden of illness approaching $1.3 billion in this PCI cohort. The potential clinical and cost consequences of CAC warrant additional clinical and economic attention not only on PCI strategies for particular patients but also on reporting and coding to achieve better evidence-based decision-making

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

AbstractObjectivesWe sought to evaluate the results of percutaneous coronary intervention (PCI) in elderly patients in contemporary practice.BackgroundPrior studies of PCI in the elderly population demonstrate increased in-hospital mortality, but these studies are limited by small population size.MethodsUsing 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.ResultsThe 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.ConclusionsIn patients ≥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

The Implications of Blood Transfusions for Patients With Non–ST-Segment Elevation Acute Coronary Syndromes: Results From the CRUSADE National Quality Improvement Initiative

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.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.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.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.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

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

Abstract 103: Clinical Process and Outcome Improvements Based on Within Site Communication: Insights from the Patient Navigator Acute Myocardial Infarction and Heart Failure Program

Background: Team communication about hospital quality efforts in acute myocardial infarction and heart failure (AMI-HF) may affect compliance with hospital transitional care metrics. Methods: At 2 years, hospitals (n=35) participating in the Patient Navigator Program completed surveys on 5 types of communication (sharing meeting minutes, regular team meetings or conference calls with team leaders, a shared checklist, and electronic medical record (EMR)-directed communication) supporting program implementation. Results were assessed for association with 3 outcomes (30-day unadjusted AMI-HF readmission and in-hospital risk adjusted AMI death) and 14 processes: left ventricular systolic dysfunction evaluation, prescription of renin-angiotensin system and beta-blocker medications; identifying HF cases pre-discharge; medication reconciliation documentation on admission, discharge and both times [AMI-HF); planned follow-up in 7 days [HF]; documentation of self-care education and when to call healthcare providers [AMI-HF] and documentation of medication instructions, timing, and changes [AMI-HF]). In STEMI and NSTEMI, performance composites, overall defect free care and referral to cardiac rehabilitation were assessed. Univariate analyses were completed. Results: There were no differences in process or outcome metrics for sharing meeting minutes, regular team meetings or conference calls with leaders or using a shared checklist. EMR-directed communication was associated with a greater likelihood of discharge medication reconciliation (100% vs 68.4%, p=.027) and prescribed medication documentation, 100% vs 66.7%, p=.024). Sites that used 2-5 vs 0-1 communication types were more likely to identify patients with HF pre-discharge (100% vs 60%, p=.018), perform discharge medication reconciliation (100% vs 66.7%, p=.021), complete education documentation (93.3% vs 58.8%, p=.041) and medication instruction documentation (100% vs 64.7%, p=.019); but they were less likely to improve STEMI performance composite scores (37.5% vs 76.5%, p=.036). Conclusion: Team communication via EMR and using 2+ communication methods promoted some process metric improvements. Some communication methods may have had low use and process and outcome metrics that were unchanged may have been underpowered to detect differences

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

AbstractObjectivesThe 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).BackgroundSeveral 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.MethodsBoth 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.ResultsA 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 ≤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%.ConclusionsThis 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