2016 Report from 4 ACC National Cardiovascular Data Registries

80 Pages·2016·1.04 MB·English

Accepted Manuscript
Trends in U.S. Cardiovascular Care: 2016 Report from 4 ACC National
Cardiovascular Data Registries
Frederick A. Masoudi, MD, MSPH, Angelo Ponirakis, PhD, James A. de Lemos, MD,
James G. Jollis, MD, Mark Kremers, MD, John C. Messenger, MD, John W.M. Moore,
MD, MPH, Issam Moussa, MD, William J. Oetgen, MD, MBA, Paul D. Varosy, MD,
Robert N. Vincent, MD, CM, Jessica Wei, MD, MS, Jeptha P. Curtis, MD, Matthew T.
Roe, MD, MHS, John A. Spertus, MD, MPH
PII: S0735-1097(16)37338-7
DOI: 10.1016/j.jacc.2016.12.005
Reference: JAC 23279
To appear in: Journal of the American College of Cardiology
Received Date: 18 July 2016
Revised Date: 8 December 2016
Accepted Date: 16 December 2016
Please cite this article as: Masoudi FA, Ponirakis A, de Lemos JA, Jollis JG, Kremers M, Messenger
JC, Moore JWM, Moussa I, Oetgen WJ, Varosy PD, Vincent RN, Wei J, Curtis JP, Roe MT, Spertus JA,
Trends in U.S. Cardiovascular Care: 2016 Report from 4 ACC National Cardiovascular Data Registries,
Journal of the American College of Cardiology (2017), doi: 10.1016/j.jacc.2016.12.005.
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Trends in U.S. Cardiovascular Care:
2016 Report from 4 ACC National Cardiovascular Data Registries

Brief Title: NCDR® Cardiovascular Care Trends

Frederick A. Masoudi, MD, MSPH*,y; Angelo Ponirakis, PhDz; James A. de Lemos, MTDx;
James G. Jollis, MDjj; Mark Kremers, MD{; John C. Messenger, MD*; John W. M. Moore, MD,
MPH#; Issam Moussa, MDyy; William J. Oetgen, MD, MBAz; Paul D. Varosy, MPDzz; Robert
N. Vincent, MD, CMxx; Jessica Wei, MD, MSz; Jeptha P. Curtis, MDjjjj; Matthew T. Roe, MD,
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MHS{{; John A. Spertus, MD, MPH##
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Affiliations: *Department of Medicine, University of Colorado Anschutz Medical Campus,
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Aurora, Colorado; yColorado Cardiovascular Outcomes Research Consortium, Denver,
Colorado; zAmerican College of Cardiology Foundation, Washington, DC; xDepartment of
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Medicine, University of Texas Southwestern, Dallas, Texas; jjUniversity of North Carolina,
Chapel Hill, North Carolina; {Novant Health Heart and VasculaUr Institute, Charlotte, North
Carolina; #Division of Cardiology, Department of Pediatrics, Rady Children’s Hospital,
University of California-San Diego, San Diego, California; NyyDivision of Cardiology,
Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New
Jersey; zzVA Eastern Colorado Health Care System, UnAiversity of Colorado, and the Colorado
Cardiovascular Outcomes Research Group, Denver, Colorado; xxDivision of Cardiology,
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Department of Pediatrics, Children’s Healthcare of Atlanta, Emory University, Atlanta, Georgia;
jjjjDepartment of Medicine, Yale University, New Haven, Connecticut; {{Duke Cardiovascular
Research Institute, Durham, North Carolina; # #Division of Cardiovascular Diseases, Mid-
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America Heart Institute, Kansas City, Kansas

Disclosures: Dr. Masoudi has a contracEt with the ACCF for his role as Chief Science Officer of
the NCDR®; Dr. Ponirakis, Dr. Oetgen, and Ms. Wei are employed by the ACCF; Dr. de Lemos
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has received grant support from Roche Diagnostics and Abbott Diagnostics, consulting income
from Roche Diagnostics, and honoraria for participation in DSMB or steering committees from
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Novo Nordisc, St. Jude Medical and Amgen; Dr. Kremers has equity <$20K in Boston
Scientific, provides consulting for Medtronic, and is a member of the Speaker's Bureau for
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Boston Scientific; Dr. Messenger is an investigator in Clinical Research Studies, Philips Medical
Systems and a member oCf the Clinical Events Committee of Novate Medical; Dr. Moore is a
consultant for pfm Medical, an investigator in research protocols funded by Medtronic and St.
Jude’s, and on the MCedical Advisory Boards for 480 BioMedical and Transmural Systems; Dr.
Curtis receives salary support through a contract with the American College of Cardiology to
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provide data analytic services; Dr. Roe has received research funding from Eli Lilly, Sanofi-
Aventis, Daiichi-Sanko, Janssen Pharmaceuticals, Ferring Pharmaceuticals, Astra Zeneca,
American College of Cardiology, American Heart Association, Familial Hypercholesterolemia
Foundation and consulting fees or honoraria from PriMed, Astra Zeneca, Boehringer-Ingelheim,
Merck, Amgen, Myokardia, Eli Lilly, Daiichi-Sanyko, and Elsevier Publishers. All conflicts of
interest are listed at https://www.dcri.org/about-us/conflict-of-interest; Dr. Spertus is affiliated
with the Saint Luke’s Mid America Heart and Institute, which is the major analytic center for the
PINNACLE® program and receives funding from the American College of Cardiology for this
role and is also on the Scientific Advisory Board of United Healthcare, provides consulting
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(United Healthcare, Novartis, Amgen, Bayer which are all moderate), has copyright to the SAQ,
KCCQ and PAQ (significant), grants from Gilead, Lilly, Novartis and Abbott Vascular (all
significant), and has equity in Health Outcomes Sciences (Significant). All other authors have
reported that they have no relationships relevant to the contents of this paper to disclose.

Acknowledgments: The authors wish to thank Jim Beachy, RCIS, Christina Koutras, BTSN, RN,
CPHQ, Beth Pruski, MSN, RN, CPHQ, Traci Connolly, RN, MS, and Cornelia Anderson, BSN,
RN, CPHQ, for assistance in compiling the data for this report. P

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Address for correspondence:
Frederick A Masoudi, MD, MSPH
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12401 E 17th Ave
Room 522, Campus Box B132
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Aurora, Colorado 80045
Telephone: [phone] U
Fax: [phone]
E-mail: [email protected] N

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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 proceduresT
performed in 1,612 hospitals) ICD™ for implantable cardioverter defibrillators (158,649
procedures performed in 1,715 hospitals); 3) ACTION®-GWTG™ for acute coronPary
syndromes (182,903 patients admitted to 907 hospitals); and 4) IMPACT® for cardiac
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catheterization and intervention for pediatric and adult congenital heart disease (20,169
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procedures in 76 hospitals). The report provides perspectives on the demographic and clinical
characteristics of enrolled patients; characteristics of participating centers; selected measures of
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processes and outcomes of care.

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Condensed Abstract
National quality programs such as the National Cardiovascular DUata 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® hosNpital quality programs: 1) CathPCI®
for coronary angiography and percutaneous coronary intervention (667,424 procedures
performed in 1,612 hospitals) ICD™ for implantable caArdioverter defibrillators (158,649
procedures performed in 1,715 hospitals); 3) ACTION®-GWTG™ for acute coronary
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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).
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Keywords: percutaneous coronary intervention, acute coronary syndromes, implantable
cardioverter defibrillators, congenital heEart disease, quality of care

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Abbreviations
AUC: Appropriate Use Criteria
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CABG: Coronary artery bypass graft surgery
ICD: Implantable cardioverter defibrillator
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NCDR: National Cardiovascular Data Registries
NCDR ACTION®-GWCTG™: NCDR program for acute coronary syndromes
NCDR CathPCI®: NCDR program for coronary angiography and percutaneous coronary
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NCDR ICD™: NCDR program for implantable cardioverter defibrillators
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NCDR IMPACT®: NCDR program for cardiac catheterization and percutaneous structural
intervention for congenital heart disease
NSTEMI: Non-ST-segment elevation myocardial infarction
PCI: Percutaneous coronary intervention
STEMI: ST-segment elevation myocardial infarction

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Background
The mission of the American College of Cardiology’s (ACC’s) National Cardiovascular
Data Registries (NCDR®) is to improve the quality of cardiovascular care by measuring
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adherence to performance metrics and establishing the foundation for new quality assessment
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measures, providing direct feedback to participating sites together to improve performance;
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implementing quality initiatives; and supporting research that improves patient care and
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outcomes. NCDR data provide a US national perspective on the care and outcomes of high-
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impact cardiovascular conditions and procedures that are not available elsewhere.
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The first NCDR® program, CathPCI®, was launched in 1998 and has collected detailed
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clinical information on more than 17.5 million coronary angiography and percutaneous coronary
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intervention procedures performed in the United States since that time (1). The NCDR® has
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subsequently expanded to include ten programs across the spectrum of cardiovascular disease.

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Of these, eight are hospital-based, including: Diagnostic Catheterization and Percutaneous
Coronary Intervention (CathPCI)®, ImpElantable Cardioverter Defibrillator (ICD)™, Acute
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Coronary Treatment and Intervention Outcomes Network (ACTION)®–Get With The
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Guidelines (GWTG)™, Improving Pediatric and Adult Congenital Treatment (IMPACT)®, Left
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Atrial Appendage Occlusion (LAAO)™, Peripheral Vascular Intervention (PVI)™, Atrial
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Fibrillation (AFib) Ablation™, and The Society of Thoracic Surgeons/American College of
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Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry™ (2). The remaining two
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are outpatient programs for the ambulatory care setting including Practice Innovation and
Clinical Excellence (PINNACLE)® and the Diabetes Collaborative Registry® (DCR) (3).
NCDR programs have also been initiated internationally, facilitating quality improvement in
health systems outside of the United States.
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This report provides a description and overview of the patient populations, participating
centers, and patterns of care from four NCDR® hospital quality programs (CathPCI, ICD,
ACTION-GWTG, and IMPACT) for which comprehensive data from 2014 are available
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(Central Illustration), similar to a prior report summarizing 2011 data (4). As PVI replaced
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Carotid Artery Revascularization and Endarterectomy (CARE)® in 2014, PVI data will be
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presented in a future report. Data from recently initiated programs (Atrial Fibrillation Ablation
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and Left Atrial Appendage Occlusion) will be presented in future reports as data become
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available; those from the outpatient programs (PINNACLE and the Diabetes Collaborative
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Registry) will be presented separately. STS/ACC TVT Registry data are presented in a separate
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annual report (5). This report intended to provide a national perspective on the quality of
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cardiovascular care for common procedures and inform clinical practice and health policy. While
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NCDR programs include international participants, the summary data from this report are limited

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to those submitted by US participants.
NCDR Program Methods E
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Program datasets are developed using an established methodology and employ explicit
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data definitions. Committees of experts from multiple disciplines and professional societies,
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reflecting both clinical quality improvement and research priorities, identify key data elements
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and define metrics to assess the quality of care. Proposed data elements and definitions undergo
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review and iterative refinement, which includes a ranking process and public comment period.
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Upon completion of the final dataset and data dictionary, a data collection form is designed and
tested. Datasets are regularly revised to reflect current clinical practice and on-going scientific
relevance.
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Data are collected by participants for entry into central repositories maintained by the
ACC. The NCDR® applies a comprehensive data quality program to enhance data validity and
reliability (6). This program focuses on data completeness, consistency, and accuracy. All data
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submitted by participating hospitals is subjected to a Data Quality Report process, which applies
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criteria for data field completeness and consistency (ie assessments for implausible outlier
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values). Transactional steps during the construction of data sets for analytic purposes further
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ensure data consistency. Finally, audits are conducted on an annual basis to assess data validity
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and reliability. Sites are selected either at random or as the result of “outlier analysis” that
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identifies patterns of data that may be indicative of inconsistent data entry. This audit focuses
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primarily on data elements that are required to calculate performance metrics or that are used in
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risk-adjustment outcomes models.
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All program metrics are based on ACC guidelines. Many are adopted directly from

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ACC/AHA Performance Measures documents. Others are recommended by the individual
registry Steeering Commitees and are deEveloped by the NCDR Measures and Risk Adjustment
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Subcommittee. Measures developed by NCDR are subject ot a 30-day open comment period and
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are reviewed and approved by the NCDR Science and Quality Oversight Committee. A subset of
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metrics are considered Performance Measures, which are measures meeting the criteria for
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inclusion in accountability programs (e.g. public reporting) (7). Others are considered Quality
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Metrics, which are those measures that are not currently considered suitable for accountability
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but that are useful for quality improvement purposes. When available, NCDR also reports ACC
Appropriate Use Criteria (AUC), which provides feedback on the extent to which proccedures
are performed according to evidence-based clinical parameters.
APPLICATIONS OF NCDR DATA
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Since 1998, NCDR programs have provided a mechanism for centers to identify
opportunities for quality improvement based upon evidence-based performance feedback that
includes national benchmarks. Using these data, hospitals can identify gaps in care as well as
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understand the range of performance that can be achieved in other participating centers in the US
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and with an increasing international presence. NCDR hospital programs are now employed in
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more than 2,000 US healthcare facilities, and thus in many cases, the benchmarks reported by the
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programs can be considered accurate reflections of care provided across the US.
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Key performance metrics are provided to participating hospitals on a quarterly basis
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accompanied by an explanation of the benchmarking methodology used to facilitate comparison
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of one institution’s outcomes to national results.
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The NCDR also participates in state- and nation-wide quality reporting initiatives.
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Program metrics are used by a number of payers as well several US states as part of efforts to

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assess and ensure quality within their jurisdictions (8,9). The ACC has initiated a voluntary
hospital-level public reporting program E(10,11) that includes Performance Measures from the
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CathPCI and ICD programs available on the ACC CardioSmart patient website (12). The
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measures used in this voluntary program are only those that satisfy the reliability and validity
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criteria for the purposes of accountability. To this point, all measures employed in the NCDR
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public reporting program have been endorsed by the National Quality Forum. US News also
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includes NCDR participation in its Best Hospital Rankings. Specifically, hospitals that
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participate in the NCDR public reporting program receive credit in the Best Hospitals in
Cardiology & Heart Surgery rankings (13). Participation in the IMPACT registry results in credit
in the Children’s Cardiology and Heart Surgery specialty rankings (14). Thus, the evidence-
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based metrics developed by NCDR have become established as national standards for
cardiovascular care.
The NCDR also supports generalizable health services, outcomes, and policy research.
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Each contributes to the broader understanding of cardiovascular care in the US and illustrates the
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power of the large community of NCDR participants collectively to improve cardiovascular
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health. The NCDR has been employed to elucidate myriad aspects of care and outcomes in
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contemporary practice across the registries. Recent examples include procedural success and
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complications after pulmonary artery stenting from IMPACT (15); observational comparative
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effectiveness of CRT-D vs. ICD in patients with chronic kidney disease from ICD (16); or
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outcomes of interventions for chronic total occlusions from CathPCI (17). Risk models from the
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NCDR have been developed for death (18), bleeding (19), and acute kidney injury (20), allowing
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clinicians to target more intensive risk reduction strategies to the highest risk patients (21). The

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NCDR programs have generated insights into the appropriateness of cardiovascular procedures
(22); analysis of trends from the CathPCEI program suggest that the benchmarking and feedback
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of procedural appropriateness has resulted in meaningful improvements in patient selection for
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procedures (23). The NCDR also contributes to the science of quality of care, including the
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assessment of the validity of the program outcome metrics (24) or the potential impact of new
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practice guidelines on clinical care (25,26).
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NCDR Programs
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NCDR® CathPCI®
Diagnostic Catheterization and Percutaneous Coronary Intervention (CathPCI)® is
sponsored by ACCF in conjunction with the Society for Cardiovascular Angiography and
Interventions. The CathPCI® was designed to create a national surveillance system to assess the
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characteristics, treatments, and outcomes of patients who undergo procedures in cardiac
catheterization (Cath) laboratories including coronary angiography and percutaneous coronary
intervention (PCI). As of the end of 2014, CathPCI® included data on over 17,600,000 records
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since its inception in 1998. The program does not mandate data collection for all angiography
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procedures but does require inclusion of all PCIs. In 2014, CathPCI® was used in more than
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90% of PCI-capable hospitals in the US. Currently, 70% of sites submit data for all diagnostic
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catheterization and PCI procedures; the remaining 30% of sites provide all PCI procedures and
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the associated diagnostic catheterizations but do not include all ‘diagnostic only’ procedures (1).
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Eligible patients are adults (18 years and older) undergoing an eligible procedure. For diagnostic
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catheterization, eligible procedures include catheterization with the passage of a catheter into the
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aortic root for pressure measurements and/or angiography, and can include left ventricular (LV)
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pressure measurements, LV angiography, coronary angiography, and coronary artery bypass

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angiography. For PCI, eligible procedures include those where PCI was attempted and/or
performed, defined so by the introductioEn of a guidewire for the purpose of achieving
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mechanical revascularization.
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In 2014, 667,424 patients who underwent PCI were included in the program, with a
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mean age of 64.6 years (SD = + 12.3); most (86.5%) were White (Table 1). Prior coronary
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events, including prior MI (30.4%), prior PCI (41.2%), and prior CABG (17.8%) were relatively
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common (Table 2). Approximately one third of procedures were for elective indications. The
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number of participating hospitals was 1,612, the majority of which (87%) were private or
community hospitals and in urban or suburban locations (81%, Table 3). The geographic
distribution of participating centers is shown in Figure 1; CathPCI® is used 11 sites outside of
the US and US territories.
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