Michael J. Mirro

The National Cardiovascular Data Registry (NCDR) Data Quality Brief : The NCDR Data Quality Program in 2012

OBJECTIVES The National Cardiovascular Data Registry (NCDR) developed the Data Quality Program to meet the objectives of ensuring the completeness, consistency, and accuracy of data submitted to the observational clinical registries. The Data Quality Program consists of 3 main components: 1) a data quality report; 2) a set of internal quality assurance protocols; and 3) a yearly data audit program. BACKGROUND Since its inception in 1997, the NCDR has been the basis for the development of performance and quality metrics, site-level quality improvement programs, and peer-reviewed health outcomes research. METHODS Before inclusion in the registry, data are filtered through the registry-specific algorithms that require predetermined levels of completeness and consistency for submitted data fields as part of the data quality report. Internal quality assurance protocols enforce data standards before reporting. Within each registry, 300 to 625 records are audited annually in 25 randomly identified sites (i.e., 12 to 25 records per audited site). RESULTS In the 2010 audits, the participant average raw accuracy of data abstraction for the CathPCI Registry, ICD Registry, and ACTION Registry-GWTG were, respectively, 93.1% (range, 89.4% minimum, 97.4% maximum), 91.2% (range, 83.7% minimum, 95.7% maximum), and 89.7.% (range, 85% minimum, 95% maximum). CONCLUSIONS The 2010 audits provided evidence that many fields in the NCDR accurately represent the data from the medical charts. The American College of Cardiology Foundation is undertaking a series of initiatives aimed at creating a quality assurance rapid learning system, which, when complete, will monitor, evaluate, and improve data quality.

Review of the Registry's Fourth Year, Incorporating Lead Data and Pediatric ICD Procedures, and Use as a National Performance Measure

tephen C. Hammill, MD, Mark S. Kremers, MD, Lynne Warner Stevenson, MD, aul A. Heidenreich, MD, Christine M. Lang, RN, MSN, Jeptha P. Curtis, MD, Yongfei Wang, MS, harles I. Berul, MD, Alan H. Kadish, MD, Sana M. Al-Khatib, MD, MHS, Ileana L. Pina, MD, ary Norine Walsh, MD, Michael J. Mirro, MD, Bruce D. Lindsay, MD, Matthew R. Reynolds, MD, athryn Pontzer, Laura Blum, Frederick Masoudi, MD, MSPH, John Rumsfeld, MD, PhD, alph G. Brindis, MD, MPH

Review of the ICD Registry's Third Year, Expansion to include Lead Data and Pediatric ICD Procedures, and Role for Measuring Performance

ntroduction he National ICD Registry became the sole repository of CD implantation data for Medicare beneficiaries on April , 2006, and as of June 2009 had collected data from ,432 hospitals in the United States totaling over 380,000 mplants. The registry was developed through a partnership f the Heart Rhythm Society (HRS [www.HRSonline.org]) nd the American College of Cardiology Foundation ACCF [www.acc.org]) utilizing the expertise of the ational Cardiovascular Data Registry (NCDR [www. ccncdr.com]) and has made substantial progress toward everal predefined goals:

Review of the Registry's Second Year, Data Collected, and Plans to Add Lead and Pediatric ICD Procedures

esenc F d m l b t G t N d s Q o M N h a c p i t t i e r i e t a e y p c e t t b T t ntroduction he National ICD Registry became the sole repository of CD implantation data for Medicare beneficiaries April 1, 006 and as of June 2008 had collected data from 1,448 ospitals in the United States totaling over 270,373 imlants. This registry was developed through a partnership of he Heart Rhythm Society (HRS; www.HRSonline.org) and he American College of Cardiology Foundation (ACCF; ww.acc.org) utilizing the expertise of the National C iovascular Data Registry (NCDR; www.accncdr.com). he National ICD Registry is accruing ICD implants at the ate of 10,000 per month with 88% of implants being done n hospitals that enter all patients receiving ICDs including oth primary and secondary prevention indications in all ge groups. A rigorous Data Quality Reporting process is in lace to ensure data accuracy and hospital auditing will egin the summer of 2008. Six abstracts have been pr ed, and four manuscripts are in development utilizing ata generated from the National ICD Registry answering ey clinical questions elicited from the growing ICD imlant patient database ( http://www.accncdr.com). Funding or the Longitudinal ICD Registry Study has been procured, nd the study will begin in 2008. The scope of the National CD registry is being expanded to include data on new trial, ventricular, defibrillation, and left-heart leads placed t the time of ICD implant and whenever existing leads are epositioned, replaced, extracted or abandoned. These data ill assist the Food and Drug Administration (FDA) with urveillance of lead performance. Pediatric ICD implantaions will be followed in the Registry; and the Registry is eing positioned to serve as a performance reporting tool to ssist with quality measures.

Angular displacement of the papillary muscles during the cardiac cycle.

Left ventricular rotation about the longitudinal axis of the heart has been qualitatively described but difficult to quantitate. Cross-sectional echocardiography offers a simple, noninvasive method for determining both the presence and degree of left ventricular rotation. In this study we examined normals and patients with various forms of heart disease for angular displacement of the papillary muscles during the cardiac cycle. Assuming that the papillary muscles represent fixed internal reference points, angular displacement of these points represents left ventricular rotation about the longitudinal axis. Short-axis, cross-sectional echocardiograms were recorded in 100 patients 34 normals, 16 patients with secundum atrial septal defect and 50 patients with various forms of valvular, congenital and ischemic heart disease. Angular displacement of the papillary muscles was determined by measuring the angle subtended between a line drawn parallel to the chest wall and a second line drawn through the tips of the papillary muscles. The degree of angular displacement of the papillary muscles was then derived by subtracting the diastolic angle from the systolic angle. This value was interpreted to represent the degree of left ventricular rotation about the longitudinal axis during the cardiac cycle. The normal group had a minimal degree of counterclockwise left ventricular rotation (mean 3.00; range 0-6%deg;). Exaggerated counterclockwise left ventricular rotation was noted in patients with secundum atrial septal defect (mean 17.20; range 9-29%deg;; p < 0.001). Eight of these patients were studied after surgical closure of the defect, and the pattern of left ventricular rotation was not significantly different from that in normals (mean 3.3%deg;; range 2-5%deg;). The third group of patients, who had various forms of heart disease, including right ventricular volume and pressure overload, had minimal left ventricular rotation (mean 3.20; range 0-7%deg;). e conclude that minimal counterclockwise left ventricular rotation occurs in normals and patients with heart disease. Exaggerated left ventricular rotation is characteristically observed in patients with secundum atrial septal defect, and is abolished after surgical closure of the defect.

ACCF 2008 health policy statement on principles for public reporting of physician performance data: A Report of the American College of Cardiology Foundation Writing Committee to develop principles for public reporting of physician performance data.

Janet S. Wright, MD, FACC, Chair Kathleen Blake, MD, FACC Robert O. Bonow, MD, FACC Ralph G. Brindis, MD, FACC John E. Brush, Jr, MD, FACC Joseph G. Cacchione, MD, FACC Gregory J. Dehmer, MD, FACC Joseph P. Drozda, Jr, MD, FACC Kim A. Eagle, MD, FACC James W. Fasules, MD, FACC Kathleen B

Addressing barriers to optimal oral anticoagulation use and persistence among patients with atrial fibrillation: Proceedings, Washington, DC, December 3-4, 2012

Approximately half of patients with atrial fibrillation and with risk factors for stroke are not treated with oral anticoagulation (OAC), whether it be with vitamin K antagonists (VKAs) or novel OACs (NOACs); and of those treated, many discontinue treatment. Leaders from academia, government, industry, and professional societies convened in Washington, DC, on December 3-4, 2012, to identify barriers to optimal OAC use and adherence and to generate potential solutions. Participants identified a broad range of barriers, including knowledge gaps about stroke risk and the relative risks and benefits of anticoagulant therapies; lack of awareness regarding the potential use of NOAC agents for VKA-unsuitable patients; lack of recognition of expanded eligibility for OAC; lack of availability of reversal agents and the difficulty of anticoagulant effect monitoring for the NOACs; concerns with the bleeding risk of anticoagulant therapy, especially with the NOACs and particularly in the setting of dual antiplatelet therapy; suboptimal time in therapeutic range for VKA; and costs and insurance coverage. Proposed solutions were to define reasons for oral anticoagulant underuse classified in ways that can guide intervention and improve use, to increase awareness of stroke risk as well as the benefits and risks of OAC use via educational initiatives and feedback mechanisms, to better define the role of VKA in the current therapeutic era including eligibility and ineligibility for different anticoagulant therapies, to identify NOAC reversal agents and monitoring strategies and make knowledge regarding their use publicly available, to minimize the duration of dual antiplatelet therapy and concomitant OAC where possible, to improve time in therapeutic range for VKA, to leverage observational data sets to refine understanding of OAC use and outcomes in general practice, and to better align health system incentives.

Performance measures to promote quality improvement in sudden cardiac arrest prevention and treatment

Sudden cardiac arrest (SCA) is one of the most impactful public health problems in the United States. Despite the progress made in reducing the number of cardiac deaths, the incidence of sudden cardiac death remains high. Studies of life-saving interventions for prevention and treatment of SCA, like β-blockers, aldosterone antagonists, implantable cardioverter defibrillator therapy, automated external defibrillators, and cardiopulmonary resuscitation, have brought to light substantial underutilization, variations in care, and disparities. Thus, a comprehensive systems-based approach to addressing these gaps in care should be implemented. In addition to educating stakeholders about SCA and its prevention and developing tools that could help physicians identify patients who could benefit from primary prevention of SCA, robust performance measures with strong, evidence-based association between process performance and patient outcomes are needed. In this article, we review the burden of SCA and highlight the need to develop performance measures related to the prevention and treatment of SCA.

Impact of electronic personal health record use on engagement and intermediate health outcomes among cardiac patients: a quasi-experimental study.

OBJECTIVES To determine the impact of tethered personal health record (PHR) use on patient engagement and intermediate health outcomes among patients with coronary artery disease (CAD). METHODS Adult CAD patients (N = 200) were enrolled in this prospective, quasi-experimental observational study. Each patient received a PHR account and training on its use. PHRs were populated with information from patient electronic medical records, hosted by a Health Information Exchange. Intermediate health outcomes including blood pressure, body mass index, and hemoglobin A1c (HbA1c) were evaluated through electronic medical record review or laboratory tests. Trends in patient activation measure® (PAM) were determined through three surveys conducted at baseline, 6 and 12 months. Frequency of PHR use data was collected and used to classify participants into groups for analysis: Low, Active, and Super users. RESULTS There was no statistically significant improvement in patient engagement as measured by PAM scores during the study period. HbA1c levels improved significantly in the Active and Super user groups at 6 months; however, no other health outcome measures improved significantly. Higher PAM scores were associated with lower body mass index and lower HbA1c, but there was no association between changes in PAM scores and changes in health outcomes. Use of the PHR health diary increased significantly following PHR education offered at the 6-month study visit and an elective group refresher course. CONCLUSIONS The study findings show that PHR use had minimal impact on intermediate health outcomes and no significant impact on patient engagement among CAD patients.

Clinical Experience and Procedural Outcomes Associated with the DF4 Implantable Cardioverter Defibrillator System: The SJ4 Postapproval Study

Current implantable cardioverter defibrillators (ICDs) employ two or three low‐ and high‐voltage lead connectors, adding complexity and bulk, sometimes resulting in incorrect connections and adverse events. The SJ4 study evaluates the performance of a novel integrated single‐lead DF4 connection system by characterizing lead measurements, handling characteristics, and outcomes.