A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Registries have been proven useful to assess clinical outcomes, but data entry and personnel expenses are challenging. We developed a registry to track patients undergoing endovascular aortic aneurysm repair (EVAR) in an integrated health care system, leveraging an electronic medical record (EMR) to evaluate clinical practices, device performance, surgical complications, and medium-term outcomes. This study describes the registry design, data collection, outcomes validation, and ongoing surveillance, highlighting the unique integration with the EMR. METHODS: EVARs in six geographic regions of Kaiser Permanente were entered in the registry. Cases were imported using a screening algorithm of inpatient codes applied to the EMR. Standard note templates containing data fields were used for surgeons to enter preoperative, postoperative, and operative data as part of normal workflows in the operating room and clinics. Clinical content experts reviewed cases and entered any missing data of operative details. Patient comorbidities, aneurysm characteristics, implant details, and surgical outcomes were captured. Patients entered in the registry are followed up for life, and all relevant events are captured. RESULTS: Between January 2010 and June 2013, 2112 procedures were entered in the registry. Surgeon compliance with data entry ranges from 60% to 90% by region but has steadily increased over time. Mean aneurysm size was 5.9 cm (standard deviation, 1.3). Most patients were male (84%), were hypertensive (69%), or had a smoking history (79%). The overall reintervention rate was 10.8%: conversion to open repair (0.9%), EVAR revision (2.6%), other surgical intervention (7.3%). Of the reinterventions, 27% were for endoleaks (I, 34.3%; II, 56.9%; III, 8.8%; IV and V, 0.0%), 10.5% were due to graft malfunction, 3.4% were due to infection, and 2.3% were due to rupture. CONCLUSIONS: Leveraging an EMR provides a robust platform for monitoring short-term and midterm outcomes after abdominal aortic aneurysm repair. Use of standardized templates in the EMR allows data entry as part of normal workflow, improving compliance, accuracy, and data capture using limited but expert personnel. Assessment of patient demographics, device performance, practice variation, and postoperative outcomes benefits clinical decision-making by providing complete and adjudicated event reporting. The findings from this large, community-based EVAR registry augment other studies limited to perioperative and short-term outcomes or small patient cohorts.

Kaiser Permanente implant registries benefit patient safety, quality improvement, cost-effectiveness.

BACKGROUND: In response to the increased volume, risk, and cost of medical devices, in 2001 Kaiser Permanente (KP) developed implant registries to enhance patient safety and quality, and to evaluate cost-effectiveness. METHODS: Using an integrated electronic health record system, administrative databases, and other institutional databases, orthopedic, cardiology, and vascular implant registries were developed in 2001, 2006, and 2011, respectively. These registries monitor patients, implants, clinical practices, and surgical outcomes for KP's 9 million members. Critical to registry success is surgeon leadership and engagement; each geographical region has a surgeon champion who provides feedback on registry initiatives and disseminates registry findings. RESULTS: The registries enhance patient safety by providing a variety of clinical decision tools such as risk calculators, quality reports, risk-adjusted medical center reports, summaries of surgeon data, and infection control reports to registry stakeholders. The registries are used to immediately identify patients with recalled devices, evaluate new and established device technology, and identify outlier implants. The registries contribute to cost-effectiveness initiatives through collaboration with sourcing and contracting groups and confirming adherence to device formulary guidelines. Research studies based on registry data have directly influenced clinical best practices. CONCLUSIONS: Registries are important tools to evaluate longitudinal device performance and safety, study the clinical indications for and outcomes of device implantation, respond promptly to recalls and advisories, and contribute to the overall high quality of care of our patients.

Multi-Center, Community-Based Cardiac Implantable Electronic Devices Registry: Population, Device Utilization, and Outcomes.

BACKGROUND: The purpose of this study is to describe key elements, clinical outcomes, and potential uses of the Kaiser Permanente-Cardiac Device Registry. METHODS AND RESULTS: This is a cohort study of implantable cardioverter defibrillators (ICD), pacemakers (PM), and cardiac resynchronization therapy (CRT) devices implanted between January 1, 2007 and December 31, 2013 by ≈400 physicians in 6 US geographical regions. Registry data variables, including patient characteristics, comorbidities, indication for procedures, complications, and revisions, were captured using the healthcare system's electronic medical record. Outcomes were identified using electronic screening algorithms and adjudicated via chart review. There were 11 924 ICDs, 33 519 PMs, 4472 CRTs, and 66 067 leads registered. A higher proportion of devices were implanted in males: 75.1% (ICD), 55.0% (PM), and 66.7% (CRT), with mean patient age 63.2 years (ICD), 75.2 (PM), and 67.2 (CRT). The 30-day postoperative incidence of tamponade, hematoma, and pneumothorax were ≤0.3% (ICD), ≤0.6% (PM), and ≤0.4% (CRT). Device failures requiring revision occurred at a rate of 2.17% for ICDs, 0.85% for PMs, and 4.93% for CRTs, per 100 patient observation years. Superficial infection rates were <0.03% for all devices; deep infection rates were 0.6% (ICD), 0.5% (PM), and 1.0% (CRT). Results were used to monitor vendor-specific variations and were systematically shared with individual regions to address potential variations in outcomes, utilization, and to assist with the management of device recalls. CONCLUSIONS: The Kaiser Permanente-Cardiac Device Registry is a robust tool to monitor postprocedural patient outcomes and postmarket surveillance of implants and potentially change practice patterns.

Effect of Advancing Age and Multiple Chronic Conditions on Mortality in Patients with End-Stage Renal Disease after Implantable Cardioverter-Defibrillator Placement.

CONTEXT: There is insufficient information on the effect that advancing age and multiple chronic conditions (MCC) have on mortality after placement of an implantable cardioverter-defibrillator in patients with end-stage renal disease (ESRD) vs non-ESRD. OBJECTIVE: To assess whether a differential effect of age and MCC exists between ESRD and non-ESRD. DESIGN: Population-based, retrospective cohort study using data from the national Kaiser Permanente Cardiac Device Registry of patients who underwent placement of an implantable cardioverter-defibrillator between January 1, 2007, and December 31, 2013. MAIN OUTCOME MEASURES: All-cause mortality. RESULTS: Of 7825 patients with implantable cardioverter-defibrillator placement, ESRD-affected patients constituted 4.0% of the cohort (n = 311), were similar in age (p = 0.91), and presented with a larger comorbidity burden (3.3 ± 1.3 vs 2.4 ± 1.5, p < 0.001). The effect of advancing age (every 5 years) on mortality in the ESRD cohort (hazard ratio [HR] = 1.11, 95% confidence interval [CI] = 1.03-1.20) was less than in the non-ESRD cohort (HR = 1.28, 95% CI = 1.25-1.32). Similarly, the effect of each additional comorbidity in the ESRD cohort was less (HR = 1.04, 95% CI = 0.91-1.19) than in the non-ESRD group (HR = 1.20, 95% CI = 1.16-1.25). Lastly, ESRD was independently associated with a 3-fold greater hazard of mortality. CONCLUSIONS: Advancing age and increasing number of MCC have a differential effect on mortality risk in patients with ESRD compared with their non-ESRD counterparts. Future studies should focus on assessment of nonlinear relationships of age, MCC, and naturally occurring clusters of MCC on mortality.

Analysis of mitral valve replacement outcomes is enhanced by meaningful clinical use of electronic health records.

OBJECTIVE: Cardiac surgical mortality has improved during the last decade despite the aging of the population. An integrated US health plan developed a heart valve registry to track outcomes and complications of heart valve operations. This database was used for longitudinal evaluation of mitral valve (MV) outcomes from 1999 to 2008 at four affiliated hospitals. METHODS: We identified 3130 patients in the Apollo database who underwent 3180 initial MV procedures. Internal administrative and Social Security Administration databases were merged to determine survival rates. Electronic health records were searched to ascertain demographics, comorbidities, and postoperative complications. Cox regression was used to evaluate mean survival and identify risk factors. RESULTS: The procedures included 1160 mechanical valve replacements, 1159 tissue valve replacements, and 861 annuloplasties. The mean age of patients undergoing these procedures was 58 ± 11 years, 69 ± 12 years, and 62 ± 12 years, respectively. Mean survival was 8.9 ± 0.1 years for mechanical valve replacement, 7.0 ± 0.1 years for tissue valve replacement, and 7.7 ± 0.1 years for annuloplasty. Early in the study, there was a preference for implanting mechanical MVs. Beginning in 2003, more patients received tissue valve replacements rather than mechanical valves. Over time, there was an increasing trend of annuloplasty. Cox regression analysis identified the following risk factors for increased ten-year mortality: tissue valve implantation; advanced age; female sex; nonelective, nonisolated procedure; diabetes; postoperative use of banked blood products; previous cardiovascular intervention; dialysis; and longer perfusion time. Hospital location, reoperation, preoperative anticoagulation, and cardiogenic shock were not statistically significant risk factors. CONCLUSIONS: When controlling for other risk factors, we observed a lower long-term survival rate for tissue valve replacement compared with mechanical valve replacement. Integrating electronic health records with existing electronic databases provided near-real-time analysis of longitudinal cardiac surgical outcomes.

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

INTRODUCTION: Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. METHODS: Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. RESULTS: Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. CONCLUSIONS: The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.