Shah, Nilay D.

Background: Shared decision-making with decision aids (DA) improves patient knowledge and reduces decisional conflict. The extent to which they do so across sociodemographic subgroups remains unknown. Methods: An encounter-level meta-analysis of five DA randomized trials examined the impact of sociodemographic variables on knowledge transfer and decisional conflict using a generalized linear model stratified by study and adjusted by treatment arm. Results: We analyzed 595 patient-clinician encounters. Significantly higher knowledge transfer with DA occurred in nearly all patient subgroups when compared to usual care (UC). Patients with more formal education tended to have greater knowledge transfer with UC; this was diminished with DA. There was a trend towards improved decisional conflict in all subgroups with the use of DA; overall decisional conflict was low. (see Table) Conclusion: The use of DA compared to UC significantly increases knowledge transfer across diverse subgroups and there is a tendency towards reduced decisional conflict. Differences at baseline, such as knowledge transfer across educational strata, may be mitigated with use of DA. In conclusion, DA are found to be effective across patient subgroups and may represent a novel strategy to lessen disparities.

Background: Heart failure (HF) care constitutes an increasing economic burden on the healthcare system, and has become a key focus in the healthcare debate. Costs incurred at the end of life can be particularly high in some populations, however, end of life costs among a community population of HF patients have not been well delineated. Methods: Olmsted County residents with incident HF from 1987-2006 were identified and followed until death. Direct medical costs incurred in the last 6 months prior to death were obtained using population-based administrative data through 2010. For those that died within 6 months of HF diagnosis, costs were included from diagnosis until death. Costs were inflated to 2010 U.S. dollars using the general Consumer Price Index (CPI). Results: A total of 862 HF patients were identified, died during follow-up, and had complete cost data (mean age 79.4 years, 46.4% male, 56.5% EF≥50%). Median costs within the last 6 months of life were $12,069 per person (25 th -75 th percentile $1768 - $30,841, mean $24,052), with the majority accumulated during hospitalizations (median $8849 per person, mean $20,263, 84.2% total costs for population). A total of 596 (69.1%) patients were hospitalized in the last 6 months of life, and 235 (27.3%) died in the hospital. Costs progressively increased in the months prior to death (Figure), with nearly half (43.4%) of total costs in the last 6 months of life accumulated during the month before death. End of life costs did not change over the study period (p=0.154 adjusted for age and sex). Conclusions: End of life costs are high among community HF patients, particularly in the final month of life. Most of these costs are accumulated during hospitalizations, and a large proportion of HF patients died in the hospital. Among patients with HF nearing the end of life, alternative strategies of care that avoid hospitalizations may be particularly cost-saving.

Introduction: As the US population ages and indications for cardiac device implantation expand, there is a concomitant increase in patients undergoing lead removal/extraction (LR/E).. We sought to examine trends in outcomes and complications associated with LR/E. Methods: We conducted a retrospective analysis using data from a large U.S. commercial insurance database (privately insured and Medicare Advantage patients) identifying all patients undergoing LR/E between 2004 and 2013 with at least one year continuous medical plan enrollment prior to LR/E (to identify baseline comorbidities). Using ICD9 codes and CPT codes, major complications (hemorrhage requiring transfusion, vascular injury, pericardial complications, respiratory complications, cerebrovascular complications, and requirement for cardiac surgery) associated with LR/E and 30-day readmission rates were evaluated. Results: Among 42,878 patients who underwent LR/E (median age of 62 ( 54, 72) years, 70% male); approximately 1 in 40 experienced a major adverse event (2.4%) during the study period. Respiratory complications were the most common complication and 311 patients required cardiac surgery. 30-day readmission occurred in 11.1% of the total population. The most common reasons for readmission were heart failure exacerbation (18.7%) and device related complications (13.2%). Conclusion: The observed complication rates after LE/R in clinical practice are similar to those seen in recent clinical trials and have been relatively stable over the past 10 years.

Introduction: Medicines don’t work in those who don’t take them. Although novel oral anticoagulants (NOACs) are more convenient than warfarin due to fewer drug-drug interactions and less need for laboratory monitoring, their considerable costs and lack of regular interactions with the healthcare system may also contribute to poor adherence. Little is known about the persistence and adherence in the era of NOACs, nor how such behaviors are associated with the risk of ischemic stroke and transient ischemic attack (TIA) among patients of varying baseline risk. Methods: We conducted a retrospective analysis using a large U.S. commercial insurance database, and identified 61,646 patients with atrial fibrillation who initiated one of OACs (warfarin, dabigatran, rivaroxaban and apixaban) between October 2010 and September 2014. We defined discontinuation as being off OACs for at least 3 months and adherence as the proportion of days covered of at least 80%. Cox proportional hazard models was used to examine whether the time that patients were off OACs, including both the gaps between medication fills and the time of discontinuation, increased the risk of ischemic stroke and TIA. Results: Approximately 1 in 3 patients discontinued OACs within one year after initiation and 1 in 10 switched to another OAC. The estimated likelihood of adherence was 0.77 during the time when patients were on their first-line medications. Apixaban had the highest continuation rate (65% at 1 year), while rivaroxaban had the best adherence (predicted probability of adherence 0.83). The event rate of stroke was 1.6 per 100 person years. Patients with high baseline risk (CHA2DS2-VASc ≥2) were more likely to have a stroke when they were off OACs for 1-3 months (HR=1.47, p<0.01), 3-6 months (HR=1.78, p<0.001) and ≥6 months (HR=2.16, p<0.001), compared to off OACs for less than a week. No significant effect was found among low-risk patients (CHA2DS2-VASc 0 or 1). Switching to another OAC was related to 22% increased risk of stroke (p=0.05). Conclusions: Despite their greater convenience relative to warfarin, discontinuation and nonadherence to NOACs is high. Lack of persistence and adherence was associated with increased risk of ischemic stroke and TIA among patients with elevated baseline risk.

Background: In July 2015, the FDA approved the use of sacubitril/ valsartan in patients with heart failure (HF) and reduced ejection fraction. It was shown in a large clinical trial to reduce the risk of both hospitalization and death compared with enalapril, and has since received a class I recommendation for use in the 2016 ACC/ AHA HF guidelines. However, the use of sacubitril/ valsartan in a clinical practice has not been described. We aimed to assess the uptake and cost of sacubitril/ valsartan in its first year following FDA approval. Methods: Using a large U.S. insurance database, we identified privately insured and Medicare Advantage (MA) patients who filled a first prescription for sacubitril/ valsartan between July 1, 2015 and July 31, 2016. We restricted to persons with medical and pharmacy enrollment for 6 months prior to first fill. For reference, we identified all individuals with a diagnosis of HF on a billing claim (ICD9 428.X or ICD-10 I50.X) in the same time period. Results: There were 314,410 individuals with a diagnosis of HF in the study period. In total, 972 filled a new prescription for sacubitril/ valsartan, and the number of new users steadily increased over time (Figure). The mean age of sacubitril/ valsartan users was 68.1±12.3 years, 32.5% were women, 61.1% were white, and 77% were enrolled in MA plans. Most prescribing clinicians were cardiologists (82.5%). A majority of prescription costs were covered by the health plan (mean $324.05, median $335.38, interquartile range [IQR] $266.56-$370.10). Out-of-pocket (OOP) costs per 30-day prescription filled were variable (mean $101.53, median $45.00, IQR $7.40-$97.49), and were similar in beneficiaries enrolled in MA and commercial plans. By comparison, median OOP costs were $2-4 for lisinopril, losartan, carvedilol, and spironolactone per 30-day prescription. Discussion: These finding suggest that the uptake of sacubitril/ valsartan has been slow in the first year after FDA approval. While the majority of prescription costs are covered by the health plan, OOP costs are still much higher than other guideline-recommended HF medications. Further studies are needed to determine if uptake of sacubril/ valsartan continues to rise and if the higher prescription cost is associated with lower downstream costs of hospitalization and mortality benefit.

e18862 Background: Hematopoietic cell transplantation (HCT) is a medically complicated, expensive and resource intensive medical technology. High health care costs are usually associated with high Out-of-Pocket (OOP) costs. In this population-based study, using deidentified administrative claims data from OptumLabs Data Warehouse, we describe total and patient level costs for one-year pre and post HCT and describe the characteristics of those with top 25% cost. Methods: Patients who had undergone an autologous or allogeneic HCT in 2015 to 2019 and had continuous health plan coverage for one year prior and post the index date-the date of the first claim for HCT, were included. We examined total costs, patient paid (OOP) and plan paid costs for one year before and after HCT. We also examined inpatient, outpatient, and pharmacy costs for the one year before and after the HCT. Logistic regression models examined factors including age, gender, race/ ethnicity, Charlson comorbidity index, geographic region and costs in the year prior to HCT (baseline costs) for their association with high total costs and high OOP costs (top 25%). Results: A total of 3,346 patients (2,344 commercial plan (CPE) and 1,002 under Medicare Advantage plan (MAPE) enrollees) were included in the study. Median one year post HCT costs for CPE was $ 612,517 (IQR 413,348- 960,456) and for MAPE was $ 521,000 (IQR 347,388-736,685). Median one year post HCT OOP costs were $ 5,407 (IQR 1,584 -10,000) in CPE and $7,199 (IQR 3,485 -16,396) in MAPE group. 625 subjects in the CPE and 253 subjects in MAPE group had overall costs in the top 25%. Median baseline costs were $482,107 vs. $846,943 in the low vs. high cost group in CPE and $278,656 vs. $343,633 in MAPE. There was a low correlation between OOP costs and overall costs (r = 0.17 for CPE and 0.15 for MAPE; p < 0.05). Younger age (OR for age 0.98; p < 0.001) and higher baseline costs (OR1.89; p < 0.001) predicted top 25% total costs post HCT in the CPE group. Not being African American (OR for African American 0.5; p = 0.02) and higher baseline costs (OR 1.07; p < 0.001) predicted top 25% total costs post HCT in MAPE group. Age (OR 0.97; p < 0.001), not being African American (OR 0.5; p = 0.001) and high baseline costs (OR 1.44; p < 0.001) also predicted higher OOP costs in the CPE group. The only factor that was associated with lower likelihood of OOP costs in top 25% in MAPE group was being Hispanic (OR 0.6; p = 0.004). Conclusions: HCT is an expensive treatment modality. High costs prior to HCT are associated with high post HCT costs both for patients on commercial and Medicare Advantage plan. The magnitude of correlation between patient level and total costs was low, likely due to differences in benefit plan. A careful assessment of benefits and costs of HCT is needed for providing high-value care and allow optimum allocation of the finite resources while minimizing patient level financial burden.

Abstract Objective The study sought to conduct an informatics analysis on the National Evaluation System for Health Technology Coordinating Center test case of cardiac ablation catheters and to demonstrate the role of informatics approaches in the feasibility assessment of capturing real-world data using unique device identifiers (UDIs) that are fit for purpose for label extensions for 2 cardiac ablation catheters from the electronic health records and other health information technology systems in a multicenter evaluation. Materials and Methods We focused on data capture and transformation and data quality maturity model specified in the National Evaluation System for Health Technology Coordinating Center data quality framework. The informatics analysis included 4 elements: the use of UDIs for identifying device exposure data, the use of standardized codes for defining computable phenotypes, the use of natural language processing for capturing unstructured data elements from clinical data systems, and the use of common data models for standardizing data collection and analyses. Results We found that, with the UDI implementation at 3 health systems, the target device exposure data could be effectively identified, particularly for brand-specific devices. Computable phenotypes for study outcomes could be defined using codes; however, ablation registries, natural language processing tools, and chart reviews were required for validating data quality of the phenotypes. The common data model implementation status varied across sites. The maturity level of the key informatics technologies was highly aligned with the data quality maturity model. Conclusions We demonstrated that the informatics approaches can be feasibly used to capture safety and effectiveness outcomes in real-world data for use in medical device studies supporting label extensions.