Sangaralingham, Lindsey R.

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.

Introduction: Watchman has been increasingly used in AF patients who have difficulties taking anticoagulation, but the RCTs only compared Watchman to warfarin. There was also a signal of increased ischemic stroke with Watchman in comparison to warfarin in RCTs, which made some clinicians question the fundamental premise that Watchman can reduce stroke. We aimed to compare Watchman to no anticoagulation in a large national cohort of patients in the US. Methods: We identified AF patients treated with Watchman (N=7,309) or no anticoagulation (N=1,234,543) between 2015-2017 from the OptumLabs Data Warehouse, which is the first to link private insurance, Medicare Advantage, and Medicare Fee-for-Service records at patient level longitudinally. One-to-one propensity score matching was used to balance patients on demographics and medical history. The primary outcomes were ischemic stroke or systemic embolism (hereafter referred to as stroke) and major bleeding. Secondary outcomes included all-cause mortality and intracranial bleeding. Results: In the unmatched cohort, the mean age was 76.6±6.4 yr in the Watchman group and 76.6 ±8.5 yr in the no anticoagulation group, but Watchman patients were more likely to have a history of bleeding (44.9% vs 13.7%) and intracranial bleeding (9.5% vs 2.6%). After matching, the two groups were similar on 18 baseline characteristics. Watchman was associated with a lower risk of stroke and mortality, but a higher risk of major bleeding and a similar risk of intracranial bleeding. The associations were largely consistent across subgroups, including those with relative contraindications to anticoagulation (Figure). Conclusions: In AF patients who had difficulties taking anticoagulation, Watchman offers an alternative approach to reduce stroke and mortality. The results provide important evidence to inform clinical decision making in the absence of RCTs, since 40% of AF patients in routine practice are not on anticoagulation.

Abstract Aims This study aims to evaluate the impact of the combination of cardiogenic shock (CS) and cardiac arrest (CA) complicating non-ST-segment elevation myocardial infarction (NSTEMI). Methods and results Adult (&gt;18 years) NSTEMI admissions using the National Inpatient Sample database (2000 to 2017) were stratified by the presence of CA and/or CS. Outcomes of interest included in-hospital mortality, early coronary angiography, hospitalization costs, and length of stay. Of the 7 302 447 hospitalizations due to NSTEMI, 147 795 (2.0%) had CS only, 155 522 (2.1%) had CA only, and 41 360 (0.6%) had both CS and CA. Compared with 2000, the adjusted odds ratios (ORs) and 95% confidence interval (CIs) for CS, CA, and both CS and CA in 2017 were 3.75 (3.58–3.92), 1.46 (1.42–1.50), and 4.52 (4.16–4.87), respectively (all P &lt; 0.001). The CS + CA (61.2%) cohort had higher multiorgan failure than CS (42.3%) and CA only (32.0%) cohorts, P &lt; 0.001. The CA only cohort had lower rates of overall (52% vs. 59–60%) and early (17% vs. 18–27%) angiography compared with the other groups (all P &lt; 0.001). CS + CA admissions had higher in-hospital mortality compared with those with CS alone (aOR 4.12 [95% CI 4.00–4.24]), CA alone (aOR 1.69 [95% CI 1.65–1.74]), or without CS/CA (aOR 22.66 [95% CI 22.06–23.27]). The presence of CS, either alone or with CA, was associated with higher hospitalization costs and longer hospital length of stay. Conclusions The combination of CS and CA is associated with higher rates of acute non-cardiac organ failure and in-hospital mortality in NSTEMI admissions as compared with those with either CS or CA alone.

AbstractBackgroundTo evaluate the economic burden of locally advanced rectal cancer (LARC) treatment from a society perspective through analysis of health insurance‐derived data of commercially insured and Medicare Advantage (MA) patients.MethodsRetrospective cost analysis of patients undergoing rectal resection within a multimodal (neoadjuvant chemoradiation + adjuvant chemotherapy) treatment strategy between January 1, 2010 and October 31, 2018, using the claims OptumLabs Data Warehouse database.ResultsIn total, 1738 (935 commercial and 803 MA) patients were included. Overall treatment costs totaled $230,881,746 (on average $183 653 ± 82 384 per commercially insured and $73 681 ± 32 917 per MA patient). Cost distribution according to category (commercially insured patients) was: 29.92% related to outpatient care (follow‐up visits/diagnostics), radiotherapy: 21.83%, index resection: 20.62%, chemotherapy: 17.44%, surgical inpatient: 6.32%, medical inpatient: 3.28%, emergency room: 0.58%. Relative cost distribution of the index resection itself differed marginally between the three approaches and was 21.49% for open, 19.30% for laparoscopic, and 20.93% for robotic surgery. Relative cost distributions of neoadjuvant, adjuvant, and outpatient treatments remained unchanged, independently of the surgical approach. This representation was similar in MA patients.ConclusionIndex‐surgery related costs were outweighed by costs related to oncological and outpatient workup/follow‐up treatments independently of both surgical approach and insurance type.

Abstract Rationale In October 2014, the antifibrotic medications pirfenidone and nintedanib became the first medications approved by the U.S. Food and Drug Administration for use in patients with idiopathic pulmonary fibrosis (IPF). Since approval, there has been no nonregistry analysis of the real-world adoption of these medications in everyday clinical practice. Objectives To evaluate the adoption, persistence, and out-of-pocket (OOP) costs of pirfenidone and nintedanib since their approval in the United States in 2014. Methods A retrospective cohort analysis was performed by identifying privately insured and Medicare Advantage beneficiaries with IPF. We then split the patients into three cohorts: those who were untreated and those who filled a prescription for either pirfenidone or nintedanib between October 1, 2014, and July 31, 2019. The primary outcome was adoption of the medications. Secondary outcomes included medication persistence and prescription drug costs. Results A total of 10,996 patients with IPF were identified in the data set. A minority of patients (26.4%) with IPF identified in the cohort had started either medication since approval in 2014, with the adoption of both medications being comparable at around 13.2%. Those receiving the medications were younger (72 vs. 73.9 yr; P &lt; 0.0001) and healthier (3.9 vs. 4.9 comorbidities; P &lt; 0.0001) than those not receiving treatment. Men were significantly more likely to receive treatment than woman (30.0% vs. 21.9%; P &lt; 0.0001). Among treated patients, 42.8% discontinued the medications during the study period. Patients’ OOP expenses per month were high for both drugs (mean, $397.51 for nintedanib; mean, $394.49 for pirfenidone). Conclusions The adoption of both the antifibrotic medications in the United States in everyday practice has been low since approval and may be associated with the high OOP cost.