Minimally invasive epicardial surgical left atrial appendage exclusion for atrial fibrillation patients at high risk for stroke and for bleeding.

BACKGROUND: Atrial fibrillation (AF) patients at high risk for stroke and for bleeding may be unsuitable for either oral anticoagulation or endocardial left atrial appendage (LAA) occlusion. However, minimally invasive, epicardial left atrial appendage exclusion (LAAE) may be an option. OBJECTIVE: The purpose of this study was to evaluate outcomes of LAAE in high-risk AF patients not receiving oral anticoagulation. METHODS: A retrospective analysis of Medicare claims data was conducted to evaluate thromboembolic events in AF patients who underwent LAAE compared to a 1:4 propensity score-matched group of patients who did not receive LAAE (control). Neither group was receiving any oral anticoagulation at baseline or follow-up. Fine-Gray models estimated hazard ratios and evaluated between-group differences. Bootstrapping was applied to generate 95% confidence intervals (CIs). RESULTS: The LAAE group (n = 243) was 61% male (mean age 75 years). AF was nonparoxysmal in 70% (mean CHA2DS2-VASc score 5.4; mean HAS-BLED score 4.2). The matched control group (n = 972) had statistically similar characteristics. One-year adjusted estimates of thromboembolic events were 7.3% (95% CI 4.3%-11.1%) in the LAAE group and 12.1% (95% CI 9.5%-14.8%) in the control group. Absolute risk reduction was 4.8% (95% CI 0.6%-8.9%; P = .028). Adjusted hazard ratio for thromboembolic events for LAAE vs non-LAAE was 0.672 (95% CI 0.394-1.146). CONCLUSION: In AF patients not taking oral anticoagulation who are at high risk for stroke and for bleeding, minimally invasive, thoracoscopic, epicardial LAAE was associated with a lower rate of thromboembolic events.

Economic and Humanistic Burden Among Medicare-Aged Women With Fragility Fracture in the United States.

OBJECTIVE: Describe patient characteristics, health care resource utilization, costs, and humanistic burden of women with Medicare insurance with incident fragility fracture who were admitted to post-acute-care (PAC). DESIGN: Retrospective cohort study using 100% Medicare Fee-for-Service (FFS) data. SETTING AND PARTICIPANTS: Community-dwelling female Medicare beneficiaries with incident fragility fracture January 1, 2017, to October 17, 2019, resulting in PAC admission to a skilled nursing facility (SNF), home-health care, inpatient-rehabilitation facility, or long-term acute-care hospital. METHODS: Patient demographic/clinical characteristics were measured during 1-year baseline. Resource utilization and costs were measured during baseline, PAC event, and PAC follow-up. Humanistic burden was measured among SNF patients with linked Minimum Data Set assessments. Multivariable regression examined predictors of PAC costs after discharge and changes in functional status during SNF stay. RESULTS: A total of 388,732 patients were included. Compared with baseline, hospitalization rates were 3.5, 2.4, 2.6, and 3.1 times higher and total costs 2.7, 2.0, 2.5, and 3.6 times higher for SNF, home-health, inpatient-rehabilitation, and long-term acute-care, respectively, following PAC discharge. Utilization of dual-energy X-ray absorptiometry (DXA) and osteoporosis medications remained low: 8.5% to 13.7% received DXA during baseline vs 5.2% to 15.6% following PAC; 10.2% to 12.0% received osteoporosis medication during baseline vs 11.4% to 22.3% following PAC. Dual eligibility for Medicaid (ie, low income) was associated with 12% higher costs; Black patients had 14% higher costs. Activities of daily living scores improved 3.5 points during SNF stay, but Black patients had 1.22-point lower improvement than White patients. Pain intensity scores showed small improvement (-0.8 points). CONCLUSIONS AND IMPLICATIONS: Women admitted to PAC with incident fracture had high humanistic burden with little improvement in pain and functional status and significantly higher economic burden after discharge compared with baseline. Disparities in outcomes related to social risk factors were observed, with consistently low utilization of DXA and osteoporosis medications even after fracture. Results indicate a need for improved early diagnosis and aggressive disease management to prevent and treat fragility fractures.

Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson's Disease.

INTRODUCTION: Complex polypharmacy regimens to manage persistent motor fluctuations result in significant pill burden for patients with advanced Parkinson's disease (APD). This study evaluated the effectiveness of carbidopa/levodopa enteral suspension (CLES) and deep brain stimulation (DBS) on reducing pill burden in APD patients. METHODS: We utilized 100% Medicare fee-for-service claims from 2014 to 2018 linked to CLES Patient Support Program (PSP) data. CLES initiators (CLES-I) were propensity matched 1:1 with patients enrolled in PSP who did not initiate treatment (CLES-NI) (N = 188) or undergo DBS, and 1:3 with patients who received DBS (N = 204, N = 612). Average daily pill burden and levodopa equivalent daily dosage (LEDD) were measured at baseline, 0-6 months and 7-12 months follow-up. RESULTS: CLES-I and CLES-NI had higher pill burden than DBS patients at baseline. However, at 6 months post-treatment, CLES-I had significantly fewer pills/day than CLES-NI (4.7 versus 11.4, p < 0.05) and DBS (4.8 versus 7.4, p < 0.05). A significant reduction in pill burden was observed at 0-6 months (46.3%) and 7-12 months (68.3%) follow-up for CLES-I (p < 0.001) versus increased burden for CLES-NI (+10.5%, p < 0.05 and +8.2%, p > 0.05) and insignificant reductions for DBS (-3.9% and -6.1%, p > 0.05). Mean adjusted pill burden showed 57.3% fewer pills at 0-6 months and 74.1% at 7-12 months among CLES-I compared with CLES-NI, and 49.6% and 70.1% reduction compared with DBS. CLES-I showed a decrease in LEDD at 7-12 months compared with baseline (935 to 237 mg) and to CLES-NI (237 mg versus 1112 mg) and DBS patients (236 mg versus 594 mg). CONCLUSION: CLES led to a significant reduction in pill burden and oral LEDD compared with CLES-NI and DBS patients. Pill burden reduction could be considered a treatment goal for patients with APD challenged by complex polypharmacy regimens that interfere with activities of daily living and quality of life.

Management of uncontrollable motor movements in patients with advanced Parkinson's disease rely on oral levodopa-based treatments. Non-motor symptoms such as depression and anxiety are managed with additional oral medications. Over time, higher and more frequent dosing of oral medications is required, resulting in complex medication regimens that impact quality of life and adherence.A real-world study of 10,752 Parkinson's disease patients between 2014 and 2018 evaluated the effectiveness of two device-aided therapies to reduce pill burden, carbidopa/levodopa enteral suspension and deep brain stimulation. Carbidopa/levodopa suspension treatment involves continuous delivery of levodopa to the intestines through a surgical port attached to a portable pump. Brain stimulation involves surgery to attach metal wires to the brain to send electrical pulses via an implanted stimulator.As Parkinson's disease predominately affects the elderly, we compared Medicare patients on carbidopa/levodopa suspension to a matched control group receiving no suspension and to those receiving brain stimulation. Average pill burden/day was measured prior to receiving a device-aided treatment (baseline) and at 0­6 months and 7­12 months post-treatment (follow-up).The top graph shows that by 6-months post-treatment, patients on carbidopa/levodopa suspension required fewer pills than those without suspension (4.7 versus 11.4), with further pill reduction at 12 months (3.5 versus 11.1). The bottom graph shows that by 6 months, patients on carbidopa/levodopa suspension required fewer pills than patients treated with brain stimulation (4.8 versus 7.4), with further reduction at 12 months (3.6 versus 7.0). The reduction in oral pill burden suggests that the carbidopa/levodopa suspension may present an opportunity to simplify treatment regimens.

Diabetes-Related Complications and Costs in Medicare Beneficiaries with Comorbid Rheumatoid Arthritis and Diabetes Treated with Abatacept Versus Other Targeted DMARDs.

INTRODUCTION: Targeted DMARD (tDMARD) use in patients with rheumatoid arthritis (RA) and type 2 diabetes mellitus (T2DM) may increase whole-body insulin sensitivity. Evidence comparing the T2DM-related clinical and economic impact of abatacept versus other tDMARDs is limited. This study compared differences in T2DM-related healthcare resource utilization (HCRU) and costs in patients with RA and T2DM. METHODS: This retrospective study used 100% Medicare Fee-for-Service claims (parts A/B/D) to identify patients ≥ 65 age, diagnosed with RA and T2DM, and were either TNFi-experienced (switched from a TNFi to another tDMARD) or tDMARD-naïve, initiating their first tDMARD (abatacept, TNFi, or non-TNFi) between 2010 and 2017. Abatacept users were propensity-score (PS) matched to TNFi and other non-TNFi users separately on baseline demographics, comorbidities, medications, T2DM-related HCRU, and costs. Post-index follow-up: until discontinuation of index treatment, disenrollment, death, or end of study period, whichever occurred first. T2DM-related complications and HCRU were assessed. Costs were normalized to per-patient-per-month (PPPM) and inflated to 2019 US$. RESULTS: The TNFi-experienced group included 2169 abatacept/TNFi and 2118 abatacept/other non-TNFi PS-matched pairs; the tDMARD-naïve group included 2667 abatacept/TNFi and 2247 abatacept/other non-TNFi PS-matched pairs. For TNFi-experienced patients, T2DM-related complication rates for inpatient settings PPPM trended lower for abatacept than TNFi (21 vs. 24, p = 0.046) and other non-TNFi groups (21 vs. 26; p < 0.0001). T2DM-related total costs PPPM for TNFi-experienced patients demonstrated lower trends for abatacept than TNFi ($489 vs. $594, p = 0.016) and other non-TNFi users ($493 vs. $606, p = 0.012). CONCLUSIONS: Medicare beneficiaries with RA and T2DM who switch to/initiate abatacept as their first tDMARD have directionally lower rates and costs of T2DM-related complications compared with patients switching to/initiating other tDMARDs. Abatacept treatment may help reduce clinical and economic burdens associated with T2DM in patients with RA.

Out-of-pocket payments for part d covered medications by medicare fee-for-service beneficiaries with heart failure with reduced ejection fraction.

BACKGROUND: Out-of-pocket (OOP) drug costs for Medicare Fee-for-Service (FFS) beneficiaries with heart failure with reduced ejection fraction (HFrEF) are not well characterized. This study evaluated Part D OOP spending by Medicare beneficiaries with chronic HFrEF, stratified by those with and without a worsening HF event (WHFE). METHODS: Medicare FFS 100% Part D claims were used to identify HFrEF patients with 12 months of continuous Part D enrollment in 2018. HFrEF was defined as 1 inpatient or 2 outpatient claims of systolic HF or 1 systolic HF plus 1 HF outpatient claim. WHFE was defined as having a HF hospitalization or intravenous diuretic use within 12 months of HFrEF index date. OOP costs by Medicare Part D coverage phase for all covered drugs were calculated for HFrEF patients, and those with and without WHFE. RESULTS: Of 305,373 Medicare patients with HFrEF, 26% had a WHFE. Total mean (SD) OOP drug costs among all HFrEF patients was $1,166 (1,205)/year. Patients with WHFE and patients without WHFE had respectively a mean (SD) annual OOP costs of $1,302 (1,273) and $1,117 (1,176). Over 39% of HFrEF patients entered the "donut hole" (44% and 37% of patients with WHFE and without WHFE, respectively), while 11% of HFrEF patients entered the catastrophic phase (13% and 10% of patients with and without WHFE, respectively). CONCLUSIONS: More than 1 in 10 patients with heart failure entered the catastrophic phase within Medicare-Fee-For-Service, whereas in 2018 only 10% of costs were attributable to heart failure medication and 90% to comorbidities.

Medication Trajectory and Treatment Patterns in Medicare Patients With Heart Failure and Reduced Ejection Fraction.

BACKGROUND: Although a worsening heart failure event (WHFE) is associated with poor outcomes in patients with heart failure with reduced ejection fraction (HFrEF), it is unclear how guideline-directed medical therapy (GDMT) is used in this population compared to those without WHFEs. This study evaluated treatment patterns in patients with HFrEF, both with and without WHFEs. METHODS: A retrospective study using 100% Medicare Fee-For-Service claims identified beneficiaries with HFrEF, stratified by those with and without WHFEs (defined as hospitalization due to HF or outpatient intravenous diuretic use). The use of GDMT for HFrEF before and after WHFEs and adherence were assessed in patients who were prescribed and initiated GDMT. Logistic regression identified patients' characteristics associated with medication nonadherence. RESULTS: Of 353,642 patients with HFrEF, 31.4% had a WHFE. Although there was no overall change in the treatment trajectory of patients without WHFEs, GDMT use in patients with WHFEs intensified within the first 3 months of a WHFE, but the intensification was not sustained in subsequent months. From 0-3 months pre-WHFE to 0-3 months post-WHFE, the proportion of patients receiving dual (41%-48%) and triple-therapy (4%-12%) increased, followed by a decline to pre-WHFE rates. The 1-year adherence rates for those with and without WHFEs were 67.9% vs 73.3% for beta-blockers; 59.1% vs 70.9% for angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists; 53.9% vs 61.3% for angiotensin receptor-neprilysin inhibitors; and 49.2% vs 59.3% for mineralocorticoid receptor antagonists. WHFE, age < 65 years, Black race, asthma, chronic kidney disease, and depression were associated with nonadherence to medications. Asians and Hispanics were less adherent to some medication classes. CONCLUSIONS: This study demonstrated underuse of GDMT for patients with HFrEF with or without WHFEs. Although there was a treatment escalation within 3 months following WHFE, it was not sustained thereafter.

Quality outcomes, healthcare resource utilization and costs in Medicare patients with chronic heart failure with reduced ejection fraction with and without a worsening event.

AIMS: The study compared quality outcomes, resource utilization, and costs in Medicare beneficiaries with chronic heart failure with reduced ejection fraction (HFrEF) with and without a worsening heart failure event (WHFE). METHODS: This retrospective observational study evaluated claims data for two cohorts of Medicare beneficiaries with chronic HFrEF who were enrolled in Medicare fee-for-service (FFS) or Medicare advantage (MA) plans. The index date was the first claim of HFrEF between October 2015 and September 2017. Patients with WHFE were identified if they had IV diuretic use or hospitalization for HF during 12 months after index date; with remaining patients classified as non-WHFE. During follow-up, starting from the 13th month after HFrEF index date to end of follow-up, generalized linear models were used to adjust for patient characteristics to compare mean per patient per year (PPPY) quality outcomes, resource utilization, and costs between HFrEF patients with and without WHFE. RESULTS: Of the 1,182,509 FFS and 28,645 MA patients with HFrEF, 34.2% and 32.5% developed WHFE, respectively. Compared to patients without WHFE, patients with WHFE had higher rates of all-cause 30-day readmissions (FFS: 42% vs. 31%; MA: 41% vs. 31%), hospitalizations (FFS: 2.27 vs. 1.36; MA: 1.47 vs. 0.78 PPPY) and ED visits (FFS: 1.82 vs. 1.25; MA: 1.43 vs. 0.96 PPPY); all comparisons p < .05. Mortality rates in FFS patients were higher among patients with WHFE (34.3%) compared to those without (23.4%). All-cause total PPPY costs were higher for patients with WHFE compared to those without by $20,825 in FFS and $15,974 in MA. Similar trends were observed for HF-related outcomes. CONCLUSION: Medicare patients with chronic HFrEF experiencing a WHFE had worse quality outcomes as well as higher resource utilization and costs compared to those without WHFE, thus, suggesting the need for better treatments and interventions to manage these patients.

Risk and cost of infection-related hospitalizations in medicare beneficiaries with comorbid rheumatoid arthritis treated with abatacept versus other targeted disease-modifying anti-rheumatic drugs.

OBJECTIVE: This study evaluated infection-related hospitalization risk and cost in tumor necrosis factor inhibitor (TNFi)-experienced and targeted DMARD (tDMARD) naïve rheumatoid arthritis (RA) patients that were treated with abatacept, TNFi, or other non-TNFi. METHODS: This retrospective study used 100% Medicare Fee-for-Service claims to identify patients ≥65 age, diagnosed with RA, and were either 1) TNFi-experienced, who switched from a TNFi to another tDMARD (subsequent tDMARD claim served as index), or 2) tDMARD naïve (first therapy claim served as index), who initiated either abatacept, TNFi, or non-TNFi as their first tDMARD, between 2010 and 2017. Follow-up ended at the date of disenrollment, death, end of study period, or end of index treatment, whichever occurred first. Infection-related hospitalizations included pneumonia, bacterial respiratory, sepsis, skin and soft tissue, joint or genitourinary infections. A Cox proportional hazard model and two part generalized linear model were developed to estimate adjusted infection-related hospitalization risk and costs. Costs were normalized to per-patient-per-month (PPPM) and inflated to 2019 US$. RESULTS: The infection-related hospitalizations rate was lower during follow-up than during baseline periods for abatacept users, but was reversed for both TNFi and other non-TNFi users in both TNFi-experience and tDMARD naïve (p value < .001 based on Breslow-Day test for homogeneity of odds ratios). Infection-related hospitalization PPPM cost was significantly lower in abatacept treated patients compared to TNFi (TNFi-experienced: by $74; tDMARD naïve: $42) and other non-TNFi (TNFi-experienced: by $68; tDMARD naïve: $60). The adjusted infection-related hospitalization risk was significantly higher for RA patients treated with TNFi (TNFi-experienced HR: 1.48; 95% CI: 1.26-1.75, p < .0001; tDMARD naïve HR:1.59; 95% CI: 1.43-1.77, p < .0001) and other non-TNFi (TNFi-experienced HR:1.46; CI:1.28-1.66; tDMARD naïve HR:1.63; 95% CI: 1.44-1.83) than with abatacept. CONCLUSION: RA Medicare Fee-For-Service beneficiaries who either switched or initiated abatacept have a lower infection-related hospitalization risk and cost compared to patients who switched to or initiated other tDMARDs.

Comparative safety of atypical antipsychotics and the risk of pneumonia in the elderly.

PURPOSE: Previous studies have documented increased risk of pneumonia with antipsychotic use in the elderly; however, differential risk across individual atypical antipsychotics remains unaddressed. This study examines the effect of individual atypical antipsychotics on risk of pneumonia in elderly patients. METHODS: This retrospective cohort study was conducted using a large claims database. The study population included new users of atypical antipsychotics (≥65 years). The multiple propensity-score adjusted survival model was used to examine risk of pneumonia within a 1-year follow-up period. RESULTS: A total of 92 234 patients newly prescribed atypical antipsychotic medication were identified. Of these, 41 780 (45.30%) were quetiapine users, 31 048 (33.66%) risperidone users, 11 375 (12.33%) olanzapine users, 6790 (7.36%) aripiprazole users, and 1241 (1.35%) ziprasidone users. Within the 1-year follow-up period, 12 411 (13.46%) patients taking atypical antipsychotics had a diagnosis of pneumonia. The multiple propensity-score-adjusted survival model revealed increased risk of pneumonia with the use of risperidone (hazard ratios (HR) 1.14, 95%CI 1.10-1.18) and olanzapine (HR 1.10, 95%CI 1.04-1.16) compared with the use of quetiapine. CONCLUSION: This large population-based study suggests that use of risperidone and olanzapine increases risk of pneumonia compared with use of quetiapine in elderly patients. This study provides new information on the comparative risk of pneumonia associated with different atypical antipsychotics in the elderly to support optimal treatment decisions.