Objective To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. Design Observational surveillance study. Setting 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). Participants 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. Main outcome measures Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. Results Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. Conclusions The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.
Background/Objectives Neurohormonal therapy, which includes beta‐blockers and angiotensin‐converting enzyme inhibitor/angiotensin receptor blockers (ACEi/ARBs), is the cornerstone of heart failure with reduced ejection fraction (HFrEF) treatment. While neurohormonal therapies have demonstrated efficacy in randomized clinical trials, older patients, which now comprise the majority of HFrEF patients, were underrepresented in those original trials. This study aimed to determine the association between short‐ (30 day) and long‐term (1 year) mortality and the use of neurohormonal therapy in HFrEF patients, across the age spectrum. Design/Setting/Participants This is a population‐based, retrospective, cohort study between January 2008 and December 2015. We used 100% Medicare Parts A and B and a random 40% sample of Part D to create a cohort of 295,494 fee‐for‐service beneficiaries with at least one hospitalization for HFrEF between 2008 and 2015. All analyses were performed between May 2019 and July 2020. Exposure We used Part D data to determine exposure to beta‐blocker and ACEi and ARB therapy. Results We found that in 295,494 patients admitted for HFrEF between 2008 and 2015, the average age was 80 years, 54% were female and 17% were non‐white. The baseline mortality rate was higher among those aged ≥85, but the mortality benefits of neurohormonal therapy were preserved across the age spectrum. Among those ≥85 years old, the hazard ratio for death within 30 days was 0.59 (95% confidence interval [CI] 0.56–0.62; p < 0.001) for beta‐blockers and 0.47 (95% CI 0.44–0.49; p < 0.001) for ACEi/ARBs. The hazard ratio for death within 1 year was 0.37–0.56 (95% CI 0.35–0.58; p < 0.001) for beta‐blockers and 0.38–0.53 (95% CI 0.37–0.55; p < 0.001) for ACEi/ARB. Conclusion At a population level, neurohormonal therapy was associated with lower short‐ and long‐term mortality across the age spectrum.
BACKGROUND:The demographics of heart failure are changing. The rate of growth of the "older" heart failure population, specifically those ≥ 75, has outpaced that of any other age group. These older patients were underrepresented in the early beta-blocker trials. There are several reasons, including a decreased potential for mortality benefit and increased risk of side effects, why the risk/benefit tradeoff may be different in this population. OBJECTIVE: We aimed to determine the association between receipt of a beta-blocker after heart failure discharge and early mortality and readmission rates among patients with heart failure and reduced ejection fraction (HFrEF), specifically patients aged 75+. DESIGN AND PARTICIPANTS: We used 100% Medicare Parts A and B and a random 40% sample of Part D to create a cohort of beneficiaries with ≥ 1 hospitalization for HFrEF between 2008 and 2016 to run an instrumental variable analysis. MAIN MEASURE: The primary measure was 90-day, allcause mortality; the secondary measure was 90-day, allcause readmission. KEY RESULTS: Using the two-stage least squared methodology, among all HFrEF patients, receipt of a betablocker within 30-day of discharge was associated with a − 4.35% (95% CI − 6.27 to − 2.42%, p < 0.001) decrease in 90-day mortality and a − 4.66% (95% CI − 7.40 to − 1.91%, p = 0.001) decrease in 90-day readmission rates. Even among patients ≥ 75 years old, receipt of a betablocker at discharge was also associated with a significant decrease in 90-day mortality, − 4.78% (95% CI − 7.19 to − 2.40%, p < 0.001) and 90-day readmissions, − 4.67% (95% CI − 7.89 to − 1.45%, p < 0.001). CONCLUSION: Patients aged ≥ 75 years who receive a beta-blocker after HFrEF hospitalization have significantly lower 90-day mortality and readmission rates. The magnitude of benefit does not appear to wane with age. Absent a strong contraindication, all patients with HFrEF should attempt beta-blocker therapy at/after hospital discharge, regardless of age.
Background: Endovascular repair (EVR) has replaced open surgery as the procedure of choice for patients requiring elective abdominal aortic aneurysm (AAA) repair. Long-term outcomes of the 2 approaches are similar, making the relative cost of caring for these patients over time an important consideration. Methods and Results: We linked Medicare claims to Vascular Quality Initiative registry data for patients undergoing elective EVR or open AAA repair from 2004 to 2015. The primary outcome was Medicare’s cumulative disease-related spending, adjusted to 2015 dollars. Disease-related spending included the index operation and associated hospitalization, surveillance imaging, reinterventions (AAA-related and abdominal wall procedures), and all-cause admissions within 90 days. We compared the incidence of disease-related events and cumulative spending at 90 days and annually through 7 years of follow-up. The analytic cohort comprised 6804 EVR patients (median follow-up: 1.85 years; interquartile range: 0.82–3.22 years) and 1889 open repair patients (median follow-up: 2.62 years; interquartile range: 1.13–4.80 years). Spending on index surgery was significantly lower for EVR (median [interquartile range]: $25 924 [$22 280–$32 556] EVR versus $31 442 [$24 669–$40 419] open; P <0.001), driven by a lower rate of in-hospital complications (6.6% EVR versus 38.0% open; P <0.001). EVR patients underwent more surveillance imaging (1.8 studies per person-year EVR versus 0.7 studies per person-year open; P <0.001) and AAA-related reinterventions (4.0 per 100 person-years EVR versus 2.1 per 100 person-years open; P =0.041). Open repair patients had higher rates of 90-day readmission (12.9% EVR versus 17.8% open; P <0.001) and abdominal wall procedures (0.6 per 100 person-years EVR versus 1.5 per 100 person-years open; P <0.001). Overall, EVR patients incurred more disease-related spending in follow-up ($7355 EVR versus $2706 open through 5 years). There was no cumulative difference in disease-related spending between surgical groups by 5 years of follow-up (−$33 EVR [95% CI: −$1543 to $1476]). Conclusions: We observed no cumulative difference in disease-related spending on EVR and open repair patients 5 years after surgery. Generalized recommendations about which approach to offer elective AAA patients should not be based on relative cost.
Objectives To evaluate the ability of claims‐based risk adjustment and incremental components of clinical data to identify 90‐day episode costs among lower extremity joint replacement (LEJR) patients according to the Centers for Medicare & Medicaid Services (CMS) Comprehensive Care for Joint Replacement (CJR) program provisions. Data Sources Medicare fee‐for‐service (FFS) data for qualifying CJR episodes in the United States, and FFS data linked with clinical data from CJR‐qualifying LEJR episodes performed at High Value Healthcare Collaborative (HVHC) and Mayo Clinic in 2013. HVHC and Mayo Clinic populations are subsets of the total FFS population to assess the additive value of additional pieces of clinical data in correctly assigning patients to cost groups. Study Design Multivariable logistic models identified high‐cost episodes. Data Collection/Extraction Methods Clinical data from participating health care systems merged with Medicare FFS data. Principal Findings Our three populations consisted of 363 621 patients in the CMS population, 4881 in the HVHC population, and 918 in the Mayo population. When modeling per CJR specifications, we observed low to moderate model performance (CMS C‐Stat = 0.714; HVHC C‐Stat = 0.628; Mayo C‐Stat = 0.587). Adding CMS‐HCC categories improved identification of patients in the top 20% of episode costs (CMS C‐Stat = 0.758, HVHC C‐Stat = 0.692, Mayo C‐Stat = 0.677). Clinical variables, particularly functional status in the population for which this was available (Mayo C‐Stat = 0.783), improved ability to identify patients within cost groups. Conclusions Policy makers could use these findings to improve payment adjustments for bundled LEJR procedures and in consideration of new data elements for reimbursement.
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