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The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking.The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD.The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models.A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161).In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients.

e16252 Background: Treatment options remain limited for pts newly diagnosed with mPDAC. NCCN and ASCO guidelines both recommend treatment with FOLFIRINOX or gemcitabine plus nab-paclitaxel in the first line (1L) setting for pts with mPDAC and good performance status. Over 80% of randomized clinical trials (RCTs) studying treatments for mPDAC have failed to meet their primary endpoints. Recently published analyses have utilized real-world (RW) data to compare outcomes between pts enrolled in clinical trials and RW pts. This study sought to identify the eligible population of pts with mPDAC treated with FOLFIRINOX in the 1L setting who would meet RCT eligibility criteria for the phase 1/2 study (NCT02551991) evaluating NALIRIFOX for pts with previously untreated locally advanced or mPDAC, and to assess their survival outcomes. Methods: This retrospective observational study utilized the Flatiron Health EHR database. Data were analyzed for adult pts diagnosed with mPDAC between January 2016 and February 2020 who initiated treatment with FOLFIRNOX in 1L within 90 days of their diagnosis for metastatic disease. Eligibility criteria from the phase 1/2 trial were applied to select a population of RW pts who may have been eligible to enter the RCT. Pts meeting the following criteria were included: good performance scores (ECOG 0-1), adequate hematological, hepatic, and renal function, were recovered from the effects of surgery, were untreated in the year prior to initiating 1L, and had no evidence of a different cancer in the last three years. Kaplan-Meier analyses were used to assess the median overall survival (mOS) from the start of 1L FOLFIRNOX treatment. Results: Of the 1,210 pts treated with 1L FOLFIRINOX, 652 pts (53.8%) met less stringent versions of the RCT eligibility criteria in which missing values were deemed to indicate normal function/performance; 244 pts (20.2%) met the more stringent criteria and had complete data. The most restrictive selection criteria were the requirements for adequate hematological, hepatic, and renal function and having received prior therapy. The median age at treatment initiation among the 244 pts was 64 years (IQR: 58 – 70). 153 pts were male (62.7%), 158 were White (64.8%), and ECOG scores of 0 and 1 were split among the cohort 50%/50%. The mOS observed for the 244 pts was 10.1 months (95% CI: 9.1 – 11.3). The reported mOS from the phase 1/2 trial of NALIRIFOX was 12.6 months (8.7 – 18.7). Conclusions: This study demonstrates that RW data may be used to select a comparator cohort for a clinical trial. Initial estimates suggest NALIRIFOX pts from the RCT experienced longer survival than those receiving 1L FOLFIRINOX in the RW setting. Further analysis is necessary to minimize the effects of confounding and the differences in data collection between the RW and the RCT settings.

Background: In 2010, the Department of Justice (DOJ) announced an investigation into the placement of implantable cardioverter defibrillators (ICDs) outside CMS’ National Coverage Determination (NCD). Recently, more than 500 hospitals reached settlements with the DOJ totaling $250 million. We sought to examine the potential impact of the DOJ investigation on clinical practice. Methods: Within the NCDR ICD registry, we calculated the proportion of initial primary prevention ICDs among Medicare beneficiaries not meeting NCD criteria between January 2007 and December 2015 stratified by whether the implanting hospital eventually paid a settlement to the DOJ. To examine changes in primary and secondary prevention ICD volume, we restricted to facilities implanting at least 10 ICDs in each year of the study. Results: A total of 331,349 ICD procedures from 1820 hospitals were included; 452 of these hospitals settled with the DOJ. Prior to announcement of the DOJ investigation in 2010, hospitals that eventually settled had significantly higher proportions of primary prevention ICDs that did not meet NCD criteria (P< 0.001, Figure left panel). Following the announcement of the DOJ investigation, the proportion of implantations not meeting NCD criteria declined at all hospitals, but the pace of decline accelerated and was significantly larger in hospitals that settled (P int = 0.009). Over the study period, there was a 33% decline in primary prevention ICD volume at hospitals that settled with DOJ as compared with a 17% reduction at hospitals that did not settle. In contrast, the volume of secondary prevention ICDs remained relatively constant over time (Figure, right panel). Conclusion: The proportion of primary prevention ICDs not meeting NCD criteria has declined at all hospitals. Announcement of the DOJ investigation was associated with more rapid and larger reductions at hospitals that settled without evidence of unintended consequences on secondary prevention ICDs.

Background: ICDs are frequently inserted in older patients, who are at high risk for short-term mortality. Though hospice is the main provider of end-of-life care in the United States, its use in patients following ICD implantation is not known. We aimed to describe the incidence, timing, regional variation, and predictors of hospice use in a nationally-representative sample of older patients following ICD placement. Methods: ICD registry data for Medicare fee-for-service patients aged >65 was linked to Medicare Hospice Claims from January 1, 2006 - December 31, 2010 using indirect identifiers. Use of hospice services among decedents in the Health Referral Region (HRR) where the ICD was placed was evaluated using the Dartmouth Health Atlas. Cumulative incidence of hospice admission was calculated and multivariable Cox regression was used to identify factors associated with time-to-hospice enrollment with both analyses accounting for the competing risk of death. Results: A total of 194,969 eligible older ICD recipients were identified, whose mean age was 75.5 + 6.4 years, 25.7% were female, and 89.6% were white; 80.0% had CHF, 46.6% had CRT devices, and 79.0% had primary prevention ICDs. During the follow-up period (median 1.92 years, 25%-75% IQR, 1.13 - 2.97,) a total of 52,990 (27.1%) patients died and 22,336 (11.4%) were enrolled in hospice care. Among the subset of patients who died, 36.8% received hospice services. The cumulative incidence of hospice use, accounting for the competing risk of death, was 4.7% (95% CI, 4.6% - 4.8%) within 1 year and 21.3% (95% CI, 20.7% - 21.8%) at 5 years. The median time from ICD implantation to hospice enrollment was 1.3 years (25% - 75% IQR, 209 days - 2.3 years); median length of stay in hospice was only 10 days (25% - 75% IQR, 4 - 36 days). In multivariable analysis, the following factors were most strongly associated with shorter time to hospice enrollment: older age, Class IV HF, LVEF < 20, lung disease, and HRR (Table). Conclusions: After accounting for the competing risk of death, the cumulative incidence rate of hospice admission in the 5 years following ICD placement was 21%. This finding indicates a need for a greater understanding of the clinical experience, symptom management, treatment preferences, and end-of-life outcomes for these patients.

The use and in-hospital outcomes of the subcutaneous (S) implantable cardioverter defibrillator (ICD) in the US have not been described. We studied patients (pts) in the National Cardiovascular Data Registry (NCDR) ICD registry who underwent ICD implant between September 28, 2012 (SICD FDA approval