Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis.

Objective: To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft). Design: Multicentre retrospective cohort study. Setting: Four real-world data sources were used: a national quality improvement registry, a statewide clinical research network, a regional quaternary health system and two tertiary academic medical centres. Participants: In total, 30 patients with 37 IBE+VBX stent graft were identified. Of those, the mean age was 72±10.2 years and 90% were male. The cohort was 77% white, 10% black, 3% Hispanic and 10% other. Main outcome measures: Outcome measures included: proportion of percutaneous vs open surgical access, intensive care admission, intensive care unit (ICU) length-of-stay (LOS), total LOS, postoperative complications, discharge disposition and 30-day mortality. Results: The majority (89%) of cases were performed percutaneously, 5% required surgical exposure following failed percutaneous access and 6% required open surgical exposure outright. Nearly half (43%) required intensive care admission with a median ICU LOS of 1 day (range: 1-2). Median total LOS was 1 day (IQR: 1-2). There were zero postoperative myocardial infarctions, zero reported leg embolisations and no reported reinterventions. Access site complications were described in 1 of 28 patients, manifesting as a haematoma or pseudoaneurysm. Ultimately, 97% were discharged to home and one patient was discharged to a nursing home or rehabilitation facility. There were no 30-day perioperative deaths. Conclusions: This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms.

Sacubitril/valsartan vs ACEi/ARB at hospital discharge and 5-year survival in older patients with heart failure with reduced ejection fraction: A decision analysis approach.

BACKGROUND: In clinical trials, sacubitril/valsartan has demonstrated significant survival benefits compared to angiotensin converting enzyme inhibitors or angiotensin receptor blockers (ACEi/ARB). Whether older patients with heart failure with reduced ejection fraction (HFrEF) benefit as much, due to higher rates of comorbidities, frailty and drug discontinuation, is unknown. METHODS AND RESULTS: Using a cohort of Medicare beneficiaries hospitalized with HFrEF between 2016 and 2018, we determined all-cause mortality and HF-readmission rates among patients not given ACEi/ARB or sacubitril/valsartan at hospital discharge, by age. We then used risk reductions from the SOLVD, PARADIGM-HF and PIONEER-HF trials to estimate the benefits of ACEi/ARB and sacubitril/valsartan. We then incorporated age-specific estimates of drug discontinuation from Medicare. A Markov decision process model was used to simulate 5-year survival and estimate number needed to treat, comparing discharge on ACEi/ARB vs sacubitril/valsartan by age. After accounting for drug discontinuation rates, which were surprisingly slightly higher among those discharged on ACEi/ARB (2.3%/month vs 1.9%/month), there was a small but significant survival advantage to discharge on sacubitril/valsartan over 5 years (+0.81 months [95% CI 0.80, 0.81]). The benefit of sacubitril/valsartan over ACEi/ARB did not decrease with increasing age - the number needed to treat among 66 to 74-year-old patients was 84 and among 85+ year-old patients was 67. CONCLUSIONS: Even after accounting for "real world" rates of drug discontinuation, discharge on sacubitril/valsartan after conferred a small, but significant, survival advantage which does not appear to wane with increasing age.

Short-Term Concerns Primarily Determine Patient Preference for Abdominal Aortic Aneurysm Repair.

INTRODUCTION: Abdominal aortic aneurysm (AAA) repair may be performed through open or endovascular approaches, but the factors influencing a patient's repair-type preference are not well characterized. Here we performed a qualitative analysis to better understand factors influencing patient preference within the Preference for Open Versus Endovascular Repair of AAA Trial. METHODS: Open-ended responses regarding primary (n = 21) and secondary (n = 47) factors influencing patient preference underwent qualitative analysis using the constant comparative method with iterative reviews. Codes were used to generate themes and themes grouped into categories, with each step conducted via consensus agreement between three researchers. Relative prevalence of themes were compared to ascertain trends in patient preference. RESULTS: Patient responses regarding both primary and secondary factors fell into four categories: Short-term concerns, long-term concerns, advice & experience, and other. Patients most frequently described short-term concerns (23) as their primary influence, with themes including post-op complications, hospitalization & recovery, and intraoperative concerns. Long-term concerns were more prevalent (20) as secondary factors, which included themes such as survival, and chronic management. The average age of patients voicing only long-term concerns as a primary factor was 11 years younger than those listing only short-term concerns. CONCLUSION: Short-term concerns relating to the procedure and recovery are more often the primary factor influencing patient preference, while long term concerns play a more secondary role. Long-term concerns are more often a primary factor in younger patients. Vascular surgeons should consider this information in shared decision making to reach an optimal outcome.

Procedure-Associated Costs and Mid-Term Outcomes of Endovascular Zone 0 and Zone 1 Aortic Arch Repair.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) of proximal aortic arch pathology provides a less-invasive treatment option for high-risk patients ineligible for open arch reconstruction. However, the fiscal impact of these techniques remains unclear. Therefore, our objective was to characterize the mid-term outcomes after Zone 0 and Zone 1 TEVAR and describe the associated technical costs, revenues, and net margins at a single tertiary medical center. METHODS: We examined all patients who underwent TEVAR between April 2011 and August 2019 via retrospective chart review. Patients were categorized by proximal endograft extent to identify Zone 0 or Zone 1 repairs. Procedural characteristics and outcomes were described. Technical costs, revenues, and margins were obtained from the hospital finance department. RESULTS: We identified 10 patients (6 Zone 0, 4 Zone 1) who were denied open arch reconstruction. Patients were predominantly female (n = 8; 80%) and the mean age was 72.8 ± 5.5 years. TEVAR was performed in 5 asymptomatic patients, urgently in 3 symptomatic patients, and emergently in 2 ruptured patients. TEVAR plus extra-anatomic bypass was performed in 4 patients. Another 4 patients also received parallel stent-grafting while 1 patient received a branched thoracic endograft and yet another an in-situ laser fenestration followed by branch stent grafting. Within the 30-day postoperative period, 1 patient experienced stroke and 1 patient died. Bypass and branch vessel patency were 100% through the duration of follow-up (mean 19.3 months). Mean total technical cost associated with all procedures or repair stages was $105,164 ± $59,338 while mean net technical margin was -$25,055 ± $18,746. The net technical margin was negative for 9 patients. CONCLUSIONS: Endovascular repair of the proximal aortic arch is associated with good mid-term outcomes in patients considered too high-risk for open repair. However, reimbursement does not adequately cover treatment cost, with net technical margins being negative in nearly all cases. To remain financially sustainable, efforts should be made to both optimize aortic arch TEVAR delivery as well as advocate for reimbursement commensurate with associated costs.