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Reduced 2-Year Aneurysm Retreatment And PLOS ONE RESEARCH ARTICLE Reduced 2-year aneurysm retreatment and costs among patients treated with flow diversion versus non-flow diversion embolization: A Premier Healthcare Database retrospective cohort study 1 1 1 2 Ramesh GrandhiID *, Michael Karsy , Philipp Taussky , Christine Nichols Ricker , Ajay Malhotra3 a1111111111 a1111111111 1 Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, Utah, a1111111111 United States of America, 2 Medtronic Pain Therapies, Fridley, Minnesota, United States of America, a1111111111 3 Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut, a1111111111 United States of America * [email protected] OPEN ACCESS Abstract Citation: Grandhi R, Karsy M, Taussky P, Ricker CN, Malhotra A (2020) Reduced 2-year aneurysm retreatment and costs among patients treated with Introduction flow diversion versus non-flow diversion The use of endovascular treatments, including Pipeline embolization devices (PEDs) and embolization: A Premier Healthcare Database coiling approaches (non-PEDs), has played an increasingly important role in the treatment retrospective cohort study. PLoS ONE 15(6): e0234478. https://doi.org/10.1371/journal. of intracranial aneurysms. Despite multiple studies evaluating PEDs, a real-world evaluation pone.0234478 of follow-up outcomes and costs remains to be completed. Editor: Peter Dziegielewski, University of Florida, UNITED STATES Methods Received: December 13, 2019 The Premier Healthcare Database (PHD), 2010±2017, was queried to identify patients with unruptured intracranial aneurysms treated endovascularly. Rates of readmission, retreat- Accepted: May 26, 2020 ment, and cost at the same hospital were compared between patients who underwent PED Published: June 18, 2020 and non-PED endovascular treatments of their aneurysms. One-to-three (PED±to±non- Copyright: © 2020 Grandhi et al. This is an open PED) propensity score (PS) matching was performed to adjust for potential case selection access article distributed under the terms of the bias into the PED cohort, with covariates including age group, sex, Charlson Comorbidity Creative Commons Attribution License, which permits unrestricted use, distribution, and Index (CCI) group, payor, region, and randomized hospital identifier. reproduction in any medium, provided the original author and source are credited. Results Data Availability Statement: The data underlying A total of 679 patients underwent PED placement and 8432 had non-PED treatments. Prior the results presented in the study are available from Premier, Inc. at https://www.premierinc.com/ to PS matching, there were significant but minor differences in age (56.7±12.8 vs. 58.2±12.6 solutions/data-analytics. Access to the Premier years, p = 0.004) and sex (male 16.6% vs. 24.4%, p<0.0001) for PED and non-PED, respec- database was purchased by Medtronic. This tively, but no differences in CCI (p = 0.08), length of stay (p = 0.88), or rate of routine dis- access can be purchased by other interested charge (p = 0.21). All-cause readmission/emergency department reevaluation rates in the researchers as well. The authors had no special access privileges that other researchers would not two cohorts were similar at 30, 90, and 180 days and 1 and 2 years. Our results identified a have. significantly lower retreatment rate for PEDs at all follow-up time points over a 2-year period PLOS ONE | https://doi.org/10.1371/journal.pone.0234478 June 18, 2020 1 / 11 PLOS ONE Pipeline evaluation using Premier Healthcare Database Funding: Medtronic, Inc. provided support in the (range: 0.9±8.1%) compared with non-PED treatments (range: 1.7±11.6%). These findings form of salary for author CR, purchase of database remained consistent after PS matching: all-cause readmission/reevaluation rates were sig- access, and funding of open access but did not have any additional role in funding the study nificantly lower in patients treated with PED at 90 days, 180 days, 1 year, and 2 years design, data collection and analysis, decision to (p<0.001). Although the initial treatment costs were higher for PED at time of treatment publish, or preparation of the manuscript executed (p<0.001), cumulative follow-up emergency department visit and readmission costs (inclu- by the other authors. The specific roles of these sive of patients with no readmission and/or no retreatment) were significantly lower for authors are articulated in the `author contributions.' The roles of author CR are articulated in the patients with initial PED relative to non-PED treatment at 2 years (p = 0.021). contributions section, but arerepeated here: data curation, formal analysis, methodology, writing ± original draft, writing ±review & editing. Conclusions These results suggest that PEDs may potentially reduce downstream retreatment rates and Competing interests: The authors report the following competing interests. Christine Nichols costs. Further work is required to improve identification of patient subgroups that could ben- Ricker is a full-time employee of Medtronic, Inc. efit from PED over non-PED treatments both initially and during follow-up. Philipp Taussky is a consultant for Medtronic, Stryker Neurovascular, and Cerenovus. Ramesh Grandhi is a consultant for Medtronic Neurovascular, Cerenovus, and BALT Neurovascular. These do not alter our adherence to PLOS ONE policies on sharing data and materials. Introduction Intracranial aneurysms represent a relatively common intracranial disease, with a prevalence of 3±11% and rupture rate of roughly 3±5% per year [1±3]. The advent of minimally invasive, catheter-based endovascular approaches for aneurysm treatment has represented a significant change in the way aneurysms are treated in the modern healthcare setting [4±7]. The results of the Analysis of Treatment by Endovascular approach of Non-ruptured Aneurysms (ATENA) [8], the Internal Subarachnoid Trial (ISAT) [9], the Clinical and Anatomical Results in the Treatment of Ruptured Intracranial Aneurysms (CLARITY) trial [10], and the Barrow Rup- tured Aneurysm Trial (BRAT) [11], combined with advancements in neurointerventional technologies and techniques, including improvement in coil technology, development of bal- loons and stents for use as adjuncts during coil embolization procedures, endosaccular devices, and flow diverters, have influenced the management strategy of practitioners caring for patients with unruptured and ruptured intracranial aneurysms [6]. The introduction of the PipelineTM Embolization Device (PED) (Medtronic, Irvine, CA, USA), in particular, has been a disruptive innovation in the field of cerebrovascular surgery for the treatment of intracere- bral aneurysms [12±15]. The PED was initially approved by the U.S. Food and Drug Adminis- tration in 2011 for the treatment of large, wide-necked aneurysms, with the indication more recently expanded in 2018 to include small internal carotid artery aneurysms. Off-label uses (e.g., for smaller aneurysms) are also widely reported and have shown clinical efficacy with good outcomes. Nevertheless, the treatment of intracranial aneurysms remains challenging, because of the possibility of intraprocedural complications and also delayed postprocedural complications with consequent need for readmission, in addition to the potential need for retreatment because of aneurysm residual and regrowth [16, 17]. The Premier Healthcare Database (PHD) is a U.S. hospital-based all-payor database with detailed information on inpatient admissions that has previously been used in one study of PED treatment among patients with intracranial aneurysms [18]. A significant limitation of the current literature is the lack of head-to-head comparison of the various neurointerven- tional techniques in a large-scale, multicenter, real-world setting including evaluation of patients over follow-up. Thus, important considerations such as rates of readmission after aneurysm treatment, rates of retreatment, and consequent costs have not been well elucidated. We aimed to evaluate rates of readmission and retreatment of unruptured aneurysms among PLOS ONE | https://doi.org/10.1371/journal.pone.0234478 June 18, 2020 2 / 11 PLOS ONE Pipeline evaluation using Premier Healthcare Database patients in whom PED was used relative to patients treated with non-PED endovascular modalities using this large-scale, multicenter database. The secondary aim was to study hospi- tal costs associated with each treatment strategy. Materials and methods Study patients The PHD includes diagnosis, procedure, and product-level information pertaining to 108 mil- lion unique inpatient visits from 970 hospitals, which represents approximately 25% of annual admissions in the U.S. [19]. Hospitals included in PHD comprise teaching/academic facilities as well as community-based hospitals from geographically diverse regions, including both urban and rural environments. The PHD provides hospital-level encounter data tracking patients through inpatient, outpatient hospital, and emergency department visits. No Internal Review Board approval was required for this study because the data used for analyses were deidentified. Data were abstracted from the PHD from 2010 through 2017. International Classifications of Diseases, Ninth Revision, Clinical Modification (ICD9-CM) code 437.3 (cerebral aneurysm, unruptured) and ICD10-CM code I67.1 (cerebral aneurysm, nonruptured) were used to identify patients with an admitting or principal diagnosis of unrup- tured intracranial
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