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Ischemic stroke
Original research
Real-world outcomes associated with the use of the EmboTrap revascularization device for ischemic stroke in the United States
  1. Waleed Brinjikji1,
  2. Shelly Ikeme2,
  3. Emilie Kottenmeier2,
  4. Alia Khaled2,
  5. Sidharth M3,
  6. Rahul Khanna4
  1. 1 Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
  2. 2 Franchise Health Economics and Market Access, Johnson and Johnson, Irvine, California, USA
  3. 3 Mu Sigma, Inc, Bangalore, Karnataka, India
  4. 4 Medical Device Epidemiology and Real-World Data Sciences, Johnson and Johnson, New Brunswick, New Jersey, USA
  1. Correspondence to Dr Rahul Khanna, Medical Device Epidemiology and Real-World Data Sciences, Johnson and Johnson, New Brunswick, New Jersey, 08901, USA; rkhann14{at}its.jnj.com

Abstract

Background Mechanical thrombectomy (MT) has become the standard of care for the treatment of acute ischemic stroke (AIS). The EmboTrap revascularization device (CERENOVUS, Johnson & Johnson Medical Devices, Irvine, California, USA) has an innovative, dual layer feature designed to facilitate thrombus retrieval.

Objective To investigate the real-world clinical and economic outcomes among patients with AIS undergoing MT using the EmboTrap device in the United States (US).

Methods Adult patients (≥18 years) who underwent MT for AIS using the EmboTrap device between July 2018 and December 2020 were identified from the Premier Healthcare Database. Patient outcomes included discharge status (including in-hospital mortality), mean length of stay (LOS), intracranial hemorrhage (ICH), mean hospital costs, and 30-day readmissions (all-cause, cardiovascular (CV)-related, and AIS-related).

Results A total of 318 patients (mean age 68.5±14.6 years) with AIS treated with the EmboTrap device as the only stent retriever used were identified. Approximately 25% of patients were discharged to home/home health organization, and the in-hospital mortality rate was 10.7%. The rate of ICH was 16.7%. Mean hospital LOS was 9.9±11.3 days, and the mean hospital costs were US$47 367±30 297. The 30-day readmission rate was 9.6% for all-causes, 5.9% for CV-related causes, and 2.6% for AIS-related causes.

Conclusions This is the first study in the US to report real-world outcomes sourced by retrospective database analysis among patients with AIS undergoing MT using the EmboTrap device. Further research is needed to better understand performance of the EmboTrap device in real-world settings.

  • stroke
  • thrombectomy

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/neurintsurg-2021-018175

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    Introduction

    Several randomized clinical trials have demonstrated that mechanical thrombectomy (MT) using stent retrievers is a safe and effective treatment for acute ischemic stroke (AIS) due to large vessel occlusion,1 and, combined with intravenous tissue-type plasminogen activator (tPA), is the standard of care.2 Following favorable results from two more recent randomized controlled trials,3 4 guidelines from the American Heart Association/American Stroke Association have expanded the treatment window for MT to 16–24 hours after stroke onset.5

    The EmboTrap Revascularization Device (CERENOVUS, Johnson & Johnson Medical Devices, Irvine, California, USA) is an innovative stent retriever indicated for thrombus retrieval approved in the USA in May, 2018. Its unique design includes an open outer cage for clot capture and a closed inner channel for clot stabilization. Initial prospective, multicenter studies using the EmboTrap device, ARISE I and ARISE II (Analysis of Revascularization in Ischemic Stroke with EmboTrap I and II),6 7 reported high reperfusion rates (modified Thrombolysis in Cerebral Infarction (mTICI) ≥2b within three EmboTrap passes without rescue) of 75.0% and 80.2%, respectively. ARISE II reported rates of 90-day functional independence of 67.3% and mortality of 9.0%. The ARISE trials, however, had prespecified patient inclusion and exclusion criteria, and thus patient outcomes may differ from real-world use of the EmboTrap device.8 At this time, three European studies using the EmboTrap device in a real-world setting have reported revascularization rates and functional independence similar to those found in ARISE II.9–11 Only one prospective registry study in the USA has examined outcomes associated with the use of the EmboTrap device in patients.12 In this study, real-world hospital resource use, economic costs, and mortality associated with the use of the EmboTrap device in patients with AIS are presented from a retrospective analysis of the Premier Healthcare Database (PHD).13

    Methods

    Data source

    Using the PHD,13 which represents approximately 20% of all inpatient discharges in the USA, complete clinical coding, hospital cost, and patient billing data from more than 1000 hospitals were analyzed. Although the database excludes federally funded hospitals (eg, Veterans Affairs), the hospitals included are nationally representative based on bed size, geographic region, location (urban/rural), and teaching status. The study did not require institutional review board approval.

    Study population

    Patients aged ≥18 years who underwent MT using only the EmboTrap revascularization device (any generation) for AIS treatment between July 2018 and December 2020 were identified; patients treated in combination with other stent retrievers were excluded. Eligible patients had a primary or secondary procedure code for MT during an inpatient stay. Patients were excluded if they had a primary or secondary diagnosis of AIS in any setting in the PHD in the 12 months before index admission. The study cohort attrition process is listed in table 1.

    View this table:
    Table 1

    Study cohort formation

    Primary outcomes

    Primary outcomes included discharge status (including in-hospital mortality, discharge to home/home health organization, discharge to skilled nursing facility, and others [including discharge/transfer to other facility, discharge to rehab facility, discharge to hospice-medical facility, etc.]), intracranial hemorrhage (ICH), mean length of stay (LOS), mean hospital cost, and 30-day readmissions (all-cause, cardiovascular (CV)-related, and AIS-related). Mean hospital costs (reported in 2020 USD) capture all billable items including room and board, supply, pharmacy, and laboratory costs. Inpatient readmissions (all-cause, AIS-related, and CV-related) were assessed among patients who were treated in a hospital that continuously provided data to the PHD for 30 days post-procedure. Our study period included the COVID-19 pandemic of 2020, hence we presented results by year which allowed us to better examine any potential influence the pandemic might have had on outcomes.

    Study covariates

    Patient characteristics including age group (18–49, 50–59, 60–69, 70+), sex, race, payor type (commercial, Medicare or Medicaid, other), existing co-morbidities, Elixhauser co-morbidity index (score 0–1; score 2–3; score 4+),14 and tPA use during index admission were collected. Hospital characteristics were also collected, including teaching status (teaching/non-teaching), geographic location (Midwest, Northeast, South, West), size (<300 beds, 300–499 beds, and ≥500 beds), and urban–rural classification.

    Statistical analysis

    All study variables were summarized with frequency and percentage. All analyses were conducted using R Studio 3.5.2.

    Results

    Patient and hospital characteristics

    A total of 318 patients (mean age 68.5±14.6 years), treated with the EmboTrap device were identified in the PHD. Patient demographics and characteristics are reported in table 2. Over half of the patients were aged ≥70 years (52.2%), 48.4% were male, and 58.5% were white. The majority (74.8%) of patients were enrolled in Medicare or Medicaid, with 18.6% having commercial coverage. A total of 78.3% had an Elixhauser score of 4 or higher. Patient co-morbidities included diabetes (34.0%), hypertension (84.9%), atrial fibrillation (35.5%), and congestive heart failure (28.3%). Dyslipidemia was reported in 59.1% of patients, and coronary artery disease in 26.1%. tPA was administered in 30.2% of patients.

    View this table:
    Table 2

    Patient demographics and characteristics

    Geographically, 64.2% of the cases were reported by hospitals in the south, with a high concentration in urban areas (95.0%). Many were teaching hospitals (86.5%), and 74.5% were large hospitals with 500 beds or more (table 2).

    Study outcomes

    Study outcomes are reported in table 3. The overall in-hospital mortality rate was 10.7% (34/318). Among those discharged, 25.2% (80/318) were discharged to home/home health organization, 18.9% (60/318) were discharged to a skilled nursing facility, and the remaining 56.0% (178/318) were discharged to another type of facility such as a rehab facility, or hospice-medical facility. The rate of ICH among EmboTrap patients was 16.7% (53/318). The mean LOS among patients undergoing MT using the EmboTrap device was 9.9±11.3 days (median 7.0 days). The mean hospital costs were US$47 367 ±$30 297 (median $38 291). The 30-day all-cause, CV-related, and AIS-related inpatient readmission rates were 9.6% (26/271), 5.9% (16/271), 2.6% (7/271), respectively, among patients who had a procedure in hospitals that continuously provided data to the PHD for 30 days post-procedure.

    View this table:
    Table 3

    Study outcomes

    Discussion

    To the best of our knowledge, this is the first study to report real-world costs, mortality, and hospital-related outcomes associated with the use of a specific clot retrieval device (in this case, the EmboTrap revascularization device) in patients with AIS. The findings from this study are important for a few reasons; first, this study introduces the feasibility of using large administrative databases for real-world comparisons of device-specific outcomes in AIS. Additionally, these findings show the real-world use and effectiveness of the EmboTrap device in the treatment and management of patients with AIS in US hospitals.

    The results of the current study are not directly comparable to the ARISE II clinical trial owing to differences in the design, patient population, inclusion/exclusion criteria, and outcome variables.6 As with all clinical trials, ARISE II had prespecified inclusion/exclusion criteria, with precise treatment protocols in place; however, a real-world setting involves considerable variability in patient and provider characteristics. For example, patients in the current study sample had higher rates of co-morbidities such as diabetes (34.0% vs 19.8%, respectively), hypertension (84.9% vs 68.3%, respectively), and dyslipidemia (59.1% vs 43.2%, respectively) than patients in the ARISE II study.6 Further, tPA use was lower among patients in the current study (30.2%) than in those in the ARISE II study (52.9%), suggesting variability in patient care protocols, given the broader inclusion of facilities in a database study.

    Three studies from Europe and one from the USA have evaluated the real-world performance of the EmboTrap device and reported AIS-related outcomes comparable to those of ARISE II.9–12 These studies had revascularization rates of 84.6–95.7% (mTICI 2b/3 with rescue), and good 90-day functional outcomes (modified Rankin Scale (mRS) score ≤2) in 52.8–62.8% of patients.9–11 While the study in Sweden reported a somewhat higher 90-day mortality rate of 12.9%,9 the studies in France, Italy, and the USA reported 90-day mortality rates of 11.5%,10 10.0%,11 and 11.4%,12 respectively, which are similar to the rates reported in this study and in ARISE II (9%).6 Although it is difficult to compare the current results with these studies given the differences in study design, setting, and study outcomes (eg, in-hospital mortality vs 90-day mortality) our study did find a lower rate of ICH (16.7%) than the rates of 21.3%, 21.9%, and 22.9% reported in three of these studies.9 10 12 Further research is needed to more effectively compare AIS-related outcomes in the US real-world setting with ARISE II.

    To evaluate the current results in the context of real-world data with comparable patient populations and outcome parameters, comparisons with two thrombectomy device agnostic US studies that assessed hospital outcomes among patients undergoing endovascular treatment for AIS in a real-world setting are presented in table 4. Using the same PHD, Rai et al compared patients with AIS undergoing MT, with any device, between 2011–2017 and reported an LOS ranging from 8.7 to 11.7 days.15 In a subsequent study by Rai et al using the IBM MarketScan database, patients with AIS were found to have a similar LOS, ranging from 9.1 to 11.0 days overall, 8.4–10.0 days among those with Medicare supplemental insurance, and 9.5–11.6 days among those with commercial insurance.16 LOS findings in our study among patients treated with the EmboTrap device are comparable to these findings. Similarly, in their assessment of patients with AIS in the PHD, Rai et al reported annualized in-hospital mortality rates ranging from 12.8% to 21.6%,15 which is higher than the rate of 10.7% reported in the current study and might be due to differences in study design, use of different stent retrievers, or differences in retrieval and combination techniques. However, it is worthy of note that the current study and the study by Rai et al used the same retrospective claims database, with the latter inclusive of any MT device users and the former an EmboTrap device only cohort, hence this difference may be attributable to the EmboTrap device.15 More comparative effectiveness research of stent retrieval devices is warranted to understand if there are any outcome or cost benefit associated with one stent retrieval device over the other.

    View this table:
    Table 4

    Current study results compared with other real-world studies in the US

    Costs in the current study were similar to index admission costs reported by Rai et al, which ranged from $42,023 to $50,157.15 Costs were also comparable to the SWIFT-PRIME trial,17 which reported index hospitalization costs of $45 761 for patients treated with the Solitaire revascularization device and tPA.18

    For hospitals treating patients with a stroke, the 30-day readmission rate is a key indicator of quality of care and is increasingly tied to value-based reimbursement.19 Readmission costs can be attributed to a higher cost burden affecting both payers and hospitals treating patients with a stroke and as such, it is important to understand this outcome among patients treated with novel MT devices such as the EmboTrap device. In our study, the 30-day AIS-related readmission rate was 2.6%. Studies have reported considerable variation in 30-day readmission rates among patients with AIS, ranging from 6.0% to 15.0%.20–28 This variation may be attributable to differences in readmission definitions across studies, including whether or not studies included elective readmissions, distinguished between all-cause and specific diagnosis-related readmissions, or if specific patient populations were excluded from readmission counts owing to their discharge category. For example, Ramchand et al reported a 30-day readmission rate of 12.5%, but only included non-elective procedures and all-cause readmissions.28 Chaudhry et al reported 13.29% 30-day readmission rates based on the Nationwide Readmissions Data, and further identified that age ≥65, presence of chronic kidney disease, congestive heart failure, and diabetes, and postprocedural ICH were associated with readmission.27 The current study included both elective and non-elective procedures when determining the 9.6% rate of all-cause readmission. These differences make it difficult to compare readmission rates from our study with those from prior studies.

    Our study period included 2020, and the influence of the COVID-19 pandemic on assessment of study outcomes should be considered in data interpretation. Studies have reported declines in AIS-related hospitalizations during the pandemic.29 In their assessment of the impact of COVID-19, Nogueira et al reported a nearly 39% decline in AIS-related hospitalizations in 2020 as compared with a similar time frame in the pre-pandemic period.29 In our study, we also observed a lower volume of patients identified in 2020 (n=139) versus 2019 (n=158). When examining study outcomes by index procedure year, limited variation was observed for mortality, discharge status, LOS, and hospital cost. However, 30-day readmissions differed considerably by index procedure year, with patients with AIS undergoing treatment using the EmboTrap device having considerably lower rates of readmission in 2020 than in the previous year(2019). Delays in postoperative care due to the pandemic would probably have contributed to lower rates of readmission in 2020 than in 2019 in our sample.

    Limitations

    This study has some limitations. EmboTrap device use was identified using text search strategy, which does not account for miscoding. As unique device identifiers are yet to be fully implemented, a combination of device name and catalog identifiers was used to determine device use. Clinical parameters such as occlusion location, baseline National Institutes of Health Stroke Scale score, pre-mRS score, and Alberta Stroke Program Early CT score are not reported in the PHD and therefore were not assessed in this study, although these factors are known to affect patient outcomes. The PHD does not collect clinical and radiological outcomes, including mRS scores and reperfusion status (TICI), which makes these findings difficult to compare with clinical trial and registry results. The PHD only captures readmission if a patient returns to the same hospital as the index admission, and thus readmission rates may be under-reported. Results, while consistent with those of Rai et al (2019),15 were driven by large academic centers in urban areas, and may influence generalizability to facilities that are small or rural. Finally, data were included from procedures using both first- and second-generation EmboTrap devices, which may mask potential differences in outcomes related to device generation.

    Conclusion

    This is the first retrospective hospital database study in the USA to report outcomes associated with a specific thrombectomy device, in this case the EmboTrap device, for MT treatment among patients with AIS. Further research is needed to examine the real-world performance of the EmboTrap device in improving AIS-related outcomes and mitigating health resource use.

    Data availability statement

    Data are available upon reasonable request.

    Ethics statements

    Patient consent for publication

    Acknowledgments

    The authors acknowledge Superior Medical Experts for research and editing assistance.

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    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Contributors SI, EK, AK, and RK were involved in study design, results interpretation, and manuscript development. RK and SM were involved in data analysis. WB was involved in results interpretation and manuscript development. RK is is responsible for the overall content as the guarantor.

    • Funding This study was sponsored by CERENOVUS, Johnson & Johnson.

    • Competing interests SI, EK, AK, and RK are Johnson and Johnson employees. SM is an employee of MuSigma Inc, which has a consulting agreement with Johnson and Johnson. WB consults for Johnson and Johnson, Medtronic, Stryker, Microvention, and MIVI Neuroscience.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.