The KEEP SIMPLEST Study: Improving In-House Delays and Periinterventional Management in Stroke Thrombectomy—A Matched Pair Analysis

Schönenberger, Silvia; Weber, Dorothea; Ungerer, Matthias; Pfaff, Johannes; Schieber, Simon; Uhlmann, Lorenz; Heidenreich, Pia; Bendszus, Martin; Kieser, Meinhard; Wick, Wolfgang; Möhlenbruch, Markus; Ringleb, Peter A.; Bösel, Julian

doi:10.1007/s12028-018-00667-3

Cited by 13 publications

(9 citation statements)

References 26 publications

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“…Main clinical and procedural findings of KEEP SIM-PLEST showed that early neurological improvement and modified Rankin Scale (mRS) scores at 3 months were not different compared with the preceding approach in the procedural sedation group of SIESTA, but operational advantages, such as reduced in-house treatment times, were achieved [10].…”

Section: Design Of the Keep Simplest Studymentioning

confidence: 96%

“…Keep Evaluating Protocol Simplification in Managing Periinterventional Light Sedation for Endovascular Stroke Treatment [10] was a prospective observational single-center study comparing the outcome of patients undergoing EST in procedural sedation under an optimized, lean standard operating procedure (SOP), with the preceding SOP in the procedural sedation arm of the Sedation vs. Intubation for Endovascular Stroke Treatment (SIESTA) trial [11]. To compare both SOPs, a propensity score matching approach was applied to the study cohort and the historical SIESTA cohort.…”

Section: Design Of the Keep Simplest Studymentioning

confidence: 99%

“…In this post hoc analysis of the Keep Evaluating Protocol Simplification in Managing Periinterventional Light Sedation for Endovascular Stroke Treatment (KEEP SIM-PLEST) study [10], we aimed to identify potential associations of BP variations during four different phases of EST with short-term and long-term functional outcome and reperfusion in the setting of procedural sedation and with protocol-based BP management.…”

Section: Introductionmentioning

confidence: 99%

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Hemodynamic Status During Endovascular Stroke Treatment: Association of Blood Pressure with Functional Outcome

et al. 2021

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Background Optimal blood pressure (BP) management during endovascular stroke treatment in patients with large-vessel occlusion is not well established. We aimed to investigate associations of BP during different phases of endovascular therapy with reperfusion and functional outcome. Methods We performed a post hoc analysis of a single-center prospective study that evaluated a new simplified procedural sedation standard during endovascular therapy (Keep Evaluating Protocol Simplification in Managing Periinterventional Light Sedation for Endovascular Stroke Treatment). BP during endovascular therapy in patients was managed according to protocol. Data from four different phases (baseline, pre-recanalization, post recanalization, and post intervention) were obtained, and mean BP values, as well as changes in BP between different phases and reductions in systolic BP (SBP) and mean arterial pressure (MAP) from baseline to pre-recanalization, were used as exposure variables. The main outcome was a modified Rankin Scale score of 0–2 three months after admission. Secondary outcomes were successful reperfusion and change in the National Institutes of Health Stroke Scale score after 24 h. Multivariable linear and logistic regression models were used for statistical analysis. Results Functional outcomes were analyzed in 139 patients with successful reperfusion (defined as thrombolysis in cerebral infarction grade 2b–3). The mean (standard deviation) age was 76 (10.9) years, the mean (standard deviation) National Institutes of Health Stroke Scale score was 14.3 (7.5), and 70 (43.5%) patients had a left-sided vessel occlusion. Favorable functional outcome (modified Rankin Scale score 0–2) was less likely with every 10-mm Hg increase in baseline (odds ratio [OR] 0.76, P = 0.04) and pre-recanalization (OR 0.65, P = 0.011) SBP. This was also found for baseline (OR 0.76, P = 0.05) and pre-recanalization MAP (OR 0.66, P = 0.03). The maximum Youden index in a receiver operating characteristics analysis revealed an SBP of 163 mm Hg and MAP of 117 mm Hg as discriminatory thresholds during the pre-recanalization phase to predict functional outcome. Conclusions In our protocol-based setting, intraprocedural pre-recanalization BP reductions during endovascular therapy were not associated with functional outcome. However, higher intraprocedural pre-recanalization SBP and MAP were associated with worse functional outcome. Prospective randomized controlled studies are needed to determine whether BP is a feasible treatment target for the modification of outcomes.

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Section: Design Of the Keep Simplest Studymentioning

confidence: 96%

Section: Design Of the Keep Simplest Studymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Hemodynamic Status During Endovascular Stroke Treatment: Association of Blood Pressure with Functional Outcome

et al. 2021

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“…Several authors have proposed strategies that may reduce the incidence of demand in excess of capacity (DEC). These strategies include a backup neurointerventional team, reduced procedure duration through equipment standardization, a distinct team to manage pre-intervention evaluation, optimized triage protocols, and diversion of patients to other hospitals 8 13–20. To date, however, there has been no quantitative assessment of the actual effectiveness of these strategies to reduce DEC.…”

Section: Introductionmentioning

confidence: 99%

Strategies to reduce the impact of demand for concurrent endovascular thrombectomy

Dalsania

Kansagra

2020

J NeuroIntervent Surg

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BackgroundThe rise in demand for endovascular thrombectomy (EVT) has increased the possibility that multiple patients with acute ischemic stroke may present concurrently and exceed local capacity to provide timely treatment. In this work, we quantitatively compared the efficacy of various strategies to mitigate demand in excess of capacity (DEC).MethodsStrategies evaluated included a backup neurointerventional team for 3 hours, 8 hours, or 24 hours per day; a separate pre-intervention imaging team; and a 30% decrease in procedure duration. For each strategy, empirical distributions were used to probabilistically generate arrival time and case duration for 16 000 independent trials repeated across a range of annual case volumes. DEC was calculated from time series representing the number of concurrent cases at each minute of the year for each trial at each case volume.ResultsAll strategies decreased DEC compared with baseline. At a representative volume of 250 cases per year, availability of a backup team for 3 hours, 8 hours, and 24 hours per day reduced DEC by 27.0%, 60.3%, and 97.2%, respectively, compared with baseline. Similarly, availability of a pre-intervention imaging team and a 30% decrease in procedure duration reduced DEC by 26.6% and 17.7%, respectively, compared with baseline.ConclusionsA backup neurointerventional team, even if available only part time, was an effective strategy for decreasing DEC for EVT. Understanding the actual quantitative benefit of each strategy can facilitate rational cost–benefit analyses underlying the development of efficient and sustainable models of care.

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“…This work is motivated by a real data example, the KEEP SIMPLEST trial [6]. The trial aimed to compare aspects of periinterventional management in acute ischemic stroke (AIS) patients treated according to a new SOP (standard operating procedure) with patients having been randomized into the conscious sedation group of the SIESTA trial [7].…”

Section: Introductionmentioning

confidence: 99%

Adaptive propensity score procedure improves matching in prospective observational trials

Weber

Uhlmann

Schönenberger

et al. 2019

BMC Med Res Methodol

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Background Randomized controlled trials are the gold-standard for clinical trials. However, randomization is not always feasible. In this article we propose a prospective and adaptive matched case-control trial design assuming that a control group already exists. Methods We propose and discuss an interim analysis step to estimate the matching rate using a resampling step followed by a sample size recalculation. The sample size recalculation is based on the observed mean resampling matching rate. We applied our approach in a simulation study and to a real data set to evaluate the characteristics of the proposed design and to compare the results to a naive approach. Results The proposed design achieves at least 10% higher matching rate than the naive approach at final analysis, thus providing a better estimation of the true matching rate. A good choice for the interim analysis seems to be a fraction of around to of the control patients. Conclusion The proposed resampling step in a prospective matched case-control trial design leads to an improved estimate of the final matching rate and, thus, to a gain in power of the approach due to sensible sample size recalculation. Electronic supplementary material The online version of this article (10.1186/s12874-019-0763-3) contains supplementary material, which is available to authorized users.

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The KEEP SIMPLEST Study: Improving In-House Delays and Periinterventional Management in Stroke Thrombectomy—A Matched Pair Analysis

Cited by 13 publications

References 26 publications

Hemodynamic Status During Endovascular Stroke Treatment: Association of Blood Pressure with Functional Outcome

Hemodynamic Status During Endovascular Stroke Treatment: Association of Blood Pressure with Functional Outcome

Strategies to reduce the impact of demand for concurrent endovascular thrombectomy

Adaptive propensity score procedure improves matching in prospective observational trials

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