Association Between Use of a Flying Intervention Team vs Patient Interhospital Transfer and Time to Endovascular Thrombectomy Among Patients With Acute Ischemic Stroke in Nonurban Germany.

Importance: The benefit of endovascular thrombectomy (EVT) for acute ischemic stroke is highly time-dependent, and it is challenging to expedite treatment for patients in remote areas. Objective: To determine whether deployment of a flying intervention team, compared with patient interhospital transfer, is associated with a shorter time to endovascular thrombectomy and improved clinical outcomes for patients with acute ischemic stroke. Design, Setting, and Participants: This was a nonrandomized controlled intervention study comparing 2 systems of care in alternating weeks. The study was conducted in a nonurban region in Germany including 13 primary telemedicine-assisted stroke centers within a telestroke network. A total of 157 patients with acute ischemic stroke for whom decision to pursue thrombectomy had been made and deployment of flying intervention team or patient interhospital transfer was initiated were enrolled between February 1, 2018, and October 24, 2019. The date of final follow-up was January 31, 2020. Exposures: Deployment of a flying intervention team for EVT in a primary stroke center vs patient interhospital transfer for EVT to a referral center. Main Outcomes and Measures: The primary outcome was time delay from decision to pursue thrombectomy to start of the procedure in minutes. Secondary outcomes included functional outcome after 3 months, determined by the distribution of the modified Rankin Scale score (a disability score ranging from 0 [no deficit] to 6 [death]). Results: Among the 157 patients included (median [IQR] age, 75 [66-80] y; 80 [51%] women), 72 received flying team care and 85 were transferred. EVT was performed in 60 patients (83%) in the flying team group vs 57 (67%) in the transfer group. Median (IQR) time from decision to pursue EVT to start of the procedure was 58 (51-71) minutes in the flying team group and 148 (124-177) minutes in the transfer group (difference, 90 minutes [95% CI, 75-103]; P < .001). There was no significant difference in modified Rankin Scale score after 3 months between patients in the flying team (n = 59) and transfer (n = 57) groups who received EVT (median [IQR] score, 3 [2-6] vs 3 [2-5]; adjusted common odds ratio for less disability, 1.91 [95% CI, 0.96-3.88]; P = .07). Conclusions and Relevance: In a nonurban stroke network in Germany, deployment of a flying intervention team to local stroke centers, compared with patient interhospital transfer to referral centers, was significantly associated with shorter time to EVT for patients with acute ischemic stroke. The findings may support consideration of a flying intervention team for some stroke systems of care, although further research is needed to confirm long-term clinical outcomes and to understand applicability to other geographic settings.

The role of telemedicine in acute stroke treatment in times of pandemic.

PURPOSE OF REVIEW: The coronavirus disease 2019 (COVID-19) pandemic challenges many healthcare systems. This review provides an overview of the advantages of telemedicine during times of pandemic and the changes that have followed the outbreak of the COVID-19 disease. RECENT FINDINGS: Telemedicine has been utilized during infectious outbreaks for many years. COVID-19 has induced a variety of changes in laws (i.e. data privacy protection) and reimbursement procedures to accelerate new setups of telemedicine. Existing networks provide novel data about teleactivation resulting from social restrictions during the nadir of the lockdown in spring 2020. SUMMARY: Telemedicine is a safe and ideal expert support system for hospitals during infectious outbreaks. It makes high-quality medical procedures possible, limits potentially contagious interhospital transfers, saves critical resources such as protective gear and rescue/emergency transport services, and offers safe home office work for medical specialists.

Impact of the coronavirus disease 2019 pandemic on stroke teleconsultations in Germany in the first half of 2020.

BACKGROUND AND PURPOSE: The effects of the coronavirus disease 2019 (COVID-19) pandemic on telemedical care have not been described on a national level. Thus, we investigated the medical stroke treatment situation before, during, and after the first lockdown in Germany. METHODS: In this nationwide, multicenter study, data from 14 telemedical networks including 31 network centers and 155 spoke hospitals covering large parts of Germany were analyzed regarding patients' characteristics, stroke type/severity, and acute stroke treatment. A survey focusing on potential shortcomings of in-hospital and (telemedical) stroke care during the pandemic was conducted. RESULTS: Between January 2018 and June 2020, 67,033 telemedical consultations and 38,895 telemedical stroke consultations were conducted. A significant decline of telemedical (p < 0.001) and telemedical stroke consultations (p < 0.001) during the lockdown in March/April 2020 and a reciprocal increase after relaxation of COVID-19 measures in May/June 2020 were observed. Compared to 2018-2019, neither stroke patients' age (p = 0.38), gender (p = 0.44), nor severity of ischemic stroke (p = 0.32) differed in March/April 2020. Whereas the proportion of ischemic stroke patients for whom endovascular treatment (14.3% vs. 14.6%; p = 0.85) was recommended remained stable, there was a nonsignificant trend toward a lower proportion of recommendation of intravenous thrombolysis during the lockdown (19.0% vs. 22.1%; p = 0.052). Despite the majority of participating network centers treating patients with COVID-19, there were no relevant shortcomings reported regarding in-hospital stroke treatment or telemedical stroke care. CONCLUSIONS: Telemedical stroke care in Germany was able to provide full service despite the COVID-19 pandemic, but telemedical consultations declined abruptly during the lockdown period and normalized after relaxation of COVID-19 measures in Germany.

Decline and Recurrence of Stroke Consultations during the COVID-19 Pandemic Lockdown Parallels Population Activity Levels.

BACKGROUND: The COVID-19 pandemic lockdown (CPL) lead to a significant decrease in emergency admissions worldwide. We performed a timely analysis of ischemic stroke (IS) and related consultations using the telestroke TEMPiS "working diagnosis" database prior (PL), within (WL), and after easing (EL) of CPL. METHODS: Twelve hospitals were selected and data analyzed regarding IS (including intravenous thrombolysis [intravenous recombinant tissue plasminogen; IV rtPA] and endovascular thrombectomy [EVT]) and related events from February 1 to June 15 during 2017-2020. In addition, we aimed to correlate events to various mobile phone mobility data. RESULTS: Following the significant reduction of IS, IV rtPA, and EVT cases during WL compared to PL in 2020 longitudinally (p values <0.048), we observed increasing numbers of consultations, IS, recommendations for EVT, and IV rtPA with the network in EL over WL not reaching PL levels yet. Absolute numbers of all consultations paralleled best to mobility data of public transportation over walking and driving mobility. CONCLUSIONS: While the decrease in emergency admissions including stroke during CPL can only be in part attributed by patients not seeking medical attention, stroke awareness in the pandemic, and direct COVID-19 triggered stroke remains of high importance. The number of consultations in TEMPiS during the lockdown parallels best with mobility of public transportation. As a consequence, exposure to common viruses, well-known triggers for acute cerebrovascular events and other diseases, are reduced and may add to the decline in stroke consultations. Further studies comparing national responses toward the course of the COVID-19 pandemic and stroke incidences are needed.

The "Flying Intervention Team": A Novel Stroke Care Concept for Rural Areas.

BACKGROUND: Endovascular treatment of large vessel occlusion in acute ischemic stroke patients is difficult to establish in remote areas, and time dependency of treatment effect increases the urge to develop health care concepts for this population. SUMMARY: Current strategies include direct transportation of patients to a comprehensive stroke center (CSC) ("mothership model") or transportation to the nearest primary stroke center (PSC) and secondary transfer to the CSC ("drip-and-ship model"). Both have disadvantages. We propose the model "flying intervention team." Patients will be transported to the nearest PSC; if telemedically identified as eligible for thrombectomy, an intervention team will be acutely transported via helicopter to the PSC and endovascular treatment will be performed on site. Patients stay at the PSC for further stroke unit care. This model was implemented at a telestroke network in Germany. Fifteen remote hospitals participated in the project, covering 14,000 km2 and a population of 2 million. All have well established telemedically supported stroke units, an angiography suite, and a helicopter pad. Processes were defined individually for each hospital and training sessions were implemented for all stroke teams. An exclusive project helicopter was installed to be available from 8 a.m. to 10 p.m. during 26 weeks per year. Key Messages: The model of the flying intervention team is likely to reduce time delays since processes will be performed in parallel, rather than consecutively, and since it is quicker to move a medical team rather than a patient. This project is currently under evaluation (clinicaltrials NCT04270513).

Validating the TeleStroke Mimic Score: A Prediction Rule for Identifying Stroke Mimics Evaluated Over Telestroke Networks.

BACKGROUND AND PURPOSE: Up to 30% of acute stroke evaluations are deemed stroke mimics, and these are common in telestroke as well. We recently published a risk prediction score for use during telestroke encounters to differentiate stroke mimics from ischemic cerebrovascular disease derived and validated in the Partners TeleStroke Network. Using data from 3 distinct US and European telestroke networks, we sought to externally validate the TeleStroke Mimic (TM) score in a broader population. METHODS: We evaluated the TM score in 1930 telestroke consults from the University of Utah, Georgia Regents University, and the German TeleMedical Project for Integrative Stroke Care Network. We report the area under the curve in receiver-operating characteristic curve analysis with 95% confidence interval for our previously derived TM score in which lower TM scores correspond with a higher likelihood of being a stroke mimic. RESULTS: Based on final diagnosis at the end of the telestroke consultation, there were 630 of 1930 (32.6%) stroke mimics in the external validation cohort. All 6 variables included in the score were significantly different between patients with ischemic cerebrovascular disease versus stroke mimics. The TM score performed well (area under curve, 0.72; 95% confidence interval, 0.70-0.73; P<0.001), similar to our prior external validation in the Partners National Telestroke Network. CONCLUSIONS: The TM score's ability to predict the presence of a stroke mimic during telestroke consultation in these diverse cohorts was similar to its performance in our original cohort. Predictive decision-support tools like the TM score may help highlight key clinical differences between mimics and patients with stroke during complex, time-critical telestroke evaluations.

Thrombolysis in Postoperative Stroke.

BACKGROUND AND PURPOSE: Intravenous thrombolysis (IVT) is beneficial in reducing disability in selected patients with acute ischemic stroke. There are numerous contraindications to IVT. One is recent surgery. The aim of this study was to analyze the safety of IVT in patients with postoperative stroke. METHODS: Data of consecutive IVT patients from the Telemedical Project for Integrative Stroke Care thrombolysis registry (February 2003 to October 2014; n=4848) were retrospectively searched for keywords indicating preceding surgery. Patients were included if surgery was performed within the last 90 days before stroke. The primary outcome was defined as surgical site hemorrhage. Subgroups with major/minor surgery and recent/nonrecent surgery (within 10 days before IVT) were analyzed separately. RESULTS: One hundred thirty-four patients underwent surgical intervention before IVT. Surgery had been performed recently (days 1-10) in 49 (37%) and nonrecently (days 11-90) in 85 patients (63%). In 86 patients (64%), surgery was classified as major, and in 48 (36%) as minor. Nine patients (7%) developed surgical site hemorrhage after IVT, of whom 4 (3%) were serious, but none was fatal. One fatal bleeding occurred remotely from surgical area. Rate of surgical site hemorrhage was significantly higher in recent than in nonrecent surgery (14.3% versus 2.4%, respectively, odds ratioadjusted 10.73; 95% confidence interval, 1.88-61.27). Difference between patients with major and minor surgeries was less distinct (8.1% and 4.2%, respectively; odds ratioadjusted 4.03; 95% confidence interval, 0.65-25.04). Overall in-hospital mortality was 8.2%. Intracranial hemorrhage occurred in 9.7% and was asymptomatic in all cases. CONCLUSIONS: IVT may be administered safely in postoperative patients as off-label use after appropriate risk-benefit assessment. However, bleeding risk in surgical area should be taken into account particularly in patients who have undergone surgery shortly before stroke onset.

Telemedizin: "TEMPiS"-Netzwerk für Schlaganfallbehandlung in der Regelversorgung.

Despite all efforts that have been made stroke is a burden and remains one of the most devastating neurological diseases. Treatment of patients on a Stroke Unit improves stroke prognosis and is recommended for all patients with acute stroke. In rural areas population-wide implementation of Stroke Units is extremely challenging. Therefore the Telemedical Project for integrated Stroke Care (TEMPiS) was established in 2003 as a TeleStroke network to overcome this barrier in Southeast Bavaria/Germany. TEMPiS was one of the very early telemedical stroke networks worldwide and was evaluated intensively during its implementation phase between February 2003 and December 2005. It was shown to be effective in providing safe and extended thrombolysis and in improving stroke outcome. TEMPiS hereby has always been concentrating on the key features of the network: 1. implementation of stroke wards in each hospital, 2. usage of standard operating procedures (SOP), 3. center-based and on-site training, 4. quality management and 5. 24/7 availability of teleconsultations. The TeleStroke Unit network TEMPiS is an example of how the challenges of area-wide implementation of Stroke Units in rural areas can be met. Stroke Units supported by telemedicine, so-called TeleStroke Units, can perform high quality level of acute stroke care and should always be considered in regions, where implementation of standard Stroke Units is not feasible.

Stroke Thrombolysis in a Centralized and a Decentralized System (Helsinki and Telemedical Project for Integrative Stroke Care Network).

BACKGROUND AND PURPOSE: Intravenous thrombolysis with tissue-type plasminogen activator (tPA) for acute ischemic stroke is more effective when delivered early. Timely delivery is challenging particularly in rural areas with long distances. We compared delays and treatment rates of a large, decentralized telemedicine-based system and a well-organized, large, centralized single-hospital system. METHODS: We analyzed the centralized system of the Helsinki University Central Hospital (Helsinki and Province of Uusimaa, Finland, 1.56 million inhabitants, 9096 km2) and the decentralized TeleStroke Unit network in a predominantly rural area (Telemedical Project for Integrative Stroke Care [TEMPiS], South-East Bavaria, Germany, 1.94 million inhabitants, 14 992 km2). All consecutive tPA treatments were prospectively registered. We compared tPA rates per total ischemic stroke admissions in the Helsinki and TEMPiS catchment areas. For delay comparisons, we excluded patients with basilar artery occlusions, in-hospital strokes, and those being treated after 270 minutes. RESULTS: From January 1, 2011, to December 31, 2013, 912 patients received tPA in Helsinki University Central Hospital and 1779 in TEMPiS hospitals. Area-based tPA rates were equal (13.0% of 7017 ischemic strokes in the Helsinki University Central Hospital area versus 13.3% of 14 637 ischemic strokes in the TEMPiS area; P=0.078). Median prehospital delays were longer (88; interquartile range, 60-135 versus 65; 48-101 minutes; P<0.001) but in-hospital delays were shorter (18; interquartile range, 13-30 versus 39; 26-56 minutes; P<0.001) in Helsinki University Central Hospital compared with TEMPiS with no difference in overall delays (117; interquartile range, 81-168 versus 115; 87-155 minutes; P=0.45). CONCLUSIONS: A decentralized telestroke thrombolysis service can achieve similar treatment rates and time delays for a rural population as a centralized system can achieve for an urban population.

TeleStroke units serving as a model of care in rural areas: 10-year experience of the TeleMedical project for integrative stroke care.

BACKGROUND AND PURPOSE: Stroke Unit care improves stroke prognosis and is recommended for all patients with stroke. In rural areas, population-wide implementation of Stroke Units is challenging. Therefore, the TeleMedical Project for integrative Stroke Care (TEMPiS) was established in 2003 as a TeleStroke Unit network to overcome this barrier in Southeast Bavaria/Germany. Evaluation of its implementation between 2003 and 2005 had revealed improved process quality and clinical outcomes compared with matched hospitals without TeleStroke Units. Data on sustainability of these effects are lacking. METHODS: Effects on the stroke care of the local population were analyzed by using data from official hospital reports. Prospective registries from 2003 to 2012 describe processes and outcomes of consecutive patients with stroke and transient ischemic attack treated in TEMPiS hospitals. Quality indicators assess diagnostics, treatment, and outcome. Rates and timeliness of intravenous thrombolysis as well as data on teleconsultations and secondary interhospital transfers were reported over time. RESULTS: Within the covered area, network implementation increased the number of patients with stroke and transient ischemic attack treated in hospitals with (Tele-)Stroke Units substantially from 19% to 78%. Between February 2003 and December 2012, 54 804 strokes and transient ischemic attacks were treated in 15 regional hospitals, and 31 864 teleconsultations were performed. Intravenous thrombolysis was applied 3331 stroke cases with proportions increasing from 2.6% to 15.5% of all patients with ischemic stroke. Median onset-to-treatment times decreased from 150 (interquartile range, 127-163) to 120 minutes (interquartile range, 90-160) and door-to-needle times from 80 (interquartile range, 68-101) to 40 minutes (interquartile range, 29-59). CONCLUSIONS: TeleStroke Units can provide sustained high-quality stroke care in rural areas.

Clinical outcome of rural in-hospital-stroke patients after interhospital transfer for endovascular therapy within a telemedical stroke network in Germany: a registry-based observational study.

OBJECTIVES: Little is known about in-hospital-stroke (IHS) patients with large vessel occlusion and subsequent transfer to referral centres for endovascular therapy (EVT). However, this subgroup is highly relevant given the substantial amount of IHS, the ongoing trend towards greater use of EVT and lack of EVT possibilities in rural hospitals. The study objective is to explore the clinical outcomes of this vulnerable patient group, given that both IHS and interhospital transfer are associated with worse clinical outcomes due to a higher proportion of pre-existing conditions and substantial time delays during transfer. DESIGN AND SETTING: Prospectively collected data of patients receiving EVT after interhospital transfer from 14 rural hospitals of the Telemedical Stroke Network in Southeast Bavaria (TEMPiS) between February 2018 and July 2020 was analysed. PARTICIPANTS: 49 IHS and 274 out-of-hospital-stroke (OHS) patients were included. OUTCOME MEASURES: Baseline characteristics, treatment times and outcomes were compared between IHS and OHS. The primary endpoint was a 3-month modified Rankin Scale (mRS). RESULTS: In IHS patients, atrial fibrillation (55.3% vs 35.9%, p=0.012), diabetes (36.2% vs 21.1%, p=0.024) and use of oral anticoagulants (44.7% vs 20.8%, p<0.001) were more frequent. Stroke severity was similar in both groups. Treatment times from symptom onset to first brain imaging, therapy decision or EVT were shorter for IHS patients. IHS patients displayed worse clinical outcomes: 59.2% of IHS patients died within 3 months compared with 28.5% of OHS patients (p<0.001). They were less likely to achieve moderate outcomes (mRS 0-3) 3 months after stroke (20.4% vs 39.8%, p=0.010). After controlling for possible confounding variables, IHS was associated with worse clinical outcomes (adjusted OR 3.04 (95% CI 1.57 to 6.04), p<0.001). CONCLUSIONS: The mortality of IHS patients after interhospital transfer and EVT was high and functional outcomes were worse compared with those of OHS patients. Further research is needed to ascertain whether IHS patients benefit from this therapeutic approach. A more careful selection of IHS patients for transfer and means to enable faster treatment should be considered. TRIAL REGISTRATION NUMBER: NCT04270513; Post-results.

Recommendations for the organization of the teleconsultation service in a telestroke network.

Telestroke networks aim to improve acute stroke care within their catchment area. Through a teleconsultation service, the network centers provide support to network hospitals that lack continuous neurological expertise for acute stroke management decisions. Although the importance of telemedical treatment in stroke care is steadily increasing, so far no standards exist for the organization of the teleconsultation service in networks.To ensure a high-level of quality for all processes and measures concerning telemedical stroke treatment, the commission for telemedical stroke care of the German Stroke Society (Deutsche Schlaganfall-Gesellschaft, DSG) created the following recommendations on how to organize a teleconsultation service within a telestroke network. The recommendations are the result of an adjustment process between the authors and include guidance on requirements, qualifications, processes and quality management within the teleconsultation service.

Physician Transfer Versus Patient Transfer for Mechanical Thrombectomy in Patients With Acute Ischemic Stroke: A Systematic Review and Meta-Analysis.

BACKGROUND: Physician transfer is an alternate option to patient transfer for expedient performance of mechanical thrombectomy in patients with acute ischemic stroke. METHODS AND RESULTS: We conducted a systematic review to identify studies that evaluate the effect of physician transfer in patients with acute ischemic stroke who undergo mechanical thrombectomy. A search of PubMed, Scopus, and Web of Science was undertaken, and data were extracted. A statistical pooling with random-effects meta-analysis was performed to examine the odds of reduced time interval between stroke onset and recanalization, functional independence, death, and angiographic recanalization. A total of 12 studies (11 nonrandomized observational studies and 1 nonrandomized controlled trial) were included, with a total of 1894 patients. Physician transfer was associated with a significantly shorter time interval between stroke onset and recanalization with a pooled mean difference estimate of -62.08 (95% CI, -112.56 to -11.61]; P=0.016; 8 studies involving 1419 patients) with high between-study heterogeneity in the estimates (I2=90.6%). The odds for functional independence at 90 days were significantly higher (odds ratio, 1.29 [95% CI, 1.00-1.66]; P=0.046; 7 studies with 1222 patients) with physician transfer with low between-study heterogeneity (I2=0%). Physician transfer was not associated with higher odds of near-complete or complete angiographic recanalization (odds ratio, 1.18 [95% CI, 0.89-1.57; P=0.25; I2=2.8%; 11 studies with 1856 subjects). CONCLUSIONS: Physician transfer was associated with a significant reduction in the mean of time interval between symptom onset and recanalization and increased odds for functional independence at 90 days with physician transfer compared with patient transfer among patients who undergo mechanical thrombectomy.

Access to and application of recanalizing therapies for severe acute ischemic stroke caused by large vessel occlusion.

BACKGROUND: Groundbreaking study results since 2014 have dramatically changed the therapeutic options in acute therapy for severe ischemic stroke caused by large vessel occlusion (LVO). The scientifically proven advances in stroke imaging and thrombectomy techniques have allowed to offer the optimal version or combination of best medical and interventional therapy to the selected patient, yielding favorable or even excellent clinical outcomes within time windows unheard of before. The provision of the best possible individual therapy has become a guideline-based gold standard, but remains a great challenge. With geographic, regional, cultural, economic and resource differences worldwide, optimal local solutions have to be strived for. AIM: This standard operation procedure (SOP) is aimed to give a suggestion of how to give patients access to and apply modern recanalizing therapy for acute ischemic stroke caused by LVO. METHOD: The SOP was developed based on current guidelines, the evidence from the most recent trials and the experience of authors who have been involved in the above-named development at different levels. RESULTS: This SOP is meant to be a comprehensive, yet not too detailed template to allow for freedom in local adaption. It comprises all relevant stages in providing care to the patient with severe ischemic stroke such as suspicion and alarm, prehospital acute measures, recognition and grading, transport, emergency room workup, selective cerebral imaging, differential treatment by recanalizing therapies (intravenous thrombolysis, endovascular stroke treatmet, or combined), complications, stroke unit and neurocritical care. CONCLUSIONS: The challenge of giving patients access to and applying recanalizing therapies in severe ischemic stroke may be facilitated by a systematic, SOP-based approach adapted to local settings.

Clinical Course and Recurrence in Transient Global Amnesia: A Study From the TEMPiS Telestroke Network.

BACKGROUND AND PURPOSE: While the clinical hallmarks of transient global amnesia (TGA) are well defined, its pathophysiological causes are poorly understood. Specifically, risk factors for recurrences are yet to be determined. METHODS: This retrospective study analyzed TGA cases diagnosed and treated within the TEMPiS telestroke network and a university stroke center in Germany. Demographic and clinical data were assessed and characteristics of TGA episodes were recorded, such as season of occurrence, trigger factors, duration, and concomitant symptoms. Follow-up of the potential recurrence of TGA was performed using a standardized questionnaire. RESULTS: Overall 109 patients were included (age 64±8 years [mean±SD], 59.6% female). The most common vascular risk factor was arterial hypertension (60.6%), and other concomitant conditions included migraine (11.9%), hypothyroidism (22.9%), and atrial fibrillation (4.6%). The most frequent concomitant clinical feature accompanying the TGA episode at admission was elevated blood pressure (48.6%). Nineteen patients experienced at least one recurrent TGA episode. Migraine and hypothyroidism were only observed in subjects with a single TGA episode without recurrence (migraine: 14.4% without recurrence vs. none in the recurrence group, p=0.02; hypothyroidism: 27.8% without recurrence vs. none in the recurrence group, p=0.009). In contrast, atrial fibrillation was more common in subjects with TGA recurrence (p<0.001). CONCLUSIONS: Arterial hypertension is prevalent in TGA patients, with elevated blood pressure being the most-frequent concomitant condition. In our cohort, recurrence of TGA occurred in approximately one-fifth of patients. Concomitant conditions such as migraine, hypothyroidism, and atrial fibrillation occurred at different frequencies in the two groups.

Feasibility, Safety, and Technical Success of the Flying Intervention Team in Acute Ischemic Stroke : Comparison of Interventions in Different Primary Stroke Centers with those in a Comprehensive Stroke Center.

BACKGROUND: Prompt endovascular care of patients with ischemic stroke due to large vessel occlusion (LVO) remains a major challenge in rural regions as primary stroke centers (PSC) usually cannot provide neuro-interventional services. Objective The core content of the Flying Intervention Team (FIT) project is to perform thrombectomy on-site at a local PSC after the neuro-interventionalist has been transported via helicopter to the target hospital. An important and so far unanswered question is whether mechanical thrombectomy can be performed as safely and successfully on-site as in a specialized comprehensive stroke center (CSC). METHODS: Comparison of 100 FIT thrombectomies on site in 14 different PSCs with 128 control thrombectomies at 1 CSC (79 drip-and-ship, 49 mothership) performed by a single interventionalist with respect to technical-procedural success parameters, procedural times, and complications. RESULTS: There were no significant differences between the two groups in terms of technical success (95.0% successful interventions in FIT group vs. 94.5% in control group, p = 0.60) and complications (3% major complications in FIT vs. 1.6% in control group, p = 0.47). Regarding time from onset to groin puncture, there was no difference between FIT and the entire control group (182 vs. 183 min, p = 0.28), but a trend in favor of FIT compared with the drip-and-ship control subgroup (182 vs. 210 min, p = 0.096). CONCLUSIONS: Airborne neuro-interventional thrombectomy service is a feasible approach for rural regions. If performed by experienced neuro-interventionalists, technical success and complication rates are comparable to treatment in a specialized neuro-interventional department.

Health economic evaluation of the 'Flying Intervention Team' as a novel stroke care concept for rural areas: study protocol of the TEMPiS-GÖA study.

INTRODUCTION: Providing comprehensive stroke care poses major organisational and financial challenges to the German healthcare system. The quasi-randomised TEMPiS-Flying Intervention Team (TEMPiS-FIT) study aims to close the gap in the treatment of patients who had ischaemic stroke in rural areas of Southeast Bavaria by flying a team of interventionalists via helicopter directly to patients in the regional TEMPiS hospitals instead of transporting the patients to the next comprehensive stroke centre. The objective of the present paper is to describe the methods for the economic evaluation (TEMPiS-Gesundheitsökonomische Analyse (TEMPiS-GÖA)) alongside the TEMPiS-FIT study to determine whether the new form of care is cost-effective compared with standard care. METHODS AND ANALYSIS: The within-trial cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will be performed from a statutory health insurance perspective as well as from a societal perspective over the time horizon of 12 months after the patients' hospital discharge. Direct costs from outpatient and inpatient care are collected from routine data of the participating health insurance funds, while medical and non-medical costs from a patient's perspective are retrieved from primary data collected during the TEMPiS-FIT study and follow-up questionnaires. Results will be presented as incremental cost-effectiveness ratio and incremental cost-utility ratio quantifying the incremental costs and health benefits compared with standard care practice. The outcome of the CEA will be measured in costs per minute reduction in mean process time to thrombectomy. The outcome of the CUA will be presented as costs per quality-adjusted life year gained. ETHICS AND DISSEMINATION: Ethical approval for the TEMPiS-FIT study was granted by the Bavarian State Medical Association Ethics Committee (# 17056). Results will be disseminated via reports, presentations of the results in publications and at conferences and on the TEMPiS website. TRIAL REGISTRATION NUMBER: German Clinical Trials Register DRKS00023885. Registered on 2 July 2021 - retrospectively registered.