Search

ObjectiveTo evaluate the comparative safety and efficacy of direct endovascular thrombectomy (dEVT) compared to bridging therapy (BT; IV tissue plasminogen activator + EVT) and to assess whether BT potential benefit relates to stroke severity, size, and initial presentation to EVT vs non-EVT center.MethodsIn a prospective multicenter cohort study of imaging selection for endovascular thrombectomy (Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke [SELECT]), patients with anterior circulation large vessel occlusion (LVO) presenting to EVT-capable centers within 4.5 hours from last known well were stratified into BT vs dEVT. The primary outcome was 90-day functional independence (modified Rankin Scale [mRS] score 0–2). Secondary outcomes included a shift across 90-day mRS grades, mortality, and symptomatic intracranial hemorrhage. We also performed subgroup analyses according to initial presentation to EVT-capable center (direct vs transfer), stroke severity, and baseline infarct core volume.ResultsWe identified 226 LVOs (54% men, mean age 65.6 ± 14.6 years, median NIH Stroke Scale [NIHSS] score 17, 28% received dEVT). Median time from arrival to groin puncture did not differ in patients with BT when presenting directly (dEVT 1.43 [interquartile range (IQR) 1.13–1.90] hours vs BT 1.58 [IQR 1.27–2.02] hours, p = 0.40) or transferred to EVT-capable centers (dEVT 1.17 [IQR 0.90–1.48] hours vs BT 1.27 [IQR 0.97–1.87] hours, p = 0.24). BT was associated with higher odds of 90-day functional independence (57% vs 44%, adjusted odds ratio [aOR] 2.02, 95% confidence interval [CI] 1.01–4.03, p = 0.046) and functional improvement (adjusted common OR 2.06, 95% CI 1.18–3.60, p = 0.011) and lower likelihood of 90-day mortality (11% vs 23%, aOR 0.20, 95% CI 0.07–0.58, p = 0.003). No differences in any other outcomes were detected. In subgroup analyses, patients with BT with baseline NIHSS scores p = 0.006); this association was not evident for patients with NIHSS scores ≥15 (aOR 1.05, 95% CI 0.40–2.74, p = 0.92). Similarly, functional outcomes improvements with BT were detected in patients with core volume strata (ischemic core 3: aOR 2.10, 95% CI 1.02–4.33, p = 0.044 vs ischemic core ≥50 cm3: aOR 0.41, 95% CI 0.01–16.02, p = 0.64) and transfer status (transferred: aOR 2.21, 95% CI 0.93–9.65, p = 0.29 vs direct to EVT center: aOR 1.84, 95% CI 0.80–4.23, p = 0.15).ConclusionsBT appears to be associated with better clinical outcomes, especially with milder NIHSS scores, smaller presentation core volumes, and those who were “dripped and shipped.” We did not observe any potential benefit of BT in patients with more severe strokes.Trial Registration InformationClinicalTrials.gov Identifier: NCT02446587.Classification of EvidenceThis study provides Class III evidence that for patients with ischemic stroke from anterior circulation LVO within 4.5 hours from last known well, BT compared to dEVT leads to better 90-day functional outcomes.

Objectives The aim of this multicenter, randomized, single-blind study was to prospectively evaluate the short-and long-term outcomes of pulmonary vein isolation (PVI) versus PVI with concomitant left atrial posterior wall isolation (PWI) using the cryoballoon in patients with symptomatic persistent/long-standing persistent atrial fibrillation (P/LSP-AF). Background Some studies have suggested a clinical benefit associated with PVI+PWI in patients with P/LSP-AF. However, there are limited safety and efficacy data on this approach using cryoballoon ablation. Methods The immediate and long-term outcomes in patients with P/LSP-AF randomized to PVI (n = 55) versus PVI+PWI (n = 55) using the cryoballoon were prospectively examined. Results Baseline characteristics were similar. PVI was achieved in all patients (21 ± 11 min). PWI was attained using 23 ± 8 min of cryoablation. Adjunct radiofrequency ablation was required in 4 of 110 patients (7.3%) to complete PVI (3 ± 2 min) and in 25 of 55 patients (45.5%) to complete PWI (4 ± 6 min). Although left atrial dwell time (113 ± 31 min vs. 75 ± 32 min; p Conclusions In patients with P/LSP-AF, PVI+PWI using the cryoballoon is associated with a significant reduction in atrial fibrillation recurrence, but similar safety, as compared with PVI alone.

BackgroundIt is unknown whether endovascular thrombectomy (EVT) is cost effective in large ischemic core infarcts.MethodsIn the prospective, multicenter, cohort study of imaging selection study (SELECT), large core was defined as computed tomography (CT) ASPECTSResultsFrom 361 patients enrolled in SELECT, 105 had large core on CT or CTP (EVT 62, MM 43). 19 (31%) EVT vs 6 (14%) MM patients achieved modified Rankin Scale (mRS) score 0–2 (OR 3.27, 95% CI 1.11 to 9.62, P=0.03) with a shift towards better mRS (cOR 2.12, 95% CI 1.05 to 4.31, P=0.04). Over the projected lifetime of patients presenting with large core, EVT led to incremental costs of $33 094 and a gain of 1.34 QALYs per patient, resulting in ICER of $24 665 per QALY. EVT has a higher NMB compared with MM at lower (EVT -$42 747, MM -$76 740) and upper (EVT $155 041, MM $57 134) WTP thresholds. PSA confirmed the results and CEAC showed 77% and 92% acceptability of EVT at the WTP of $50 000 and $100 000, respectively. EVT was associated with an increment of $29 225 in societal costs. The pivotal EVT trials (HERMES, DAWN, DEFUSE 3) were dominant in a sensitivity analysis at the same inputs, with societal cost-savings of $37 901, $86 164 and $22 501 and a gain of 1.62, 2.36 and 2.21 QALYs, respectively.ConclusionsIn a non-randomized prospective cohort study, EVT resulted in better outcomes in large core patients with higher QALYs, NMB and high cost-effectiveness acceptability rates at current WTP thresholds. Randomized trials are needed to confirm these results.Clinical trial registrationNCT02446587

There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon. The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF. The PIVoTAL is a prospective, randomized controlled study ( ClinicalTrials.gov : NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I–IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (n = 183) versus PVI+PWI (n = 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7–14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation. The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence.

Background Approximately one third of needle biopsies that are performed to rule out malignancy of indeterminate pulmonary nodules detected radiologically during lung cancer screening are negative, thus exposing cancer-free patients to risks of pneumothorax, bleeding, and infection. A noninvasive confirmatory tool (eg, liquid biopsy) is urgently needed in the lung cancer diagnosis setting to stratify patients who should receive biopsy versus those who should be monitored. Methods A novel antigen-independent, 4-color fluorescence in situ hybridization (FISH)-based method was developed to detect circulating tumor cells (CTCs) with abnormalities in gene copy numbers in mononuclear cell-enriched peripheral blood samples from patients with (n = 107) and without (n = 100) lung cancer. Results Identification of CTCs using FISH probes at 10q22.3/CEP10 and 3p22.1/3q29 detected lung cancer cases with 94.2% accuracy, 89% sensitivity, and 100% specificity compared with biopsy. Conclusion The high accuracy of this liquid biopsy method suggests that it may be used as a noninvasive decision tool to reduce the frequency of unnecessary needle biopsy in patients with benign pulmonary lesions.

Background and Purpose— Timely access to endovascular thrombectomy (EVT) centers is vital for best acute ischemic stroke outcomes. Methods— US stroke-treating centers were mapped utilizing geo-mapping and stratified into non-EVT or EVT if they reported ≥1 acute ischemic stroke thrombectomy code in 2017 to Center for Medicare and Medicaid Services. Direct EVT-access, defined as the population with the closest facility being an EVT-center, was calculated from validated trauma-models adapted for stroke. Current 15- and 30-minute access were described nationwide and at state-level with emphasis on 4 states (TX, NY, CA, IL). Two optimization models were utilized. Model-A used a greedy algorithm to capture the largest population with direct access when flipping 10% and 20% non-EVT to EVT-centers to maximize access. Model-B used bypassing methodology to directly transport patients to the nearest EVT centers if the drive-time difference from the geo-centroid to hospital was within 15 minutes from the geo-centroid to the closest non-EVT center. Results— Of 1941 stroke-centers, 713 (37%) were EVT. Approximately 61 million (19.8%) Americans have direct EVT access within 15 minutes while 95 million (30.9%) within 30 minutes. There were 65 (43%) EVT centers in TX with 22% of the population currently within 15-minute access. Flipping 10% hospitals with top population density improved access to 30.8%, while bypassing resulted in 45.5% having direct access to EVT centers. Similar results were found in NY (current, 20.9%; flipping, 34.7%; bypassing, 50.4%), CA (current, 25.5%; flipping, 37.3%; bypassing, 53.9%), and IL (current, 15.3%; flipping, 21.9%; bypassing, 34.6%). Nationwide, the current direct access within 15 minutes of 19.8% increased by 7.5% by flipping the top 10% non-EVT to EVT-capable in all states. Bypassing non-EVT centers by 15 minutes resulted in a 16.7% gain in coverage. Conclusions— EVT-access within 15 minutes is limited to less than one-fifth of the US population. Optimization methodologies that increase EVT centers or bypass non-EVT to the closest EVT center both showed enhanced access. Results varied by states based on the population size and density. However, bypass showed more potential for maximizing direct EVT-access. National and state efforts should focus on identifying gaps and tailoring solutions to improve EVT-access.

PURPOSE: There is a growing interest in performing pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) using the cryoballoon for the treatment of patients with persistent atrial fibrillation (AF). However, there is little known about the long-term durability of PWI using this approach. METHODS: In this multicenter study, we retrospectively examined the durability of PVI + PWI using the 28-mm cryoballoon by investigating the outcomes from consecutive patients referred for repeat catheter ablation. RESULTS: Altogether, 81/519 patients (15.6%) were referred for repeat catheter ablation. Repeat ablation was associated with a longer AF duration, hypertension, heart failure, multiple cardioversions, and antiarrhythmic therapy as well as larger left atrial (LA) diameters (49 ± 4 mm versus 43 ± 5 mm; P < 0.001) and greater need for "touch-up" (adjunct) radiofrequency ablation (44.4% versus 18.3%; P < 0.001). LA diameter also emerged as a significant predictor for adjunct radiofrequency ablation (P < 0.001). Durable PVI was observed in 66/81 patients (81.5%) and PWI in 67/81 patients (82.7%). Those with incomplete PWI exhibited larger LA diameters, particularly > 48 mm (negative predictive value = 89.7%). Lastly, an atypical LA posterior wall/roof flutter represented the third most common cause of arrhythmia recurrence and essentially every patient with incomplete PWI exhibited such an arrhythmia. CONCLUSION: PWI performed using a 28-mm cryoballoon in conjunction with PVI exhibits long-term durability in the vast majority of patients with persistent AF. While LA diameter (particularly > 48 mm) is a significant predictor for the need for adjunct radiofrequency ablation when performing this technique, those with incomplete PWI invariably present with an atypical flutter using this substrate.

Rationale Randomized evidence for endovascular thrombectomy safety and efficacy in patients with large core strokes is lacking. Aims To demonstrate endovascular thrombectomy efficacy and safety in patients with large core on non-contrast CT or perfusion imaging (CT/MR) and determine if there is heterogeneity of treatment effect in large cores based on the imaging modality. Design SELECT2 is a prospective, randomized, multi-center, assessor-blinded controlled trial with adaptive enrichment design, enrolling up to 560 patients. Procedure Patients who meet the clinical criteria and have anterior circulation large vessel occlusions with large core on either NCCT (ASPECTS 3–5) or perfusion imaging (CTP [rCBF Study outcomes The distribution of 90-day mRS scores is the primary outcome. Functional independence (mRS = 0–2) rate is a secondary outcome. Other secondary outcomes include safety (symptomatic ICH, neurological worsening, mortality) and imaging outcomes. Analysis A normal approximation of the Wilcoxon-Mann-Whitney test (the generalized likelihood ratio test) to assess the primary outcome. Functional independence rates, safety and imaging outcomes will also be compared. Discussion The SELECT2 trial will evaluate endovascular thrombectomy safety and efficacy in large cores on either CT or perfusion imaging and may provide randomized evidence to extend endovascular thrombectomy eligibility to larger population. Registration: ClinicalTrials.gov–NCT03876457

Background: The accuracy of CT perfusion imaging for estimating the ischemic core has been questioned. Methods: In SELECT, a prospective cohort study of imaging selection, pts who achieved complete reperfusion after EVT were stratified on time from LKW to imaging acquisition and time from imaging to reperfusion. The difference between baseline CTP core volume and f/up infarct volume (on DWI after EVT) was classified as over-estimation (core >10 cc larger than infarct), adequate, or under-estimation (≥ 25 cc smaller). F/up DWI lesion was outlined using a semiautomated algorithm and co-registered to CTP. Results: Of 361 enrolled, 117 achieved TICI 3. F/up MRIs were acquired at 21 (13-30) hrs from EVT with median infarct volume of 16.4 cc, median 8.1 cc larger than baseline core. Median (IQR) time from imaging acquisition to groin puncture (GP) was 70 (50-95) min. Reperfusion was achieved at 35 (25-54) min of GP. The frequency of overestimation decreased as time LKW to imaging increased: < 90 min 6 (14%), 90 – 270 min 3 (6%) and > 270 min 1 (4%), and adequate estimation increased (< 90 min 21 (50%), 90 – 270 min 32 (65%) and > 270min 19 (73%), p for trend 0.048) Fig 1. Overestimation primarily occurred in pts imaged within 90 min who had short imaging to reperfusion times Fig 2. Volumetric correlation between pre-procedure and f/up imaging improved as LKW time to imaging acquisition increased; Spearman’s ρ: 270 min: 0.79 (p Conclusion: In patients who achieve reperfusion, the correlation between baseline CTP ischemic core volume and f/up DWI volume improved as time LKW to imaging increased. Core estimation accuracy improved by using the < 20% CBF threshold for patients imaged within 90 minutes of LKW.

Background: Women have been shown to have greater disability than men after acute ischemic stroke (AIS) treated by thrombolysis. Whether endovascular thrombectomy (EVT) outcomes differ by sex with AIS from large vessel occlusion (LVO) is controversial. We compared sex differences in EVT outcomes and assessed relationship to post-discharge improvement. Methods: In SELECT prospective cohort, EVT treated anterior circulation LVOs (ICA, MCA M1/M2) ≤24 hrs from LKW were stratified by sex. Discharge, 90-day mRS were compared in all patients and a propensity matched cohort. We evaluated mRS improvement (discharge to 90-day) using repeated measure mixed regression with linear approximation of mRS. Results: Of 285 patients, 139 (48.8%) were women, and older (mean IQR 69 years (57,81) vs 65 (56,75), p=0.04) with similar NIHSS (17 (11,22) vs 16 (12,20), p=0.44). Women had smaller perfusion lesion 109 (66,151) vs 154 (104,198) cc, p Conclusion: Women had similar discharge outcomes as men following EVT, but improvement at 90 days was significantly worse in women. Further exploration of the influence of post-discharge factors to identify target interventions is warranted.

Background: Acute ischemic strokes outcomes may be less favorable in elderly patients. Whether transferring octogenarians with large vessel occlusion (LVO) for endovascular thrombectomy (EVT) results in similar outcomes to younger patients is uncertain. Methods: A pooled cohort from 6 centers (Europe, US) from 1/2014 to 5/2020 of pts with (ICA, M1, M2) LVO transferred for EVT ≤ 24 hrs from LKW. Patients were stratified into < 80 vs ≥ 80 years old. We compared 90 day functional independence and safety outcomes and assessed for predictors of good outcome (mRS 0-2) and profound disability (mRS 5-6). Results: Of 1176 pts received EVT as transfers, 216 (18%) were octogenarians. Baseline NIHSS was higher in octogenarians [19 (14, 22) vs 17 (12, 21), p Milder strokes (aOR 0.88, 95%CI 0.86-0.91, p Conclusion: EVT may be associated with lower independence rates in transferred octogenarians with LVO. Milder stroke severity, earlier presentation and IV thrombolysis increased the odds of good outcomes in octogenarians. Severe strokes and later treatment were associated with profound disability. Optimized selection and workflow is warranted in transferring elderly patients for EVT.

Background: Efficacy and safety of endovascular thrombectomy (EVT) in large vessel occlusion (LVO) patients with mild deficits is unclear. Methods: Pooled cohort of pts with mild deficits (NIHSS Results: Of 371 pts, 189 (51%) had EVT. Time LKW to EVT center: EVT 165 (70- 416) vs MM 200 (72-564) min, p=0.35 were similar. EVT pts had larger perfusion lesions (51 cc (23-86) vs 30.1 (5, 65), p0.99, neuro-worsening 17% vs 6%, p=0.30) and mortality 5% vs 3%, p>0.99). Without target profile, excellent outcomes were similar without a shift, Fig 1C. Safety was worse with EVT: sICH 8% vs 0%, p=0.001; neuro-worsening 20% vs 3%, p Conclusion: EVT was not associated with improved outcomes in patients with mild deficits; safety was worse. However, EVT was safe and associated with improved outcomes in target profile patients.

Background and objective: Endovascular Thrombectomy (EVT) treatment for patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO) was shown to improve functional outcomes. However, many eligible patients have no direct access to EVT capable centers, necessitating emergent inter-facilities transfers. Prolonged transfer time and reperfusion delay result in stroke progression and poor long-term outcomes. We evaluated the correlation between stroke evolution on non-enhanced Computed Tomography (CT) determined by Alberta Stroke Program Early CT Score (ASPECTS) decay and functional outcomes in transferred LVO patients. Method: Retrospective analysis of prospectively collected comprehensive stroke center data of patients with anterior circulation LVO (ICA, MCA M1 & M2) transferred for EVT. Stroke evolution was assessed based on CT ASPECTS decay defined as: [Outside hospital ASPECTS - Arrival pre-treatment ASPECTS]. A significant ASPECTS decay was defined as at least 2 points decrement in ASPECTS from initial imaging. Primary outcome was functional independence at 90-days, mRS 0-2. The correlation between functional independence and ASPECTS decay was assessed using logistic regression. Results: Of 108 patients transferred for EVT both initial outside and follow up CTs were available for 78 patients. Median IQR NIHSS was 16 (11, 20), age was 65.5 (54, 77), 33 (42%) of patients were women. Time from LKW to groin puncture was 9.91 (5.77, 13.35) hours and time from initial CT to repeat images was 3.6 (2.5, 4.8) hours. Median IQR ASPECTS decay was 1 (1, 2). Median IQR ASPECTS decay/hour 0.3 (0.0, 0.6). Significant ASPECTS decay was observed in 32 (41%) patients, and was more likely to occur with images repeated more than 3 hours from initial imaging (38% vs 10%, P Conclusion: ASPECTS decay was more likely to occur in prolonged transfers and correlated with lower likelihood of functional independence following EVT. Expedited transfers and faster reperfusion are vital to optimize thrombectomy outcomes in transfer patients.

Introduction: Successful and fast reperfusion with endovascular thrombectomy (EVT) improves outcomes in acute ischemic strokes due to large vessel occlusion (LVO). While complete reperfusion (mTICI 3) is the ideal target, multiple passes could prolong EVT and increase complications likelihood without improving clinical outcomes. We hypothesized that pts with a single pass mTICI2b would have similar good outcomes to those with multiple passes mTICI3 with a better safety profile. Methods: From the prospective multicenter cohort study of imaging selection (SELECT), EVT pts who achieved mTICI2b and mTICI3 were stratified into those with single pass vs multiple passes. Functional independence rates at 90 day mRS and safety (sICH, neuro-worsening and mortality) were compared between pts with single pass mTICI 2b and multiple passes mTICI 3. Results: Of 361 pts enrolled, 285 received EVT, of those 70 (25%) achieved mTICI 2b and 159 (56%) mTICI 3. 89 (31%) achieved mTICI 3 with single pass, 70 (25%) with multiple passes, 33 (12%) had mTICI 2b with a single pass and 37 (13%) with multiple passes. Baseline characteristics were similar between the two groups except for larger perfusion deficit (Tmax >6s) volume in pts with multiple passes mTICI3 55 (25, 99) cc vs first pass mTICI 2b 43 (4, 79), p=0.047). Functional independence rates were higher with single pass mTICI 2b as compared to multiple passes mTICI 3 (70% vs 56%, aOR=1.51, 95% CI=0.48-4.76, p=0.78), fig 1 but did not reach statistical significance. Multiple passes mTICI 3 was associated with numerically higher mortality (13% vs 3%, p=0.16) and Neuro-worsening (13% vs 3%, p=0.16) with similar sICH: 4% vs 3%, p=1.00 rates. Conclusion: Complete reperfusion with multiple passes did not confer better outcome rates than single pass mTICI 2b and was associated with worse safety profiles. These results suggest that in the absence of complete reperfusion on first attempt, a single pass mTICI 2b may be sufficient for a successful thrombectomy.

Background: Direct To Angio (DTA) for transferred large vessel occlusions (LVO) lowers time to endovascular thrombectomy (EVT), reperfusion and potentially improves outcomes. Safety and efficacy of DTA in late time window and on-call hours is unknown. Methods: Pooled cohort from 6 centers (EU, US) from 1/14-5/20 (ICA, M1, M2) LVO pts transferred for EVT≤24 hrs from LKW. Pts stratified into with repeat imaging (RI) (CT+/- CTA/CTP) and without RI (DTA). We compared time metrics, good outcome (90 day mRS 0-2), safety (sICH, mortality) and assessed the impact of arrival for EVT; regular (M-F, 8am-5pm) vs on-call hrs. Propensity matched analysis was done. Results: Of 1178 EVT transfers, 334 (28%) were DTA. DTA pts had more tPA (61% vs 51%, p=0.002), trended to lower NIHSS 17 (12, 20) vs 17 (13, 21), p=0.07 and lower LKW to arrival 268 (190, 430) min vs 280 (190, 518), p=0.097. Groin puncture (GP) was faster with DTA (p6-24, p=0.88 for interaction). In propensity matched 75 pairs, DTA had shorter time to EVT (19 min vs 52, p Conclusion: In pooled, non-randomized data DTA may result in faster treatment, safe and better functional outcomes, during all hours and treatment windows. Repeat imaging may be reasonable with prolonged transfer times. Optimal EVT workflow in transfers may result in faster, safe reperfusion with higher good outcomes.

Background: The efficacy of endovascular thrombectomy (EVT) in M2 occlusions is uncertain. Methods: In a pooled patient level analysis of the prospective multicenter cohort study of imaging selection (SELECT) and the INternational Stroke Perfusion Imaging REgistry (INSPIRE) EVT outcomes were compared to medical management (MM) in M2 occlusions. Further, we assessed for potential treatment benefit in patients with higher stroke severity (NIHSS). The primary outcome was excellent outcome (mRS 0-1). Results: 387 patients with isolated M2 occlusion (EVT 112, MM 275) met the inclusion criteria. Baseline NIHSS median (IQR) (EVT: 13 (9-19), MM: 10 (6-15), p10 had a trend towards higher excellent outcome rates outcomes with EVT (43%) vs MM (27%), aOR=3.11, 95% CI=0.81-11.95, p=0.098) as shown in figure 1. Conclusion: EVT may result in better rates of excellent outcomes in isolated M2 occlusions, especially those with more severe strokes who are more likely to have worse outcomes without emergent reperfusion.

Background and Purpose: Time elapsed from last-known well (LKW) and baseline imaging results are influential on endovascular thrombectomy (EVT) outcomes. Methods: In a prospective multicenter cohort study of imaging selection for endovascular thrombectomy (SELECT [Optimizing Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke], the early infarct growth rate (EIGR) was defined as ischemic core volume on perfusion imaging (relative cerebral blood flow2. The primary outcome was 90-day functional independence (modified Rankin Scale score =0–2). Results: Of 445 consented, 361 (285 EVT, 76 medical management only) patients met the study inclusion criteria. The optimal EIGR was P P P P =0.001). EIGR independently correlated with functional independence after EVT, adjusting for age, National Institutes of Health Stroke Scale, time LKW to groin puncture, reperfusion (modified Thrombolysis in Cerebral Infarction score of ≥2b), IV-tPA (intravenous tissue-type plasminogen activator), and transfer status (aOR: 0.78 [0.65–0.94], P =0.01). Slow progressors had higher functional independence rates (121 [61%] versus 30 [35%], P P =0.001) as compared to fast progressors, who had substantially worse clinical outcomes both in early and late time window. The odds of good outcome decreased by 14% for each 5 mL/h increase in EIGR (aOR, 0.87 [0.80–0.94], P Conclusions: The EIGR strongly correlates with both collateral status and clinical outcomes after EVT. Fast progressors demonstrated worse outcomes when receiving EVT beyond 6 hours of stroke onset as compared to those who received EVT within 6 hours. Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT02446587.

Environment monitoring and control has become a vital part of present-day to control air pollution and help in agriculture, fishery, shipping and military operations. Environment monitoring using traditional manually operated Weather Monitoring Stations requires skilled technicians for operation, is not scalable, and demands human intervention, which increases the cost of the Weather Monitoring Station. To address these issues, authors have attempted to design and develop E-Sense, an Internet of Things based environment monitoring system. E-Sense measures important environment parameters like temperature, humidity, air quality index, CO concentrations, rain and light. The data collected from the sensors is transmitted to ThingSpeak using the ESP8266 Wi-Fi module. The ThingSpeak helps in analyzing the data and present it in graphical and tabular forms. Additionally, E-Sense creates a heat map of the monitored area. A testbed implementation and experimentation show that the system works without human intervention, is user friendly, compact, and is cost-efficient.

BackgroundTrials of endovascular thrombectomy (EVT) mostly excluded patients with large core strokes so the safety and efficacy of EVT is not well established in such patients. Moreover, the definition of large core and its measurement differ between semi-quantitative (ASPECTS) and quantitative (core volume) imaging modalities. We evaluated functional and safety outcomes in studies reporting large core stroke patients treated with EVT and compared them with patients treated with medical management (MM) only.MethodsA systemic search using three large databases was performed to identify studies evaluating functional and safety outcomes in patients with large core strokes (ASPECTSResultsTwelve studies reporting outcomes for patients treated with EVT compared with MM in large core strokes were included. A pooled random-effect meta-analysis of large core patients by either definition (ASPECTS 2=37%, P for Cochran Q:0.15) and decreased mortality (EVT: 101/439 (23%), MM: 215/645 (33%), pooled OR:0.53 [95% CI: 0.40 to 0.71], overall effect Z-score:4.32, P2=0%, P for Cochran Q:0.78) at 90 days, without significant increase in symptomatic intracranial hemorrhage (ICH) (EVT: 42/462 (9%), MM: 35/663 (5%), pooled OR: 1.68 [95% CI: 0.92 to 3.09], overall effect Z-score:1.68, P=0.09, I2=26%, P for Cochran Q:0.24). Similar effects were observed in studies reporting large core outcomes based on ASPECTS ConclusionIn large core stroke patients, EVT is associated with improved functional independence and lower mortality at 90 days without significant increase in symptomatic ICH across various definitions, thresholds of large core size, and time windows. Further randomized evidence is warranted to establish EVT efficacy and safety in this population.

Background: The effect of anesthesia choice on endovascular thrombectomy (EVT) outcomes is unclear. Methods: In the prospective multicenter cohort study of imaging selection for EVT (SELECT), patients were stratified based on their anesthesia type into general anesthesia (GA) and conscious sedation (CS). EVT times and outcomes were compared. Further we assessed the impact of ischemic core size (rCBF Results: Of 361 enrolled, 285 received EVT. 129 (45%%) received GA and 156 (54%) CS. The baseline characteristics were similar, except for presentation NIHSS (GA 17(13-21), CS 15(11-20), p=0.027) and ischemic core volume (GA 14.1 cc (0-38) vs CS 6.3(0-26.1), p=0.034). GA was associated with numerically longer arrival to GP times 92 (68—115) vs. 85(60-117) mins, p=0.58. After adjustment for baseline imbalances, patients who received CS had a shift toward better outcome (adj cOR 1.72, 95% CI=1.08-2.75, p=0.022) with higher functional independence rates 56.8% vs 48.8%, p=0.75. Furthermore, GA was associated with higher mortality rates (19% vs 9%, p=0.017), figure 1A. In patients with core volume ≥ 50 cc, there was a trend for a shift towards better outcomes (adj cOR=5.84, 95%CI= 0.90-38.00, P=0.065), figure 1B while there was no difference in patients with core volume < 50 cc (adj cOR=1.01 (95%CI 0.53-1.94, P=0.96), figure 1C. There was an interaction between core volume size and anesthesia type on functional outcome (p=0.042). For every 10cc increase in the core volume, the odds of attaining better functional outcome decreased by 29% (adjusted cOR: 0.71, 95% CI=0.61-0.83, p Conclusion: Conscious sedation was associated with a shift towards better EVT outcomes. This effect was driven by patients with larger ischemic core volumes and has implications for randomized trials of conscious sedation vs general anesthesia.

Introduction: Whether reperfusion therapy is safe and efficacious in acute ischemic strokes (AIS) due to posterior circulation large vessel occlusions (PCLVO) beyond 4.5 hrs is unknown. Methods: A retrospective analysis of AIS due to PCLVO presenting to a comprehensive stroke center up to 24 hrs from last known well. Patients were stratified based on the treatment received into reperfusion therapy (IV-tPA and/or endovascular thrombectomy) and no reperfusion therapy. All patients received CT/CTA and CT perfusion with RAPID mismatch determination. Functional independence (90 day mRS 0-2) and sICH were primary and secondary outcomes. The two groups were compared in the overall cohort in an ordinal logistic regression and in a propensity matched analyses. Results: Between 8/2017 and 5/2019, 52 patients were included [reperfusion = 23(44%) vs no-reperfusion=29(56%)]. Reperfusion rate beyond 4.5 hours was 26% (6/23). The two groups were similar at baseline except for larger perfusion delays (Tmax>6s) volume [median (IQR), 16 (0, 46) vs. 0 (0, 25) cc, p=0.03], and higher presentation NIHSS [median (IQR), 10 (5, 21) vs. 4 (1, 8), p=0.004] in the reperfusion group. Reperfusion was associated with higher functional independence rates 10 (43%) vs. 8 (28%), p=0.23 (fig 1), and a trend for a shift towards better outcomes adj cOR 1.89, 95% CI=0.59-6.13, p=0.29. There was no difference in sICH rates 9% vs. 0%, P=0.19. In a propensity matched analysis on NIHSS and perfusion deficit of 14 pairs, reperfusion was associated with statistically significant higher mRS 0-2 rates 9 (64%) vs. 1 (7%), p=0.004 (fig 2). Functional independence rates did not differ in the reperfusion group in relation to time (47% Conclusion: PCLVOs with more severe strokes and large perfusion deficits were more likely to receive reperfusion which was associated with a shift towards better outcomes both earlier and beyond 4.5 hours without worsening safety outcomes.

Background: Whether IV tPA has adjunctive benefit to endovascular thrombectomy (EVT) is unclear. Methods: In a prospective multicenter cohort study of imaging selection for EVT (SELECT), patients who received IV tPA vs. no IV tPA were compared stratified by stroke severity and ischemic core size (rCBF Results: Of 361 enrolled, 285 received EVT; 226 presented within 4.5 hrs, 162 (72%) received IV tPA. IV tPA patients had lower median ASPECTS (8 vs 9, p=0.007) and larger ischemic core size (11.4 (1.5-37) vs 3.9 (0-32.15), p=0.042, otherwise similar at baseline. There were no delays in EVT delivery associated with tPA: median time (IQR) from arrival to groin puncture 95.0 min (66.0, 118.0) tPA vs 81.5 (63.5, 107.5) no tPA, p=0.21. IV tPA use was associated with higher mRS 0-2 rates (57% vs 44%), aOR 2.02 (95% CI 1.01-4.03, p=0.046) after adjustment for baseline differences with a shift towards better outcomes on all mRS levels (cOR 2.06, 95% CI 1.18-3.59, p=0.01) with lower mortality (11% vs 22%, p=0.026) and similar sICH rates (and 6% vs 6%, p=1.0). In patients with NIHSS Conclusion: IV tPA did not result in thrombectomy delivery delays and may result in better outcomes. Patients with less severe strokes and smaller infarct size had a stronger association between the use of IV tPA and favorable outcomes.

Background: Whether Endovascular Thrombectomy (EVT) may improve clinical outcomes in patientswith Pre-Stroke disability as compared to medical management only (MM) is unknown. Methods: A retrospective analyses of anterior circulation LVOs (ICA, MCA M1/M2) with mRS 2-4presenting 0-24 hrs from last-known-well to a single comprehensive stroke center was performed.Patients were stratified based on the treatment received into EVT and MM. The primary outcome was90-day mRS. Safety (sICH and mortality) was a secondary outcome. Ordinal analysis compared the twogroup for a shift towards less severe disability with EVT and identified variables independentlycorrelated with better and worse outcomes in both EVT and MM. Results: From Jan 2012 - Aug 2019, 101 patients were identified (EVT=42, MM=59). Baselinecharacteristics were similar in the two groups. EVT resulted in higher rates of mRS 2 and 3 (15% vs 4%,P=0.064) and a shift towards better outcomes (adj cOR 1.142; 95% CI1.050-1.369, p=0.039) as comparedto MM only (Figure 1). There was no significant difference in the composite outcome of sICH andmortality (aOR=0.47, 95% CI 0.307 - 1.810, p=0.167). Higher ASPECTS was associated with betteroutcomes in EVT (adj cOR 1.312 for each point, 95%CI 1.021 - 3.859, p-0.027) while higher NIHSS (adjcOR 0.886 for each point increment in NIHSS, 95%CI 0.793-0.951, p-0.034), left hemispheric strokes (adjcOR 1.615; CI 1.24 - 4.5; p = 0.04) independently correlated with worse outcomes in MM. Conclusions: EVT may result in better outcomes and avoid worsening disability in patients with Prestrokeimpairment without increasing safety concerns. Those with more severe and left hemisphericstrokes were more likely to have devastating outcomes if not treated with EVT.

Background: Timely access to endovascular thrombectomy (EVT) centers is vital for best stroke outcome. We map current EVT access in the US then utilize modeling to optimize it. Methods: US designated stroke centers were mapped utilizing geo-mapping and stratified into EVT or non-EVT if they reported ≥1 thrombectomy code for acute ischemic stroke in 2017 to CMS. Direct EVT access, defined as the population with the closest facility to EVT centers, was calculated from validated trauma models adapted for stroke. Current 15 and 30 min access were described nationwide and in 4 states (TX, NY, CA, IL). Two optimization models were utilized. Model A used a greedy algorithm to capture the largest population with direct access when flipping 10 non-EVT to EVT centers to maximize access. Model B used bypassing methodology to directly transport patients to EVT centers within 15 min from the closest non-EVT center. Results: Of 1941 stroke centers, 714 were EVT. Approximately 99 million/32% Americans have direct EVT access within 15 min while 111 million (36.0%) within 30 minutes (Fig 1). There were 65 (43%) EVT centers in TX with 22% current 15 min access. Flipping the top 10 population density hospitals improved access to 32%, while bypassing resulted in 46% having direct access to EVT centers (fig 2 A-B). Direct access in CA was 26% which improved to 35% with flipping and 54% by 15 min bypassing from the closest non-EVT to EVT centers. Similar results were found in NY (current 21%, flipping 39%, bypassing 50%) and IL (15%, 27% and 35%, respectively), Tab 1. Conclusion: EVT access within 15 min is limited to less than 1/3 of the US population. Optimization methodology that increase EVT centers or bypass non-EVT to the closest EVT center both showed enhanced access. Results varied by states based on the population size and density. However, bypass showed more potential for maximizing direct EVT access. National and state efforts should focus on identifying gaps and tailoring solutions to improve EVT access.

Background: The efficacy of endovascular thrombectomy (EVT) in M2 occlusions is uncertain. Methods: In a prospective multicenter cohort study of imaging selection (SELECT), EVT outcomes were compared to medical managment (MM) in M2 occlusions. Further, we assessed for potential treatment benefit in patients with higher stroke severity (NIHSS) and a larger perfusion deficit on CTP (Tmax > 6 sec - ischemic core volume)The primary outcome was excellent outcome (mRS 0-1). Results: of 361 patients enrolled in SELECT, 87 had isolated M2 occlusion (EVT 59, MM 28). Baseline NIHSS median (IQR) (EVT 14 (10-20), MM 15 (9.5-19.5), p=0.72) and infarct volume rCBF10 had better outcomes with EVT (46%) vs MM (10%), aOR=11.39, 95% CI=1.80-72.11, p=0.01 as shown in figure 1. As perfusion deficit lesion size increased, the odds of achieving excellent outcomes was reduced (for each 10cc by 11%, aOR: 0.89, 95% CI=0.79-1.00, p=0.05). Excellent outcomes declined in patients with MM as perfusion deficit lesion size increased, yet in the EVT they were maintained as shown in figure 2. Similar results were obtained for mRS 0-2. Conclusion: EVT may result in better rates of excellent outcomes in isolated M2 occlusions, especially those with more severe strokes and larger perfusion deficits who are more likely to have worse outcomes without emergent reperfusion.

Background: Whether Endovascular Thrombectomy (EVT) is cost-effective in large ischemic core infarcts is unknown. Methods: In the prospective multicenter cohort study of imaging selection study (SELECT), large core was defined as CT ASPECTS < 6 or CTP ischemic core volume (rCBF Results: Of 361 enrolled, 105 had large core on CT or CTP (EVT 62, MM 43). 19 (31%) EVT patients achieved mRS 0-2 vs 6 (14%) MM (aOR: 3.27, 95% CI: 1.11-9.62; P = .03) with a shift towards better mRS (adj cOR: 2.12, 95% CI: 1.05-4.31, P = .04). Over 20 years EVT was associated with $26589 (C.I. $8672- $43978) incremental costs and a gain of 1.18 QALYs (C.I. 0.091- 2.2) per patient. EVT could avert 75 deaths over a theoretical cohort of 1000 patients (MM 861 vs EVT 786) thus the ICER of EVT compared to MM was $22400 per QALY (CI. $10109 - $66140), which is EVT has a higher NMB compared to MM at the lower and upper WTP thresholds (EVT $86,3 and 271,4 million vs MM $53,6-$179,3 million), Tab 2. The PSA confirmed the results (fig 1). The CEAC showed 94% and 97% cost-effectiveness probability of EVT at the lower and upper values respectively of the maximum WTP, fig 2. EVT ICER in SELECT large core ($22400/QALY) was higher but still comparable to those in HERMES ($16882/QALY), DAWN ($7335/QALY) and DEFUSE3 ($14673/QALY), Tab 3. Conclusion: EVT may result in better outcomes and more lives saved in large core patients with higher QALYs, NMB and an acceptable ICER. The results were comparable to other EVT RCTs.

Pulmonary vein isolation (PVI) in conjunction with isolation of the posterior left atrial wall (PVI+PWI) is associated with improved clinical outcomes in certain patients with atrial fibrillation (AF).The purpose of this multicenter study was to evaluate the acute and long-term outcomes of PVI+PWI vs PVI alone performed using cryoballoon ablation in patients with persistent AF (persAF).We examined the procedural safety and efficacy and short- and long-term outcomes in 390 consecutive patients with persAF who underwent a first-time cryoballoon ablation procedure using PVI+PWI (n = 222 [56.9%]) vs PVI alone (n = 168 [43.1%]).Acute isolation was achieved in 99.7% of all pulmonary veins (PVI+PWI = 99.8% vs PVI alone = 99.3%; P = .23) using 6.3 ± 1.4 applications and 17 ± 2 minutes of cryoablation. PWI was achieved using 13.7 ± 3.2 applications and 34 ± 10 minutes of cryoablation. Adjunct radiofrequency ablation was required in 1.8% of patients to complete PVI (4 ± 2 minutes) and in 32.4% to complete PWI (5 ± 2 minutes). PVI+PWI yielded significantly greater posterior wall (77.2% ± 6.4% vs 40.6% ± 4.9%; P .001) and total left atrial (53.3% ± 4.2% vs 36.3% ± 3.8%; P.001) isolation. In addition, PVI+PWI was associated with greater AF termination (19.8% vs 8.9%; P = .003) and conversion to atrial flutters (12.2% vs 5.4%; P = .02). Adverse events were similar in both groups, whereas recurrence of AF and all atrial arrhythmias was lower with PVI+PWI at 12 months of follow-up. Moreover, in a Cox regression analysis, PVI+PWI emerged as a significant predictor of freedom from recurrent atrial arrhythmias (hazard ratio: 2.04; 95% confidence interval: 1.15-3.61; P = .015).PVI+PWI can be achieved safely and effectively using the cryoballoon. This approach appears superior to PVI alone in patients with persAF.

Objectives The aim of this study was to evaluate the incidence, predictors, and associated mortality of pre-implantation, early, and late ventricular arrhythmias (VAs) in patients receiving continuous-flow left ventricular assist devices (CFLVADs). Background VAs are common both pre- and post-implantation of left ventricular assist devices. Limited data exist on their prognostic impact in contemporary CFLVADs. Methods A retrospective review was performed to identify patients who underwent CFLVAD implantation between 2000 and 2015 with 2 years of follow-up. All VAs, defined as ventricular fibrillation, ventricular tachycardia lasting >30 s, or a ventricular rhythm requiring defibrillation, were analyzed. VAs occurring within 30 days of implantation were defined as early. Recorded outcomes included death and receipt of cardiac transplant. Results A total of 517 patients were included for analysis. Early VAs were associated with a significant reduction in survival (hazard ratio: 1.83; 95% confidence interval: 1.28 to 2.61; p = 0.001) compared with patients with late or no VAs. Pre-implantation variables independently predictive of early VAs included prior cardiac surgery (odds ratio: 1.90; 95% confidence interval: 1.09 to 3.32; p = 0.023) and pre-CFLVAD ventricular tachycardia storm (odds ratio: 3.15; 95% confidence interval: 1.49 to 6.69; p = 0.003). The incidence of early VAs from 2000 to 2007 was as high as 47%, whereas the highest incidence from 2008 to 2015 was Conclusions VAs within 30 days after CFLVAD implantation are associated with an increased risk for death. Predictors of early VAs include prior cardiac surgery and pre-CFLVAD ventricular tachycardia storm. Temporal trends have shown a decrease in VA from 2000 to 2015. Strategies to reduce arrhythmia burden shortly after CFLVAD implantation warrant further investigation.

IMPORTANCE: A direct to angiography (DTA) treatment paradigm without repeated imaging for transferred patients with large vessel occlusion (LVO) may reduce time to endovascular thrombectomy (EVT). Whether DTA is safe and associated with better outcomes in the late (>6 hours) window is unknown. Also, DTA feasibility and effectiveness in reducing time to EVT during on-call vs regular-work hours and the association of interfacility transfer times with DTA outcomes have not been established. OBJECTIVE: To evaluate the functional and safety outcomes of DTA vs repeated imaging in the different treatment windows and on-call hours vs regular hours. DESIGN, SETTING, AND PARTICIPANTS: This pooled retrospective cohort study at 6 US and European comprehensive stroke centers enrolled adults (aged ≥18 years) with anterior circulation LVO (internal cerebral artery or middle cerebral artery subdivisions M1/M2) and transferred for EVT within 24 hours of the last-known-well time from January 1, 2014, to February 29, 2020. EXPOSURES: Repeated imaging (computed tomography with or without computed tomographic angiography or computed tomography perfusion) before EVT vs DTA. MAIN OUTCOMES AND MEASURES: Functional independence (90-day modified Rankin Scale score, 0-2) was the primary outcome. Symptomatic intracerebral hemorrhage, mortality, and time metrics were also compared between the DTA and repeated imaging groups. RESULTS: A total of 1140 patients with LVO received EVT after transfer, including 327 (28.7%) in the DTA group and 813 (71.3%) in the repeated imaging group. The median age was 69 (interquartile range [IQR], 59-78) years; 529 were female (46.4%) and 609 (53.4%) were male. Patients undergoing DTA had greater use of intravenous alteplase (200 of 327 [61.2%] vs 412 of 808 [51.0%]; P = .002), but otherwise groups were similar. Median time from EVT center arrival to groin puncture was faster with DTA (34 [IQR, 20-62] vs 60 [IQR, 37-95] minutes; P 6 to 24 hours; P = .88 for interaction). Three-month mortality was lower with DTA (53 of 312 [17.0%] vs 186 of 763 [24.4%]; P = .008). A 10-minute increase in EVT-center arrival to groin puncture in the repeated imaging group correlated with 5% reduction in the functional independence odds (aOR, 0.95 [95% CI, 0.91-0.99]; P = .01). The rates of modified Rankin Scale score of 0 to 2 decreased with interfacility transfer times of greater than 3 hours in the DTA group (96 of 161 [59.6%] vs 15 of 42 [35.7%]; P = .006), but not in the repeated imaging group (75 of 208 [36.1%] vs 71 of 192 [37.0%]; P = .85). CONCLUSIONS AND RELEVANCE: The DTA approach may be associated with faster treatment and better functional outcomes during all hours and treatment windows, and repeated imaging may be reasonable with prolonged transfer times. Optimal EVT workflow in transfers may be associated with faster, safe reperfusion with improved outcomes.

The purpose of this study was to determine the frequency of tumor-related gastrointestinal obstruction and identify variables associated with functional outcomes and survival in patients with advanced malignancy and gastrointestinal obstruction.We reviewed the medical records of 490 patients with advanced cancer, who underwent surgical consultation for gastrointestinal obstruction between January 2000 and May 2014. We used chi-square and logistic regression analyses to identify variables associated with survival and eating at discharge.Obstructions were tumor-related in 334 (68%) patients, adhesion-related in 96 (20%), and of unclear etiology in 60 (12%). The obstruction site was the gastric outlet in 78 (16%), small bowel in 312 (64%), and large bowel in 100 (20%). Treatment was classified as medical (49% of patients), surgical (32%), and procedural (interventional radiology or endoscopy) (17%). Sixty-eight percent of patients were eating at the time of discharge, and 42% died within 90 days of surgical consultation. Median overall survival rates for patients managed with procedural, medical, and surgical treatment were 69, 135, and 314 days, respectively (p0.001). Intact primary/local recurrence, carcinomatosis, and albumin level3.5 g/dL were negatively associated with eating at discharge. Compared with medical management, surgery was not associated with the ability to eat. Variables associated with death within 90 days of consultation included an intact primary/local recurrence, carcinomatosis, abdominal visceral metastasis, and procedural treatment.Patients managed with surgery demonstrated improved survival on unadjusted analysis. However, on multivariate analysis that included the imaging extent of disease, surgery was not associated with outcome, which highlights the importance of patient selection and the need for additional research to identify variables critical for treatment selection.

OBJECTIVE The primary imaging modalities used to select patients for endovascular thrombectomy (EVT) are noncontrast computed tomography (CT) and CT perfusion (CTP). However, their relative utility is uncertain. We prospectively assessed CT and CTP concordance/discordance and correlated the imaging profiles on both with EVT treatment decisions and clinical outcomes. METHODS A phase 2, multicenter, prospective cohort study of large-vessel occlusions presented up to 24 hours from last known well was conducted. Patients received a unified prespecified imaging evaluation (CT, CT angiography, and CTP with Rapid Processing of Perfusion and Diffusion software mismatch determination). The treatment decision, EVT versus medical management, was nonrandomized and at the treating physicians' discretion. An independent, blinded, neuroimaging core laboratory adjudicated favorable profiles based on predefined criteria (CT:Alberta Stroke Program Early CT Score ≥ 6, CTP:regional cerebral blood flow (

Background: While CT ASPECT scores predict clinical outcomes, the association between the scores and ischemic lesion volume is not linear as the subcortical regions involve small volumes while the cortical areas often involve large volumes. We evaluated whether ASPECTS and CTP ischemic core volume, modify each other’s association with clinical outcome in patients undergoing endovascular thrombectomy (EVT). Methods: In a prospective multicenter cohort study of imaging selection (SELECT), anterior circulation large vessel occlusion patients up to 24 hours from last known well were enrolled at 9 centers. All patients received a unified imaging profile (NCCT, CTA, and CTP with ischemic core volume [rCBF Results: Of 445 enrolled, 284 received EVT and are included in this analysis. Median (IQR) ASPECTS was 8 (7-9), median (IQR) ischemic core volume 10 ml (0-33). Both ASPECTS and ischemic core volume independently correlated with good outcome after EVT. For ASPECTS, the probability of good outcome decreased by 14% per point (aOR 1.18, 95% CI 1.01-1.38, p=0.03). For CTP mRS 0-2 probability dropped by 25% for each 10 ml increase in core volume (aOR 0.75, 95% CI 0.67-0.84, P Conclusion: ASPECTS association with clinical outcome after EVT was strongly modified by ischemic core volumes. Favorable outcomes were achieved in patients with small ischemic core volume despite low ASPECTS.

Background: Large infarct cores on CT or CTP were an exclusion from most trials of Endovascular thrombectomy (EVT). However, large cores may be seen in occasional patients presenting within the early window (0-3 hours) and may not preclude potential benefit from thrombectomy. We studied clinical outcomes with thrombectomy in patients presenting with large cores measured by CT or CTP within 3 hours of last known well (LKW). Methods: From a multicenter prospective cohort study of imaging selection for EVT (SELECT), patients with a large ischemic core (CBF 50cc or ASPECT≤5 presenting within 3 hours from LKW to imaging were identified. All patients received CT and CTP with mismatch determination by RAPID software. A blinded independent core-lab adjudicated all images. Good (90 day mRS 0-2) and safety (sICH and mortality) outcomes were compared between patients who received EVT and those with medical management (MM) only. Results: Of 445 patients enrolled, 54 met criteria for large core and early presentation; 28 had ASPECT≤5 (17 EVT, 11 MM) and 40 had CTP >50 cc (26 EVT, 14 MM) and 14 on both CT and CTP. Median (IQR) age 66 years (60, 75), NIHSS 20 (18, 23), LKW to puncture 162 min (range 69-343). Baseline characteristics were similar between EVT and MM. Patients with large core whether on CT (ASPECT≤5) or CTP (CBF>50cc) had more frequent good outcome with EVT (30% overall, CT 35%, and CTP 27% vs 0% MM, p=0.04, Fig 1) Furthermore, EVT resulted in smaller average final infarcts (77 vs 202 ml, p=0.03), similar mortality (31% vs 29%, p=0.87) and sICH (16% vs 6%,p=0.34). In patients who achieved good outcome with thrombectomy, EVT resulted in smaller infarct growth 31 ml (10-58) vs 111 cc (67-233) in patients who had poor outcome, p=0.01. Outcome rates were similar if large core was defined as >70ml. Conclusion: Patients with large core infarct measured by CT or CTP presenting within 3 hours may benefit from EVT. Time may trump imaging in patients with large core who present early.

Background: Whether bridging therapy with IV tPA delays endovascular thrombectomy (EVT) or alters clinical outcomes is unknown. Methods: In this prospective multicenter cohort study of imaging selection for EVT (SELECT), consecutive patients with anterior circulation (ICA, M1, M2) occlusions who presented within 24 hrs from last known well were enrolled at 9 centers. We stratified patients into those who received IV tPA prior to EVT vs those who did not. Results: Of 445 enrolled, 284 received EVT; 222 (78%) treated within 6 hrs and 62 (22%) >6-24 hrs. 65% received IV tPA. Baseline characteristics were similar between the tPA and no tPA groups. There were no workflow delays associated with IV tPA: arrival to groin puncture, median (IQR) 92 (64-117) min in the tPA group vs. 82 (64-113) no IV tPA, p=0.52. The rate of functional independence (90 day mRS 0-2) was 57% with IV tPA vs. 47% without, aOR 1.7 (95% CI 0.95-3.05), p=0.07. The ordinal analysis showed a significant shift towards better 90 day mRS scores in the tPA group, aOR 1.9, 95% CI: 1.19-3.00, p=0.007. Mortality was 11% (tPA) vs 18% (no tPA), p=0.07 and sICH rates were 7% (tPA) vs. 5% (no tPA), p=0.5. Restricting the analyses to patients presenting directly to EVT centers within 4.5 hours (N=115), no significant delays were evident; arrival to puncture with tPA 95 (76-121) min vs 86 (68-114) without tPA, p=0.4. Functional independence was 62% with tPA vs 51% without, aOR 1.73 (95% CI 0.78-3.83, p=0.18) with a statistically significant shift in favor of tPA on the ordinal analysis, aOR 1.8, 95% CI: 1.08-3.45, p=0.038. Patients with M2 occlusions, smaller baseline infarct core volume, earlier treatment, and milder strokes were most likely to have better outcomes with tPA vs no tPA (Fig 1). Conclusion: IV tPA administration did not result in delays to EVT and was associated with higher rates of good outcome. Randomized trials are required to more definitively establish the efficacy of bridging therapy with tPA prior to EVT.

Background: It is unknown if repeat imaging of transfer patients for endovascular thrombectomy (EVT) results in better patient selection and improved clinical outcomes or if bypassing repeat imaging and direct transfer to the angiosuite is safe, saves time and improve outcomes. Methods: A multicenter retrospective cohort was pooled from 6 centers (Europe and US) from 1/2014 to 4/2018 of patients with anterior circulation occlusion (ICA, M1, M2) transferred for EVT up to 24 hours from last known well. Patients were divided based on imaging acquisition at the EVT center into those who underwent any repeat imaging (CT+/- CTA, CTP) and those who bypassed imaging and went directly to the angiosuite. We compared good outcome (90 day mRS 0-2) and safety (sICH, mortality) between the two groups. Results: Of 646 patients, 559 received EVT and 87 were excluded for poor imaging profiles. In patients who received EVT, 173 (31%) had no repeat nd 386 (69%) had repeat images. The two groups had similar age and NIHSS. ASPECTS was lower in the repeat images group 8(7-10) when compared to ASPECTS from the outside facility in the non-repeat 9(8-10), p Conclusion: In patients transferred for EVT, repeat imaging resulted in treatment delays without improving good outcome. Direct angio suite access may result in more patients treated safely who achieve good outcome.

Background: We assessed the correlation between early infarct growth rate (EIGR), collaterals and clinical outcomes following endovascular thrombectomy (EVT). Methods: In a prospective multicenter cohort study of imaging selection for EVT (SELECT), consecutive patients with large vessel occlusion (ICA, M1, M2) presenting up to 24 hr from last known well (LKW) were enrolled at 9 centers. CT perfusion was obtained prior to EVT. EIGR was defined as CTP ischemic core volume (rCBF> 2. Results: Of 445 enrolled, 284 received EVT. The optimal EIGR was Conclusion: The early infarct growth strongly correlates with both collateral status and clinical outcomes after EVT. Fast progressors have a much more rapid decline in favorable outcomes at late treatment times.

Background: Endovascular thrombectomy (EVT) efficacy and safety is not established in patients with large core. We evaluated the clinical and radiologic outcomes following EVT in acute strokes with large ischemic core lesions defined by CT ASPECTS and/or CTP. Methods: From a multicenter prospective cohort study of imaging selection for thrombectomy (SELECT), patients with large ischemic core on CTP (rCBF< 30%) >50 ml and/or ASPECT≤5 up to 24 hrs from last known well were identified at 9 U.S centers. All patients received a baseline CT and CTP with automated ischemic core determination by RAPID. A blinded core lab adjudicated all images. The primary outcome was 90 day mRS 0-2. Safety outcomes were sICH and mortality. Outcomes of EVT patients were compared to those who received medical management (MM) only. Results: Of 445 enrolled, 106 had large core on either CT or CTP: 71 ASPECTS≤5 (EVT 37, MM 34) and 75 CTP core >50 ml (EVT 40, MM 35), 40 on both CT and CTP. Median (IQR) age 66 yr, NIHSS 20 (16-23), time to puncture 224 min (range 69-832), ASPECTS 5 (4-6) and CTP core 72 ml (41-96). Baseline characteristics were similar in EVT vs. MM patients in both CT and CTP definition groups. The EVT group had better mRS 0-2 rates as compared to MM (32 % vs 14%), aOR: 2.9 (95% CI: 1.0-7.9, p=0.041) and a favorable mRS shift on ordinal analysis aOR: 2.0 (95% CI 1.0-4.1, p=0.049), smaller final infarct volume 96 (49-196) vs 175 (127-225) ml, p=0.02, and less infarct growth 44 (0.7-107.6) vs 83 (61-133) ml, p=0.03 with similar mortality 29% EVT, 42% MM, p=0.16 and sICH 13% EVT, 7% MM, p=0.3. EVT patients were more likely to achieve mRS 0-2 if treated early (0-6) vs late (>6-24 hrs) for both CTP defined (27% vs 0%) and CT defined large core (44% vs. 18%). The good outcome declined by 20% for each hr of treatment delay (Fig 1). Conclusion: EVT may be effective and safe for patients with a large core, especially if treated early. RCTs are needed.

Background The optimal irrigation flow rate (IFR) during epicardial radiofrequency (RF) ablation has not been established. Objective This study specifically examined the impact of IFR and intrapericardial fluid (IPF) accumulation during epicardial RF ablation. Methods Altogether, 452 ex vivo RF applications (10 g for 60 seconds) delivered to the epicardial surface of bovine myocardium using 3 open-irrigated ablation catheters (ThermoCool SmartTouch, ThermoCool SmartTouch-SF, and FlexAbility) and 50 in vivo RF applications delivered (ThermoCool SmartTouch-SF) in 4 healthy adult swine in the presence or absence of IPF were examined. Ex vivo, RF was delivered at low (≤3 mL/min), reduced (5–7 mL/min), and high (≥10 mL/min) IFRs using intermediate (25–35 W) and high (35–45 W) power. In vivo, applications were delivered (at 9.3 ± 2.2 g for 60 seconds at 39 W) using reduced (5 mL/min) and high (15 mL/min) IFRs. Results Ex vivo, surface lesion diameter inversely correlated with IFR, whereas maximum lesion diameter and depth did not differ. While steam pops occurred more frequently at low IFR using high power (ThermoCool SmartTouch and ThermoCool SmartTouch-SF), tissue disruption was rare and did not vary with IFR. In vivo, charring/steam pop was not detected. Although there were no discernible differences in lesion size with IFR, surface lesion diameter, maximum diameter, depth, and volume were all smaller in the presence of IPF at both IFRs. Conclusion Cooled-tip epicardial RF ablation created using reduced IFRs (5–7 mL/min) yields lesion sizes similar to those created using high IFRs (≥10 mL/min) without an increase in steam pop/tissue disruption, whereas the presence of IPF significantly reduces the lesion size.

PURPOSE: Catheter ablation of atrial fibrillation (CAAF) using the cryoballoon has emerged as an alternate strategy to point-by-point radiofrequency. However, there is little comparative data on long-term durability of pulmonary vein (PV) isolation comparing these two modalities. METHODS: In this multicenter, retrospective analysis, the incidences/patterns of late PV reconnection following an index CAAF using the second-generation cryoballoon versus open-irrigated, non-force-sensing radiofrequency were examined. RESULTS: Of the 2002 patients who underwent a first-time CAAF, 186/1126 patients (16.5 %) ablated using cryoballoon and 174/876 patients (19.9 %) with non-contact force-guided radiofrequency required a repeat procedure at 11 ± 5 months. During follow-up, the incidence of atrial flutters/tachycardias was lower (19.9 vs. 32.8 %; p = 0.005) and fewer patients exhibited PV reconnection (47.3 vs. 60.9 %; p = 0.007) with cryoballoon versus radiofrequency. Additionally, fewer PVs had reconnected with cryoballoon versus radiofrequency (18.8 vs. 34.6 %; p

Importance: Ischemic strokes pose a significant health burden. However, the etiology of between 20 and 40% of these events remains unknown. Left atrial appendage morphology may influence the occurrence of thromboembolic events. Design: A retrospective cross-sectional study was conducted to investigate the role of LAA morphology in patients with atrial fibrillation (AF) and cardioembolic-associated stroke and patients with cryptogenic stroke without atrial fibrillation. LAA morphology is classified into two groups: (1) simple (chicken-wing) vs. (2) complex (non-chicken wing) based on transesophageal echocardiography (TEE) findings. In addition to the LAA morphology, left atrial parameters, including orifice diameter, depth, emptying velocity, and filling velocity, were collected for both groups. Mathematical, computational models were constructed to investigate flow velocities in chicken-wing and non-chicken wing morphological patterns to assess LAA function further. Findings: TEE values for volume, size, emptying, and filling velocities were similar between simple and complex LAA morphology groups. Patients with cryptogenic stroke without coexisting AF were noted to have significantly higher rates of complex LAA morphology. Chicken-wing LAA morphology was associated with four-fold higher flow rate (kg/s) in computational simulations. Conclusions: Complex LAA morphology may be an independent contributing factor for cryptogenic strokes. Further studies are warranted to investigate the mechanism involved in LAA morphology and thromboembolic events.

Second-Generation Cryoballoon versus RF Introduction There are limited comparative data on catheter ablation of atrial fibrillation (CAAF) using the second-generation cryoballoon (CB-2) versus point-by-point radiofrequency (RF). This study examines the acute/long-term CAAF outcomes using these 2 strategies. Methods and Results In this multicenter, retrospective, nonrandomized analysis, procedural and clinical outcomes of 1,196 patients (76% with paroxysmal AF) undergoing CAAF using CB-2 (n = 773) and open-irrigated, non-force sensing RF (n = 423) were evaluated. Pulmonary vein isolation was achieved in 98% with CB-2 and 99% with RF (P = 0.168). CB-2 was associated with shorter ablation time (40 ± 14 min vs. 66 ± 26 min; P < 0.001) and procedure time (145 ± 49 minutes vs. 188 ± 42 minutes; P < 0.001), but greater fluoroscopic utilization (29 ± 13 minutes vs. 23 ± 14 minutes; P < 0.001). While transient (7.6% vs. 0%; P < 0.001) and persistent (1.2% vs. 0%; P = 0.026) phrenic nerve palsy occurred exclusively with CB-2, other adverse event rates were similar between CB-2 (1.6%) and RF (2.6%); P = 0.207. However, freedom from AF/atrial flutter/tachycardia at 12 months following a single procedure without antiarrhythmic therapy was greater with CB-2 (76.6%) versus RF (60.4%); P < 0.001. While this difference was evident in patients with paroxysmal AF (P < 0.001), it did not reach significance in those with persistent AF (P = 0.089). Additionally, CB-2 was associated with reduced long-term need for antiarrhythmic therapy (16.7% vs. 22.0%; P = 0.024) and repeat ablations (14.6% vs. 24.1%; P < 0.001). Conclusion In this multicenter, retrospective, nonrandomized study, CAAF using CB-2 coupled with RF as occasionally required was associated with greater freedom from atrial arrhythmias at 12 months following a single procedure without antiarrhythmic therapy when compared to open-irrigated, non-force sensing RF, alone.

IMPORTANCE: The efficacy and safety of endovascular thrombectomy (EVT) in patients with large ischemic cores remains unknown, to our knowledge. OBJECTIVE: To compare outcomes in patients with large ischemic cores treated with EVT and medical management vs medical management alone. DESIGN, SETTING, AND PARTICIPANTS: This prespecified analysis of the Optimizing Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) trial, a prospective cohort study of imaging selection that was conducted in 9 US comprehensive stroke centers, enrolled patients between January 2016 and February 2018, and followed them up for 90 days. Patients with moderate to severe stroke and anterior circulation large-vessel occlusion presenting up to 24 hours from the time they were last known to be well were eligible for the cohort. Of these, patients with large ischemic cores on computed tomography (CT) (Alberta Stroke Program Early CT Score

BACKGROUND: Limited data exist on procedural and biophysical indicators of pulmonary vein (PV) isolation durability after the cryoballoon ablation of atrial fibrillation (AF). OBJECTIVE: The aim of this study was to investigate the procedural and biophysical characteristics associated with late PV reconnection (PVR) and durable PV isolation (PVI) after cryoablation using the currently available second-generation cryoballoon. METHODS: Data from 435 PVs targeted in 112 consecutive patients who underwent a repeat procedure 14 ± 3 months after an index cryoablation of AF were examined. RESULTS: Altogether, 111 PVs (25.5%) in 71 patients (63.4%) demonstrated PVR whereas 324 PVs (74.5%) exhibited PVI. The number and duration of cryoballoon applications did not differ between PVR and PVI. However, the time to PV isolation (time to effect) was considerably shorter (39.1 ± 11.7 seconds vs 67.6 ± 19.7 seconds; P < .001), the balloon temperature at time to effect was significantly warmer (-32.1°C ± 7.8°C vs -39.4°C ±5.8°C; P < .001), the balloon nadir temperature was slightly cooler (-48.7°C ± 4.6°C vs -47.8°C ± 2.9°C; P = .034), and the total thaw time (56.5 ± 25.4 seconds vs 34.8 ± 9.1 seconds; P < .001) and interval thaw times at 0°C (iTT0; 14.8 ± 10.9 seconds vs 7.1 ± 2.0 seconds; P < .001) and 15°C (54.2 ± 25.4 seconds vs 33.3 ± 9.1 seconds; P < .001) were notably longer with PVI than with PVR. However, only a time to effect of ≤60 seconds and an iTT0 of ≥10 seconds emerged as significant predictors of PV isolation durability. Consequently, in a multivariate model, presence of both criteria predicted

Background A significant proportion of patients with history of ventricular arrhythmia experience resolution of ventricular arrhythmia(VAs) after implantation of continuous-flow left ventricular assist devices (CF-LVADs). Factors associated with resolution of these VAs remain unexplored. Objective Identify factors associated with resolution of ventricular arrhythmia after CF-LVAD implantation. Methods A single center retrospective review of patients undergoing CF-LVAD implantation between 2000 and 2015 was done to identify patients with documented history of at least one episode of VT, VF or VT storm preoperatively. Patient characteristics, operative variables and outcomes including development of arrhythmia were assessed. Results 192 patients(82 females (42.71%); 46 patients with age >65 (23.96%)) with previously documented ventricular arrhythmia underwent CF-LVAD implant. 60 (31.3%) patients developed at least 1 episode of ventricular arrhythmia(VAs) after CF-LVAD, whereas 132 (68.7%) experienced no ventricular arrhythmia during the follow-up period. On multivariable analysis, emergent status (OR: 2.97, p=0.040) and need for temporary Mechanical Circulatory Support (2.09, p=0.033) were associated with increased odds of resolution of VAs, whereas previous cardiac surgery (OR:0.47, p=0.038) and use of multiple anti-arrhythmic drugs (OR:0.32, p=0.010) were associated with reduced likelihood of resolution of VAs after CF-LVAD implant. Conclusions Features suggestive of acute hemodynamic failure demonstrated better odds of VA resolution after CF-LVAD implant, whereas structural damage after previous cardiac procedure and severe rhythm disorders requiring aggressive management were associated with reduced likelihood of resolution of VAs after CF-LVAD implant.

Background A significant proportion of patients develop new onset ventricular arrhythmia (VAs) after implantation of continuous-flow left ventricular assist devices (CF-LVADs). Factors associated with these de novo VAs remain unexplored. Objective Identify factors associated with de-novo ventricular arrhythmia after CF-LVAD implantation. Methods A single center retrospective review of patients undergoing CF-LVAD implantation between 2000 and 2015 was done to identify patients without any history of VAs. Patient characteristics, operative variables and outcomes including development of arrhythmias were assessed. Results 296 patients without previously documented ventricular arrhythmia underwent CF-LVAD implant. Two hundred and thirty (77.7%) remained free of VAs for their respective duration of follow-up. The remaining 66 (22.3%) patients developed de novo ventricular arrhythmia (VAs). Of these, 37 (12.5%) had early onset ( 30 days) de-novo VAs. On multivariable analysis, need for temporary mechanical circulatory support (OR:2.15, p=0.013); diabetes mellitus (OR: 1.79, p=0.043); pre-op hemoglobin 600 U/L (OR:0.53, p=0.041) were associated with early onset de-novo VAs. Low ejection fraction 7.5 cm (OR: 3.90, P=0.099)] and history of diabetes mellitus (OR:2.07, p=0.083) also exhibited statistical trends towards late onset de novo VAs in the multivariable model. Conclusions Whereas immediate preoperative clinical status or comorbidities of the patients undergoing CF-LVAD implant predicted early onset VAs, the structural and compromised functional cardiac status turned out to be predictors for late onset de novo VAs.

Extracorporeal membrane oxygenation has evolved in design, technology, patient selection, insertion techniques, adjunct devices, and management in the past 45 years since it began. Outcomes have improved and indications have expanded. It continues to be an expeditious, cost-effective tool for rapid resuscitation of patients with cardiorespiratory failure, whose outcomes without extracorporeal membrane oxygenation intervention are predominately fatal. However, results are still moderately satisfactory, and the ethical aspects of ongoing care need to be at the forefront of daily family discussions in patients for whom a bridge to transplant or definitive device is not possible.