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.

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.

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.

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.

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: 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.

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.

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: 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.

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.

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.

Background: Catheter ablation (CA) of long-standing persistent (LSP) atrial fibrillation (AF) is associated with reduced success rates. This analysis examines the acute/long-term outcomes of a staged hybrid surgical and catheter-based ablation strategy for treatment of LSP AF. Methods: In this