Mechanical thrombectomy in patients with heart failure: the Italian registry of Endovascular Treatment in Acute Stroke.

BACKGROUND: Heart failure (HF) is the second most important cardiac risk factor for stroke after atrial fibrillation (AF). Few data are available on mechanical thrombectomy (MT) in acute ischemic stroke (AIS) patients with HF. METHODS: The source of data is the multicentre Italian Registry of Endovascular Treatment in Acute Stroke (IRETAS). All AIS patients ≥ 18 years receiving MT were categorised in two groups: HF and no-HF. Baseline clinical and neuroradiological findings on admission were analysed. RESULTS: Of 8924 patients, 642 (7.2%) had HF. Compared to the no-HF group, HF patients had higher prevalence of cardiovascular risk factors. Rate of complete recanalisation (TICI 2b-3) was 76.9% in HF vs 78.1% in no-HF group (p = 0.481). Rate of symptomatic intracerebral haemorrhage at 24-h non-contrast computed tomography (NCCT) was 7.6% in HF vs 8.3% in no-HF patients (p = 0.520). At 3 months, 36.4% of HF patients and 48.2% of no-HF patients (p < 0.001) had mRS 0-2, and mortality was, respectively, 30.7% and 18.5% (p < 0.001). In multivariate logistic regression, HF was independently associated with mortality at 3 months (OR 1.53, 1.24-1.88 95% CI, p < 0.001). In multivariate ordinal regression, HF patients had a probability of transitioning to a higher mRS level of 1.23 (1.05-1.44 95% CI, p = 0.012). The propensity score analysis of two groups matched for age, sex, and NIHSS at admission yielded the same results. CONCLUSION: MT is safe and effective in HF patients with AIS. Patients with HF and AIS suffered from higher 3-month mortality and unfavourable outcome regardless of acute treatments.

Endovascular treatment of acute ischemic stroke due to tandem lesions of the anterior cerebral circulation: a multicentric Italian observational study.

PURPOSE: Acute ischemic stroke (AIS) due to tandem lesions (TLs) of extracranial Internal Carotid Artery and Anterior Cerebral Circulation are challenging for endovascular treatment (EVT). This study aims to evaluate feasibility, safety and efficacy of EVT for TLs' AIS, with or without emergent carotid artery stenting (eCAS), in a real-life scenario. METHODS: Retrospective review of prospectively collected non-randomized thrombectomy databases from five stroke centers between 2015 and 2019. Consecutive patients with TLs' AIS were selected. Clinical, neuroimage and procedure features, as well as antiplatelet therapy regimen, were evaluated. Primary outcome was 90-day mRS ≤ 2. Secondary outcomes included: mTICI score 2b-3, extracranial recanalization, procedural complications, symptomatic intracerebral hemorrhage (SICH) and 90-day mortality. RESULTS: Two hundred twenty-seven patients were enrolled (67.8% males; mean age 65.9 ± 12.9 years). We obtained mTICI 2b-3 in 77.1%, extracranial recanalization in 86.8%, 90-day mRS (available in 201/227 cases) ≤ 2 in 49.8%. Procedural complications occurred in 16.7%, SICH in 9.7%; 90-day mortality rate (available in 201/227 cases) was 14.4%. The strongest predictors of good clinical outcome were young age (p < 0.0001), low baseline NIHSS (p = 0.008), high baseline ASPECTS (p < 0.0001), good collateral flow (p = 0.013) and extracranial recanalization (p = 0.001). The most significant predictors of SICH were low baseline ASPECTS (p < 0.0001), occurrence of complications (p < 0.0001) and eCAS (p = 0.002). CONCLUSION: In our real-life series, the EVT for TLs' AIS was feasible, safe and effective in improving 90-day functional outcome with acceptable morbi-mortality rates. ECAS increased the risk of SICH, independently from the antiplatelet therapy regimen.

General Anesthesia Versus Conscious Sedation and Local Anesthesia During Thrombectomy for Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: As numerous questions remain about the best anesthetic strategy during thrombectomy, we assessed functional and radiological outcomes in stroke patients treated with thrombectomy in presence of general anesthesia (GA) versus conscious sedation (CS) and local anesthesia (LA). METHODS: We conducted a cohort study on prospectively collected data from 4429 patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke. RESULTS: GA was used in 2013 patients, CS in 1285 patients, and LA in 1131 patients. The rates of 3-month modified Rankin Scale score of 0-1 were 32.7%, 33.7%, and 38.1% in the GA, CS, and LA groups: GA versus CS: odds ratios after adjustment for unbalanced variables (adjusted odds ratio [aOR]), 0.811 (95% CI, 0.602-1.091); and GA versus LA: aOR, 0.714 (95% CI, 0.515-0.990). The rates of modified Rankin Scale score of 0-2 were 42.5%, 46.6%, and 52.4% in the GA, CS, and LA groups: GA versus CS: aOR, 0.902 (95% CI, 0.689-1.180); and GA versus LA: aOR, 0.769 (95% CI, 0.566-0.998). The rates of 3-month death were 21.5%, 19.7%, and 14.8% in the GA, CS, and LA groups: GA versus CS: aOR, 0.872 (95% CI, 0.644-1.181); and GA versus LA: aOR, 1.235 (95% CI, 0.844-1.807). The rates of parenchymal hematoma were 9%, 12.6%, and 11.3% in the GA, CS, and LA groups: GA versus CS: aOR, 0.380 (95% CI, 0.262-0.551); and GA versus LA: aOR, 0.532 (95% CI, 0.337-0.838). After model of adjustment for predefined variables (age, sex, thrombolysis, National Institutes of Health Stroke Scale, onset-to-groin time, anterior large vessel occlusion, procedure time, prestroke modified Rankin Scale score of <1, antiplatelet, and anticoagulant), differences were found also between GA versus CS as regards modified Rankin Scale score of 0-2 (aOR, 0.659 [95% CI, 0.538-0.807]) and GA versus LA as regards death (aOR, 1.413 [95% CI, 1.095-1.823]). CONCLUSIONS: GA during thrombectomy was associated with worse 3-month functional outcomes, especially when compared with LA. The inclusion of an LA arm in future randomized clinical trials of anesthesia strategy is recommended.

Efficacy of ADAPT with large-bore reperfusion catheter in anterior circulation acute ischemic stroke: a multicentric Italian experience.

INTRODUCTION: A direct aspiration first pass technique (ADAPT) is an alternative technique as first-line thrombectomy for large vessel occlusion in acute ischemic stroke, still debated when compared to first-line stent retriever. To retrospectively evaluate technical and clinical outcomes of the ADAPT as first-line treatment for anterior circulation acute ischemic stroke with large-bore reperfusion catheters. METHODS: A multicentric data collection from 14 medical centers was retrospectively analyzed. Large-bore catheters had a distal diameter between 0.64 and 0.71 in; stent retriever was added when aspiration alone failed. Baseline characteristics, technical and clinical variables were collected, including NIHSS, thrombolysis in cerebral infarction (TICI), peri-procedural complications, 90-day mRS and 90-day mortality. RESULTS: Overall, 501 patients were treated. No statistically significant difference in terms of baseline features or tPA administration was recorded between patients treated with ADAPT and with additional stent retriever. ADAPT alone was successful in achieving TICI ≥ 2b in 71.8% with a median of 1.55 aspiration attempts. In terms of TICI ≥ 2b, ADAPT alone was better than additional stent retriever (p < 0.001), while no statistical difference was achieved from catheter diameter. Embolization to a new territory was less frequent in ADAPT group (5.2 vs 18%; p = 0.0026). Patients treated with ADAPT alone had better clinical outcomes in terms of mRS ≤ 2 (p < 0.001). CONCLUSIONS: ADAPT is a valid technique with respect to the rates of TICI 2b/3 recanalization and 90-day mRS scores. In this series, an attempt at recanalization with ADAPT with larger-bore reperfusion catheter may be warranted prior to stentriever thrombectomy.

IER-SICH Nomogram to Predict Symptomatic Intracerebral Hemorrhage After Thrombectomy for Stroke.

Background and Purpose- As a reliable scoring system to detect the risk of symptomatic intracerebral hemorrhage after thrombectomy for ischemic stroke is not yet available, we developed a nomogram for predicting symptomatic intracerebral hemorrhage in patients with large vessel occlusion in the anterior circulation who received bridging of thrombectomy with intravenous thrombolysis (training set), and to validate the model by using a cohort of patients treated with direct thrombectomy (test set). Methods- We conducted a cohort study on prospectively collected data from 3714 patients enrolled in the IER (Italian Registry of Endovascular Stroke Treatment in Acute Stroke). Symptomatic intracerebral hemorrhage was defined as any type of intracerebral hemorrhage with increase of ≥4 National Institutes of Health Stroke Scale score points from baseline ≤24 hours or death. Based on multivariate logistic models, the nomogram was generated. We assessed the discriminative performance by using the area under the receiver operating characteristic curve. Results- National Institutes of Health Stroke Scale score, onset-to-end procedure time, age, unsuccessful recanalization, and Careggi collateral score composed the IER-SICH nomogram. After removing Careggi collateral score from the first model, a second model including Alberta Stroke Program Early CT Score was developed. The area under the receiver operating characteristic curve of the IER-SICH nomogram was 0.778 in the training set (n=492) and 0.709 in the test set (n=399). The area under the receiver operating characteristic curve of the second model was 0.733 in the training set (n=988) and 0.685 in the test set (n=779). Conclusions- The IER-SICH nomogram is the first model developed and validated for predicting symptomatic intracerebral hemorrhage after thrombectomy. It may provide indications on early identification of patients for more or less postprocedural intensive management.

[The Cannulation of the Arteriovenous Fistula in the Presence of a Stent: Precautions, Risks, and Possibilities].

A proper management and tailored interventions represented two fundamental steps to ensure a long-term use of the arteriovenous fistula (AVF). AVF failure can be attributed to various factors, with stenosis being the most common cause. Different techniques are employed for treating complications, but percutaneous endovascular procedures are the most widely used. In addition to angioplasty (PTA), the possibility of utilizing stents, particularly stent grafts (SG), has further improved outcomes. However, the insertion of these devices involves commitment to a segment of the vessel, which may vary in length, making the indication necessitate a careful evaluation. The positioning of a stent graft indeed limits the space for needle insertion, and on the other hand, the cannulation of the device is considered off-label according to technical specification. This work addresses the issue of puncturing these devices. Alongside a rapid overview, we describe a clinical case of continuous cannulation of a multiply stented AVF, for over 9 years, which opens up the discussion about the possibility of long-term cannulation through proper planning.

Woven EndoBridge Device for Unruptured Wide-Neck Bifurcation Aneurysm: A Multicenter 5-Year Follow-up.

BACKGROUND AND OBJECTIVES: This multicenter study aimed to assess the safety and efficacy of the Woven EndoBridge (WEB) device for treating unruptured wide-neck intracranial bifurcation aneurysms (WIBAs) with short-, mid-, and long-term follow-ups (FUPs). METHODS: Consecutive patients with unruptured WIBAs treated with WEB between December 2014 and January 2018 were included. Patient, aneurysm, and device characteristics were collected and analyzed retrospectively. Morbidity and mortality rates were determined by collecting intraprocedural, periprocedural, and delayed complications. Aneurysm occlusion was assessed at 1, 3, and 5 years using a 3-grade scale: complete occlusion, neck remnant, and residual aneurysm. Complete occlusion and neck remnant were considered as adequate occlusion. Patients who received re-treatment were also evaluated. RESULTS: The study included 104 consecutive patients (55.8% female, mean age 58.6 ± 11.8 years). Aneurysm maximum size, neck, and dome-to-neck mean were, respectively, 6.9 ± 2.1 mm, 4.5 ± 1.2 mm, and 1.4 ± 0.3 mm. One-year FUP was collected for 95 patients, and 3- and 5-year FUPs were collected for 83 patients. Adequate occlusion was observed at 1-year FUP in 90.5% (86/95), 91.6% (76/83) was observed at 3-year FUP, and 92.8% (77/83) at 5-year FUP. None of the aneurysms bled after treatment. During FUP, 6/83 patients (7.2%) were re-treated for residual aneurysm. Morbidity and mortality rates closely related to aneurysm occlusion were 0% (0/104). CONCLUSION: The WEB device was safe and effective for treating unruptured WIBAs, both in short-term and long-term FUPs.

Association of the Careggi Collateral Score with 3-month modified Rankin Scale score after thrombectomy for stroke with occlusion of the middle cerebral artery.

BACKGROUND: The Careggi Collateral Score (CCS) (qualitative-quantitative evaluation) was developed from a single-centre cohort as an angiographic score to describe both the extension and effectiveness of the pial collateral circulation in stroke patients with occlusion of the anterior circulation. We aimed to examine the association between CCS (quantitative evaluation) and 3-month modified Rankin Scale (mRS) score in a large multi-center cohort of patients receiving thrombectomy for stroke with occlusion of middle cerebral artery (MCA). METHODS: We conducted a study on prospectively collected data from 1284 patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke. According to the extension of the retrograde reperfusion in the cortical anterior cerebral artery (ACA)-MCA territories, CCS ranges from 0 (absence of retrograde filling) to 4 (visualization of collaterals until the alar segment of the MCA). RESULTS: Using CCS of 4 as reference, CCS grades were associated in the direction of unfavourable outcome on 3-month mRS shift (0 to 6); significant difference was found between CCS of 0 and CCS of 1 and between CCS of 3 and CCS of 4. CCS ≥ 3 was the optimal cut-off for predicting 3-month excellent outcome, while CCS ≥ 1 was the optimal cut-off for predicting 3-month survival. CCS of 0 and CCS < 3 were associated in the direction of unfavourable recanalization on TICI shift (0 to 3) compared with CCS ≥ 1 and CCS ≥ 3, respectively. Compared with CCS ≥ 3 as reference, CCS of 0 and CCS 1 to 2 were associated in the direction of unfavourable recanalization on TICI shift. There was no evidence of heterogeneity of effects of successful recanalization and procedure time ≤ 60 min on 3-month mRS shift across CCS categories. CONCLUSION: The CCS could provide a future advantage for improving the prognosis in patients receiving thrombectomy for stroke with M1 or M1-M2 segment of the MCA occlusion.

Use of a 4 mm Amplatzer Vascular Plug II in the treatment of a renal arteriovenous fistula: a case report.

BACKGROUND: We report the use of a 4 mm vascular Amplatzer for the occlusion of a renal arterovenous fistula between the renal artery, at the hylum trifurcation point, and an aneurismatic vein draining into the main renal vein, where there was no possibility to use any other device from the venous side, because of the diameter and the high flow, neither from the arterious side without sacrificing lobar branches. The device was implanted at the exact point of communication, like a patent foramen ovale occluder, with the distal disc into the artery lumen and the other two proximal discs into the venous side. CASE PRESENTATION: A 34-years-old Caucasian woman suffered several episodes of paroxysmal supraventricular tachycardia associated with dyspnoea, after the onset of post-pregnancy hypertension. She underwent CTA, spectral Doppler sonography and angiography which showed a renal arteriovenous fistula (RAVF) between the renal artery, at the hylum trifurcation point, and an extremely ectatic vein draining into the main renal vein of the right kidney. With both arterial and venous access, the RAVF was selectively embolized using a 4 × 6 mm Amplatzer Vascular Plug II, released into the communication between artery and vein ensuring the patency of vessels involved. The RAVF was almost completely excluded and the hemodynamic effects associated were also corrected. CONCLUSIONS: The use of this device, though in an alternative way, allowed the exclusion of the high flow A-V fistula without sacrificing any parent renal vessel and preserving the renal function.

Long-term follow-up of the Derivo® Embolization Device (DED®) for intracranial aneurysms: the Italian Multicentric Registry.

BACKGROUND: The flow-diverter devices (FDDs) safety and effectiveness have been demonstrated by large series and meta-analyses. Due to the high occlusion rates and the acceptable morbidity rates of FDDs, the indications for their use are continuously expanding. We presented our Italian multicentric experience using the second generation of DERIVO® Embolization Device (DED®; Acandis, Pforzheim, Germany) to cure cerebral aneurysms, evaluating both middle and long-term safety and efficacy of this device. METHODS: Between July 2016 and September 2017 we collected 109 consecutive aneurysms in 108 patients treated using DED® during 109 endovascular procedures in 34 Italian centers (100/109 aneurysms were unruptured, 9/109 were ruptured). The collected data included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and post-treatment modified Rankin Scale scores. Midterm and long-term clinical, angiographic and cross-sectional CT/MR follow-up were recorded and collected until December 2018. RESULTS: In 2/109 cases, DED® placement was classified as technical failures. The overall mortality and morbidity rates were respectively 6.5% and 5.5%. Overall DERIVO® related mortality and morbidity rates were respectively 0% and 4.6% (5 out of 108 patients). Midterm neuroimaging follow-up showed the complete or nearly complete occlusion of the aneurysm in 90% cases, which became 93% at long-term follow-up. Aneurysmal sac shrinking was observed in 65% of assessable aneurysms. CONCLUSIONS: Our multicentric experience using DED® for endovascular treatment of unruptured and ruptured aneurysms showed a high safety and efficacy profile, substantially equivalent or better compared to the other FDDs.

IER-START nomogram for prediction of three-month unfavorable outcome after thrombectomy for stroke.

BACKGROUND: The applicability of the current models for predicting functional outcome after thrombectomy in strokes with large vessel occlusion (LVO) is affected by a moderate predictive performance. AIMS: We aimed to develop and validate a nomogram with pre- and post-treatment factors for prediction of the probability of unfavorable outcome in patients with anterior and posterior LVO who received bridging therapy or direct thrombectomy <6 h of stroke onset. METHODS: We conducted a cohort study on patients data collected prospectively in the Italian Endovascular Registry (IER). Unfavorable outcome was defined as three-month modified Rankin Scale (mRS) score 3-6. Six predictors, including NIH Stroke Scale (NIHSS) score, age, pre-stroke mRS score, bridging therapy or direct thrombectomy, grade of recanalization according to the thrombolysis in cerebral ischemia (TICI) grading system, and onset-to-end procedure time were identified a priori by three stroke experts. To generate the IER-START, the pre-established predictors were entered into a logistic regression model. The discriminative performance of the model was assessed by using the area under the receiver operating characteristic curve (AUC-ROC). RESULTS: A total of 1802 patients with complete data for generating the IER-START was randomly dichotomized into training (n = 1219) and test (n = 583) sets. The AUC-ROC of IER-START was 0.838 (95% confidence interval [CI]): 0.816-0.869) in the training set, and 0.820 (95% CI: 0.786-0.854) in the test set. CONCLUSIONS: The IER-START nomogram is the first prognostic model developed and validated in the largest population of stroke patients currently candidates to thrombectomy which reliably calculates the probability of three-month unfavorable outcome.

Ruptured Intracranial Aneurysms Treated with Woven Endobridge Intrasaccular Flow Disruptor: A Multicenter Experience.

BACKGROUND: The woven endobridge intrasaccular flow disruptor (WEB) device for ruptured broad-based intracranial aneurysm (rBBA) remains underrepresented in existing studies. In this case series, the safety and efficacy results of the use of WEB in rBBA were evaluated from a multi-center experience. MATERIALS AND METHODS: Between November 2014 and October 2017, data of all patients with rBBA (≥4 mm and/or dome/neck ratio ≥1 and ≤1.6) treated with WEB were prospectively collected and retrospectively analyzed from 3 Italian neurointerventional centers. The interventional procedures and the clinical and angiographic outcomes are reported for the periprocedural phase with midterm follow-up. RESULTS: 33 patients were included in this series (10 patients with Hunt-Hess scores 4-5; 23 patients with Hunt-Hess scores 1-3). Technical success was obtained for all 33 patients (100%). The mean fluoroscopy time was 24 minutes (range, 8-40 minutes). Adjunctive devices were used in 6% of patients (2 stents). At the 1-month follow-up visit, the overall mortality was 33%. The overall rate of WEB-related complications was 27% (5 device protrusion, 2 sac perforation, 2 thromboembolism), with a WEB-related mortality of 12% and permanent neurologic deficit of 3%. Of the surviving patients, 1 was lost to follow-up. At 14 months, the mean follow-up (range, 2-35 months), no early or delayed reruptured aneurysms were observed; complete occlusion was obtained in 7/21 patients (33%), neck remnant in 8/21 (38%), and residual aneurysm filling in 6/21 (29%) patients, with a modified Rankin Scale of 0sto 2 observed in 17/21 patients (80%). CONCLUSIONS: The WEB device for rBBA is a fast and effective treatment, with a low rate of aneurysm rebleeding; however, procedure-related complications seem not negligible. Further evaluation comparing this device with other treatment options should be performed.