Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size.

BACKGROUND: The use of thrombectomy in patients with acute stroke and a large infarct of unrestricted size has not been well studied. METHODS: We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage. RESULTS: A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group. CONCLUSIONS: In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.).

Comparison of rescue intracranial stenting versus best medical treatment alone in acute refractory large vessel occlusion: study protocol for the PISTAR multicenter randomized trial.

BACKGROUND: Mechanical thrombectomy (MT) has become a standard treatment for acute ischemic strokes (AIS). However, MT failure occurs in approximately 10-30% of cases, leading to severe repercussions (with mortality rates up to 40% according to observational data). Among the available rescue techniques, rescue intracranial stenting (RIS) appears as a promising option. OBJECTIVE: This trial is poised to demonstrate the superiority of RIS in addition to the best medical treatment (BMT) in comparison with BMT alone, in improving the functional outcomes at 3 months for patients experiencing an AIS due to a large vessel occlusion refractory to MT (rLVO). METHODS: Permanent Intracranial STenting for Acute Refractory large vessel occlusions (PISTAR) is a multicenter prospective randomized open, blinded endpoint trial conducted across 11 French University hospitals. Adult patients (≥18 years) with an acute intracranial occlusion refractory to standard MT techniques will be randomized 1:1 during the procedure to receive either RIS+BMT (intervention arm) or BMT alone (control arm). RESULTS: The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin Scale score ≤2 and evaluated by an independent assessor blinded to the randomization arm. Secondary outcomes include hemorrhagic complications, all adverse events, and death. The number of patients to be included is 346. Two interim analyses are planned with predefined stopping rules. CONCLUSION: The PISTAR trial is the first randomized controlled trial focusing on the benefit of RIS in rLVOs. If positive, this study will open new insights into the management of AIS. TRIAL REGISTRATION NUMBER: NCT06071091.

Robotically assisted deployment of flow diverter stents for the treatment of cerebral and cervical aneurysms.

BACKGROUND: Despite the growing sophistication of robot-assisted surgery, it is necessary to demonstrate that robots can reliably perform complex procedures on site and then remotely. Although a flow diverter stent is one of the most effective and widely used devices, its placement is sometimes challenging. OBJECTIVE: To evaluate the feasibility and safety of the CorPath GRX robotic platform for the embolization of cerebral and cervical aneurysms using flow diverter stents. METHODS: We performed a single-center technical study of the first 10 flow diverter stent deployments with the CorPath GRX Robotic System (Corindus Inc, Waltham, Massachusetts, USA) for the treatment of cerebral aneurysms between April and October 2022. RESULTS: Ten patients underwent robot-assisted embolization with flow diverter stents: there were nine intracranial aneurysms (paraclinoid n=6; posterior communicating artery aneurysm n=1; anterior communicating artery n=2) and one cervical aneurysm. Four procedures were performed with coils plus a flow diverter stent, one was performed with woven endobridge plus a flow diverter stent and four were performed with flow diverter stents alone. Of these procedures, two were performed with telescoping flow diverters.All flow diverter stents were deployed with robotic assistance, with only one partial conversion to a manual technique (caused by guidewire torquability limitations). No perioperative complications were observed. CONCLUSION: Robot-assisted flow diverter stent deployment using the CorPath GRX platform is feasible and appears to be safe. Larger, in-depth studies of the technique's safety and benefits are now warranted.

Antithrombotic therapies for neurointerventional surgery: a 2021 French comprehensive national survey.

BACKGROUND: Neurointerventionists lack guidelines for the use of antithrombotic therapies in their clinical practice; consequently, there is likely to be significant heterogeneity in antithrombotic use between centers. Through a nationwide survey, we aimed to obtain an exhaustive cross-sectional overview of antithrombotic use in neurointerventional procedures in France. METHODS: In April 2021, French neurointerventional surgery centers were invited to participate in a nationwide 51-question survey disseminated through an active trainee-led research collaborative network (the JENI-RC). RESULTS: All 40 centers answered the survey. Fifty-one percent of centers reported using ticagrelor and 43% used clopidogrel as premedication before intracranial stenting. For flow diversion treatment, dual antiplatelet therapy was maintained for 3 or 6 months in 39% and 53% of centers, respectively, and aspirin was prescribed for 12 months or more than 12 months in 63% and 26% of centers, respectively. For unruptured aneurysms, the most common heparin bolus dose was 50 IU/kg (59%), and only 35% of centers monitored heparin activity for dose adjustment. Tirofiban was used in 64% of centers to treat thromboembolic complications. Fifteen percent of these comprehensive stroke centers reported using tenecteplase to treat acute ischemic strokes. Cangrelor appeared as an emergent drug in specific indications. CONCLUSION: This nationwide survey highlights the important heterogeneity in clinical practices across centers. There is a pressing need for trials and guidelines to further evaluate and harmonize antithrombotic regimens in the neurointerventional field.

A novel technique to perform cerebral angiography via the left radial approach: An 80 patients series.

PURPOSE: To demonstrate that left radial access for diagnostic cerebral angiography with Extra backup and 4F vertebral catheters is feasible and safe. MATERIALS AND METHODS: This study is a retrospective review of our prospective database on left radial access for cerebral angiography procedures, using an extra backup catheter associated with a 4Fr vertebral catheter, performed between March and September 2019. Patient demographics, procedural and radiographic metrics as well as clinical data were recorded. RESULTS: Seventy five patients with mean age of 51...years (range 21...73) underwent 80 cerebral angiographies. An average of four vessels were catheterized and mean fluoroscopy times per subject and vessel were was of 13.9 and 3.3...min, respectively. One patient required crossover to transfemoral access because of radial artery spasm. There were one asymptomatic distal radial artery occlusion and one patient presenting with asymptomatic skin blanching area on the forearm, just proximal to the tip of the sheath, that spontaneously resolved within an hour. CONCLUSION: Diagnostic cerebral angiography via left radial access is feasible and safe and allows to preserve the right radial access for future neurointerventions while providing more comfort to the right handed patient.

Distal radial access for cerebral aneurysm embolization.

OBJECTIVES: To demonstrate the feasibility and safety of distal radial access for embolization of ruptured and unruptured cerebral aneurysms. METHODS: This study is a retrospective review of our prospective cerebral aneurysm embolization database. Between January and September 2019, distal radial access was considered for consecutive subjects addressed for cerebral aneurysm embolization at our institution. All procedures were performed by the same experienced operator. Technical success was defined as distal radial access with insertion of the sheath and completion of the intervention without change of access site to conventional femoral access. Primary safety endpoint was the in hospital + 30 days incidence of radial artery occlusion. Secondary endpoints included intra-procedural complications and neurologic complications at discharge and at 30 days. RESULTS: Fifty-seven patients with cerebral aneurysms underwent 61 embolization procedures. Twenty eight embolizations were performed using coils, 8 used a stent-assisted coil technique, 22 used a balloon-assisted coil technique, and 3 used a flow diverter. One patient (1.6%) required crossover to femoral access. Three patients developed coil-induced thrombus that required intra-arterial Tirofiban injections. Two patients were asymptomatic and one patient presented confusion due to right frontal ischemia. One periprocedural aneurysm rupture occurred without clinical impact. Radial artery occlusion and hand ischemia were not observed. CONCLUSION: Findings of the present study showed the feasibility of distal transradial access for cerebral aneurysm embolization without increasing the risk of the procedure.

Safety and efficacy of percutaneous transhepatic-endoscopic rendezvous procedure in a single session.

PURPOSE: To demonstrate the feasibility and safety of PTE-RV performed in a single session. MATERIALS AND METHODS: This is a retrospective review of a prospective database on ERCP between January 2014 and December 2018. PTE-RV was performed in case of second ERCP failure. Technical success was defined as the establishment of an intestinal access to the biliary tract using a PTE-RV procedure allowing an immediate internal biliary drainage. Safety endpoints included intra-operative complications, morbidity and mortality occurring within 30 days after the procedure. RESULTS: Eighty-four patients (44 M/40F) with a median age of 69 years (range 40-91 years) underwent combined PTE-RV. The PTE-RVs were successfully performed in the same session in 80 subjects, resulting in an overall technical success rate of 95.2%. Adverse events were observed in 19% (16/84) of cases. The mortality rate within 30 days after the procedure was 9.5%. CONCLUSION: Percutaneous transhepatic-endoscopic rendezvous technique is feasible in a single session with acceptable level of risk. A randomized trial is required to compare EUBD and PTE-RV.

Management of bleeding peptic duodenal ulcer refractory to endoscopic treatment: surgery or transcatheter arterial embolization as first-line therapy? A retrospective single-center study and systematic review.

BACKGROUND: The objective of this study was to compare the results of transcatheter arterial embolization (TAE) with surgery in terms of efficacy in the context of bleeding duodenal ulcer (BDU) refractory to endoscopic treatment. MATERIALS AND METHODS: From January 2006 to December 2016, all patients treated for a BDU refractory to endoscopic treatment were included in this observational, comparative, retrospective, single-center study. Primary endpoint was the overall success of treatment of BDU requiring surgical and/or TAE. The secondary endpoints were pre-interventional data, recurrence rates, feasibility of secondary treatment, morbidity and mortality of surgical and radiological treatment, intensive care unit and length of stay. A systematic review of the literature was performed to compare results of surgery and TAE. RESULTS: 59 out of 396 patients (14.9%) treated for BDU required embolization and/or surgery: 15 patients underwent surgery (group S) including 7 patients after embolization failure and 44 patients underwent TAE (group TAE). The overall treatment success in intention to treat (85.7% vs 67.3%), per protocol (80% vs 79.5%) and bleeding recurrence rates (20% vs 15.9%) were also identical. Mortality (14.2% vs 15.3%) was similar between the two groups. Our study data were pooled with data from eight published studies and suggest that surgery have significant increased overall success (68.3% vs. 55.4%, p < 0.005). CONCLUSION: The overall success rate was in favour of surgery according our meta-analysis. Our single-center study highlights the fact that predictive factors for recurrent bleeding after TAE must be identified to select good candidates for TAE and/or surgery.

"Adaptative endovascular strategy to the CloT MRI in large intracranial vessel occlusion" (VECTOR): Study protocol of a randomized control trial.

A correlation between the susceptibility vessel sign (SVS) and red thrombi has been identified in MRI. We hypothesized that the Embotrap allow better retrieving of SVS+ thrombi. The AdaptatiVe Endovascular strategy to the CloT MRI in large intracranial vessel Occlusion (VECTOR) trial is a multicenter, prospective and randomized study designed to compare a first-line strategy combining Embotrap added to contact aspiration (CA) versus CA alone in patients with SVS+ occlusions.

Two duodenal gastrointestinal stroma tumors: Management by minimally invasive surgery and then by conservative surgery.

We report the case of a 48-year-old woman treated for a gastrointestinal stroma tumor of the duodenum after presenting with upper gastrointestinal bleeding. She was treated with a combination of a radiological and endoscopic approach and minimally invasive surgery. During follow-up, the patient developed a second metachronous duodenal gastrointestinal stroma tumor, distinct from a local recurrence. This tumor was treated with a conservative surgical approach.

Direct aspiration for thrombectomy in ischemic stroke: Impact of dwell time.

OBJECTIVE: To evaluate the impact of dwell time on the efficacy of the direct aspiration thrombectomy in ischemic stroke. METHODS: The study is a review of our prospective cerebral thrombectomy database of subjects admitted from January to December 2017. We performed direct aspiration with 2 min dwell time as recommended by the manufacturer (group 1) and 5 min dwell time (group 2) between January-June and July-December, respectively. The primary outcome was successful reperfusion after the first pass defined as modified Thrombolysis in Cerebral Infarction scores 2 b/3. RESULTS: Eighty-five patients had a cerebral thrombectomy by direct aspiration, 45 in group 1 and 40 in group 2. There was no statistically significant difference between the two groups but a trend toward a better modified Thrombolysis in Cerebral Infarction first pass 2 b/3 rate in group 2 (70% versus 48.8%, p = 0.06). Although not statistically significant (p = 0.07), the ratio of rescue therapy with stent retriever was higher in group 1 (40%) than in group 2 (22.5%). After all passes, modified Thrombolysis in Cerebral Infarction 2 b-3 was obtained in 82.2% (37/45) of cases in group 1 and in 90% (36/40) of cases in group 2. Among 76 patients (89.5%) with modified Rankin Scale assessment at three months, no significant difference (p = 0.3) was found in the proportion of functionally independent individuals between groups 1 and 2 (51.8% versus 55.6%, respectively). CONCLUSION: Although statistical significance was not reached, our retrospective analysis exhibited a strong trend toward modified Thrombolysis in Cerebral Infarction first pass improvement when dwell time was increased from 2 to 5 min.

3D C-Arm cone beam CT for targeting the portal vein during TIPS: Initial clinical experience.

PURPOSE: To evaluate the feasibility, safety and usefulness of 3D CBCT with a new injection protocol for targeting the portal vein during TIPS and to determine if it allows decreasing the duration of the procedure. MATERIALS AND METHODS: 3D CBCT was obtained during creation of TIPS in 15 patients (group 2). Portogram quality score was defined using a 5 points scale. The time required to achieve portal puncture was also recorded and results were compared retrospectively in 15 patients who underwent TIPS without 3D CBCT (group 1). RESULTS: The mean time required to puncture the portal vein was shorter when CBCT was used: 15 min versus 24 min (p = 0.156). We recorded 3 failures requiring a second procedure in group 1. There were no complications and no failure in group 2. We recorded 93% of good portography and 80% of good 3D roadmaps. CONCLUSION: 3D CBCT coupled with this new injection protocol provided high rate of good quality portography allowing to bring positional and directional information to improve the needle pass efficiency and to decrease the duration of the procedure.

[Severe acute alcoholic hepatitis]. / Hépatite alcoolique aiguë sévère.

All chronic and excessive consumer of alcohol with recent jaundice should be assessed using a Maddrey's score for severe acute alcoholic hepatitis. Corticosteroids are the first line of treatment, associated with an appropriate nutritional support and alcohol abstinence. Corticosteroids plus N-acetylcysteine combination improves short-term survival over corticosteroids alone, and could be proposed as a first line therapy. The response to treatment is evaluated at the 7th day of treatment, with the Lille model≤0.45. Prognostic of non-responders to corticosteroids with Lille model>0.45 is dramatically low with 23% survival at 6 month. Early liver transplantation in a selected group of patients with non-response to corticosteroids significantly improves 6th month and long-term survival.

Safety and Efficacy of Femoral Artery Closure with the FemoSeal Device After Cerebral Thrombectomy Using an 8 French Sheath.

PURPOSE: To evaluate the feasibility and safety of using the FemoSeal vascular closure device (VCD) to seal 8F access sites during mechanical thrombectomy for stroke. METHODS: A retrospective review of a prospective database was undertaken to evaluate the safety and efficacy of femoral arterial closure using FemoSeal device in all patients who underwent mechanical thrombectomy using an 8F sheath between January 2015 and July 2017. Efficacy endpoints were the successful deployment of the system and haemostasis success. Safety endpoints included the incidence of in hospital access site haematoma >5 cm, bleeding complications, pseudoaneurysms, arteriovenous fistula, infection, or other complications requiring surgery. RESULTS: 197 patients (96 men; mean age 68 years, range 25-99) were included. Successful haemostasis with FemoSeal was obtained in 98.9% of the patients. Only one haematoma >5 cm (0.5%) was observed, which reabsorbed spontaneously without issue. Nine haematomas <5 cm (4.5%) were also found. No major complications requiring surgical repair or transfusion were observed. There were no pseudoaneurysms, arteriovenous fistulae, or infections. CONCLUSION: The use of the FemoSeal device to close an 8F access sheath puncture site is feasible and safe, with a low complication rate.

Value of routine upper gastrointestinal swallow study after laparoscopic sleeve gastrectomy.

BACKGROUND: Gastric leak (GL) is one of the main early-onset postoperative complications of sleeve gastrectomy (SG). Many institutions perform routine upper gastrointestinal (UGI) contrast studies within 24 hours of surgery, looking for GL or gastric stenosis and to determine the need for urgent re-exploration, but this examination delays oral feeding, can cause side effects and is responsible for systematic and probably unnecessary irradiation of the patient. OBJECTIVE: Determine the efficacy of routine UGI contrast studies to predict postoperative complications after SG in a large population. SETTING: University hospital, France, public practice. MATERIAL AND METHODS: This study consisted of retrospective review of a prospective database of a cohort of patients who underwent primary SG between January 2007 and August 2013 (n = 1137). Routine UGI contrast studies, performed on postoperative day 1, were independently reviewed by 2 radiologists. The primary endpoint of the study was the effect of routine UGI contrast study on detecting postoperative complications. The secondary endpoints were comparison of the findings of routine UGI contrast study and abdominal computed tomography (CT) scan, sensitivity, and specificity of different imaging signs on abdominal CT scan in the presence of GL, evaluation of the SG learning curve based on the findings of routine UGI contrast studies. RESULTS: A total of 1137 patients underwent primary SG and 30 GL (2.6%) with a mean time to diagnosis of 23.4 days (1-245) and 15 cases of gastric stenosis (1.3%) were observed during the study period. Routine UGI study was performed in 1108 patients, whereas 29 patients were assessed by first-line CT scan. None of the 1108 UGI studies found a GL or gastric stenosis. In the 30 cases of GL, the most sensitive and specific sign was the presence of perigastric abscess without contrast material leak (sensitivity: 56.6%; specificity: 95%). The mean time interval between routine postoperative UGI contrast study and abdominal CT scan was 12.9 days (0-86). Uniform gastric shape was acquired after 30-32 SG procedures. CONCLUSION: Routine postoperative UGI on postoperative day 1 is of limited value after SG. Abdominal CT scan should be preferred in the presence of clinical suspicion of postoperative complications. Selective UGI contrast study remains indicated when gastric stenosis is suspected and at the beginning of the SG learning curve.

Eliminating routine upper gastrointestinal contrast studies after sleeve gastrectomy decreases length of stay and hospitalization costs.

BACKGROUND: Recent series have shown the lack of value of routine upper gastrointestinal (UGI) contrast studies on postoperative day 1 or 2 for the detection of gastric leak (GL) after sleeve gastrectomy (SG). Despite this finding, many centers still perform routine early UGI contrast studies after SG. No series has evaluated the impact of eliminating this examination on the overall management of patients undergoing SG. OBJECTIVES: To evaluate the impact of UGI contrast studies on SG management. SETTING: University hospital, France, public practice. METHODS: This study was an ambispective study of a cohort of patients who underwent primary SG between January 2014 and December 2014 (n = 267). Two consecutive groups were compared: patients with routine UGI contrast studies on postoperative day 1 (UGI+group, n = 154) and patients without routine UGI contrast studies (UGI-group, n = 113). The efficacy endpoint of the study was the overall impact of not performing routine UGI contrast studies (length of hospital stay, radiological data, rehospitalization data, and economic assessment). RESULTS: The overall complication rate was 9.3% and no deaths were observed. The GL rate was 1.5%. The mean hospital stay was 1.8 days (2.1 days versus 1.5 days; P = .57). Routine UGI contrast studies did not detect any cases of GL or gastric stenosis. After UGI contrast studies, 56 patients complained of events related to UGI contrast studies (36.4%). A total of 27 computed tomography scans were performed during the first 3 postoperative months (16 in the UGI+group (10.4%) versus 11 in the UGI-group (9.7%); P = .52). Twelve patients were rehospitalized (7 and 5; P = .6). The median length of rehospitalization was 7 days (7 and 5 days; P = .6). Overall cost per patient during SG hospitalization was $5,219 in the UGI+group and $3,678 in the UGI-group (P = .01). CONCLUSION: Eliminating routine UGI contrast studies was associated with decreased length of hospital stay and cost of SG procedures. Larger series are required to show that not performing routine UGI contrast studies has no impact on the postoperative complication rate and the management of these complications.

Intra-Arterial Delivery of Idarubicin in Two Patients with Glioblastoma.

There is no effective treatment for recurrent glioblastoma (GB) when temozolomide-based radiochemotherapy fails. In theory, intra-arterial (IA) delivery of cytotoxic agents could achieve higher drug concentrations in tumors compared to intravenous injection. Moreover, choosing a highly lipid-soluble drug could make the most of the first-pass effect. Here, we evaluated idarubicin (IDA), a lipophilic anthracycline, in an in vitro assay using four human GB cell lines and compared it with 11 other drugs previously used for the IA treatment of brain tumors. Despite impressive in vitro cytotoxicity, IA IDA did not produce a beneficial effect in 2 patients with recurrent GB.

Congenital afibrinogenemia: a case report of a spontaneous hepatic hematoma.

INTRODUCTION: Afibrinogenemia is a rare coagulation disorder. Clinical features of spontaneous bleeding, bleeding after minor trauma, or after surgery have been described as well as thrombo-embolic complications. In this article, we presented the case of a 19-year old female with congenital afibrinogenemia who was admitted with a spontaneous intrahepatic hematoma. CONCLUSIONS: Supportive treatment including transfusion and fibrinogen administration, associated with repeated packing surgeries and selective embolization, were successfully performed.

Use of transanastomotic double-pigtail stents in the management of grade B colorectal leakage: a pilot feasibility study.

INTRODUCTION: Anastomotic leakage (AL) is a major complication of colorectal surgery. The leakage is classified as grade B when the patient's clinical condition requires an active therapeutic intervention but does not require further surgery. The management of grade B AL commonly includes administration of antibiotics and/or the placement of a pelvic drainage performed under radiological guidance or transanal drain. The objective of this study was to evaluate the feasibility and the efficacy of endoscopic transanastomotic drainage using double-pigtail stents (DPSs) in the management of grade B AL in colorectal surgery. PATIENTS AND METHODS: Between September 2011 and December 2014, 650 patients underwent a colorectal procedure in our university hospital; 8.7 % presented with AL, including 42.8 % with grade B. Fourteen patients required endoscopic management and constituted the study population. The study's primary objective was to assess the feasibility and efficacy of DPS placement for the treatment of grade B AL after colorectal surgery. The secondary endpoints were the requirement for radiological drainage, the DPS placement failure rate, the rate of stoma closure and, lastly, feasibility of chemotherapy (if indicated). RESULTS: DPS placement was feasible in 92.8 % of the 14 patients (n = 13). The overall success rate for endoscopic management was 78.5 % (n = 11). The median length of hospitalization after DPS placement was 5 days (3-17). The average duration of drainage through a DPS was 62 days (28-181). Five patients (35.7 %) also underwent drainage with radiological guidance. Of the 10 patients with stoma, closure occurred in 80 %. All patients that required adjuvant chemotherapy were able to receive it. CONCLUSION: The treatment of AL requires multidisciplinary collaboration to save the anastomosis. DPS placement under endoscopic control is associated with AL healing, good clinical tolerance and the ability to undergo chemotherapy and is an alternative to repeat laparotomy when radiological drainage is unfeasible or inefficient.