Impacts on functional and oncological outcomes of Robotic-assisted Radical Prostatectomy 10 years after the US Preventive Service Taskforce recommendations against PSA screening.

OBJECTIVE: In the following years after the United States Preventive Service Task Force (USPSTF) recommendation against prostate cancer screening with PSA in 2012, several authors worldwide described an increase in higher grades and aggressive prostate tumors. In this scenario, we aim to evaluate the potential impacts of USPSTF recommendations on the functional and oncological outcomes in patients undergoing robotic-assisted radical prostatectomy (RARP) in a referral center. MATERIAL AND METHODS: We included 11396 patients who underwent RARP between 2008 and 2021. Each patient had at least a 12-month follow-up. The cohort was divided into two groups based on an inflection point in the outcomes at the end of 2012 and the beginning of 2013. The inflection point period was detected by Bayesian regression with multiple change points and regression with unknown breakpoints. We reported continuous variables as median and interquartile range (IQR) and categorical variables as absolute and relative percent frequencies. RESULTS: Group 1 had 4760 patients, and Group 2 had 6636 patients, with a median follow-up of 109 and 38 months, respectively. In the final pathology, Group 2 had 9.5% increase in tumor volume, 24% increase on Gleason ≥ 4+3 (ISUP 3) , and 18% increase on ≥ pT3. This translated to a 6% increase in positive surgical margins and 24% reduction in full nerve sparing in response to the worsening pathology. There was a significant decline in post-operative outcomes in Group 2, including a 12-month continence reduction of 9%, reduction in potency by 27%, and reduction of trifecta by 22%. CONCLUSIONS: The increasing number of high-risk patients has led to worse functional and oncologic outcomes. The initial rapid rise in PSM was leveled by the move towards more partial nerve sparing. Among some historical changes in prostate cancer diagnosis and management in the period of our study, the USPSTF recommendation coincided with worse outcomes of prostate cancer treatment in a population who could benefit from PSA screening at the appropriate time.

Technical and anatomical challenges to approach robotic-assisted radical prostatectomy in patients with Urolift®.

INTRODUCTION: Urolift® is a surgical modality to treat lower urinary tract symptoms (LUTS) in patients with enlarged prostates (1). However, the inflammatory process caused by the device usually displaces the prostate's anatomical landmarks and challenges surgeons performing robotic-assisted radical prostatectomy (RARP). In this video, we will illustrate several technical challenges in patients with Urolift ® who underwent RARP. MATERIAL AND METHODS: We performed a video compilation with several surgical steps illustrating key aspects and critical details of the anterior bladder neck access, lateral bladder dissection from the prostate, and posterior prostate dissection to avoid ureteral and neural bundles injuries. RESULTS: We perform our RARP technique with our standard approach in all patients (2-6). The beginning of the case is performed like every patient with an enlarged prostate. We first identify the anterior bladder neck and then complete its dissection with Maryland and Scissors. However, extra care must be taken in the anterior and posterior bladder neck approach due to the clips found during the dissection. The challenge starts when opening the lateral sides of the bladder until the base of the prostate. It is crucial to perform the bladder neck dissection beginning at the internal plane of the bladder wall. Such dissection is the easiest way to recognize the anatomical landmarks and potential foreign materials, such as clips, placed during previous surgeries. We cautiously work around the clip to avoid using cautery on the top of the metal clips because energy is transmitted from one edge to the other of the Urolift ®. This can be dangerous if the edge of the clip is close to the ureteral orifices. The clips are usually removed to minimize cautery conduction energy. Finally, after isolating and removing the clips, the prostate dissection and subsequent surgical steps are continued with our conventional technique. Before proceeding, we ensure that all clips are removed from the bladder neck to avoid complications during the anastomosis. CONCLUSIONS: Robotic-assisted radical prostatectomy in patients with Urolift ® is challenging due to modified anatomical landmarks and intense inflammatory processes in the posterior bladder neck. When dissecting the clips placed next to the base of the prostate, it is crucial to avoid cautery because energy conduction to the other edge of the Urolift ® can cause thermal damage to the ureters and neural bundles.

Pivotal Trial of the Neuroform Atlas Stent for Treatment of Anterior Circulation Aneurysms: One-Year Outcomes.

BACKGROUND AND PURPOSE: Stent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented. METHODS: ATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio <2) intracranial aneurysms in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. The primary efficacy end point was complete aneurysm occlusion (Raymond-Roy class 1) on 12-month angiography, in the absence of retreatment or parent artery stenosis (>50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee. RESULTS: A total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%-90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%-8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death. CONCLUSIONS: In the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and <5% morbidity. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02340585.

Age ≥80 Years Is Not a Contraindication for Intra-Arterial Therapy after Ischemic Stroke.

BACKGROUND: Clinical trials confirmed the safety and efficacy of intra-arterial therapy (IAT) in the management of ischemic stroke. At a community hospital, we compared outcomes in patients aged ≥80 and patients in the age range 55-79 years receiving IAT following ischemic stroke. METHODS: Data were retrospectively abstracted for ischemic stroke patients ≥55 years treated with IAT at an urban comprehensive stroke center between 2010 and 2013. Baseline demographics, incidence of symptomatic intracranial hemorrhage (sICH), in-hospital mortality, discharge modified Rankin scale (mRS) score (favorable ≤2) and improvement in National Institutes of Health Stroke Scale Score (NIHSS; decreased score at discharge) were compared between patients in the age range 55-79 and patients ≥80 years. Data were analyzed using univariate analyses and multivariate logistic regression. RESULTS: IAT was performed in 239 patients with ischemic stroke; 63 (26.4%) were ≥80 years. When compared to patients aged 55-79, the elderly patients were more often female and non-smokers, with a history of atrial fibrillation. No differences were observed in those ≥80 years compared to patients in the age range 55-79 years for sICH (10 vs. 5%, p = 0.23), mortality (24 vs. 18%, p = 0.28), favorable discharge mRS score (13 vs. 19%, p = 0.27), or improvement in NIHSS (83 vs. 92%, p = 0.10). The nonsignificant association of age with the outcomes persisted after adjusting for covariates and when analyzing the subset of patients who received IAT only. CONCLUSIONS: These findings suggest that in a cohort not subject to the criteria of a clinical trial, age ≥80 years should not be a contraindication to IAT.

Comparison between intra- and postoperative outcomes of the da Vinci SP and da Vinci Xi robotic platforms in patients undergoing radical prostatectomy.

The new SP robot incorporates a single trocar that houses a flexible camera and three bi-articulated arms, which minimize the number of incisions needed to assess the surgical site, allowing for a less invasive procedure. To compare the postoperative pain scale and outcomes in patients with similar demographic characteristics undergoing robotic-assisted radical prostatectomy (RARP) with SP and Xi robots, One-hundred consecutive patients undergoing RARP with the SP robot were matched, using a propensity score (PS), with 100 patients from a cohort of 1757 who were operated on with the da Vinci Xi from June 2019 to January 2021. We described and compared the perioperative pain scores and outcomes of both groups. The SP group had less blood loss (50 cc vs. 62.5 cc, P < 0.001) and longer operative time (114 min. vs. 94 min, P < 0.001). The only period we could show a difference in postoperative pain scores was 6 h after surgery, with a small advantage for the SP (2 vs. 2.5, P < 0.001). Both groups had satisfactory postoperative continence recovery, 91% vs. 90% for the SP and Xi, respectively. The groups had a mean follow-up of 24.5 and 22 months for SP and Xi, respectively. The tumor stage and percentage of positive surgical margins were similar between groups (15% vs. 15%, P = 1). Patients undergoing RARP with the SP had longer operative times with less blood loss than the Xi. However, despite the lower number of abdominal incisions on the SP, the groups had similar intraoperative performance, and we were unable to demonstrate clinically significant differences in postoperative pain scores between the groups 6, 12, and 18 h after surgery.

Anterior circulation location-specific results for stent-assisted coiling - carotid versus distal aneurysms: 1-year outcomes from the Neuroform Atlas Stent Pivotal Trial.

BACKGROUND: The Neuroform Atlas Stent System is an established treatment modality for unruptured anterior and posterior circulation intracranial aneurysms. Location-specific results are needed to guide treatment decision-making. However, it is unclear whether there are differences in safety and efficacy outcomes between carotid and more distal anterior circulation aneurysms. METHODS: The ATLAS IDE trial was a prospective, multicenter, single-arm, open-label interventional study that evaluated the safety and efficacy of the Neuroform Atlas Stent System. We compared differences in efficacy and safety outcomes of proximal internal carotid artery (ICA) versus distal and bifurcation anterior circulation aneurysms. RESULTS: Of 182 cases, there were 70 aneurysms in the ICA and 112 in the distal anterior circulation (including ICA terminus/bifurcation). There were no significant differences in the primary efficacy endpoint (85.5% vs 83.9%, p=0.78) and complete aneurysm occlusion rates (88.7% vs 87.9%, p=0.78) between proximal ICA aneurysms and distal aneurysms, respectively. Complications were more often encountered in distal and bifurcation aneurysms, but the overall rate of major safety events was low and comparable between the two groups (1.4% vs 6.3%, p=0.14). Recanalization and retreatment rates were also similar between the groups. CONCLUSION: The results of this study suggest that the Neuroform Atlas Stent System is a safe and efficacious treatment modality for unruptured anterior circulation intracranial aneurysms, regardless of aneurysm location. TRIAL REGISTRATION NUMBER: NCT02340585.

Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes.

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.

Neuroform Atlas Stent for Treatment of Middle Cerebral Artery Aneurysms: 1-Year Outcomes From Neuroform Atlas Stent Pivotal Trial.

BACKGROUND: Heterogeneous effect of endovascular aneurysm therapy has been observed across different anatomic locations. There is a paucity of data for stent-assisted coiling of middle cerebral artery (MCA) aneurysms. OBJECTIVE: To present the results of the MCA aneurysm group from the Neuroform Atlas (Stryker Neurovascular) investigational device exemption (IDE) trial. METHODS: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of wide-neck aneurysms (neck ≥ 4 mm or dome-to-neck ratio < 2) in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. Follow-up was obtained immediately postprocedure and 2, 6, and 12 mo postoperatively. We herein describe safety and efficacy outcomes, and functional independence of the subjects with aneurysms from all segments of MCA. RESULTS: A total of 35 patients were included (27 MCA bifurcation, 5 M1, 3 M2). The mean aneurysm size was 6.0 ± 1.8 mm, and the mean neck was 4.4 ± 1.2 mm. Technical procedural success was achieved in all patients. A total of 26 patients had follow-up digital subtraction angiography available at 12 mo, with 80.8% (21/26) having complete aneurysm occlusion. Twelve-month safety data were collected for 91.4% (32/35), 8.5% (3/35) had primary safety endpoint, all 3 major ischemic strokes. Mortality occurred in 2 patients beyond 30 d unrelated to procedure (1 gallbladder cancer and 1 fentanyl intoxication). At 1 yr, modified Rankin Score was 0 to 2 in 84.4% (27/32), 3 in 9.4%, and 3 patients were missing. Approximately 5.7% (2/35) of patients were retreated at 12 mo. CONCLUSION: Stent-assisted coiling with the Neuroform Atlas Stent is a viable alternative to clipping for selected MCA aneurysms. Complete aneurysm occlusion rates have improved compared to historical data. Proper case selection can lead to acceptable endovascular results.

Time-of-flight magnetic resonance angiography imaging of a residual arteriovenous malformation nidus after Onyx embolization for stereotactic radiosurgery planning. Technical note.

This report demonstrates that time-of-flight (TOF) MR angiography is a useful adjunct for planning stereotactic radiosurgery (SRS) of large arteriovenous malformations (AVMs) after staged embolization with Onyx. Onyx (ethylene vinyl copolymer), a recently approved liquid embolic agent, has been increasingly used to exclude portions of large AVMs from the parent circulation prior to SRS. Limiting SRS to regions of persistent arteriovenous shunting and excluding regions eliminated by embolization may reduce unnecessary radiation doses to eloquent brain structures. However, SRS dosimetry planning presents unique challenges after Onyx embolization because it creates extensive artifacts on CT scans, and it cannot be delineated from untreated nidus on standard MR sequences. During the radiosurgery procedure, MR images were obtained using a GE Signa 1.5-T unit. Standard axial T2 fast spin echo high-resolution images (TR 3000 msec, TE 108 msec, slice thickness 2.5 mm) were generated for optimal visualization of brain tissue and AVM flow voids. The 3D TOF MR angiography images of the circle of Willis and vertebral arteries were subsequently obtained to visualize AVM regions embolized with Onyx (TR 37 msec, TE 6.9 msec, flip angle 20 degrees). Adjunct TOF MR angiography images demonstrated excellent contrast between nidus embolized with Onyx and regions of persistent arteriovenous shunting within a large AVM prior to SRS. Additional information derived from these sequences resulted in substantial adjustments to the treatment plan and an overall reduction in the treated tissue volume.

Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort.

BACKGROUND AND OBJECTIVE: Stent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial. METHOD: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints. RESULTS: 30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths. CONCLUSION: The Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort. CLINICAL TRIALGOV REGISTRATION NUMBER: NCT0234058;Results.

Impacts on functional and oncological outcomes of Robotic-assisted Radical Prostatectomy 10 years after the US Preventive Service Taskforce recommendations against PSA screening

ABSTRACT Objective: In the following years after the United States Preventive Service Task Force (USPSTF) recommendation against prostate cancer screening with PSA in 2012, several authors worldwide described an increase in higher grades and aggressive prostate tumors. In this scenario, we aim to evaluate the potential impacts of USPSTF recommendations on the functional and oncological outcomes in patients undergoing robotic-assisted radical prostatectomy (RARP) in a referral center. Material and Methods: We included 11396 patients who underwent RARP between 2008 and 2021. Each patient had at least a 12-month follow-up. The cohort was divided into two groups based on an inflection point in the outcomes at the end of 2012 and the beginning of 2013. The inflection point period was detected by Bayesian regression with multiple change points and regression with unknown breakpoints. We reported continuous variables as median and interquartile range (IQR) and categorical variables as absolute and relative percent frequencies. Results: Group 1 had 4760 patients, and Group 2 had 6636 patients, with a median follow-up of 109 and 38 months, respectively. In the final pathology, Group 2 had 9.5% increase in tumor volume, 24% increase on Gleason ≥ 4+3 (ISUP 3), and 18% increase on ≥ pT3. This translated to a 6% increase in positive surgical margins and 24% reduction in full nerve sparing in response to the worsening pathology. There was a significant decline in post-operative outcomes in Group 2, including a 12-month continence reduction of 9%, reduction in potency by 27%, and reduction of trifecta by 22%. Conclusions: The increasing number of high-risk patients has led to worse functional and oncologic outcomes. The initial rapid rise in PSM was leveled by the move towards more partial nerve sparing. Among some historical changes in prostate cancer diagnosis and management in the period of our study, the USPSTF recommendation coincided with worse outcomes of prostate cancer treatment in a population who could benefit from PSA screening at the appropriate time.

Comparative Safety and Efficacy of Modified TICI 2b and TICI 3 Reperfusion in Acute Ischemic Strokes Treated With Mechanical Thrombectomy.

BACKGROUND: Mechanical thrombectomy (MT) is the current standard of care for acute ischemic stroke (AIS) patients with emergent large-vessel occlusions (ELVO). Successful reperfusion of ELVO is traditionally defined by modified Thrombolysis in Cerebral Infarction (mTICI) grades of 2b or 3. OBJECTIVE: To evaluate the comparative safety and efficacy of mTICI 2b and mTICI 3 reperfusion in AIS patients treated with MT. METHODS: Consecutive ELVO patients who underwent MT at 6 high-volume centers were included in this analysis. Standard safety (3-mo mortality, symptomatic intracranial hemorrhage [sICH]) and efficacy (absolute and relative reduction in NIHSS-scores during hospitalization, functional-improvement [shift analysis in mRS-scores], and functional-independence [mRS-scores of 0-2] at 3-mo) were compared between patients who had mTICI 2b and mTICI 3 reperfusion post MT. RESULTS: A total of 416 ELVO patients achieved successful reperfusion with mTICI 2b (n = 216) and mTICI 3 (n = 200) following MT. The mTICI 3 group had significantly (P < .05) greater absolute (11 vs 9 points) and relative (77% vs 63%) reduction in NIHSS-scores during hospitalization, lower sICH (6% vs 12%), and higher 3-mo functional-independence (55% vs 44%) rates. Successful reperfusion with mTICI 3 was independently (P < .05) associated with greater absolute and relative reduction in NIHSS-scores during hospitalization as well as higher odds of 3-mo functional improvement (common odds ratios: 1.67; 95% confidence interval: 1.10-2.56) and functional independence (odds ratio: 2.08; 95% confidence interval: 1.22-3.53) in multivariable regression models adjusting for confounders. CONCLUSION: Successful reperfusion with mTICI 3 was associated with greater neurological improvement during hospitalization and better 3-mo functional outcomes in comparison to mTICI 2b reperfusion.

Technical and anatomical challenges to approach robotic-assisted radical prostatectomy in patients with Urolift®

ABSTRACT Introduction Urolift® is a surgical modality to treat lower urinary tract symptoms (LUTS) in patients with enlarged prostates (1). However, the inflammatory process caused by the device usually displaces the prostate's anatomical landmarks and challenges surgeons performing robotic-assisted radical prostatectomy (RARP). In this video, we will illustrate several technical challenges in patients with Urolift ® who underwent RARP. Material and Methods We performed a video compilation with several surgical steps illustrating key aspects and critical details of the anterior bladder neck access, lateral bladder dissection from the prostate, and posterior prostate dissection to avoid ureteral and neural bundles injuries. Results We perform our RARP technique with our standard approach in all patients (2 -6). The beginning of the case is performed like every patient with an enlarged prostate. We first identify the anterior bladder neck and then complete its dissection with Maryland and Scissors. However, extra care must be taken in the anterior and posterior bladder neck approach due to the clips found during the dissection. The challenge starts when opening the lateral sides of the bladder until the base of the prostate. It is crucial to perform the bladder neck dissection beginning at the internal plane of the bladder wall. Such dissection is the easiest way to recognize the anatomical landmarks and potential foreign materials, such as clips, placed during previous surgeries. We cautiously work around the clip to avoid using cautery on the top of the metal clips because energy is transmitted from one edge to the other of the Urolift ®. This can be dangerous if the edge of the clip is close to the ureteral orifices. The clips are usually removed to minimize cautery conduction energy. Finally, after isolating and removing the clips, the prostate dissection and subsequent surgical steps are continued with our conventional technique. Before proceeding, we ensure that all clips are removed from the bladder neck to avoid complications during the anastomosis. Conclusions Robotic-assisted radical prostatectomy in patients with Urolift ® is challenging due to modified anatomical landmarks and intense inflammatory processes in the posterior bladder neck. When dissecting the clips placed next to the base of the prostate, it is crucial to avoid cautery because energy conduction to the other edge of the Urolift ® can cause thermal damage to the ureters and neural bundles.

A multicenter study of the safety and effectiveness of mechanical thrombectomy for patients with acute ischemic stroke not meeting top-tier evidence criteria.

BACKGROUND: While mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke (AIS) with emergent large-vessel occlusions (ELVO), recently published guidelines appropriately award top-tier evidence to the same selective criteria that were employed in completed clinical trials. We sought to evaluate the safety and effectiveness of MT in patients with AIS with ELVO who do not meet top-tier evidence criteria (TTEC). METHODS: We conducted an observational study on consecutive patients with AIS with ELVO who underwent MT at six high-volume endovascular centers. Standard safety outcomes (3-month mortality, symptomatic intracranial hemorrhage) and effectiveness outcomes (3-month functional independence: modified Rankin Scale scores of 0-2) were compared between patients meeting and failing TTEC. RESULTS: The sample consisted of 349 (60%) controls fulfilling TTEC and 234 (40%) non-TTEC patients. Control patients meeting TTEC for MT tended to have higher functional independence rates at 3 months (47% vs 39%; p=0.055), while the rates of symptomatic intracerebral hemorrhage (sICH) were similar (9%) in both groups (p=0.983). In multivariable logistic regression models, adherence to TTEC for MT was not independently related to any safety outcome (sICH: OR 0.71, 95% CI 0.30 to 1.68, p=0.434; 3-month mortality: OR 1.27, 95% CI 0.69 to 2.33, p=0.448) or effectiveness outcome (3-month functional independence: OR 0.81, 95% CI 0.48 to 1.37, p=0.434; 3-month functional improvement: OR 0.73, 95% CI 0.48 to 1.11, p=0.138) after adjusting for potential confounders. CONCLUSIONS: Approximately 40% of patients with AIS with ELVO offered MT do not fulfill TTEC for MT. Patients who did not meet TTEC had high rates of good clinical outcome and low complication rates.

Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion.

OBJECTIVE: In this multicenter study, we sought to evaluate comparative safety and efficacy of combined IV thrombolysis (IVT) and mechanical thrombectomy (MT) vs direct MT in emergent large vessel occlusion (ELVO) patients. METHODS: Consecutive ELVO patients treated with MT at 6 high-volume endovascular centers were evaluated. Standard safety and efficacy outcomes (successful reperfusion [modified Thrombolysis in Cerebral Infarction IIb/III], functional independence [FI] [modified Rankin Scale (mRS) score of 0-2 at 3 months], favorable functional outcome [mRS of 0-1 at 3 months], functional improvement [mRS shift by 1-point decrease in mRS score]) were compared between patients who underwent combined IVT and MT vs MT alone. Additional propensity score-matched analyses were performed. RESULTS: A total of 292 and 277 patients were treated with combination therapy and direct MT, respectively. The combination therapy group had greater functional improvement (p = 0.037) at 3 months. After propensity score matching, 104 patients in the direct MT group were matched to 208 patients in the combination therapy group. IVT pretreatment was independently (p < 0.05) associated with higher odds of FI (odds ratio [OR] 1.75; 95% confidence interval [CI] 1.02-2.99) and functional improvement (common OR 1.64; 95% CI 1.05-2.56). Combination therapy was independently (p < 0.05) related to lower likelihood of 3-month mortality (0.50; 95% CI 0.26-0.96). CONCLUSIONS: This observational study provides preliminary evidence that IVT pretreatment may improve outcomes in ELVO patients treated with MT. The question of the potential effect of IVT on ELVO patients treated with MT should be addressed with a randomized controlled trial. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for stroke patients with emergent large vessel occlusion, combined IVT and MT is superior to direct MT in improving functional outcomes.

Diffusion tensor imaging predicts hyperacute spinal cord injury severity.

Experimental strategies that focus on ventral white matter (VWM) preservation during the hyperacute phase hold great potential for our improved understanding of functional recovery following traumatic spinal cord injury (SCI). Critical comparisons of human SCI to rapidly accumulating data derived from rodent models are limited by a basic lack of in vivo measures of subclinical pathophysiologic changes and white matter damage in the spinal cord. Spinal cord edema and intraparenchymal hemorrhage demonstrated with routine MR sequences have limited value for predicting functional outcomes in SCI animal models and in human patients. We recently demonstrated that in vivo derived diffusion tensor imaging (DTI) parameters are sensitive and specific biomarkers for spinal cord white matter damage. In this study, non-invasive in vivo DTI was utilized to evaluate the white matter of C57BL/6 mice 3 h after mild (0.3 mm), moderate (0.6 mm), or severe (0.9 mm) contusive SCI. In the hyperacute phase, relative anisotropy maps provided excellent gray-white matter contrast in all degrees of injury. In vivo DTI-derived measurements of axial diffusion differentiated between mild, moderate, and severe contusive SCI with good histological correlation. Cross-sectional regional measurements of white matter injury severity between dorsal columns and VWM varied with increasing cord displacement in a pattern consistent with spinal cord viscoelastic properties.

Comprehensive analysis of intra-arterial treatment for acute ischemic stroke due to cervical artery dissection.

OBJECTIVE: The safety and efficacy of intra-arterial treatment (IAT) in patients with acute ischemic stroke (AIS) due to cervical artery dissection (CeAD) has not been formally studied. The purpose of this study was twofold: first, describe a large series with CeAD treated with IAT; second, analyze outcomes with CeAD receiving IAT versus (a) CeAD not treated with IAT, (b) CeAD receiving intravenous thrombolysis (IVT) alone, and (c) non-CeAD mechanism of AIS receiving IAT. DESIGN: Demographics, clinical characteristics, treatment, and outcomes were summarized for all CeAD patients treated with IAT from January 2010 to May 2015. Outcomes included favorable 90 day modified Rankin Scale (mRS) score of 0-2, symptomatic intracerebral hemorrhage (sICH), recanalization (Thrombolysis in Cerebral Infarction 2b-3), procedural complications, and mortality. Outcomes were analyzed with χ2 tests and multivariate logistic regression. RESULTS: There were 161 patients with CeAD: 24 were treated with IAT and comprised our target population. Dissections were more common in the internal carotid (n=18) than in the vertebral arteries (n=6). All but one patient had intracranial embolus. IAT techniques included thrombectomy (n=19), IA thrombolysis (n=17), stent (n=14), and angioplasty (n=7). Outcomes included favorable 90 day mRS score of 0-2 in 63%, 4 deaths, 1 sICH, and 3 procedural complications. After adjustment, favorable mRS in our target population was similar to comparison populations: (a) in CeAD, IAT versus no IAT (OR 0.62, p=0.56); (b) In CeAD, IAT versus IVT alone (OR 1.32, p=0.79); and (c) IAT in CeAD versus non-CeAD mechanism of AIS (OR 0.58, p=0.34). CONCLUSIONS: IAT is a valid alternative therapeutic option for AIS caused by CeAD due to the low complication rate and excellent outcomes observed in this study.

Epidemiology, Endovascular Treatment, and Prognosis of Cerebral Venous Thrombosis: US Center Study of 152 Patients.

BACKGROUND: Cerebral venous thrombosis is a rare cause of stroke that poses diagnostic, therapeutic, and prognostic challenges. Mainstay treatment is systemic anticoagulation, but endovascular treatment is increasingly advocated. Our objectives were to describe the epidemiology, treatment, and prognosis of 152 patients with cerebral venous thrombosis. METHODS AND RESULTS: This was a retrospective study of consecutive cerebral venous thrombosis cases from 2006 to 2013 at a comprehensive stroke center through hospital discharge. Predictors of full recovery (modified Rankin Scale scores 0-1) were analyzed with multiple logistic regression and presented as adjusted odds ratios (AORs) with 95% confidence intervals (CIs). The population was young (average age: 42 years), majority female (69%), and commonly presenting with cerebral edema (63%), and 72% were transferred in. All patients received systemic anticoagulation; 49% (n=73) required endovascular treatment. Reasons for requiring endovascular treatment included cerebral edema, herniation, or hemorrhagic infarct (n=38); neurologic decline (n=17); rethrombosis, persistent occlusion, or clot propagation (n=10); extensive clot burden (n=7); and persistent headache despite anticoagulation (n=1). There were 7 (10%) procedural complications. Recanalization was successful (61%), partial (30%), and unsuccessful (9%). Overall, 60% fully recovered. Positive predictors of full recovery included hormonal etiology, particularly for patients who were transferred in (AOR: 7.06 [95% CI, 2.27-21.96], interaction P=0.03) and who had migraine history (AOR: 4.87 [95% CI, 1.01-23.50], P=0.05), whereas negative predictors of full recovery were cerebral edema (AOR: 0.11 [95% CI, 0.04-0.34], P<0.001) and motor weakness (AOR: 0.28 [95% CI, 0.09-0.96], P=0.04). CONCLUSIONS: As one of the largest cohort studies, our findings suggest that cerebral edema, history of migraine, and hormonal etiology were prognostic and that endovascular treatment might be a safe and effective treatment for cerebral venous thrombosis when conventional management is inadequate.

Initial Technical Experience with the SMART Coil for the Embolization of Intracranial Aneurysms.

BACKGROUND/OBJECTIVE: Traditional platinum coils used for cerebral aneurysm embolization have a uniform degree of softness throughout an individual coil's length. Recently, SMART Coils (Penumbra Inc., Alameda, California, USA) have been developed, which transition in softness along the length of their coils. We report the initial clinical results with this technology. METHODS: A retrospective study of all patients undergoing aneurysm coiling with SMART Coils at 2 centers was performed to evaluate the safety and efficacy of this new technology. Outcome and angiographic data were self-reported by individual treatment centers. RESULTS: Fifty-nine patients underwent treatment for cerebral aneurysms with SMART Coils (44% in the setting of subarachnoid hemorrhage). Mean aneurysm size was 5.9 ± 2 mm × 4.5 ± 2 mm. Mean neck size was 3.4 ± 1 mm. More than half (54.2%) of the patients underwent coiling exclusively with SMART Coils. The remainder used either framing or finishing coils of another type. About one third (33.9%) underwent balloon-assisted coiling, and 47.5% underwent stent-assisted coiling. There were no device malfunctions in any of the patients. Six (10.1%) minor complications without clinical sequelae occurred. Raymond I or II occlusion was achieved in 71.2%. CONCLUSIONS: Our results demonstrate adequate device safety in a variety of both ruptured and unruptured aneurysm locations. This design enables progressive changes in softness along the length of an individual coil, which offers several potential advantages in the clinical use. This initial investigation of SMART Coil technology demonstrates safety and efficacy in the treatment of a wide range of aneurysm sizes, locations, and morphologies in both ruptured and unruptured settings.

A standardized neurointerventional thrombectomy protocol leads to faster recanalization times.

BACKGROUND AND PURPOSE: Intra-arterial therapy (IAT) is most effective when performed rapidly after ischemic stroke onset. However, there are limited performance benchmarks in IAT and there is a scarcity of information on how to structure an effective IAT protocol and its impact on time to treatment. The objective of our study was to detail a standardized IAT protocol, and to assess its influence on time to treatment in ischemic stroke. METHODS: This was a retrospective observational study over 4 years at a comprehensive stroke center. A standardized IAT protocol was implemented in June 2013 that included pre-notifying the stroke team before hospital arrival, defining clinician roles, processing tasks in parallel, and standardizing IAT procedures. Three time metrics were examined and reported as median (IQR) minutes: arrival to CT imaging, CT to groin puncture, and puncture to recanalization. We compared these metrics in patients admitted before implementation (January 2012-May 2013) to patients admitted after (June 2013-December 2015) using Wilcoxon Mann-Whitney tests. RESULTS: 380 patients were included. After the protocol was implemented, there were significant reductions in time from arrival to CT (17 (14-21) vs 13 (11-19) min, p<0.001), CT to puncture (46 (30-82) vs 31 (23-54) min, p<0.001), and puncture to recanalization (65 (33-90) vs 37 (22-65) min, p<0.001). 60% of time was saved during puncture to recanalization. Significant reductions in time were observed during both normal working hours and off-hours. CONCLUSIONS: Implementation of a standardized protocol resulted in a significant reduction in time to recanalization for patients with an ischemic stroke. A standardized IAT protocol decreases time to recanalization when team roles are clearly defined, tasks are processed in parallel, and procedures are standardized.