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72 citation(s) found for "Hanel, Ricardo A".

Quantitative Prognostic Modeling in Aneurysmal Subarachnoid Hemorrhage: Multicenter Validation of the eSAH Score
Salman, Saif, Moy, Constantin Graf von , Haidenberger, Flora, Ahmed, Mahlika, Foettinger, Fabian, Sharma, Rohan, Gutierrez-Aguirre, Salvador, Toledo, Otávio de, Patel, Vishal , Yujia-Wei, David, Brandmeir, Nicholas, Lakkaraju, Kausik , Ombada, Mutaz , Aguilar-Salinas, Pedro, Miller, David, Erickson, B E, Hanel, Ricardo, Tawk, Rabih, Byrne, Richard, Salman, Saif , Haidenberger, Flora, Gutierrez‐Aguirre, Salvador F. , Toledo, Otavio F. De , Patel, Vishal, Jahromi, Behnam Rezai , Brandmeir, Nicholas J. , Erickson, B E, Tawk, Rabih G. , Freeman, William D.

Mayo Clinic

No container title available | July 21, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.64898/2026.07.18.26358390 Get It

Abstract Background aneurysmal subarachnoid hemorrhage (aSAH) is neurological emergency associated with substantial mortality and disability. Current grading systems such as the modified Fisher Scale (mFS) and World Federation of Neurological Societies (WFNS) score, rely on semiquantitative and examination based assessments. Hence, they demonstrate limited predictive precision. The enhanced subarachnoid hemorrhage (eSAH) score is a simplified quantitative model integrating age, Glasgow Coma Scale (GCS), and cisternal subarachnoid hemorrhage volume (SAHV) to predict clinical outcomes after aSAH. Methods We performed a retrospective multicenter cohort study that included 1088 patients across three tertiary-care centers the United States. Predictive performance for unfavorable functional outcome, in-hospital mortality and delayed cerebral ischemia (DCI) was evaluated using receiver operating characteristic (ROC) analysis and area under the curve (AUC). Comparative analyses were performed and compared to the WFNS and mFS grading systems. Results the eSAH score demonstrated excellent discrimination for unfavorable functional outcome at discharge ( AUC 0.89 ) and in-hospital mortality (AUC 0.87). The DCI subscore demonstrated good discriminatory performance for predicting DCI (AUC 0.77). Compared with conventional grading systems, this was superior to both the WFNS (AUC 0.75) and the mFS ( AUC 0.70). increasing eSAH scores were additionally associated with progressively higher rates of mortality and unfavorable functional outcomes. Conclusion the eSAH score demonstrates strong external validity, reproducibility and superior predictive performance compared with conventional grading systems in a large multicenter cohort. These findings support the clinical utility of quantitative hemorrhage burden integration for early risk stratification in patients with aSAH.
From CHESS to CHECKMATE: A Practical Score for Predicting Shunt Dependency Following Subarachnoid Hemorrhage
Salman, Saif, Haidenberger, Flora, Ahmad, Mahlika, Albaramony, Nadia, Patel, Vishal , Peel, Jeffrey, Ombada, Mutaz , Gutierrez-Aguirre, Salvador, Toledo, Otávio de, Aguilar-Salinas, Pedro, Tawk, Rabih, Byrne, Richard, Hanel, Ricardo, Rabinstein, Alejandro, Salman, Saif , Jahromi, Behnam Rezai , Albaramony, N., Patel, Vishal N., Peel, Jeffrey B., Gutierrez‐Aguirre, Salvador F. , Toledo, Otavio F. De , Tawk, Rabih G. , Rabinstein, Alejandro A. , Freeman, William D.

Mayo Clinic

No container title available | July 21, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.64898/2026.07.18.26358389 Get It

Abstract Objective Shunt-dependent hydrocephalus is a common and costly complication of aneurysmal subarachnoid hemorrhage (aSAH), affecting up to 28% of survivors. Existing prediction tools, including the Chronic Hydrocephalus Ensuing from SAH Score (CHESS), have limited discriminative accuracy. We developed the CHECKMATE score, a clinically practical tool to improve prediction of ventriculoperitoneal shunt dependency after aSAH. Methods In this multicenter retrospective cohort of 486 patients with aSAH from Mayo Clinic (January 1, 2006-December 31, 2021), we used multivariable logistic regression and machine learning to identify independent predictors of ventriculoperitoneal shunt placement. The CHECKMATE score was derived from 5 weighted variables: symptomatic hydrocephalus (10 points), intraventricular hemorrhage (5 points), SAH volume greater than 10 mL (3 points), neutrophil-to-lymphocyte ratio greater than 12 (2 points), and 10-year incremental age thresholds starting at older than 60 years (1 point each). Results Of 486 patients (mean age, 56.3 years; 64.6% female), 137 (28.2%) required ventriculoperitoneal shunt placement. The CHECKMATE score achieved an area under the curve of 0.808 (compared to 0.737 for CHESS), with a sensitivity of 0.85, specificity of 0.67, and negative predictive value of 0.92 at the optimal cutoff of 14 points. Conclusions The CHECKMATE score outperforms CHESS for predicting ventriculoperitoneal shunt dependency after aSAH and is easily used at the bedside. Its high negative predictive value helps identify low-risk patients who may benefit from earlier external ventricular drain weaning and shorter hospital stays.
Patient's Age Impact on Stroke Risk and Intracranial Aneurysm Occlusion: SCENT Flow Diverter Study—A Nonrandomized Clinical Trial on Large and Giant Aneurysms
Wakhloo, Ajay K. , Jenkins, Paul, Meyers, Philip M. , Coon, A , Kan, Peter T., Puri, Ajit S., Vries, Joost de, Lanzino, Giuseppe, Bain, Mark D., Ebersole, Koji , Welch, B, Dog⫧an, Aclan , Jabbour, Pascal M., Mocco, J., Siddiqui, Adnan H., Turk, Aquilla S., Taussky, Philipp, Hanel, Ricardo A., Investigators, for the SHaRe and IPHCC, Siddiqui, Adnan H. , Siddiqui, Adnan H , Coon, Alexander Lewis , Kan, Peter , Puri, Ajit S., Vries, Joost de , Lanzino, Giuseppe , Welch, Babu G. , Jabbour, Pascal , Turk, Aquilla S , Taussky, Philipp , Hanel, Ricardo A.

Mayo Clinic

Neurosurgery Practice | April 17, 2026 | Volume: 7 | Issue: 2 | Pages: No page available

10.1227/neuprac.0000000000000222 | PMID 42007246 Get It

BACKGROUND AND OBJECTIVES: The prospective single-arm nonrandomized SCENT (Surpass Intracranial Aneurysm Embolization System Pivotal) trial on flow diverter treatment of large and giant intracranial aneurysms (IA) was analyzed for patients' age and IA characteristics affecting stroke and occlusion rates over 5 years (Trial registration NCT01716117). METHODS: Impact on major ipsilateral stroke and IA occlusion was studied by stratifying age as 65 years and younger vs older than 65. Kaplan–Meier estimates of time to both endpoints, stratified by age, were created. Univariate predictors of time-to-stroke were analyzed using univariable proportional hazards regression models. Limited bivariable modeling was also attempted. RESULTS: Of 180 patients with large or giant IA enrolled, 119 were 65 years and younger, whereas 61 were older than 65 years. The 3-year risk of stroke for the older than 65 years group (19.7%) was more than double that of the 65 years and younger group (9.2%), P = .047. No new strokes were reported between 3 and 5 years. Four patients (2.2%) experienced aneurysm rupture within the first week post-treatment, 3 being 65 years and younger and the fourth older than 65 (>.99). Complete IA occlusion within age strata at 1 year was: older than 65 60% (33/55), 65 years and younger 79.1% (87/110), P = .009, 3 years: older than 65 67.6% (25/37), 65 years and younger 82.5% (66/80), P = .071, and 5 years: older than 65 85.7% (18/21), 65 years and younger 91.8% (56/61), P = .417. CONCLUSION: Age older than 65 was associated with an increased risk of stroke and predictive of incomplete healing and increased time to healing.
Delayed aneurysm rupture after flow-diverter deployment in unruptured aneurysms: a systematic review and meta-analysis
Rodriguez‐Erazú, Fernanda , Ghozy, Sherief , Gutierrez‐Aguirre, Salvador F. , Lara-Velazquez, Montserrat , Cortese, Jonathan , Douri, Dani, Toledo, Otavio F. De , Patel, Milin , Sriraman, Sheetal , Sauvageau, Eric , Kallmes, David F, Ghozy, Sherief , Gutierrez-Aguirre, Salvador F , Lara-Velazquez, Montserrat , Cortese, Jonathan , De Toledo, Otavio Frederico , Aghaebrahim, Amin , Sauvageau, Eric , Hanel, Ricardo A , Hamouda, Abdelrahman M. , Sriraman, Sri, Kallmes, David F. , Hanel, Ricardó A.

Mayo Clinic

Journal of NeuroInterventional Surgery | December 3, 2025 | Volume: No volume available | Issue: No issue available | Pages: jnis-2025-024135

10.1136/jnis-2025-024135 | PMID 41339075 Get It

Background Delayed aneurysm rupture (DAR) is a potentially devastating complication after flow-diverters (FD) deployment and their exact mechanisms are still unclear. The purpose of this meta-analysis is to synthesize the latest evidence on DAR after FD treatment and identify predictive factors. Methods A systematic review and meta-analysis were conducted according to established protocols. Searches were conducted in PubMed, Scopus, Web of Science, and Embase databases up to June 2024 using variations of “aneurysm “and “delayed aneurysm rupture” terms. Original studies reporting DAR and including more than five patients were included. All analyses were conducted in R software (version 4.4.2), employing the “meta” and “tableone” packages. Results 64 studies with 9820 patients were included, large aneurysm size (OR=1.08, 95% CI (1.02, 1.14), P value=0.008), intra-aneurysmal thrombus (OR=1.05, 95% CI (1.01, 1.09), P value=0.010) and posterior circulation location (OR=1.02, 95% CI (1.00, 1.04), P value=0.014) were significant risk factors for DAR. The pooled prevalence of DAR was 1.40%, with a rate of 1.18% after removing outliers. DAR occurred within 30 days in 66.7% of cases, with a mortality rate of 73.3% at discharge. Conclusion DAR following flow diversion treatment is an uncommon but devastating complication and remains a limitation of the technique. It is influenced by factors such as large aneurysm size, intra-aneurysmal thrombosis, and posterior circulation involvement. The first 30 days post-procedure represent a particularly high-risk period. Despite advancements in FD technology, significant gaps remain, highlighting the need for further research to improve risk assessment and treatment strategies.
Abstract 290: Treatment Strategies for Residual and Recurrent Aneurysms After Woven EndoBridge Therapy: A Multicenter Propensity‐Matched Analysis
Gudino, Andres, Reddi, Preethi , Sridhar, V., Haranhalli, Neil , Karandish, Alireza , Aghaebrahim, Amin, Sauvageau, Eric , Crowley, W F, Dabus, Guilherme , Paul, A.R. , Puri, A, Rinaldo, Lorenzo , Brinjikji, Waleed , Goren, Oded , Siddiqui, Adnan, Jaikumar, Vinay , Essibayi, Muhammed Amir , Gutierrez‐Aguirre, Salvador F. , Hendrix, Philipp , Ransom, Ryan C. , Gudino, Andres , Ringer, Andrew J. , Kühn, Anna Luisa , Field, N., Ríos-Zermeño, Jorge , Amllay, Abdelaziz , Monteiro, Andre , Khatri, Deepak , Toledo, Otavio F. De , Crowley, W., Dabus, Guilherme C. , Matouk, Charles , Tawk, Rabih G. , Paul, A. R., Mocco, J , Majidi, Shahram , Samaniego, Edgar A , Lanzino, Giuseppe , Hanel, Ricardó A. , Altschul, David , Levy, Elad I.

Mayo Clinic

Stroke: Vascular and Interventional Neurology | December 2, 2025 | Volume: 5 | Issue: S1 | Pages: No page available

10.1161/svi270000_290 Get It

Introduction Post‐market and multicenter studies report low complete occlusion rates (41‐49%) and higher retreatment rates (13%) following WEB deployment, compared to 3.8% with microsurgical clipping. While retreatment after WEB has been shown to be technically feasible, data on final angiographic outcomes remain limited. We performed a retrospective analysis of prospective databases from 14 cerebrovascular centers in the US to compare the safety and efficacy of retreatment versus continued observation for residual and recurrent aneurysms after initial WEB deployment. Materials/Methods Multinomial logistic regression was used to identify baseline characteristics of untreated and residual/recurrent aneurysms that may act as confounders, which then underwent propensity scored matching (PSM). Results Among 211 patients (125 observed, 86 retreated), retreatment was more common in initially ruptured aneurysms (p<0.001), which showed higher recurrence (p=0.036) and sac‐dominant residuals (p=0.004). These were primarily due to WEB compression on follow‐up (p=0.001), rather than incomplete occlusion with an appropriately sized device (p<0.001). Retreatment was associated with significantly higher rates of complete angiographic occlusion at last follow‐up compared to observation alone (p<0.001), a finding that remained consistent across subgroups defined by initial unruptured status, residual type, and recurrence patterns (all p<0.05). Clipping demonstrated higher, though statistically insignificant, rates of complete occlusion; flow diversion and stent‐assisted coil embolization yielded comparable complete occlusion rates at follow‐up. After propensity score matching, retreatment remained significantly associated with higher rates of complete angiographic occlusion (all p<0.05), with comparable outcomes observed between clipping and various endovascular approaches as above. Conclusion Retreatment improved complete occlusion rates; however, no aneurysmal hemorrhages occurred in either group. Further intervention may be unnecessary when the WEB device—whether compressed or intact (BOSS 0/1)—adequately protects the dome. In cases where WEB compression significantly exposes the aneurysm wall, stent‐assisted coiling or flow diversion can be performed safely and successfully, depending on vascular anatomy and surgeon preference. image image
Multicenter analysis of flow diversion for recurrent/persistent intracranial aneurysms after stent-assisted coiling
Salem, Mohamed M. , Helal, Ahmed , Gajjar, Avi A. , Sioutas, Georgios S. , Heiferman, Daniel M. , Lylyk, Iván , Levine, Alex, Salih, Mira , Abbas, Rawad , Saber, Hamidreza , Lanzino, Giuseppe, Brinjikji, Waleed , Tanweer, Omar , Spiotta, Alejandro M , Park, Min S. , Dumont, Aaron S. , Kim, Louis J. , Kan, Peter , Wolfe, Stacey Q , Raz, Eytan , Shapiro, Maksim , Siddiqui, Adnan H. , Ares, William J. , Ogilvy, Christopher S. , Srinivasan, Visish M. , Starke, Robert M., Ducruet, Andrew F. , Tjoumakaris, Stavropoula , Jankowitz, Brian T. , Albuquerque, Felipe C , Nelson, Peter Kim , Riina, Howard A. , Lylyk, Pedro , Jabbour, Pascal , Burkhardt, Jan Karl, Heiferman, Daniel M , Lylyk, Ivan , Desai, Sohum , Borg, Nicholas , Brinjikji, Waleed , Spiotta, Alejandro M , Arthur, Adam Stephen , Levitt, Michael R , Kan, Peter , Hassan, Ameer E , Wolfe, Stacey Quintero , Raz, Eytan , Siddiqui, Adnan H , Ares, William J , Ogilvy, Christopher S , Tjoumakaris, Stavropoula , Jankowitz, Brian , Albuquerque, Felipe C , Jabbour, Pascal , Burkhardt, Jan‐Karl , Naamani, Kareem El , Renieri, Leonardo , Monteiro, Andre , Abdelsalam, Ahmed, Catapano, Joshua S , Lanzino, Giuseppe , Kim, Louis J. , Levitt, Michael R. , Hassan, Ameer E , Limbucci, Nicola , Colby, Geoffrey P. , Hanel, Ricardó A. , Levy, Elad I. , Thomas, Ajith J , Lopes, Demetrius K.

Mayo Clinic

Journal of NeuroInterventional Surgery | March 27, 2025 | Volume: 18 | Issue: 2 | Pages: 324-331

10.1136/jnis-2024-022422 | PMID 40139781 Get It

Background Flow-diverter stents (FDS) have become the standard of care for a wide range of intracranial aneurysms, but their efficacy/safety in the context of recurrent/recanalized aneurysms following stent-assisted coiling (SAC) is not well established. We evaluate the outcomes of FDS retreatment in a large multicenter cohort. Methods We retrospectively analyzed data from 118 patients across 22 institutions who underwent FDS retreatment for recurrent/persistent aneurysms after SAC (2008–22). The primary outcome was angiographic occlusion status at last follow-up, categorized as complete (100%), near-complete (90–99%), or incomplete (<90%) occlusion. Secondary outcomes included procedural complications and clinical outcomes measured by the modified Rankin Scale (mRS). Results A total of 118 patients (median age 57, 74.6% female) with median follow-up of 15.3 months were identified. Complete occlusion was achieved in 62.5% and near-complete occlusion in 25%. FDS deployment within the pre-existing stent was successful in 98.3% of cases. Major complications occurred in 3.4% of cases, including postoperative aneurysmal rupture with resultant mortality (1.6%) and thromboembolic events with long-term disability (1.6%). Favorable clinical outcomes (mRS 0–2) were observed in 95.1% of patients. Wider aneurysm neck diameter was a significant predictor of incomplete occlusion (adjusted OR (aOR) 1.23 per mm, P=0.044), with male sex trending towards association with non-occlusion (aOR 3.2, P=0.07), while baseline hypertension was associated with complete occlusion (aOR 0.32, P=0.048). Conclusions FDS treatment for recurrent/residual aneurysms after SAC represents a viable treatment option for these challenging cases with acceptable safety and reasonable occlusion rates, although lower than de novo FDS occlusion rates.
Application of the 6 pillars of sustainable global surgical partnerships by the Neurosurgery Outreach Foundation with lower-middle-income countries in Asia
Aldana, Philipp R. , Aldana, Carmina, -, Wyben Ricardo Briones, Rama, Jaime, Villamor, Reynaldo Benedict V., Tan, C. B. , Gigataras, Roland Mark M., Legaspi, Gerardo D., Altantuya, Shirchinjav, Bolormaa, Tovuudorj, Clerkin, Patricia, Öcal, Eylem , Gluf, Wayne M., Barkley, Ariana, Gutierrez‐Aguirre, Salvador F. , Pirris, Stephen M. , Pirris, Stephen , Gutierrez-Aguirre, Salvador F , Hanel, Ricardó A. , Rama, Jaime, Villamor, Reynaldo Benedict V., Tan, Charles, Baticulon, Ronnie E. , Khu, Kathleen Joy O. , Enkhmaa, Davaasambuu , Shao, Belinda

Mayo Clinic

Neurosurgical Focus | March 1, 2025 | Volume: 58 | Issue: 3 | Pages: E15

10.3171/2025.1.focus24828 | PMID 40022756 Get It

OBJECTIVE The global need for neurosurgical care is significant and often unmet. Building partnerships between high-income countries (HICs) and lower-middle-income countries (LMICs) can help bridge the gap. Six features of sustainable global surgical partnerships have been identified; however, their application in neurosurgery has not been studied. The authors analyzed how the 6 pillars of sustainability are applied to neurosurgical partnerships established by the Neurosurgery Outreach Foundation (NOF) with hospitals in LMICs in Asia. METHODS NOF is an all-volunteer, nonprofit US foundation with the mission to advance neurosurgical care in underserved communities through education, service, and support. The authors examined the NOF programs and identified the characteristics associated with the 6 pillars of sustainability, which are community engagement, multidisciplinary collaboration, education and training, outcome measurement, multisource funding, and bilateral authorship. The authors discuss how these pillars contribute to the establishment of sustainable partnerships. RESULTS From 2010 to 2024, NOF has established partnerships at 4 sites: Cebu, Manila, and Davao, the Philippines; and Ulaanbaatar, Mongolia. Partnerships were established with tertiary or quaternary government hospitals to develop neurosurgical programs tailored to the needs of each site and remained sustained and active. Educational surgical missions were in-person outreach activities conducted annually or biennially and were supplemented with online or remote collaboration. The 5 pillars of sustainable partnerships present at all sites include community engagement, multidisciplinary collaboration, education and training, outcome measurement, and multisource funding. The sixth pillar, bilateral authorship, was present at University of the Philippines–Philippine General Hospital in Manila. CONCLUSIONS Using the 6 pillars of sustainable global partnerships, neurosurgical partnerships can be developed and maintained by all-volunteer nonprofit organizations such as NOF. Incorporating these pillars during the planning and executing of global neurosurgical partnerships are essential for long-term success.
Abstract 187: Age impact on stroke risk and healing in patients treated with flow diverters for intracranial aneurysms: SCENT substudy
Wakhloo, Ajay K. , Meyers, Philip M. , Kan, Peter , Vries, Joost de , Bain, Mark, Ebersole, K. C., Welch, Babu G. , Dog⫧an, Aclan , Turk, Quill, Jenkins, P., Coon, Alexander Lewis , Puri, A., Lanzino, Giuseppe , Jabbour, Pascal , Mocco, J , Siddiqui, Adnan H. , Taussky, Philipp , Hanel, Ricardó A.

Mayo Clinic

Stroke: Vascular and Interventional Neurology | January 15, 2025 | Volume: 4 | Issue: S1 | Pages: No page available

10.1161/svin.04.suppl_1.187 Get It

Introduction/Purpose The multicenter, prospective, single‐arm, controlled, non‐randomized SCENT trial on flow diverter (FD) treatment for intracranial aneurysms (IA) was analyzed for patients’ age and IA characteristics impacting stroke and occlusion rates over 5 years. Materials and Methods Impact on major ipsilateral stroke and IA occlusion was studied by stratifying age as </= 65 years versus >65 years. Twice as many subjects treated were </= 65 years old (n=119/180). Product‐limit (Kaplan‐Meier) estimates of time to both endpoints, stratified by age group, were created. Univariate predictors of time to stroke were identified by including candidate variables in univariable proportional hazards regression models. Those variables found to be significant (p<0.10) at the univariate level were entered into a multivariable survival model to identify independent predictors. The stepwise selection produced a final reduced model with a significance level to both enter and stay set at 0.05. Results When parent artery stenosis and IA size were entered into a multiple‐stepwise survival model, only stenosis remained as an independently significant predictor of time to stroke. At 3‐year follow‐up, there were a total of 23 strokes (12.8%), with 11 (47.8%) occurring in subjects </= 65 years; there was a greater risk for seniors (HR1.96, 95% CI 0.83‐4.78, p=.122). Four patients (4/180; 2.2%) experienced aneurysm ruptured within the first week post‐treatment, with 3 being </= 65 and the fourth aged 66 years. No new strokes were reported between 3 and 5 years. Complete IA occlusion rates for seniors were 60.0% (33/55), 67.6% (25/37), and 85.7% (18/21) at 12, 36, and 60 months, respectively, as compared to 79.1% (87/110), 82.5% (66/80), and 91.8% (56/61) for younger subjects. The time to complete IA occlusion was shorter in younger patients (HR1.53, 95% CI 1.07‐2.19, p=.020). Five subjects (2.8%) underwent retreatment, 2 in 60‐year‐old patients, and one each aged 64, 70, and 75. Conclusion Stroke, early rupture risk, and aneurysm occlusion in patients treated with FD are related to age and pre‐existing parent artery stenosis, IA size, and location. With demographic shifts, future treatments need to focus on expedited and improved healing.
EXCELLENT Registry: A Prospective, Multicenter, Global Registry of Endovascular Stroke Treatment With the EMBOTRAP Device
Nogueira, Raul G. , Andersson, Tommy , Haussen, Diogo C , Yoo, Albert J. , Hanel, Ricardó A. , Zaidat, Osama O. , Hacke, Werner , Fiehler, Jens , Brinjikji, Waleed , Doyle, Karen , Kallmes, David F. , Liebeskind, David S. , Kokoszka, Malgosia A., Inoa, Violiza , Humphries, William, Woodward, Keith, Bozorgchami, Hormozd, Boor, Stephan , Cohen, José E. , Taqi, Muhammad , Budzik, Ronald F. , Hussain, M. Shazam , Estrade, Laurent , Puri, Ajit S., Brekenfeld, Caspar , Siddiqui, Adnan H. , Jovin, Tudor G , Fiehler, Jens , De Meyer, Simon F , Brinjikji, Waleed , Doyle, Karen M , Liebeskind, David S. , Virmani, Renu , Inoa, Violiza , Jabbour, Pascal , Levy, Elad I , Boor, Stephan , Cohen, Jose E , Dashti, Shervin R , Schirmer, Clemens M , Estrade, Laurent , De Leacy, Reade , Chitale, Rohan V , Brekenfeld, Caspar , Siddiqui, Adnan H , Andersson, Tommy , Hanel, Ricardo A , Nogueira, Raul G , Yoo, Albert J , Jovin, Tudor G. , Virmani, Renu , Jabbour, Pascal , François, Olivier , Levy, Elad I. , Schirmer, Clemens M. , Leacy, Reade De , Puri, Ajit S

Mayo Clinic

Stroke | November 19, 2024 | Volume: 55 | Issue: 12 | Pages: 2804-2814

10.1161/strokeaha.124.047324 | PMID 39559856 Get It

BACKGROUND: The EXCELLENT registry aimed to evaluate the effectiveness of the EMBOTRAP Revascularization Device in an all-comer population in a real-world setting, with a focus on the composition of retrieved clots. METHODS: EXCELLENT is a prospective, global registry of patients with acute ischemic stroke treated with EMBOTRAP as the first-line mechanical thrombectomy device conducted at 34 sites (25 sites contributing clot) from September 2018 to March 2021, utilizing core imaging and central histology laboratories blinded to clinical data, independent 90-day modified Rankin Scale assessment and Clinical Events Committee. RESULTS: After screening 3799 patients, a total of 997 subjects (mean age, 70.0±14.2 years; 51.8% women; 19.7% non-White) were included. The first-pass modified Treatment in Cerebral Infarction (mTICI) ≥2b rate was 64.5% (623/966), first-pass mTICI ≥2c was 39.1% (378/966), and final mTICI ≥2b was 94.5% (931/985). A total of 427/912 (46.8%) patients achieved a 90-day modified Rankin Scale of 0 to 2 or ≤baseline. Embolization to a new territory occurred in 0.2% (2/984), and symptomatic intracranial hemorrhage at 24 hours in 1.6% (16/997). The 90-day mortality was 19.1% (175/918). Device- and/or procedure-related serious adverse events occurred in 5.9% (54/912) through 90 days. The mean RBC percentage of retrieved clots was 45.62±21.372. Among patients who achieved mTICI ≥2b with the first pass, 15.7% (52/331) and 9.7% (32/331), respectively, had RBC-poor (<25%) and RBC-rich (>75%) clots. Patients with no clot retrieved in any procedural pass had a lower percentage of hyperdense or susceptibility vessel sign on baseline imaging (58.9% versus 74.7%; P <0.001), pointing to a potential preprocedure indicator of challenging clot. CONCLUSIONS: The EXCELLENT registry informs real-world practices in mechanical thrombectomy and sheds light on the range of clots effectively retrieved by current technology. This is the first report of detailed patient characteristics where mechanical thrombectomy maneuvers failed to remove any clot material. Although the composition of nonretrievable clots cannot be assessed histologically, the results support the notion that no retrieval may be correlated with imaging findings suggesting clots lower in RBC. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03685578.
Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data
Rodriguez‐Erazú, Fernanda , Cortez, Gustavo M , Gutierrez‐Aguirre, Salvador F. , Toledo, Otavio F. De , Aghaebrahim, Amin, Sauvageau, Eric , Kallmes, David F. , Fiehler, Jens , Hanel, Ricardó A. , Gutierrez-Aguirre, Salvador F , De Toledo, Otavio Frederico , Aghaebrahim, Amin , Sauvageau, Eric , Fiehler, Jens , Hanel, Ricardo A , Lopes, Demetrius K.

Mayo Clinic

Journal of NeuroInterventional Surgery | October 2, 2024 | Volume: 17 | Issue: 12 | Pages: 1362-1367

10.1136/jnis-2024-022350 | PMID 39357888 Get It

Background The pipeline embolization device (PED) has been increasingly used to treat brain aneurysms; however, concerns have been raised about braid stability with newer drawn filled tubing technology devices. Objective To evaluate braid stability of PED early generations using data from the PREMIER trial. Methods All consecutive intracranial aneurysms treated with PED (Classic and Flex) within the PREMIER trial were reviewed for braid stability (fish mouthing, foreshortening, braid bump, braid collapsing). Immediate postprocedure cone-beam CT and angiography were compared with 1- and 2- years' follow-up. Analyses included safety, measured with the modified Rankin Scale (mRS) score, including +1 mRS point and a good clinical outcome (mRS score 0–2), vessel stenosis ≥50%, effectiveness measured with Raymond-Roy Scale, and re-treatment rates. Results 133/141 aneurysms had a complete dataset. 8/133 (6%) aneurysms showed braid deformations. Inter-reader agreement was excellent (κ=0.83). Braid deformations were statistically significantly associated with in-stent vessel stenosis >50% (P=0.029), without impact on effectiveness or safety. Fish mouthing was found in 1/133 (0.75%) at 1 year, causing >50% vessel stenosis. Foreshortening occurred in 6/133 (4.5%), and braid bump in 1/133 (0.75%) associated with severe in-stent stenosis. Four other cases (3.0%) of asymptomatic in-stent stenosis due to neointimal hyperplasia were seen without braid changes. No new braid stability deformations were found at the 2-year follow-up. Conclusion Our study demonstrates excellent braid stability among patients treated with the PED Classic and Flex in the PREMIER trial. Within the uncommon braid changes observed, none affected the PED safety or efficacy. Trial registration number NCT02186561 .