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Sauvageau, Eric

https://orcid.org/0000-0003-4399-1142

Mayo Clinic

Baptist Medical Center Jacksonville

Citations 15

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.

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

10.1136/jnis-2025-024135 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.

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
Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion
Goyal, Mayank , Möhlenbruch, Markus , Nimjee, Shahid M. , Buck, Brian , Kennedy, James , Zhang, Liqun , Hametner, Christian , Nardai, Sándor , Zafar, Atif , Diprose, William K. , Vatanpour, Shabnam , Stebner, Alexander, Bosshart, Salome , Uchida, Kazutaka , Ryckborst, Karla J., Fahed, Robert, Hu, Sherry , Zaidi, Syed , Lee, Vivien , Teal, Rachel, Trivedi, Anurag , Ogungbemi, Ayokunle, Orosz, Péter , Abdalkader, Mohamad , Taschner, Christian , Tarpley, Jason , Poli, Sven , Sahlas, Demetrios J. , Burns, Paul , Marigold, Richard , Amole, Adewumi, Field, Thalia S. , Settecase, Fabio , Lenzsér, Gábor, Asdaghi, Negar , Lobotesis, Kyriakos , Siddiqui, Adnan H. , Berrouschot, J., Ebersole, Koji , Schneider, Hauke , Mandzia, Jennifer, Klostranec, Jesse , Jadun, Changez, Patankar, Tufail , Sauvageau, Eric , Lenthall, Robert , Peeling, Lissa, Budzik, Ronald F. , Lee, Seon-Kyu, Perry, Richard , Hlaing, Thant , Singh, Paul, Hill, Michael D. , Vakharia, Kunal , Harston, George , Möhlenbruch, Markus A , Nimjee, Shahid M , Buck, Brian H , Kennedy, James , Zhang, Liqun , Hametner, Christian , Diprose, William , Vatanpour, Shabnam , Stebner, Alexander , Bosshart, Salome , Singh, Nishita , Hu, Sherry X , Vollherbst, Dominik F , Lee, Vivien H , Rempel, Jeremy L , Teal, Rachel , Trivedi, Anurag , Bode, Felix J , Abdalkader, Mohamad , Poli, Sven , Singh, Ravinder-Jeet , Lopez, George , Schaafsma, Joanna D , Marigold, Richard , Field, Thalia S , Settecase, Fabio , Ortega-Gutierrez, Santiago , Mokin, Maxim , Ebersole, Koji , Schneider, Hauke , Yoo, Albert J , Klostranec, Jesse , Lenthall, Robert , Huynh, Thien , Budzik, Ronald , Levitt, Michael R , Jahromi, Babak S , Hill, Michael D , Siddiqui, Adnan H , Ospel, Johanna M. , Ganesh, Aravind , Dowlatshahi, Dar , Volders, David , Jumaa, Mouhammad , Booth, Thomas Calvert , Shankar, Jai , Dorn, Franziska , Sebastian, Ivy Anne , Fahed, Robert , Lynch, Jeremy , Bode, Felix J. , Pham, Mirko , Leacy, Reade De , Chen, Michael , Reich, Arno , Swartz, Richard H. , Yoo, Albert J. , Huynh, Thien , Makalanda, Levansri , Levitt, Michael R. , Jahromi, Babak S. , Demchuk, Andrew M.

New England Journal of Medicine | February 5, 2025 | Volume: 392 | Issue: 14 | Pages: 1385-1395

10.1056/nejmoa2411668 Get It

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.

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

10.1136/jnis-2024-022350 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 .
Safety and Efficacy of Flow Diverters for Treatment of Unruptured Anterior Communicating Artery Aneurysms: Retrospective Multicenter Study
Benalia, Victor H. C. , Saatçi, Işıl , Cekirge, H Saruhan , Dabus, Guilherme , Brinjikji, Waleed , Nishi, Hidehisa , Siddiqui, Adnan H. , Aghaebrahim, Amin, Sauvageau, Eric , Saatci, Isil , Çekirge, Saruhan , Dabus, Guilherme C. , Nishi, Hidehisa , Monteiro, Andre , Aghaebrahim, Amin , Hanel, Ricardo A , Siddiqui, Adnan H , Cortez, Gustavo M , Mounayer, Charbel , Koçer, Naci , Işlak, Civan , Baltacıoğlu, Feyyaz , Mendes Pereira, Vitor , Lopes, Demetrius K. , Hanel, Ricardó A.

Journal of NeuroInterventional Surgery | October 16, 2023 | Volume: 15 | Issue: 12 | Pages: 1181-1186

10.1136/jnis-2023-020673 Get It

Background The anterior communicating artery (AComm) region is the most common site of intracranial aneurysms, with increased rupture risk compared with other locations. Overall, flow diverters present as a safe and efficacious treatment for intracranial aneurysms, but there is paucity of data for their use in the treatment of unruptured AComm aneurysms. We present the largest multicentric analysis evaluating the outcomes of flow diverters in AComm aneurysm treatment. Methods Databases from 10 centers were retrospectively reviewed for unruptured AComm aneurysms treated with flow diverters. Demographics, clinical presentation, radiographic characteristics, procedural complications, and outcomes were assessed. Results A total of 144 patients harboring 147 AComm aneurysms were treated between January 2012 and December 2021. Seventy-four were women (51.4%) and median age was 60 (IQR 50–67) years. All were unruptured AComm aneurysms. Half of the cohort had similar anterior cerebral artery sizes (51.4%). The most common morphology was saccular (94.6%), with a branch involvement in 32.7% of cases. Median vessel diameter was 2.4 mm, and the Pipeline Flex was the most prevalent device (32.7%). Median follow-up time was 17 months, with complete occlusion in 86.4% at the last follow-up. Functional independence (modified Rankin Scale score 0–2) was reported in 95.1%. Intraprocedural complications occurred in 5.6%, and postoperative complications were noted in 9.7% of cases. Combined major complication and mortality rate was 2.1%. Conclusions Our study suggests that flow diverters are a useful treatment for AComm aneurysms. Mid-term results indicated favorable aneurysm occlusion with a good safety profile. Additional prospective studies with longer follow-up periods and independent adjudication are warranted to better assess these results.
Abstract 99: Clot Composition And Reperfusion Outcomes In 1430 Mechanical Thrombectomy Patients: Analysis Of The Stroke Thromboembolism Registry Of Imaging And Pathology
Brinjikji, Waleed , Abbasi, Mehdi , Mohammaden, Mahmoud , Viana, Lorena Souza , Ferreira, Felipe , Abdelhamid, Hend M, Kvamme, Peter , Gounis, Matthew J. , Doyle, Karen, Cloft, Harry J. , Thacker, Ike, Copelan, Alexander , Aghaebrahim, Amin, Sauvageau, Eric , Bhuva, Parita, Soomro, Jazba , Cantrell, Donald R. , Puri, Ajit S , Frankel, Michael , Kallmes, David F. , Nogueira, Raul G. , Pinheiro, Agostinho C. , Al‐Bayati, Alhamza R , Bhatt, Nirav , Layton, Kennith F. , Almandoz, Josser E Delgado , Hanel, Ricardó A. , Mendes Pereira, Vitor , Almekhlafi, Mohammed , Yoo, Albert J. , Jahromi, Babak S. , Patel, Biraj M. , Larco, Jorge Arturo , Fitzgerald, Seán , Mereuta, Oana Madalina , Savastano, Luis , Kayan, Yasha , Demchuk, Andrew M. , Nazari, Pouya , Entwistle, John, Polley, Eric C. , Haussen, Diogo C

Stroke | February 2, 2023 | Volume: 54 | Issue: Suppl_1 | Pages: No page available

10.1161/str.54.suppl_1.99 Get It

Background: Understanding clot composition may allow for better technical planning and improved outcomes in mechanical thrombectomy (MT). We sought to correlate clot composition with reperfusion outcomes in MT. Methods: Clinical, imaging, and clot data from patients enrolled in the STRIP Registry from September 2016 to September 2020 were analyzed. Samples were fixed in 10% phosphate-buffered formalin and stained with hematoxylin and eosin and Martius Scarlett Blue. Percent composition, richness, and gross appearance were evaluated. Outcome measures included the rate of First-Pass Effect (mTICI2c/3, FPE) and the number of device passes. Results: A total of 1430 patients (mean age, 68.4±13.5years; median [IQR] baseline NIHSS,17.2 [10.5-23]; IV-tPA use, 36%; Stent-Retrievers [SR], 27%; Contact Aspiration [CA], 27%; Combined SR + CA, 43%) were included. The median [IQR] number of passes was 1 [1-2]. FPE was achieved in 39.3% of the cases. There was no association between percent histological composition or clot richness and FPE in the overall population. However, the combined technique resulted in lower FPE rates for RBC-rich (P<0.0001), platelet-rich (P=0.003), and mixed (P<0.0001) clots. Fibrin-rich and platelet-rich clots required a higher number of passes compared to RBC-rich and mixed clots (median, 2 and 1.5 vs.1, respectively, P=0.02). CA displayed a trend towards a higher number of passes with fibrin-rich clots (2 vs.1, P=0.12). By gross appearance, mixed/heterogeneous clots had lower FPE rates than red and white clots. Conclusion: Despite the lack of correlation between clot histology and FPE in the overall population, our study adds to the growing body of evidence supporting the notion that clot composition influences reperfusion treatment strategy outcomes. Additional studies are needed.
Histological evaluation of acute ischemic stroke thrombi may indicate the occurrence of vessel wall injury during mechanical thrombectomy
Mereuta, Oana Madalina , Abbasi, Mehdi , Fitzgerald, Seán , Dai, Daying , Kadirvel, Ram , Almekhlafi, Mohammed , Kvamme, Peter , Gounis, Matthew J. , Patel, Biraj M. , Aghaebrahim, Amin, Sauvageau, Eric , Bhuva, Parita, Soomro, Jazba , Thacker, Ike, Copelan, Alexander , Nazari, Pouya , Cantrell, Donald R. , Mohammaden, Mahmoud , Pisani, Leonardo , Puri, Ajit S , Meves, Alexander , Larco, Jorge Arturo , Cloft, Harry J. , Kallmes, David F. , Doyle, Karen , Brinjikji, Waleed , Almekhlafi, Mohammed A , Mendes Pereira, Vitor , Jahromi, Babak S , Gounis, Matthew J , Nazari, Pouya , Al-Bayati, Alhamza , Pisani, Leonardo , Rodrigues, Gabriel Martins , Arturo Larco, Jorge L , Savastano, Luis , Doyle, Karen M , Brinjikji, Waleed , Patel, Biraj M , Fitzgerald, Seán , Dai, Daying , Madalina Mereuta, Oana , Kadirvel, Ramanathan , Hanel, Ricardó A. , Yoo, Albert J. , Layton, Kennith F. , Almandoz, Josser E Delgado , Jahromi, Babak S. , Nogueira, Raul G. , Demchuk, Andrew M. , Kayan, Yasha , Haussen, Diogo C , Al‐Bayati, Alhamza R , Entwistle, John

Journal of NeuroInterventional Surgery | May 11, 2021 | Volume: 14 | Issue: 4 | Pages: 356-361

10.1136/neurintsurg-2021-017310 Get It

Background Several animal studies have demonstrated that mechanical thrombectomy (MT) for acute ischemic stroke (AIS) may cause vessel wall injury (VWI). However, the histological changes in human cerebral arteries following MT are difficult to determine. Objective To investigate the occurrence of VWI during MT by histological and immunohistochemical evaluation of AIS clots. Methods As part of the multicenter STRIP registry, 277 clots from 237 patients were analyzed using Martius Scarlett Blue stain and immunohistochemistry for CD34 (endothelial cells) and smooth muscle actin (smooth muscle cells). Results MT devices used were aspiration catheters (100 cases), stentriever (101 cases), and both (36 cases). VWI was found in 33/277 clots (12%). There was no significant correlation between VWI and MT device. The degree of damage varied from grade I (mild intimal damage, 24 clots), to grade II (relevant intimal and subintimal damage, 3 clots), and III (severe injury, 6 clots). VWI clots contained significantly more erythrocytes (p=0.006*) and less platelets/other (p=0.005*) than non-VWI clots suggesting soft thrombus material. Thrombolysis correlated with a lower rate of VWI (p=0.04*). VWI cases showed a significantly higher number of passes (2 [1–4] vs 1 [1–3], p=0.028*) and poorer recanalization outcome (p=0.01*) than cases without VWI. Conclusions Histological markers of VWI were present in 12% of AIS thrombi, suggesting that VWI might be related to MT. VWI was associated with soft thrombus consistency, higher number of passes and poorer revascularization outcome. There was no significant correlation between VWI and MT device.
Per pass analysis of thrombus composition retrieved by mechanical thrombectomy
Abbasi, Mehdi , Kvamme, Peter , Patel, Biraj M. , Gounis, Matthew J. , Kadirvel, Ramanathan , Kallmes, David F. , Doyle, Karen , Cloft, Harry J. , Liu, Yang , Thacker, Ike, Aghaebrahim, Amin, Sauvageau, Eric , Copelan, Alexander , Nazari, Pouya , Cantrell, Donald R. , Bhuva, Parita, Soomro, Jazba , Mohammaden, Mahmoud , Pisani, Leonardo , Puri, Ajit S , Brinjikji, Waleed , Patel, Biraj M , Fitzgerald, Seán , Mereuta, Oana M, Dai, Daying , Kadirvel, Ram , Kallmes, David F , Savastano, Luis E., Kayan, Yasha , Nazari, Pouya , Al-Bayati, Alhamza , Brinjikji, Waleed , Liu, Yang , Layton, Kennith F. , Hanel, Ricardó A. , Almekhlafi, Mohammed , Almandoz, Josser E Delgado , Mendes Pereira, Vitor , Jahromi, Babak S. , Yoo, Albert J. , Nogueira, Raul G. , Fitzgerald, Seán , Mereuta, Oana Madalina , Dai, Daying , Savastano, Luis , Demchuk, Andrew M. , Entwistle, John, Haussen, Diogo C , Al‐Bayati, Alhamza R , Rodrigues, Gabriel Martins

Interventional Neuroradiology | April 7, 2021 | Volume: 27 | Issue: 6 | Pages: 815-820

10.1177/15910199211009119 Get It

Background and aim Mechanical thrombectomy (MT) for large vessel occlusion often requires multiple passes to retrieve the entire thrombus load. In this multi-institutional study we sought to examine the composition of thrombus fragments retrieved with each pass during MT. Methods Patients who required multiple passes during thrombectomy were included. Histopathological evaluation of thrombus fragments retrieved from each pass was performed using Martius Scarlet Blue staining and the composition of each thrombus component including RBC, fibrin and platelet was determined using image analysis software. Results 154 patients underwent MT and 868 passes was performed which resulted in 263 thrombus fragments retrieval. The analysis of thrombus components per pass showed higher RBC, lower fibrin and platelet composition in the pass 1 and 2 when compared to pass 3 and passes 4 or more combined (P values <0.05). There were no significant differences between thrombus fragments retrieved in pass 1 and pass 2 in terms of RBC, WBC, fibrin, and platelet composition (P values >0.05). Similarly, when each composition of thrombus fragments retrieved in pass 3 and passes 4 or more combined were compared with each other, no significant difference was noted (P values >0.05). Conclusion Our findings confirm that thrombus fragments retrieved with each pass differed significantly in histological content. Fragments in the first passes were associated with lower fibrin and platelet composition compared to fragments retrieved in passes three and four or higher. Also, thrombus fragments retrieved after failed pass were associated with higher fibrin and platelet components.
The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil
Bendok, Bernard R. , Abi-Aad, Karl R., Ward, Jennifer , Kniss, Jason F , Kwasny, Mary , Rahme, Rudy J. , Aoun, Salah G. , Tecle, Najib E. El , Zammar, Samer G. , Aoun, Rami James N. , Patra, Devi Prasad, Raymond, Jean , Woo, Henry H. , Dabus, Guilherme , Milot, Geneviève , Scott, John A. , DeNardo, Andrew , Investigators, HEAT Study, Lavine, Sean D., Bozorgchami, Hormozd, Veznedaroglu, Erol, Albuquerque, Felipe C. , Fiorella, David, Boulos, Alan S. , Cortes, Maria, Kanaan, Hilal, Jindal, Gaurav , Klucznik, Richard , Kalmes, David, Xavier, Andrew, Hussain, Muhammad , Moran, Christopher J. , Adel, Brian van , Milot, Genevieve, Hirsch, Joshua A , Carpenter, Jeffrey , Powers, Ciarán J. , Luh, George, Tummala, Ramanchandra, Evans, Avery J. , Garg, Ankur, James, Roberts, Sauvageau, Eric , Fields, Jeremy D. , Grobelny, Thomas, Hartman, J., Patra, Devi P. , Bendok, Bernard R , Ward, Jennifer D, Ahmadieh, Tarek Y. El , Ansari, Sameer A. , Fiorella, David , Dabus, Guilherme C. , Almandoz, Josser E Delgado , Dashti, Shervin R , Investigators, HEAT Study, Deshaies, Eric Michael , Fiorella, David, Tawk, Rabih G. , Romero, Charles, Kelly, Michael , Chaudry, Imran , Pandey, Aditya S , Wang, Dennis Y.Q. , Milot, Genevieve, Jabbour, Pascal , Shankar, Jai , Patsalides, Athos T , Lee, Sung , James, Robert F. , Jayaraman, Mahesh V. , Satti, Sudhakar R

Neurosurgery | February 10, 2020 | Volume: 86 | Issue: 5 | Pages: 615-624

10.1093/neuros/nyaa006 Get It

Abstract BACKGROUND Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm. OBJECTIVE To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT). METHODS HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up. RESULTS A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm ( P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms. CONCLUSION Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms. Video Abstract