Article Text
Abstract
Introduction Initial experience with cobalt-chromium Surpass Evolve (SE; Stryker) for the treatment of intracranial aneurysms (IAs) has shown promising results, but there are still no studies that evaluated the efficacy of a SE for the treatment of remnant previously treated IAs. This study aimed to evaluate the efficacy and safety of SE for the treatment of pretreated remnant IAs, compared to untreated saccular IAs.
Methods This sub-analysis is derived from the Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) registry, which is a retrospective, observational, single-arm, multicentric, international cohort study conducted across 15 academic institutions in North America and Europe from July 2020 to October 2022. Adult patients (≥18 years) undergoing SE implantation for single saccular aneurysms were included and were grouped based on prior treatment to those with remnant (residual or recurrent) IAs previously treated by coiling or intrasaccular devices, and those with untreated IAs. Baseline characteristics and outcomes were compared between the two groups. The inverse probability of treatment weighting was used to match between the two groups based on the potential confounders that would impact the outcomes.
Results A total of 257 patients (median [IQR] age: 59 years [50–67 years]) and IAs were included in this study. Of those, 66 patients had previously treated remnant IAs, while 191 patients had untreated IAs. Of the 246 patients that had imaging follow-up at a median time of 10.5 months (IQR, 6.4–12.8 months), the core lab adjudicated complete occlusion rate was less in the previously treated IAs group compared to the untreated IAs group (59.7% vs 72.3%, Adjusted OR: 0.43, 95%CI: 0.21–0.88, p=0.022). Furthermore, we found similar rates of adequate occlusion between the previously treated IAs group (83.9%) and the untreated IAs group (82.1%, p=0.746). There was no difference in rates of major stroke (1.5% vs 2.6%, p>0.999) and mortality (1.5% vs 1.0%, p>0.999) between the previously treated IAs group and the untreated IAs group. Furthermore, there was no difference in mRS 0–2 between the previously treated IAs group and the untreated IAs group (93.7% vs 95.7%, p=0.504). Retreatment rates were similar between the two groups (1.6% vs 3.3%, p=0.684).
Conclusion Our results revealed reasonable rates of complete occlusion, high rate of adequate occlusion and an acceptable safety profile for the use of SE to treat remnant previously treated IAs. Future large prospective studies with longer duration of follow-up are warranted to explore that further.
Disclosures M. Dibas: None. J. Vivanco-Suarez: None. D. Lopes: 1; C; Mentice. 2; C; Asahi, Stryker, Corindus, Siemens, and Medtronic. 4; C; Syncron, Three Rivers Inc., Q’apel, VIZ.AI, Methinks, Vastrax, Borvo, BendIT, Collavidence, NDI, Prometheus, NextGen, Galaxy, Global Intervention, and Sim&Cure. 6; C; Cerenovus, Medtronic, INFINITY, Stryker. R. Hanel: 1; C; NIH, Interline Endowment, Microvention, Stryker, and CNX. Investor/Stoker: InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc., Scientia, RisT, BlinkTBI, and Corindus. 2; C; Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. 6; C; MiVI, eLum, Three Rivers Medical Inc., Shape Medical, and Corindus. A. Rodriguez-Calienes: None. G. Cortez: None. J. Fifi: 1; C; Viz. Investor/Stoker: Imperative care and Cerebrotech. 2; C; Penumbra, Stryker, Microvention, and Cerenovus. A. Devarajan: None. G. Toth: 2; C; Medtronic and Dynamed. T. Patterson: None. D. Altschul: 2; C; Microvention, Stryker, and Von Vascular Inc. V. Pereira: 2; C; Stryker, Medtronic, Penumbra, Neurovasc, and Balt. X. Liu: None. A. Puri: 1; C; Medtronic, Stryker, and Cerenovus. 2; C; Medtronic, Stryker, Cerenovus, Microvention, Agile, Merit, Corindus, Q’apel, Arsenal, and Imperative Care. A. Kühn: None. W. Guerrero: None. P. Khandelwal: 2; C; Stryker and Medtronic. I. Bach: None. P. Kan: 1; C; NIH, Siemens, Joe Niekro, and Medtronic. 2; C; Stryker, Imperative Care, Cerenovus, and Microvention. G. Edhayan: None. M. Martinez-Galdamez: 2; C; Medtronic. C. Given: 2; C; Stryker and Medtronic. B. Gross: 2; C; Medtronic, Microvention, and Stryker. S. Narayanan: 2; C; Cerenovus, MicroVention, Inc. and Imperative Care. M. Galecio-Castillo: None. S. Derakhshani: None. S. Ortega-Gutierrez: 1; C; NIH-NINDS (R01NS127114–01, RO3NS126804–01), Stryker, Medtronic, Microvention, Methinks, Viz.ai. 2; C; Medtronic, Stryker Neurovascular.