HydroCoils Are Associated with Lower Angiographic Recurrence Rates Than Are Bare Platinum Coils in Treatment of “Difficult-to-Treat” Aneurysms: A Post Hoc Subgroup Analysis of the HELPS Trial

Brinjikji, Waleed; White, Phil; Nahser, Hans; Wardlaw, Joanna M.; Sellar, Robin; Gholkar, A; Cloft, Harry J.; Kallmes, David F.

doi:10.3174/ajnr.a4349

Cited by 11 publications

(4 citation statements)

References 23 publications

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“…In our study the use of HSC was not associated with an increased incidence of parent vessel perforation, parent vessel occlusion, procedural aneurysm rupture, and thromboembolic events. Further on, recurrence was a high-profile and controversial issue among different clinical trials and systematic reviews: HELPS (Hydrocoil Endovascular aneurysm occlusion and Packing Study), 14 – 16 GREAT (German--French Randomized Endovascular Aneurysm Trial) 8 , 17 and Serafin's systematic review 18 illustrated that hydrogel coils resulted in a lower rate of recurrence when compared to BPC. In contrast, no significant differences between coil types were observed through Poncyljusz's RCT 19 and PRET (Patients prone to Recurrence after Endovascular Treatment).…”

Section: Discussionmentioning

confidence: 99%

Comparison between second generation HydroSoft coils and bare platinum coils for the treatment of large intracranial aneurysms

et al. 2022

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Background The development of HydroSoft coils (HSC) aims to reduce the high recurrence and retreatment rates observed in large brain aneurysms by improving primary brain aneurysm filling and thus occlusion efficacy. We compared clinical and angiographic effectiveness of bare platinum coils (BPC) versus second generation HSC for large intracranial aneurysms at our center. Methods We included 61 large aneurysms between 2015 and 2018, 29 embolized primarily using HSC and 32 treated with BPC. The aneurysm occlusion rates were assessed after 3 and 12 months with an MRI scan and at 6 moths with a control digital subtraction angiography (DSA) using the Raymond-Roy occlusion classification (RROC). Clinical outcomes were evaluated using the modified ranking scale (mRS). Results The observed immediate occlusion rate was slightly better in the BPC group, however, this group had a significant increase of progressive reperfusion at all imaging follow-up. Contrarily, the rate of complete occlusion increased significantly in the HSC group, starting from the 6 and 12-months follow-up. 7 aneurysms (11.4%) were re-treated (15.6% BPC and 6.9% HSC). The 6 and 12-months clinical data showed mRS score 0-1 in 96.7% of patients. Conclusions In our single-center experience, the second generation HydroSoft coils were shown to be safe and effective for endovascular treatment of large intracranial aneurysms with encouraging clinical and angiographic results, also for ruptured aneurysms. Even if the validity is limited due to our small cohort size, HSC showed a significantly lower rate of recurrence at mid-term follow-up when compared to BPC.

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Section: Discussionmentioning

confidence: 99%

Comparison between second generation HydroSoft coils and bare platinum coils for the treatment of large intracranial aneurysms

et al. 2022

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“…Some comparative studies of hydrogel-coated coils and inert coils have demonstrated that hydrogel coils achieve greater packing density with decreased coil length and may have lower aneurysm recurrence rates 9 10. Recently published post hoc subgroup analyses of the HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) demonstrated that, compared with bare platinum coils, the use of HydroCoils is independently associated with significantly lower rates of major recurrence for treatment of ruptured aneurysms <10 mm in size (20% vs 48%) as well as for aneurysms with irregular shapes and wide necks 1 2. However, a recently published meta-analysis showed no statistically significant difference in aneurysm recanalization rates when modified coils such as the HydroCoil were compared with bare platinum coils 11…”

Section: Discussionmentioning

confidence: 99%

GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device

Brinjikji

Amar

Almandoz

et al. 2017

J NeuroIntervent Surg

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“…Ten of the 17 RCT reports (59%) showed a high risk of bias (Figure 2). 35,[37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52] We found improper reporting in 546 of the included studies (40%) (eAppendix 3 in Supplement 1). In 68 studies (5%), the conclusion in the abstract was more positive than the conclusion in the text.…”

Section: Risk Of Biasmentioning

confidence: 99%

Outcomes Associated With Intracranial Aneurysm Treatments Reported as Safe, Effective, or Durable

Volovici,

Verploegh,

Satoer

et al. 2023

JAMA Netw Open

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ImportanceTesting new medical devices or procedures in terms of safety, effectiveness, and durability should follow the strictest methodological rigor before implementation.ObjectivesTo review and analyze studies investigating devices and procedures used in intracranial aneurysm (IA) treatment for methods and completeness of reporting and to compare the results of studies with positive, uncertain, and negative conclusions.Data SourcesEmbase, MEDLINE, Web of Science, and The Cochrane Central Register of Clinical Trials were searched for studies on IA treatment published between January 1, 1995, and the October 1, 2022. Grey literature was retrieved from Google Scholar.Study SelectionAll studies making any kind of claims of safety, effectiveness, or durability in the field of IA treatment were included.Data Extraction and SynthesisUsing a predefined data dictionary and analysis plan, variables ranging from patient and aneurysm characteristics to the results of treatment were extracted, as were details pertaining to study methods and completeness of reporting. Extraction was performed by 10 independent reviewers. A blinded academic neuro-linguist without involvement in IA research evaluated the conclusion of each study as either positive, uncertain, or negative. The study followed Preferring Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Main Outcomes and MeasuresThe incidence of domain-specific outcomes between studies with positive, uncertain, or negative conclusions regarding safety, effectiveness, or durability were compared. The number of studies that provided a definition of safety, effectiveness, or durability and the incidence of incomplete reporting of domain-specific outcomes were evaluated.ResultsOverall, 12 954 studies were screened, and 1356 studies were included, comprising a total of 410 993 treated patients. There was no difference in the proportion of patients with poor outcome or in-hospital mortality between studies claiming a technique was safe, uncertain, or not safe. Similarly, there was no difference in the proportion of IAs completely occluded at last follow-up between studies claiming a technique was effective, uncertain, or noneffective. Less than 2% of studies provided any definition of safety, effectiveness, or durability, and only 1 of the 1356 studies provided a threshold under which the technique would be considered unsafe. Incomplete reporting was found in 546 reports (40%).Conclusions and RelevanceIn this systematic review and meta-analysis of IA treatment literature, studies claiming safety, effectiveness, or durability of IA treatment had methodological flaws and incomplete reporting of relevant outcomes supporting these claims.

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HydroCoils Are Associated with Lower Angiographic Recurrence Rates Than Are Bare Platinum Coils in Treatment of “Difficult-to-Treat” Aneurysms: A Post Hoc Subgroup Analysis of the HELPS Trial

Cited by 11 publications

References 23 publications

Comparison between second generation HydroSoft coils and bare platinum coils for the treatment of large intracranial aneurysms

Comparison between second generation HydroSoft coils and bare platinum coils for the treatment of large intracranial aneurysms

GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device

Outcomes Associated With Intracranial Aneurysm Treatments Reported as Safe, Effective, or Durable

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