Invasive Diagnostic and Therapeutic Management of Cerebral VasoSpasm after Aneurysmal Subarachnoid Hemorrhage (IMCVS)—A Phase 2 Randomized Controlled Trial

Abstract

Cerebral vasospasm (CVS) is associated with delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH). The most frequently used form of rescue therapy for CVS is invasive endovascular therapy. Due to a lack of prospective data, we performed a prospective randomized multicenter trial (NCT01400360). A total of 34 patients in three centers were randomized to invasive endovascular treatment or conservative therapy at diagnosis of relevant CVS onset. Imaging data was assessed by a neuroradiologist blinded for treatment allocation. Primary outcome measure was development of DCI. Secondary endpoints included clinical outcome at 6 months after SAH. A total of 18 of the 34 patients were treated conservatively, and 16 patients were treated with invasive endovascular treatment for CVS. There was no statistical difference in the rate of cerebral infarctions either at initial or at the follow-up MRI between the groups. However, the outcome at 6 months was better in patients treated conservatively (mRs 2 ± 1.5 vs. 4 ± 1.8, p = 0.005). Invasive endovascular treatment for CVS does not lead to a lower rate of DCI but might lead to poorer outcomes compared to induced hypertension. The potential benefits of endovascular treatment for CVS need to be addressed in further studies, searching for a subgroup of patients who may benefit.

Neuroradiological diagnosis and therapy of cerebral vasospasm after subarachnoid hemorrhage

“…Insight from meta-analyses, Cochrane reviews, and multinational registry databases should still be taken into consideration for standardization and large randomized studies should be performed 13 78 . However, the path to definitive evidence supporting EST is still long which can be attributed to the repeatedly sobering results of individual studies on this topic 79 80 . However, interdisciplinary guidelines on the standardization of diagnostic and treatment procedures would already be helpful now and, in our opinion, would be able to be implemented rather quickly.…”

“…Nach wie vor sollten für Vereinheitlichungen natürlich Erkenntnisse aus Metaanalysen, Cochrane Reviews und multinational gespeisten Registerdatenbanken Beachtung finden und groß angelegte randomisierte Studien angestrebt werden 13 78 . Der Weg hin zur Evidenz von EST ist aber weiterhin lang, was auch wiederkehrend ernüchternden Resultaten aus einzelnen Studien zu diesem Thema zuzuschreiben ist 79 80 . Interdisziplinär verzahnte Leitlinien zur Standardisierung von Diagnostik- und Therapieabläufen wären aber bereits jetzt hilfreich und unserer Ansicht nach eigentlich auch rasch umsetzbar.…”

Early and recurrent cerebral vasospasms after aneurysmal subarachnoid hemorrhage: The impact of age

“…However, whether endovascular therapies, such as intra-arterial infusion of nimodipine or balloon angioplasty are sufficient in reducing vasospasms and improving outcomes after aSAH remains debated. 23,24 Patients with relevant vasospasms or vasospasm-associated infarctions presented with worse functional outcome at follow-up. However, we observed no difference in functional outcomes between patients with early versus late vasospasms.…”

“…However, whether endovascular therapies, such as intra-arterial infusion of nimodipine or balloon angioplasty are sufficient in reducing vasospasms and improving outcomes after aSAH remains debated. 23 , 24 …”

Contemporary management of aneurysmal subarachnoid haemorrhage. An update for the intensivist

“…verapamil, nicardipine or milrinone) and/or balloon angioplasty may be considered when haemodynamic augmentation fails or is contraindicated [ 55 ]. There is no evidence supporting these interventions from phase 3 RCTs, although a recent small phase 2 RCT [ 56 ] showed worse outcomes in patients treated with endovascular rescue therapy than those treated with hypertension induction. Retrospective data suggest improved outcomes in centres offering endovascular intervention for DCI compared to those that do not [ 56 ].…”