New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial
- 198 Downloads
Aneurysm recanalization constitutes a limitation in the endovascular treatment of intracranial aneurysms using conventional bare platinum coils. The development of platinum coils coupled with hydrogel polymers aimed at decreasing the rates of recurrence by way of enhanced coil packing density and biological healing within the aneurysm. While enhanced occlusion and durability has been shown for the first generation hydrogel coils, their use was limited by technical challenges. Less data is available regarding the second-generation hydrogel coils which have been designed to perform like bare platinum coils.
The new generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT) is a multicenter, randomized controlled trial that compares the health outcomes of the second-generation HydroCoil Embolic System with bare platinum coils in the endovascular intracranial aneurysms. The primary endpoint is aneurysm recurrence, defined as any progression on the Raymond aneurysm scale, over a 24-month follow-up period. Secondary endpoints include packing density, functional independence, procedural adverse events, mortality rate, initial complete occlusion, aneurysm retreatment, hemorrhage from treated aneurysm, and any aneurysm recurrence.
Patient recruitment initiated in June 2011 and ended in January 2016 in 46 centers. Six hundred eligible patients diagnosed with an intracranial aneurysm, ruptured or unruptured were randomly assigned to one of the two treatment arms.
The HEAT trial compares the durability, imaging, and clinical outcomes of the second-generation hydrogel versus bare platinum coils in the endovascular treatment of ruptured or unruptured intracranial aneurysms. The results of this trial may further inform current endovascular treatment guidelines based on observed long-term outcomes.
KeywordsIntracranial aneurysms Endovascular coils Hydrogel coil Bare platinum coil Subarachnoid hemorrhage
New generation Hydrogel Endovascular Aneurysm Treatment Trial
Bare platinum coil
Institutional review board
Electronic data capture
Procedure electronic case report form
Data and Safety Monitoring Board
Informed consent form
Compliance with ethical standards
The HEAT study was funded by MicroVention, Inc.
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
- 2.Molyneux A, Kerr R, International Subarachnoid Aneurysm Trial Collaborative G et al (2002) International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomized trial. J Stroke Cerebrovasc Dis 11(6):304–314CrossRefPubMedGoogle Scholar
- 4.Molyneux AJ, Kerr RS, Birks J, Ramzi N, Yarnold J, Sneade M, Rischmiller J, ISAT Collaborators (2009) Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the international subarachnoid aneurysm trial (ISAT): long-term follow-up. Lancet Neurol 8(5):427–433CrossRefPubMedPubMedCentralGoogle Scholar
- 6.Chalouhi N, Bovenzi CD, Thakkar V, Dressler J, Jabbour P, Starke RM, Teufack S, Gonzalez LF, Dalyai R, Dumont AS, Rosenwasser R, Tjoumakaris S (2014) Long-term catheter angiography after aneurysm coil therapy: results of 209 patients and predictors of delayed recurrence and retreatment. J Neurosurg 121(5):1102–1106CrossRefPubMedGoogle Scholar
- 8.White PM, Lewis SC, Nahser H, Sellar RJ, Goddard T, Gholkar A, on behalf of the HELPS Trial Collaboration (2008) HydroCoil endovascular aneurysm occlusion and packing study (HELPS trial): procedural safety and operator-assessed efficacy results. AJNR Am J Neuroradiol 29(2):217–223CrossRefPubMedGoogle Scholar
- 14.Gaba RC, Ansari SA, Roy SS, Marden FA, Viana MA, Malisch TW (2006) Embolization of intracranial aneurysms with hydrogel-coated coils versus inert platinum coils: effects on packing density, coil length and quantity, procedure performance, cost, length of hospital stay, and durability of therapy. Stroke 37(6):1443–1450CrossRefPubMedGoogle Scholar