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New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial

  • Interventional Neuroradiology
  • Published:
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Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.

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Abbreviations

HEAT:

New generation Hydrogel Endovascular Aneurysm Treatment Trial

BPC:

Bare platinum coil

HC1:

First-generation HydroCoil

IRB:

Institutional review board

EDC:

Electronic data capture

eCRF:

Procedure electronic case report form

DSMB:

Data and Safety Monitoring Board

ICF:

Informed consent form

References

  1. Guglielmi G, Vinuela F, Duckwiler G et al (1992) Endovascular treatment of posterior circulation aneurysms by electrothrombosis using electrically detachable coils. J Neurosurg 77(4):515–524

    Article  CAS  PubMed  Google Scholar 

  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):304–314

    Article  PubMed  Google Scholar 

  3. Byrne JV, Sohn MJ, Molyneux AJ, Chir B (1999) Five-year experience in using coil embolization for ruptured intracranial aneurysms: outcomes and incidence of late rebleeding. J Neurosurg 90(4):656–663

    Article  CAS  PubMed  Google 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):427–433

    Article  PubMed  PubMed Central  Google Scholar 

  5. Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D (2003) Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke 34(6):1398–1403

    Article  PubMed  Google 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):1102–1106

    Article  PubMed  Google Scholar 

  7. Cognard C, Weill A, Castaings L, Rey A, Moret J (1998) Intracranial berry aneurysms: angiographic and clinical results after endovascular treatment. Radiology 206(2):499–510

    Article  CAS  PubMed  Google 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):217–223

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Kallmes DF, Fujiwara NH (2002) New expandable hydrogel-platinum coil hybrid device for aneurysm embolization. AJNR Am J Neuroradiol 23(9):1580–1588

    PubMed  PubMed Central  Google Scholar 

  10. Yoshino Y, Niimi Y, Song JK, Silane M, Berenstein A (2004) Endovascular treatment of intracranial aneurysms: comparative evaluation in a terminal bifurcation aneurysm model in dogs. J Neurosurg 101(6):996–1003

    Article  PubMed  Google Scholar 

  11. Reinges MH, Krings T, Drexler AY et al (2010) Bare, bio-active and hydrogel-coated coils for endovascular treatment of experimentally induced aneurysms. Long-term histological and scanning electron microscopy results. Interv Neuroradiol 16(2):139–150

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Zhang C, Chaudhary N, Gemmete JJ, Thompson BG, Xi G, Pandey AS (2014) Reactive tissue proliferation and damage of elastic lamina caused by hydrogel coated coils in experimental rat aneurysms. J Neurointerv Surg 6(6):480–486

    Article  PubMed  Google Scholar 

  13. Fanning NF, Berentei Z, Brennan PR, Thornton J (2007) HydroCoil as an adjuvant to bare platinum coil treatment of 100 cerebral aneurysms. Neuroradiology 49(2):139–148

    Article  PubMed  Google 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):1443–1450

    Article  PubMed  Google Scholar 

  15. Khan SH, Nichols C, Depowell JJ, Abruzzo TA, Ringer AJ (2012) Comparison of coil types in aneurysm recurrence. Clin Neurol Neurosurg 114(1):12–16

    Article  PubMed  Google Scholar 

  16. White PM, Lewis SC, Gholkar A, Sellar RJ, Nahser H, Cognard C, Forrester L, Wardlaw JM (2011) Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial. Lancet 377(9778):1655–1662

    Article  CAS  PubMed  Google Scholar 

  17. Killer M, Kallmes D, Jones R, Ding Y, Vestal M, Hauser T, Virmani R, Cruise G (2010) Long-term angiographic and histological results of a new hydrogel-containing filling coil in experimental rabbit aneurysms. Minim Invasive Neurosurg 53(3):97–105

    Article  CAS  PubMed  Google Scholar 

  18. Tsumoto T, Niimi Y, Berenstein A (2009) Evaluation of the new HydroSoft coil in a canine model of bifurcation aneurysm. Laboratory investigation. J Neurosurg 111(1):11–16

    Article  PubMed  Google Scholar 

  19. Park JH, Kang HS, Han MH, Jeon P, Yoo DS, Lee TH, for the Korean HydroSoft Registry Investigators (2011) Embolization of intracranial aneurysms with HydroSoft coils: results of the Korean multicenter study. AJNR Am J Neuroradiol 32(9):1756–1761

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. Guo XB, Fan YM, Zhang JN (2011) HydroSoft coil versus HydroCoil for endovascular aneurysm occlusion study: a single center experience. Eur J Radiol 79(2):e42–e46

    Article  PubMed  Google Scholar 

  21. Meyers PM, Schumacher HC, Higashida RT, Derdeyn CP, Nesbit GM, Sacks D, Wechsler LR, Bederson JB, Lavine SD, Rasmussen P (2010) Reporting standards for endovascular repair of saccular intracranial cerebral aneurysms. AJNR Am J Neuroradiol 31(1):E12–E24

    CAS  PubMed  PubMed Central  Google Scholar 

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Authors and Affiliations

  1. Department of Neurological Surgery, Mayo Clinic, 5777 E Mayo Boulevard, Phoenix, AZ, 85054, USA

    Karl R. Abi-Aad, Mithun G. Sattur, Matthew E. Welz & Bernard R. Bendok

  2. Department of General Surgery, Cleveland Clinic, Cleveland, OH, USA

    Rami James N. Aoun

  3. Department of Neurological Surgery, Northwestern University, Chicago, IL, USA

    Rudy J. Rahme, Jennifer D. Ward & Jason Kniss

  4. Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Mary Jeanne Kwasny

Authors
  1. Karl R. Abi-Aad
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  2. Rami James N. Aoun
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  3. Rudy J. Rahme
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  4. Jennifer D. Ward
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  5. Jason Kniss
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  6. Mary Jeanne Kwasny
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  7. Mithun G. Sattur
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  8. Matthew E. Welz
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  9. Bernard R. Bendok
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Corresponding author

Correspondence to Bernard R. Bendok.

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Funding

The HEAT study was funded by MicroVention, Inc.

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

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

Informed consent was obtained from all individual participants included in the study.

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Abi-Aad, K.R., Aoun, R.J.N., Rahme, R.J. et al. New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial. Neuroradiology 60, 1075–1084 (2018). https://doi.org/10.1007/s00234-018-2074-5

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  • DOI: https://doi.org/10.1007/s00234-018-2074-5

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