The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil-Reference-Cited by-同舟云学术

The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil

Published:2020-02-17 Issue:5 Volume:86 Page:615-624
ISSN:0148-396X
Container-title:Neurosurgery
language:en
Short-container-title:

Author:

Bendok Bernard R¹²³⁴⁵^ORCID,Abi-Aad Karl R¹⁴⁵,Ward Jennifer D⁶,Kniss Jason F⁶,Kwasny Mary J⁷,Rahme Rudy J⁶,Aoun Salah G⁸,El Ahmadieh Tarek Y⁸,El Tecle Najib E⁹,Zammar Samer G¹⁰,Aoun Rami James N¹¹,Patra Devi P¹⁴⁵,Ansari Sameer A¹²,Raymond Jean¹³,Woo Henry H¹⁴,Fiorella David¹⁵,Dabus Guilherme¹⁶,Milot Genevieve¹⁷,Delgado Almandoz Josser E¹⁸,Scott John A¹⁹,DeNardo Andrew J¹⁹,Dashti Shervin R²⁰, ,Ansari Sameer²¹,Deshaies Eric²²,Lavine Sean²³,Bozorgchami Hormozd²⁴,Delgado Josser²⁵,Veznedaroglu Erol²⁶,Albuquerque Felipe²⁷,Fiorella David²⁸,Boulos Alan²⁹,Cortes Maria³⁰,Kanaan Hilal³¹,Jindal Gaurav³²,Klucznik Richard³³,Dabus Guilherme³⁴,Kalmes David³⁵,Tawk Rabih³⁶,Raymond Jean³⁷,Romero Charles³⁸,Xavier Andrew³⁹,Hussain Muhammad⁴⁰,Kelly Michael⁴¹,Moran Christopher⁴²,Chaudry Imran⁴³,Pandey Aditya⁴⁴,Wang Dennis⁴⁵,van Adel Brian⁴⁶,Milot Genevieve⁴⁷,Hirsch Joshua⁴⁸,Carpenter Jeffrey⁴⁹,Powers Ciaran⁵⁰,Jabbour Pascal⁵¹,Luh George⁵²,Shankar Jai⁵³,Tummala Ramanchandra⁵⁴,Patsalides Athos⁵⁵,Evans Avery⁵⁶,Garg Ankur⁵⁷,Dashti Shervin⁵⁸,Lee Sung⁵⁹,James Roberts⁶⁰,Jayaraman Mahesh⁶¹,Satti Sudhakar⁶²,Sauvageau Eric⁶³,Fields Jeremy⁶⁴,Grobelny Thomas⁶⁵,Hartman Johnathan⁶⁶

Affiliation:

1. Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona

2. Department of Otolaryngology, Mayo Clinic, Phoenix, Arizona

3. Department of Radiology, Mayo Clinic, Phoenix, Arizona

4. Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, Arizona

5. Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, Arizona

6. Department of Neurological Surgery, Northwestern University, Chicago, Illinois

7. Department of Preventive Medicine, Feinberg School of Medicine, Chicago, Illinois

8. Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas

9. Department of Neurological Surgery, Saint Louis University Hospital, St. Louis, Missouri

10. Department of Neurological Surgery, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania

11. Department of General Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio

12. Department of Radiology, Northwestern University, Chicago, Illinois

13. Laboratoire de Neuroradiologie Interventionnelle, Université de Montréal, Montreal, Canada

14. Department of Neurological Surgery, North Shore University Hospital, Manhasset, New York

15. Department of Radiology, Stony Brook University Hospital, Stony Brook, New York

16. Interventional Neuroradiology and Neuroendovascular Surgery, Miami Cardiac and Vascular Institute, Miami, Florida

17. Département de Chirurgie, CHU de Quebec, Quebec City, Canada

18. Department of Neurointerventional Radiology, Abbott Northwestern Hospital, Minneapolis, Minnesota

19. Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana

20. Department of Neurological Surgery Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky

21. Northwestern University, Chicago, Illinois

22. SUNY Upstate Medical University, Syracuse, New York

23. Columbia University, New York, New York

24. Oregon Health & Science University, Portland, Oregon

25. Abbott Northwestern/Consulting Radiologists, Inc, Minneapolis, Minnesota

26. Capital Health Regional Medical Center, Trenton, New Jersey

27. St. Joseph's Hospital, Phoenix, Arizona

28. SUNY, Stony Brook, New York

29. Albany Medical College, Albany, New York

30. McGill University, Montreal, Canada

31. East Carolina University, Greenville, North Carolina

32. University of Maryland, Baltimore, Maryland

33. Methodist Hospital Research Institute, Houston, Texas

34. Baptist Health of Miami, Miami, Florida

35. Mayo Clinic, Rochester, New York

36. Mayo Clinic, Jacksonville, Florida

37. CHUM Research Centre, Montreal, Canada

38. UPMC Hamot, Erie, Pennsylvania

39. McLaren Flint/Wayne State University, Flint, Michigan

40. Cleveland Clinic, Cleveland, Ohio

41. University of Saskatchewan, Saskatoon, Canada

42. Washington University, St. Louis, Missouri

43. Medical University of South Carolina, Charleston, South Carolina

44. University of Michigan, Ann Arbor, Michigan

45. MultiCare Health System, Tacoma, Washington

46. Hamilton Health/McMaster University, Hamilton, Canada

47. CHU de Quebec, Quebec, Canada

48. Massachusetts General Hospital, Boston, Massachusetts

49. West Virginia University, Morgantown, West Virginia

50. Ohio State University, Columbus, Ohio

51. Thomas Jefferson University, Philadelphia, Pennsylvania

52. Mercy General Hospital, Sacramento, California

53. Dalhousie University, Halifax, Canada

54. University of Minnesota, Minneapolis, Minnesota

55. Weill Medical College of Cornell University, New York, New York

56. University of Virginia, Charlottesville, Virginia

57. Oklahoma University, Oklahoma City, Oklahoma

58. Norton Healthcare, Louisville, Kentucky

59. Queens Medical Center, Honolulu, Hawaii

60. University of Louisville, Louisville, Kentucky

61. Rhode Island Hospital, Providence, Rhode Island

62. Christiana Hospital, Newark, New Jersey

63. Lyerly Neurosurgery, Jacksonville, Florida

64. Kaiser Permanente, Clackamas, Oregon

65. Advocate Health, Park Ridge, Illinois

66. Kaiser Permanente, Sacramento, California

Abstract

Abstract BACKGROUND Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm. OBJECTIVE To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT). METHODS HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up. RESULTS A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms. CONCLUSION Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms. Video Abstract

Funder

Northwestern University

Mayo Clinic

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Clinical Neurology,Surgery

Link

http://academic.oup.com/neurosurgery/article-pdf/86/5/615/33040150/nyaa006.pdf

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