Total aortic arch replacement using a frozen elephant trunk device: Results of a 1-year US multicenter trial

Joseph S. Coselli, Eric E. Roselli, Ourania Preventza, S. Chris Malaisrie, Allan Stewart, Paul Stelzer, Hiroo Takayama, Edward P. Chen, Anthony L. Estrera, Thomas G. Gleason, Michael P. Fischbein, Leonard N. Girardi, Himanshu J. Patel, Joseph E. Bavaria, Scott A. LeMaire*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

Abstract

Objective: In this prospective US investigational device exemption trial, we assessed the safety and 1-year clinical outcomes of the Thoraflex Hybrid device (Terumo Aortic) for the frozen elephant trunk technique to repair the ascending aorta, aortic arch, and descending thoracic aorta. Methods: For the trial, which involved 12 US sites, 65 patients without rupture were recruited into the primary study group, and 9 patients were recruited into the rupture group. All patients underwent open surgical repair of the ascending aorta, aortic arch, and descending thoracic aorta in cases of aneurysm and/or dissection. The primary end point was freedom from major adverse events (MAE), defined as permanent stroke, permanent paraplegia/paraparesis, unanticipated aortic-related reoperation (excluding reoperation for bleeding), or all-cause mortality. Results: In the primary study group, 2 patients were lost to follow-up at 1 year. Freedom from MAE at 1 year was 81% (51/63). Seven patients (11%) died (including 2 before 30 days or discharge), 3 patients (5%) suffered permanent stroke, and 3 (5%) developed permanent paraplegia/paraparesis. Twenty-six patients (41%) underwent planned extension procedures, including 22 endovascular procedures within a median of 122 (interquartile range, 64-156) days. In the aortic rupture group, 2 patients were lost to follow-up at 1 year. Freedom from MAE at 1 year was 71% (5/7). One patient (14%) died, 2 patients (29%) had permanent stroke, and none had permanent paraplegia/paraparesis. No extension procedures were performed in the rupture group. Conclusions: One-year results with the Thoraflex Hybrid device are acceptable. Long-term data are necessary to assess the durability of these repairs.

Original languageEnglish (US)
Pages (from-to)1680-1692.e2
JournalJournal of Thoracic and Cardiovascular Surgery
Volume167
Issue number5
DOIs
StatePublished - May 2024

Keywords

  • aortic aneurysm
  • aortic arch (total)
  • aortic dissection
  • frozen elephant trunk
  • hybrid repair

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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