Commercial hybrid graft versus traditional arch replacement with frozen elephant trunk: A multi-institutional comparison.

Objective: Traditional total arch replacement with frozen elephant trunk requires 2 separate grafts in the descending thoracic aorta and arch, and frequently requires a graft-to-graft anastomosis, which is prone to bleeding. The Thoraflex (Terumo Aortic) device treats the arch and descending thoracic aorta in a single device but has not been compared directly to traditional total arch replacement with frozen elephant trunk and has not been studied in a real-world context in the United States.

Methods: A consecutive sample of total arch replacement with frozen elephant trunk patients across 5 different institutions between January 2018 and January 2024, identified 438 patients of which 83 out of 438 (18.9%) had a Thoraflex device. Propensity score matching in a 1:2 ratio identified 166 well-matched controls. Groups were compared across perioperative outcomes.

Results: One hundred forty out of 438 (32%) patients presented with acute type A dissection, 112 out of 438 (26%) had an aneurysm, and 87 out of 438 (20%) had chronic dissection with a previous proximal repair. One hundred thirty-two out of 438 (30%) underwent surgery on an emergency or emergency/salvage basis. Median (interquartile range [IQR]) crossclamp times in the Thoraflex and traditional matched groups were 71 (IQR, 48-105) and 82 (IQR, 62-123), respectively, ( = .012). Total circulatory arrest times were 19 minutes (IQR, 13-32 minutes) and 23 minutes (IQR, 17-37 minutes), respectively ( = .009). Total procedure times were 6.1 hours (IQR, 5.2-7.3 hours) and 6.8 hours (IQR, 5.7-8.2 hours), respectively ( = .012). The operative mortality, stroke, and paralysis rates were 11 out of 83 (13%), 16 out of 83 (19%), and 4 out of 83 (5%), respectively, in the Thoraflex group and were not significantly different than matched controls.

Conclusions: The Thoraflex hybrid device facilitates shorter crossclamp and circulatory arrest times for arch replacement, with similar observed mortality and stroke rates compared with matched controls.