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

Abstract

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, (P = .012). Total circulatory arrest times were 19 minutes (IQR, 13-32 minutes) and 23 minutes (IQR, 17-37 minutes), respectively (P = .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 (P = .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.

Keywords: aorta; aortic arch; frozen elephant trunk.

Graphical abstract

The commercial Thoraflex (Terumo Aortic) hybrid graft shortens crossclamp and circulatory arrest times.

Figure 1

Thoraflex (Terumo Aortic) device utilization in the western United States over time (Food and Drug Administration approval: April 2022).

Figure 2

Boxplots of aortic crossclamp time, total circulatory arrest time, total procedure time, and operating room time in matched patients undergoing total arch replacement with frozen elephant trunk utilizing the Thoraflex (Terumo Aortic) device compared with traditional techniques. Middle line represents median (labeled), box limits represent first and third quartiles, and whiskers represent minimum and maximum values (excluding outliers).

Figure 3

Graphical abstract.

Figure 4

Boxplots of aortic crossclamp time, total circulatory arrest time, total procedure time, and operating room time in unmatched patients undergoing total arch replacement with frozen elephant trunk utilizing the Thoraflex (Terumo Aortic) device compared with traditional techniques. Middle line represents median (labeled), box limits represent first and third quartiles, and whiskers represent minimum and maximum values (excluding outliers).

Figure E1

Love plot of propensity score matching model demonstrating covariate balance. ∗indicates variables for which the displayed value is the raw (unstandardized) difference in means.