Total aortic arch replacement using the Thoraflex Hybrid device: evolution from investigational to federally approved use in the United States.

Abstract

Background: After the US Food and Drug Administration (FDA) approved the Thoraflex Hybrid device in April 2022, hybrid devices to facilitate total arch replacement (TAR) became commercially available in the United States. However, little is known about how the Thoraflex device has been used since then. We present our experience (2016-2025) with this device.

Methods: At our practice, 62 patients [median age, 65 (54-73) years] underwent frozen elephant trunk (FET) TAR with the Thoraflex device: 14 under an investigational device exemption (IDE) (2016-2018) and 48 after FDA approval (2022-2025). Both Ante-Flo (straight) and Plexus (branched) models were used.

Results: Patients with aortic dissection were common (n=38; 61%). Many patients had prior open or endovascular aortic repair (n=28; 45%). Initial cannulation was commonly done via the innominate artery (n=30; 48%) or the right axillary artery (n=22; 36%). Both branched and island strategies were used to reattach the brachiocephalic arteries. Selectively, left subclavian artery (LSCA) bypass was performed before TAR in 18 patients (29%). The distal anastomosis was performed proximal to the LSCA in 27 repairs (43%). A short (10-cm) endograft extension was used in most cases (n=49; 79%). Eight (13%) patients underwent concomitant aortic root replacement. Overall, four patients (7%) had operative deaths, and three (5%) were discharged with stroke or persistent need for renal dialysis. Two patients had spinal cord deficits that resolved before discharge. Twenty-five downstream extensions (12 open, 13 endovascular) were needed in 22 patients; two patients underwent more than one repair. After discharge, seven additional patients died within one year of surgery.

Conclusions: TAR is a complex procedure. Patients requiring such repair tend to have substantial disease that often eventually necessitates subsequent downstream aortic repair, especially when dissection is present. Using the Thoraflex Hybrid device in TAR results in good early outcomes and provides a reliable base for extension.