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.

Keywords: Aortic aneurysm; aortic dissection; frozen elephant trunk (FET); total arch replacement (TAR); transverse aortic arch.

Figure 1

Illustration of total aortic arch replacement using the Thoraflex Hybrid Plexus (branched) device, manufactured by Terumo Aortic. (A) An extensive aneurysm spans the ascending aorta, aortic arch, and descending thoracic aorta. (B) The right axillary artery is cannulated, and antegrade cerebral perfusion is aided by inserting a balloon perfusion catheter into the left common carotid artery. The aorta is transected at the sinotubular junction and distal to the left subclavian artery. A guidewire is advanced retrograde via the femoral artery and manually retrieved through the transected descending thoracic aorta. The Thoraflex device is threaded onto the guidewire and advanced antegrade into the descending thoracic aorta. (C) After the endograft is deployed, the delivery system is removed. Incorporating the device collar and residual native aorta completes the distal anastomosis, which secures the endograft portion and prevents migration. The brachiocephalic arteries are incorporated into the non-stented graft portion of the device with graft bypass using the branched Plexus model or by island reattachment using the Ante-Flo model (inset). The proximal anastomosis is completed at the level of the sinotubular junction unless additional patient-specific repair is needed. Supplemental perfusion is provided through a side branch while the brachiocephalic arteries are incorporated into the repair. (D) Although the total arch replacement repair (stage 1) is complete, additional repair to address the descending thoracic aorta is needed. Inset: In some patients, definitive repair in a single stage is possible. (E) After a variable period of recovery, an endovascular completion (stage 2) repair is performed. Commonly, one or more stent-grafts are advanced retrograde via the femoral artery. Stent-grafts are recommended to overlap the Thoraflex by 4 cm whenever possible. Used with permission of Baylor College of Medicine.

Figure 2

In advance of total aortic arch replacement, the left subclavian artery can be accessed through a minimal supraclavicular incision. The artery is exposed and bypassed to the left common carotid artery in a side-to-side fashion. An alternate approach (not shown) involves transposing native arteries rather than bypass grafting. Used with permission of Baylor College of Medicine.

Figure 3

Surgical photograph of the proximal anastomosis during a completion Crawford extent II thoracoabdominal aortic aneurysm repair. Here, the distal edge of the Thoraflex device (circle) used in a prior frozen elephant trunk repair is directly incorporated into the open replacement graft (star). A band of felt (triangle) provides additional support. Used with permission of Baylor College of Medicine.