Surgical outcomes of the newly approved hybrid Thoraflex endoprosthesis in the United States: a multi-institutional experience

P0319 

Abstract Submission 

Markian Bojko (1), Wililam Oslund (1), Michael Kirsch (2), Emma Longo (1), Kamso Okonkwo (1), Nithya Rajeev (1), T. Brett Reece (3), Chris Burke (4), Jason Glotzbach (5), FERNANDO FLEISCHMAN (1)

(1) Division of Cardiac Surgery, Department of Surgery, University of Southern California, Los Angeles, CA, (2) University of Colorado, Aurora, CO, (3) University of Colorado Hospital, Aurora, CO, (4) University of Washington, Seattle, WA, (5) University of Utah, Salt Lake City, UT

Markian Bojko    -  Contact Me
Division of Cardiac Surgery, Department of Surgery, University of Southern California

Wililam Oslund    -  Contact Me
Division of Cardiac Surgery, Department of Surgery, University of Southern California

Michael Kirsch    -  Contact Me
University of Colorado

Emma Longo    -  Contact Me
Division of Cardiac Surgery, Department of Surgery, University of Southern California

Kamso Okonkwo    -  Contact Me
Division of Cardiac Surgery, Department of Surgery, University of Southern California

Nithya Rajeev    -  Contact Me
Division of Cardiac Surgery, Department of Surgery, University of Southern California

*T. Brett Reece    -  Contact Me
University of Colorado Hospital

Christopher Burke    -  Contact Me
University of Washington

Jason Glotzbach    -  Contact Me
University of Utah

*Fernando Fleischman    -  Contact Me
Division of Cardiac Surgery, Department of Surgery, University of Southern California

*Fernando Fleischman    -  Contact Me
Keck Medical Center of USC

Objective: Traditional techniques of total arch replacement (TAR) with frozen elephant trunk (FET) deployment require the use of two separate grafts for the arch and descending thoracic aorta. The newly approved hybrid Thoraflex endoprosthesis treats the arch and descending aorta with a single continuous device. This eliminates the need for a graft-to-graft anastomosis which is prone to bleeding and extends circulatory arrest time. Preliminary studies in Europe and Asia have demonstrated the safety and feasibility of the Thoraflex device with favorable early and midterm results. However, no such results have been published in the United States due to the novelty of its authorization and small numbers of patients at individual hospitals. By combining data from multiple institutions, this study aims to describe the early results of the Thoraflex device among a larger cohort of patients in the United States.
Methods: Each participating institution obtained STS data on patients undergoing TAR/FET using the Thoraflex device. Data were shared and merged into a single database. Categorical variables were summarized as count (percent) and numerical variables were summarized as median (interquartile range). Baseline characteristics, operative details, and postoperative outcomes were compared across different aortic pathologies.
Results: A total of 77 patients underwent Thoraflex implantation across four institutions, of which 23/77 (30%) had acute type A aortic dissections, 17/77 (22%) had aneurysms, 13/77 (17%) had type B dissections with arch pathology, and 24/77 (31%) had previous type A repair with residual dissections or aneurysmal degeneration (Table 1). The median age was 64 years old. 39/77 (51%) patients underwent a redo sternotomy after previous cardiac surgery, 26/77 (34%) had urgent operations, and 17/77 (22%) had emergent surgery. The median lowest temperature was 28 degrees Celsius, and the median circulatory arrest time was 19 minutes. The most common site of Thoraflex deployment was in zone 2 of the aortic arch in 51/77 (66%) patients. The most common stent diameter was 32mm, and the most common stent length was 15cm. Cardiopulmonary bypass time, cross clamp time, circulatory arrest time, and intraoperative transfusions were similar across aortic pathologies. The overall in-hospital or 30-day mortality rate was 9/77 (12%). 15/77 (20%) patients suffered a stroke, and 9/77 (12%) developed renal failure. Operative mortality and stroke rates were 7/23 (30%) and 9/23 (39%) respectively among patients undergoing acute type A aortic dissection repair and were significantly higher than in patients with other aortic pathologies (p=0.005, and p=0.042).
Conclusions: In this study, we present multi-institutional early "real world" Thoraflex results in the United States that will improve with additional volume and experience. This cohort of patients demonstrates that the Thoraflex is an effective device for TAR/FET procedures across multiple aortic pathologies. Patients who underwent Thoraflex implantation for acute type A aortic dissections had the highest morbidity and mortality rates compared to other surgical indications. Notably, there were no deaths even in emergent cases of type B and residual type A dissections. The mortality rate was acceptable given the acuity of patient presentations, and these outcomes compare similarly to published results of Thoraflex implantation outside the United States.

Aortic Arch