Faculty Collaboration Database

One-Year Results of a Low-Profile Endograft in Acute, Complicated Type B Aortic Dissection. Ann Thorac Surg 2024 Feb;117(2):336-343

Date

09/29/2023

Pubmed ID

37769702

DOI

10.1016/j.athoracsur.2023.08.035

Scopus ID

2-s2.0-85175354472 (requires institutional sign-in at Scopus site)   2 Citations

Abstract

BACKGROUND: The safety and effectiveness of the RelayPro endograft (Terumo Aortic) was assessed for the treatment of acute, complicated type B aortic dissection (TBAD).

METHODS: A prospective pivotal trial analyzed a primary end point of all-cause mortality at 30 days. Secondary end points included technical success, major adverse events (disabling stroke, renal failure, and paraplegia/paralysis), endoleaks, patency, rupture, device integrity, false lumen perfusion, reinterventions, aortic expansion, and migration evaluated to 5 years.

RESULTS: The study involved 22 United States centers and enrolled 56 patients (mean age, 59.5 ± 11.4 years) from 2017 to 2021; of whom, 73.2% were men and 53.6% were African American. TBAD was complicated by malperfusion of the kidneys (51.8%), lower extremities (35.7%), and viscera (33.9%), and rupture (10.7%). Dissection extended proximally to zones 1/2 (14.3%) and zone 3 (78.6%) and distally to the iliac arteries (67.3%). Most procedures were percutaneous (85.5%). Technical success was 100%. Median hospitalization was 7 days (interquartile range, 5-12 days). All-cause mortality at 30 days was 1.8% (1 of 56; upper 95% CI, 8.2%; P < .0001). Seven major adverse events occurred in 6 patients (10.7%), consisting of paraplegia (n = 3), paraparesis (n = 2), disabling stroke (n = 1), and renal failure (n = 1). All paraplegia/paraparesis resolved with lumbar drainage. Kaplan-Meier analysis estimated a freedom from major adverse events of 89.1% at each interval from 30 days to 3 years. There was 1 endoleak (Type Ia), 2 retrograde dissections, and aortic diameter growth occurred in 2. There has been no rupture, fistula, component separation, patency loss, stenosis, kinking, twisting, bird beak, loss of device integrity, or fracture.

CONCLUSIONS: RelayPro is safe and effective in acute, complicated TBAD. Follow-up is ongoing to evaluate longer-term outcomes and durability.

Author List

Rossi PJ, Desai ND, Malaisrie SC, Lyden SP, Nassiri N, Reece TB, Adams JD, Moanie SL, Shults CC, RelayPro-D Investigators

Author

Peter J. Rossi MD Chief, Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Aged
Aortic Aneurysm, Thoracic
Blood Vessel Prosthesis
Blood Vessel Prosthesis Implantation
Endoleak
Endovascular Procedures
Female
Humans
Male
Middle Aged
Paraparesis
Paraplegia
Prospective Studies
Renal Insufficiency
Retrospective Studies
Stents
Stroke
Treatment Outcome
United States