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One-Year Results of a Low-Profile Endograft in Acute, Complicated Type B Aortic Dissection.

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Citation: Annals of Thoracic Surgery. 2023 Sep 26PMID: 37769702Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXED | Year: 2023 ISSN:

0003-4975

Name of journal: The Annals of thoracic surgeryAbstract: BACKGROUND: Safety and effectiveness of the RelayPro endograft was assessed for the treatment of acute, complicated Type B aortic dissection (TBAD).CONCLUSIONS: RelayPro is safe and effective in acute, complicated TBAD. Follow-up is ongoing to evaluate longer-term outcomes and durability. Copyright © 2023. Published by Elsevier Inc.METHODS: A prospective pivotal trial analyzed a primary endpoint of all-cause mortality at 30 days. Secondary endpoints include: technical success, major adverse events (disabling stroke, renal failure, paraplegia/paralysis), endoleaks, patency, rupture, device integrity, false lumen perfusion, reinterventions, aortic expansion, and migration evaluated to five years.RESULTS: The study involved 22 US centers and enrolled 56 patients (mean age, 59.5+/-11.4 years) from 2017-2021: 73.2% male, 53.6% African American. TBAD was complicated by malperfusion of the kidneys (51.8%), lower extremities (35.7%), 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 (5-12) days. All-cause mortality at 30 days was 1.8% (1/56, upper 95% CI 8.2%, P < .0001). Six subjects (10.7%) had 7 MAEs: 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 MAEs of 89.1% at each interval from 30 days to three years. There was one endoleak (Type Ia), two retrograde dissections, and two aortic diameter growth. There have been no ruptures, fistula, component separation, patency loss, stenosis, kinking, twisting, bird beak, loss of device integrity, or fracture.All authors: Rossi PJ, Desai ND, Malaisrie SC, Lyden SP, Nassiri N, Reece TB, Adams JD, Moanie SL, Shults CCFiscal year: FY2024 Digital Object Identifier:

https://dx.doi.org/10.1016/j.athoracsur.2023.08.035

Date added to catalog: 2023-12-20

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Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	37769702	Available		37769702

BACKGROUND: Safety and effectiveness of the RelayPro endograft was assessed for the treatment of acute, complicated Type B aortic dissection (TBAD).

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

RESULTS: The study involved 22 US centers and enrolled 56 patients (mean age, 59.5+/-11.4 years) from 2017-2021: 73.2% male, 53.6% African American. TBAD was complicated by malperfusion of the kidneys (51.8%), lower extremities (35.7%), 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 (5-12) days. All-cause mortality at 30 days was 1.8% (1/56, upper 95% CI 8.2%, P < .0001). Six subjects (10.7%) had 7 MAEs: 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 MAEs of 89.1% at each interval from 30 days to three years. There was one endoleak (Type Ia), two retrograde dissections, and two aortic diameter growth. There have been no ruptures, fistula, component separation, patency loss, stenosis, kinking, twisting, bird beak, loss of device integrity, or fracture.

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