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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 336-343 |
| Number of pages | 8 |
| Journal | Annals of Thoracic Surgery |
| Volume | 117 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2024 |
Funding
All authors were principal investigators in the study and as such received research grants to conduct the study. This study was sponsored by Bolton Medical Inc (Terumo Aortic). The authors wish to thank Katie Taggart, Valerie DePetrillo, and Patrick Bohan of Terumo Aortic. RelayPro-D Investigators: Prashanth Vallabhajosyula, MD,1 Jean Panneton, MD,2 Norman Kumins, MD,3 Melhem Sharafuddin, MD,4 Shahab Toursavadkohi, MD,5 Brant Ullery, MD,6 Yazan Duwayri, MD,7 Sukgu Han, MD,8 Saum Rahimi, MD,9 Robert Meisner, MD,10 Maciej Dryjski, MD,11 Benjamin Starnes, MD,12 Shinchi Fukuhara, MD,13 and Mohiuddin Cheema, MD14, 1Division of Cardiac Surgery, Department of Surgery, Aortic Institute, Yale School of Medicine, New Haven, Connecticut; 2Division of Vascular Surgery, Sentara Vascular Specialists, Norfolk, Virginia; 3Department of Vascular Surgery, The Heart and Vascular Institute, University Hospitals, Cleveland, Ohio; 4Division of Vascular Surgery, University of Iowa Hospital and Clinic, Iowa City, Iowa; 5Division of Vascular Surgery, Department of Surgery, University of Maryland Medical Center, Baltimore, Maryland; 6Center for Cardiovascular Analytics, Research and Data Science (CARDS), Providence Heart Institute, Portland, Oregon; 7Division of Vascular Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia; 8Division of Vascular Surgery and Endovascular Therapy, Aortic Center, Keck Medical Center of University of Southern California, Los Angeles, California; 9Division of Vascular Surgery and Endovascular Therapy, Rutgers Robert Wood Johnson Medical Center, Rutgers University, New Brunswick, New Jersey; 10Department of Surgery, Lankenau Medical Center, Wynnewood, Pennsylvania; 11Department of Vascular Surgery, University at Buffalo, Buffalo General, Buffalo, New York; 12Division of Vascular Surgery, Department of Surgery, Harborview Medical Center, Seattle, Washington; 13Cardiac Surgery Clinic, Frankel Cardiovascular Center, University of Michigan Health, Ann Arbor, Michigan; and 14Department of Surgery, Hartford Hospital, Hartford, Connecticut, All authors were principal investigators in the study and as such received research grants to conduct the study. This study was sponsored by Bolton Medical Inc (Terumo Aortic). Peter J. Rossi, Nimesh D. Desai, S. Chris Malaisrie, Sean P. Lyden, Naiem Nassiri, T. Brett Reece, Joshua D. Adams, Sina L. Moanie, Edward Y. Woo, and Christian C. Shults report financial support was provided by Terumo Aortic. Peter J. Rossi reports a relationship with Terumo Aortic that includes: consulting or advisory. In addition to Peter Rossi, consulting fees were paid to the following authors by Terumo Aortic over the last 3 years: Nimesh Desai, S. Chris Malaisrie, Naiem Nassiri, T. Brett Reece, Joshua D. Adams, and Edward Y. Woo.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Pulmonary and Respiratory Medicine
- Surgery