One-Year Results of Novel Aortic Arch Hybrid Prosthesis for Repair of Acute DeBakey Type I Dissection With Malperfusion: PERSEVERE Study

Wilson Y Szeto; Shinichi Fukuhara; Fernando Fleischman; Ibrahim Sultan; William Brinkman; George Arnaoutakis; Hiroo Takayama; Kyle Eudailey; Arminder Jassar; Michael C Moon; PERSEVERE Investigators

doi:10.1016/j.athoracsur.2025.10.036

One-Year Results of Novel Aortic Arch Hybrid Prosthesis for Repair of Acute DeBakey Type I Dissection With Malperfusion: PERSEVERE Study

Ann Thorac Surg. 2026 May;121(5):1069-1079. doi: 10.1016/j.athoracsur.2025.10.036. Epub 2025 Nov 12.

Authors

Collaborators

PERSEVERE Investigators:
John Frederick¹¹, Marc Moon¹², Patrick Vargo¹³, Bradley Leshnower¹⁴, Mohiuddin Cheema¹⁵, Basel Ramlawi¹⁶, Joseph DeRose¹⁷, Ismail El-Hamamsy¹⁸, Sanford Zeigler¹⁹, Derek Brinster²⁰, Chris Malaisrie²¹, Castigliano Bhamidipati²², Amelia Claire Watkins²³, Eric Jeng²⁴, Brett T Reece²⁵, Joshua Grimm²⁶, Puja Kachroo²⁷

Affiliations

¹ Division of Cardiovascular Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: wilson.szeto@pennmedicine.upenn.edu.
² Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan.
³ USC Cardiac and Vascular Institute, University of Southern California, Los Angeles, California.
⁴ Division of Cardiac Surgery, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
⁵ Cardiac Surgery Specialists, Thoracic Aortic Clinic, The Heart Hospital Baylor Plano, Plano, Texas.
⁶ Division of Cardiovascular and Thoracic Surgery, Dell Medical School, University of Texas at Austin, Austin, Texas.
⁷ Division of Cardiac, Thoracic, and Vascular Surgery, Columbia University, New York, New York.
⁸ Division of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama.
⁹ Division of Cardiac Surgery, Massachusetts General Hospital, Boston, Massachusetts.
¹⁰ Division of Cardiac Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.
¹¹ Atrium Health Sanger Heart & Vascular Institute Kenilworth, Charlotte, North Carolina.
¹² Baylor St. Luke's Medical Center, Houston, Texas.
¹³ Department of Cardiovascular Surgery Cleveland Clinic Foundation, Cleveland, Ohio.
¹⁴ Emory Heart & Vascular Center Atlanta, Georgia.
¹⁵ Hartford Hospital, Hartford, Connecticut.
¹⁶ Lankenau Medical Center, Wynnewood, Pennsylvania.
¹⁷ Montefiore Einstein, New York, New York.
¹⁸ Icahn School of Medicine at Mount Sinai, New York, New York.
¹⁹ Medical University of South Carolina.
²⁰ Lenox Hill Hospital, New York, New York.
²¹ Northwestern School of Medicine, Chicago, Illinois.
²² Oregon Health and Science University, Portland, Oregon.
²³ Stanford University, Stanford, California.
²⁴ University of Florida College of Medicine, Gainesville, Florida.
²⁵ University of Colorado School of Medicine, Aurora, Colorado.
²⁶ The University of Texas at Austin, Austin, Texas.
²⁷ Washington University, St Louis, Missouri.

PMID: 41238072
DOI: 10.1016/j.athoracsur.2025.10.036

Abstract

Background: High rates of major adverse events and negative aortic remodeling are common after hemiarch repair for acute DeBakey type I aortic dissection. The ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection (PERSEVERE; NCT05174767) study evaluated 1-year outcomes with the AMDS Hybrid Prosthesis i(Artivion, Inc) n patients with malperfusion.

Methods: PERSEVERE is a prospective, single arm study. Primary end point events of mortality, new disabling stroke, new renal failure requiring dialysis, myocardial infarction, and rate of distal anastomotic new entry (DANE) tears were assessed through 1 year. Reoperation, aortic patency, and changes in aortic remodeling, including total aortic growth, true lumen expansion, and false lumen thrombosis, were also reported.

Results: Of 93 enrolled patients, 63 (68%) completed 1-year follow-up, and 56 patients had a computed tomographic angiogram. Through 1 year, 19 (20%) patients died, 11 (12%) had new disabling strokes, 19 (20%) required dialysis, and 2 (2%) had a myocardial infarction; most events Occurred within 30 days. DANE was not documented in any postoperative computed tomographic angiograms. Freedom from unanticipated aortic reoperations and occlusion in the arch was 96% (89 of 93) and 100% (91 of 91), respectively. Freedom from total aortic growth at 1 year was 100% in zone 1, 98.2% in zone 2, and 73.2% in zone 3. In zones 1 to 3, true lumen expansion occurred in 96%, 94%, and 70% of patients, respectively. In zones 1 to 3, false lumen thrombosis occurred in 91%, 92%, and 88% of patients, respectively.

Conclusions: The 1-year outcomes with the AMDS Hybrid Prosthesis are encouraging, with lower than observed mortality, limited primary events after 30 days, and the absence of DANE. There is evidence of positive aortic remodeling. Follow-up is ongoing.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aorta, Thoracic* / diagnostic imaging
Aorta, Thoracic* / surgery
Aortic Aneurysm, Thoracic* / diagnostic imaging
Aortic Aneurysm, Thoracic* / mortality
Aortic Aneurysm, Thoracic* / surgery
Aortic Dissection* / diagnosis
Aortic Dissection* / diagnostic imaging
Aortic Dissection* / mortality
Aortic Dissection* / surgery
Blood Vessel Prosthesis Implantation* / methods
Blood Vessel Prosthesis*
Female
Follow-Up Studies
Humans
Male
Middle Aged
Postoperative Complications / epidemiology
Prospective Studies
Prosthesis Design
Time Factors
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT05174767

Grants and funding

Artivion, Inc