LB2. Relationship between Intimal Hyperplasia and Saphenous Vein Graft Disease: Insights from the Cardiothoracic Surgical Trials Network VEST Trial

Objective
Diffuse intimal hyperplasia (IH) and graft irregularity adversely affect long-term patency of saphenous vein grafts (SVG), and the clinical outcomes of patients undergoing CABG. Mitigation of IH may, therefore, result in improved long-term success of CABG surgery. The VEST trial, which evaluated the efficacy of external graft support demonstrated a trend toward lower IH at one year in supported vs unsupported SVGs (p=0.07) in the primary analysis. Among the subgroup of patients for whom both randomized SVGs were evaluable at 1 year, IH area was reduced in supported SVGs (p=0.04). Here, we explore the relationship between IH and graft disease, and their associations with clinical events.

Methods
VEST is a randomized, multicenter, within-subject controlled trial in which one of two SVGs was randomized to external vein graft support or no support in patients undergoing multi-vessel CABG. The trial enrolled 224 patients of which 203 were evaluated at 12 months. The primary endpoint was IH area assessed by intravascular ultrasound at one-year post-randomization for each study graft. Secondary endpoints included degree of lumen irregularity (Fitzgibbon classification) and graft failure (>50% stenosis), assessed by invasive angiography and quantitative coronary angiography, respectively. Major cardiac and cerebrovascular events (MACCE, including death, MI, stroke and SVG or target vessel revascularization) are being collected as part of a 5- year follow-up. We conducted descriptive analyses of the associations among IH area, graft disease and MACCE.

Results
Over a median follow-up of 3 years, we observed 70 events in 46 of 224 patients (event rate 0.115/pt/year; 95%CI: [0.084, 0.156]). Patients with perfect SVG uniformity (Fitzgibbon I; n=41/199 with readable images) in both supported and unsupported SVGs had a lower incidence of MACCE compared to those with Fitzgibbon II or III in at least one graft (12% vs 20%). Analogously, SVG failure (87/202) or graft occlusion (74/203) of either or both randomized SVGs was associated with a higher incidence of MACCE (11% vs 30%; 14% vs 30%, respectively). Correspondingly, larger IH area was associated with greater lumen irregularity, a higher degree of SVG stenosis and higher incidence of MACCE (Table 1). Ischemia-driven revascularization of randomized SVGs or respective coronary targets was proportionally higher in unsupported grafts (4.0% vs 2.7%), confirming safety of the external support device.

Conclusions
In this sub-analysis of the VEST trial, the largest randomized evaluation of an external SVG support device intended to limit IH, we observed an association between IH area and presence of SVG disease at 1 year post surgery. Moreover, more severe SVG disease and larger IH areas were associated with an increased incidence of 3-year MACCE. Ongoing follow up to 5 years will further clarify the potential impact of IH area reduction by an external SVG support device on long-term clinical outcomes of CABG.

Daniel Goldstein (1), John Alexander (2), Helena Chang (3), John Puskas (4), James Gammie (5), Mary Marks (3), Alexander Iribarne (6), Yuliya Vengrenyuk (7), Samantha Raymond (3), Bradley Taylor (8), Orit Yarden (9), Eyal Orion (9), Francois Dagenais (10), Gorav Ailawadi (11), Michael Chu (12), J. DiMaio (13), Jagat Narula (14), Ellen Moquete (3), Karen O'Sullivan (3), Judson Williams (15), Juan Crestanello (16), Eric Rose (3), Vincent Scavo (17), Michael Acker (18), Marc Gillinov (19), Michael, (1) MOntefiore Medical Center, Bronx, NY, (2) Duke University Medical Center, Durham, NC, (3) Icahn School of Medicine at Mount Sinai, New York, NY, (4) Mount SInai Morningside (St. Luke's), New York, NY, (5) Johns Hopkins Hospital, Stevenson, MD, (6) Dartmouth-Hitchcock Medical Center, Lebanon, NH, (7) Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai, New York, NY, (8) University of Maryland Medical Center, Baltimore, MD, (9) Vascular Graft Solutions, Ltd., Tel Aviv, none, (10) IUCPQ, Quebec, QC, (11) University of Michigan, Ann Arbor, MI, (12) University Hospital, London Health Sciences Centre, London, Canada, (13) The Heart Hospital Baylor Plano, Dallas, TX, (14) Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, NY, (15) WakeMed Health and Hospitals, Durham, NC, (16) Mayo Clinic, Rochester, MN, (17) Lutheran Medical Group, Fort Wayne, IN, (18) Hospital of the University of PA, Philadelphia, PA, (19) Cleveland Clinic, Cleveland, OH, (20) Baylor Scott & White The Heart Hospital Plano, Plano, TX, (21) Brigham and Women's Hospital, Boston, MA, (22) Quebec Heart and Lung Insitute, Quebec, Quebec

Derrick Tam

Invited Discussant

Derrick Tam is a minimally invasive robotic fellow at Cedars-Sinai Medical Center in Los Angeles

Daniel Goldstein

Abstract Presenter

Dr. Daniel Goldstein is an Alpha Omega Alpha graduate from the Mount Sinai School of Medicine in New York. He completed his General Surgery Residency and Cardiothoracic Surgery Fellowship at Columbia Presbyterian where he was recipient of multiple research and teaching awards. He is a Professor and Vice-Chairman of the Department of Cardiovascular and Thoracic Surgery and Surgical Director of the Cardiac Transplantation and Mechanical Assistance Programs at the Montefiore Medical Center and Albert Einstein School of Medicine in New York.

Dr. Goldstein is an internationally renowned surgeon. He has published over 200 manuscripts in peer review journals, including several in the the highest ranked journals in Medicine. He has been invited to speak in several countries and has been National Principal Investigator and Co-Investigator in several seminal clinical trials in cardiac surgery and mechanical support, including the seminal MOMENTUM 3 Clinical trial and the ongoing IMPACT trial.  He has served as Board Member of the International Society for Heart and Lung Transplantation and heads IMACS, the world's largest durable LVAD  registry. He has co-authored several book chapters and authored 4 books in Cardiac Surgery including the just released 2-volume compedium on Transplantation and Mechanical Support for End-Stage Heart and Lung Disease (Wiley Pub), the most comprehensive on the topic ever published.  He is a pianist, a magician and has appeared in a film based on one of his patients that was shown at the Tribeca Film Festival. Because of his efforts in educating the public about the Cvoid pandemic, he was elected as the #1 Top Voice for Healthcare on Linked In, a social platform with over 600 million users.

 

Specialties: Adult Cardiac, Coronary, Procedures, Treatment/Procedure/Operation/Surgery, Coronary Disease, CABG, Minimally Invasive, Robotics