June 5, 2012
The National Heart, Lung and Blood Institute (NHLBI) convened this multi-disciplinary Working Group (WG) to encourage a broad-based discussion about gaps in knowledge of best clinical practices for surgical and endovascular treatment of peripheral vascular disease (PVD). The primary goals were to seek consensus on PVD research priorities and identify research challenges. Experts in vascular surgery, interventional cardiology, interventional radiology, and vascular medicine were invited to participate. Comments were also broadly solicited in advance of the meeting from membership of several professional organizations including the Society for Vascular Surgery, the Society of Interventional Radiology, the Society of Vascular Medicine, the Council on PVD of the American Heart Association, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions. The NHLBI viewed this WG as a step toward increased collaborative design and conduct of studies that could potentially improve decision-making and outcomes for patients with PVD. The WG addresses NHLBI Strategic Goals 2 & 3.
PVD, defined as non-coronary arterial and venous disease, includes common disorders such as atherosclerotic occlusive disease, aneurysm, and venous thromboembolism (VTE) that are responsible for substantial disability and mortality, as well as high healthcare costs. Treatment options for vascular repair and revascularization in the peripheral circulation include many permutations of surgical and catheter-based endovascular procedures, provided in conjunction with medical therapy. In view of the fact that several different specialists routinely perform endovascular interventions for PVD, collaborative research efforts across disciplines will best ensure agreement about clinical study design and feasibility of enrollment.
WG panel discussions were centered on identifying research priorities related to anatomic categories of PVD. They went on to highlight cross-cutting themes that impact multiple PVD areas, including risk stratification methods, study design issues, and the need for a robust research infrastructure. The WG also identified specific research challenges affecting PVD research beyond those common to most clinical research. These included the lack of a strong culture or tradition in pursuing collaborative research; pressure to adopt new technology, often off-label, before clear evidence of long-term safety and superiority is available; and a lack of established criteria for operator competency.
Research Gaps and Challenges
Research priorities in each specific area were ranked by the WG after discussion of their expected clinical impact. General considerations for judging impact included magnitude of the clinical problem, limitations of current therapy, and opportunity for clinical benefit. Gap areas of highest priority are listed below:
- Infra-inguinal disease
- Study comparative effectiveness of anatomic versus non-anatomic treatments for lower extremity claudication. Build an evidence base to aid everyday clinical decisions.
- Determine optimal medical plus surgical/endovascular management for critical limb ischemia.
- Carotid disease
- Determine optimal management of asymptomatic carotid occlusive disease with a randomized controlled trial (RCT) that includes a medical management arm.
- Venous disease
- Find novel methods to improve physician and patient adherence to existing guidelines for prophylaxis of venous thromboembolism (VTE).
- Aorto-iliac disease
- Determine best surveillance methods and medical management for early abdominal aortic aneurysm.
- Renal and mesenteric disease
- Perform systematic data collection to better characterize fibromuscular dysplasia.
- Establish parameters that predict likelihood of renal salvage through renal artery revascularization in patients with severe renal artery stenosis.
- Collective PVD
- Strengthen basic understanding of vascular response to injury and treatment failure, e.g., restenosis.
- Define optimal medical management for PVD, both pre- and post-intervention.
The WG will develop a report of the meeting for publication in an appropriate peer-reviewed journal.
Working Group Members
- Elliot L. Chaikof, MD, PhD, Beth Israel Deaconess Medical Center, Chair
- Ronald M. Fairman, MD, Hospital of the University of Pennsylvania, Chair
- Gary Ansel, M.D., University of Toledo
- Richard Cambria, MD, Massachusetts General Hospital
- Kenneth J. Cavanaugh, Jr., PhD, Food and Drug Administration
- Daniel Clair, MD, Cleveland Clinic
- Michael S. Conte, MD, University of California, San Francisco
- Ronald Dalman, MD, Stanford University
- Matthew Edwards, MD, Wake Forest Baptist Medical Center
- Timothy J. Gardner, MD, Christiana Care Health System
- Elias A. Iliadis, MD, Cooper Heart Institute, NJ
- Melina Kibbe, MD, Northwestern University
- Larry W. Kraiss, MD, University of Utah
- Alan H. Matsumoto, MD, University of Virginia
- Mary McDermott, MD, Northwestern University
- Matthew T. Menard, MD, Brigham and Women's Hospital
- Jeffrey W. Olin, DO, Mount Sinai School of Medicine, NY
- Zorina Galis, PhD, Vascular Biology and Hypertension Branch (VBHB), Basic and Early Translational Research Program (BETR), Division of Cardiovascular Sciences (DCVS)
- Albert Lee, PhD, Advanced Technologies & Surgery Branch, BETR/DCVS
- Cheryl McDonald, MD, VBHB, BETR/DCVS
- Michele Olive, PhD, VBHB, BETR/DCVS and Atherothrombosis & Coronary Artery Disease Branch, DCVS
- Diane Reid, MD, VBHB, BETR/DCVS
- Jane Scott, ScD, MSN, Office of Research Training and Career Development, DCVS
- Eser Tolunay, PhD, VBHB, BETR/DCVS
Zorina Galis, PhD
Diane Reid, MD
Last Updated: August 2012