Clinical event adjudication: Peripheral arterial revascularization procedure

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Editors-in-Chief: C. Michael Gibson, M.S., M.D. [1]

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Peripheral arterial revascularization procedure

This chapter presents peripheral arterial revascularization procedure definitions used in the Clinical Event Committee adjudication processes. These definitions are current as of 3/26/10.

1. Definition of Peripheral Arterial Revascularization Procedure

A peripheral arterial revascularization procedure is a catheter-based or open surgical procedure designed to improve peripheral arterial blood flow. This procedure may include thrombectomy, embolectomy, aneurysm/dissection repair, angioplasty, and stent placement.
The intention to perform percutaneous peripheral arterial intervention is denoted by the insertion of a guidewire through a guide catheter into a peripheral artery.
The target vessel(s) should be specified (e.g., carotid, vertebral, aorta, renal, iliac, femoral) and recorded as well as the type of revascularization procedure (e.g., surgical, angioplasty, stent placement, thromboembolectomy, aneurysm repair).

2. Procedural Success

In the case of percutaneous intervention for obstructive lesions, procedural success is defined as the achievement of a final residual diameter stenosis < 30% by angiography at the end of the procedure without any in-hospital major adverse events (death, acute onset of limb ischemia, need for urgent/emergent vascular surgery). The balloon inflation and/or stent placement may be preceded by device activation (e.g., angiojet, directional or rotational atherectomy, lasers).

3. Elective and Non-elective Procedures

Elective: An elective procedure is one that is scheduled and is performed on a patient with stable peripheral arterial disease.

Non-elective: A non-elective procedure is one that is performed immediately upon diagnosis because of urgency of the medical condition (e.g., acute limb ischemia, acute stroke, acute aortic dissection, acute aneurysm rupture).

4. Target Vessel

A target vessel is any vessel (e.g., carotid, peripheral artery, mesenteric/renal artery) that contains the target lesion treated with the study device. The target vessel includes the target lesion as well as segments of the vessel that are upstream and downstream to the target lesion, including side branches (native vessel).

5. Non-target Vessel

A non-target vessel is one for which revascularization is not attempted or one is which revascularization is performed using a non-study device.

References

1. ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine, Circulation, 2007, 116:803-877.
   
2. Campeau L, Grading of angina pectoris (letter), Circulation, 1976, 54:522-23.
   
3. Cutlip DE, S Windecker, R Mehran, A Boam, DJ Cohen, G-A van Es, PG Steg, M-A Morel, L Mauri, P Vranckx, E McFadden, A Lansky, M Hamon, MW Krucoff, PW Serruys and on behalf of the Academic Research Consortium, Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions, Circulation, 2007, 115:2344-2351.
   
4. Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL; Definition and Evaluation of Transient Ischemic Attack, A Scientific Statement for Healthcare Professionals from the American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease, Stroke, 2009 Jun; 40(6):2276-93. Epub 2009 May 7. Review.
   
5. Thygesen, Kristian, Alpert JS, White HD on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal Definition of Myocardial Infarction, Circulation, 2007, 116:1-20.

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