TABLE 4.
Acute Procedural Success
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Definition of acute procedural success (endovascular and surgical): evidence of both acute technical success and absence of major adverse events (e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 h of the index procedure. | |||
Acute Technical Success | |||
Definition of acute technical success (endovascular and surgical): evidence of successful revascularization as presented in the following text. | |||
Endovascular revascularization | Angioplasty alone | ≤50% stenosis Absence of flow-limiting dissection or hemodynamically significant translesion gradient |
Confirmed by digital subtraction angiography and/or invasive pressure measurement demonstrating <10 mm Hg gradient |
Atherectomy alone | ≤50% stenosis Absence of flow-limiting dissection or hemodynamically significant translesion gradient |
Confirmed by digital subtraction angiography and/or invasive pressure measurement demonstrating <10 mm Hg gradient | |
Stent or stent graft | ≤30% stenosis Absence of flow-limiting dissection or hemodynamically significant translesion gradient |
Confirmed by digital subtraction angiography and/or invasive pressure measurement demonstrating <10 mm Hg gradient | |
Surgical revascularization | Endarterectomy | Patent native vessel on which operation was performed | Confirmed by at least 1 of the following: • Doppler examination • Digital subtraction angiography • Noninvasive hemodynamic measurement |
Bypass graft/conduit | Patent graft or conduit | Confirmed by at least 1 of the following: • Doppler examination • Digital subtraction angiography • Noninvasive hemodynamic measurement |
Applies to both patients with intermittent claudication/other exertional limb symptoms and patients with critical limb ischemia. Completion angiogram from common femoral artery to pedal/plantar arteries is recommended to exclude acute adverse events. Two angiographic, tangential views of the treated segment are recommended to define acute technical success. A focused examination of the index limb after sheath removal (endovascular) and skin closure (surgical), including pulse examination and presence/absence of Doppler signals, is also recommended. Definition of acute procedures success assumes that other previously defined safety endpoints such as major bleeding or acute renal failure would also be collected and assessed with regards to timing from the procedure.
PARC = Peripheral Academic Research Consortium.