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Table 1 Outcome definitions

From: Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients

Term Definition
Major bleeding Type 3 ((3a) bleeding with hemoglobin drop ≥ 3 and < 5 g/dL, or packed red cells transfusion; (3b) bleeding with hemoglobin drop ≥ 5 g/dL, heart tamponade, bleeding requiring surgical intervention or bleeding requiring intravenous inotropic drugs; (3c) intracranial hemorrhage; subcategories confirmed by autopsy, imaging examinations or lumbar puncture; intraocular bleeding with vision impairment) or type 5 bleeding ((5a) possibly fatal bleeding, (5b) definitive fatal bleeding), according to the Bleeding Academic Research Consortium definition [30].
Retroperitoneal hematoma Defined as building up of blood in the retroperitoneal space, caused by common femoral artery puncture above the inguinal ligament, not obtaining an adequate hemostasis with consequent hematoma formation. It is clinically manifested by dorsal, loin or inguinal pain, hypotension and/or hematocrit drop. Its diagnosis has to be confirmed by abdominal ultrasound and/or CT.
Compartment syndrome Defined as abnormal tissue pressure increase inside an osteo-fascial compartment (considering in this analysis the involvement of upper or lower limbs after arterial puncture), impairing nervous and muscular structure irrigation, characterized by paresthesia, continuous pain, hypoesthesia, edema and stiffening of the affected region, peaking with tissue necrosis and/or permanent functional injury if not adequately treated.
Hematoma Defined as localized collection of extravascular blood adjacent to the vessel, located in the topography of the punctured artery used to perform the procedure.
Pseudoaneurysm Defined as a neocavity delimited by tissues adjacent to the injured vessel, fed by continuous blood flow into and out, coming from the real lumen through a narrow neck connecting it to the inside of the cavity. Diagnosis is determined by the presence of a pulsating bulge close to the puncture hole and is confirmed by duplex scanning.
Arterio-venous fistula Defined as an abnormal and acquired communication between the arterial and venous surface caused by the inadvertent puncture of a vein adjacent to the femoral or radial artery. Diagnosis is determined by the presence of a continuous murmur or thrill at the puncture site and is confirmed by duplex scanning.
Infection Defined as the introduction and/or colonization of microorganisms in structures adjacent to the puncture site and/or blood flow, predisposed by difficult access, repeated punctures, long introducer stay, multiple catheters or a prolonged procedure. It is manifested by pain, hyperemia, local edema, adenopathy, fever and/or leukocytosis with a shift to the left in the blood count.
Limb ischemia Defined as the presence of signs and/or symptoms such as local pain, paresthesia, paresis, skin pallor, cyanosis, lack of pulse, cold extremities and/or muscle tenderness, caused by acute or sub-acute arterial occlusion and confirmed by duplex scanning and/or arteriography.
Asymptomatic arterial occlusion Defined by blockade of the arterial blood flow without manifestations of disturbance of the cell mechanism or insufficient tissue blood supply, not involving the terminal arterial segment (example: radial artery occlusion).
Adjacent nerve injury Defined by the presence of sensory and/or motor disorders in the limb through which the invasive coronary procedure was performed, with persistence of signs and/or symptoms for ≥ 24 hours, as a consequence of direct injury by inadvertent nerve puncture, excessive compression or extrinsic compression by a hematoma and/or a pseudoaneurysm.
Vascular surgical repair Defined by the presence of complications at the arterial puncture site requiring immediate or late (first 15 days) surgical intervention to prevent and/or minimize sequelae to the affected limb.