TABLE 1.
Type of complication | Classification | Criteria |
---|---|---|
Bleeding | Life‐threatening or disabling bleeding |
Fatal bleeding (BARC type 5) OR Bleeding in a critical organ (BARC type 3b and 3c) OR Bleeding causing hypovolaemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR Overt source of bleeding with drop in haemoglobin ≥ 5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥ 4 unitsa (BARC type 3b) |
Major |
Overt bleeding either with haemoglobin drop of > 3.0 g/dl or requiring transfusion of two or three units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND Does not meet criteria of life‐threatening or disabling bleeding |
|
Minor | Any bleeding worthy of clinical mention (eg access site haematoma) that does not qualify as life‐threatening, disabling, or major | |
Vascular and access‐related | Major |
Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR Access site or access‐related vascular injury leading to death, life‐threatening or major bleeding, visceral ischaemia, or neurological impairment OR Distal embolization (non‐cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end‐organ damage OR The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment OR Any new ipsilateral lower extremity ischaemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR Surgery for access site‐related nerve injury OR Permanent access site‐related nerve injury |
Minor |
Access site or access‐related vascular injury not leading to death, life‐threatening or major bleeding, visceral ischaemia, or neurological impairment OR Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end‐organ damage OR Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication OR Vascular repair or the need for vascular repair |
Abbreviations: BARC, bleeding academic research consortium; RBC, red blood cell units.