Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique

Table 2 Bleeding and vascular adverse events according to the updated standardized endpoint from Valve Academic Research Consortium-2

Adverse events	n (%)	Adverse event description and management
Bleeding complications
Life-threatening bleeding (bleeding in a critical organ or causing hypovolemic shock or severe hypotension requiring vasopressors or surgery or overt source of bleeding with drop in hemoglobin ≥ 5 g/dL or transfusion ≥ 4 units)	0
Major bleeding (bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2-3 units, or causing hospitalization or permanent injury, or requiring surgery but does not meet criteria of life-threatening or disabling bleeding)	1 (6.7%)	1 patient requiring post-operative blood transfusion (2 units) without further bleeding source
Minor bleeding (any bleeding worthy of clinical mention that does not qualify as life-threatening, disabling, or major)	0
Vascular complications
Major vascular complications	0
Minor vascular complications	2 (13.3%)
Access site or access-related vascular injury (not leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment)	2 (13.3%)	Two femoral artery non-occlusive dissections successfully treated by balloon angioplasty during the index procedure
Distal embolization	0
Any unplanned vascular intervention (endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication)
Need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft)	0
Primary safety end-point (life-threatening bleedings or major bleedings or major vascular complications)	1 (6.7%)