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

Table 1 Main characteristics of study population

	Patients
Patient number	15
Age, yr (mean ± SD)	80.0 ± 7.2
Female gender	10 (66.7%)
BMI, kg/m2 (mean ± SD)	27.41 ± 3.6
Risk factors
Diabetes	2 (13.3%)
Hypertension	13 (86.7%)
Dyslipidemia	6 (40.0%)
Smoking	0
Medical history/comorbidities
Chronic kidney disease (not on dialysis)	3 (20.0%)
Chronic dialysis	0
Peripheral artery disease	2 (13.3%)
Atrial Fibrillation	8 (53.3%)
Previous stroke	2 (13.3%)
Chronic pulmonary disease	2 (13.3%)
Previous myocardial infarction	2 (13.3%)
Previous PCI	4 (26.7%)
Previous CABG	1 (6.7%)
STS mortality	3.7 ± 2.5
TAVR score	2.69 ± 0.7
Anticoagulant and antiplatelet therapy
Anticoagulants	7 (46.6%)
Dual antiplatelet therapy	6 (40%)
Clopidogrel	11 (73.3%)
Acetyl salicylic acid	8 (53.3%)

PCI: Percutaneous coronary intervention; CABG: Coronary artery bypass grafting; STS: Society of Thoracic Surgeons; TAVR: Transcatheter-aortic-valve-replacement; SD: Standard deviation.

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%)