In Anlehnung an die VARC-2-Kriterien sind schwere vaskuläre Komplikationen zu dokumentieren:
„Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm
OR
Access site or access-related vascular injury (dissection, stenosis,
perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma,
irreversible nerve injury, compartment syndrome, percutaneous closure
device failure) leading to death, lifethreatening or major bleeding*,
visceral ischemia, or neurological impairment
OR
Distal embolization (noncerebral) 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 ischemia or neurological impairment
OR
Any new ipsilateral lower extremity ischemia 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“
* „Overt bleeding either associated with a drop in the hemoglobin
level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of
whole blood/RBC, or causing hospitalization or permanent injury, or
requiring surgery“
Quelle: Updated standardized endpoint definitions for transcatheter
aortic valve implantation: The Valve Academic Research Consortium-2
consensus document, Kappetein, A. et al., The Journal of Thoracic and
Cardiovascular Surgery, January 2013