Table 1 Prosthetic heart valve related complications*

30-day mortality

Death, of any cause within 30 days of operation regardless of the patient’s geographic location

Valve thrombosis

Thrombosis in the absence of infection attached to or near an operated valve that occludes part of the blood flow path or that interferes with function of the valve

Bleeding event

Any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or requires transfusion

Structural dysfunction

Wear and tear, fracture, poppet escape, calcification, leaflet tear, stent creep, and suture line disruption of components (e.g. leaflets, chordae) causing dysfunction of an operated valve

Non-structural dysfunction—stenosis

Abnormality resulting in stenosis or regurgitation of the operated valve (exclusive of thrombus and infection). Examples include: entrapment by pannus, tissue, or suture; paravalvular leak; inappropriate sizing or positioning; residual leak or obstruction from valve implantation / repair, and clinically important hemolytic anaemia

PHV IE

Valvular IE of any infection involving an operated valve. The diagnosis is based on clinical criteria including an appropriate combination of positive blood cultures, clinical signs, and/or histologic confirmation of endocarditis at re-operation or autopsy

PHV IE requiring re-do

Operated valvular IE of  any infection involving an operated valve (as per PHV IE) which requires re-do intervention

Re-do for altered PHV function

Re-operation that seeks to repair, alter, or replace a previously operated valve

PHV related mortality

Valve-related mortality is death caused by structural valvular deterioration, non-structural dysfunction, valve thrombosis, embolism, bleeding event, operated valvular IE, or death related to re-operation of an operated valve

Deaths caused by heart failure in patients with advanced myocardial disease and satisfactorily functioning cardiac valves are not included