Categories of Bioprosthetic Valve Dysfunction

Structural valve deterioration

Ÿ Intrinsic permanent changes to the prosthetic valve, including leaflet tear, disruption, flail leaflet, leaflet fibrosis and/or calcification.

Ÿ See Online Table 2 for definitions of stages.

Non-structural valve dysfunction

Ÿ Any abnormality, not intrinsic to the prosthetic valve, resulting in valve dysfunction. Examples include residual intra- or para-prosthetic aortic regurgitation; leaflet entrapment by pannus, tissue, or suture; inappropriate positioning or sizing; dilatation of the aortic root after stentless prostheses or aortic valve sparing operations; prosthesis-patient mismatch; and embolization.

Valve thrombosis

Ÿ Subclinical: Imaging findings of hypo-attenuated (CT) or hypo-echogenic (echocardiography) leaflet thickening and/or reduced leaflet motion with absent of mild hemodynamic changes and no symptoms/sequelae.

Ÿ Clinically significant: 1) Clinical sequelae of thrombo-embolic event or of worsening bioprosthetic valve stenosis or regurgitation and hemodynamic valve deterioration Stage 2 or 3 (See Online Table 2). 2) In the absence of clinical sequelae, both hemodynamic valve deterioration Stage 2 or 3 and confirmatory imaging (leaflet thickening and/or reduced leaflet motion).

Valve endocarditis

Ÿ Meeting at least one of the following criteria: (1) Fulfillment of the Duke endocarditis criteria (2) Evidence of abscess, pus, or vegetation confirmed as secondary to infection by histological or microbiological studies during re-operation; (3) Evidence of abscess, pus, or vegetation confirmed on autopsy.

Clinical Presentation

Subclinical

Ÿ Stage 1: Any bioprosthetic valve dysfunction associated with absent or mild hemodynamic changes, AND absent symptoms or sequelae.

Bioprosthetic valve failure

Ÿ Stage 1: Any significant bioprosthetic valve dysfunction with clinically expressive criteria (new-onset or worsening symptoms, LV dilation/hypertrophy/dysfunction, or pulmonary hypertension) OR Stage 3 hemodynamic valve deterioration related to permanent changes to the prosthetic valve.

Ÿ Stage 2: Aortic valve reoperation or reintervention.

Ÿ Stage 3: Valve-related death.^†