American College of Cardiology / American Heart Association Guidelines for Reporting Morbidity and Mortality After Cardiac Valve Intervention

Mortality or operative mortality

Death within 30 days of operation regardless of the patient's geographic location. Follow-up for 30-day mortality must be complete.

Hospital mortality is death within any time interval after operation if the patient is not discharged from the hospital. Hospital to hospital transfer is not considered discharge; transfer to a nursing home or rehabilitation unit is considered hospital discharge unless the patient subsequently dies of complications of the operation.

Structural valvular deterioration (SVD)

Any change in function (a decrease of one New York Heart Association functional class or more) of an operated valve including:

• Operated valve dysfunction or deterioration exclusive of infection or thrombosis as determined by reoperation, autopsy, or clinical investigation.
• Wear, fracture, poppet escape, calcification, leaflet tear, stent creep, and suture line disruption of components (e.g., leaflets, chordae) of an operated valve.

Any abnormality, exclusive of thrombosis and infection, resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself e.g. pannus, tissue, or suture, paravalvular leak, inappropriate sizing or positioning, residual leak or obstruction from valve implantation or repair, and clinically important hemolytic anemia.

Valve thrombosis

Any thrombus, in the absence of infection, attached to or near an operated valve  

Embolism

Any embolic event that occurs in the absence of infection after the immediate perioperative period.

A neurologic event includes any new, temporary or permanent, focal or global neurologic deficit. Patients who do not awaken or who awaken after operation with a new stroke are excluded in tabulations of valve-related morbidity.

A peripheral embolic event is an operative, autopsy, or clinically documented embolus that produces symptoms from complete or partial obstruction of a peripheral (noncerebral) artery. Emboli proven to consist of nonthrombotic material (e.g., atherosclerosis, myxoma) are excluded.

Bleeding event (formerly anticoagulant-related hemorrhage)

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

The complication bleeding event applies to all patients whether or not they are taking anticoagulants or antiplatelet drugs, since bleeding events can occur in patients who are not receiving anticoagulants. Embolic stroke complicated by bleeding is classified as a neurologic event under embolism and is not included as a separate bleeding event.

Operated valvular endocarditis

Any infection involving an operated valve.

Reoperation

Any operation that repairs, alters, or replaces a previously operated valve.

Valve-related mortality

Death caused by structural valvular deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, operated valvular endocarditis, or death related to reoperation of an operated valve. Sudden, unexplained, unexpected deaths of patients with an operated valve are included as valve-related mortality. Deaths caused by heart failure in patients with advanced myocardial disease and satisfactorily functioning cardiac valves are not included.

Sudden, unexpected, unexplained death

The cause of these deaths is unknown and the relationship to an operated valve is also unknown. Therefore, these deaths should be reported as a separate category of valve-related mortality if the cause cannot be determined by clinical data or autopsy.

Cardiac death

All deaths resulting from cardiac causes. This category includes valve-related deaths (including sudden unexplained deaths) and non-valve-related cardiac deaths (e.g., congestive heart failure, acute myocardial infarction, documented fatal arrhythmias).

Permanent valve-related impairment

Any permanent neurologic or other functional deficit caused by structural valvular deterioration, nonstructural dysfunction, valve thrombosis, thrombotic embolism, bleeding event, operated valvular endocarditis, or reoperation.