Table 4:
Heart failure event diagnostic criteria.
| Author | Event | Diagnostic criteria |
|---|---|---|
| Chertow [37](2012) | Heart failure hospitalization | An unplanned presentation to an acute care setting (hospital or dialysis unit) with signs/symptoms of volume overload (see below) and the patient received mechanical fluid removal therapy (e.g. ultrafiltration or dialysis) OR acute exacerbation of HF with symptomatic pulmonary oedema during an ongoing hospitalization for another condition in which HF becomes a major component of the hospitalization provided that the patient received a mechanical fluid removal (e.g. ultrafiltration or dialysis). |
| Cice [38](2010) | Pump failure death | Pump failure death was defined as death due to progressive deterioration of heart failure, acute pulmonaryoedema, or cardiogenic shock. |
| Cice [38](2010) | Heart failure hospitalization | A CHF hospital admission was defined as admission to hospital necessitated by heart failure and primarily for its treatment or when heart failure was a major component of the hospital admission of the patient. A patient admitted to a hospital for CHF decompensation had to have documented signs and symptoms of worsening heart failure requiring intravenous drug administration and a supplementary haemodialysis treatment. |
| MacDougall [17](2019) | Death due to heart failure | Death due to heart failure refers to a death occurring in the context of new or worsening clinical manifestations of heart failure (see ‘hospitalization for heart failure definition’—section 5.2.6, below) without evidence of another cause of death (e.g. acute myocardial infarction). In general, the new or worsening clinical manifestations should require the initiation of, or an increase in, treatment directed at heart failure, or occur in a patient already receiving maximal therapy for heart failure. However, if time does not allow for the initiation of, or an increase in, treatment directed at heart failure or if the circumstances were such that doing so would have been inappropriate (e.g. patient refusal), the EPAC will adjudicate based on clinical presentation and, if available, investigative evidence. |
| MacDougall [17](2019) | Heart failure hospitalization | For the diagnosis of hospitalization for heart failure, there should be emergency/unplanned admission to a hospital setting (emergency room, observation, or inpatient unit) that results in at least one overnight stay (i.e. a date change) with fulfilment of the following criteria:There should be:(i) Clinical manifestations of new or worsening heart failure including at least one of the following:• New or worsening dyspnoea on exertion• New or worsening dyspnoea at rest• New or worsening fatigue/decreased exercise tolerance• New or worsening orthopnoea• New or worsening PND• New or worsening lower limb or sacral oedema• New or worsening pulmonary crackles/crepitations• New or worsening elevation of JVP• New or worsening third heart sound or gallop rhythmAnd(ii) Investigative evidence of structural or functional heart disease (if available) with at least oneof the following:• Radiological evidence of pulmonary oedema/congestion or cardiomegaly.• Imaging (e.g. echocardiography, cardiac magnetic resonance imaging, radionuclideventriculography) evidence of an abnormality (e.g. left ventricular systolic dysfunction,significant valvular heart disease, left ventricular hypertrophy).• Elevation of B-type natriuretic peptide (BNP) or NT-proBNP levels.• Other investigative evidence of structural or functional heart disease (e.g. evidence obtainedfrom pulmonary artery catheterization).And(iii) Need for new/increased therapy specifically for the treatment of heart failure including atleast one of the following:• Initiation of intravenous diuretic, inotrope, vasodilator, or other recognized intravenous heartfailure treatment or up titration of such intravenous therapy if already receiving it.• Mechanical or surgical intervention (e.g. mechanical or non-invasive ventilation, mechanicalcirculatory support).• Alteration to the dialysis schedule to facilitate extra mechanical fluid removala (this may include extra dialysis sessions or longer dialysis).And(iv) The EPAC should be satisfied that heart failure was the primary disease process accounting for the clinical presentation. |
| Matmsumoto [39](2014) | Heart failure hospitalization | New occurrence or exacerbation of heart failure that was not improved by water removal through dialysis (clinical symptoms together with left ventricular dysfunction by echocardiography according to the American Heart Association/ACC guidelines). |
| Parfrey [40](2005) | Heart failure | De novo heart failure was defined as dyspnoea at rest with two of the following: increased JVP, bilateral basal crackles, radiographic pulmonary hypertension, and radiographic interstitial oedema. |
| Shoji [16](2018) | Heart failure hospitalization | Congestive heart failure (NYHA grade III or IV) requiring hospitalization, excluding dyspnoea due to non-cardiac causes. |
| Suzuki [41](2008) | Heart failure | Congestive heart failure was defined according to the guidelines of the ACC and AHA (Hunt SA, Baker DW, Chin MH, et al. Circulation 104:2996–3007, 2001). |
| Takahashi [42](2006) | Heart failure hospitalization | Congestive heart failure requiring hospitalization (New York Heart Association class III or IV). |
| Walsh [15](2015) | Heart failure | The definition of congestive heart failure requires at least one of the following clinical signs (i.e. any of the following signs: elevated JVP, respiratory rales/crackles, crepitations, or presence of S3) and at least one of the following radiographic findings (i.e. vascular redistribution, interstitial pulmonary oedema, or frank alveolar pulmonary oedema). |
| Zannad [43](2006) | Heart failure hospitalization | Heart failure was defined by a period of >24 h hospitalization for new onset or worsening of dyspnoea with signs and symptoms of clinical and/or radiological signs of peripheral and/or pulmonary congestion and documented worsening of cardiac function (increase in X-ray cardiothoracic ratio or increase of echocardiogram LV dimension with decrease in LV shortening fraction or increase in heart catheterization pulmonary capillary wedge pressure or LV filling pressure). In addition or alternatively, the dialysis strategy had to be changed for up to one consecutive month, including increase in weekly dialysis duration >20% and/or increase in baseline weight >1 kg, and/or switch to hemofiltration. These changes could not be in response to an omission or reduction in routine dialysis. |
Note: uniform definitions for CV outcomes and heart failure developed in 2014 and 2017 by the SCTI/FDA
Diagnostic criteria were abstracted the primary publication, protocol, or supplementary material.
aWhen classifying an event as meeting the definition of ‘hospitalization for heart failure’, the adjudication committee will record whether or not the treatment administered included extra mechanical fluid removal.