Table 10.

Hospitalization Endpoints

All-cause hospitalization	Hospitalization is defined as an unplanned admission to an inpatient unit or ward in the hospital for ≥24 h or as measured by a change in calendar date, including an emergency department stay. Preplanned hospitalizations for pre-existing conditions or for planned procedures are excluded unless theses are arranged for a condition related to the tricuspid valve dysfunction such as worsening heart failure.
Cardiovascular hospitalization	Heart failure hospitalization
	Heart failure–related hospitalizations requiring that new or worsening heart failure be the predominant reason for a hospital stay >24 h on the basis of symptoms and signs of heart failure with confirmation by diagnostic tests and necessitating treatment using intravenous or mechanical heart failure therapies. Note: Pleural effusions requiring medical or interventional therapy >24 h but within 4 weeks of surgical intervention, not associated with new postprocedural valvular or ventricular dysfunction, are not considered a heart failure complication or a heart failure hospitalization equivalent. Both of the following additional criteria are present: At least 1 symptom and 2 physical findings or 1 physical finding and at least 1 laboratory or invasively measured criterion (if measured within 24 h of admission) all of which are new or worsening Administration of intravenous, intensification of oral, or mechanical heart failure therapy
	Other cardiovascular hospitalization
	Cardiovascular hospitalization not directly related to the valve or index procedure including: acute coronary syndrome or chronic coronary syndrome, hypertension, arrhythmia (not related to the procedure or tricuspid valve), peripheral vascular disease.
	Valve- or procedure-related hospitalization
	Device-related dysfunction such as single leaflet attachment, device embolization, arrhythmias, and so on Exacerbation or deterioration of previous in-hospital periprocedural complication Untreated tricuspid valve disease Bioprosthetic valve dysfunction such as valve thrombosis, endocarditis, structural valve deterioration, or nonstructural valve dysfunction Bleeding complications related to oral anticoagulation or antiplatelet therapy for valve-related thromboembolic prevention or atrial fibrillation
	Unknown
	Hospitalizations from unknown causes and not clearly cardiovascular or noncardiovascular
Noncardiovascular hospitalization	Noncardiovascular hospitalization - Hospitalization not caused by cardiovascular causes as listed in the previous text
Heart failure exacerbation	Heart failure exacerbation without hospitalization
	The patient experiences signs and symptoms of new or worsening heart failure and is seen in a clinic, emergency department, or observational unit but does not require hospitalization and the stay is <24 h. Both of the following additional criteria are present: At least 1 symptom and 2 physical findings or 1 physical finding and at least 1 laboratory or invasively measured criterion (if measured within 24 h of admission) all of which are new or worsening Administration of intravenous or intense oral heart failure therapy is administered

Relatedness to device therapy should be adjudicated for each endpoint. Timing with respect to device therapy to be classified as per Table 8.