Table 5.

Transcatheter aortic valve intervention—clinical outcomes and their definitions

Transcatheter aortic valve intervention—level 1 variables
Aortic regurgitation	Presence of aortic regurgitation, and severity (mild/moderate/severe) as determined by echocardiography based on Doppler parameters according to the criteria of the VARC 3 criteria.53
Device implantation	Implantation of: Transvenous permanent pacemaker is an electronic device that is implanted in the subcutaneous tissue and gives the heart an electrical stimulation through transvenous wires. Leadless pacemaker is an electronic device that is implanted directly into the right ventricle. Transvenous ICD is a device that is used to correct abnormal heartbeat through transvenous wires. Subcutaneous ICD is an ICD with a presternal lead and is positioned between the latissimus dorsi and serratus muscle within the subcutaneous tissue. Extravascular ICD is an ICD with a substernal lead and the device in the subcutaneous tissue of the lateral thorax. CRT device and pacemaker (CRT-P) is defined as a biventricular pacemaker that sends electrical stimulation to both ventricles. CRT-D is a biventricular pacemaker and defibrillator.55,56
NYHA class	NYHA class I: no limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitations, or dyspnoea. NYHA class II: slight limitation of physical activity. The patient is comfortable at rest. Ordinary physical activity results in fatigue, palpitations, or dyspnoea. NYHA class III: marked limitation of physical activity. The patient is comfortable at rest. Less than ordinary activity causes fatigue, palpitations, or dyspnoea. NYHA class IV: inability to carry on any physical activity without discomfort. Heart failure symptoms are present even at rest or with minimal exertion.49,63
Re-intervention on the aortic valve:	Re-do TAVI is a different procedure to the index TAVI, and a separate registration form should be completed. Balloon aortic valvuloplasty is a transcatheter balloon dilatation of the implanted aortic valve after the completion of the index procedure. Surgical aortic valve replacement is defined as a deployment of a new (mechanical or bioprosthetic) aortic valve surgically. Other aortic valve surgery is any other surgical intervention on the aortic valve.
Transcatheter aortic valve intervention—level 2 variables
Access-related non-vascular complications	Major access-related non-vascular events are defined as one of the following: Non-vascular structure, non-cardiac structured perforation, injury, or infection resulting in death, BARC type ≥3 bleeding, irreversible nerve injury or requiring unplanned surgery or percutaneous intervention. Non-vascular access site (e.g. trans-apical left ventricular) perforation, injury, or infection resulting in death, BARC type ≥3 bleeding, irreversible nerve injury or requiring unplanned surgery or percutaneous intervention. Minor access-related non-vascular events are defined as one of the following: Non-vascular structure, non-cardiac structured perforation, injury, or infection not resulting in death, BARC type ≥ 3 bleeding, irreversible nerve injury, or requiring unplanned surgery or percutaneous intervention. Non-vascular access site (e.g. trans-apical left ventricular) perforation, injury, or infection not resulting in death, BARC type ≥3 bleeding, irreversible nerve injury or requiring unplanned surgery or percutaneous intervention.53
All-cause re-hospitalisation	Unscheduled hospital admission for any reason. Unscheduled hospitalisation is defined as a being admitted for more than 24 h or past a calendar day.6,53
Cardiac arrest	Cardiac arrest is defined as a verified sudden cessation of cardiac activity causing unresponsiveness, absence of normal breathing and no signs of circulation (excluding syncope or profound vagally mediated bradycardia) with ventricular fibrillation, rapid ventricular tachycardia, or bradycardia resulting in loss of consciousness, pulseless electrical activity, or asystole as the major causes. ROCS is defined as the resumption of a sustained heart rhythm that perfuses the body after cardiac arrest. Signs include a palpable pulse, measurable blood pressure, and/or respiratory effort.51
Cardiogenic shock	Cardiogenic shock is defined as any one of the following: (1) ‘beginning’ cardiogenic shock or compensated shock where a patient may be volume overloaded, tachycardic, and/or hypotensive but no evidence of hypoperfusion on physical exam or laboratory studies. It also includes patients with a (2) ‘classic’ cardiogenic shock with evidence of hypoperfusion on physical exam and laboratory studies ‘cold and wet.’ Invasive haemodynamics (if available) demonstrate the classic depressed cardiac index associated with cardiogenic shock. Cardiogenic shock also includes patients with (3) ‘deteriorating’ and includes above patients plus failure of initial interventions in restoring adequate perfusion in 30 min and further escalation is required. Cardiogenic shock also includes (4) ‘escalation’ cardiogenic shock in which an increase in the number or intensity of intravenous therapies to address hypoperfusion, or addition of mechanical circulatory support after the initial 30-min period of observation and treatment. It can also include patients who are highly unstable, often with circulatory collapse and/or refractory cardiac arrest with ongoing CPR. They are being supported by multiple simultaneous acute interventions including ECMO-facilitated CPR (eCPR).52
CCS angina status	CCS Grade I: ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation. CCS Grade II: slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions. CCS Grade III: marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace. CCS Grade IV: inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.67
CABG surgery	CABG surgery after the TAVI procedure. CABG is a procedure to bypass diseased segment(s) of the coronary tree using blood vessels derived from other parts of the body and connected to the aorta.62
Creatinine	Serum creatinine assay, in µmol/L.
Endocarditis	Infective endocarditis is diagnosed if at least one of the following criteria is met: (1) Fulfilment of the Duke criteria for endocarditis (2) Evidence of abscess, pus, or vegetation confirmed as secondary to infection by histological or microbiological studies during re-operation; and (3) Evidence of abscess, pus, or vegetation confirmed on autopsy.53
Left ventricular ejection fraction	Ejection fraction, ideally measured with echocardiography.
AF or AFL	A new diagnosis of AF or AFL. AF is defined as a supraventricular tachyarrhythmia with uncoordinated atrial electrical activation and consequently ineffective atrial contraction. The minimum duration of an ECG tracing of AF required to establish the diagnosis of clinical AF is at least 30 s, or entire 12-lead ECG. AFL is defined as a supraventricular tachyarrhythmia with co-ordinated but overly rapid atrial electrical activation, usually with some degree of atrioventricular node conduction block. The minimum duration of an ECG tracing of AFL required to establish the diagnosis of clinical AFL is at least 30 s, or entire 12-lead ECG.58
Renal replacement therapy	The patient developed a new requirement for renal replacement therapy. Renal replacement therapy includes ultrafiltration (haemofiltration), haemodialysis, or peritoneal dialysis.50
Other transcatheter heart valve procedure	Valve intervention after the index TAVI procedure, excluding repeat aortic valve intervention.
PCI	PCI after the TAVI procedure. PCI is the placement of an angioplasty guidewire, balloon, or other device (e.g. stent, atherectomy, brachytherapy, or thrombectomy catheter) into a native coronary artery or a graft for the purpose of mechanical coronary revascularisation. The assessment of the severity of a coronary lesion by fluoroscopy, intracoronary imaging (e.g. intravascular ultrasonography), or intracoronary physiology (e.g. fractional flow reserve) is not considered a PCI procedure.65
Residual aortic stenosis	Stage 1: Evidence of structural valve deterioration, non-structural valve dysfunction (other than paravalvular regurgitation or prosthesis-patient mismatch), thrombosis, or endocarditis without significant haemodynamic changes. Stage 2: Increase in mean trans valvular gradient >10 mm Hg resulting in mean gradient >20 mm Hg with concomitant decrease in effective orifice area (EOA) > 0.3 cm2 or > 25% and/or decrease in Doppler velocity index >0.1 or >20% compared with echocardiographic assessment performed 1–3 months post-procedure. Stage 3: Increase in mean trans valvular gradient >20 mm Hg resulting in mean gradient >30 mm Hg with concomitant decrease in EOA > 0.6 cm2 or > 50% and/or decrease in Doppler velocity index > 0.2 or > 40% compared with echocardiographic assessment performed 1–3 months post-procedure.20
Sternotomy/thoracotomy due to bleeding	The patient had a sternotomy/thoracotomy due to bleeding.

Abbreviations: AF, atrial fibrillation; AFL, atrial flutter; BARC, Bleeding Academic Research Consortium; CABG, coronary artery bypass; CCS, Canadian Cardiovascular Society; CPR, cardiopulmonary resuscitation; CRT, cardiac resynchronization therapy; ECG, electrocardiogram; ECMO, extracorporeal membrane oxygenation; ICD, implantable cardioverter defibrillator; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; TAVI, transcatheter aortic valve intervention; VARC, Valve Academic Research Consortium.