Table 11

Composite Endpoints

Device success
 Absence of procedural mortality AND
 Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
 Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Early safety (at 30 days)
 All-cause mortality
 All stroke (disabling and non-disabling)
 Life-threatening bleeding
 Acute kidney injury—Stage 2 or 3 (including renal replacement therapy)
 Coronary artery obstruction requiring intervention
 Major vascular complication
 Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Clinical efficacy (after 30 days)
 All-cause mortality
 All stroke (disabling and non-disabling)
 Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
 NYHA class III or IV
 Valve-related dysfunction (mean aortic valve gradient >20 mmHg, EOA <0.9-1.1 cm2 and/or DVI <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Time-related valve safety
 Structural valve deterioration
  Valve-related dysfunction (mean aortic valve gradient >20 mm Hg, EOA <0.9–1.1 cm2 and/or DVI <0.35 m/s, AND/ OR moderate or severe prosthetic valve regurgitation)
  Requiring repeat procedure (TAVI or SAVR)
 Prosthetic valve endocarditis
 Prosthetic valve thrombosis
 Thrombo-embolic events (e.g. stroke)
 VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)

BAV = balloon aortic valvuloplasty; TAVI = transcatheter aortic valve implantation; SAVR = surgical aortic valve replacement.

  • Refers to VARC definitions.

  • As a basis for calculation of 'days alive outside the hospital' endpoint. Supplementary appendix of Leon et al. (43) Includes heart failure, angina, or syncope due to aortic valve disease requiring intervention or intensified medical management; clinical symptoms of CHF with objective signs including pulmonary oedema, hypoperfusion, or documented volume overload AND administration of IV diuresis or inotropic therapy, performance of aortic valvuloplasty, institution of mechanical support (IABP or ventilation for pulmonary oedema) or haemodialysis for volume overload; clear documentation of anginal symptoms AND no clinical evidence that angina was related to CAD or ACS; documented loss of consciousness not related to seizure or tachyarrhythmia.

  • Depending on the body surface area.