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From: Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry

  IMPACT (NCT04053088) INDURE (NCT03666741) RESILIENCE (NCT03680040)
Valve used INSPIRIS valves INSPIRIS valves RESILIA tissue valves
Design Prospective Prospective Retrospective inclusion, prospective follow-up
Study Start date 12 December 2019 26 April 2019 5 November 2018
Baseline Implantation Implantation 5 years
Follow-up 5 years – projected completion 2026 5 years – projected completion 2025 6 years (from year 5 to year 11) – projected completion 2027
Subjects/centers 500 subjects, ~ 25 centers (Austria, Germany, The Netherlands and Switzerland), patients ≥18 years at the time of their SAVR 400 subjects, 20–25 centers (EU and Canada), patients ≤60 years at the time of their SAVR 220 subjects, up to 15 centers (US and EU), patients ≤65 years at the time of their SAVR
Objective Assess clinical outcomes in patients with pre-existing comorbidities Assess clinical outcomes Time to valve failure due to valve degeneration requiring re-intervention & early potential predictors of valve durability
Primary endpoints All-cause mortality at 1, 3 and 5 years after SAVR Time-related valve safety at 1 year (VARC-2) Time to BVF due to SVD, defined as requiring re-intervention (redo surgery or ViV), or confirmed valve related death, according to Akin criteria [27]
  Rate of severe SVD (stage 3 following Salaun [19]) at 5 years (Echo CoreLab)
Secondary endpoints Mortality (all-cause, cardiac-related and valve-related) in overall population and patient subgroups
Hemodynamics and durability
Clinical outcomes (NYHA; freedom from rehospitalization, new pacemaker implant and valve-related complications)
Hemodynamics and durability (Echo CoreLab)
Clinical outcomes (NYHA and freedom from rehospitalization)
Quality-of-life (KCCQ & SF-12)
Early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve degeneration:
- Valve leaflet calcification via CoreLab evaluated MSCT (no contrast)
- Hemodynamic performance (Echo CoreLab)
  1. Legend: BVF, bioprosthetic valve failure; EU, European Union; KCCQ, Kansas City Cardiomyopathy Questionnaire; MSCT, multi-slice computed tomography; NYHA, New York Heart Association; SF-12, Short Form-12; SVD, structural valve degeneration; US, United States; VARC, Valve Academic Research Consortium; ViV, valve-in-valve