TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial

The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms.

Inclusion Criteria:Severe aortic stenosisIndication to TAVI confirmed by the Study Heart TeamAND one of the following:Inoperable due to prohibitive operative riskHigh surgical risk as defined as STS score >8%The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery:Porcelain aorta or severely atherosclerotic aortaFrailty/Reduced physical performanceCognitive impairment, dementia, or Parkinson's diseaseSevere liver disease/cirrhosisHostile chestInternal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternumSevere pulmonary hypertension and/or severe right ventricular dysfunctionSevere Chronic Obstructive Pulmonary Disease (COPD)Age ≥85 yearsExclusion Criteria:Unsuitable for transfemoral TAVIEmergent TAVINoncardiovascular comorbidity reducing life expectancy to <1 yearAny factor precluding 1-year follow-upRefusal informed consent