Table 1 Eligibility criteria for the transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) study
Criteria | Definition |
|---|---|
Inclusion criteria | |
Patients aged ≥18 years | |
Severe aortic valve stenosis | Mean gradient ≥40 mmHg or aortic valve area <1 cm2 on TTEa |
Symptoms suggestive of severe aortic stenosis | Dyspnea, heart failure, angina, syncope |
Contraindication for open heart surgery or excessive surgical risk | Decision of the multidisciplinary heart team |
TAVI using the balloon-expandable SAPIEN 3 valve | |
Vascular access | Transfemoral, transcarotid, transaortic or subclavian access |
Exclusion criteria | |
Preexisting aortic prosthesis | “Valve in valve” technique |
Transapical access | |
BAVb performed for less than 1 week | |
Recent myocardial infarction | Within the last 3 months |
Left ventricular or atrial thrombus | TTE evaluation |
Significant mitral or tricuspid regurgitation | >grade II on TTE |
Recent cerebrovascular event | Within the last 3 months |
Carotid or vertebral arterial narrowing | Stenosis >80% (Doppler or CT scan) |
Active internal bleeding | |
Thrombocytopenia | Platelet count <50,000/mm3 |
Lack of written informed consent | |
Severe mental disorder, drug/alcohol addiction | Specialized evaluation |
Life expectancy <1 year | |
Participation in another drug or device study | Any study that would jeopardize |
the appropriate analysis of study endpoints | |
High probability of nonadherence to the follow-up | Social, psychological or medical requirement reason |
Pregnancy | |