TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Mar 31, 2016

Keywords

ClinConnect Summary

Background Transcatheter aortic valve implantation (TAVI) is now the standard of care for inoperable patients with severe symptomatic aortic stenosis and an accepted alternative to surgery for high-risk patients. Despite a high procedure success rate (\> 95%), TAVI remained associated with complications directly related to the technique (stroke, aortic regurgitation, vascular access bleeding) or to co morbidities frequently associated with aortic valve disease in elderly and frail patients. Reducing periprocedural complications is thereby the key for the future use of TAVI in lower-risk pat...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Symptomatic Aortic valve stenosis with an aortic valve area \<1 cm2 (\<0,6 cm3/m2)
• • Males or females of at least 18 years of age
• • Logistic EuroSCORE ≥15% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD) or all patients considered as having excessive surgical risk by the heart team
• • Signed informed consent
• • TAVI performed via transfemoral, sub clavicular or transaortic route with the SAPIEN 3 THV (Edwards Lifescience)
• Exclusion Criteria:
• • Transapical TAVI
• • Preexisting aortic prosthesis (valve in valve technique)
• • Vascular conditions that make insertion and endovascular access to the aortic valve impossible
• • BAV performed for less than one week
• • Recent myocardial infarction (STEMI within the last 3 months)
• • Left ventricular or atrial thrombus by echocardiography
• • Mitral or tricuspidal valvular insufficiency (\> grade II)
• • Evolutive or recent cerebrovascular event (within the last 3 months)
• • Symptomatic carotid or vertebral arterial narrowing (\>70%) disease
• • Bleeding diathesis or coagulopathy or patient refusing blood transfusion
• • Lack of written informed consent, severe mental disorder, drug/alcohol addiction
• • Life expectancy \< 1 year
• • Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media that cannot be adequately premedicated
• • Participation in another drug or device study that would jeopardize the appropriate analysis of end-points of this study.
• • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
• • Pregnancy