Transcatheter Aortic Valve Implantation Without Predilation

Launched by UNIVERSITY HOSPITAL, BONN · Feb 24, 2012

Keywords

ClinConnect Summary

Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk. Before deployment of transcatheter heart valves (THV), current medical practice requires right-ventricular rapid burst pacing (\>180 bpm) with induction of a functional cardiac arrest for up to 30 seconds for balloon aortic valvuloplasty (BAV). This step is thought to be necessary to predilate the native aortic ...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • LVEF ≤35%
• • Aortic valve stenosis with an aortic valve area \<1 cm2 (\<0,6 cm3/m2)
• • Males or females at least 18 years of age
• • Logistic EuroSCORE ≥15% and age ≥75 years or if age \<75 years: logistic EuroSCORE ≥20% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD)
• • Signed informed consent
• Exclusion Criteria:
• • Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator)
• • Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines
• • 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, nitinol or sensitivity to contrast media that cannot be adequately premedicated
• • Recent myocardial infarction (STEMI within the last 3 months)
• • Left ventricular or atrial thrombus by echocardiography
• • Uncontrolled atrial fibrillation
• • Mitral or tricuspidal valvular insufficiency (\> grade II)
• • Previous aortic valve replacement with mechanical valve
• • Evolutive or recent cerebrovascular event (within the last 3 months)
• • Vascular conditions that make insertion and endovascular access to the aortic valve impossible
• • Symptomatic carotid or vertebral arterial narrowing (\>70%) disease
• • Abdominal or thoracic aortic aneurysm in the path of the delivery system
• • Bleeding diathesis or coagulopathy or patient refusing blood transfusion
• • Active gastritis or peptic ulcer disease
• • Severely impaired renal function, GFR \< 30 ml/min
• • 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