Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement

Exclusion Criteria

• •Subject unable or unwilling to give informed consent
• •Concomitant disease of another heart valve or the aorta that requires either transcatheter or surgical intervention
• •Any condition that is considered a contraindication for placement of a bioprosthetic aortic valve (e.g. patient requires a mechanical aortic valve)
• •Aortic stenosis secondary to a bicuspid aortic valve
• •Prior bioprosthetic surgical aortic valve replacement
• •Mechanical heart valve in another position
• •End-stage renal disease requiring hemodialysis or peritoneal dialysis, or a creatinine clearance \<20 cc/min
• •Left ventricular ejection fraction \<20%
• •Recent (\<6 months) history of stroke
• •Symptomatic carotid or vertebral artery disease, or recent (\<6 weeks) surgical or endovascular treatment of carotid stenosis
• •Any contraindication to oral antiplatelet or anticoagulation therapy following the procedure, including recent or ongoing bleeding, or HASBLED score \>3 (Table 2 - HASBLED scoring system)
• •Severe coronary artery disease that is unrevascularized
• •Recent (\<30 days) acute myocardial infarction
• •Patient cannot undergo transfemoral TAVR for anatomic reasons (as determined by supplemental imaging studies); this would include inadequate size of iliofemoral access vessels or an aortic annulus size that is not accommodated by the commercially available valves
• •Any comorbidity not captured by the STS score that would make SAVR high risk, as determined by a cardiothoracic surgeon who is a member of the heart team; this includes:
• •Porcelain or severely atherosclerotic aorta
• •Frailty
• •Hostile chest
• •Internal mammary artery or other conduit either crosses midline of sternum or is adherent to sternum
• •Severe pulmonary hypertension (PA systolic pressure \> 2/3 of systemic pressure)
• •Severe right ventricular dysfunction
• •Ongoing sepsis or infective endocarditis
• •Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory volume (FEV1) \<750 cc
• •Liver failure with Childs class C or D
• •Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest
• •Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
• •Known allergy to warfarin or aspirin