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

This is an interventional treatment trial for Aortic Stenosis Read More

Inclusion Criteria:

• Severe, degenerative AS, defined as:
• Mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND
• Calculated aortic valve area ≤1.0 cm2 OR aortic valve area index ≤0.6 cm2/m2
• Symptomatic AS, defined as a history of at least one of the following:
• Dyspnea that qualifies at New York Heart Association (NYHA) class II or greater
• Angina pectoris
• Cardiac syncope
• The Heart Team agrees that the patient is low-risk, quantified by an estimated risk of death ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that SAVR would be an appropriate therapy if offered
• A surgeon who is experienced in Surgical Aortic Valve Replacement (SAVR) has spoken with the patient in person and stipulates that the patient understands his/her alternatives for FDA approved therapy, including open heart surgery to replace their aortic valve
• The institutional Heart Team determines that transfemoral TAVR is appropriate
• Aortic valve anatomy and dimensions suitable for TAVR using a commercially available valve
• Iliofemoral artery anatomy and dimensions suitable for transfemoral TAVR using a commercially available valve and delivery system
• Procedure status is elective
• Expected survival is at least 24 months

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