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Transcatheter Aortic Valve Replacement

Severe symptomatic aortic stenosis has a poor prognosis and valve replacement can save a patient’s life. Surgical aortic valve replacement used to be the standard of care for severe symptomatic aortic stenosis. Elderly and patients with co-morbidities, such as severe systolic heart failure or coronary artery disease, cerebrovascular/peripheral arterial disease, chronic kidney disease, and chronic respiratory dysfunction carry an increased risk for surgical aortic valve replacement. Thus, transcatheter aortic valve replacement (TAVR) was developed as an alternative to surgical approach in high risk patients. The current devices that are available include the self-expandable CoreValve prosthesis and the balloon-expandable Edwards SAPIEN prosthesis.

Indications

  • Calcific aortic stenosis with the following echocardiographic criteria:
    • Severe calcified valve leaflets with reduced systolic motion AND mean gradient >40 mmHg (normal <5 mmHg) or jet velocity > 4.0 m/s (normal <2.5 m/s)

OR

  • Aortic valve area of <1.0 cm² (normal 3-4 cm²) or indexed effective orifice area <0.5 cm²/m²
    • In the setting of left ventricular systolic dysfunction, severe aortic stenosis is present if the leaflets are calcified, with reduced systolic motion, and dobutamine stress echocardiography reveals aortic velocity >4.0 m/s OR mean gradient >40 mmHg with valve area <1.0 cm² OR aortic valve area index <0.6 cm²/m² at any flow rate.
  • Symptomatic patients from aortic stenosis (NYHA functional class II or greater), unrelated to co-morbid conditions
  • A cardiac interventionalist and 2 experienced cardiothoracic surgeons must agree that surgical aortic valve replacement is either precluded or high risk, based on the probability of death or serious irreversible morbidity exceeding the probability of meaningful improvement.
    • At least 1 of the cardiac surgeon assessors must physically evaluate the patient. Surgeon’s consult notes should specify the medical or anatomic factors leading to this conclusion and should include a printout of the calculation of the Society of Thoracic Surgeons score.

Contraindications

  • Evidence of acute MI at 1 month or less before the intended treatment
  • Noncalcified or congenital unicuspid or bicuspid aortic valve
  • Severe( >2+) aortic regurgitation
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation
  • Need for emergency surgery for any reason
  • Hypertrophic cardiomyopathy
  • Severe left ventricular dysfunction with a left ventricular ejection fraction of <20%
  • Severe pulmonary hypertension and right ventricular dysfunction
  • Echocardiograph that reveals intracardiac mass, thrombus, or vegetation
  • Contraindication or hypersensitivity to all anticoagulation treatments
  • Native aortic annulus <18 mm or >25 mm
  • MRI confirmed stroke or TIA within 6 months of the procedure
  • Renal insufficiency with creatinine >3 mg/dL and/or end stage renal disease that requires dialysis
  • Estimated life expectancy of <12 months due to noncardiac comorbidities
  • Severe dementia
  • Significant aortic disease, such as abdominal aortic or thoracic aneurysm that is defined as maximal luminal diameter of 5cm or more, marked tortuosity (hyperacute bend), aortic arch atheroma (especially if >5mm thick, protruding, or ulcerated) or narrowing (with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta
  • Severe mitral regurgitation

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