AORTIC STENOSIS

Severe symptomatic aortic stenosis carries a poor prognosis. Surgical aortic valve replacement has been the standard of care in

adults with severe symptomatic AS. The risks associated with surgical aortic valve replacement are

increased in: (High Risk Population)

Elderly patients: + Following Co Morbidity Severe systolic heart failure CVD CAD PVD CKD Ch respiratory dysfunction.

Transcatheter aortic valve implantation(TAVI) has been developed as an alternative to the surgical approach in high-risk population.

Dr. Alain Cribier…..

TAVI• More than 30,000 patients with severe

symptomatic aortic stenosis considered high risk for surgery have undergone the treatment.

• This technique is still in its early stages, but rapidly growing evidence has been developed through observational studies, national and device-specific registries, and randomized clinical trials.

Indication:Currently, there are no established indications or

guidelines for TAVR in the United States. Indications are based on following trial and consensus.

PARTNER Trial - Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21. 363(17):1597-607.

ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Mar 27. 59(13):1200-54.

Indication No 1: Patients with calcific aortic valve stenosis with the following echocardiographic criteria:

Mean gradient greater than 40 mm Hg or jet velocity more than 4 m/s and an initial aortic valve area (AVA) of less than 0.8 cm 2 or indexed effective orifice area (EOA) of less than 0.5 cm 2/m 2;

Qualifying AVA baseline measurement must be within 45 days of the date of the procedure

Indication No 2: One cardiac interventionalist and 2 experienced

cardiothoracic surgeons agree that medical factors either preclude operation or are high risk for surgical aortic valve replacement, based on a conclusion that the probability of death or serious irreversible morbidity exceeds the probability of meaningful improvement.

The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the Society of Thoracic Surgeons (STS) score to additionally identify the risks in the patient; at least 1 of the cardiac surgeon assessors must have physically evaluated the patient

Indication No 3:

Patient is deemed to have symptomatic aortic valve stenosis, as differentiated from symptoms related to comorbid conditions and as demonstrated by New York Heart Association (NYHA) functional class II or greater.

In the European Union, Transcatheter Aortic Valve Implantation is performed in patients with severe aortic stenosis who are high-risk surgical candidates with a logistic EuroScore of more than 20% and in patients who have a contraindication to surgical aortic valve replacement.

Contraindications and exclusion criteria for TAVI are as follows:

Evidence of an acute MI at 1 month or less before the intended treatment (defined as Q-wave MI, or non–Q-wave MI with CK-MB twice normal in the presence of MB elevation and/or troponin level elevation [WHO definition].

Contraindications….

Aortic valve is a congenital unicuspid or congenital bicuspid valve or is noncalcified.

Mixed aortic valve disease ( AS+ AR) with predominant AR (>3+).

Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.

Contraindications….Need for emergency surgery for any reasonHOCM with or without obstruction.Severe left ventricular dysfunction with LVEF of

less than 20%.Severe pulmonary hypertension RV dysfunction.Echocardiographic evidence of intracardiac mass,

thrombus, or vegetation.

Contraindications…A known contraindication or hypersensitivity

to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure.

Native aortic annulus smaller than 18 mm or larger than 25 mm as measured with echo.

MRI-confirmed stroke or TIA within 6 months (180 days) of the procedure.

Contraindications…

Estimated life expectancy of less than 12 months due to noncardiac comorbid conditions.

Severe incapacitating dementia.Severe MR. Renal insufficiency (creatinine level >3

mg/dL) and/or end-stage renal disease requiring chronic dialysis at the time of screening.

Contraindications:

Significant aortic disease, including abdominal aortic or thoracic aortic aneurysm defined as a maximal luminal diameter of 5 cm or greater, marked tortuosity, atheroma or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta.

Severe "unfolding" and tortuosity of the thoracic aorta.

Aortic Regurgitation •AR is typically paravalvular mild or mild-moderate severity•Most AR disappears or reduces at 1 yr follow-up.

Embolic protection device

(A) Left main coronary artery occlusion resulting from a bulky leaflet displaced over the ostium.

(B) Successful percutaneous intervention restored left coronaryflow.

The principal transcatheter aortic valve implantation devices currently in use:(A) Edwards Sapien XT bioprosthesis and(B) Medtronic CoreValve® bioprosthesis

• Implanted since 2002• Transfemoral, transapical,

alternate access routes• Bovine pericardium leaflets• Cobalt-chromium balloon

expandable stent• Annular fixation• Sub coronary implant

Edwards Sapien Valve

Medtronic CoreValve

Penrose program was the first CoreValve program in CO, NM, UT, WY

Retrograde approach onlyEquine Pericardium LeafletsNitinol Self-ExpandingAnnular and Supra-coronary

fixation18fr delivery systemOffers a 31mm valve size

TAVI PROCEDURE

Conclusion….• Catheter based treatment of aortic stenosis is

improving.• Restenosis after valvuloplasty has been overcome after

development of TAVI.• Indications for TAVI can be expanded after the

availability of follow up of patients of the cohort.• Team approach is essential for successful procedure.• Training required for performance of TAVI and

dedicated imaging instruments.• Patient selection is complex.