I will not discuss off label use or investigational use in my presentation

• I will not discuss off label use or investigational use in my presentation.

• I have no financial relationships to disclose.

• Employee of MaineHealth Cardiology

Independent clinical factors associated with degenerative aortic valve disease include the following:4

• Independent clinical factors associated with degenerative aortic valve disease include the following:4

• Increasing age

• Male gender

• Hypertension

• Smoking

• Elevated lipoprotein A

• Elevated LDL cholesterol

Heart Failure

• Heart Failure

• Angina

• Syncope

Survival after onset of symptoms is 50% at 2 years and 20% at 5 years1

• Survival after onset of symptoms is 50% at 2 years and 20% at 5 years1

• Surgical intervention for severe aortic stenosis should be performed promptly once even minor symptoms occur1

5 year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis

• 5 year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis

According to the 2014 ACC/AHA guidelines, severe aortic stenosis is defined as:

• According to the 2014 ACC/AHA guidelines, severe aortic stenosis is defined as:

• Aortic valve area (AVA) less than 1.0 cm2
• Mean gradient greater than 40 mmHg or jet velocity greater than 4.0 m/s

Low gradient with a small calculated valve area in the setting of poor systolic function. This may result in lack of referral for AVR because of the low gradient.

• Low gradient with a small calculated valve area in the setting of poor systolic function. This may result in lack of referral for AVR because of the low gradient.

• Dobutamine Stress Echo:

• By increasing cardiac output, we can determine if the AS is severe by reassessing the gradient across the aortic valve (increases) AND the aortic valve area (decreases).
• Assess myocardial contractile reserve
• Does the cardiac output improve by 20% or more.
• Critical for decision making regarding aortic valve replacement.

Some patients with severe aortic stenosis based on valve area have a lower than expected gradient (e.g. mean gradient < 30 mmHg) despite preserved LV ejection fraction (e.g. EF > 50%)

• Some patients with severe aortic stenosis based on valve area have a lower than expected gradient (e.g. mean gradient < 30 mmHg) despite preserved LV ejection fraction (e.g. EF > 50%)

• Up to 35% of patients with severe aortic stenosis present with low flow, low gradient
• These low gradients often lead to an underestimation of the severity of the disease, so many of these patients do not undergo surgical aortic valve replacement

Study data demonstrate that early and late outcomes were similarly good in both symptomatic and asymptomatic patients

• Study data demonstrate that early and late outcomes were similarly good in both symptomatic and asymptomatic patients

• It is important to note that among asymptomatic patients with SAS, omission of surgical treatment was the most important risk factor for late mortality

Studies show at least 40% of patients with severe AS are not treated with an AVR9-15

• Studies show at least 40% of patients with severe AS are not treated with an AVR9-15

An aortic valve replacement as an alternative to traditional thoracotomy.

• An aortic valve replacement as an alternative to traditional thoracotomy.

• Less invasive than traditional thoracotomy for patients considered too high risk for traditional surgery.

Edwards Sapien Valve

• Edwards Sapien Valve

• Stainless Steel Frame

• More Aortic Regurg, less AV block/PPM

• Better for severe bulky calcification.

Exclusion Criteria:

• Exclusion Criteria:

• bicuspid or noncalcified aortic valve
• acute myocardial infarction
• substantial coronary artery disease requiring revascularization
• left ventricular ejection fraction of less than 20%
• a diameter of the aortic annulus of less than 18 mm or more than 25 mm
• severe (>3+) mitral or aortic regurgitation
• a transient ischemic attack or stroke within the previous 6 months
• severe renal insufficiency (creatinine greater than 3 or on dialysis).
• Iliac-femoral anatomy precluding safe sheath insertion

Primary End-Points:

• Primary End-Points:

• Death from any cause
• Rate of a hierarchical composite of the time to death from any cause or the time to the first repeat hospitalization from aortic valve disease or procedure related complication

Secondary End-Points:

• Secondary End-Points:

• the rate of death from cardiovascular causes
• NYHA functional class
• The distance covered during a 6-minute walk test
• Valve performance (assessed by echocardiography)
• The rates of myocardial infarction, stroke, acute kidney injury, vascular complications, and bleeding

179 Patients assigned

• 179 Patients assigned

• Balloon Valvuloplasty perfomed in 114 (63.7%) patients in first 30 days and 36 (20.1%) additional patients 30 days after randomization.

• 12 (6.7%) underwent AVR!

• 5 (2.8%) LV apex to Aorta conduit

179 Patients

• 179 Patients

• 6 did not undergo TAVR

• 2 died before implantation
• 2 unsuccessful transfemoral access
• 2 aortic valve annulus was to large

• Aortic Stenosis is prevalent with a high morbidity and mortality when symptomatic and aortic valve replacement is the only treatment associated with improved outcomes.

• Asymptomatic low risk patients will benefit from surgical AVR.

• Low gradient does not necessarily exclude severe aortic stenosis, even when the ejection fraction is normal!!

• TAVR is an excellent alternative to traditional Aortic Valve Surgery but increased risk of stroke and vascular injury and the need for a permanent pacemaker.

• MMC Heart Team has performed over 100 TAVR procedures in three years with excellent outcomes.