The Edwards SAPIEN XT transcatheter heart
valve builds upon the proven SAPIEN
balloon-expandable platform


Edwards SAPIEN Transcatheter Heart Valve

Implanting SAPIEN Valve

The TAVR procedure is not right for all patients. In certain cases, the risks of the procedure may outweigh the benefits.

The TAVR Procedure

For high-risk patients and those who are not suitable for open-heart surgery, another option is now available - transcatheter aortic valve replacement (TAVR) - a less invasive procedure that does not require open-heart surgery.  TAVR produces results in lengthening patients’ lives.

 

The TAVR procedure can be performed through multiple approaches:

Transfemoral approach
In the transfemoral approach, the valve is delivered via a catheter through the femoral artery.

Transapical Approach
In the transapical approach, the valve is delivered via a catheter through the apex of the heart.

Transaortic Approach
In the transaortic approach, the valve is delivered via a catheter through the ascending aorta.

TAVR Animation TAVR Animation TAVR Animation
Transfemoral TAVR Indication Transapical TAVR Indication Transaortic TAVR Indication

SAPIEN XT TAVR Indication
The Edwards SAPIEN XT transcatheter heart valve, model 9300TFX, systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).

Identifying Patients Who May be Appropriate for TAVR

TAVR Patient Symptoms

 



TAVR case study example

  TAVR Case Study
Patient TAVR Heart Team



TAVR Qualification Process Conducted by the Heart Team

Once a patient is referred to a TAVR hospital, a Heart Team will conduct a thorough evaluation to determine whether the patient is an appropriate candidate.

Step 1

Confirm the Patient is Diagnosed with Severe Symptomatic Native Aortic Stenosis

Step 2

Confirm the Patient has been Evaluated by Two Cardiac Surgeons and Meets the Indication for TAVR

Step 3

Evaluate the Aortic Valvular Complex Using Echocardiography

Step 4

Evaluate the Aortic Valvular Complex and Peripheral Vasculature Using MDCT

Step 5

Evaluate the Aortic Valvular Complex and Peripheral Vasculature Using Catheterization

Step 6

Determine Access Route for Transcatheter Heart Valve Replacement



Aortic Stenosis Patient Treatment Plan