You are currently viewing SMART Trial two year data continues to demonstrate superior valve performance for Evolut TAVR system in small annulus patients
Representation image: This image is an artistic interpretation related to the article theme.

SMART Trial two year data continues to demonstrate superior valve performance for Evolut TAVR system in small annulus patients

The study found that the TAVR procedure was associated with a significant reduction in mortality rates compared to surgical aortic valve replacement (SAVR). The results of the SMART trial have significant implications for the treatment of aortic stenosis, a condition that affects millions of people worldwide.

  • TAVR is a minimally invasive procedure that involves inserting a new valve through a small incision in the leg or arm.
  • SAVR is a more invasive procedure that involves opening the chest and replacing the aortic valve with a new one.
  • TAVR is typically performed in patients who are at high risk for surgical complications or who have severe aortic stenosis.
  • SAVR is typically performed in patients who are in good physical condition and have a lower risk of complications.

    The data also showed that Evolut TAVR had a lower rate of paravalvular regurgitation (PVR) compared to SAPIEN TAVr2.

    The trial is designed to evaluate the safety and efficacy of the SAPIEN 3 valve in patients with severe aortic stenosis.

    Trial Design

    The SMART Trial is an international, prospective, multi-center, randomized (1:1) post-market trial. This means that the trial is:

  • International: The trial is being conducted in multiple countries around the world.
  • Prospective: The trial is looking forward in time, with patients being enrolled and followed up on over the next five years.
  • Multi-center: The trial is being conducted at multiple research centers and hospitals.
  • Randomized (1:1): Patients are being randomly assigned to either receive the SAPIEN 3 valve or continue with their current treatment.

    • Eligible Patients

    Eligible patients had an aortic valve annulus area of ≤430 mm as measured by computed tomography.

    Narrowing of the aortic valve restricts blood flow, potentially leading to heart failure.

    The condition affects the aortic valve, which regulates blood flow from the heart to the rest of the body. Aortic stenosis occurs when the valve becomes narrowed, restricting blood flow and potentially leading to heart failure.

  • Genetic predisposition
  • High blood pressure
  • High cholesterol
  • Atherosclerosis
  • Previous heart surgery or valve replacement

    • Symptoms and Diagnosis

    The symptoms of aortic stenosis can vary depending on the severity of the condition.

    Medtronic plc is the manufacturer of the Edwards SAPIEN valve. Medtronic plc is a global leader in medical technology, with a portfolio of innovative products and services that improve patient outcomes and enhance the quality of life for people around the world. The company’s focus on innovation, quality, and customer satisfaction has earned it a reputation as a trusted partner for healthcare professionals and patients alike. The Edwards SAPIEN valve is a transcatheter aortic valve replacement (TAVR) system designed for the treatment of aortic stenosis.

    Further details on this topic will be provided shortly.

    Leave a Reply