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By Michael J. Rinaldi, MD

If your patient has severe aortic stenosis (AS), you might be wondering if TAVR is a treatment option for them. After all, TAVR has been shown to be superior to surgery for patients at increased risk for surgery, delivering lower rates of mortality, stroke and overall complications, and reduced lengths of stay and recovery.

There’s great news: New clinical trials are making TAVR available to more and more patients, regardless of their level of symptoms or surgery risk.

Bringing TAVR to Low-Risk Surgery Patients

TAVR is currently only approved for severe, symptomatic AS patients at moderate or high risk for surgery. (Severe AS is defined as aortic valve area (AVA) ≤1.0 cm2 or AVA index ≤0.6 cm2/m2 AND peak jet velocity ≥4.0 m/s or mean gradient 40mmHg.) These are typically patients over 80 years old who have had prior heart surgery or have kidney or lung issues. For patients who are younger and healthier, surgical AVR remains the only option covered by Medicare and private insurance.

But now, important clinical trials are actively enrolling lower-risk patients. Sanger Heart & Vascular Institute is a top enroller of the PARTNER III study, which randomizes severe, symptomatic lower-risk patients to either surgery or TAVR. For patients who want a less invasive alternative to surgery, participation in such low-risk trials is the only option.

We don’t yet know how TAVR will compare to surgical AVR, but with the superior performance of TAVR in higher-risk populations, this clinical trial is critical to finding an answer.

Expanding Access to Asymptomatic Patients

Some patients with severe AS present with fulminant symptoms or even sudden cardiac death. Given the risks of traditional surgery, the current standard of care is for these patients to wait for the onset of symptoms or left ventricular dysfunction.

Considering TAVR’s safety and recovery profile, it is possible that earlier intervention might improve patient outcomes. Sanger is part of a multi-center study called the EARLY TAVR trial, which randomizes asymptomatic patients with severe AS to either TAVR prior to symptom onset, or clinical surveillance (the current standard of care). This offers a potential way for asymptomatic patients who desire a less invasive approach to have access to TAVR.

At Sanger, we treated the first patient in the world in the EARLY TAVR trial.

 Who Can Get TAVR?
Type of Patient Treatment Options  Strategy
High, Moderate and Low Risk; Asymptomatic EARLY TAVR Trial TAVR vs. clinical surveillance
(current standard of care)
Low Risk; Symptomatic Partner III Trial or Surgery TAVR vs. SAVR
High and Moderate Risk; Symptomatic  TAVR commercially available TAVR when anatomy favorable
Failed Bioprosthetic Valve (Aortic, Mitral, Tricuspid, Pulmonic – stenosis or insufficiency) Valve-in-Valve commercially available Catheter Valve-in-Valve or re-do surgery

The SAPIEN 3 transcatheter heart valve demonstrates excellent outcomes for TAVR patients.

Your Referral Partner for Aortic Stenosis

Sanger Heart & Vascular Institute is your easy referral center for your patients with AS, offering:

  • The highest-volume program in the Carolinas and top 15 by volume in the US
  • 0.6 percent mortality, better than most centers nationally over the last 12 months (Q2 2016-Q1 2017, TVT national registry)
  • 95 percent transfemoral access, fully percutaneous, mostly by conscious sedation without general anesthesia
  • Length of stay as little as 24 hours, with median approaching 2 days

Referral is easy for you and your patients. Appointments are available within one week, or patients may be transferred hospital to hospital. We guarantee seamless communication every time, and your patients will always return back to you. We also give all referring physicians our cell phone numbers so you can contact anyone on our team at any time.

Contact us. Call 704-617-8154 or email SHVIStructuralHeart@AtriumHealth.org.

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