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May 24, 2016

TAVR Offers Safe Alternative to Surgery for Many Patients with Aortic Stenosis

Minimally invasive procedure is as safe, if not moreso, than traditional surgery for higher-risk patients.

A new, minimally invasive procedure used to treat aortic stenosis may offer a safe option for patients that are too high-risk for surgery, according to research published in the New England Journal of Medicine.

Known as the PARTNER (Placement of Aortic Transcatheter Valves) 2 trial, this study compared the safety of two treatments for severe aortic stenosis—transcatheter vs. surgical aortic valve placement.

Transcatheter aortic valve replacement, often referred to as TAVR, is a new, minimally invasive procedure used to repair faulty aortic valves in patients with aortic stenosis. Surgical valve replacement, on the other hand, is a more invasive surgery that has been used for decades to treat this condition. Although surgery is the gold-standard for treatment, it can be too risky for certain patients like those with other serious health conditions. So while it’s a relatively new procedure, TAVR may be a safer, less-invasive option for higher risk patients.

To explore further, researchers randomly assigned more than 2,000 patients with severe aortic stenosis to TAVR or surgical replacement. Patients were considered “intermediate” risk for surgery, with overall risk scores from 4–8%. Participants were then followed for two years, tracking complications such as stroke and death.

After analysis, researchers found that TAVR was, at the very least, just as safe as surgery in higher-risk patients. After two years, risk of stroke or death was 19.3% in the TAVR group, compared with 21.1% in the surgical group. TAVR had even lower risk of complications when the valve was accessed through arteries in the leg rather than the chest.

Authors also note that patients undergoing TAVR had significantly lower rates of hospitalization, bleeding, kidney injury, and an abnormal heart rhythm called atrial fibrillation.  

Based on findings, authors conclude that TAVR is, at the very least, equally as safe as surgery for intermediate-risk patients with aortic stenosis. In fact, data suggests that TAVR may actually have lower risk of complications and faster recovery than traditional surgery.

However, it’s important to note that while the study included patients with “intermediate” risk for surgery, this level of risk is still fairly high. Past trials already suggest that TAVR is safe and effective in the highest-risk patients that are ineligible for surgery. This trial extended findings to confirm safety in intermediate risk patients. So while promising, findings only apply to patients with severe aortic stenosis that are considered higher risk for surgery.

Questions for You to Consider

  • What is aortic stenosis and how does it progress over time?

  • Aortic stenosis occurs when the aortic valve does not open fully, which can obstruct normal blood flow and put extra stress on the heart. Aortic stenosis can start out mild, but worsen over time as the area of the aortic valve decreases lessening the amount of blood flowing from the heart. Patients with aortic stenosis should be continually monitored by a cardiologist to track the progression of this condition, and strenuous activity should be avoided in those with moderate to severe aortic stenosis.
  • What is TAVI?

  • Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure in which the faulty aortic valve is replaced with a prosthetic valve using a small tube that travels from an artery in the leg or chest to the heart. TAVI is less invasive than traditional open-heart surgery and often reserved for individuals at increased risk of complications from aortic valve surgery.

Related

Minimally Invasive Procedure for Replacing Surgical Aortic Valves

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Treatment Options for Patients with Severe Aortic Stenosis

Minimally-invasive procedure, TAVI, is promising for patients with severe aortic stenosis.

Update on Transcatheter Aortic Valve Replacements in the U.S.

National registry helps assess safety and efficacy of minimally-invasive procedure used to treat aortic valve stenosis.

Head-to-Head Comparison of Heart Valves

New research clarifies which type of valve replacement device is most effective in treating patients with severe aortic stenosis.