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May 01, 2015

Study Helps Patients Understand Risks of Non-Surgical Valve Replacement

New data will help patients better understand risks tied to factors like age, gender and existing medical conditions.

Patients with aortic stenosis will have a better understanding of the risks associated with a transcatheter aortic valve replacement, thanks to a recent study published in the Journal of the American Medical Association.

Transcatheter aortic valve replacement, often referred to as TAVR, is a minimally invasive procedure used to treat aortic stenosis (narrowing of the aortic heart valve). TAVR is typically reserved for patients with severe aortic stenosis who can’t undergo open-heart surgery, often due to high risk of surgical complications.

Although TAVR has been approved for use in the United States, it is a relatively new procedure and long-term data on risks and benefits are limited. That’s why the American College of Cardiology and Society of Thoracic Surgeons teamed up to create a national program called the Transcatheter Valve Therapy (TVT) Registry, which tracks outcomes of patients undergoing TAVR.

Using this registry, researchers recently analyzed the risk of serious complications from TAVR, including stroke, rehospitalization and death. The study included more than 12,000 patients from 299 U.S. hospitals that underwent TAVR anytime between 2011 and 2013. Analyzing short-term data, researchers found that risk of death within one month of the procedure was 7%. After following patients for one-year, overall risk of stroke was 4%, and risk of death was 24%.

However, risks varied significantly depending on factors like age, gender and existing medical conditions. Age had a major influence on risk of complications. The younger the patient, the lower their risk of death. For example, patients greater than 95 years old had 61% greater risk of death within one year compared to patients less than 75 years old. Men also had 21% greater risk of death compared to women. Patients with conditions like end-stage kidney disease and COPD (chronic obstructive pulmonary disease) had significantly greater risk of death than those without coexisting conditions.

Authors hope findings will be helpful in patient-clinician discussions around the risks and benefits of TAVR. TAVR can be a great treatment option for patients with aortic stenosis who are moderate to high risk for surgical treatment. However, risk can vary greatly depending on the unique characteristics of each patient. It’s important to take these factors into account when considering TAVR as a potential treatment.

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

TAV-in-SAV procedure safe and effective in high-risk patients.

TAVR Improves Quality of Life for Patients with Aortic Stenosis

A minimally invasive procedure improves quality of life in 62% patients with aortic stenosis, finds recent study.

Heart Disease and Aortic Stenosis Remain a Challenging Combination

Experts address challenges in performing transcatheter aortic valve replacement in patients with heart disease.

Treatment Options for Patients with Severe Aortic Stenosis

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