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TAVR with CoreValve outperforms surgery at one year

Peter Tadros, MD, cardiologist, George Trip Zorn III, MD, cardiothoracic surgeon

Severe aortic stenosis is a lethal disease with lower survival rates than some metastatic cancers: as low as 50% at two years and 20% at five years.

This condition commonly develops with age and occurs when the aortic valve narrows and obstructs blood flow from the heart to the body. As a result, blood pressure in the heart increases, causing weakness and poor function. Severe aortic stenosis frequently leads to heart failure and sudden cardiac death when left untreated. As many as 50% of patients with severe symptoms die within two years without appropriate medical intervention.

Current treatment options

Surgical aortic valve replacement, or SAVR, is almost always recommended as a course of treatment for symptomatic patients. However, many patients are not ideal candidates for SAVR due to increased surgical risks. It has been estimated that as many as 30-60% of patients with severe aortic stenosis will not undergo surgical valve replacement.

A less-invasive option for high-risk patients is transcatheter aortic valve replacement.* TAVR uses a wired catheter to percutaneously implant a prosthetic valve by way of the femoral artery or left ventricular apex of the heart. This technique offers many advantages, including:
  • Faster surgery time
  • Quicker recovery
  • Less stress to patients
Once in position, the device functions as a healthy valve.

TAVR research in high-risk patients

Previous research comparing TAVR techniques to SAVR in high-risk patients demonstrated equivalency at best. The Partner Trial is a well-known, randomized, controlled study that tested the safety and effectiveness of TAVR compared to surgical valve replacement using the Edwards SAPIEN transcatheter heart valve. Results showed expected 30-day all-cause mortality rate for TAVR at 3.4% and surgery at 6.5%, with similar outcomes observed at one year (24.2% TAVR vs. 26.8% SAVR, P = 0.001 for noninferiority).

Research and findings

The CoreValve® prosthesis by Medtronic acts similarly to the Edwards SAPIEN valve. Like SAPIEN, CoreValve can be implanted through a delivery catheter and channeled through the arteries to the aorta without open-heart surgery. The CoreValve design features a flexible, self-expanding nitinol frame and can be deployed in multiple stages for precise position adjustments.

The University of Kansas Hospital was one of 45 clinical sites in the United States participating in the CoreValve U.S. Pivotal Trial. This study is the first instance in which TAVR therapy has demonstrated superiority to surgery in high-risk patients with severe aortic stenosis.

In the study, patients were randomized in a 1:1 fashion to receive either CoreValve or standard surgical valve replacement surgery. At one year, TAVR demonstrated superiority to SAVR with all-cause mortality at 14.2% for TAVR and 19.1% for SAVR (p=0.04), despite excellent surgical technique and surgery results. The study was reported at the American College of Cardiology 2014 Scientific Sessions and published in the New England Journal of Medicine.

Long-term implications

Treatment with TAVR is clearly proven for those who are high-risk or inoperable. Whether TAVR will demonstrate superiority over surgery in moderate or low-risk patients is still under investigation. As the design for prosthetic valves improves and technology becomes more sophisticated, we may see a day when TAVR becomes the predominant therapy for severe aortic stenosis.

Dr. Tadros is a cardiologist at The University of Kansas Hospital. He also serves as associate professor of cardiology and director of interventional cardiology at the University of Kansas Medical Center.

Dr. Zorn is a cardiothoracic surgeon at The University of Kansas Hospital, as well as assistant clinical professor of cardiothoracic surgery at the University of Kansas Medical Center.


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