Even after the results of the PARTNER trial showed promise for balloon-expandable transcatheter aortic valve implantation (TAVI) in patients unsuitable for surgery, researchers are still questioning the role the technology will have, and said that many issues still need to be resolved, according to a commentary published in the Oct. 21 issue of the New England Journal of Medicine.
“Aortic-valve replacement is the most effective treatment to alleviate symptoms and improve survival in patients with critical aortic stenosis,” wrote Harold L. Lazar, MD, of the Boston Medical Center, Boston.
Because many elderly patients with coexisting conditions are ineligible for surgery but still require aortic-valve replacement, the TAVI technique has emerged as an alternative, less-invasive treatment method.
While PARTNER trial results showed a lower incidence rate of death at one-year, fewer readmissions and a reduction in cardiac symptoms, Lazar asked, “Where do we go from here?” Before this question is answered, he said that many issues must first be resolved.
First, researchers must determine a specific set of criteria that will outline who is not a candidate for surgical aortic valve replacement—this must involve surgeons, he said.
“It is important to define the criteria for high risk or inoperable aortic stenosis, since there are discrepancies among various risk scoring systems in the prediction of the risk of death,” he wrote. However, age alone should not be used as inclusion criteria.
Secondly, Lazar offered that criteria must outline who should perform TAVI and where it should be performed. He said it is important that the technique is performed by physicians with a strong expertise in catheter techniques and said that there is a “definite learning curve” that has been outlined in previous studies.
While the PARTNER trial outlined the 30-day and one-year survival rates of TAVI, Lazar said that further trials that measure the quality of life and that compare TAVI with surgical aortic valve replacement in both high-risk and low-risk patients are needed.
“Only then can we determine where we go from here,” Lazar concluded.