Despite concerns to the contrary, the introduction of transcatheter aortic valve implantation (TAVI) into everyday practice has not decreased the number of patients undergoing surgical valve replacement, researchers found.
Rather, the volume of patients undergoing surgery has actually increased since the Edwards Sapien valve was cleared by the FDA in November 2011, with the biggest gains seen at centers in which TAVI was also available, according to J. Matthew Brennan, MD, MPH, of Duke University Medical Center.
Outcomes improved, as well, with in-hospital mortality declining overall for patients undergoing an aortic valve procedure, he reported at the Society of Thoracic Surgeons (STS) meeting in Orlando.
“With more options available for patients, we can better fit them to the treatment that’s appropriate for them rather than trying to treat them with a treatment that maybe is not the best for them,” he told MedPage Today. “So more individualization of treatment decisions. And that’s good for everybody. That’s good for patients. That’s good for treating physicians.”
But there was some bad news. After TAVI was introduced commercially, in-hospital mortality ticked up in patients undergoing the procedure, even after accounting for differences between patients treated in various time periods. Brennan called that finding “somewhat concerning.”
Although the increase in mortality needs to be explored further, Brennan said it could have to do with the learning curve at new centers that did not participate in the TAVI clinical trials or with the treatment of sicker patients who would not have met the inclusion criteria of the trials.
“Even though patients in general are doing better, there’s a signal that something has happened since commercialization that we need to look into more,” he said.
Brennan and his colleagues combined data from the STS Adult Cardiac Surgery Database and the Transcatheter Valve Therapy (TVT) Registry created by the STS and the American College of Cardiology after the Sapien valve hit the market. The analysis included 215,767 patients who underwent surgical aortic valve replacement and 11,536 who underwent TAVI from January 2008 through June 2013.