Currently, the majority of individuals who undergo transcather aortic valve replacement (TAVR)—a minimally invasive alternative to open-heart surgery—are elderly or subject to compounding complications such as kidney disease. Thanks to a pair of new studies published in the New England Journal of Medicine, however, TAVR is poised to become an increasingly accessible option for low-risk patients, including the young and generally healthy.
Compared to traditional open-heart surgery, which involves cracking the chest open and stopping the heart, TAVR is a relatively simple procedure. Cardiologists use a catheter to insert a replacement valve via an incision in the patient’s groin, Michelle Cortez writes for Bloomberg, and then thread the device into place. According to The New York Times’ Gina Kolata, recovery takes days rather than months.
As Peter Loftus reports for the Wall Street Journal, two clinical trials sponsored by competing valve makers Edwards Lifesciences and Medtronic suggest TAVR is just as beneficial as, or perhaps even better than, open-heart surgery for low- and high-risk patients alike. The Edwards-funded study found that TAVR offers lower rates of death, stroke and re-hospitalization than surgery, while the Medtronic-funded study revealed similar incidences of death and disabling stroke amongst those treated with TAVR versus invasive surgery.
Of 1,000 healthy, lower-risk patients who received an Edwards Sapien 3 valve, 8.5 percent died, suffered a stroke or were re-hospitalized within a year of treatment. Comparatively, Bloomberg’s Cortez observes, 15.1 percent of surgery patients experienced these same consequences during the first year post-procedure.
Turning to the more than 1,400 individuals treated with Medtronic’s Evolut valve, Cortez notes that 5.3 percent—as opposed to 6.7 percent of surgery patients—died or had a disabling stroke within two years of treatment. This difference is not considered statistically significant, according to Reuters’ Tamara Mathias, but still managed to meet the company’s stated goal of “non-inferiority” to open-heart surgery.
To date, Loftus points out for the Journal, nearly 200,000 U.S. patients have undergone TAVR. As the Times’ Kolata adds, some 60,000 intermediate- and high-risk patients receive the treatment annually. If the Food and Drug Administration approves the technique for use in lower-risk patients—Michael Reardon, a co-author of the Medtronic study, tells the Houston Chronicle’s Todd Ackerman this may happen as early as June—an additional 20,000 individuals per year will become eligible for the operation. Within several years, Reardon predicts, the number of TAVR procedures performed in the U.S. annually could jump to 100,000.
“This is a clear win for TAVR,” Michael J. Mack, lead investigator of the Edwards study, says in an interview with Kolata.
Moving forward, Mack continues, “we will be very selective” about who must undergo open-heart surgery.
As Ackerman writes, the key question remaining is biological versus mechanical valves’ longevity. Although mechanical valves last for decades, they require the lifelong use of blood thinners and, of course, carry the physical toll exacted by invasive surgery. Biological valves, on the other hand, don’t require blood thinners but likely won’t last as long as mechanical ones. If a patient’s biological valve wears out, he or she will need to undergo follow-up procedures.
Still, Reardon tells Ackerman, he thinks that most patients, if given the choice, will opt for TAVR over open-heart surgery.
“With TAVR, most patients are home within 24 hours and back to normal within a week,” Reardon concludes. “The evening after I do a morning procedure, I’ll find the patients sitting in a chair in their room having dinner, chatting with family and wanting to know when they can go home.”