A new study in NEJM offers the most promising evidence to date to support the use of transcatheter aortic valve replacement (TAVR) over open-heart surgery.
Approximately 70,000 U.S. residents undergo aortic valve procedures to alleviate symptoms like chest pain and shortness of breath so severe it can interfere with everyday activities, according to the Society of Thoracic Surgeons. Traditionally, the condition has been treated with open-heart surgery, which involves cracking open the chest cavity, removing the damaged valve, and replacing the tissue with a prosthesis.
While the older and more invasive approach requires eight weeks of recovery, patients can recover in one week or less with TAVR, which requires just a tiny incision between the ribs or through the femoral artery in the groin. Doctors say the difference in recovery times could make aortic valves created by Edwards Lifesciences and Medtronic part of standard cardiac care.
NEJM: Promising findings for Medtronic's CoreValve
The NEJM study, which was presented at the American College of Cardiology's annual meeting, examined 795 patients with severe aortic stenosis who were at high risk for surgery. The patients either received traditional surgical valve replacement or TAVR using Medtronic's CoreValve device.
After one year, about 14% of patients treated with Medtronic's CoreValve had died, compared with 19% of patients who underwent open-heart surgery.
However, 22% of patients on CoreValve required a permanent pacemaker by the end of the first year, compared to just 11% of open-heart surgery patients. Moreover, CoreValve patients had more leakage around the device than patients who underwent open-heart surgery.
Other risks associated with CoreValve compared with surgery included major vascular complications and heart perforation. However, surgery was more risky in terms of severe and life-threatening bleeding, acute kidney injury, cardiac shock, and new or worsening atrial fibrillation.
JAMA: The first comparison of valves from Edwards and Medtronic
Meanwhile, a study published this week in JAMA offered the first randomized comparison of the Edwards' Sapien balloon-expanding valve to Medtronic's self-expanding CoreValve.
The study involved 241 high-risk patients with severe aortic stenosis who underwent TAVR at five German hospitals. It found that physicians were able to successfully implant the Sapien in 96% of patients, compared with 76% of patients using Medtronic's self-expanding CoreValve.
However, experts say that the comparison is not so simple. "There are clearly features of both valves that are good and not so good," says Gordon Tomaselli, Johns Hopkins' chief of cardiology, adding that this "trial is not going to be the final arbiter about which valve one uses. It's not to me definitive." He notes that the difference could have stemmed from physicians' varying levels of comfort with the valves.
Overall, Michael Rinaldi of the Carolinas HealthCare System's Sanger Heart & Vascular Institute says the increasingly positive TAVR results "shows that technique and patient selection is getting better." He added that open-heart "surgery is an established technique and we don't expect that to get better over time," but "[w]ith new devices, clinicians get better over time" (Fay Cortez, Bloomberg BusinessWeek, 3/29; Husten, Forbes, 3/29; Peck, MedPage Today, 3/31; Fay Cortez, Bloomberg, 3/30).
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