![]() ![]() TAVR in low-risk patients is FDA-approved, and many people want it now. Unfortunately, most surgeons do not have a lot of experience in removing CoreValve and SAPIEN 3 valves yet, which could pose a risk to patients.Ģ. But if the patient needs surgery, the doctor would have to remove the existing valves and then replace them. Valve replacement or revision might be simple if the patient can have another TAVR procedure – a new tissue valve can be placed inside the previous valve. After the valve wears out, a patient will need to have a new valve placed or have another valve implanted during open heart surgery.Ī 65-year-old patient likely could be expected to live longer than 10 to 20 years after surgery, so durability of tissue valves must be validated. However, we don’t have data to verify that. Since TAVR valves are made of the same biological tissue, it is expected they will have the same longevity. ![]() Medical literature suggests the lifespan of the tissue valves used in surgical aortic valve replacement is typically about 10 to 20 years. And because TAVR candidates have traditionally been a sicker cohort, we do not have substantial data on the effectiveness of TAVR beyond five years or so after placement. However, aortic stenosis is a degenerative disorder, so it is more common in older patients. Data showed that these patients had similar or better outcomes compared to surgery in the midterm. The studies followed patients for only one to two years. The data were relatively short-term, and patients might need surgery later. The two competing medical device companies have both since published two-year results, which are in line with the initial reported findings.ġ. After a year, deaths related to stroke or re-hospitalization related to the disease, valve, or procedure occurred in 8.5 percent of patients who had TAVR and 15.1 percent of patients who had surgery. The data showed that outcomes with TAVR were significantly better than outcomes with surgery. #TO HEART 2 BEST ROUTE TRIAL#The three trial endpoints were death, stroke, or re-hospitalization after one year. The Edwards Lifescience’s trial studied the SAPIEN 3 valve. Disabling stroke affected 1.1 percent of TAVR patients and 3.5 percent of surgery patients. All-cause mortality rates were the same for both procedures. This study found that 5.3 percent of patients who had TAVR died or suffered a disabling stroke compared to 6.7 percent of patients who had surgery. Researchers assessed two endpoints after two years: death and disabling stroke. Medtronic’s trial studied the CoreValve platform. Approximately half of patients with aortic stenosis today are considered to have low surgical risk – hence the excitement about those studies. The new heart valve is inserted via catheter through an incision in the groin, guided inside the affected valve, and expanded to reopen it. ![]() In a TAVR procedure, a doctor can repair a diseased aortic valve without open heart surgery. Two separate studies presented at the March 2019 American College of Cardiology conference supported similar findings: After one to two years of follow-up, TAVR outcomes were found to be similar to surgical aortic valve replacement (SAVR) outcomes in patients with aortic stenosis and low surgical risk. Before we dive into that discussion, let’s go through the research on the topic. Still, some some long-term unknowns remain surrounding TAVR for low surgical risk patients. It’s understandable that patients are excited about TAVR, which offers immediate benefits of shorter recovery and less time spent in the hospital. However, two years have passed, and surgery still remains a viable and important treatment for aortic valve disease. Some were concerned about how open heart surgery is portrayed in the media, such as in this article in The New York Times that referred to “cracking open the ribs” and “stopping the heart.” While medically accurate, that type of verbiage is likely to be scary to patients and overly dramatic. As many as 50 percent of patients with aortic stenosis are low-surgical risk patients.Īfter the presentation of those landmark studies and the FDA approval of TAVR for low-risk individuals, many predicted the beginning of the end of open heart surgery. Food and Drug Administration's approval of TAVR for low-risk individuals – replacing a narrowed aortic valve through a small incision in a procedure performed in the cardiac catheterization laboratory or hybrid operating room, as opposed to open heart surgery – for patients with low surgical risk. Data from these studies supported the U.S. In March 2019, media outlets hailed two new studies on transcatheter aortic valve replacement (TAVR) as potentially signaling the beginning of the end of open heart surgery for aortic stenosis. ![]()
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