JAMA Deputy Editor Gregory Curfman, MD, gives editorial insight into the UK TAVI Trial results and accompanying editorial published in the May 17, 2022, issue of JAMA.
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I’m Dr. Gregory Curfman, a deputy editor of JAMA. I’ll be discussing a new Original Investigation published in JAMA by Dr. William D. Toff and colleagues titled, “Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients with Aortic Stenosis,” referred to as The UK TAVI Trial, which is paired with an accompanying editorial by Drs. Catherine M. Otto and Jae-Kwan Song titled, “Treatment of Aortic Stenosis with Transcatheter Aortic Valve Implantation.”
Several important randomized clinical trials of transcatheter aortic valve implantation (or TAVI) versus surgical aortic valve replacement (or SAVR) have been published previously, so why did the editors decide to publish this new study in JAMA?
There are some important differences in study organization and design. The study included all institutions in the UK that perform TAVI and, in contrast to previous trials in which a single valve type was used, the new study included all types of TAVI valves that had received European Commission authorization. All patients with severe aortic stenosis who met eligibility criteria based on age and comorbidities were enrolled in this pragmatic trial. The 913 patients were 70 years of age or older, with a median age of 81 years, and all were determined to be at moderately increased surgical risk based on age and comorbidities, a specific category of risk that has not been previously studied. And in contrast to many prior trials, this study was investigator-initiated and received no industry sponsorship.
The investigators found that treatment with TAVI was noninferior to treatment with SAVR for the primary endpoint of all-cause mortality at one year. This finding confirms previous trials in patients with moderate surgical risk, suggesting that the choice of TAVI vs SAVR in such patients may be based on shared decision making between the physician and the patient. It’s also noteworthy that TAVI was associated with shorter hospital stays and less major bleeding, but more vascular complications and need for permanent pacemakers.
It's important to highlight, as the editorialists do, that these findings may not necessarily apply to younger patients with severe aortic stenosis. It’s not yet known if TAVI valves may be prone to degeneration and calcification over time, as bioprosthetic surgical valves are. Longer-term follow up will be essential to study TAVI valve durability.
The first TAVI procedure was performed 20 years ago, on April 16, 2002, by Dr. Alain Cribier, in Rouen, France, and this new study in JAMA is a demonstration of just how far this pathbreaking technology has come in 20 years. But, as Drs. Otto and Song mention in their editorial, “The best valve for each patient is their own valve.” By the time a patient with aortic stenosis is symptomatic, pathological changes in the myocardium, such as myocardial fibrosis, have already occurred due to prolonged pressure overload. Medical therapies to prevent and treat calcific aortic stenosis at an earlier stage are an important long-term goal.
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