Cardiologists, heart surgeons sound alarm over widespread use of TAVR in low-risk patients
Transcatheter aortic valve replacement (TAVR) is being used to treat a rising number of patients with severe aortic stenosis. However, according to a new commentary published in the Journal of the American College of Cardiology (JACC), this trend may have gone too far.[1] The authors fear that too many low-risk patients are undergoing TAVR when they should be considered for surgical aortic valve replacement (SAVR) instead.[1]
“With some U.S. states documenting that nearly 50% of patients requiring aortic valve replacement aged <65 years receive TAVR rather than guideline-directed SAVR, a significant public health concern may be looming,” wrote first author J. Hunter Mehaffey, MD, MSc, a cardiac surgeon with West Virginia University (WVU), and colleagues. “While we await long-term data from trials, there are growing questions surrounding valve durability and reintervention rates, particularly in younger and lower-risk populations. These concerns include the potential deleterious effects of accelerated structural valve deterioration, and the commensurate rise in the need for premature surgical TAVR explantation.”
Mehaffey et al. emphasized that the risks associated with SAVR are typically procedural. With TAVR, however, some risks persist for up to two years after treatment. In addition, the group added, many patients who care teams treat on a daily basis were excluded from the initial studies used to track the safety and effectiveness of TAVR in low-risk patients. This creates uncertainty about whether or not a patient with a bicuspid aortic valve, for example, should be treated with TAVR over SAVR.
Still waiting on long-term data
Another key takeaway from the new commentary is the fact that additional data is still on the way. For example, some clinicians are concerned about so many low-risk patients undergoing TAVR because 10-year results from the PARTNER 3 and Evolut Low Risk trials will not be published for another five years or so.
These studies were specifically designed to evaluate the long-term impact of TAVR in low-risk patients who may have previously undergone SAVR. Anticipation for 10-year results is already high. Until those results arrive, however, the concerns about structural valve deterioration and other potential issues are unlikely to subside.
The importance of communication
The commentary’s authors also noted that patients should always be given as much information as possible about their different treatment options. There may be an initial push from the patient and/or their family to go with TAVR, but the facts should be presented before any final decision is set in stone.
“Counseling patients on the short- and long-term risk and benefits of valve intervention is a critical role of the multidisciplinary heart team,” they wrote. “It is incumbent upon heart teams to use all available evidence, including both randomized and registry data, to communicate the longitudinal effects of TAVR and SAVR before making recommendations to patients with 15- to 20-year life expectancy, especially given that the risks of multiple aortic valve interventions may be exponential rather than additive. That said, to address the important weight of patient choice, SAVR also must evolve to a reproducible least-invasive method that avoids a conventional sternotomy.”
Additional details
The commentary’s other co-authors were Ramesh Daggubati, MD, and Vinay Badhwar, MD, two veterans of WVU’s department of cardiovascular and thoracic surgery. Daggubati is WVU’s interim chief of cardiology, and Badhwar is the executive chair of the WVU Heart and Vascular Institute
Click here to read their full commentary.
Another cardiologist shares his concerns
Sanjay Kaul, MD, a cardiologist with Cedars-Sinai Medical Center, shared his own concerns about the rise of TAVR among low-risk patients in another JACC commentary.[2] He reviewed several recent studies, including five-year updates from the PARTNER 3 and Evolut Low Risk trials, and concluded that they “reinforce previous reports indicating that the advantage of TAVR over SAVR is not constant over time and might disappear or be reversed with longer follow-up.”
Kaul concluded by asking if care teams can “put the genie back in the bottle.” He even asked if TAVR should only receive a Class 2 recommendation for the treatment of low-risk patients.
Click here to read Kaul’s full analysis.
Defending TAVR’s role
Yet another new commentary in JACC included a more positive perspective when it comes to the increased use of TAVR among certain patient populations.[3] Its co-authors pushed back against the idea that TAVR should lose its Class 1 recommendation for the treatment of low-risk patients.
“Over 20 years have passed since the first successful TAVR, and the cumulative evidence is more comprehensive than for any other device intervention across cardiovascular medicine,” wrote first author Rohin K. Reddy, MBBS, a researcher with Imperial College London, and colleagues. “More than 10,000 participants across the spectrum of surgical risk have been enrolled in 11 randomized controlled trials (RCTs) comparing TAVR with SAVR. At a similar stage of maturity, only one RCT comparing percutaneous coronary revascularization with medical therapy had been completed, and none vs. bypass surgery.”
The group did acknowledge the potential risks of indication creep, noting that “lifetime management issues” are especially important when discussing the treatment of younger patients. Ultimately, Reddy et al. landed on a point made in every other commentary: more research is still required.
Their full commentary is available here.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.