TAVR Looms Large in First Appropriate-Use Criteria for Severe Aortic Stenosis

October 20, 2017

WASHINGTON, DC — A group of specialty societies have released what's billed as the first appropriate-use criteria (AUC) for treating severe aortic stenosis, at a time of increasing questions about applying transcatheter or surgical aortic-valve replacement (TAVR or SAVR) guidelines to individual patients with often-complex presentations[1].

"We have a therapy available now for anyone with severe aortic stenosis," AUC writing group chair Dr Robert O Bonow (Northwestern University Feinberg School of Medicine, Chicago IL) told theheart.org | Medscape Cardiology.

"The real concern is on the high end of the riskiest patient, the elderly patient with lots of other diseases." TAVR, for example, might just be for them, he said, but is it appropriate to recommend it for every such patient?

The AUC document lists 95 clinical scenarios across seven broad patient categories accounting for presentations that vary by such features as LVEF, transvalvular pressure gradient, prevalence of specific comorbidities, or Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) score.

It rates the appropriateness of several available therapies for severe aortic stenosis, including "no intervention," TAVR, SAVR, balloon aortic valvotomy (BAV), and in some cases PCI or CABG.

The AUC "provide a way of moving beyond the guidelines, which give you black-and-white recommendations, sometimes based on evidence and sometimes based on consensus," Bonow observed.

In contrast, the AUC clinical scenarios, which he acknowledges can't be comprehensive but account for most cases, help "when you're faced with an individual patient, who has individual circumstances."

TAVR or SAVR may be recommended for symptomatic aortic stenosis overall, "but what do you do when then patient has diabetes or lung disease and is 92 years old?" Kidney disease, liver disease, and dementia can also complicate matters and are represented among the AUC scenarios.

"And in some cases, doing nothing would be equally appropriate and sometimes more appropriate," said Bonow.

The first dozen scenarios apply to patients with asymptomatic, high-transvalvular-gradient aortic stenosis that is severe to varying extents, with high or low LVEF, positive or negative stress tests, varying STS-PROM scores, and by other criteria. Of note, when intervention is appropriate in such cases, the document says that either SAVR or TAVR could fill the bill.

The next 17 scenarios note the appropriateness of no intervention, balloon valvotomy, or either SAVR or TAVR by varying degrees of flow, transvalvular gradients, and LVEFs.

Scenarios 30 to 54 focus on patients with severe aortic stenosis at either high or extreme risk as determined by STS-PROM score and complicated by either multiple or specific comorbidities, frailty, or complex anatomy like porcelain aorta.

The next dozen scenarios focus on symptomatic, severe aortic stenosis with high transvalvular gradient and coronary artery disease; almost two-thirds of patients undergoing TAVR have CAD, the report notes. "No intervention" is not even mentioned among the possibly appropriate interventions.

Scenarios 67 to 85 cover symptomatic cases with "other valve or ascending aortic pathology," such as mitral, tricuspid, or bicuspid valve disease, septal hypertrophy, or narrow left ventricular outflow tract.

The next four focus on patients with hemodynamically severe aortic stenosis undergoing noncardiac surgery, either elective or urgent.

And scenarios 90 to 95 address patients with symptomatic aortic stenosis due to an aortic bioprosthesis no longer functioning properly.

The AUC assume the patient is under the care of a heart team that may include cardiologists, surgeons, imaging specialists, nurses, and social workers, Bonow said.

The document is "going to have to be" a dynamic one, the field changes so fast, he said. "We started this process 2 years ago when the playing field was moving, and it continues to move now."

At the time, "TAVR was considered an appropriate alternative to surgical therapy only for patients who were high risk for surgery." Then it expanded to include intermediate risk, and more game changers may be on the way, Bonow noted, including TAVR trials in low-surgical-risk patients and those without symptoms.

Participants in the AUC report's development, other than the American College of Cardiology, include the STS and the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.

Bonow discloses institutional, organizational, or other financial benefit from Gilead Sciences, the Journal of the American Medical Association (editorial board), and the National Heart, Lung, and Blood Institute. Disclosures for the coauthors are listed in the paper's appendix.

Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

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