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New Valve Disease Guideline: Rethinking TAVR vs SAVR, MitraClip Indications

— PARTNER 3, Evolut Low Risk, COAPT trials make their mark

MedpageToday
A closeup of a surgeon holding an aortic valve replacement with forceps.

Transcatheter interventions get more love in updated valvular heart disease guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA).

Patients with severe aortic stenosis who have choices for intervention should be included in shared decision-making that considers the lifetime risks and benefits associated with type of valve and type of approach, according to a class I recommendation in the guideline, .

That said, when aortic valve replacement is indicated, the surgical approach continues to be recommended for most groups. Notable exceptions are people age 65-80 years for whom shared decision-making is emphasized, and people over 80 years old (or younger patients with short life expectancy) for whom transfemoral transcatheter aortic valve replacement (TAVR) is now recommended.

This marks a change from previous guidelines, namely the 2014 version and its 2017 focused update, that had the pool of TAVR candidates further narrowed by surgical risk.

"Current research and new technology continue to transform the treatment of heart valve disease, as updated lifestyle and medication guidance evolve, and less invasive procedures have replaced traditional surgery for many patients," said guideline writing committee co-chair Catherine Otto, MD, of the University of Washington in Seattle, in a .

With the new guideline, ACC/AHA reviewers incorporated evidence from 2019 that people with severe aortic stenosis and low surgical risk have clinical outcomes that are on par with or even better than surgery. The indication for low-risk TAVR was FDA approved within months of the PARTNER 3 and Evolut Low Risk trial presentations.

Guideline authors noted that the timing of treatment for aortic stenosis should be based primarily on symptoms or reduced ventricular systolic function. For some with severe aortic stenosis but no symptoms, aortic valve replacement may be reasonable.

As for people with valvular regurgitation, Otto's group determined that the indications for intervention are for symptom relief and prevention of the irreversible long-term consequences of left ventricular volume overload.

Other class I recommendations call for aortic valve surgery in symptomatic patients with severe aortic regurgitation, regardless of left ventricular (LV) systolic function, and in asymptomatic patients with severe aortic regurgitation and LV systolic dysfunction. Aortic valve surgery may be considered in other asymptomatic patients meeting certain criteria.

"Thresholds for intervention now are lower than they were previously because of more durable treatment options and lower procedural risks," according to the authors.

Another important addition to the guidelines is the class IIa recommendation for mitral transcatheter edge-to-edge repair (previously dubbed "transcatheter mitral valve repair") to treat patients with chronic severe secondary mitral regurgitation related to LV systolic dysfunction who remain severely symptomatic despite guideline-directed medical therapy.

Supporting this decision was evidence from 2019's COAPT trial showing quality of life benefits of MitraClip therapy in these patients.

Otto and colleagues also handed a small boost to mitral transcatheter edge-to-edge repair for people with severely symptomatic primary mitral regurgitation who are at high or prohibitive risk for surgery.

The old class IIb (weak) recommendation for this procedure was bumped up to class IIa (moderate) when mitral valve anatomy is favorable and patient life expectancy is at least 1 year.

The ACC/AHA guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, the Society of Cardiovascular Anesthesiologists, and the Society of Thoracic Surgeons.

  • author['full_name']

    Nicole Lou is a reporter for ֱ, where she covers cardiology news and other developments in medicine.

Disclosures

Otto had no disclosures.

Primary Source

Circulation

Otto CM, et al "2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines" Circulation 2020; DOI: 10.1161/CIR.0000000000000923.