Disclosures: The study was funded by Edwards Lifesciences. Makkar reports receiving research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and receiving personal fees from Edwards Lifesciences for travel. Otto and Newby report no relevant financial disclosures.
September 21, 2021
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In patients with TAVR, outcomes similar in bicuspid, tricuspid aortic valves

Disclosures: The study was funded by Edwards Lifesciences. Makkar reports receiving research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and receiving personal fees from Edwards Lifesciences for travel. Otto and Newby report no relevant financial disclosures.
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In patients at low surgical risk who underwent transcatheter aortic valve replacement with a balloon-expandable valve, those with bicuspid aortic valves had no excess death and stroke risk compared with those with tricuspid aortic valves.

Raj R. Makkar

Raj R. Makkar, MD, vice president of cardiovascular innovation and intervention and the Stephen R. Corday, MD, Chair in Interventional Cardiology at Cedars-Sinai, and colleagues analyzed 3,168 propensity-matched pairs of patients (mean age, 69 years; 70% men) from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry who underwent TAVR with a balloon-expandable valve (Sapien 3 and Sapien 3 Ultra, Edwards Lifesciences) from June 2015 to October 2020.

Older man having stroke
Source: Adobe Stock

The primary outcomes were 30-day and 1-year mortality and stroke. STS Predicted Risk of Mortality was 1.7% in both the bicuspid group and the tricuspid group.

Similar mortality, stroke rates

The bicuspid and tricuspid groups had similar mortality rates at 30 days (bicuspid, 0.9%; tricuspid, 0.8%; HR = 1.18; 95% CI, 0.68-2.03; P = .55) and at 1 year (bicuspid, 4.6%; tricuspid, 6.6%; HR = 0.75; 95% CI, 0.55-1.02; P = .06), Makkar and colleagues found.

The groups were also similar in stroke rates at 30 days (bicuspid, 1.4%; tricuspid, 1.2%; HR = 1.14; 95% CI, 0.73-1.78; P = .55) and 1 year (bicuspid, 2%; tricuspid, 2.1%; HR = 1.03; 95% CI, 0.69-1.53; P = .89), they found.

The bicuspid and tricuspid groups also did not differ bicuspid and tricuspid groups in procedural complications, aortic valve gradient (bicuspid, 13.2 mm Hg; tricuspid, 13.5 mm Hg; absolute risk difference, 0.3 mm Hg; 95% CI, –0.9 to 0.3 mm Hg) and moderate or severe paravalvular leak (bicuspid, 3.4%; tricuspid, 2.1%; absolute risk difference, 1.3 percentage points; 95% CI,–0.6 to 3.2), according to the researchers.

“While the short-term outcomes with TAVR for bicuspid aortic stenosis in this study were not significantly different from those for tricuspid aortic stenosis, randomized clinical trials comparing TAVR vs. surgery with longer-term follow-up data are needed to direct the optimal interventional or surgical management of aortic stenosis in these patients,” Makkar and colleagues wrote.

Longevity questions remain

In a related editorial, Catherine M. Otto, MD, director of the Heart Valve Clinic, the J. Ward Kennedy-Hamilton Endowed Chair in Cardiology and professor of medicine at the University of Washington School of Medicine in Seattle, and David E. Newby, MD, British Heart Foundation Professor of Cardiology at the University of Edinburgh, United Kingdom, wrote that: “Additional evidence is needed to understand the precise implications of TAVR longevity. The majority of long-term data are based on studies that involved older populations with higher surgical risk. Because of competing risks, many older patients die of nonvalvular causes, and those who survive will be more sedentary and their valves may appear more durable than they really are. TAVR in younger lower-risk patients may result in adverse outcomes and more complex surgery for later life. Therefore, physicians need to be mindful of these issues when considering patients for TAVR. More robust long-term durability data are needed for patients with either bicuspid or trileaflet aortic valve disease, but particularly for those with bicuspid aortic valves.”

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