It may be safe to expand TAVR to new patient populations, including those with a bicuspid aortic valve (BAV) or those with cardiogenic shock, according to two recent studies using data from the STS/ACC TVT Registry.

The BAV study, published in JACC: Cardiovascular Interventions, found that patients with BAVs undergoing TAVR has similar 30-day and one-year mortality and stroke rates as patients with a tricuspid aortic valve.

John K. Forrest, MD, FACC, et al., compared outcomes of patients with bicuspid valves vs. tricuspid valves undergoing TAVR with the self-expanding Evolut R or Evolut PRO valve. The researchers performed propensity matching to create 929 matched pairs for analysis.

All patients were at increased surgical risk based on age or conditions like diabetes, prior surgery, stroke or peripheral vascular disease. The majority of bicuspid patients were at intermediate or high surgical risk.

After propensity matching, there were no significant differences in baseline characteristics between the two groups. At 30 days, the all-cause mortality rates were 2.6% in the bicuspid group vs. 1.7% in the tricuspid group. The one-year mortality rates were 10.4% and 12.1% for the bicuspid and tricuspid groups, respectively.

Stroke rates were also similar for both groups at 30 days (3.4% for bicuspid patients vs. 2.7% for tricuspid patients) and one year (3.9% for bicuspid patients vs. 4.4% for tricuspid patients).

In addition, there were no significant differences between the two groups for in-hospital events, including mortality, stroke, coronary obstruction, pacemaker implantations, vascular complications or length of stay.

Patients with bicuspid valves were more likely than those with tricuspid valves to require aortic valve reintervention at 30 days (0.8% vs. 0.1%) and at one year (1.7% vs. 0.3%).

According to the researchers, the study demonstrates that patients with bicuspid valves undergoing TAVR have similar 30-day and one-year mortality and stroke rates and quality of life improvement as those with tricuspid valves.

The study's findings are promising for patients with BAVs, who are often at a higher risk of valve complications. Earlier research has shown that up to 20% of people with a bicuspid valve will need replacement at some point.

"No one's valve works as well at age 70 as it does at age 20, but in patients with a bicuspid aortic valve, it's more likely to wear out and require replacement," said study lead author Forrest, director of the Structural Heart Disease Program at Yale University School of Medicine and Yale New Haven Hospital.

The researchers added that further randomized trials evaluating TAVR in low-risk patients with BAVs are needed to validate the findings. "This study suggests TAVR is a viable option for patients with bicuspid valve disease who are at increased surgical risk," Forrest said.

"It will be very important to continue to monitor these patients to see how the valves perform in 10 or 15 years."

The second study, also published in JACC: Cardiovascular Interventions, suggests that TAVR may be a viable option for patients with aortic stenosis (AS) presenting with acute cardiogenic shock.

For this study, Luke Masha, MD, MPH, FACC, et al., compared outcomes in AS patients presenting with cardiogenic shock before TAVR with a cohort of high-risk patients who were not in cardiogenic shock before undergoing TAVR.

The study's primary outcome was 30-day mortality following TAVR, while secondary outcomes looked at 30-day complications after TAVR.

The median STS score in the cardiogenic shock group was 9.8 vs. 10.3 in the high-risk control cohort. The shock population, compared with the high-risk population, was slightly younger (median age 83 vs. 86 years) and predominantly male (55.5% vs. 45.3%).

They were also more likely to have had a myocardial infarction (30.6% vs. 27.6%), at least moderate aortic insufficiency preprocedure (21.9% vs. 19.2%), and at least moderate mitral regurgitation (38.6% vs. 35.0%).

Nonfemoral access for TAVR was more common for the shock population (21.8% vs. 16.2%), and they were less likely to undergo annulus sizing with CT angiography (60.1% vs. 64.1%).

A total of 2,220 patients with AS and cardiogenic shock, representing 4.1% of the U.S. TAVR population, were compared with 12,851 high-risk patients undergoing TAVR. Patients with cardiogenic shock had higher 30-day mortality vs. those without cardiogenic shock (19.1% vs. 4.9%).

Compared with the control population, 30-day mortality in the cardiogenic shock group was associated with an adjusted hazard ratio of 3.7 (95% confidence interval [CI], 3.1-4.5; p<0.001).

In addition, 30-day mortality was higher among patients with prior cardiac arrest or who required preprocedural mechanical circulatory support.

The study demonstrates that TAVR is a viable treatment option for AS patients presenting with cardiogenic shock, according to the researchers.

Although these patients may have a higher mortality risk up to one year after the procedure, mortality "does not appear to be particularly driven by procedural complications, but rather by the degree of shock itself," they conclude.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, CHD and Pediatrics and Interventions, CHD and Pediatrics and Quality Improvement, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: ACC Publications, Cardiology Magazine, Aged, 80 and over, Adolescent, Aortic Valve, Mitral Valve, Tricuspid Valve, Mitral Valve Insufficiency, Shock, Cardiogenic, Transcatheter Aortic Valve Replacement, Confidence Intervals, Quality of Life, Universities, Bicuspid, Length of Stay, Heart Valve Diseases

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