One-Year Mortality With TAVI Rose in Recent Years: TVT Registry

One-year mortality rates—both cardiac and noncardiac—have been nudging upwards in recent years, according to an analysis of US data from 2017 to 2022. The COVID-19 pandemic could have driven the shift, researchers say, but it’s too early to know whether that trajectory will persist.

Dhaval Kolte, MD, PhD (Massachusetts General Hospital and Harvard Medical School, Boston), and colleagues reported their results recently in JACC: Cardiovascular Interventions.

“I wasn’t expecting to see these trends,” Kolte told TCTMD. “What I was expecting to see is just declining trends in mortality.” Troublingly, the findings dovetail with those of another study, done by a different group but also using the TVT Registry as its data source, showing a rise over time in 30-day all-cause mortality after TAVI.

“We need to stop and take a pulse of what kind of patients are getting TAVI, and obviously when you look at the [big picture], it seems like patients are getting younger and less sick, because of the low-risk approvals and so on,” said Kolte.

However, the increase in noncardiac mortality raises questions about which types of patients are dying and why they were considered TAVI candidates, he added. “But at the same time, if their expected survival life expectancy is a year, which is what at least the high-risk and intermediate-risk trials used, then they would still be candidates for TAVR.”

Dharam Kumbhani, MD (UT Southwestern Medical Center, Dallas, TX), who serves on the TVT Registry Steering Committee, was similarly surprised by the data.

“I would have expected TAVR outcomes to improve over time between 2012 and 2022, both due to procedural improvements (sheath sizes, valve technology, etc) and due to expansion to low-risk patients,” he commented. “The increase in 1-year mortality is therefore confusing to me, and if true, a greater cause for concern.”

Kolte said that the researchers couldn’t tease out what drove the rising 1-year mortality they saw annually between 2018 and 2022. The COVID pandemic, which delayed all but essential treatment for many diseases and is also known to have shortened lifespans more generally, could well be responsible, he said. Other possibilities include expansion of TAVI to new centers and changes to reimbursement that loosened volume requirements.

Kumbhani agreed that it’s hard to know what to make of these results, given that the study period included the pandemic. “If these differences persist in the post-2022 (post-COVID) era, it would be a significant concern,” he said.

Higher Mortality From 2018 to 2022

The investigators analyzed data from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry on 36,877 patients (mean age 82.0 years; 42.8% women; 93.9% white) who died within 1 year of undergoing isolated TAVI between January 2012 and October 2022.

Nearly one-third (31.3%) died of a cardiac cause, with a median time to death of 1.3 months, and 68.7% of a noncardiac cause, with a median time to death of 4.4 months. Most of the noncardiac deaths were pulmonary (13.4%), while 9.3% were due to infections, 6.6% neurologic, 3.3% renal, 2.3% vascular, 2.2% due to malignancies, 1.1% gastrointestinal, and 0.5% due to trauma or suicide. Fully 29.9% were attributed to “other” noncardiac causes.

Compared with those whose deaths were cardiac, patients who died from noncardiac causes were more likely to be men; were more apt to be on dialysis and immunocompromised; had a lower prevalence of atrial fibrillation or flutter, carotid artery stenosis, conduction defect, hostile chest, porcelain aorta, and peripheral artery disease; were less likely to have had a prior aortic valve procedure, MI, CABG surgery, PCI, pacemaker, implantable cardioverter-defibrillator; and were less likely to present with heart failure, cardiogenic shock, or CAD. They also had a lower STS Predicted Risk of Mortality score and had fewer in-hospital complications (apart from stroke) than those who died of cardiac causes.

Between 2012 and 2017, the adjusted 1-year incidence and risk of post-TAVI mortality declined for both cardiac death (from 10.6% to 7.1%; HR 0.95 per year; 95% CI 0.92-0.97) and noncardiac death (7.1% to 4.4%; HR 0.92 per year; 95% CI 0.90-0.93). Then, between 2018 and 2022, 1-year mortality rose for both cardiac death (from 7.1% to 12.2%; HR 1.07 per year; 95% CI 1.05-1.09) and noncardiac death (from 4.4% to 9.2%; HR 1.22 per year; 95% CI 1.20-1.24).

If these differences persist in the post-2022 (post-COVID) era, it would be a significant concern. Dharam Kumbhani

Independent predictors for increases in both types of mortality included procedure year, age older than 80 years, comorbidities, poor functional status, nonelective procedure, nonfemoral access, and in-hospital complications. For cardiac death, predictors of higher mortality included baseline cardiac comorbidities and in-hospital intracardiac complications. For noncardiac death, they included sex, current dialysis, current smoking, and in-hospital complications.

Some of these factors are under operators’ control, of course, and others aren’t.

For nonmodifiable comorbidities, Kolte et al predict the data “will help counsel and facilitate shared decision-making” about the best management strategy. Regarding modifiable factors, they suggest “meticulous attention to sterile techniques, tailored antibiotic prophylaxis, and a minimalist approach to TAVR may help lower the risk for early infections and associated mortality.”

Kumbhani advised that heart teams “need to look at their own 1-year data and introspect whether any adjustments in patient selection may be warranted.”

He did offer the caveat, however, that data on cause of death in the TVT Registry are site-reported and not adjudicated. It may be helpful to link the numbers to the National Death Index or other databases and to compare the TAVI trends with what’s occurring in SAVR, where the cause of death within the first year tends to be cardiac, Kumbhani pointed out. “In contrast, a higher rate of noncardiac deaths following TAVR may reflect greater procedural safety in an older patient population, leading to a higher proportion of noncardiovascular deaths.”

What’s Behind the Trends?

COVID-19 is probably an important contributor to the rise in mortality after TAVI, “both in terms of patient selection and outcomes,” Kumbhani agreed. The expansion of TAVI to less-experienced sites also could be a driver, he added. “Newer sites are typically lower-volume sites, which is inversely related to mortality and complications. In addition, there is a well-defined learning curve for operators, which may be an important factor as well.”

Both physicians pointed out that data collection has changed over the years, something that could possibly affect risk adjustment and thus the results observed.

“Further studies are needed to understand the impact of the COVID-19 pandemic on TAVR outcomes at the patient and hospital levels in the United States, as well as to examine trends in all-cause and cause-specific mortality after TAVR in the postpandemic era,” the study authors conclude. It will be important not only to track these trends in the TVT Registry but also to confirm them through other data sources, like the Centers for Medicare & Medicaid Services, said Kolte.

We need to stop and take a pulse of what kind of patients are getting TAVI. Dhaval Kolte

Joaquin Cigarroa, MD (Oregon Health & Science University, Portland), and Steven R. Bailey, MD (LSU Health Medicine, Shreveport, LA), in an accompanying editorial, frame the fact that cardiac causes were in the minority as a positive. “The finding . . . reflects the enhancement in patient selection as well as improved technology and enhanced expertise over the past decade,” they write.

For noncardiac deaths, though, this study is a “call to action,” they stress. “Multidisciplinary follow-up teams are often fragmented at TAVR centers and are virtually nonexistent at non-TAVR centers. Implementing a multidisciplinary team that evaluates high-risk patients, focusing on changes in clinical status with early recognition and treatment, will be a lifeline that decreases hospitalization and late clinical events.”

The rise in mortality, regardless of its root cause, underlines the need to improve care both before and after TAVI, Cigarroa and Bailey say.