Deaths after TAVR are on the rise: Is the pandemic to blame or should cardiologists be concerned?
Patient mortality in the first year after transcatheter aortic valve replacement (TAVR) decreased from 2012 to 2018, but then started rising again in 2019. The COVID-19 pandemic is one likely explanation, researchers noted, but there are several other factors to consider as well.
That is just one key takeaway from a new analysis published in JACC: Cardiovascular Interventions.[1] The study’s authors reviewed nearly 11 years of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, focusing on one-year mortality among patients who underwent isolated TAVR from January 2012 to October 2022.
“TAVR has rapidly evolved as a safe and effective treatment option for patients with symptomatic severe aortic stenosis,” wrote first author Dhaval Kolte, MD, PhD, MPH, an interventional cardiologist with Massachusetts General Hospital and Harvard Medical School, and colleagues. “More than 70,000 TAVRs are now being performed annually across >700 centers in the United States. Technological advances, increasing institutional and operator experience, and decreasing patient risk profiles have contributed to significant improvement in outcomes of TAVR. However, the impact of changing patient demographics and risk profiles on the causes of death and cause-specific mortality after TAVR remains unclear.”
Most TAVR deaths in the first year are not from cardiovascular causes
Overall, 68.7% of patients who died in that first year following TAVR had a noncardiac death, leaving 31.3% who had a cardiac death. The causes for noncardiac deaths included pulmonary issues (13.4%), infections (9.3%), neurologic issues (6.6%) and a handful of others.
“These findings are relevant when considering TAVR in patients with chronic lung disease, especially those with home oxygen use, who are prone to acute exacerbations or respiratory failure and infections including pneumonia or sepsis, with associated increased risk for mortality,” the authors wrote.
Noncardiac deaths were more common among men, the authors noted, and more likely when patients presented with a history of atrial fibrillation, atrial flutter, carotid artery stenosis, a conduction defect, a hostile chest, a porcelain aorta, peripheral artery disease, previous aortic valve procedures, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (PCI), heart failure, cardiogenic shock or coronary artery disease.
TAVR mortality is on the rise in recent years
One-year TAVR mortality decreased from 10.6% in 2012 to 7.1% in 2019, but then it was up to 12.2% by 2022. Kolte et al. looked at several possible explanations for this trend, starting with the COVID-19 pandemic.
“First, as the increase in one-year cardiac and noncardiac deaths was seen in patients who underwent TAVR between 2019 and 2022, these findings may be attributed to the COVID-19 pandemic and the significant burden of COVID-19 mortality and excess all-cause mortality in the United States,” the group wrote. “Second, prior studies have shown that patients who underwent TAVR during COVID-19 surge periods had higher Society of Thoracic Surgeons Predicted Risk of Mortality score, delayed procedure scheduling, and increased mortality compared with those who underwent TAVR during nonsurge and prepandemic periods.”
The authors also provided a list of other potential reasons for this trend, including “the declining life expectancy in the United States even prior to COVID-19” and “temporal changes in coding comorbidities, especially if comorbidities were undercoded in the more recent years.”
Another significant factor could be shifts in policies put forth by the U.S. Centers for Medicare and Medicaid Services (CMS) and U.S. Food and Drug Administration (FDA).
“CMS revised its national coverage determination for TAVR in June 2019, lowering the aortic valve replacement and PCI volume requirements to initiate a TAVR program,” the authors wrote. “This coupled with the FDA’s approval of TAVR for low-risk patients in August 2019 may have led to an increase in the number of new TAVR programs in the United States. New programs are likely to have lower TAVR volumes, and prior studies have shown an inverse relationship between hospital TAVR volume and mortality, which may be further exaggerated for hospitals trying to start new TAVR programs during the COVID-19 pandemic.”
Risk factors directly associated with cardiac, noncardiac death after TAVR
Several factors were confirmed to be predictors of one-year mortality after TAVR. This included an age older than 80 years old, atrial fibrillation or atrial flutter, chronic lung disease, home oxygen use, prior stroke, prior myocardial infarction, peripheral artery disease, decrease left ventricular ejection fraction, decreased estimated glomerular filtration rate, nonelective procedures, nonfemoral access and a poor baseline quality of life. Certain in-hospital complications such as aortic dissection, cardiac arrest, device migration, renal failure and moderate/severe paravalvular leak were also independently linked to an increased risk of cardiac or noncardiac mortality.
Certain in-hospital complications are “rare and unpredictable or potentially unavoidable,” the group added, but careful planning, a “meticulous implantation technique” and strong post-procedural care can still reduce the risk of some complications.
Kolte and colleagues did emphasize that more research is still needed to gain a better understanding of these trends, especially when it comes to exploring the pandemic's long-term impact.
Click here to read the full study in JACC: Cardiovascular Interventions, an American College of Cardiology journal.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.