Nonfemoral access routes for transcatheter aortic valve replacement (TAVR) are associated with significantly higher 30-day mortality rates for frail patients but not among other older adults, according to a post hoc analysis of the FRAILTY-AVR study published in JACC: Cardiovascular Interventions.
“Frail patients are less likely to tolerate invasive procedures, which is one of the reasons why the minimally invasive TAVR procedure has gained acceptance in this patient population,” wrote lead author Laura M. Drudi, MD, MSc, with McGill University in Montreal, and colleagues. “However, TAVR has a spectrum of access site options with nonfemoral TAVR procedures being inherently more invasive than transfemoral, hence exposing frail patients to additional operative stress and risk.”
In this analysis, Drudi et al. assessed 30-day and 12-month mortality outcomes in 723 patients who underwent TAVR from 2012 to 2017 as part of a multicenter study. Frailty was assessed using the Essential Frailty Toolset (EFT), with 35 percent of the cohort scoring 3 or higher and being categorized as frail.
For those patients, nonfemoral access was associated with 3.91-fold odds of 30-day mortality and double the odds of one-year mortality after multivariable adjustment. Interestingly, though, nonfrail patients showed statistically insignificant increases in 30-day (odds ratio: 1.29) and one-year mortality (OR: 1.83).
“Risk factors such as frailty and PAD (peripheral artery disease) should be carefully considered in identifying older adults likely to tolerate a nonfemoral procedure,” Drudi and coauthors wrote. “Although access site is largely dictated by vascular anatomy, and cannot necessarily be altered on the basis of frailty status, clinicians should be alerted to the incremental short-term risk of nonfemoral access in highly frail patients. This may influence the clinician’s or patient’s decision to pursue the procedure or encourage them to optimize frailty status before the procedure.”
More than three-fourths of patients in the study—77 percent—underwent transfemoral TAVR. But other access routes comprised a substantial minority of procedures, as apical and direct aortic pathways accounted for 10 percent and 9 percent of all TAVRs, respectively. Carotid access and axillary or subclavian access each represented 2 percent of all procedures.
Notably, among patients with PAD, only 52 percent received transfemoral TAVR while 48 percent had alternative access routes.
The authors hypothesized the added invasiveness of nonfemoral TAVR contributed to the higher short-term mortality rates in frail patients, particularly because those individuals have limited reserves to ward off procedural complications. But they said another explanation is the frail group’s higher burden of PAD, which “represents a state of systemic vascular inflammation associated with an elevated risk of cardiovascular events and mortality.”
David R. Holmes Jr., MD, noted in a related editorial that nonfemoral access wasn’t only linked to increased mortality in frail patients. Those people were also exposed to longer ventilation periods, longer hospital stays, a higher incidence of delirium and an increased likelihood of being discharged to another healthcare facility rather than home.
But although the study didn’t capture the reasoning behind clinicians’ access-site decisions, Holmes agreed nonfemoral approaches are often necessitated by a patient’s anatomy.
“Typically, those factors cannot be modified, although the development of smaller catheter and sheath sizes may help,” wrote Holmes, of the Mayo Clinic in Rochester, Minnesota. “In all cases, particularly in frail patients, those factors responsible for frailty must be evaluated and if possible ameliorated before proceeding with TAVR. As the investigators conclude, ‘Frailty should not be equated with nonoperability, but rather integrated alongside clinical and anatomical factors to tailor the procedural approach and periprocedural case of these vulnerable patients.’”