Image: A new study suggests bleeding complications following TAVR can predict mortality (Photo courtesy of Shutterstock).
Patients with severe aortic stenosis who experience bleeding complications following transcatheter aortic valve replacement (TAVR) face an increased risk for mortality, according to a new study.
Researchers at Swiss Cardiovascular Center Bern (CVRC; Switzerland) and the University of Bern (Switzerland) conducted a study involving 926 consecutive patients who underwent TAVR from 2007 through 2014 in order to examine frequency, timing, and association of access-site and non–access-site bleeding with mortality. Bleeding was assessed according to Valve Academic Research Consortium 2 (VARC2) criteria. The primary outcome of interest was all-cause mortality up to five years of follow-up.
The results revealed that 30.7% of patients had at least one subsequent bleeding event, which were split between bleeds from the access site and those at other sites. In all, 80% of the bleeding events occurred within the first 30 days after TAVR. In fact, all access-site bleeds took place during this early period; 40% of non-access-site bleeds happened later on throughout the follow-up period. For those who underwent transfemoral access, access-site bleeding did not significantly increase the risk of mortality, but non-access-site bleeding did.
Most access-site bleeds were minor, while non-access-site bleeds tended to be major. Minor bleeding was not significantly associated with mortality over follow-up, unlike major bleeds and life-threatening ones. Death from any cause was less likely for patients with access-site bleeds (58.7%) than non-access-site bleeds (72.8%). Analysis revealed that female sex was a significant correlate of access-site bleeding, whereas chronic kidney disease (CKD) was significantly associated with non–access-site bleeding. The study was published on July 24, 2017, in JACC: Cardiovascular Interventions.
“These findings parallel those observed in the field of percutaneous coronary intervention [PCI], in which non–access-related major bleeding complications have a significantly greater impact on mortality compared with access-site complications,” concluded senior author Stefan Stortecky, MD, of CVRC, and colleagues. “Non–access-site bleeding is a multifactorial event that encapsulates the patient risk profile as well as coexisting comorbidities, and whose risk is longitudinal and extends over time, which is not the case for access-site events that typically occur in the aftermath of the index procedure.”
The percutaneous treatment of severe aortic valve disease using prosthetic aortic valve replacement, without the need for open-heart surgery or cardiopulmonary bypass, is faster and less invasive than current open-heart procedures. TAVR has so far been proven effective in high-risk and inoperable patients, and could soon become the standard of care, even in moderate and low surgical risk patients.
Swiss Cardiovascular Center Bern
University of Bern