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.