Early and late bleeding events according to Valve Academic Research Consortium 3 criteria following transcatheter aortic valve implantation.

Abstract

Background: Transcatheter aortic valve implantation may be associated with significant haemorrhagic complications.

Aims: To evaluate the timing, incidence, predictors and clinical impact of bleeding events after transcatheter aortic valve implantation, according to the updated Valve Academic Research Consortium (VARC)-3 criteria, compared with the VARC-2 criteria.

Methods: A retrospective observational study involving 487 consecutive patients who underwent transcatheter aortic valve implantation between July 2017 and May 2019 was performed. Bleeding events were classified according to the VARC-2 and VARC-3 definitions.

Results: Bleeding events occurred in 17.6% of patients, with early bleeding (in-hospital) in 12.5% and late bleeding (occurring after discharge) in 6.1%. The primary vascular access site was the most common source of early bleeding, whereas gastrointestinal bleeding was predominant in late events. Significant predictors of early VARC-3-defined bleeding included active cancer, previous implantable cardioverter-defibrillator, history of mitral valve surgery, a non-transfemoral approach and occurrence of an in-hospital major vascular complication or new-onset atrial fibrillation. Late bleeding was independently associated with a history of myocardial infarction and treatment with vitamin K antagonists at discharge. Early bleeding events were not associated with increased late all-cause mortality. No significant difference was observed based on the VARC-2 and VARC-3 bleeding definitions.

Conclusions: Bleeding events occurred in one sixth of patients undergoing transcatheter aortic valve implantation without significant difference in their incidence between the VARC-2 and VARC-3 classifications. Early bleeding events were not associated with poorer long-term survival, regardless of the classification used. Larger studies with greater statistical power, including more contemporary patients, are needed to confirm these findings.