Transcatheter aortic valve implantation in patients with uninterrupted vitamin K antagonists

Abstract

Background Bridging of vitamin K antagonist (VKA) with heparin is usually not promoted during interventional or surgical procedures related to increased risk of bleeding and thrombotic events but this strategy has not been evaluated during transcatheter aortic valve implantation (TAVI). Purpose The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA. Methods From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (International Normalized Ratio [INR] between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI was performed according to current guidelines and a 50 U/kg bolus of heparin was injected at the beginning of the procedure for all patients. Vascular and bleeding complications were assessed using the Valve Academic Research Consortium 3 (VARC3) and the Bleeding Academic Research Consortium (BARC) definitions at a 30‐day follow‐up. Results A total of 88 patients were included with a median age of 84 years (81.8–87.0), 42% being female. The median society of thoracic surgeons score was 5.1 (4.1–7.5), the median CHADS2‐VASc was 5.5 (5–6) and 60.2% had a chronic kidney failure. Median INR at the time of implantation was 2.1 (1.8–2.6). The main VKA indication was atrial fibrillation. Transfemoral access was used in 88.6% of the patients. Major bleeding (BARC ≥ 3b) occurred in five patients (5.7%) and major vascular complications occurred in seven patients (8.0%). At 1 month follow‐up, major bleeding (BARC ≥ 3) or vascular complications occurred in 10 patients (11.4%). In patients with major bleeding peripheral arterial disease (RR = 10.95; 95% confidence interval (CI) 1.63–73.75; p = 0.014) and carotid access (RR = 8.56; 95% CI 1.19–1.51; p = 0.033) were more common. INR > 2.5 was significantly associated with vascular complications (RR = 7.14; 95% CI 1.29–39.63; p = 0.025). At 30 days, mortality and stroke rates were 2.3% and 4.5%, respectively. Conclusion TAVI with uninterrupted VKA treatment seems feasible and safe with a low risk of major bleeding and vascular complications in this first single‐center experience. Particular caution is advocated in high body mass index patients and to keep INR < 2.5.

Advances in technology and techniques for transcatheter aortic valve replacement with concomitant peripheral arterial disease

“…In the BRAVO-3 trial, it was found that among patients with PAD, anticoagulation with bivalirudin does not reduce the risk of bleeding or vascular complication when compared to unfractionated heparin, which is the standard anticoagulation used in most centers ( 19 ). Among patients who have an alternative indication for vitamin K antagonist, it was found that uninterrupted warfarin therapy among patients with PAD was associated with a drastically high risk of vascular complication when compared to those who had no PAD, with a relative risk of 10.95 ( 20 ).…”

Uninterrupted vitamin K antagonists in patients undergoing transcatheter aortic valve implantation: A promising strategy still looking for the right patient

“…In this issue of CCI, 3 Robert et al analyzed data from an observational, prospective, monocenter registry, including 88 patients with an indication for long‐term OAC who underwent TAVI between January 2016 and October 2017. The median STS score was 5.1 and the main reason for long‐term OAC was atrial fibrillation (90%).…”