Outcomes and costs of left atrial appendage closure from randomized controlled trial and real-world experience relative to oral anticoagulation

Abstract

Aims: The aim of this study was to analyse randomized controlled study and real-world outcomes of patients with non-valvular atrial fibrillation (NVAF) undergoing left atrial appendage closure (LAAC) with the Watchman device and to compare costs with available antithrombotic therapies.

Methods and results: Registry data of LAAC from two centres were prospectively collected from 110 patients with NVAF at risk of stroke, suitable and unsuitable for long-term anticoagulation (age 71.3 ± 9.2 years, CHADS2 2.8 ± 1.2, CHA2DS2-VASc 4.5 ± 1.6, and HAS-BLED 3.8 ± 1.1). Outcomes from PROTECT AF and registry study LAAC were compared with warfarin, dabigatran, rivaroxaban, apixaban, aspirin, and no treatment using a network meta-analysis. Costs were estimated over a 10-year horizon. Uncertainty was assessed using sensitivity analyses. The procedural success rate was 92% (103/112). Follow-up was 24.1 ± 4.6 months, during which annual rates of stroke, major bleeding, and all-cause mortality were 0.9% (2/223 patient-years), 0.9% (2/223 patient-years), and 1.8% (4/223 patient-years), respectively. Anticoagulant therapy was successfully stopped in 91.2% (93/102) of implanted patients by 12 months. Registry study LAAC stroke and major bleeding rates were significantly lower than PROTECT AF results: mean absolute difference of stroke, 0.89% (P = 0.02) and major bleeding, 5.48% (P < 0.001). Left atrial appendage closure achieved cost parity between 4.9 years vs. dabigatran 110 mg and 8.4 years vs. warfarin. At 10 years, LAAC was cost-saving against all therapies (range £1162-£7194).

Conclusion: Left atrial appendage closure in NVAF in a real-world setting may result in lower stroke and major bleeding rates than reported in LAAC clinical trials. Left atrial appendage closure in both settings achieves cost parity in a relatively short period of time and may offer substantial savings compared with current therapies. Savings are most pronounced among higher risk patients and those unsuitable for anticoagulation.

Keywords: Anticoagulation; Atrial fibrillation; Health economics; Left atrial appendage; Stroke prevention.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Figures

Figure 1

Model structure for the left atrial appendage closure (LAAC) arm.

Figure 2

Model structure for the drug arm.

Figure 3

(A) Expected annual rates of stroke in the study population based on CHADS2 score, compared with the cumulative observed rates during the entire study period (mean, 95% CI). There was a significant reduction in the expected rates of stroke (88%, P < 0.001). (B) Expected annual rates of major bleeding events in the study population based on HAS-BLED score, compared with the cumulative observed rates during the entire study period (mean, 95% CI). There was a significant reduction in the expected rates of major bleeding events (60%, P < 0.01). LACC, left atrial appendage closure; AF, atrial fibrillation.

Figure 4

(A) Ten-year cumulative stroke rates. (B) Ten-year cumulative major bleeding rates. (C) Ten-year cumulative all-cause mortality rates. LAAC, aspirin, and no therapy were the therapeutic options for anticoagulation unsuitable patients. Asterisks indicate that inputs for ‘PROTECT AF LAAC—Anticoagulation Unsuitable’ were modelled. LACC, left atrial appendage closure; AF, atrial fibrillation.

Figure 5

Whole group (CHADS2)—cumulative cost per patient over 10 years. Cost parity occurs between two treatment options at points of cost-line intersection. LACC, left atrial appendage closure; AF, atrial fibrillation.

Figure 6

Whole group (CHA2DS2-VASc)—cumulative cost per patient over 10 years. Cost parity occurs between two treatment options at points of cost-line intersection. LACC, left atrial appendage closure; AF, atrial fibrillation.