The University of Southampton
University of Southampton Institutional Repository

Outcomes and costs of left atrial appendage closure fromrandomized controlled trial and realworld experience relative to oral anticoagulation

Outcomes and costs of left atrial appendage closure fromrandomized controlled trial and realworld experience relative to oral anticoagulation
Outcomes and costs of left atrial appendage closure fromrandomized controlled trial and realworld experience relative to oral anticoagulation

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.

Anticoagulation, Atrial fibrillation, Health economics, Left atrial appendage, Stroke prevention
0195-668X
3470-3482
Panikker, Sandeep
8f128c6c-17cc-4a85-aa63-bd604e953f60
Lord, Joanne
fd3b2bf0-9403-466a-8184-9303bdc80a9a
Jarman, Julian W.E.
725c3d9c-bdec-4e98-a9fa-ac7b3d748da5
Armstrong, Shannon
48d659a5-0ace-4c68-88ef-6d450dc4156a
Jones, David G.
6efa6efe-bb9e-4662-b44e-88aee2a665c2
Haldar, Shouvik
6cc78f9a-8489-4881-92fc-57b3c2d231f2
Butcher, Charles
a2c10f45-21f3-4b87-b8fb-e8294746f907
Khan, Habib
ef5e6248-435c-40ff-97f2-1bf0a759c43e
Mantziari, Lilian
242b22bf-4bcb-403c-99ef-a20cd28296a2
Nicol, Edward
aa40bb75-90a6-401e-b329-19331e447767
Hussain, Wajid
22c34337-b684-4454-9830-de6a52e3a9f5
Clague, Jonathan R.
c8c668e7-393b-4e83-9d75-5b5cf7fc8816
Foran, John P.
87c989e4-746a-40be-98a5-042f9f8f47ee
Markides, Vias
271df9c2-26f7-4f1e-831e-bdb8e40f1a4a
Wong, Tom
d7ddec6a-c082-4ef2-b224-2c45a058b0fb
Panikker, Sandeep
8f128c6c-17cc-4a85-aa63-bd604e953f60
Lord, Joanne
fd3b2bf0-9403-466a-8184-9303bdc80a9a
Jarman, Julian W.E.
725c3d9c-bdec-4e98-a9fa-ac7b3d748da5
Armstrong, Shannon
48d659a5-0ace-4c68-88ef-6d450dc4156a
Jones, David G.
6efa6efe-bb9e-4662-b44e-88aee2a665c2
Haldar, Shouvik
6cc78f9a-8489-4881-92fc-57b3c2d231f2
Butcher, Charles
a2c10f45-21f3-4b87-b8fb-e8294746f907
Khan, Habib
ef5e6248-435c-40ff-97f2-1bf0a759c43e
Mantziari, Lilian
242b22bf-4bcb-403c-99ef-a20cd28296a2
Nicol, Edward
aa40bb75-90a6-401e-b329-19331e447767
Hussain, Wajid
22c34337-b684-4454-9830-de6a52e3a9f5
Clague, Jonathan R.
c8c668e7-393b-4e83-9d75-5b5cf7fc8816
Foran, John P.
87c989e4-746a-40be-98a5-042f9f8f47ee
Markides, Vias
271df9c2-26f7-4f1e-831e-bdb8e40f1a4a
Wong, Tom
d7ddec6a-c082-4ef2-b224-2c45a058b0fb

Panikker, Sandeep, Lord, Joanne, Jarman, Julian W.E., Armstrong, Shannon, Jones, David G., Haldar, Shouvik, Butcher, Charles, Khan, Habib, Mantziari, Lilian, Nicol, Edward, Hussain, Wajid, Clague, Jonathan R., Foran, John P., Markides, Vias and Wong, Tom (2016) Outcomes and costs of left atrial appendage closure fromrandomized controlled trial and realworld experience relative to oral anticoagulation. European Heart Journal, 37 (46), 3470-3482. (doi:10.1093/eurheartj/ehw048).

Record type: Article

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.

Full text not available from this repository.

More information

Accepted/In Press date: 26 January 2016
e-pub ahead of print date: 1 March 2016
Published date: 7 December 2016
Keywords: Anticoagulation, Atrial fibrillation, Health economics, Left atrial appendage, Stroke prevention

Identifiers

Local EPrints ID: 433796
URI: http://eprints.soton.ac.uk/id/eprint/433796
ISSN: 0195-668X
PURE UUID: 5f894429-bcc4-43be-8368-efbcd5ac0eeb
ORCID for Joanne Lord: ORCID iD orcid.org/0000-0003-1086-1624

Catalogue record

Date deposited: 04 Sep 2019 16:30
Last modified: 07 Oct 2020 02:08

Export record

Altmetrics

Contributors

Author: Sandeep Panikker
Author: Joanne Lord ORCID iD
Author: Julian W.E. Jarman
Author: Shannon Armstrong
Author: David G. Jones
Author: Shouvik Haldar
Author: Charles Butcher
Author: Habib Khan
Author: Lilian Mantziari
Author: Edward Nicol
Author: Wajid Hussain
Author: Jonathan R. Clague
Author: John P. Foran
Author: Vias Markides
Author: Tom Wong

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×