Skip to main content
Erschienen in: Applied Health Economics and Health Policy 6/2018

01.12.2018 | Systematic Review

Level of Evidence in Economic Evaluations of Left Atrial Appendage Closure Devices: A Systematic Review

verfasst von: Etienne Nédellec, Judith Pineau, Patrice Prognon, Nicolas Martelli

Erschienen in: Applied Health Economics and Health Policy | Ausgabe 6/2018

Einloggen, um Zugang zu erhalten

Abstract

Objectives

The objective of the present work was to assess the level of evidence in economic evaluations of percutaneous left atrial appendage closure devices, and to test the complementarity of three different tools for assessing the quality of economic evaluations.

Methods

We conducted a systematic review of articles in English or French listed in MEDLINE, Embase, Cochrane, the Cost-Effectiveness Analysis registry and the National Health Service Economic Evaluation Database. We included only economic evaluations concerning left atrial appendage closure devices. Data were extracted from articles by two authors working independently and using three analysis grids to measure the quality of economic evaluations [the British Medical Journal (BMJ) checklist, the hierarchy scale developed by Cooper et al. (J Health Serv Res Policy 10:245–50, 2005) and the Quality of Health Economic Studies (QHES) instrument].

Results

Seven economic evaluations met our inclusion criteria. All were published between 2013 and 2016. All were cost-utility analyses, and fully complied with the BMJ checklist. According to the hierarchy scale developed by Cooper et al., the quality of data used was heterogeneous. Finally, the mean score for the seven economic studies was 90/100 with the QHES instrument.

Conclusions

Despite the recent development of left atrial appendage closure devices, most economic evaluations conducted here were well-designed studies. Furthermore, different tools used to assess the quality of these studies were complementary, but none gave a global vision of the quality of economic studies.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Zurück zum Zitat Lane DA, Lip GYH. Use of the CHA(2)DS(2)-VASc and HAS-BLED scores to aid decision making for thromboprophylaxis in nonvalvular atrial fibrillation. Circulation. 2012;126:860–5.CrossRef Lane DA, Lip GYH. Use of the CHA(2)DS(2)-VASc and HAS-BLED scores to aid decision making for thromboprophylaxis in nonvalvular atrial fibrillation. Circulation. 2012;126:860–5.CrossRef
2.
Zurück zum Zitat Mahajan R, Brooks AG, Sullivan T, Lim HS, Alasady M, Abed HS, et al. Importance of the underlying substrate in determining thrombus location in atrial fibrillation: implications for left atrial appendage closure. Heart Br Card Soc. 2012;98:1120–6. Mahajan R, Brooks AG, Sullivan T, Lim HS, Alasady M, Abed HS, et al. Importance of the underlying substrate in determining thrombus location in atrial fibrillation: implications for left atrial appendage closure. Heart Br Card Soc. 2012;98:1120–6.
3.
Zurück zum Zitat Ostermayer SH, Reisman M, Kramer PH, Matthews RV, Gray WA, Block PC, et al. Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials. J Am Coll Cardiol. 2005;46:9–14.CrossRef Ostermayer SH, Reisman M, Kramer PH, Matthews RV, Gray WA, Block PC, et al. Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials. J Am Coll Cardiol. 2005;46:9–14.CrossRef
4.
Zurück zum Zitat Holmes DR, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64:1–12.CrossRef Holmes DR, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64:1–12.CrossRef
5.
Zurück zum Zitat Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet Lond Engl. 2009;374:534–42.CrossRef Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet Lond Engl. 2009;374:534–42.CrossRef
6.
Zurück zum Zitat Drummond M, Griffin A, Tarricone R. Economic evaluation for devices and drugs–same or different? Value Health J Int Soc Pharmacoeconomics Outcomes Res. 2009;12:402–4.CrossRef Drummond M, Griffin A, Tarricone R. Economic evaluation for devices and drugs–same or different? Value Health J Int Soc Pharmacoeconomics Outcomes Res. 2009;12:402–4.CrossRef
7.
Zurück zum Zitat Ciani O, Wilcher B, van Giessen A, Taylor RS. Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments. Health Econ. 2017;26(Suppl 1):13–29.CrossRef Ciani O, Wilcher B, van Giessen A, Taylor RS. Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments. Health Econ. 2017;26(Suppl 1):13–29.CrossRef
8.
Zurück zum Zitat Boudard A, Martelli N, Prognon P, Pineau J. Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment? J Eval Clin Pract. 2013;19:697–702.CrossRef Boudard A, Martelli N, Prognon P, Pineau J. Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment? J Eval Clin Pract. 2013;19:697–702.CrossRef
9.
Zurück zum Zitat Sorenson C, Drummond M, Bhuiyan Khan B. Medical technology as a key driver of rising health expenditure: disentangling the relationship. Clin Outcomes Res CEOR. 2013;5:223–34.CrossRef Sorenson C, Drummond M, Bhuiyan Khan B. Medical technology as a key driver of rising health expenditure: disentangling the relationship. Clin Outcomes Res CEOR. 2013;5:223–34.CrossRef
10.
Zurück zum Zitat Martelli N, Devaux C, van den Brink H, Pineau J, Prognon P, Borget I. A systematic review of the level of evidence in economic evaluations of medical devices: the example of vertebroplasty and kyphoplasty. PLoS One. 2015;10:e0144892.CrossRef Martelli N, Devaux C, van den Brink H, Pineau J, Prognon P, Borget I. A systematic review of the level of evidence in economic evaluations of medical devices: the example of vertebroplasty and kyphoplasty. PLoS One. 2015;10:e0144892.CrossRef
11.
Zurück zum Zitat Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg Lond Engl. 2010;8:336–41.CrossRef Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg Lond Engl. 2010;8:336–41.CrossRef
12.
Zurück zum Zitat Schardt C, Adams MB, Owens T, Keitz S, Fontelo P. Utilization of the PICO framework to improve searching PubMed for clinical questions. BMC Med Inform Decis Mak. 2007;7:16.CrossRef Schardt C, Adams MB, Owens T, Keitz S, Fontelo P. Utilization of the PICO framework to improve searching PubMed for clinical questions. BMC Med Inform Decis Mak. 2007;7:16.CrossRef
13.
Zurück zum Zitat Teerawattananon Y, Russell S, Mugford M. A systematic review of economic evaluation literature in Thailand: are the data good enough to be used by policy-makers? PharmacoEconomics. 2007;25:467–79.CrossRef Teerawattananon Y, Russell S, Mugford M. A systematic review of economic evaluation literature in Thailand: are the data good enough to be used by policy-makers? PharmacoEconomics. 2007;25:467–79.CrossRef
14.
Zurück zum Zitat Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 2015. Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 2015.
15.
Zurück zum Zitat Cooper N, Coyle D, Abrams K, Mugford M, Sutton A. Use of evidence in decision models: an appraisal of health technology assessments in the UK since 1997. J Health Serv Res Policy. 2005;10:245–50.CrossRef Cooper N, Coyle D, Abrams K, Mugford M, Sutton A. Use of evidence in decision models: an appraisal of health technology assessments in the UK since 1997. J Health Serv Res Policy. 2005;10:245–50.CrossRef
16.
Zurück zum Zitat Ofman JJ, Sullivan SD, Neumann PJ, Chiou C-F, Henning JM, Wade SW, et al. Examining the value and quality of health economic analyses: implications of utilizing the QHES. J Manag Care Pharm JMCP. 2003;9:53–61.PubMed Ofman JJ, Sullivan SD, Neumann PJ, Chiou C-F, Henning JM, Wade SW, et al. Examining the value and quality of health economic analyses: implications of utilizing the QHES. J Manag Care Pharm JMCP. 2003;9:53–61.PubMed
17.
Zurück zum Zitat Micieli A, Wijeysundera HC, Qiu F, Atzema CL, Singh SM. A decision analysis of percutaneous left atrial appendage occlusion relative to novel and traditional oral anticoagulation for stroke prevention in patients with new-onset atrial fibrillation. Med Decis Mak Int J Soc Med Decis Mak. 2016;36:366–74.CrossRef Micieli A, Wijeysundera HC, Qiu F, Atzema CL, Singh SM. A decision analysis of percutaneous left atrial appendage occlusion relative to novel and traditional oral anticoagulation for stroke prevention in patients with new-onset atrial fibrillation. Med Decis Mak Int J Soc Med Decis Mak. 2016;36:366–74.CrossRef
18.
Zurück zum Zitat Reddy VY, Akehurst RL, Armstrong SO, Amorosi SL, Brereton N, Hertz DS, et al. Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin. Eur Eur Pacing Arrhythm Card Electrophysiol J Work Groups Card Pacing Arrhythm Card Cell Electrophysiol Eur Soc Cardiol. 2016;18:979–86. Reddy VY, Akehurst RL, Armstrong SO, Amorosi SL, Brereton N, Hertz DS, et al. Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin. Eur Eur Pacing Arrhythm Card Electrophysiol J Work Groups Card Pacing Arrhythm Card Cell Electrophysiol Eur Soc Cardiol. 2016;18:979–86.
19.
Zurück zum Zitat Singh SM, Micieli A, Wijeysundera HC. Economic evaluation of percutaneous left atrial appendage occlusion, dabigatran, and warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. Circulation. 2013;127:2414–23.CrossRef Singh SM, Micieli A, Wijeysundera HC. Economic evaluation of percutaneous left atrial appendage occlusion, dabigatran, and warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. Circulation. 2013;127:2414–23.CrossRef
20.
Zurück zum Zitat Lee VW-Y, Tsai RB-C, Chow IH-I, Yan BP-Y, Kaya MG, Park J-W, et al. Cost-effectiveness analysis of left atrial appendage occlusion compared with pharmacological strategies for stroke prevention in atrial fibrillation. BMC Cardiovasc Disord. 2016;16:167. Lee VW-Y, Tsai RB-C, Chow IH-I, Yan BP-Y, Kaya MG, Park J-W, et al. Cost-effectiveness analysis of left atrial appendage occlusion compared with pharmacological strategies for stroke prevention in atrial fibrillation. BMC Cardiovasc Disord. 2016;16:167.
21.
Zurück zum Zitat Reddy VY, Akehurst RL, Armstrong SO, Amorosi SL, Beard SM, Holmes DR. Time to cost-effectiveness following stroke reduction strategies in AF: warfarin versus NOACs versus LAA closure. J Am Coll Cardiol. 2015;66:2728–39.CrossRef Reddy VY, Akehurst RL, Armstrong SO, Amorosi SL, Beard SM, Holmes DR. Time to cost-effectiveness following stroke reduction strategies in AF: warfarin versus NOACs versus LAA closure. J Am Coll Cardiol. 2015;66:2728–39.CrossRef
22.
Zurück zum Zitat Freeman JV, Hutton DW, Barnes GD, Zhu RP, Owens DK, Garber AM, et al. Cost-effectiveness of percutaneous closure of the left atrial appendage in atrial fibrillation based on results from PROTECT AF versus PREVAIL. Circ Arrhythm Electrophysiol. 2016;9:e003407.CrossRef Freeman JV, Hutton DW, Barnes GD, Zhu RP, Owens DK, Garber AM, et al. Cost-effectiveness of percutaneous closure of the left atrial appendage in atrial fibrillation based on results from PROTECT AF versus PREVAIL. Circ Arrhythm Electrophysiol. 2016;9:e003407.CrossRef
23.
Zurück zum Zitat Saw J, Bennell MC, Singh SM, Wijeysundera HC. Cost-effectiveness of left atrial appendage closure for stroke prevention in atrial fibrillation patients with contraindications to anticoagulation. Can J Cardiol. 2016;32:1355.e9–1355.e14.CrossRef Saw J, Bennell MC, Singh SM, Wijeysundera HC. Cost-effectiveness of left atrial appendage closure for stroke prevention in atrial fibrillation patients with contraindications to anticoagulation. Can J Cardiol. 2016;32:1355.e9–1355.e14.CrossRef
24.
Zurück zum Zitat Health Quality Ontario. Left atrial appendage closure device with delivery system: a health technology assessment. Ont Health Technol Assess Ser. 2017;17:1–106. Health Quality Ontario. Left atrial appendage closure device with delivery system: a health technology assessment. Ont Health Technol Assess Ser. 2017;17:1–106.
25.
Zurück zum Zitat Maisel WH. Left atrial appendage occlusion–closure or just the beginning? N Engl J Med. 2009;360:2601–3.CrossRef Maisel WH. Left atrial appendage occlusion–closure or just the beginning? N Engl J Med. 2009;360:2601–3.CrossRef
26.
Zurück zum Zitat Abrishami P, Boer A, Horstman K. Value in co-creation: subjecting innovative in-hospital technologies to multi-stakeholder appraisal. Int J Hosp Based Health Technol Assess. 2017;2017:12–30. Abrishami P, Boer A, Horstman K. Value in co-creation: subjecting innovative in-hospital technologies to multi-stakeholder appraisal. Int J Hosp Based Health Technol Assess. 2017;2017:12–30.
Metadaten
Titel
Level of Evidence in Economic Evaluations of Left Atrial Appendage Closure Devices: A Systematic Review
verfasst von
Etienne Nédellec
Judith Pineau
Patrice Prognon
Nicolas Martelli
Publikationsdatum
01.12.2018
Verlag
Springer International Publishing
Erschienen in
Applied Health Economics and Health Policy / Ausgabe 6/2018
Print ISSN: 1175-5652
Elektronische ISSN: 1179-1896
DOI
https://doi.org/10.1007/s40258-018-0429-z

Weitere Artikel der Ausgabe 6/2018

Applied Health Economics and Health Policy 6/2018 Zur Ausgabe