Evidence map›Paper›PMID 27307517›Full record

ArticleCirculation. Arrhythmia and electrophysiology2016

Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL.

James V Freeman, David W Hutton, Geoffrey D Barnes, Ruo P Zhu, Douglas K Owens, Alan M Garber, Alan S Go, Mark A Hlatky, Paul A Heidenreich, Paul J Wang and 2 more

Open access · bronzeAbstract read
In one paragraph

Article in Circulation. Arrhythmia and electrophysiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Percutaneous left atrial appendage closure reduces cost of care independent of the institutional cumulative caseload in patients with non-valvular atrial fibrillation.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2022
    Article
  8. Review
  9. Left atrial appendage closure with the watchman device reduces atrial fibrillation management costs.Clinical research in cardiology : official journal of the German Cardiac Society · 2022
    Article
  10. Article
  11. Observational
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

James V FreemanFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.). james.freeman@yale.edu.
David W HuttonFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Geoffrey D BarnesFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Ruo P ZhuFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Douglas K OwensFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Alan M GarberFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Alan S GoFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Mark A HlatkyFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Paul A HeidenreichFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Paul J WangFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Amin Al-AhmadFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Mintu P TurakhiaFrom the Yale University School of Medicine, New Haven, CT (J.V.F.); University of Michigan, Ann Arbor (D.W.H., G.D.B., R.P.Z.); VA Palo Alto Health Care System, CA (D.K.O., P.A.H., M.P.T.); Stanford University School of Medicine, CA (D.K.O., A.S.G., M.A.H., P.A.H., P.J.W., M.P.T.); Harvard University, Cambridge, MA (A.M.G.); Kaiser Permanente Northern California Division of Research, Oakland (A.S.G.); University of California, San Francisco (A.S.G.); and Texas Cardiac Arrhythmia Institute, Austin (A.A.-A.).
Harvard University Press · USUniversity of California, San Francisco · USUniversity of Michigan–Ann Arbor · USVA Palo Alto Health Care System · USKaiser Permanente · US

Funding

TRAINING IN MOLECULAR AND CELLULAR CARDIOLOGYT32HL007853 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI David J. Pinsky · 1996 to 2026
$11.6M
HMO Research Network Cardiovascular Research NetworkU19HL091179 · NHLBI · KAISER FOUNDATION RESEARCH INSTITUTE · PI GO, ALAN S · 2007 to 2011
$8.7M
Contemporary Treatment and Outcomes for Atrial Fibrillation in Clinical PracticeRC2HL101589 · NHLBI · KAISER FOUNDATION RESEARCH INSTITUTE · PI GO, ALAN S, SINGER, DANIEL EDWIN · 2009 to 2010
$5.0M
Comparative effectiveness of catheter ablation vs medical therapy for atrial fibrK23HL118147 · NHLBI · YALE UNIVERSITY · PI FREEMAN, JAMES · 2013 to 2017
$856k
NHLBI NIH HHS K23 HL118147NHLBI NIH HHS RC2 HL101589NHLBI NIH HHS T32 HL007853NHLBI NIH HHS U19 HL091179
6 · The paper itself

Abstract

backgroundRandomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data. METHODS AND

resultsWe used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation.

conclusionsUsing data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice.

Indexed as

Cost-Benefit AnalysisAgedAnticoagulantsAtrial AppendageAtrial FibrillationDabigatranDecision TreesFemaleHumansMaleMarkov ChainsPercutaneous Coronary InterventionQuality-Adjusted Life YearsRandomized Controlled Trials as TopicSeptal Occluder DeviceStrokeAnticoagulantsDabigatranWarfarinanticoagulantsatrial appendageatrial fibrillationintracranial hemorrhagepericardial effusion

Identifiers

PMID27307517
PMCPMC4911813
OpenAlexW2427818130

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.