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



We 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.



Using 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.
From 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.
James V
JV
Freeman
From 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.).
David W
DW
Hutton
From 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
GD
Barnes
From 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
RP
Zhu
From 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
DK
Owens
From 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
AM
Garber
From 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
AS
Go
From 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
MA
Hlatky
From 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
PA
Heidenreich
From 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
PJ
Wang
From 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
A
Al-Ahmad
From 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
MP
Turakhia
D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000191:economics; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000601:surgery*; D003362:Cost-Benefit Analysis; D000069604:Dabigatran / Q000008:administration & dosage / Q000191:economics; D003663:Decision Trees; D005260:Female; D006801:Humans; D008297:Male; D008390:Markov Chains; D062645:Percutaneous Coronary Intervention / Q000191:economics*; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D055989:Septal Occluder Device / Q000191:economics; D020521:Stroke / Q000517:prevention & control; D015996:Survival Rate; D014859:Warfarin / Q000008:administration & dosage / Q000191:economics
D000925:Anticoagulants; D014859:Warfarin; D000069604:Dabigatran
anticoagulants; atrial appendage; atrial fibrillation; intracranial hemorrhage; pericardial effusion