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

Abstract

Background Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost-effectiveness compared to anticoagulation has not been evaluated using all available contemporary trial data. Methods and Results 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 PROTECT AF and PREVAIL randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios (ICER) compared to warfarin and dabigatran were $20,486 and $23,422 per quality adjusted life year (QALY), 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 QALYs, respectively) and more costly. At a willingness-to-pay-threshold of $50,000 per QALY, 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. Conclusions 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 post-marketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice.

Cost-effectiveness of left atrial appendage closure for stroke prevention in atrial fibrillation: a systematic review appraising the methodological quality

“…Two studies we reviewed did not specify the CHADS 2 VASc score for their base-case populations [ 21 , 24 ]. Freeman et al [ 23 ] considered a score greater than 1, regardless of gender, in the base case population. The remaining studies adopted a score greater than 2.…”

“…Cycle lengths also exhibited variation, with studies employing a 1 month cycle (n = 4), a 3 month cycle (n = 4), and a 1 year cycle (n = 3). One study [ 23 ] did not specify the cycle length used in their analysis.…”

“…In six of these evaluations (67%), LAAC had a more than 50% probability of being cost-effective compared to warfarin [ 19 – 21 , 23 , 26 , 27 ]. In the majority of evaluations with dabigatran (6 out of 8 studies) [ 20 , 21 , 23 , 24 , 27 ], apixaban (3 out of 5 studies) [ 11 , 20 – 22 , 24 ], and rivaroxaban (2 out of 3 studies) [ 11 , 21 , 24 ], LAAC emerged as the cost-effective intervention in 50% or more of the times. [ 20 , 21 , 23 , 24 , 27 ].…”

Posicionamiento conjunto acerca del tratamiento para fibrilación auricular

“…The most recent results on cost-benefit analysis using dedicated statistical models (e.g. Markov's stochastic decision model) have yielded contradictory results 57 . However, several studies are ongoing and are expected to produce positive results for occluders 58 .…”

3D Printing for Left Atrial Appendage (LAA) Modeling Based on Transesophageal Echocardiography: A Step Forward in Closure with LAA Devices

“…Moreover, as to cost effectiveness, there are additional supportive indications from the PROTECT AF trial [36]. …”