MedicalResearch.com Interview with:
Dr. James V. Freeman MD
Assistant professor of cardiology and
Assistant Clinical Professor of Nursing
Yale School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Freeman: 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.
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.
MedicalResearch.com: What should readers take away from your report?
Dr. Freeman: 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.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Freeman: 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.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
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, Amin Al-Ahmad, Mintu P. Turakhia. Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL. Circulation: Arrhythmia and Electrophysiology, 2016; 9 (6): e003407 DOI:
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