Bulletin of Semashko National Research Institute of Public HealthBulletin of Semashko National Research Institute of Public Health2415-84102415-8429FSSBI «N.A. Semashko National Research Institute of Public Health»294210.69541/NRIPH.2025.03.010Научная статьяClinical and economic efficiency of endovascular left atrial appendage closure for patients with contraindication to anticoagulantOgnerubovDmitry Viktorovichdr.ognerubov@gmail.comBersenevaEvgenia Aleksandrovnaeaberseneva@gmail.comCheberdaAlexei Evgen'evichaecheberda@healtheconomics.ruBabchenkoVladislav Valer'evichvrv280699@gmail.comMerkulovaIrina Alekseevnamerkulova.irina579@list.ruPevznerDmitry Vol'fovichpevsner@mail.ruOgnerubovNikolai Alekseevichognerubov_n.a@mail.ruMerkulovEvgeny Vladimirovichev.merkulov@list.ruRussian Presidential Academy of National Economy and Public Administration (RANEPA), Moscow, Russian FederationRussian Medical Academy of Continuing Professional Education (RMANPO), Moscow, Russian FederationLLC «Centre for Pharmacoeconomics Research», Moscow, Russian FederationFederal State Budgetary Institution «National Medical Research Centre of Cardiology named after Academician E. I. Chazov» of the Ministry of Health of the Russian Federation, Moscow, Russian FederationFederal State Budgetary Educational Institution of Higher Education «Tambov State University named after G. R. Derzhavin» Tambov, Russian Federation260920253657230092025Copyright © 2025,2025<p>Study Objective. The aim of this study was to evaluate the cost-effectiveness of percutaneous occlusion of the left atrial appendage (LAA) compared with standard stroke prevention in patients with atrial fibrillation (AF) and contraindications to oral anticoagulants (OAC) from the point of view of the Russian healthcare system. Materials and Methods: We analyzed the data of 134 patients admitted to NMIC Cardiology from 2014 to 2022, of whom 74 patients underwent ULP closure and 60 patients did not receive prophylactic treatment. Treatment costs and quality of life (QALY) scores were evaluated over 3 years. Data on complication rates, survival and complication-free survival, and direct treatment costs including hospitalisation, therapy, autopsy and funeral costs were used. Results: Over 3 years, survival was 86.5% with LAAO versus 66.3% without prophylaxis; complication-free survival was 71.6% versus 40.0%, respectively; and the incidence of ischaemic stroke was 4.1% versus 30.0%, respectively. The mean 3-year cost per patient was 461,015 RUB for LAAO and 101,365 RUB without prophylaxis; total QALYs were 2.119 and 1.665, respectively; CER was 217,563 RUB/QALY (LAAO) and 60,880 RUB/QALY (no prophylaxis). Incremental estimates after excluding non-medical costs were: ICERQALY = 826,850 RUB per QALY gained, ICER per additional survivor = 1,858,366 RUB, and ICER per additional complication-free survivor = 1,187,943 RUB. One-way sensitivity analysis (15% on key cost and survival parameters) confirmed robustness relative to a hypothetical willingness-to-pay threshold; nevertheless, interpretation is made against a suboptimal comparator, warranting caution when extrapolating to populations in whom OAC remains feasible. Conclusions: From the perspective of the Russian healthcare system, LAAO in patients with AF and documented absolute contraindications to OAC shows clinical benefit with an acceptable incremental cost over a 3-year horizon; however, because the comparison was made against a guideline-suboptimal strategy and given the constraints of a retrospective design and sample size, prospective economic evaluations and randomized clinical trials in the target population are needed to definitively confirm the technologys economic value</p>Atrial fibrillation, contraindications, left atrial appendage occlusion, left atrial appendage closure, ischaemic stroke, cost-effectiveness analysis, clinical and economic analysisФибрилляция предсердий, противопоказания, окклюзия ушка левого предсердия, закрытие ушка левого предсердия, ишемический инсульт, анализ эффективности затрат, клинико-экономический анализ[GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990—2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;(18):439—58. DOI: 10.1016/S1474-4422(19)30034—1][Игнатьева В. И., Вознюк И. А., Шамалов Н. А., и соавт. Социально-экономическое бремя инсульта в Российской Федерации. Журнал неврологии и психиатрии им. С. С. Корсакова. 2023;123(8):5—15. DOI: 10.17116/jnevro20231230825][Timmis A., Townsend N., Gale C., et al. European Society of Cardiology: Cardiovascular Disease Statistics 2017. Eur Heart J. 2018;39(7):508—79. DOI: 10.1093/eurheartj/ehx628][Мареев Ю. В., Поляков Д. С., Виноградова Н. Г., и соавт. ЭПОХА: эпидемиология фибрилляции предсердий в репрезентативной выборке Европейской части Российской Федерации. Кардиология. 2022;62(4):12—19. DOI: 10.18087/cardio.2022.4.n1997][Hindricks G., Potpara T., Dagres N., et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2021;(42):373—498. DOI: 10.1093/eurheartj/ehaa612][Лукьянов М. М., Марцевич С. Ю., Драпкина О. М., и соавт. Терапия оральными антикоагулянтами у больных с фибрилляцией предсердий в амбулаторной и госпитальной медицинской практике (данные регистров РЕКВАЗА). Кардиоваскулярная терапия и профилактика. 2019;15(4):538—45. DOI: 10.20996/1819-6446-2019-15-4-538-545][Reddy V. Y., Akehurst R. L., Gavaghan M. B., et al. Cost-effectiveness of left atrial appendage closure for stroke reduction in atrial fibrillation: analysis of pooled, 5-year, long-term data. J Am Heart Assoc.2019;(8):e011577. DOI: 10.1161/JAHA.118.011577][Бойцов С. А., Погосова Н. В., Аншелес А. А., и др. Кардиоваскулярная профилактика 2022. Российские национальные рекомендации. Российский кардиологический журнал. 2023;28(5):5452. DOI: 10.15829/1560-4071-2023-5452][Kocot E., Kotarba P., Dubas-Jakóbczyk K. The application of the QALY measure in the assessment of the effects of health interventions on an older population: a systematic scoping review. Arch Public Health. 2021;(79):201. DOI: 10.1186/s13690-021-00729-7][Gage B. F., Cardinalli A. B., Owens D. K. The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Arch Intern Med. 1996;156(16):1829—36.][Lesén E., Björholt I., Björstad A., Fahlén M., Odén A. Impact of short periods with worsened or improved INR control on life expectancy and QALYs in patients with atrial fibrillation. Thromb Res. 2014;133(6):1061—7. DOI: 10.1016/j.thromres.2014.03.052][Sullivan P. W., Lawrence W. F., Ghushchyan V. A national catalog of preference-based scores for chronic conditions in the United States. Med Care. 2005;43(7):736—49. DOI: 10.1097/01.mlr.0000172050.67085.4f][Rangaraju S., Haussen D., Nogueira R. G., Nahab F., Frankel M. Comparison of 3-month stroke disability and quality of life across Modified Rankin Scale categories. Interv Neurol. 2017;6(1—2):36—41. DOI: 10.1159/000452634][Sullivan P. W., Arant T. W., Ellis S. L., Ulrich H. The cost effectiveness of anticoagulation management services for patients with atrial fibrillation and at high risk of stroke in the US. Pharmacoeconomics. 2006;24(10):1021—33. DOI: 10.2165/00019053-200624100-00009][Тепцова Т. С., Безденежных Т. П., Федяева В. К., и соавт. Возможные методики определения порога готовности платить для принятия решений о финансировании технологий здравоохранения за счет бюджетных средств. Фармакоэкономика. Современная фармакоэкономика и фармакоэпидемиология. 2018;11(3):13—22. DOI: 10.17749/2070—4909.2018.11.3-013-022][Reddy V. Y., Akehurst R. L., Armstrong S. O., et al. Cost-effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin. Europace. 2016;(18):979—86. DOI: 10.1093/europace/euv412][Saw J., Bennell M. C., Singh S. M., et al. 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—14. DOI: 10.1016/j.cjca.2016.02.056][Holmes D. R., Reddy V. Y., Turi Z. G., et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomized non-inferiority trial. Lancet. 2009;(374):534—42. DOI: 10.1016/S0140-6736(09)61343-X][Holmes D. R., Kar S., Price M. J., 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):1—12. DOI: 10.1016/j.jacc.2014.04.029]