Влияние несоответствия «пациент – протез» на отдалённые результаты лечения после протезирования аортального клапана биологическим протезом: ретроспективное одноцентровое исследование
Влияние несоответствия «пациент – протез» на отдалённые результаты лечения после протезирования аортального клапана биологическим протезом: ретроспективное одноцентровое исследование
Базылев В.В., Тунгусов Д.С., Бабуков Р.М., Бартош Ф.Л., Микуляк А.И., Лёвина А.В. Влияние несоответствия «протез – пациент» на отдалённые результаты лечения после протезирования аортального клапана биологическим протезом: ретроспективное одноцентровое исследование. CardioСоматика. 2022;13(3):139–147. DOI: https://doi.org/10.17816/CS87618
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Bazylev VV, Tungusov DS, Babukov RM, Bartosh FL, Mikulyаk AI, Levina AV. Influence of prosthesis – patient mismatch on long-term results in patients after aortic valve replacement with a biological prosthesis: retrospective single center study. Cardiosomatics. 2022;13(3):139–147. DOI: https://doi.org/10.17816/CS87618
Влияние несоответствия «пациент – протез» на отдалённые результаты лечения после протезирования аортального клапана биологическим протезом: ретроспективное одноцентровое исследование
Базылев В.В., Тунгусов Д.С., Бабуков Р.М., Бартош Ф.Л., Микуляк А.И., Лёвина А.В. Влияние несоответствия «протез – пациент» на отдалённые результаты лечения после протезирования аортального клапана биологическим протезом: ретроспективное одноцентровое исследование. CardioСоматика. 2022;13(3):139–147. DOI: https://doi.org/10.17816/CS87618
________________________________________________
Bazylev VV, Tungusov DS, Babukov RM, Bartosh FL, Mikulyаk AI, Levina AV. Influence of prosthesis – patient mismatch on long-term results in patients after aortic valve replacement with a biological prosthesis: retrospective single center study. Cardiosomatics. 2022;13(3):139–147. DOI: https://doi.org/10.17816/CS87618
Обоснование. Несмотря на многочисленные исследования, в настоящее время сохраняется неоднозначность выводов влияния несоответствия «протез – пациент» (НПП) на отдалённые результаты после протезирования аортального клапана (АК). Цель. Оценить влияние НПП на отдалённые результаты у пациентов после коррекции АК биологическим протезом. Материал и методы. Ретроспективно проанализированы данные 231 пациента (из них 151 мужчина, средний возраст 67±5 лет, и 80 женщин, средний возраст 66±4,8 лет), которым с января 2010 по декабрь 2018 года в ФГБУ «Федеральный центр сердечно-сосудистой хирургии» (Пенза) было выполнено протезирование АК биологическим протезом. Результаты. Умеренное НПП присутствовало у 131 (56%), тяжёлое – у 1 (0,7%) пациента. Нами не установлено значимых различий в госпитальной летальности у пациентов с НПП и без него. В отдалённом периоде у пациентов с НПП отмечалсь более медленная регрессия массы левого желудочка и восстановление его контрактильной функции. Не было выявлено значимой разницы в выживаемости в отдалённом периоде наблюдения между пациентами с НПП и без НПП: 77,7 и 79% соответственно (p=0,6). Также не обнаружено значимых различий по частоте развития больших сосудистых событий: свобода от неблагоприятных событий составила 90 и 91% соответственно (p=0,7). Зафиксирована тенденция к более частой госпитализации по поводу обострения хронической сердечной недостаточности (ХСН) в группе пациентов с НПП в сравнении с пациентами без него: 63,8 и 78% (отношение рисков, ОР=1,6; 95% доверительный интервал, ДИ 0,93–2,1; p=0,007). Кроме того, наблюдалась тенденция к увеличению структурной дегенерации биологического клапана в группе с НПП в сравнении с группой без НПП: 76 и 87% соответственно (ОР=1,4; 95% ДИ 1,43,1; p=0,01). Предикторами риска госпитализации по причине, вызванной обострением ХСН, были ранее перенесённый инфаркт миокарда и НПП (ОР=0,4; 95% ДИ 0,2–0,9; p=0,04 и ОР=1,5; 95% ДИ 0,9–2; p=0,005 соответственно). Независимым предиктором структурной дегенерации биологического протеза в отдалённом периоде наблюдения оказался факт наличия НПП (ОР=2; 95% ДИ 0,85–4,1; p=0,01). Заключение. НПП – частое осложнение после протезирования АК биологическим протезом, которое связано с более медленной регрессией массы левого желудочка, повышенным риском структурной дегенерации клапана и числом госпитализаций по поводу обострения ХСН.
Background. Despite numerous studies, ambiguity remains at present regarding the impact of prosthesis-patient mismatch (PPM) on long-term outcomes after aortic valve (AV) replacement.
Objective. This study evaluates the effect of PPM on long-term results in patients after AV replacement with a biological prosthesis. Material and methods. We retrospectively analyzed the data of 231 patients who underwent AV replacement with a biological prosthesis from 2010 to 2018 at the Penza Federal Center of Cardiovascular Surgery. Patients were implanted with the following biological prostheses: Medtronic Mosaic, Edwards PERIMOUNT, Biocor. Results. Moderate PPM was present in 131 patients (56%), and severe PPM in 1 patient (0.7%). The mean follow-up was 78.8±32 months. There were no significant differences in hospital mortality in patients with and without PPM, 4 (3%) and 3 (2,9%), respectively, p=0.9. In the long-term period, patients with PPM showed a slower regression of left ventricle (LV) mass and recovery of LV contractile function than patients without PPM, p=0.05. There was no significant difference in survival in the long-term follow-up period between patients with and without PPM long-term survival, 77.7% and 79%, respectively, p=0.6. Also, there were no significant differences in major adverse cardiac events and the freedom from adverse events was 90% and 91%; p=0.7. However, there was a tendency to more frequent hospitalization for chronic heart failure (CHF) exacerbation in the patient group with PPM than in those without PPM, 63.8% and 78%; HR 1.6; 95% CI 0.93–2.1, p=0.007. There was also a tendency for an increased biological valve structural degeneration in the group with PPM than in the group without PPM 76% and 87%, HR 1.4; 95% CI 1.4–3.1, p=0.01 According to the Cox regression, the overall postoperative mortality predictors were diabetes mellitus, vascular atherosclerosis HR 5; 95% CI 1.2–22, p=0.04 and HR 2.9; 95% CI 1.4–6.6, p=0.01 respectively. Predictors of the risk of hospitalization due to CHF exacerbation were previous myocardial infarction and PPM HR 0.4; 95% CI 0.2–0.9, p=0.04 and HR 1,5; 95% CI 0.9–2; p=0.005, respectively PPM HR 2; 95% CI 0.85–4.1, p=0.01. Conclusion. PPM is a common complication after AV replacement with a biological prosthesis. It is associated with a slower regression of LV mass, an increased risk of structural valve degeneration, and hospitalizations for exacerbated heart failure.
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doi: 10.1016/j.jacc.2012.07.005
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doi: 10.1161/01.cir.102.suppl_3.iii-5
4. Pibarot P., Honos G.N., Durand L.G., Dumesnil J.G. The effect of patient – prosthesis mismatch on aortic bioprosthetic valve hemodynamic performance and patient clinical status // Can J Cardiol. 1996. Vol. 12, N 4. P. 379–387.
5. Mohty D., Girad S.E., Malouf J.F., et al. The impact of severe prosthesis – patient mismatch on long-term survival in patients with small St. Jude Mechanical prostheses in the aortic position // Circulation. 2006. Vol. 113, N 3. P. 420–426. doi: 10.1161/CIRCULATIONAHA.105.546754
6. Nardi P., Russo M., Saitto G., Ruvolo G. The Prognostic Significance of Patient – Prosthesis Mismatch after Aortic Valve Replacement. Korean J Thorac Cardiovasc Surg. 2018;51(3):161–166. doi: 10.5090/kjtcs.2018.51.3.161
7. Flameng W., Herregods M.C., Vercalsteren M., et al. Prosthesis – patient mismatch predicts structural valve degeneration in bioprosthetic heart valves // Circulation. 2010. Vol. 121, N 19. P. 2123–2129. doi: 10.1161/CIRCULATIONAHA.109.901272
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doi: 10.1136/heartjnl-2014-306445
9. Pibarot P., Dumesnil J.G. Hemodynamic and clinical impact of prosthesis – patient mismatch in the aortic valve position and its prevention // J Am Coll Cardiol. 2000. Vol. 36, N 4. P. 1131–1141. doi: 10.1016/s0735-1097(00)00859-7
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doi: 10.1016/0002-8703(90)90128-k
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12. González-Juanatey J.R., García-Acuña J.M., Fernandez M.V., et al. Influence of the size of aortic valve prostheses on hemodynamics and change in left ventricular mass: implications for the surgical management of aortic stenosis // J Thorac Cardiovasc Surg. 1996. Vol. 112, N 2. P. 273–280. doi: 10.1016/s0022-5223(96)70249-0
13. Del Rizzo D.F., Abdoh A., Cartier P., et al. Factors affecting left ventricular mass regression after aortic valve replacement with stentless valves // Semin Thorac Cardiovasc Surg. 1999. Vol. 11, N 4 (Suppl. 1). P. 114–120.
14. Jamieson W.R., Ye J., Higgins J., et al. Effect of prosthesis – patient mismatch on long-term survival with aortic valve replacement: assessment to 15 years // Ann Thorac Surg. 2010. Vol. 89, N 1. P. 51–58. Discussion 59. doi: 10.1016/j.athoracsur.2009.08.070
15. Astudillo L.M., Santana O., Urbandt P.A., et al. Clinical predictors of prosthesis – patient mismatch after aortic valve replacement for aortic stenosis // Clinics (Sao Paulo). 2012. Vol. 67, N 1. P. 55–60. doi: 10.6061/clinics/2012(01)09
16. Chacko S.J., Ansari A.H., McCarthy P.M., et al. Prosthesis – patient mismatch in bovine pericardial aortic valves: evaluation using 3 different modalities and associated medium-term outcomes // Circ Cardiovasc Imaging. 2013. Vol. 6, N 5. P. 776–783. doi: 10.1161/CIRCIMAGING.112.000319
17. VARC-3 WRITING COMMITTEE; Généreux P., Piazza N., et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research // Eur Heart J. 2021. Vol. 42, N 19. P. 1825–1857. doi: 10.1093/eurheartj/ehaa799
18. Rahimtoola S.H. The problem of valve prosthesis – patient mismatch // Circulation. 1978. Vol. 58, N 1. P. 20–24. doi: 10.1161/01.CIR.58.1.20
19. Cotoni D.A., Palac R.T., Dacey L.J., O’Rourke D.J. Defining patient – prosthesis mismatch and its effect on survival in patients with impaired ejection fraction // Ann Thorac Surg. 2011. Vol. 91, N 3. P. 692–699. doi: 10.1016/j.athoracsur.2010.11.033
20. Concistrè G., Dell'aquila A., Pansini S., et al. Aortic valve replacement with smaller prostheses in elderly patients: does patient prosthetic mismatch affect outcomes? // J Card Surg. 2013. Vol. 28, N 4. P. 341–347. doi: 10.1111/jocs.12136
21. Florath I., Albert A., Rosendahl U., et al. Impact of valve prosthesis – patient mismatch estimated by echocardiographic-determined effective orifice area on long-term outcome after aortic valve replacement // Am Heart J. 2008. Vol. 155, N 6. P. 1135–1142. doi: 10.1016/j.ahj.2007.12.037
22. Howell N.J., Keogh B.E., Ray D., et al. Patient – prosthesis mismatch in patients with aortic stenosis undergoing isolated aortic valve replacement does not affect survival // Ann Thorac Surg. 2010. Vol. 89, N 1. P. 60–64. doi: 10.1016/j.athoracsur.2009.07.037
23. Tao K., Sakata R., Iguro Y., et al. Impact of valve prosthesis – patient mismatch on intermediate-term outcome and regression of left ventricular mass following aortic valve replacement with mechanical prosthesis // J Card Surg. 2007. Vol. 22, N 6. P. 486–492. doi: 10.1111/j.1540-8191.2007.00465.x
24. Garatti A., Mori F., Innocente F., et al. Aortic valve replacement with 17-mm mechanical prostheses: is patient – prosthesis mismatch a relevant phenomenon? // Ann Thorac Surg. 2011. Vol. 91, N 1. P. 71–77. doi: 10.1016/j.athoracsur.2010.08.036
25. Vicchio M., Della Corte A., De Santo L.S., et al. Prosthesis – patient mismatch in the elderly: survival, ventricular mass regression, and quality of life // Ann Thorac Surg. 2008. Vol. 86, N 6. P. 1791–1797. doi: 10.1016/j.athoracsur.2008.09.005
26. Fallon J.M., DeSimone J.P., Brennan J.M., et al. The incidence and consequence of prosthesis – patient mismatch after surgical aortic valve replacement // Ann Thorac Surg. 2018. Vol. 106, N 1. P. 14–22. doi: 10.1016/j.athoracsur.2018.01.090
27. Sá M.P.B.O., de Carvalho M.M.B., Sobral Filho D.C., et al. Surgical aortic valve replacement and patient – prosthesis mismatch: meta-analysis of 108,182 patients // Eur J Cardiothorac Surg. 2019. Vol. 56, N 1. P. 44–54. doi: 10.1093/ejcts/ezy466
28. Daneshvar S.A., Rahimtoola S.H. Valve prosthesis – patient mismatch (VP-PM): a long-term perspective // J Am Coll Cardiol. 2012. Vol. 60, N 13. P. 1123–1135.
doi: 10.1016/j.jacc.2012.05.035
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31. Pibarot P., Dumesnil J.G., Lemieux M., et al. Impact of prosthesis – patient mismatch on hemodynamic and symptomatic status, morbidity and mortality after aortic valve replacement with a bioprosthetic heart valve // J Heart Valve Dis. 1998. Vol. 7, N 2. P. 211–218.
32. Blackstone E.H., Cosgrove D.M., Jamieson W.R., et al. Prosthesis size and long-term survival after aortic valve replacement // J Thorac Cardiovasc Surg. 2003. Vol. 126, N 3. P. 783–796. doi: 10.1016/S0022-5223(03)00591-9
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1. Pibarot P, Dumesnil JG. Valve prosthesis – patient mismatch, 1978 to 2011: from original concept to compelling evidence. J Am Coll Cardiol. 2012;60(13):1136–1139.
doi: 10.1016/j.jacc.2012.07.005
2. Lancellotti P, Pibarot P, Chambers J, et al. Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Interamerican Society of Echocardiography and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016;17(6):589–590. doi: 10.1093/ehjci/jew025
3. Rao V, Jamieson WR, Ivanov J, et al. Prosthesis – patient mismatch affects survival following aortic valve replacement. Circulation. 2000;102(19 Suppl 3):III5–III9.
doi: 10.1161/01.cir.102.suppl_3.iii-5
4. Pibarot P, Honos GN, Durand LG, Dumesnil JG. The effect of patient – prosthesis mismatch on aortic bioprosthetic valve hemodynamic performance and patient clinical status. Can J Cardiol. 1996;12(4):379–387.
5. Mohty D, Girad SE, Malouf JF, et al. The impact of severe prosthesis – patient mismatch on long-term survival in patients with small St. Jude Mechanical prostheses in the aortic position. Circulation. 2006;113(3):420–426. doi: 10.1161/CIRCULATIONAHA.105.546754
6. Nardi P, Russo M, Saitto G, Ruvolo G. The Prognostic Significance of Patient – Prosthesis Mismatch after Aortic Valve Replacement. Korean J Thorac Cardiovasc Surg. 2018;51(3):161–166. doi: 10.5090/kjtcs.2018.51.3.161
7. Flameng W, Herregods MC, Vercalsteren M, et al. Prosthesis – patient mismatch predicts structural valve degeneration in bioprosthetic heart valves. Circulation. 2010;121(19):2123–2129. doi: 10.1161/CIRCULATIONAHA.109.901272
8. Mahjoub H, Mathieu P, Larose É, et al. Determinants of aortic bioprosthetic valve calcification assessed by multidetector CT. Heart. 2015;101(6):472–477.
doi: 10.1136/heartjnl-2014-306445
9. Pibarot P, Dumesnil JG. Hemodynamic and clinical impact of prosthesis – patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol. 2000;36(4):1131–1141. doi: 10.1016/s0735-1097(00)00859-7
10. Hoffmann A, Burckhardt D. Patients at risk for cardiac death late after aortic valve replacement. Am Heart J. 1990;120(5):1142–1147.
doi: 10.1016/0002-8703(90)90128-k
11. Sim EKW, Orszulak TA, Schaff HV, Schub C. Influence of prosthesis size on change in left ventricular mass following aortic valve replacement. Eur J Cardiothorac Surg. 1994;8(6):293–297. doi: 10.1016/s1010-7940(05)80088-0
12. González-Juanatey JR, García-Acuña JM, Fernandez MV, et al. Influence of the size of aortic valve prostheses on hemodynamics and change in left ventricular mass: implications for the surgical management of aortic stenosis. J Thorac Cardiovasc Surg. 1996;112(2):273–280. doi: 10.1016/s0022-5223(96)70249-0
13. Del Rizzo DF, Abdoh A, Cartier P, et al. Factors affecting left ventricular mass regression after aortic valve replacement with stentless valves. Semin Thorac Cardiovasc Surg. 1999;11(4 Suppl 1):114–120.
14. Jamieson WR, Ye J, Higgins J, et al. Effect of prosthesis – patient mismatch on long-term survival with aortic valve replacement: assessment to 15 years. Ann Thorac Surg. 2010;89(1):51–58;discussion 59. doi: 10.1016/j.athoracsur.2009.08.070
15. Astudillo LM, Santana O, Urbandt PA, et al. Clinical predictors of prosthesis – patient mismatch after aortic valve replacement for aortic stenosis. Clinics (Sao Paulo). 2012;67(1):55–60. doi: 10.6061/clinics/2012(01)09
16. Chacko SJ, Ansari AH, McCarthy PM, et al. Prosthesis-patient mismatch in bovine pericardial aortic valves: evaluation using 3 different modalities and associated medium-term outcomes. Circ Cardiovasc Imaging. 2013;6(5):776–783. doi: 10.1161/CIRCIMAGING.112.000319
17. VARC-3 WRITING COMMITTEE; Généreux P, Piazza N, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021;42(19):1825–1857. doi: 10.1093/eurheartj/ehaa799
18. Rahimtoola SH. The problem of valve prosthesis – patient mismatch. Circulation. 1978;58(1):20–24. doi: 10.1161/01.CIR.58.1.20
19. Cotoni DA, Palac RT, Dacey LJ, O’Rourke DJ. Defining patient – prosthesis mismatch and its effect on survival in patients with impaired ejection fraction. Ann Thorac Surg. 2011;91(3):692–699. doi: 10.1016/j.athoracsur.2010.11.033
20. Concistrè G, Dell'aquila A, Pansini S, et al. Aortic valve replacement with smaller prostheses in elderly patients: does patient prosthetic mismatch affect outcomes? J Card Surg. 2013;28(4):341–347. doi: 10.1111/jocs.12136
21. Florath I, Albert A, Rosendahl U, et al. Impact of valve prosthesis – patient mismatch estimated by echocardiographic-determined effective orifice area on long-term outcome after aortic valve replacement. Am Heart J. 2008;155(6):1135–1142. doi: 10.1016/j.ahj.2007.12.037
22. Howell NJ, Keogh BE, Ray D, et al. Patient – prosthesis mismatch in patients with aortic stenosis undergoing isolated aortic valve replacement does not affect survival. Ann Thorac Surg. 2010;89(1):60–64. doi: 10.1016/j.athoracsur.2009.07.037
23. Tao K, Sakata R, Iguro Y, et al. Impact of valve prosthesis – patient mismatch on intermediate-term outcome and regression of left ventricular mass following aortic valve replacement with mechanical prosthesis. J Card Surg. 2007;22(6):486–492. doi: 10.1111/j.1540-8191.2007.00465.x
24. Garatti A, Mori F, Innocente F, et al. Aortic valve replacement with 17-mm mechanical prostheses: is patient – prosthesis mismatch a relevant phenomenon? Ann Thorac Surg. 2011;91(1):71–77. doi: 10.1016/j.athoracsur.2010.08.036
25. Vicchio M, Della Corte A, De Santo LS, et al. Prosthesis – patient mismatch in the elderly: survival, ventricular mass regression, and quality of life. Ann Thorac Surg. 2008;86(6):1791–1797. doi: 10.1016/j.athoracsur.2008.09.005
26. Fallon JM, DeSimone JP, Brennan JM, et al. The incidence and consequence of prosthesis – patient mismatch after surgical aortic valve replacement. Ann Thorac Surg. 2018;106(1):14–22. doi: 10.1016/j.athoracsur.2018.01.090
27. Sá MPBO, de Carvalho MMB, Sobral Filho DC, et al. Surgical aortic valve replacement and patient – prosthesis mismatch: meta-analysis of 108,182 patients. Eur J Cardiothorac Surg. 2019;56(1):44–54 doi: 10.1093/ejcts/ezy466
28. Daneshvar SA, Rahimtoola SH. Valve prosthesis – patient mismatch (VP-PM): a long-term perspective. J Am Coll Cardiol. 2012;60(13):1123–1135. doi: 10.1016/j.jacc.2012.05.035
29. Moon MR, Lawton JS, Moazami N, et al. POINT: prosthesis – patient mismatch does not affect survival for patients greater than 70 years of age undergoing bioprosthetic aortic valve replacement. J Thorac Cardiovasc Surg. 2009;137(2):278–283. doi: 10.1016/j.jtcvs.2008.09.059
30. Blais C, Dumesnil JG, Baillot R, et al. Impact of valve prosthesis – patient mismatch on short-term mortality after aortic valve replacement. Circulation. 2003;108(8):983–988.
doi: 10.1161/01.CIR.0000085167.67105.32
31. Pibarot P, Dumesnil JG, Lemieux M, et al. Impact of prosthesis – patient mismatch on hemodynamic and symptomatic status, morbidity and mortality after aortic valve replacement with a bioprosthetic heart valve. J Heart Valve Dis. 1998;7(2):211–218.
32. Blackstone EH, Cosgrove DM, Jamieson WR, et al. Prosthesis size and long-term survival after aortic valve replacement. J Thorac Cardiovasc Surg. 2003;126(3):783–796.
doi: 10.1016/S0022-5223(03)00591-9