Risk of death calculation after percutaneous or open surgical aortic valve replacement in high-risk patient group: a multicenter retrospective study

Hubulava G.G.¹, Marchenko S.P.¹, Naumov A.B.¹, Biryukov A.V.¹, Hubulava A.G.¹, Vlasenko S.V.², Andreev M.S.¹, Kaziev R.R.¹, Rzaeva E.SH.¹, Ivanchenko R.D.¹, Azarova I.N.¹, Didenko M.V.², Sazonov A.B.², Volkov A.M.²

Based on the long-term results of treatment of patients with acquired aortic valve disease, identify predictors of an unfavorable outcome depending on the method of prosthesis implantation. Create regression models for prediction of the outcomes of surgical treatment.

Materials and Methods. The main group included 48 patients with aortic stenosis who underwent percutaneous aortic valve implantation (TAVI). The control group included 72 patients who were operated on using frameless bioprostheses (AVR) in the period from 2002 to 2008. All patients underwent echocardiographic assessment of the parameters of the left ventricle and aortic valve. In order to assess the influence of individual factors, the method of multiple regression was used.

Results. The overall mortality rate in TAVI group was 16.6% and 11.1% in AVR group, with no statistically significant differences revealed. There was a direct correlation between the presence of COPD and poor outcomes of moderate strength (R = 0.55). A regression model was made based on a combination of the EuroScore risk, and the left ventricular ejection frac­tion. This model predicted an adverse surgical outcome with an accuracy of 92%, sensitivity of 83%, specificity of 78% at χ2 = 12 and p = 0.01. An ROC analysis was performed for each group. For the first group, the AUC was 0.789 (95% CI: 0.72-0.95) at p = 0.03, for the second group, the AUC was 0.918 (95% CI: 0.834-0.99) at p = 0.001. For all patients included in the study, the AUC was 0.817 (95% CI: 0.755-0.91) at p = 0.02. The critical value of the probability of death was calculated for each group: in the TAVI group — 75% (sensitivity 85%, specificity 77%), in AVR group 37% (sensitivity 83%, specificity 85%).

Conclusions. The regression model obtained in this study allows us to calculate the risk of unfavorable outcome after intervention on the aortic valve. The identified criti­cal values for this model can serve as an indication in determining the method of treating pathology of the aortic valve.

1. Hubulava G.G., Marchenko S.P., SHihverdiev N.N. Lechenie Pacientov Kardiologicheskogo Profilya. Sovremennye Hirurgicheskie Vozmozhnosti, 2011. (In Russ).

2. Cribier A. Right valve for right patient: between economics and data. C3. 2020: 2 [URL].

3. Husser O, Nosek BA. The prosthesis of choice for TAVI, the majority of patients should receive an Acurate neo. C3. 2020.

4. Mack M, Leon M, Thourani V, Makkar R, Kodali S, Russo M, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019; 380(18): 1695-1705. doi:10.1056/NEJMoa1814052.

5. Leon M, Smith C, Mack M, Miller C, Moses J, Svensson L. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery Martin. N Engl J Med. 2009; 361(2): 123-134. doi:10.1056/NEJMoa0900212.

6. Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): A randomised controlled trial. Lancet. 2015; 385(9986): 2477-2484. doi:10.1016/S0140-6736(15)60308-7.

7. Popma J.J., Michael Deeb G., Yakubov S.J., Mumtaz M., Gada H., O’Hair D., et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019; 380(18): 1706-1715. doi:10.1056/NEJMoa1816885.

8. SHihverdiev NN, Hubulava GG, Marchenko SP, Askerov MA. Rekonstruktivnye vmeshatel'stva na mitral'nom klapane: varianty korrekcii, neposredstvennye i otdalennye rezul'taty. Arterial'naya gipertenziya. 2008; 14(1): 91-96. (In Russ).

9. Marchenko SP, Hubulava GG, Naumov AB, Seliverstova AA, Cipurdieva ND, Suvorov VV, et al. Patofiziologicheskie principy i podhody k ocenke gemodinamiki. Pediatr. 2014; 5(4): 110-115. (In Russ).

10. Sokolov AA, Marcinkevich GI, Smorgon AV. Diagnosticheskoe znachenie ekhokardiograficheskogo miokardial'nogo indeksa Tei v ocenke narushenij nasosnoj i kontraktil'noj funkcij levogo zheludochka, vozrastnye i nozologicheskie aspekty. Sibirskij medicinskij zhurnal. 2019; 34(1): 61-68. (In Russ).

11. Sokolov AA, Marcinkevich GI. Trekhmernye, dvuhmernye i nevolyumetricheskie ekhokardiograficheskie metody ocenki kontraktil'nosti pravogo zheludochka. Kardiologiya v Belarusi. 2016; 8(1): 98-107. (In Russ).

12. Hubulava GG, Marchenko SP, Starchik DA, Suvorov VV, Krivoshchekov EV, SHihverdiev NN, et al. Geometricheskie i morfologicheskie harakteristiki kornya aorty v norme i pri nedostatochnosti aortal'nogo klapana. Hirurgiya. ZHurnal im NI Pirogova. 2018; 5: 4-12 (In Russ).

13. Starchik DA. Konstitucional'no-anatomicheskie osobennosti serdca cheloveka. Morfologicheskie vedomosti. 2016; 24(1): 120-124. (In Russ).

14. Starchik DA, Nikityuk DB. Osobennosti indeksa massy tela u zhenshchin raznyh somatotipov. Morfologicheskie vedomosti. 2015; 4: 21-24. (In Russ).

15. Starchik DA. Konstitucional'no-anatomicheskie tipy i ih kolichestvennoe predstavitel'stvo sredi zhenshchin zrelogo vozrasta. ZHurnal anatomii i gistopatologii. 2015; 4(4): 44-48. (In Russ).

16. Hubulava GG, Marchenko SP, Dubova EV, Suvorov VV. Rol' modificirovannoj ul'trafil'tracii v umen'shenii sistemnyh proyavlenij vospaleniya v kardiohirurgii. Pediatr. 2016; 7(1): 106-110. (In Russ).

17. Sokolov AA, Marcinkevich GI, Popov SV, Savenkova GM. Ekhokardiograficheskie kriterii optimizacii rezhimov biventrikulyarnogo stimulyatora. Kardiologiya. 2007; 47: 29. (In Russ).

18. Marcinkevich GI, Sokolov AA, Popov SV. Elektromekhanicheskij asinhronizm serdca. Vozmozhnosti instrumental'noj ocenki pri stimulyacionnyh tekhnologiyah lecheniya SN. Vestnik aritmologii. 2003; 34: 57. (In Russ).

19. Sokolov AA, Marcinkevich GI. Cerdechnaya nedostatochnost' u pacientov s sohranennoj frakciej vybrosa levogo zheludochka — nasosnaya nesostoyatel'nost' serdca. Kardiologiya. 2018; 58(6): 79-84. (In Russ).

20. Naumov AB, Bautin AE, Kutin AM, Povarenkov AS, Kozyrev IM, SHihverdiev NN, et al. Primenenie levosimendana dlya lecheniya kardiogennogo shoka, svyazannogo s razvitiem ostroj pravozheludochkovoj nedostatochnosti posle aortokoronarnogo shuntirovaniya. Kardiologiya i serdechno-sosudistaya hirurgiya. 2009; 2(1): 79-81. (In Russ).

21. Kazakov VA, Gutor SS, Suhodolo IV, SHipulin VM, Krivoshchyokov EV. Korrelyacionnye vzaimosvyazi gistomorfometricheskih pokazatelej miokarda razlichnyh otdelov serdca v norme i pri hronicheskoj serdechnoj nedostatochnosti. Byulleten' sibirskoj mediciny. 2009; 8(3): 43-47. (In Russ).

22. Fogt PR, Hubulava GG, Marchenko SP, Naumov AB, SHmidlin D, Berda R, et al. Eliminaciya Sternal'noj Infekcii v Kardiohirurgii. Sankt-Peterburg: B. Braun Medikal; 2012. (In Russ).

23. Hubulava GG, SHihverdiev NN, Naumov AB, Suvorov VV, Marchenko SP. Patofiziologicheskie mekhanizmy i faktory riska razvitiya sternal'noj infekcii v kardiohirurgii. Vestnik Rossijskoj Voenno-medicinskoj akademii. 2013; 41(1): 174-179. (In Russ).

24. Hubulava GG, SHihverdiev NN, Fogt PR, Marchenko SP, Naumov AB, Suvorov VV, et al. Rezul'taty primeneniya metodiki eliminacii sternal'noj infekcii u kardiohirurgicheskih pacientov. Vestnik hirurgii im I.I. Grekova. 2015; 174(5): 57-60. (In Russ).

25. SHihverdiev NN, Hubulava GG, Marchenko SP, Suvorov VV. Vliyanie mestnogo primeneniya vankomicina na funkciyu organov posle operacij na serdce. Patologiya krovoobrashcheniya i kardiohirurgiya. 2015; 19(4): 34-37. (In Russ).

26. Hubulava GG, SHihverdiev NN, Fogt PR, Marchenko SP, Suvorov VV. Prognozirovanie veroyatnosti razvitiya sternal'noj infekcii u kardiohirurgicheskih pacientov. Vestnik hirurgii im I.I.Grekova. 2018; 177(1): 11-15. (In Russ).

27. Vogt PR, Darrall A, Berdat P, Schmidlin D, Khubulava GG, Marchenko SP, et al. Significant reduction of sternal wound infection in cardiac surgical patients. Byulleten' NCSSKH im AN Bakuleva RAMN «Serdechno-sosudistye zabolevaniya». 2019; 20(4): 368-378.

28. Vogt P, Darrall A, Santoro G, Schmidlin D, Khubulava G, et al. Reduction of Sternal Wound Infections with a Refined Surgical Technique and Single Shot Systemic and Sternal Spongiosa Topical Antibiotic Prophylaxis Compared to 24 Hours Systemic Antibiotics. Am J Clin Microbiol Antimicrob. 2019; 2(2): 1-6.