Transcatheter aortic valve implantation versus conservative management for severe aortic stenosis in real clinical practice

English version

Autoři: Yasuaki Takeji ^aff001; Tomohiko Taniguchi ^aff002; Takeshi Morimoto ^aff003; Naritatsu Saito ^aff001; Kenji Ando ^aff002; Shinichi Shirai ^aff002; Genichi Sakaguchi ^aff004; Yoshio Arai ^aff004; Yasushi Fuku ^aff005; Yuichi Kawase ^aff005; Tatsuhiko Komiya ^aff006; Natsuhiko Ehara ^aff007; Takeshi Kitai ^aff007; Tadaaki Koyama ^aff008; Shin Watanabe ^aff001; Hirotoshi Watanabe ^aff001; Hiroki Shiomi ^aff001; Eri Minamino-Muta ^aff001; Shintaro Matsuda ^aff001; Hidenori Yaku ^aff001; Yusuke Yoshikawa ^aff001; Kazuhiro Yamazaki ^aff009; Masahide Kawatou ^aff009; Kazuhisa Sakamoto ^aff009; Toshihiro Tamura ^aff010; Makoto Miyake ^aff010; Hisashi Sakaguchi ^aff011; Koichiro Murata ^aff012; Masanao Nakai ^aff013; Norio Kanamori ^aff014; Chisato Izumi ^aff015; Hirokazu Mitsuoka ^aff016; Masashi Kato ^aff017; Yutaka Hirano ^aff018; Tsukasa Inada ^aff019; Kazuya Nagao ^aff019; Hiroshi Mabuchi ^aff020; Yasuyo Takeuchi ^aff021; Keiichiro Yamane ^aff022; Takashi Tamura ^aff023; Mamoru Toyofuku ^aff023; Mitsuru Ishii ^aff024; Moriaki Inoko ^aff025; Tomoyuki Ikeda ^aff026; Katsuhisa Ishii ^aff027; Kozo Hotta ^aff028; Toshikazu Jinnai ^aff029; Nobuya Higashitani ^aff029; Yoshihiro Kato ^aff030; Yasutaka Inuzuka ^aff031; Yuko Morikami ^aff032; Kenji Minatoya ^aff010; Takeshi Kimura ^aff001;
Působiště autorů: Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan ^aff001; Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan ^aff002; Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan ^aff003; Division of Cardiovascular Surgery, Kokura Memorial Hospital, Kitakyushu, Japan ^aff004; Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan ^aff005; Cardiovascular Surgery, Kurashiki Central Hospital, Kurashiki, Japan ^aff006; Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan ^aff007; Cardiovascular Surgery, Kobe City Medical Center General Hospital, Kobe, Japan ^aff008; Department of Cardiovascular Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan ^aff009; Department of Cardiology, Tenri Hospital, Tenri, Japan ^aff010; Cardiovascular Surgery, Tenri Hospital, Tenri, Japan ^aff011; Department of Cardiology, Shizuoka City Shizuoka Hospital, Shizuoka, Japan ^aff012; Cardiovascular Surgery, Shizuoka City Shizuoka Hospital, Shizuoka, Japan ^aff013; Division of Cardiology, Shimada Municipal Hospital, Shimada, Japan ^aff014; Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan ^aff015; Division of Cardiology, Nara Hospital, Kinki University Faculty of Medicine, Ikoma, Japan ^aff016; Department of Cardiology, Mitsubishi Kyoto Hospital, Kyoto, Japan ^aff017; Department of Cardiology, Kinki University Hospital, Osakasayama, Japan ^aff018; Department of Cardiovascular Center, Osaka Red Cross Hospital, Osaka, Japan ^aff019; Department of Cardiology, Koto Memorial Hospital, Higashiomi, Japan ^aff020; Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan ^aff021; Department of Cardiology, Nishikobe Medical Center, Kobe, Japan ^aff022; Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan ^aff023; Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan ^aff024; Cardiovascular Center, The Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan ^aff025; Department of Cardiology, Hikone Municipal Hospital, Hikone, Japan ^aff026; Department of Cardiology, Kansai Electric Power Hospital, Osaka, Japan ^aff027; Department of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan ^aff028; Department of Cardiology, Japanese Red Cross Otsu Hospital, Otsu, Japan ^aff029; Department of Cardiology, Saiseikai Noe Hospital, Osaka, Japan ^aff030; Department of Cardiology, Shiga Medical Center for Adults, Moriyama, Japan ^aff031; Department of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan ^aff032
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pone.0222979

Souhrn

Background

Transcatheter aortic valve implantation (TAVI) is criticized by some as an expensive treatment in super-elder patients with limited life expectancy. However, there is a knowledge gap regarding the magnitude of clinical benefit provided by TAVI in comparison with conservative management in patients with severe aortic stenosis (AS) in real clinical practice, which would be important in the decision making for TAVI.

Methods

We combined two independent registries, namely CURRENT AS and K-TAVI registries. CURRENT AS was a multicenter registry enrolling 3815 consecutive patients with severe AS irrespective to treatment modalities between January 2003 and December 2011. K-TAVI was a multicenter, prospective registry including 449 consecutive patients with severe AS, who underwent TAVI with SAPIEN XT balloon-expandable valves between October 2013 and June 2016. In these 2 registries, 449 patients received TAVI and 894 patients were managed with conservative strategy. We conducted propensity score matching and finally obtained a cohort of 556 patients (278 patients for each group) for the analysis. The primary outcome measures were all-cause death and heart failure (HF) hospitalization at 2-year.

Results

The cumulative 2-year incidences of all-cause death and HF hospitalization were significantly lower in the TAVI group than in the conservative group (16.8% versus 36.6%, P<0.001, and 10.7% versus 37.2%, P<0.001). After adjusting the residual confounders, TAVI reduced the risks of all-cause death (HR, 0.46; 95%CI, 0.32–0.69; P = 0.0001) and HF hospitalizations (HR, 0.25; 95%CI, 0.16–0.40; P<0.0001) compared with conservative strategy. There was no difference in the cumulative incidence of non-cardiovascular death between the 2 groups.

Conclusions

TAVI in the early Japanese experience was associated with striking risk reduction for all-cause death as well as HF hospitalization as compared with the historical cohort of patients with severe AS who were managed conservatively just before introduction of TAVI in Japan.

Klíčová slova:

Death rates – Medical implants – Stenosis – Myocardial infarction – Heart failure – Aortic valve – Endocarditis

Zdroje

1. Murphy ES, Lawson RM, Starr A and Rahimtoola SH. Severe aortic stenosis in patients 60 years of age or older: left ventricular function and 10-year survival after valve replacement. Circulation. 1981;64:Ii184–8. 7249320

2. Schwarz F, Baumann P, Manthey J, Hoffmann M, Schuler G, Mehmel HC, et al. The effect of aortic valve replacement on survival. Circulation. 1982;66:1105–10. doi: 10.1161/01.cir.66.5.1105 7127696

3. Brennan JM, Edwards FH, Zhao Y, O'Brien SM, Douglas PS and Peterson ED. Long-term survival after aortic valve replacement among high-risk elderly patients in the United States: insights from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, 1991 to 2007. Circulation. 2012;126:1621–9. doi: 10.1161/CIRCULATIONAHA.112.091371 22907936

4. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, 3rd, Guyton RA, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2014;63:e57–185. doi: 10.1016/j.jacc.2014.02.536 24603191

5. Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J.　2017;38:2739–2791 doi: 10.1093/eurheartj/ehx391 28886619

6. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017;70:252–289. doi: 10.1016/j.jacc.2017.03.011 28315732

7. Bouma BJ, van Den Brink RB, van Der Meulen JH, Verheul HA, Cheriex EC, Hamer HP, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart. 1999;82:143–8. doi: 10.1136/hrt.82.2.143 10409526

8. Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005;26:2714–20. doi: 10.1093/eurheartj/ehi471 16141261

9. Bach DS, Siao D, Girard SE, Duvernoy C, McCallister BD Jr. and Gualano SK. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes. 2009;2:533–9. doi: 10.1161/CIRCOUTCOMES.109.848259 20031890

10. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–98. doi: 10.1056/NEJMoa1103510 21639811

11. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686–95. doi: 10.1056/NEJMoa1200384 22443479

12. 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;385:2477–84. doi: 10.1016/S0140-6736(15)60308-7 25788234

13. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016;374:1609–20. doi: 10.1056/NEJMoa1514616 27040324

14. Thourani VH, Kodali S, Makkar RR, Herrmann HC, Williams M, Babaliaros V, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016;387:2218–25. doi: 10.1016/S0140-6736(16)30073-3 27053442

15. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607. doi: 10.1056/NEJMoa1008232 20961243

16. Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696–704. doi: 10.1056/NEJMoa1202277 22443478

17. Kapadia SR, Tuzcu EM, Makkar RR, Svensson LG, Agarwal S, Kodali S, et al. Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy. Circulation. 2014;130:1483–92. doi: 10.1161/CIRCULATIONAHA.114.009834 25205802

18. Kapadia SR, Leon MB, Makkar RR, Tuzcu EM, Svensson LG, Kodali S, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385:2485–91. doi: 10.1016/S0140-6736(15)60290-2 25788231

19. Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62:1002–12. doi: 10.1016/j.jacc.2013.05.015 23727214

20. Takimoto S, Saito N, Minakata K, Shirai S, Isotani A, Arai Y, et al. Favorable Clinical Outcomes of Transcatheter Aortic Valve Implantation in Japanese Patients- First Report From the Post-Approval K-TAVI Registry. Circ J. 2016;81:103–109. doi: 10.1253/circj.CJ-16-0546 27916776

21. Taniguchi T, Morimoto T, Shiomi H, Ando K, Kanamori N, Murata K, et al. Initial Surgical Versus Conservative Strategies in Patients With Asymptomatic Severe Aortic Stenosis. J Am Coll Cardiol. 2015;66:2827–2838. doi: 10.1016/j.jacc.2015.10.001 26477634

22. Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012;42:S45–60. doi: 10.1093/ejcts/ezs533 23026738

23. Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med. 2009;28:3083–107. doi: 10.1002/sim.3697 19757444

24. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. The New England journal of medicine. 2012;366(18):1705–15. doi: 10.1056/NEJMoa1114705 22551129

25. Ludman PF, Moat N, de Belder MA, Blackman DJ, Duncan A, Banya W, et al. Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012. Circulation. 2015;131(13):1181–90. doi: 10.1161/CIRCULATIONAHA.114.013947 25637628

26. Krasopoulos G, Falconieri F, Benedetto U, Newton J, Sayeed R, Kharbanda R, et al. European real world trans-catheter aortic valve implantation: systematic review and meta-analysis of European national registries. Journal of cardiothoracic surgery. 2016;11(1):159. doi: 10.1186/s13019-016-0552-6 27899128

27. Auffret V, Lefevre T, Van Belle E, Eltchaninoff H, Iung B, Koning R, et al. Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI. Journal of the American College of Cardiology. 2017;70(1):42–55. doi: 10.1016/j.jacc.2017.04.053 28662806

28. Reynolds MR, Magnuson EA, Wang K, Thourani VH, Williams M, Zajarias A, et al. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol. 2012;60:548–58. doi: 10.1016/j.jacc.2012.03.075 22818074

29. Krane M, Deutsch MA, Piazza N, Muhtarova T, Elhmidi Y, Mazzitelli D, et al. One-year results of health-related quality of life among patients undergoing transcatheter aortic valve implantation. Am J Cardiol. 2012;109:1774–81. doi: 10.1016/j.amjcard.2012.02.021 22520622

30. Astin F, Horrocks J, McLenachan J, Blackman DJ, Stephenson J and Closs SJ. The impact of transcatheter aortic valve implantation on quality of life: A mixed methods study. Heart Lung. 2017;46:432–438. doi: 10.1016/j.hrtlng.2017.08.005 28985898

31. Baron SJ, Arnold SV, Reynolds MR, Wang K, Deeb M, Reardon MJ, et al. Durability of quality of life benefits of transcatheter aortic valve replacement: Long-term results from the CoreValve US extreme risk trial. Am Heart J. 2017;194:39–48. doi: 10.1016/j.ahj.2017.08.006 29223434

32. Herrmann HC, Thourani VH, Kodali SK, Makkar RR, Szeto WY, Anwaruddin S, et al. One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis. Circulation. 2016;134:130–40. doi: 10.1161/CIRCULATIONAHA.116.022797 27400898