Transcatheter aortic valve replacement with Venus A-Valve and other overseas devices_West China Medical Journal

Authors：

WANG Xi , LI Yijian , OU Yuanweixiang , WANG Zijie , LIAO Yanbiao , FENG Yuan ,  CHEN Mao

Department of Cardiology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

CHEN Mao, Email: hmaochen@vip.sina.com

Keywords：

Severe aortic stenosis; Transcatheter aortic valve replacement; Venus A-Valve

DOI：

10.7507/1002-0179.201903056

Video：

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Objective To compare the efficacy and safety of Venus A-Valve and other overseas devices in transcatheter aortic valve replacement (TAVR) for patients with severe aortic stenosis (AS).Methods We retrospectively analyzed the baseline characteristics, procedural details, and postprocedural outcomes of severe AS patients who underwent TAVR with Venus A-Valve or overseas devices between April 2012 and January 2019 in West China Hospital of Sichuan University.Results A total of 342 AS patients undergoing TAVR were finally included, 238 with Venus A-Valve and the other 104 with overseas devices (43 with CoreValve, 33 with Lotus, 21 with SAPIEN XT, and 7 with SAPIEN 3). Baseline characteristics were comparable between the two groups, and the proportion of patients with bicuspid aortic valve was around 50% in both groups. After successful valve implantation, all patients’ hemodynamics were significantly improved, with the median of maximum velocity decreased to 2.30 m/s (inter-quartile range: 0.60 m/s) and 2.50 m/s (inter-quartile range: 0.62 m/s), respectively (P=0.003). Postprocedural 30-day and 1-year all cause mortalities were similar (30-day: 5.9% vs. 1.9%, P=0.086; 1-year: 8.4% vs. 5.8%, P=0.307), while low incidence of procedure-related complications and improved life quality were achieved in both groups.Conclusion TAVR with the domestic Venus A-Valve is feasible, safe, and can produce favorable outcomes for AS patients, and especially for Chinese TAVR population with a high prevalence of bicuspid aortic valve.

Citation： WANG Xi, LI Yijian, OU Yuanweixiang, WANG Zijie, LIAO Yanbiao, FENG Yuan, CHEN Mao. Transcatheter aortic valve replacement with Venus A-Valve and other overseas devices. West China Medical Journal, 2019, 34(4): 379-384. doi: 10.7507/1002-0179.201903056 Copy

1.	Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary a report of the American college of cardiology/American heart association task force on practice guidelines. J Am Coll Cardiol, 2014, 129(23): 2440-2492.
2.	Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet, 2006, 368(9540): 1005-1011.
3.	Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?. Eur Heart J, 2005, 26(24): 2714-2720.
4.	Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis - first human case description. Circulation, 2002, 106(24): 3006-3008.
5.	Otto CM, Kumbhani DJ, Alexander KP, et al. 2017 ACC expert consensus decision pathway for transcatheter aortic valve replacement in the management of adults with aortic stenosis a report of the American college of cardiology task force on clinical expert consensus documents. J Am Coll Cardiol, 2017, 69(10): 1313-1346.
6.	Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol, 2012, 60(15): 1438-1454.
7.	Meredith AI, Walters DL, Dumonteil N, et al. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol, 2014, 64(13): 1339-1348.
8.	Reardon MJ, van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376: 1321-1331.
9.	Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374: 1609-1620.
10.	Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet, 2016, 387(134): 2218-2225.
11.	Himbert D, Pontnau F, Messika-Zeitoun DA, et al. Feasibility and outcomes of transcatheter aortic valve implantation in high-risk patients with stenotic bicuspid aortic valves. Am J Cardiol, 2012, 110(6): 877-883.
12.	Hayashida K, Bouvier E, Lefevre T, et al. Transcatheter aortic valve implantation for patients with severe bicuspid aortic valve stenosis. Circ Cardiovasc Interv, 2013, 6(3): 284-291.
13.	Bauer T, Linke A, Sievert H, et al. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry). Am J Cardiol, 2014, 113(3): 518-521.
14.	Costopoulos C, Latib A, Maisano F, et al. Comparison of results of transcatheter aortic valve implantation in patients with severely stenotic bicuspid versus tricuspid or nonbicuspid valves. Am J Cardiol, 2014, 113(8): 1390-1393.
15.	Jilaihawi H, Wu YJ, Yang YE, et al. Morphological characteristics of severe aortic stenosis in China: imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv, 2015, 85(Suppl 1): 752-761.
16.	Zhao ZG, Jilaihawi H, Feng Y, et al. Transcatheter aortic valve implantation in bicuspid anatomy. Nat Rev Cardiol, 2015, 12(2): 123-128.
17.	Zegdi R, Ciobotaru V, Noghin M, et al. Is it reasonable to treat all calcified stenotic aortic valves with a valved stent? Results from a human anatomic study in adults. J Am Coll Cardiol, 2008, 51(5): 579-584.
18.	Liao YB, Zhao ZG, Wei X, et al. Transcatheter aortic valve implantation with the self-expandable Venus A-Valve and CoreValve devices: preliminary experiences in China. Catheter Cardiovasc Interv, 2017, 89(S1): 528-533.
19.	Perlman GY, Blanke P, Dvir D, et al. Bicuspid aortic valve stenosis: favorable early outcomes with a next-generation transcatheter heart valve in a multicenter study. JACC Cardiovasc Interv, 2016, 9(8): 817-824.
20.	Yoon SH, Lefevre T, Ahn JM, et al. Transcatheter aortic valve replacement with early- and New-Generation devices in bicuspid aortic valve stenosis. J Am Coll Cardiol, 2016, 68(11): 1195-1205.

1. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary a report of the American college of cardiology/American heart association task force on practice guidelines. J Am Coll Cardiol, 2014, 129(23): 2440-2492.
2. Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet, 2006, 368(9540): 1005-1011.
3. Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?. Eur Heart J, 2005, 26(24): 2714-2720.
4. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis - first human case description. Circulation, 2002, 106(24): 3006-3008.
5. Otto CM, Kumbhani DJ, Alexander KP, et al. 2017 ACC expert consensus decision pathway for transcatheter aortic valve replacement in the management of adults with aortic stenosis a report of the American college of cardiology task force on clinical expert consensus documents. J Am Coll Cardiol, 2017, 69(10): 1313-1346.
6. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol, 2012, 60(15): 1438-1454.
7. Meredith AI, Walters DL, Dumonteil N, et al. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol, 2014, 64(13): 1339-1348.
8. Reardon MJ, van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376: 1321-1331.
9. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374: 1609-1620.
10. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet, 2016, 387(134): 2218-2225.
11. Himbert D, Pontnau F, Messika-Zeitoun DA, et al. Feasibility and outcomes of transcatheter aortic valve implantation in high-risk patients with stenotic bicuspid aortic valves. Am J Cardiol, 2012, 110(6): 877-883.
12. Hayashida K, Bouvier E, Lefevre T, et al. Transcatheter aortic valve implantation for patients with severe bicuspid aortic valve stenosis. Circ Cardiovasc Interv, 2013, 6(3): 284-291.
13. Bauer T, Linke A, Sievert H, et al. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry). Am J Cardiol, 2014, 113(3): 518-521.
14. Costopoulos C, Latib A, Maisano F, et al. Comparison of results of transcatheter aortic valve implantation in patients with severely stenotic bicuspid versus tricuspid or nonbicuspid valves. Am J Cardiol, 2014, 113(8): 1390-1393.
15. Jilaihawi H, Wu YJ, Yang YE, et al. Morphological characteristics of severe aortic stenosis in China: imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv, 2015, 85(Suppl 1): 752-761.
16. Zhao ZG, Jilaihawi H, Feng Y, et al. Transcatheter aortic valve implantation in bicuspid anatomy. Nat Rev Cardiol, 2015, 12(2): 123-128.
17. Zegdi R, Ciobotaru V, Noghin M, et al. Is it reasonable to treat all calcified stenotic aortic valves with a valved stent? Results from a human anatomic study in adults. J Am Coll Cardiol, 2008, 51(5): 579-584.
18. Liao YB, Zhao ZG, Wei X, et al. Transcatheter aortic valve implantation with the self-expandable Venus A-Valve and CoreValve devices: preliminary experiences in China. Catheter Cardiovasc Interv, 2017, 89(S1): 528-533.
19. Perlman GY, Blanke P, Dvir D, et al. Bicuspid aortic valve stenosis: favorable early outcomes with a next-generation transcatheter heart valve in a multicenter study. JACC Cardiovasc Interv, 2016, 9(8): 817-824.
20. Yoon SH, Lefevre T, Ahn JM, et al. Transcatheter aortic valve replacement with early- and New-Generation devices in bicuspid aortic valve stenosis. J Am Coll Cardiol, 2016, 68(11): 1195-1205.

West China Medical Journal

Transcatheter aortic valve replacement with Venus A-Valve and other overseas devices

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