Early outcome of balloon-expandable valves in the treatment of severe aortic stenosis: A single-center study_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LI Yihang , ZHANG Jingnan , FANG Fang , WAN Junyi , XU Liang ,  PAN Xiangbin ,  ZHANG Gejun

Structural Heart Disease Center, National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, P. R. China;

Corresponding author：

PAN Xiangbin, Email: panxiangbin@fuwaihospital.org; ZHANG Gejun, Email: gjzhang212@163.com

Keywords：

Transcatheter aortic valve replacement; balloon-expandable valves; bicuspid aortic valve

DOI：

10.7507/1007-4848.202210056

Video：

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Objective To evaluate the safety and early-stage efficacy of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) using a new generation balloon-expandable (BE) valve by collecting the baseline and follow-up data. Methods We retrospectively reviewed the clinical data of severe AS patients who received TAVR with BE valve (Sapien 3) in Fuwai Hospital from September 2020 to June 2022. We collected the echocardiographic data as well as follow-up results at post-procedure, 1, 3, 6 and 12 months. According to the Sievers classification criteria, the patients were divided into a normal group and a bicuspid aortic valve group. Results Finally 62 patients were collected, including 31 females and 31 males with an average age of 71.44±9.17 years. There was 61 patients implanted successfully with BE valve and only 1 was transferred to surgical replacement. There was no mortality or severe complications. Echocardiographic assessment showed significant reduction of the pressure gradient (P＜0.001) and the effect was consistent to postoperative 12 months. After the treatment of patients with different aortic valve morphology using balloon dilation, the condition of valve stenosis improved. Conclusion The use of BE valves has good safety and early efficacy in patients with severe AS of different valve morphology.

Citation： LI Yihang, ZHANG Jingnan, FANG Fang, WAN Junyi, XU Liang, PAN Xiangbin, ZHANG Gejun. Early outcome of balloon-expandable valves in the treatment of severe aortic stenosis: A single-center study. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(7): 1007-1013. doi: 10.7507/1007-4848.202210056 Copy

1.	Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374(17): 1609-1620.
2.	Fu B, Chen Q, Zhao F, et al. Efficacy and safety of transcatheter aortic valve implantation in patients with severe bicuspid aortic stenosis. Ann Transl Med, 2020, 8(14): 873.
3.	Makkar RR, Yoon SH, Leon MB, et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke. JAMA, 2019, 321(22): 2193-2202.
4.	Rahhab Z, El Faquir N, Tchetche D, et al. Expanding the indications for transcatheter aortic valve implantation. Nat Rev Cardiol, 2020, 17(2): 75-84.
5.	Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.
6.	Nishimura RA, Otto CM, Bonow RO, 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. Circulation, 2017, 135(25): e1159-e1195.
7.	Husser O, Pellegrini C, Kessler T, et al. Outcomes after transcatheter aortic valve replacement using a novel balloon-expandable transcatheter heart valve: A single-center experience. JACC Cardiovasc Interv, 2015, 8(14): 1809-1816.
8.	Yang TH, Webb JG, Blanke P, et al. Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the Sapien 3: A comparison with the Sapien XT. JACC Cardiovasc Interv, 2015, 8(3): 462-471.
9.	Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
10.	Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
11.	Deharo P, Bisson A, Herbert J, et al. Impact of Sapien 3 balloon-expandable versus Evolut R self-expandable transcatheter aortic valve implantation in patients with aortic stenosis: Data from a nationwide analysis. Circulation, 2020, 141(4): 260-268.
12.	Tang GHL, Zaid S, Schnittman SR, et al. Novel predictors of mild paravalvular aortic regurgitation in SAPIEN 3 transcatheter aortic valve implantation. EuroIntervention, 2018, 14(1): 58-68.
13.	Husser O, Kim WK, Pellegrini C, et al. Multicenter comparison of novel self-expanding versus balloon-expandable transcatheter heart valves. JACC Cardiovasc Interv, 2017, 10(20): 2078-2087.
14.	Rodés-Cabau J, Abbas AE, Serra V, et al. Balloon- vs self-expanding valve systems for failed small surgical aortic valve bioprostheses. J Am Coll Cardiol, 2022, 80(7): 681-693.
15.	De Torres-Alba F, Kaleschke G, Diller GP, et al. Changes in the pacemaker rate after transition from Edwards Sapien XT to Sapien 3 transcatheter aortic valve implantation: The critical role of valve implantation height. JACC Cardiovasc Interv, 2016, 9(8): 805-813.
16.	Akodad M, Roubille F, Marin G, et al. Myocardial injury after balloon predilatation versus direct transcatheter aortic valve replacement: Insights from the DIRECTAVI trial. J Am Heart Assoc, 2020, 9(24): e018405.
17.	Husser O, Pellegrini C, Kim WK, et al. Transcatheter valve SELECTion in patients with right bundle branch block and impact on pacemaker implantations. JACC Cardiovasc Interv, 2019, 12(18): 1781-1793.
18.	Yoon SH, Kim WK, Dhoble A, et al. Bicuspid aortic valve morphology and outcomes after transcatheter aortic valve replacement. J Am Coll Cardiol, 2020, 76(9): 1018-1030.

1. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374(17): 1609-1620.
2. Fu B, Chen Q, Zhao F, et al. Efficacy and safety of transcatheter aortic valve implantation in patients with severe bicuspid aortic stenosis. Ann Transl Med, 2020, 8(14): 873.
3. Makkar RR, Yoon SH, Leon MB, et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke. JAMA, 2019, 321(22): 2193-2202.
4. Rahhab Z, El Faquir N, Tchetche D, et al. Expanding the indications for transcatheter aortic valve implantation. Nat Rev Cardiol, 2020, 17(2): 75-84.
5. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.
6. Nishimura RA, Otto CM, Bonow RO, 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. Circulation, 2017, 135(25): e1159-e1195.
7. Husser O, Pellegrini C, Kessler T, et al. Outcomes after transcatheter aortic valve replacement using a novel balloon-expandable transcatheter heart valve: A single-center experience. JACC Cardiovasc Interv, 2015, 8(14): 1809-1816.
8. Yang TH, Webb JG, Blanke P, et al. Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the Sapien 3: A comparison with the Sapien XT. JACC Cardiovasc Interv, 2015, 8(3): 462-471.
9. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
10. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
11. Deharo P, Bisson A, Herbert J, et al. Impact of Sapien 3 balloon-expandable versus Evolut R self-expandable transcatheter aortic valve implantation in patients with aortic stenosis: Data from a nationwide analysis. Circulation, 2020, 141(4): 260-268.
12. Tang GHL, Zaid S, Schnittman SR, et al. Novel predictors of mild paravalvular aortic regurgitation in SAPIEN 3 transcatheter aortic valve implantation. EuroIntervention, 2018, 14(1): 58-68.
13. Husser O, Kim WK, Pellegrini C, et al. Multicenter comparison of novel self-expanding versus balloon-expandable transcatheter heart valves. JACC Cardiovasc Interv, 2017, 10(20): 2078-2087.
14. Rodés-Cabau J, Abbas AE, Serra V, et al. Balloon- vs self-expanding valve systems for failed small surgical aortic valve bioprostheses. J Am Coll Cardiol, 2022, 80(7): 681-693.
15. De Torres-Alba F, Kaleschke G, Diller GP, et al. Changes in the pacemaker rate after transition from Edwards Sapien XT to Sapien 3 transcatheter aortic valve implantation: The critical role of valve implantation height. JACC Cardiovasc Interv, 2016, 9(8): 805-813.
16. Akodad M, Roubille F, Marin G, et al. Myocardial injury after balloon predilatation versus direct transcatheter aortic valve replacement: Insights from the DIRECTAVI trial. J Am Heart Assoc, 2020, 9(24): e018405.
17. Husser O, Pellegrini C, Kim WK, et al. Transcatheter valve SELECTion in patients with right bundle branch block and impact on pacemaker implantations. JACC Cardiovasc Interv, 2019, 12(18): 1781-1793.
18. Yoon SH, Kim WK, Dhoble A, et al. Bicuspid aortic valve morphology and outcomes after transcatheter aortic valve replacement. J Am Coll Cardiol, 2020, 76(9): 1018-1030.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Early outcome of balloon-expandable valves in the treatment of severe aortic stenosis: A single-center study

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