The 1-year follow-up results of intraprocedural valve-in-valve deployment for treatment of aortic regurgitation following transcatheter aortic valve replacement (TAVR) in a single center_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

ZHANG Weijing ¹ , PAN Wenzhi ¹ , GUAN Lihua ¹ , ZHANG Xiaochun ¹ , ZHANG Yuan ¹ , WU Jian ² , LI Wei ³ , PAN Cuizhen ³ ,  ZHOU Daxin ¹ , GE Junbo ¹

1. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, P.R.China;
2. Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Institutes of Biomedical Sciences, Fudan University, Shanghai, 200032, P.R.China;
3. Department of Echocardiography, Zhongshan Hospital, Fudan University, Shanghai, 200032, P.R.China;

Corresponding author：

ZHOU Daxin, Email: zhou.daxin@zs-hospital.sh.cn

Keywords：

Transcatheter aortic valve replacement (TAVR); intraprocedural valve-in-valve deployment; perivalvular leakage

DOI：

10.7507/1007-4848.202105007

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Objective To evaluate the efficiency and safety of intraprocedural valve-in-valve deployment for treatment of aortic regurgitation following transcatheter aortic valve replacement (TAVR).Methods Consecutive patients (n=333) who diagnosed with severe aortic stenosis and underwent TAVR in Zhongshan Hospital affiliated to Fudan University from October 3rd, 2010 to April 21st, 2021 were included. There were 208 males and 125 females aged 76.0±7.0 years. There were 316 patients underwent simple TAVR (simple TAVR group) and 17 patients underwent intraprocedural valve-in-valve deployment following TAVR (valve-in-valve group). Their clinical and echocardiographic outcomes were evaluated and compared.Results There was no significant difference between the two groups of patients at postoperative 30 d and 1 year in all-cause mortality (4.4% vs. 0, P=1.000; 6.3% vs. 0, P=1.000), incidence of pacemaker implantation (10.4% vs. 17.6%, P=1.000; 11.8% vs. 17.6%, P=1.000), incidence of ischemic stroke (1.3% vs. 0, P=1.000; 1.3% vs. 0, P=1.000), mean trans-aortic pressure gradient (11.4±6.4 mm Hg vs. 8.9±4.9 mm Hg, P=0.099; 10.5±7.6 mm Hg vs. 11.2±5.2 mm Hg, P=0.432), left ventricular ejection fraction (62.0%±9.0% vs. 57.0%±12.0%, P=0.189; 63.0%±7.0% vs. 60.0%±8.0%, P=0.170), and incidence of mitral valve dysfunction (0.6% vs. 5.9%, P=1.000; 0.6% vs. 5.9%, P=1.000).Conclusion It is feasible to treat perivalvular leakage with valve-in-valve technology in the procedure of TAVR, and the short and medium-term effects are satisfied.

Citation： ZHANG Weijing, PAN Wenzhi, GUAN Lihua, ZHANG Xiaochun, ZHANG Yuan, WU Jian, LI Wei, PAN Cuizhen, ZHOU Daxin, GE Junbo. The 1-year follow-up results of intraprocedural valve-in-valve deployment for treatment of aortic regurgitation following transcatheter aortic valve replacement (TAVR) in a single center. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2021, 28(8): 888-894. doi: 10.7507/1007-4848.202105007 Copy

1.	Kapadia SR, Leon MB, Makkar RR, 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(9986): 2485-2491.
2.	Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med, 2012, 366(18): 1686-1695.
3.	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.
4.	唐亮, 陈鹏飞, 易俊霖. 瓣中瓣技术在经导管主动脉瓣置入术中的应用3例报道. 中国介入心脏病学杂志, 2018, 26(11): 658-660.
5.	Welle GA, El-Sabawi B, Thaden JJ, et al. Effect of a fourth-generation transcatheter valve enhanced skirt on paravalvular leak. Catheter Cardiovasc Interv, 2021, 97(5): 895-902.
6.	葛均波, 周达新, 潘文志, 主编. 经导管心脏瓣膜治疗术. 上海: 科学技术出版社, 2019. 22-25.
7.	Bernard S, Yucel E. Paravalvular leaks-from diagnosis to management. Curr Treat Options Cardiovasc Med, 2019, 21(11): 67.
8.	Koos R, Mahnken AH, Dohmen G, et al. Association of aortic valve calcification severity with the degree of aortic regurgitation after transcatheter aortic valve implantation. Int J Cardiol, 2011, 150(2): 142-145.
9.	Haensig M, Lehmkuhl L, Rastan AJ, et al. Aortic valve calcium scoring is a predictor of significant paravalvular aortic insufficiency in transapical-aortic valve implantation. Eur J Cardiothorac Surg, 2012, 41(6): 1234-1240.
10.	Colli A, D'Amico R, Kempfert J, et al. Transesophageal echocardiographic scoring for transcatheter aortic valve implantation: Impact of aortic cusp calcification on postoperative aortic regurgitation. J Thorac Cardiovasc Surg, 2011, 142(5): 1229-1235.
11.	Détaint D, Lepage L, Himbert D, et al. Determinants of significant paravalvular regurgitation after transcatheter aortic valve: Implantation impact of device and annulus discongruence. JACC Cardiovasc Interv, 2009, 2(9): 821-827.
12.	Waterbury TM, Reeder GS, Pislaru SV, et al. Techniques and outcomes of paravalvular leak repair after transcatheter aortic valve replacement. Catheter Cardiovasc Interv, 2017, 90(5): 870-877.
13.	Stundl A, Rademacher MC, Descoups C, et al. Balloon post-dilation and valve-in-valve implantation for the reduction of paravalvular leakage with use of the self-expanding CoreValve prosthesis. EuroIntervention, 2016, 11(10): 1140-1147.
14.	Jubran A, Flugelman MY, Zafrir B, et al. Intraprocedural valve-in-valve deployment for treatment of aortic regurgitation following transcatheter aortic valve replacement: An individualized approach. Int J Cardiol, 2019, 283: 73-77.
15.	Ruiz CE, Jelnin V, Kronzon I, et al. Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks. J Am Coll Cardiol, 2011, 58(21): 2210-2217.
16.	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. J Am Coll Cardiol, 2017, 70(2): 252-289.
17.	Nandy S, Wan SH, Klarich K. Transcatheter aortic valve replacement valve in transcatheter aortic valve replacement valve for severe periprosthetic regurgitation. Heart Views. 2020, 21(1): 49-51.
18.	Goel S, Cordeiro N, Frankel R. Valve-in-valve for CoreValve pop out. JACC Cardiovasc Interv, 2019, 12(21): 2225-2226.
19.	Bianco M, Omer AR, Reitknecht F, et al. How should I manage a challenging aortic prosthesis angle during valve-in-valve implantation? Cardiovasc Revasc Med, 2020, 21(11S): 8-10.
20.	Naqvi TZ. Echocardiography in transcatheter aortic (core) valve implantation: Part 2-transesophageal echocardiography. Echocardiography, 2018, 35(7): 1020-1041.
21.	Fanous EJ, Mukku RB, Dave P, et al. Paravalvular leak assessment: Challenges in assessing severity and interventional approaches. Curr Cardiol Rep, 2020, 22(12): 166.
22.	Reiff C, Zhingre Sanchez JD, Mattison LM, et al. 3-dimensional printing to predict paravalvular regurgitation after transcatheter aortic valve replacement. Catheter Cardiovasc Interv, 2020, 96(7): E703-E710.
23.	Hartlage GR, Babaliaros VC, Thourani VH, et al. The role of cardiovascular magnetic resonance in stratifying paravalvular leak severity after transcatheter aortic valve replacement: An observational outcome study. J Cardiovasc Magn Reson, 2014, 16(1): 93.
24.	Valvo R, Costa G, Barbanti M. How to avoid coronary occlusion during TAVR valve-in-valve procedures. Front Cardiovasc Med, 2019, 6: 168.
25.	Gao Z, Wang Y, Qian D, et al. Incidence, risk factors, and outcomes of coronary obstruction following valve-in-valve transcatheter aortic valve replacement. Int Heart J, 2021, 62(1): 104-111.
26.	Corrigan FE, Gleason PT, Condado JF, et al. Imaging for predicting, detecting, and managing complications after transcatheter aortic valve replacement. JACC Cardiovasc Imaging, 2019, 12(5): 904-920.
27.	Modolo R, Chang CC, Abdelghani M, et al. Quantitative assessment of acute regurgitation following TAVR: A multicenter pooled analysis of 2, 258 valves. JACC Cardiovasc Interv, 2020, 13(11): 1303-1311.
28.	Makkar RR, Jilaihawi H, Chakravarty T, et al. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: A study of multiple valve implants in the U. S. PARTNER trial (placement of aortic transcatheter valve trial Edwards SAPIEN transcatheter heart valve). J Am Coll Cardiol, 2013, 62(5): 418-430.
29.	Ussia GP, Barbanti M, Ramondo A, et al. The valve-in-valve technique for treatment of aortic bioprosthesis malposition an analysis of incidence and 1-year clinical outcomes from the Italian CoreValve registry. J Am Coll Cardiol, 2011, 57(9): 1062-1068.
30.	Caballero A, Mao W, McKay R, et al. The impact of self-expandable transcatheter aortic valve replacement on concomitant functional mitral regurgitation: A comprehensive engineering analysis. Struct Heart, 2020, 4(3): 179-191.

1. Kapadia SR, Leon MB, Makkar RR, 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(9986): 2485-2491.
2. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med, 2012, 366(18): 1686-1695.
3. 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.
4. 唐亮, 陈鹏飞, 易俊霖. 瓣中瓣技术在经导管主动脉瓣置入术中的应用3例报道. 中国介入心脏病学杂志, 2018, 26(11): 658-660.
5. Welle GA, El-Sabawi B, Thaden JJ, et al. Effect of a fourth-generation transcatheter valve enhanced skirt on paravalvular leak. Catheter Cardiovasc Interv, 2021, 97(5): 895-902.
6. 葛均波, 周达新, 潘文志, 主编. 经导管心脏瓣膜治疗术. 上海: 科学技术出版社, 2019. 22-25.
7. Bernard S, Yucel E. Paravalvular leaks-from diagnosis to management. Curr Treat Options Cardiovasc Med, 2019, 21(11): 67.
8. Koos R, Mahnken AH, Dohmen G, et al. Association of aortic valve calcification severity with the degree of aortic regurgitation after transcatheter aortic valve implantation. Int J Cardiol, 2011, 150(2): 142-145.
9. Haensig M, Lehmkuhl L, Rastan AJ, et al. Aortic valve calcium scoring is a predictor of significant paravalvular aortic insufficiency in transapical-aortic valve implantation. Eur J Cardiothorac Surg, 2012, 41(6): 1234-1240.
10. Colli A, D'Amico R, Kempfert J, et al. Transesophageal echocardiographic scoring for transcatheter aortic valve implantation: Impact of aortic cusp calcification on postoperative aortic regurgitation. J Thorac Cardiovasc Surg, 2011, 142(5): 1229-1235.
11. Détaint D, Lepage L, Himbert D, et al. Determinants of significant paravalvular regurgitation after transcatheter aortic valve: Implantation impact of device and annulus discongruence. JACC Cardiovasc Interv, 2009, 2(9): 821-827.
12. Waterbury TM, Reeder GS, Pislaru SV, et al. Techniques and outcomes of paravalvular leak repair after transcatheter aortic valve replacement. Catheter Cardiovasc Interv, 2017, 90(5): 870-877.
13. Stundl A, Rademacher MC, Descoups C, et al. Balloon post-dilation and valve-in-valve implantation for the reduction of paravalvular leakage with use of the self-expanding CoreValve prosthesis. EuroIntervention, 2016, 11(10): 1140-1147.
14. Jubran A, Flugelman MY, Zafrir B, et al. Intraprocedural valve-in-valve deployment for treatment of aortic regurgitation following transcatheter aortic valve replacement: An individualized approach. Int J Cardiol, 2019, 283: 73-77.
15. Ruiz CE, Jelnin V, Kronzon I, et al. Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks. J Am Coll Cardiol, 2011, 58(21): 2210-2217.
16. 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. J Am Coll Cardiol, 2017, 70(2): 252-289.
17. Nandy S, Wan SH, Klarich K. Transcatheter aortic valve replacement valve in transcatheter aortic valve replacement valve for severe periprosthetic regurgitation. Heart Views. 2020, 21(1): 49-51.
18. Goel S, Cordeiro N, Frankel R. Valve-in-valve for CoreValve pop out. JACC Cardiovasc Interv, 2019, 12(21): 2225-2226.
19. Bianco M, Omer AR, Reitknecht F, et al. How should I manage a challenging aortic prosthesis angle during valve-in-valve implantation? Cardiovasc Revasc Med, 2020, 21(11S): 8-10.
20. Naqvi TZ. Echocardiography in transcatheter aortic (core) valve implantation: Part 2-transesophageal echocardiography. Echocardiography, 2018, 35(7): 1020-1041.
21. Fanous EJ, Mukku RB, Dave P, et al. Paravalvular leak assessment: Challenges in assessing severity and interventional approaches. Curr Cardiol Rep, 2020, 22(12): 166.
22. Reiff C, Zhingre Sanchez JD, Mattison LM, et al. 3-dimensional printing to predict paravalvular regurgitation after transcatheter aortic valve replacement. Catheter Cardiovasc Interv, 2020, 96(7): E703-E710.
23. Hartlage GR, Babaliaros VC, Thourani VH, et al. The role of cardiovascular magnetic resonance in stratifying paravalvular leak severity after transcatheter aortic valve replacement: An observational outcome study. J Cardiovasc Magn Reson, 2014, 16(1): 93.
24. Valvo R, Costa G, Barbanti M. How to avoid coronary occlusion during TAVR valve-in-valve procedures. Front Cardiovasc Med, 2019, 6: 168.
25. Gao Z, Wang Y, Qian D, et al. Incidence, risk factors, and outcomes of coronary obstruction following valve-in-valve transcatheter aortic valve replacement. Int Heart J, 2021, 62(1): 104-111.
26. Corrigan FE, Gleason PT, Condado JF, et al. Imaging for predicting, detecting, and managing complications after transcatheter aortic valve replacement. JACC Cardiovasc Imaging, 2019, 12(5): 904-920.
27. Modolo R, Chang CC, Abdelghani M, et al. Quantitative assessment of acute regurgitation following TAVR: A multicenter pooled analysis of 2, 258 valves. JACC Cardiovasc Interv, 2020, 13(11): 1303-1311.
28. Makkar RR, Jilaihawi H, Chakravarty T, et al. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: A study of multiple valve implants in the U. S. PARTNER trial (placement of aortic transcatheter valve trial Edwards SAPIEN transcatheter heart valve). J Am Coll Cardiol, 2013, 62(5): 418-430.
29. Ussia GP, Barbanti M, Ramondo A, et al. The valve-in-valve technique for treatment of aortic bioprosthesis malposition an analysis of incidence and 1-year clinical outcomes from the Italian CoreValve registry. J Am Coll Cardiol, 2011, 57(9): 1062-1068.
30. Caballero A, Mao W, McKay R, et al. The impact of self-expandable transcatheter aortic valve replacement on concomitant functional mitral regurgitation: A comprehensive engineering analysis. Struct Heart, 2020, 4(3): 179-191.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

The 1-year follow-up results of intraprocedural valve-in-valve deployment for treatment of aortic regurgitation following transcatheter aortic valve replacement (TAVR) in a single center

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