Early outcomes of transapical implantation of the second-generation J-Valve transcatheter heart valve for the treatment of aortic regurgitation from a multi-centre registry_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LUO Yichun ¹ , LIU Lulu ² , SHI Jun ² , QIAN Hong ² , JI Yupeng ² , WANG Wei ³ , WANG Chunsheng ⁴ ,  GUO Yingqiang ²

1. Department of Radiology, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
3. Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, P.R.China;
4. Department of Cardiac Surgery, Beijing Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, P.R.China;

Corresponding author：

GUO Yingqiang, Email: drguoyq@hotmail.com

Keywords：

Aortic regurgitation/insufficiency; transcatheter aortic valve implantation; J-Valve system

DOI：

10.7507/1007-4848.201905004

Video：

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Objective To investigate the early safety and efficacy of transapical transcatheter aortic valve implantation (TAVI) for high-risk elderly patients with pure aortic valve insufficiency. Methods A prospective multicenter clinical study of domestic J-valve^TM TAVI for high-risk native non-calcified aortic valve insufficiency was conducted from April 2014 to May 2018, and the early postoperative results were analyzed. A total of 82 patients were enrolled, including 62 patients from West China Hospital, Sichuan University, 16 patients from Zhongshan Hospital, Fudan University, and 4 patients from Beijing Fuwai Hospital, National Center for Cardiovascular Diseases. There were 55 males and 27 females. The age was 61-90 (73.8±6.3) years. The logistic EuroSCORE was 10.0%-44.4% (17.5%±8.1%). All patients underwent TAVI using J-Valve^TM system. Clinical evaluation and echocardiography were performed preoperatively and 1 month postoperatively. Multislice spiral CT was reviewed before discharge. Results Three patients were transferred to thoracotomy for cardiopulmonary bypass operation, and 1 patient had decreased cardiac function due to leakage of the valve 1 week after surgery. The overall technical and procedural success rate was 95.1% and 93.9%, respectively. During hospitalization, 1 patient died of moderate pericyclosis complicated with multiple organ failure, and 1 patient died of pulmonary infection. Six (7.6%) patients received pacemaker implantation due to new onset Ⅲ° atrioventricular block. Echocardiographic follow-up showed paravalvular leak was observed in the few of patients, mild paravalvular leak was in 13 patients on the 30th day. Two patients showed moderate paravalvular leak. Left ventricular end-diastolic volume decreased from 197.7±66.8 mL (pre-TAVI) to 147.2±53.3 mL (30-day post-TAVI) (P<0.05). Mean pressure gradient was 9.5±4.1 mm Hg (30-day post-TAVI). Conclusion This multicenter study demonstrates that TAVI with the J-Valve system for the treatment of pure aortic regurgitation is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic regurgitation early-term follow-up. Our results further support that TAVI with the specific designed J-Valve system is an acceptable alternative therapy for high-risk patients with pure AR. Our result demonstrates good early-term durability and preserved hemodynamic function. The procedure appears to offer an adequate and lasting resolution for selected patients with pure aortic regurgitation.

Citation： LUO Yichun, LIU Lulu, SHI Jun, QIAN Hong, JI Yupeng, WANG Wei, WANG Chunsheng, GUO Yingqiang. Early outcomes of transapical implantation of the second-generation J-Valve transcatheter heart valve for the treatment of aortic regurgitation from a multi-centre registry. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2019, 26(8): 737-743. doi: 10.7507/1007-4848.201905004 Copy

1.	Cribier A. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation, 2002, 106(24): 3006-3008.
2.	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. The Lancet, 2015, 385(9986): 2485-2491.
3.	Nishimura RA, Otto CM, Bonow RO, 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. J Thorac Cardiovasc Surg, 2014, 148(1): e1-e132.
4.	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.
5.	Yousef A, MacDonald Z, Simard T, et al. Transcatheter aortic valve implantation (tavi) for native aortic valve regurgitation- a systematic review. Circ J, 2018, 82(3): 895-902.
6.	Bleiziffer S, Mazzitelli D, Nobauer C, et al. Successful treatment of pure aortic insufficiency with transapical implantation of the JenaValve. Thorac Cardiovasc Surg, 2013, 61(5): 428-430.
7.	Franzone A, Piccolo R, Siontis GC, et al. Transcatheter aortic valve replacement for the treatment of pure native aortic valve regurgitation: a systematic review. JACC Cardiovasc Interv, 2016, 9(22): 2308-2317.
8.	Seiffert M, Bader R, Kappert U, et al. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv, 2014, 7(10): 1168-1174.
9.	Zhu D, Hu J, Meng W, et al. Successful transcatheter aortic valve implantation for pure aortic regurgitation using a new second generation self-expanding J-Valve(TM) system - the first in-man implantation. Heart Lung Circ, 2015, 24(4): 411-414.
10.	Yan J, Duan J, Wu X, et al. Total saponins from Aralia taibaiensis protect against myocardial ischemia/reperfusion injury through AMPK pathway. Int J Mol Med, 2015, 36(6): 1538-1546.
11.	Zhu D, Chen Y, Zhang J, et al. Transapical implantation of a new second-generation transcatheter heart valve in patients with pure aortic regurgitation: a preliminary report. Interact Cardiovasc Thorac Surg, 2015, 20(6): 860-862.
12.	Zhu D, Wei L, Cheung A, et al. Treatment of pure aortic regurgitation using a second-generation transcatheter aortic valve implantation system. J Am Coll Cardiol, 2016, 67(23): 2803-2805.
13.	Head SJ, Bogers AJJC, Serruys PW, et al. A crucial factor in shared decision making: the team approach. The Lancet, 2011, 377(9780): 1836.
14.	Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg, 2013, 145(1): 6-23.
15.	Vahanian A, Alfieri O, Al-Attar N, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J, 2008, 29(11): 1463-1470.
16.	Schaefer BM, Lewin MB, Stout KK, et al. The bicuspid aortic valve: an integrated phenotypic classification of leaflet morphology and aortic root shape. Heart, 2008, 94(12): 1634-1638.
17.	Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol, 2015, 66(2): 113-121.
18.	Holmes DR, Jr., Mack MJ, Kaul S, et al ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol, 2012, 59(13): 1200-1254.
19.	Kiefer P, Seeburger J, Mohr FW, et al. Transcatheter aortic valve replacement for isolated aortic valve insufficiency: experience with the Engager valve. J Thorac Cardiovasc Surg, 2014, 147(4): e37-38.
20.	Fei X, Elhmidi Y, Zhang B, et al. Transapical transcatheter aortic valve implantation using a new tavi system for high-risk patients with severe aortic stenosis. Heart Lung Circ, Heart Lung Circ, 2018, 27(6): e67-e69.
21.	Buellesfeld L, Gerckens U, Schuler G, et al. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol, 2011, 57(16): 1650-1657.
22.	Osten MD, Feindel C, Greutmann M, et al. Transcatheter aortic valve implantation for high risk patients with severe aortic stenosis using the Edwards Sapien balloon-expandable bioprosthesis: a single centre study with immediate and medium-term outcomes. Catheter Cardiovasc Interv, 2010, 75(4): 475-485.
23.	Ruparelia N, Thomas K, Newton JD, et al. Procedural and thirty-day outcomes following transfemoral implantation of the fully repositionable and retrievable Lotus valve without routine pre-dilatation in a consecutive patient cohort: a single centre experience. Cardiovasc Revasc Med, 2018, 19(1 Pt B): 78-82.
24.	Krasopoulos G, Falconieri F, Benedetto U, et al. European real world trans-catheter aortic valve implantation: systematic review and meta-analysis of European national registries. J Cardiothorac Surg, 2016, 11(1): 159.
25.	Sawaya FJ, Deutsch MA, Seiffert M, et al. Safety and efficacy of transcatheter aortic valve replacement in the treatment of pure aortic regurgitation in native valves and failing surgical bioprostheses: results from an international registry study. JACC Cardiovasc Interv, 2017, 10(10): 1048-1056.
26.	Ussia GP, Barbanti M, Petronio AS, et al. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J, 2012, 33(8): 969-976.
27.	Gurvitch R, Wood DA, Tay EL, et al. Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort. Circulation, 2010, 122(13): 1319-1327.
28.	Roy DA, Schaefer U, Guetta V, et al. Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol, 2013, 61(15): 1577-1584.
29.	Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA, 2014, 311(15): 1503-1514.
30.	Kaya D, Tanriverdi Z, Dursun H, et al. Echocardiographic outcomes of self-expandable CoreValve versus balloon-expandable Edwards SAPIEN XT valves: the comparison of two bioprosthesis implanted in a single centre. Int J Cardiovasc Imaging, 2016, 32(9): 1371-1378.
31.	Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol, 2013, 61(15): 1585-1595.
32.	Testa L, Latib A, Rossi ML, et al. CoreValve implantation for severe aortic regurgitation: a multicentre registry. EuroIntervention, 2014, 10(6): 739-745.
33.	Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med, 2014, 370(19): 1790-1798.
34.	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.
35.	Schlingloff F, Schafer U, Frerker C, et al. Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up. Interact Cardiovasc Thorac Surg, 2014, 19(3): 388-393.

1. Cribier A. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation, 2002, 106(24): 3006-3008.
2. 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. The Lancet, 2015, 385(9986): 2485-2491.
3. Nishimura RA, Otto CM, Bonow RO, 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. J Thorac Cardiovasc Surg, 2014, 148(1): e1-e132.
4. 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.
5. Yousef A, MacDonald Z, Simard T, et al. Transcatheter aortic valve implantation (tavi) for native aortic valve regurgitation- a systematic review. Circ J, 2018, 82(3): 895-902.
6. Bleiziffer S, Mazzitelli D, Nobauer C, et al. Successful treatment of pure aortic insufficiency with transapical implantation of the JenaValve. Thorac Cardiovasc Surg, 2013, 61(5): 428-430.
7. Franzone A, Piccolo R, Siontis GC, et al. Transcatheter aortic valve replacement for the treatment of pure native aortic valve regurgitation: a systematic review. JACC Cardiovasc Interv, 2016, 9(22): 2308-2317.
8. Seiffert M, Bader R, Kappert U, et al. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv, 2014, 7(10): 1168-1174.
9. Zhu D, Hu J, Meng W, et al. Successful transcatheter aortic valve implantation for pure aortic regurgitation using a new second generation self-expanding J-Valve(TM) system - the first in-man implantation. Heart Lung Circ, 2015, 24(4): 411-414.
10. Yan J, Duan J, Wu X, et al. Total saponins from Aralia taibaiensis protect against myocardial ischemia/reperfusion injury through AMPK pathway. Int J Mol Med, 2015, 36(6): 1538-1546.
11. Zhu D, Chen Y, Zhang J, et al. Transapical implantation of a new second-generation transcatheter heart valve in patients with pure aortic regurgitation: a preliminary report. Interact Cardiovasc Thorac Surg, 2015, 20(6): 860-862.
12. Zhu D, Wei L, Cheung A, et al. Treatment of pure aortic regurgitation using a second-generation transcatheter aortic valve implantation system. J Am Coll Cardiol, 2016, 67(23): 2803-2805.
13. Head SJ, Bogers AJJC, Serruys PW, et al. A crucial factor in shared decision making: the team approach. The Lancet, 2011, 377(9780): 1836.
14. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg, 2013, 145(1): 6-23.
15. Vahanian A, Alfieri O, Al-Attar N, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J, 2008, 29(11): 1463-1470.
16. Schaefer BM, Lewin MB, Stout KK, et al. The bicuspid aortic valve: an integrated phenotypic classification of leaflet morphology and aortic root shape. Heart, 2008, 94(12): 1634-1638.
17. Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol, 2015, 66(2): 113-121.
18. Holmes DR, Jr., Mack MJ, Kaul S, et al ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol, 2012, 59(13): 1200-1254.
19. Kiefer P, Seeburger J, Mohr FW, et al. Transcatheter aortic valve replacement for isolated aortic valve insufficiency: experience with the Engager valve. J Thorac Cardiovasc Surg, 2014, 147(4): e37-38.
20. Fei X, Elhmidi Y, Zhang B, et al. Transapical transcatheter aortic valve implantation using a new tavi system for high-risk patients with severe aortic stenosis. Heart Lung Circ, Heart Lung Circ, 2018, 27(6): e67-e69.
21. Buellesfeld L, Gerckens U, Schuler G, et al. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol, 2011, 57(16): 1650-1657.
22. Osten MD, Feindel C, Greutmann M, et al. Transcatheter aortic valve implantation for high risk patients with severe aortic stenosis using the Edwards Sapien balloon-expandable bioprosthesis: a single centre study with immediate and medium-term outcomes. Catheter Cardiovasc Interv, 2010, 75(4): 475-485.
23. Ruparelia N, Thomas K, Newton JD, et al. Procedural and thirty-day outcomes following transfemoral implantation of the fully repositionable and retrievable Lotus valve without routine pre-dilatation in a consecutive patient cohort: a single centre experience. Cardiovasc Revasc Med, 2018, 19(1 Pt B): 78-82.
24. Krasopoulos G, Falconieri F, Benedetto U, et al. European real world trans-catheter aortic valve implantation: systematic review and meta-analysis of European national registries. J Cardiothorac Surg, 2016, 11(1): 159.
25. Sawaya FJ, Deutsch MA, Seiffert M, et al. Safety and efficacy of transcatheter aortic valve replacement in the treatment of pure aortic regurgitation in native valves and failing surgical bioprostheses: results from an international registry study. JACC Cardiovasc Interv, 2017, 10(10): 1048-1056.
26. Ussia GP, Barbanti M, Petronio AS, et al. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J, 2012, 33(8): 969-976.
27. Gurvitch R, Wood DA, Tay EL, et al. Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort. Circulation, 2010, 122(13): 1319-1327.
28. Roy DA, Schaefer U, Guetta V, et al. Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol, 2013, 61(15): 1577-1584.
29. Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA, 2014, 311(15): 1503-1514.
30. Kaya D, Tanriverdi Z, Dursun H, et al. Echocardiographic outcomes of self-expandable CoreValve versus balloon-expandable Edwards SAPIEN XT valves: the comparison of two bioprosthesis implanted in a single centre. Int J Cardiovasc Imaging, 2016, 32(9): 1371-1378.
31. Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol, 2013, 61(15): 1585-1595.
32. Testa L, Latib A, Rossi ML, et al. CoreValve implantation for severe aortic regurgitation: a multicentre registry. EuroIntervention, 2014, 10(6): 739-745.
33. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med, 2014, 370(19): 1790-1798.
34. 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.
35. Schlingloff F, Schafer U, Frerker C, et al. Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up. Interact Cardiovasc Thorac Surg, 2014, 19(3): 388-393.

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Early outcomes of transapical implantation of the second-generation J-Valve transcatheter heart valve for the treatment of aortic regurgitation from a multi-centre registry

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