Clinical efficacy of transcatheter tricuspid valve replacement in cardiac implantable electronic lead-related tricuspid regurgitation: A multi-center retrospective cohort study_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

CAO Jingyi ¹ , NING Xiaoping ¹ , LI Ning ² , QIAO Fan ¹ , YANG Fan ¹ , LI Bailing ¹ , ZHOU Guangwei ¹ , HAN Lin ¹ , XU Zhiyun ¹ ,  LU Fanglin ^1,3

1. Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical University, Shanghai, 200433, P. R. China;
2. Department of Cardiothoracic Surgery, Naval Medical Center of PLA, Naval Medical University, Shanghai, 200052, P. R. China;
3. Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, 200080, P. R. China;

Corresponding author：

LU Fanglin, Email: drlufanglin@yeah.net

Keywords：

Transcatheter tricuspid valve replacement; cardiac implantable electronic device; tricuspid regurgitation; clinical efficacy; multi-center retrospective cohort study

DOI：

10.7507/1007-4848.202312041

Video：

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Objective To analyze the clinical efficacy of transcatheter tricuspid valve replacement (TTVR) in cardiac implantable electronic lead-related tricuspid regurgitation (TR). Methods The patients with severe TR who underwent LuX-Valve TTVR in 9 Chinese medical centers from June 2020 to August 2021 were retrospectively enrolled. They were divided into a cardiac implantable electronic device (CIED) group and a non-CIED group based on whether they had pre-existing CIED implantation. Success of the procedure was defined as safe implantation of the LuX-Valve and complete withdrawal of the delivery system. Prognostic improvement was defined as a decrease of TR grade to≤2+ and an improvement of cardiac function by≥2 grades. Surgical success and postoperative prognosis were compared between the two groups. Results A total of 190 patients were collected, including 50 males and 140 females with a mean age of 66.2±7.8 years. There were 29 patients in the CIED group, and 161 patients in the non-CIED group. In the CIED group, 28 patients were implanted with a permanent pacemaker and 1 patient with a cardioverter-defibrillator. Preoperative New York Heart Association (NYHA) cardiac function class, TR degree, left ventricular ejection fraction, tricuspid annular plane systolic excusion, and cardiac risk scores were comparable between the two groups (P>0.05). Postoperative TR was reduced to≤2+ in all patients, and there was no statistical difference in the incidence of perivalvular leakage between the two groups (P=0.270). Postoperative CT of CIED patients showed the valve was in place, and the lead was not extruded, twisted, or deflected. The in-hospital mortality of the two groups were 10.3% and 1.9%, respectively, and the difference was statistically significant (P=0.047). In addition, there was no statistical difference between the two groups in terms of postoperative improvement of cardiac function and mortality in the 1- and 2-year follow-up. Conclusion TTVR is feasible, safe, and effective in patients with CIED implantation, and the pre-existing lead has no significant effect on the clinical efficacy.

Citation： CAO Jingyi, NING Xiaoping, LI Ning, QIAO Fan, YANG Fan, LI Bailing, ZHOU Guangwei, HAN Lin, XU Zhiyun, LU Fanglin. Clinical efficacy of transcatheter tricuspid valve replacement in cardiac implantable electronic lead-related tricuspid regurgitation: A multi-center retrospective cohort study. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(6): 818-825. doi: 10.7507/1007-4848.202312041 Copy

1.	Lim WY, Prabhu S, Schilling RJ. Implantable cardiac electronic devices in the elderly population. Arrhythm Electrophysiol Rev, 2019, 8(2): 143-146.
2.	Greenspon AJ, Patel JD, Lau E, et al. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: Increasing complexity of patients and procedures. J Am Coll Cardiol, 2012, 60(16): 1540-1545.
3.	Al-Mohaissen MA, Chan KL. Prevalence and mechanism of tricuspid regurgitation following implantation of endocardial leads for pacemaker or cardioverter-defibrillator. J Am Soc Echocardiogr, 2012, 25(3): 245-252.
4.	Alnaimat S, Doyle M, Krishnan K, et al. Worsening tricuspid regurgitation associated with permanent pacemaker and implantable cardioverter-defibrillator implantation: A systematic review and meta-analysis of more than 66, 000 subjects. Heart Rhythm, 2023, 20(11): 1491-1501.
5.	Asmarats L, Puri R, Latib A, et al. Transcatheter tricuspid valve interventions: Landscape, challenges, and future directions. J Am Coll Cardiol, 2018, 71(25): 2935-2956.
6.	Hausleiter J, Braun D, Orban M, et al. Patient selection, echocardiographic screening and treatment strategies for interventional tricuspid repair using the edge-to-edge repair technique. EuroIntervention, 2018, 14(6): 645-653.
7.	Hahn RT, Zamorano JL. The need for a new tricuspid regurgitation grading scheme. Eur Heart J Cardiovasc Imaging, 2017, 18(12): 1342-1343.
8.	Antunes MJ, Rodríguez-Palomares J, Prendergast B, et al. Management of tricuspid valve regurgitation: Position statement of the European Society of Cardiology Working Groups of Cardiovascular Surgery and Valvular Heart Disease. Eur J Cardiothorac Surg, 2017, 52(6): 1022-1030.
9.	Asmarats L, Taramasso M, Rodés-Cabau J. Tricuspid valve disease: Diagnosis, prognosis and management of a rapidly evolving field. Nat Rev Cardiol, 2019, 16(9): 538-554.
10.	Topilsky Y, Maltais S, Medina Inojosa J, et al. Burden of tricuspid regurgitation in patients diagnosed in the community setting. JACC Cardiovasc Imaging, 2019, 12(3): 433-442.
11.	Chang JD, Manning WJ, Ebrille E, et al. Tricuspid valve dysfunction following pacemaker or cardioverter-defibrillator implantation. J Am Coll Cardiol, 2017, 69(18): 2331-2341.
12.	Al-Bawardy R, Krishnaswamy A, Bhargava M, et al. Tricuspid regurgitation in patients with pacemakers and implantable cardiac defibrillators: A comprehensive review. Clin Cardiol, 2013, 36(5): 249-254.
13.	Klutstein M, Balkin J, Butnaru A, et al. Tricuspid incompetence following permanent pacemaker implantation. Pacing Clin Electrophysiol, 2009, 32 Suppl 1: S135-S137.
14.	Seo Y, Ishizu T, Nakajima H, et al. Clinical utility of 3-dimensional echocardiography in the evaluation of tricuspid regurgitation caused by pacemaker leads. Circ J, 2008, 72(9): 1465-1470.
15.	Kim JB, Spevack DM, Tunick PA, et al. The effect of transvenous pacemaker and implantable cardioverter defibrillator lead placement on tricuspid valve function: An observational study. J Am Soc Echocardiogr, 2008, 21(3): 284-287.
16.	Taramasso M, Gavazzoni M, Pozzoli A, et al. Tricuspid regurgitation: Predicting the need for intervention, procedural success, and recurrence of disease. JACC Cardiovasc Imaging, 2019, 12(4): 605-621.
17.	Zack CJ, Fender EA, Chandrashekar P, et al. National trends and outcomes in isolated tricuspid valve surgery. J Am Coll Cardiol, 2017, 70(24): 2953-2960.
18.	Alqahtani F, Berzingi CO, Aljohani S, et al. Contemporary trends in the use and outcomes of surgical treatment of tricuspid regurgitation. J Am Heart Assoc, 2017, 6(12): e007597.
19.	Dreyfus J, Ghalem N, Garbarz E, et al. Timing of referral of patients with severe isolated tricuspid valve regurgitation to surgeons (from a French nationwide database). Am J Cardiol, 2018, 122(2): 323-326.
20.	Dhoble A, Zhao Y, Vejpongsa P, et al. National 10-year trends and outcomes of isolated and concomitant tricuspid valve surgery. J Cardiovasc Surg (Torino), 2019, 60(1): 119-127.
21.	Lu F, Qiao F, Lv Y, et al. A radial force-independent bioprosthesis for transcatheter tricuspid valve implantation in a preclinical model. Int J Cardiol, 2020, 319: 120-126.
22.	Lu FL, An Z, Ma Y, et al. Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. Heart, 2021, 107(20): 1664-1670.
23.	Lu FL, Ma Y, An Z, et al. First-in-man experience of transcatheter tricuspid valve replacement with LuX-Valve in high-risk tricuspid regurgitation patients. JACC Cardiovasc Interv, 2020, 13(13): 1614-1616.
24.	Ning XP, Cao JY, Li MX, et al. Transjugular transcatheter tricuspid valve implantation of LuX-Valve bioprosthesis in a preclinical model. J Cardiovasc Transl Res, 2023, 16(1): 31-41.
25.	Alachkar MN, Schnupp S, Eichelsdoerfer A, et al. Feasibility and efficacy of transcatheter tricuspid valve repair in patients with cardiac implanted electrical devices and trans-tricuspid leads. J Clin Med, 2023, 12(15): 4930.
26.	Anderson JH, McElhinney DB, Aboulhosn J, et al. Management and outcomes of transvenous pacing leads in patients undergoing transcatheter tricuspid valve replacement. JACC Cardiovasc Interv, 2020, 13(17): 2012-2020.
27.	Taramasso M, Gavazzoni M, Pozzoli A, et al. Outcomes of TTVI in patients with pacemaker or defibrillator leads: Data from the TriValve Registry. JACC Cardiovasc Interv, 2020, 13(5): 554-564.
28.	Gabriels JK, Schaller RD, Koss E, et al. Lead management in patients undergoing percutaneous tricuspid valve replacement or repair: A 'heart team' approach. Europace, 2023, 25(11): euad300.

1. Lim WY, Prabhu S, Schilling RJ. Implantable cardiac electronic devices in the elderly population. Arrhythm Electrophysiol Rev, 2019, 8(2): 143-146.
2. Greenspon AJ, Patel JD, Lau E, et al. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: Increasing complexity of patients and procedures. J Am Coll Cardiol, 2012, 60(16): 1540-1545.
3. Al-Mohaissen MA, Chan KL. Prevalence and mechanism of tricuspid regurgitation following implantation of endocardial leads for pacemaker or cardioverter-defibrillator. J Am Soc Echocardiogr, 2012, 25(3): 245-252.
4. Alnaimat S, Doyle M, Krishnan K, et al. Worsening tricuspid regurgitation associated with permanent pacemaker and implantable cardioverter-defibrillator implantation: A systematic review and meta-analysis of more than 66, 000 subjects. Heart Rhythm, 2023, 20(11): 1491-1501.
5. Asmarats L, Puri R, Latib A, et al. Transcatheter tricuspid valve interventions: Landscape, challenges, and future directions. J Am Coll Cardiol, 2018, 71(25): 2935-2956.
6. Hausleiter J, Braun D, Orban M, et al. Patient selection, echocardiographic screening and treatment strategies for interventional tricuspid repair using the edge-to-edge repair technique. EuroIntervention, 2018, 14(6): 645-653.
7. Hahn RT, Zamorano JL. The need for a new tricuspid regurgitation grading scheme. Eur Heart J Cardiovasc Imaging, 2017, 18(12): 1342-1343.
8. Antunes MJ, Rodríguez-Palomares J, Prendergast B, et al. Management of tricuspid valve regurgitation: Position statement of the European Society of Cardiology Working Groups of Cardiovascular Surgery and Valvular Heart Disease. Eur J Cardiothorac Surg, 2017, 52(6): 1022-1030.
9. Asmarats L, Taramasso M, Rodés-Cabau J. Tricuspid valve disease: Diagnosis, prognosis and management of a rapidly evolving field. Nat Rev Cardiol, 2019, 16(9): 538-554.
10. Topilsky Y, Maltais S, Medina Inojosa J, et al. Burden of tricuspid regurgitation in patients diagnosed in the community setting. JACC Cardiovasc Imaging, 2019, 12(3): 433-442.
11. Chang JD, Manning WJ, Ebrille E, et al. Tricuspid valve dysfunction following pacemaker or cardioverter-defibrillator implantation. J Am Coll Cardiol, 2017, 69(18): 2331-2341.
12. Al-Bawardy R, Krishnaswamy A, Bhargava M, et al. Tricuspid regurgitation in patients with pacemakers and implantable cardiac defibrillators: A comprehensive review. Clin Cardiol, 2013, 36(5): 249-254.
13. Klutstein M, Balkin J, Butnaru A, et al. Tricuspid incompetence following permanent pacemaker implantation. Pacing Clin Electrophysiol, 2009, 32 Suppl 1: S135-S137.
14. Seo Y, Ishizu T, Nakajima H, et al. Clinical utility of 3-dimensional echocardiography in the evaluation of tricuspid regurgitation caused by pacemaker leads. Circ J, 2008, 72(9): 1465-1470.
15. Kim JB, Spevack DM, Tunick PA, et al. The effect of transvenous pacemaker and implantable cardioverter defibrillator lead placement on tricuspid valve function: An observational study. J Am Soc Echocardiogr, 2008, 21(3): 284-287.
16. Taramasso M, Gavazzoni M, Pozzoli A, et al. Tricuspid regurgitation: Predicting the need for intervention, procedural success, and recurrence of disease. JACC Cardiovasc Imaging, 2019, 12(4): 605-621.
17. Zack CJ, Fender EA, Chandrashekar P, et al. National trends and outcomes in isolated tricuspid valve surgery. J Am Coll Cardiol, 2017, 70(24): 2953-2960.
18. Alqahtani F, Berzingi CO, Aljohani S, et al. Contemporary trends in the use and outcomes of surgical treatment of tricuspid regurgitation. J Am Heart Assoc, 2017, 6(12): e007597.
19. Dreyfus J, Ghalem N, Garbarz E, et al. Timing of referral of patients with severe isolated tricuspid valve regurgitation to surgeons (from a French nationwide database). Am J Cardiol, 2018, 122(2): 323-326.
20. Dhoble A, Zhao Y, Vejpongsa P, et al. National 10-year trends and outcomes of isolated and concomitant tricuspid valve surgery. J Cardiovasc Surg (Torino), 2019, 60(1): 119-127.
21. Lu F, Qiao F, Lv Y, et al. A radial force-independent bioprosthesis for transcatheter tricuspid valve implantation in a preclinical model. Int J Cardiol, 2020, 319: 120-126.
22. Lu FL, An Z, Ma Y, et al. Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. Heart, 2021, 107(20): 1664-1670.
23. Lu FL, Ma Y, An Z, et al. First-in-man experience of transcatheter tricuspid valve replacement with LuX-Valve in high-risk tricuspid regurgitation patients. JACC Cardiovasc Interv, 2020, 13(13): 1614-1616.
24. Ning XP, Cao JY, Li MX, et al. Transjugular transcatheter tricuspid valve implantation of LuX-Valve bioprosthesis in a preclinical model. J Cardiovasc Transl Res, 2023, 16(1): 31-41.
25. Alachkar MN, Schnupp S, Eichelsdoerfer A, et al. Feasibility and efficacy of transcatheter tricuspid valve repair in patients with cardiac implanted electrical devices and trans-tricuspid leads. J Clin Med, 2023, 12(15): 4930.
26. Anderson JH, McElhinney DB, Aboulhosn J, et al. Management and outcomes of transvenous pacing leads in patients undergoing transcatheter tricuspid valve replacement. JACC Cardiovasc Interv, 2020, 13(17): 2012-2020.
27. Taramasso M, Gavazzoni M, Pozzoli A, et al. Outcomes of TTVI in patients with pacemaker or defibrillator leads: Data from the TriValve Registry. JACC Cardiovasc Interv, 2020, 13(5): 554-564.
28. Gabriels JK, Schaller RD, Koss E, et al. Lead management in patients undergoing percutaneous tricuspid valve replacement or repair: A 'heart team' approach. Europace, 2023, 25(11): euad300.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Clinical efficacy of transcatheter tricuspid valve replacement in cardiac implantable electronic lead-related tricuspid regurgitation: A multi-center retrospective cohort study

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