Need for long-term permanent pacemaker and its association with mortality in patients undergoing transcatheter aortic valve implantation

Anahtar Kelimeler:

Transcatheter aortic valve replacement, pacemaker, mortality

Need for long-term permanent pacemaker and its association with mortality in patients undergoing transcatheter aortic valve implantation

Despite two decades of experience and increased procedural success in TAVI, there are still matters of debate concerning need for PPI. We aimed to investigate the frequency of permanent pacemaker implantation (PPI) need and the long-term impact of PPI on all-cause mortality in patients with Transcatheter Aortic Valve Implantation (TAVI). All TAVI recipients between June 2016 and January 2021 admitted to our tertiary center were included retrospectively. In-hospital data were retrieved from the institutional digital database and later mortalities were recorded from the national E-Health application. The primary outcome was to determine the frequency of PPI requirement following TAVI. Median follow-up was 52 (12-72) months. PPI had been required in 20 (15%) of 132 TAVI recipients. PPI was necessary in 25% of Evolut R (Medtronic, CA, USA), 4% of Edwards Sapien (Edwards Lifesciences, CA, USA), 16% of Portico (Abbott Structural Heart, St Paul, MN, USA), 26% of Medtronic CoreValve (Medtronic, CA, USA), 20% of Myval THV (Meril Life Sciences, Gujarat, India), and none of ACURATE neo™ (Boston Scientific, Marlborough, MA, USA) recipients. Mortality was similar among those with and without PPI requirement. Multiple regression revealed that hyperlipidemia and preoperative valvuloplasty significantly decreased risk for all-cause mortality, while higher CRP increased the risk of mortality. New generation TAVI devices appear to decrease the frequency of PPI need compared to older generation devices, as reported in the literature. PPI was not associated with all-cause mortality at a median follow-up of 52 months in TAVI recipients.

Keywords:

Transcatheter aortic valve replacement, pacemaker, mortality,

PDF

___

1. Spitzer E, Mylotte D, Lauten A, O'sullivan CJ. TAVI and the Challenges Ahead. Front Cardiovasc Med. 2020;7:149.
2. Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019; 380(18): 1695-705.
3. Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'hair D, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019; 380(18): 1706-15.
4. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease: developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2022; 43(7): 561-632.
5. Mangieri A, Montalto C, Pagnesi M, Lanzillo G, Demir O, Testa L, et al. TAVI and post procedural cardiac conduction abnormalities. Frontiers in Cardiovascular Medicine. 2018; 5: 85.
6. Van Rosendael PJ, Delgado V, Bax JJ. Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review. Eur Heart J. 2018; 39(21): 2003-13.
7. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002; 106(24): 3006-8.
8. Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014; 63(19): 1972-81.
9. Abdel-Wahab M, Mehilli J, Frerker C, Neumann F-J, Kurz T, Tölg R, 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): 1503-14.
10. Nazif TM, Chen S, George I, Dizon JM, Hahn RT, Crowley A, et al. New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial. Eur Heart J. 2019; 40(27): 2218-27.
11. Søndergaard L. Reevaluation of the indications for permanent pacemaker implantation after transcatheter aortic valve implantation. J Invasive Cardiol. 2014; 26(2): 94-9.
12. Labarrere CA, Woods J, Hardin J, Campana G, Ortiz M, Jaeger B, et al. Early prediction of cardiac allograft vasculopathy and heart transplant failure. Am J Transplant. 2011; 11(3): 528-35.
13. Moellmann H, Hengstenberg C, Hilker M, Kerber S, Schaefer U, Rudolph T, et al. Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry. Eurointervention. 2018; 13(15): e1764-e70.
14. Fontana, G.P. A randomized trial of Portico vs. commercially available transcatheter aortic valves in patients with severe aortic stenosis. Presented at TCT 2019, San Francisco, CA, USA, 27 September 2019. Online resource
15. Mas-Peiro S, Seppelt PC, Weiler H, Mohr G-L, Papadopoulos N, Walther T, et al. A direct comparison of self-expandable portico versus balloon-expandable Sapien 3 devices for transcatheter aortic valve replacement: a case-matched cohort study. J Invasive Cardiol. 2019; 31(7): E199-E204.
16. Santos-Martinez S, Halim J, Castro-Mejía A, De Marco F, Trani C, Martin P, et al. Myval versus alternative balloon-and self-expandable transcatheter heart valves: A central core lab analysis of conduction disturbances. Int J Cardiol. 2022; 351: 25-31.
17. Fadahunsi OO, Olowoyeye A, Ukaigwe A, Li Z, Vora AN, Vemulapalli S, et al. Incidence, predictors, and outcomes of permanent pacemaker implantation following transcatheter aortic valve replacement: analysis from the US Society of Thoracic Surgeons/American College of Cardiology TVT Registry. JACC Cardiovasc Interv. 2016; 9(21): 2189-99.
18. Sharobeem S, Boulmier D, Leurent G, Bedossa M, Leclercq C, Mabo P, et al. Prognostic impact of permanent pacemaker implantation following transcatheter aortic valve replacement. Heart Rhythm. 2022; S1547-5271(22)00218-1.
19. Zito A, Princi G, Lombardi M, D'amario D, Vergallo R, Aurigemma C, et al. Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis. Europace. 2022; euac008. Online ahead of print.
20. Walther T, Manoharan G, Linke A, Möllmann H, Holzhey D, Worthley SG, et al. Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico™ valve. Eur J Cardiothorac Surg. 2018;54(3):467-74.
21. Alasti M, Rashid H, Rangasamy K, Kotschet E, Adam D, Alison J, et al. Long-term pacemaker dependency and impact of pacing on mortality following transcatheter aortic valve replacement with the LOTUS valve. Catheter Cardiovasc Interv. 2018;92(4):777-82.
22. Mouillet G, Lellouche N, Yamamoto M, Oguri A, Dubois-Rande JL, Van Belle E, et al. Outcomes following pacemaker implantation after transcatheter aortic valve implantation with CoreValve(®) devices: Results from the FRANCE 2 Registry. Catheter Cardiovasc Interv. 2015;86(3):E158-66.
23. Biner S, Michowitz Y, Leshem-Rubinow E, Topilsky Y, Ben-Assa E, Shimiaie J, et al. Hemodynamic impact and outcome of permanent pacemaker implantation following transcatheter aortic valve implantation. Am J Cardiol. 2014;113(1):132-7.