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Safety of Transcatheter Aortic Valve Replacement for High-Risk Patients with Severe Aortic Stenosis

https://doi.org/10.18087/cardio.2025.7.n2876

Abstract

Background Severe aortic stenosis (AS) is a life-threatening condition that necessitates prompt intervention, even in high-risk patients with contraindications to surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) has become a transformative treatment, utilizing various access routes, including transfemoral (TF), transapical, and other, alternative pathways. The selection of the access route significantly impacts procedural safety and outcomes. The purpose of this study is to compare the safety profiles of different TAVR access routes in high-risk patients with severe AS.
Material and methods Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a comprehensive literature search was performed in PubMed and Cochrane Library databases to identify studies that evaluated the safety outcomes of TAVR via various access routes in high-risk patients. Key endpoints analyzed were procedural complications, 30‑day mortality, cardiac electrophysiological abnormalities, stroke incidence, and vascular complications. Meta-analysis utilizing RevMan 5.3 was performed, employing fixed or random effects models based on heterogeneity.
Results Seven studies encompassing 2,351 patients were included in the analysis. The pooled analysis revealed that the non-TF access routes were associated with a significantly higher risk ratio (RR) for procedural complications [RR=1.76; 95 % confidence interval (CI): 1.63–1.89, p<0.00001] compared to the TF approach. No statistically significant difference in 30‑day mortality was observed among the access routes [OR=0.79; 95 % CI: 0.60–1.05, p=0.11]. However, alternative routes had increased odds of
cardiac electrophysiological abnormalities [OR=1.44; 95 % CI: 1.12–1.84, p=0.004]. There was no significant difference in stroke incidence between access routes [OR=1.16; 95 % CI: 0.75–1.79, p=0.51], but vascular complications were significantly more frequent with non-femoral routes [OR=1.70; 95 % CI: 1.29–2.24, p=0.0001].
Conclusion This meta-analysis underscores the critical role of access route selection in the safety of TAVR. While the TF approach remains the gold standard due to its lower complication rates, alternative routes are indispensable for anatomically or clinically challenging cases. Refinements in procedural techniques, patient selection, and advanced imaging are essential to optimizing outcomes across all access routes. Further large-scale studies are warranted to validate these findings and enhance clinical decision-making.

About the Authors

Qinghua Meng
The First Affiliated Hospital of Army Medical University, Department of Cardiac Surgery
China

BS

Chongqing, 400000, China



Maoting Ye
The First Affiliated Hospital of Army Medical University, Department of Cardiac Surgery
China

MM

Chongqing, 400000, China



Haiying Zhang
The First Affiliated Hospital of Army Medical University, Department of Cardiac Surgery
China

BS

Chongqing, 400000, China



References

1. Patel KP. Aortic Stenosis: Multimorbidity and Myocardial Impact on Patients undergoing Transcatheter Aortic Valve Implantation. 2023. [Av. at: https://discovery.ucl.ac.uk/id/eprint/10170900/]

2. Siontis GCM, Overtchouk P, Cahill TJ, Modine T, Prendergast B, Praz F et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis. European Heart Journal. 2019;40(38):3143–53. DOI: 10.1093/eurheartj/ehz275

3. Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS et al. Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis. New England Journal of Medicine. 2012;366(18):1696–704. DOI: 10.1056/NEJMoa1202277

4. Généreux P, Schwartz A, Oldemeyer JB, Pibarot P, Cohen DJ, Blanke P et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. New England Journal of Medicine. 2025;392(3):217–27. DOI: 10.1056/NEJMoa2405880

5. Barbanti M, Costa G, Picci A, Criscione E, Reddavid C, Valvo R et al. Coronary Cannulation After Transcatheter Aortic Valve Replacement. JACC: Cardiovascular Interventions. 2020;13(21):2542–55. DOI: 10.1016/j.jcin.2020.07.006

6. Young MN, Singh V, Sakhuja R. A Review of Alternative Access for Transcatheter Aortic Valve Replacement. Current Treatment Options in Cardiovascular Medicine. 2018;20(7):62. DOI: 10.1007/s11936-018-0648-5

7. Benjamin MM, Rabbat MG. Artificial Intelligence in Transcatheter Aortic Valve Replacement: Its Current Role and Ongoing Challenges. Diagnostics. 2024;14(3):261. DOI: 10.3390/diagnostics14030261

8. Winter M-P, Bartko P, Hofer F, Zbiral M, Burger A, Ghanim B et al. Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies. Scientific Reports. 2020;10(1):15568. DOI: 10.1038/s41598-020-72453-1

9. Scarsini R, De Maria GL, Joseph J, Fan L, Cahill TJ, Kotronias RA et al. Impact of Complications During Transfemoral Transcatheter Aortic Valve Replacement: How Can They Be Avoided and Managed? Journal of the American Heart Association. 2019;8(18):e013801. DOI: 10.1161/JAHA.119.013801

10. Minici R, Paone S, Talarico M, Zappia L, Abdalla K, Petullà M et al. Percutaneous treatment of vascular access-site complications: a ten years’ experience in two centres. CVIR Endovascular. 2020;3(1):29. DOI: 10.1186/s42155-020-00120-7

11. Bapat V, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M et al. Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry. JACC: Cardiovascular Interventions. 2016;9(17):1815–22. DOI: 10.1016/j.jcin.2016.06.031

12. Barbash IM, Segev A, Berkovitch A, Fefer P, Maor E, Elian D et al. Clinical Outcome and Safety of Transcaval Access for Transcatheter Aortic Valve Replacement as Compared to Other Alternative Approaches. Frontiers in Cardiovascular Medicine. 2021;8:731639. DOI: 10.3389/fcvm.2021.731639

13. Parums DV. Editorial: Review Articles, Systematic Reviews, MetaAnalysis, and the Updated Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 Guidelines. Medical Science Monitor. 2021;27:e934475. DOI: 10.12659/MSM.934475

14. Igelström E, Campbell M, Craig P, Katikireddi SV. Cochrane’s risk of bias tool for non-randomized studies (ROBINS-I) is frequently misapplied: A methodological systematic review. Journal of Clinical Epidemiology. 2021;140:22–32. DOI: 10.1016/j.jclinepi.2021.08.022

15. Shi L, Lin L. The trim-and-fill method for publication bias: practical guidelines and recommendations based on a large database of meta-analyses. Medicine. 2019;98(23):e15987. DOI: 10.1097/MD.0000000000015987

16. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG et al. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients. New England Journal of Medicine. 2011;364(23):2187–98. DOI: 10.1056/NEJMoa1103510

17. Sawa Y, Takayama M, Mitsudo K, Nanto S, Takanashi S, Komiya T et al. Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial. Surgery Today. 2015;45(1):34–43. DOI: 10.1007/s00595-014-0855-y

18. Gleason TG, Schindler JT, Adams DH, Reardon MJ, Kleiman NS, Caplan LR et al. The risk and extent of neurologic events are equivalent for high-risk patients treated with transcatheter or surgical aortic valve replacement. The Journal of Thoracic and Cardiovascular Surgery. 2016;152(1):85–96. DOI: 10.1016/j.jtcvs.2016.02.073

19. Ito S, Nkomo VT, Orsinelli DA, Lin G, Cavalcante J, Popma JJ et al. Impact of Stroke Volume Index and Left Ventricular Ejection Fraction on Mortality After Aortic Valve Replacement. Mayo Clinic Proceedings. 2020;95(1):69–76. DOI: 10.1016/j.mayocp.2019.10.031

20. Bleiziffer S, Ruge H, Mazzitelli D, Schreiber C, Hutter A, Krane M et al. Valve Implantation on the Beating Heart: catheter-assisted surgery for aortic stenosis. Deutsches Ärzteblatt international. 2009;106(14):235–41. DOI: 10.3238/arztebl.2009.0235

21. Casado AP, Barili F, D’Auria F, Raviola E, Parolari A, Le Houérou D et al. Midterm outcomes of transaortic and transapical TAVI in patients with unsuitable vascular anatomy for femoral access: A propensity score inverse probability weight study. Journal of Cardiac Surgery. 2021;36(3):872–8. DOI: 10.1111/jocs.15313

22. Yuan Y-T, Chen Y-H, Chen P-L, Tsai H-C, Chen I-M, Weng Z-C et al. One-year results of transcatheter aortic valve implantation as an alternative treatment for severe aortic stenosis in high-risk patients. Journal of the Chinese Medical Association. 2013;76(12):698–702. DOI: 10.1016/j.jcma.2013.08.007

23. Grube E, Sinning J-M. The “Big Five” Complications After Transcatheter Aortic Valve Replacement. JACC: Cardiovascular Interventions. 2019;12(4):370–2. DOI: 10.1016/j.jcin.2018.12.019

24. Spears J, Al-Saiegh Y, Goldberg D, Manthey S, Goldberg S. TAVR: A Review of Current Practices and Considerations in Low-Risk Patients. Journal of Interventional Cardiology. 2020;2020:1–13. DOI: 10.1155/2020/2582938

25. Saad M, Seoudy H, Frank D. Challenging Anatomies for TAVR – Bicuspid and Beyond. Frontiers in Cardiovascular Medicine. 2021;8:654554. DOI: 10.3389/fcvm.2021.654554

26. Sundt TM, Jneid H. Guideline Update on Indications for Transcatheter Aortic Valve Implantation Based on the 2020 American College of Cardiology/American Heart Association Guidelines for Management of Valvular Heart Disease. JAMA Cardiology. 2021;6(9):1088–9. DOI: 10.1001/jamacardio.2021.2534

27. Hayek A, Prieur C, Dürrleman N, Chatelain Q, Ibrahim R, Asgar A et al. Clinical considerations and challenges in TAV-in-TAV procedures. Frontiers in Cardiovascular Medicine. 2024;11:1334871. DOI: 10.3389/fcvm.2024.1334871

28. Otto CM, Kumbhani DJ, Alexander KP, Calhoon JH, Desai MY, Kaul S et al. 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults With Aortic Stenosis. Journal of the American College of Cardiology. 2017;69(10):1313–46. DOI: 10.1016/j.jacc.2016.12.006

29. Chen S, Chau KH, Nazif TM. The incidence and impact of cardiac conduction disturbances after transcatheter aortic valve replacement. Annals of Cardiothoracic Surgery. 2020;9(6):452–67. DOI: 10.21037/acs-2020-av-23

30. Auffret V, Puri R, Urena M, Chamandi C, Rodriguez-Gabella T, Philippon F et al. Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives. Circulation. 2017;136(11):1049–69. DOI: 10.1161/CIRCULATIONAHA.117.028352

31. Hermans MC, Van Mourik MS, Hermens HJ, Baan Jr J, Vis MM. Remote Monitoring of Patients Undergoing Transcatheter Aortic Valve Replacement: A Framework for Postprocedural Telemonitoring. JMIR Cardio. 2018;2(1):e9. DOI: 10.2196/cardio.9075

32. Franco‐Sadud R, Schnobrich D, Mathews BK, Candotti C, Abdel‐Ghani S, Perez MG et al. Recommendations on the Use of Ultrasound Guidance for Central and Peripheral Vascular Access in Adults: A Position Statement of the Society of Hospital Medicine. Journal of Hospital Medicine. 2019;14(9):E1–22. DOI: 10.12788/jhm.3287

33. Francone M, Budde RPJ, Bremerich J, Dacher JN, Loewe C, Wolf F et al. CT and MR imaging prior to transcatheter aortic valve implantation: standardisation of scanning protocols, measurements and reporting – a consensus document by the European Society of Cardiovascular Radiology (ESCR). European Radiology. 2020;30(5):2627–50. DOI: 10.1007/s00330-019-06357-8

34. Garimella PS, Hirsch AT. Peripheral Artery Disease and Chro nic Kidney Disease: Clinical Synergy to Improve Outcomes. Advances in Chronic Kidney Disease. 2014;21(6):460–71. DOI: 10.1053/j.ackd.2014.07.005

35. Garimella PS, Hart PD, O’Hare A, DeLoach S, Herzog CA, Hirsch AT. Peripheral Artery Disease and CKD: A Focus on Peripheral Artery Disease as a Critical Component of CKD Care. American Journal of Kidney Diseases. 2012;60(4):641–54. DOI: 10.1053/j.ajkd.2012.02.340

36. Kobo O, Saada M, Roguin A. Can Transcatheter Aortic Valve Implantation (TAVI) Be Performed at Institutions Without On-Site Cardiac Surgery Departments? Cardiovascular Revascularization Medicine. 2022;41:159–65. DOI: 10.1016/j.carrev.2021.12.009

37. Athappan G, Gajulapalli RD, Sengodan P, Bhardwaj A, Ellis SG, Svensson L et al. Influence of Transcatheter Aortic Valve Replacement Strategy and Valve Design on Stroke After Transcatheter Aortic Valve Replacement. Journal of the American College of Cardiology. 2014;63(20):2101–10. DOI: 10.1016/j.jacc.2014.02.540

38. Elhmidi Y, Bleiziffer S, Piazza N, Voss B, Krane M, Deutsch M-A et al. Long-term Results After Transcatheter Aortic Valve Implantation: What do we Know Today? Current Cardiology Reviews. 2014;9(4):295–8. DOI: 10.2174/1573403X09666131202124227

39. Dogosh A, Adawi A, El Nasasra A, Cafri C, Barrett O, Tsaban G et al. Comparison of Transcatheter Aortic Valve Implantation Devices in Aortic Stenosis: A Network Meta-Analysis of 42,105 Patients. Journal of Clinical Medicine. 2022;11(18):5299. DOI: 10.3390/jcm11185299

40. Walsh KA, Plunkett T, O’Brien KK, Teljeur C, Smith SM, Harrington P et al. The relationship between procedural volume and patient outcomes for percutaneous coronary interventions: a systematic review and meta-analysis. HRB Open Research. 2021;4:10. DOI: 10.12688/hrbopenres.13203.1

41. Mangold AS, Benincasa S, Sanders BM, Patel K, Mitrev L. Neurological Complications After Transcatheter Aortic Valve Replacement: A Review. Anesthesia & Analgesia. 2024;139(5):986–96. DOI: 10.1213/ANE.0000000000007087

42. Bjursten H, Norrving B, Ragnarsson S. Late stroke after transcatheter aortic valve replacement: a nationwide study. Scientific Reports. 2021;11(1):9593. DOI: 10.1038/s41598-021-89217-0


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For citations:


Meng Q., Ye M., Zhang H. Safety of Transcatheter Aortic Valve Replacement for High-Risk Patients with Severe Aortic Stenosis. Kardiologiia. 2025;65(7):63-73. https://doi.org/10.18087/cardio.2025.7.n2876

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