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

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 ofcardiac 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.