Incidence, predictors and prognosis of major vascular complications (VARC-3) following transfemoral transcatheter aortic valve implantation: data from a two- center retrospective registry

• Aleksey A. Baranov
• Oleg V. Krestyaninov
• Aram G. Badoyan
• Dmitry A. Khelimsky
• Aryuna Y. Tsydenova
• Maryam A. Yusupova
• Sergey V. Maingart
• Aleksey N. Fedorchenko

Abstract

Background. Improving transcatheter bioprostheses and systems of their delivery, gaining surgical experience, as well as optimizing patient selection made it possible to achieve high levels of efficacy and safety of the procedure of transcatheter implantation of the aortic valve (AV). Nevertheless, complications of this technique with a negative influence on both short- and long-term outcomes are still encountered in many patients. Despite the fact that transcatheter implantation of the AV has historically been associated with lower incidence of hemorrhagic events than traditional surgery, bleeding occurring during this operation is fraught with a worse prognosis. Complications of the vascular access still remain the main cause of hemorrhage.

Objective. To assess the incidence, predictors and prognostic significance of major vascular complications associated with the transfemoral vascular access for transcatheter implantation of the aortic valve.

Patients and methods. This retrospective study initially enrolled a total of 628 patients who underwent transcatheter implantation of the AV from March 2015 to October 2024. After exclusion of patients with other than transfemoral vascular approach, as well as with unsatisfactory quality of preoperative multislice computed tomography not allowing for the assessment of vascular anatomy, the final analysis included 548 patients. The primary endpoint of the study was defined as predictors of major vascular complications of the transfemoral approach after transcatheter implantation of the AV, with the secondary endpoint being long-term survival and freedom from cardiovascular death in patients having endured nonfatal major vascular complications of the access site at the in-hospital stage after transcatheter implantation of the AV.

Results and discussion. There were a total of 32 major vascular complications. Of these, 3 (0.6%) resulted in a lethal outcome, with 29 (5.3%) accompanied by BARC type 3a and 3b bleeding. Puncture percutaneous vascular access was used in 94.9% of patients. The most frequently applied method of vascular access closure was a combination of two ProGlide devices (70.9%). The group of patients with major vascular complications of the transfemoral access was found to have a higher frequency of puncture of the left common femoral artery (21.9% vs 10.5%, p=0.04), as well as a longer length of hospital stay (13.3±8.3 vs 9.4±5.8, p=001). The only independent predictor of major vascular complications was the left side of the vascular access (odds ratio 8.85; 95% confidence interval 1.58–69.40, p=0.02). With an average follow-up period of 2.1±2.2 years, the log-rank test revealed no statistically significant differences in freedom from all-cause mortality (log-rank p=0.11) and freedom from cardiovascular death (log-rank p=0.30) in patients with and without non-fatal major vascular complications of the access site after implantation of the AV.

Conclusion. The incidence of major vascular complications of the access site after the procedure of transcatheter implantation of the aortic valve amounted to 5.9%. The only independent predictor of major vascular complications was the left side of the vascular access. The development of major nonfatal vascular complications at the in-hospital stage influenced neither survival nor freedom from cardiovascular death in the remote period.

Keywords: aortic stenos; transcatheter aortic valve implantation; vascular complication; transfemoral access