Authors

• Antonio Hanžek — University Hospital Centre Zagreb, Zagreb, Croatia — ORCID: 0000-0003-2308-3518
• Zvonimir Ostojić — University Hospital Centre Zagreb, Zagreb, Croatia — ORCID: 0000-0003-1762-9270
• Ivica Šafradin — University Hospital Centre Zagreb, Zagreb, Croatia — ORCID: 0000-0003-4519-5940
• Hrvoje Jurin — University Hospital Centre Zagreb, Zagreb, Croatia — ORCID: 0000-0002-2599-553X
• Tomislav Krčmar — University Hospital Centre Zagreb, Zagreb, Croatia — ORCID: 0000-0003-4689-1673
• Joško Bulum — University Hospital Centre Zagreb, Zagreb, Croatia — ORCID: 0000-0002-1482-6503

Keywords

transcatheter aortic valve implantation, access site-related vascular injury, stent-graft

DOI

Full Text

**Introduction:** Percutaneous transfemoral transcatheter aortic valve implantation (pTF-TAVI) is an established method for the treatment of aortic stenosis in elderly patients. Despite improvements in this approach, access site-related vascular injury (ASRVI) remains a common complication (1). Although the implantation of a stent-graft (SG) in the common femoral artery (CFA) is not recommended, it is used to treat ASRVI despite the lack of clinical evidence (2). The aim is to evaluate the clinical outcomes in patients undergoing peripheral intervention for ASRVI related to pTF-TAVI. **Patients and Methods**: This single-center retrospective analysis included all patients undergoing pTF-TAVI who experienced ASRVI treated with either balloon angioplasty or SG implantation in the CFA. Patient demographics, comorbidities, as well as procedural data during TAVI were collected. Patient clinical follow-up (FUP) data was collected during FUP interviews. **Results**: A total of 197 patients underwent pTF-TAVI with MANTA as the primary vascular closure device. A total of 31 patients (15.7%) had ASRVI, the majority of whom (N=30, 96.7%) were successfully treated percutaneously and included in the study. The general patient and procedural characteristics are shown in **Table 1**. Of the 30 patients, 8 (26.6%) underwent balloon angioplasty and 22 (73.4%) underwent SG implantation. The mean FUP was 11 ± 6.3 months. The mean diameter of the balloon or SG used was 8.04 ± 1.13 mm. In the cases in which SG was implanted, most were balloon-expanding SG (N=19, 86.36). At FUP, 2 (6.67%) patients reported intermittent claudication, 6 (20%) had nonspecific limb pain, and the majority (N=23, 76.67%) had a walking distance of > 500 m. One patient initially treated with balloon angioplasty developed limiting claudication and underwent stent implantation. A comparison of clinical outcomes between patients treated with BD or SG is shown in **Table 2**. ### TABLE 1: General and procedural characteristics of patients undergoing percutaneous treatment of access site-related vascular injury after transfemoral transcatheter aortic valve implantation. | | **N=30** | | --- | --- | | Female - n (%) | 16 (53.33) | | Age – mean ± SD | 81.38 ± 6.55 | | Coronary artery disease*, n (%) | 17 (56.67) | | Atrial fibrillation, n (%) | 8 (26.67) | | Chronic obstructive pulmonary disease, n (%) | 4 (13.33) | | Chronic renal insufficiency**, n (%) | 13 (43.33) | | Peripheral artery disease, n (%) Occlusive PAD***, n (%) | 17 (56.67) 8 (26.67) | | Aortic valve replacement before TAVI, n (%) | 3 (10) | | Mean left ventricular ejection fraction ± SD | 51.72 ± 12.41 | | Self-expanding valve, n (%) | 20 (66.6) | | Mean valve size ± SD | 29.27 ± 6.23 | [†] *defined with coronary angiography; **defined as estimated glomerular filtration rate 2; ***Occlusive peripheral artery disease defined with CT angiography; SD standard deviation ### TABLE 2: Comparison of clinical outcomes of patients treated with balloon angioplasty or stent-graft implantation. | **Clinical outcome** | **General (N=30)** | **Balloon angioplasty (N=8)** | **Stent-graft implantation (N=22)** | | --- | --- | --- | --- | | **Intermittent claudication**, n (%) | 2 (6.66) | 1 (12.5) | 1 (4.54) | | **Non-specific limb pain**, n (%) | 6 (20) | 0 (0) | 6 (27.27) | | **Additional vascular procedure***, n (%) | 1 (3.33) | 1 (12.5) | 0 (0) | | **Walking distance** (m), n (%) < 100 100 – 200 – 500 500 or more | 1 (3.33) 2 (6.66) 3 (10) 23 (76.66) | 1 (12.5) 0 (0) 0 (0) 7 (87.5) | 0 (0) 2 (9.09) 3 (13.63) 16 (72.72) | | **Mortality****, n (%) | 4 (13.33) | 1 (12.5) | 3 (13.63) | | **CVI*****, n (%) | 1 (3.33) | 1 (12.5) | 0 (0) | | **Permanent pacemaker implantation**, n (%)**** | 1 (3.33) | 0 (0) | 1 (4.54) | [†] *Need for additional vascular intervention (percutaneous or surgery) during clinical follow-up, at the access site-related vascular injury site; **Mortality during clinical follow-up; ***Cerebrovascular insult during transcatheter aortic valve implantation procedure; ****Need for permanent pacemaker implantation after the transcatheter aortic valve implantation procedure. **Conclusion**: The results of our single-center analysis demonstrate that peripheral vascular interventions, including implantation of SG in CFA, provide satisfactory 1-year clinical outcomes in elderly patients undergoing pTF-TAVI and thus can be considered as a bailout method for the treatment of ASRVI. Patients initially treated with SG did not need reintervention as they had no lifestyle-limiting claudication.

Literature

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2. Sedaghat A, Hansen KL, Schahab N, May MC, Weber M, Stundl A, et al. Long-term follow-up after stent graft placement for access-site and access-related vascular injury during TAVI - The Bonn-Copenhagen experience. Int J Cardiol. 2019 April 15;281:42–6. https://doi.org/10.1016/j.ijcard.2018.12.053