Introduction: Transfemoral TAVI has become the standard treatment for most patients with aortic stenosis. For patients with severely calcified iliofemoral disease, alternative access routes have been explored (e.g. transaxillary [TAX] TAVI). Intravascular lithotripsy (IVL) may modify iliofemoral calcifications and facilitate transfemoral TAVI (IVL-TAVI) in these patients while avoiding the drawbacks of alternative access routes. We assessed technical aspects and clinical outcomes of this novel approach.

Methods: IVL-TAVI was performed for severe iliofemoral calcifications precluding standard transfemoral access in 27 patients from 2019 to 2022 at a single center. 44 TAX-TAVI procedures performed for the same indication (2016 to 2021) served as control group. All patients consented to data acquisition as part of the HARbOR clinical cohort. Baseline variables and VARC-3 adjudicated clinical outcomes were compared. Assessment of iliofemoral anatomy and calcification patterns were performed using a dedicated CT-software. The safety outcome was a composite of all-cause death, disabling- and non-disabling stroke, ≥ type 2 bleeding and vascular access site complications at 30 days. The efficacy outcome was defined as technical success according to VARC-3.

Results: Mean age was 78.5±7.2 years overall, 43.6% were female and mean STS-PROM was 5.0% without any significant differences in baseline parameters among both groups. CT analysis revealed more severe iliofemoral calcifications in the IVL-TAVI group (severe calcification at target lesion: 92.6% vs. 68.2%; p=0.017, maximal arc calcification 336.3° ± 37.8° vs. 264.6° ± 110.6°; p=0.002). Tortuosity, vessel diameter, target lesion diameter and length were similar. Technical success was achieved in 96.3% vs. 86.4% (p=0.172) in IVL- and TAX-TAVI, respectively with good hemodynamic results. The composite safety outcome occurred in 37.0% vs. 63.6% in IVL- and TAX-TAVI (p=0.029), respectively (death: 3.7% vs. 9.1%; stroke: 3.7% vs. 9.1%; ≥ type 2 bleeding 18.5% vs. 31.8%; vascular complications 33.3% vs. 43.2%). IVL-related complications included 2 focal minor dissections with conservative treatment; no perforations were observed.

Conclusion:

IVL assisted transfemoral TAVI was feasible and safe with favorable outcomes compared to TAX-TAVI. It has the potential to further expand the number of patients eligible for a transfemoral approach, thus avoiding the potential drawbacks of alternative access routes for TAVI. However, patients with severe iliofemoral disease undergoing TAVI remain a high-risk cohort with specific complication rates.