Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry

Abstract

Objectives: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice.

Methods: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points.

Results: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P = 0.76), rates of stroke 2% vs. 0% ( P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% ( P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups.

Conclusions: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation.

Clinicaltrials.gov: NCT01991431.

Keywords: SAPIEN; TAVI; Transaortic; Transapical; Transcatheter Aortic Valve Implantation; Transfemoral.