What is the clinical evidence from this study?

Study design: Observational. Population: Severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR) (n=217). Intervention: Unilateral-access TF-TAVR vs. Bilateral-access TF-TAVR. Primary outcome: Incidence of vascular complications related to femoral access according to VARC-3 criteria (p=0.471).

November 15, 2024Open Access

Unilateral-access vs. bilateral-access in transfemoral transcatheter aortic valve replacement: A slim fit approach

Key Result

Unilateral-access TF-TAVR resulted in a similar rate of vascular complications compared to bilateral-access (10.4% vs 14.0%, p=0.471), while propensity-matched analysis showed significantly fewer bleeding complications.

Study Design

Type

Observational (n=217)

Multicenter

Structured PICO

Does unilateral-access reduce vascular complications compared to bilateral-access in patients undergoing transfemoral transcatheter aortic valve replacement?

Population

217 consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR), mean age 78.6 (bilateral group) and 77.6 (unilateral group), 53.9% male, single-center (Netherlands).

Intervention

Unilateral-access TF-TAVR (main arterial access at the common femoral artery and secondary arterial access at the ipsilateral superficial femoral artery).

Comparator

Bilateral-access TF-TAVR (main arterial access at the common femoral artery and secondary arterial access at the contralateral common femoral artery).

Outcome

Incidence of vascular complications (major and minor) related to femoral access according to the VARC-3 criteria.safety

Unilateral-access TF-TAVR is a safe and feasible alternative to bilateral-access, potentially reducing bleeding and overall complications while maintaining bailout capabilities.

Main Result

Absolute Event Rate: 10.4% vs 14%

p-value: p=0.471

Limitations

Retrospective, observational, single-center analysis
Small sample size limiting statistical power (risk of type II errors)
Selection bias due to the choice of access being left to the operator's discretion
Endpoints were reported by investigators rather than adjudicated by an independent committee
Unmeasured confounders may have influenced outcomes despite propensity score matching

Abstract

BACKGROUND: Vascular complications remain prevalent on transfemoral transcatheter aortic valve replacement (TF-TAVR) with a significant proportion related to the secondary arterial access. We hypothesized that placing the second sheath ipsilateral and distal to the delivery sheath could reduce vascular complications with similar safety and efficacy. OBJECTIVES: Comparing vascular complications and clinical outcomes when placing the secondary arterial sheath in the ipsilateral (unilateral-access) versus in the contralateral (bilateral-access) femoral artery during TF-TAVR. METHODS: Patients who underwent TF-TAVR using unilateral-access as first-choice approach were retrospectively compared with a contemporaneous bilateral-access group. The primary endpoint was the incidence of vascular complications related to femoral access according to the VARC-3 criteria. A propensity-score analysis was performed accounting for the differences in clinical, vascular, and procedural characteristics. RESULTS: A total of 217 patients were included, of whom 150 (69.1 %) underwent TF-TAVR through bilateral- and 67 (30.9 %) through unilateral-access. Vascular complications occurred in 16.0 % of the bilateral-access group and 10.4 % of the unilateral-access group (p = 0.280). The unilateral-access group achieved high procedural success with normalization of peak aortic velocity and low rates of paravalvular leaks, valve migration and pacemaker requirement. After propensity-score matching, the overall complications rate was superior in the bilateral-access group (54.4 % vs 35.1 %, p = 0.038) due to a trend of higher vascular complications (26.3 % vs 12.3 %, p = 0.058) and a significant higher occurrence of bleeding complications (17.5 % vs 1.8 %, p = 0.008). CONCLUSIONS: Unilateral-access TF-TAVR is feasible, safe, and potentially enhances procedural efficiency and patient satisfaction while maintaining the capacity for bailout interventions in managing vascular complications.

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