Key result
Sheath diameter (18F vs 19-24F) had no significant effect on the incidence of vascular complications (12.8% vs 12.4%) or mortality in patients undergoing transfemoral TAVI.
Why the study?
Does an 18F sheath diameter reduce vascular complications and mortality compared to a 19-24F sheath diameter in patients undergoing transfemoral TAVI?
Cohort (n=183)
No
Does an 18F sheath diameter reduce vascular complications and mortality compared to a 19-24F sheath diameter in patients undergoing transfemoral TAVI?
Absolute Event Rate: 12.8% vs 12.4%
p-value: p=0.9
In patients undergoing transfemoral TAVI with the Perclose-Proglide closure device, the use of larger sheath diameters (19-24F) did not significantly increase vascular complications or mortality compared to 18F sheaths.
No increased risk with larger sheaths supports flexible selection in transfemoral TAVI; leaves open confirmation in randomized trials.
OBJECTIVE: Evaluation of the impact of the sheath diameter on vascular complications and mortality in transfemoral aortic valve implantation. METHOD: Between 2012 and 2014, 183 patients underwent the procedure using a sheath diameter of 18-24 F. This collective was divided into two groups: group 1, with a sheath diameter of 18F (G1, n = 94), consisted of patients with 18F Medtronic Sentrant and 18 F Direct Flow sheaths, and group 2 with a sheath diameter of 19-24 F (G2, n = 89) consisted of patients with Edwards expandable e-sheath and Solopath sheaths. Perclose-Proglide® was used as a closure device in all patients. RESULTS: G1 had significantly more female patients (64.9% vs. 46.1% in G2, p = 0.01) and the average BMI was lower (26 ± 4.5% vs. 27.4 ± 4.7%, p = 0.03). There was no significant difference in the incidence of major and minor vascular complications (G1: 12.8% vs. G2: 12.4%, p = 0.9). 30-day mortality was similar in both groups (G1: 6.4 ± 2.5% [95% CI: 0.88-0.98], G2: 3.7 ± 1.9% [95% CI: 0.92-0.99]. The Kaplan Meier analysis of survival revealed no significant differences either. CONCLUSION: The difference in sheath diameter had no effect on either incidence or severity of vascular complications. There was no impact on mortality either.
No takes yet. Share an insight, caveat, or question.
Dimitriadis et al. (2017) conducted a cohort in Severe symptomatic aortic valve stenosis (n=183). 18F sheath diameter vs. 19-24F sheath diameter was evaluated on Incidence of major and minor vascular complications (p=0.9). Sheath diameter (18F vs 19-24F) had no significant effect on the incidence of vascular complications (12.8% vs 12.4%) or mortality in patients undergoing transfemoral TAVI.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: