Key result
In patients undergoing transfemoral TAVR, an integrated sheath showed a non-significant trend toward fewer major vascular complications compared to an expandable sheath (7.6% vs 12.7%, p=0.066).
Why the study?
Vascular access site complications increase morbidity and mortality in TAVR, and low-profile integrated sheaths and expandable sheaths aim to lower vascular trauma.
Does an integrated sheath compared to an expandable sheath reduce major vascular complications in patients undergoing transfemoral TAVR?
Cohort (n=756)
Does an integrated sheath compared to an expandable sheath reduce major vascular complications in patients undergoing transfemoral TAVR?
Absolute Event Rate: 7.6% vs 12.7%
p-value: p=0.066
In patients undergoing transfemoral TAVR, the use of an integrated sheath showed a non-significant trend towards fewer major vascular complications compared to an expandable sheath.
No significant difference in major VARC-3 complications; leaves open whether integrated or expandable sheaths reduce TAVR access-site risks.
OBJECTIVES: Vascular access site complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). BACKGROUND: Medtronic's EnVeo PRO® low-profile sheath concept and Edwards' expandable eSheath® aim to lower vascular trauma and access site complications. This study aims to compare Valve Academic Research Consortium (VARC)-3 defined access-related vascular complications using the two different transcatheter heart valve (THV) delivery concepts. METHODS: We performed a retrospective, propensity-matched study to compare access site vascular complications in 756 consecutive patients who underwent a transfemoral TAVR using a Medtronic Evolut-R®/Evolut-PRO® or an Edwards Sapien3®/Sapien3ultra® THV. RESULTS: Propensity score matching resulted in 275 patient pairs. The primary endpoint of major VARC-3 vascular complication was 7.6% in the Medtronic group and 12.7% in the Edwards group (p = 0.066). Minor VARC-3 vascular complications were 9.1% and 8%, respectively (p = 0.76). VARC-3 bleeding complications (8.4% vs. 12.7%, p = 0.129) length of hospital stay (7.6 + 5.4 vs. 7.5 + 3.7 days, p = 0.783) and in-hospital mortality (1.1% vs. 0.4%, p = 0.624) were comparable between both groups. CONCLUSIONS: In a propensity-matched TAVR population, patients treated with the integrated sheath showed a trend towards fewer major vascular complications than patients treated with an expandable sheath, however, the difference was not statistically significant.
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Ruge et al. (2022) conducted a cohort in Transcatheter aortic valve replacement (TAVR) (n=756). Medtronic Evolut-R/Evolut-PRO (integrated sheath) vs. Edwards Sapien3/Sapien3ultra (expandable sheath) was evaluated on Major VARC-3 vascular complication (p=0.066). In patients undergoing transfemoral TAVR, an integrated sheath showed a non-significant trend toward fewer major vascular complications compared to an expandable sheath (7.6% vs 12.7%, p=0.066).
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