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Balloon-expandable transfemoral sheath feasible, safe in high-risk patients
Use of a balloon-expandable large-bore sheath during transfemoral transcatheter aortic valve replacement demonstrated similar rates of mortality, vascular complications and bleeding compared with a standard sheath among patients with complex access-site anatomy.
Researchers investigated the ability of a balloon-expandable large-bored sheath (SoloPath, Terumo) to reduce vascular complications and increase access-site availability in a cohort of 257 high-risk patients who underwent transfemoral TAVR with the CoreValve (Medtronic) at two institutions in Germany from 2010 to 2013. Of those, the balloon-expandable sheath was used in 43 patients. The cohort was 32% male and the mean age was 80 years. All patients were at high surgical risk (mean logistic EuroSCORE, 30.2%; mean Society of Thoracic Surgeons score, 10.7%).
The primary endpoint, a composite of 30-day mortality, major vascular complications and major bleeding assessed by VARC-2 criteria, occurred in 20.9% of the balloon-expandable sheath group vs. 14% of a propensity matched control group.
Examined alone, mortality at 30 days was 9.3% in the balloon-expandable sheath group vs. 3.5% in the matched control group (P = .2), and mortality at 1 year was 18.6% vs. 23.3%, respectively (P = .7). There also were no significant differences in major vascular complications (9.3% vs. 4.7%; P = .3) and major bleeding (9.3% vs. 10.5%; P = .5).
Minor vascular complications occurred in 37.2% of the balloon-expandable sheath group vs. 22.1% of the matched control group (P = .1), vascular stent grant implantation was required in 30.2% vs. 12.8% (P = .02) and need for blood transfusions was 55% vs. 57.7% (P = .5).
“The use of balloon-expandable sheaths has been suggested for TAVR patients with limited femoral access, but the scientific evidence supporting the use of these sheaths is scarce. Our study indicates that the use of the SoloPath balloon-expandable sheath is safe and feasible in a transfemoral TAVI cohort with a high risk for vascular complications and results in outcome comparable with a propensity matched standard sheath cohort,” the researchers wrote. – by Rob Volansky
Disclosure: The researchers report associations with Edwards Lifesciences, Medtronic and Terumo.