New delivery sheath may enable more patients to undergo transfemoral TAVI


Walid K Abu Shaleh (Houston Methodist DeBakey Heart & Vascular Centre, Department of Cardiovascular Surgery, Houston Methodist Hospital, Houston, USA) and others report in Catheterization and Cardiovascular Interventions that a new balloon-expandable, re-collapsible (BERC) sheath (Solopath, Terumo) may “considerably expand” the population suitable for transcatheter aortic valve implantation (TAVI) via the transfemoral approach.

Shaleh et al comment that smaller valve delivery system profiles have enabled a larger proportion of patients to undergo TAVI via the transfemoral approach (the preferred approach), but add that there “remains a significant number of patients for whom the femoral approach is not feasible because of excessive atherosclerosis, calcification, or tortuosity.” They add that outcomes of transfemoral TAVI with iliofemoral access of 5.2–6mm using the BERC delivery sheath “have been favourable”, but state that the reported experience with the sheath “has been limited” to isolated case reports. “This present study aims to evaluate the outcomes of transfemoral TAVI with a self-expanding prosthesis (CoreValve and Evolut R), deployed via a BERC sheath, in patients with small and complex iliofemoral access,” the authors write.

Between 2014 and 2015, 64 patients underwent transfemoral TAVI with the BERC sheath at two institutions (Houston Medical Center and Westchester Medical Center). Of these patients, 13 had an iliofemoral artery minimum lumen diameter of ≤5mm with eccentricity ratios ranging 17–64%. Shaleh et al note that, overall:  “Vessel calcification ranged from ≤90 degrees to 360 degrees, tortuosity from 90 degrees, and sheath-to-artery ratio from 1.53 to 2.47.” 

Regarding the sheath, the authors describe it as having a 4.45mm outer diameter upon arterial entry, expanding to 7.67mm, and then re-collapsing upon removal to approximately 4.45mm, noting: “Following iliofemoral arterial insertion, the sheath is balloon expanded (20 atmospheres for 60 seconds) to accommodate the valve delivery system. Following TAVI, the sheath is actively re-collapsed prior to withdrawal by inflating an outer balloon.” They add it was able to “accommodate the valve delivery system in 100% of the cases with no mechanical failure” and that all sheaths were successfully removed with “no vascular and access-site complications”. There was also no access-site related bleeding in-hospital or at 30 days.

Shalah et al comment, according to the results of their study, transfemoral TAVI using an 11/19Fr BERC sheath is “safe, even in small iliofemoral diameters ≤5mm” and conclude: “This delivery sheath may considerably expand the population suitable for transfemoral approach and thereby contribute to improved TAVI outcomes.”

The study’s corresponding author Gilbert Tang (Westchester Medical Center, Valhalla, USA) told Cardiovascular News: “The BERC sheath further expands the number of patients eligible for transfemoral TAVI. For example, among our 13 patients with iliofemoral access ≤5mm who had transfemoral TAVI, all of them would have been high risk candidates for alternative access (eg. transapical, transaortic, transaxillary).  These patients had several comorbidities and were very frail. Performing non-femoral access TAVI on these patients would have been more invasive, required general anaesthesia, with probable longer hospital stay. The BERC sheath not only allows these patients to undergo TAVI transfemorally, but also with conscious sedation, leading to faster recovery and early hospital discharge. The BERC sheath has enabled us to perform TAVI via the transfemoral approach in >97% of our cases, all with only intravenous sedation and local anaesthesia.”