Balloon Dilatation of Expandable Sheath to Facilitate Transfemoral SAPIEN 3 Transcatheter Aortic Valve Replacement in Severely Calcified Vasculature

•Although the dynamic expansion mechanism allows transient enlargement of the Edwards Commander Delivery System, in severely calcified and stenotic iliofemoral arteries, the eSheath may not be able to expand adequately during the transcatheter heart valve advancement to allow a smooth passage.•Excessive push force may be necessary to engage the dynamic expansion mechanism to advance the transcatheter heart valve but may risk damaging the transcatheter heart valve as shown during our initial case. Worse yet, the transcatheter heart valve may get stuck, and major vascular complication may occur from removing the Edwards Commander Delivery System and expanded eSheath together.•As demonstrated in our case series, predilatation to expand the eSheath is safe with no downside but can ensure smooth passage of the balloon-expandable transcatheter heart valve to avoid potential major vascular complication. Transfemoral transcatheter aortic valve replacement (TF-TAVR) is now indicated in patients with symptomatic severe aortic stenosis irrespective of surgical risk. Given the introducer sheath size plays a significant role in vascular complications, advances have been made to decrease the sheath caliber, with the current generation Edwards SAPIEN 3 Ultra (S3U) transcatheter heart valves (THVs) accommodated through a 14-French (Fr) expandable eSheath and the 29-mm SAPIEN 3 (S3) THV accommodated through a 16-Fr eSheath.1Barbanti M. Binder R.K. Freeman M. et al.Impact of low-profile sheaths on vascular complications during transfemoral transcatheter aortic valve replacement.EuroIntervention. 2013; 9: 929-935Crossref PubMed Scopus (74) Google Scholar To facilitate TF-TAVR in patients with severely calcified peripheral artery disease (PAD), several strategies have been developed, including surgical femoral artery cutdown and/or intravascular lithotripsy (IVL).2Di Mario C. Goodwin M. Ristalli F. et al.A Prospective Registry of intravascular lithotripsy-enabled vascular access for transfemoral transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2019; 12: 502-504Crossref PubMed Scopus (41) Google Scholar,3Burri M. Ruge H. Erlebach M. Lange R. Surgical cutdown avoids vascular complications in transcatheter aortic valve replacement in calcified and Small femoral arteries.Thorac Cardiovasc Surg. 2021; https://doi.org/10.1055/s-0041-1725202Crossref PubMed Scopus (1) Google Scholar However, the eSheath still needs to expand inside the calcified and stenotic iliofemoral vasculature to accommodate the passage of the crimped balloon-expandable THV on the Edwards Commander Delivery System (ECDS). Because the crimped diameter increases with a larger-sized balloon-expandable THV, the push force to expand the eSheath would be higher with the larger THV than the smaller THV. One of the potentially catastrophic consequences of advancing the balloon-expandable THV through the eSheath in calcified PAD is the THV system getting stuck inside the sheath, risking having to remove the eSheath, THV, and delivery system in toto, causing potential major vascular complication. We present our experience of preemptive balloon angioplasty of the eSheath to facilitate successful passage of the THV in patients with severe iliofemoral PAD. The current strategy was prompted by an 86-year-old man with severe calcified PAD who underwent TF-TAVR with a 26-mm ​S3U THV via left surgical femoral cutdown and smooth insertion of the 14-Fr eSheath. However, there was difficulty advancing the valve, and it appeared to be stuck within the eSheath with a portion of the valve extruding from the sidewall of the sheath at the external iliac artery (Fig. 1A). After removal of the ECDS and the eSheath, the left external iliac artery was found avulsed which required emergency endovascular intervention (Fig. 1B). We believe that the calcified iliofemoral vasculature prevented adequate expansion of the eSheath to allow the advancement of the S3U THV. In 10 subsequent cases with similarly difficult iliofemoral access, we performed surgical femoral cutdown with or without IVL, followed by balloon angioplasty to preemptively expand the eSheath to facilitate advancement of the THV to avoid being stuck in the eSheath (Fig. 1). In 6 of 10 cases, IVL was performed before the eSheath insertion. All 10 cases had severe bilateral calcific PAD and were deemed not suitable for TAVR with a self-expanding THV or using alternate access by our heart team, which includes an experienced endovascular surgeon. Case summaries are shown in Figure 1. Cases 4 and 5 had prior endovascular intervention on the same side as eSheath insertion. Our study received institutional review board approval, and patient consent was waived. The outer diameters of the eSheath are approximately 1.2 ​mm larger and increase by another 1.7 ​mm during the valve delivery with greater enlargement observed at the pusher site during implantation.4Koehler T. Buege M. Schleiting H. Seyfarth M. Tiroch K. Vorpahl M. Changes of the eSheath outer Dimensions used for transfemoral transcatheter aortic valve replacement.Biomed Res Int. 2015; 2015: 572681Crossref PubMed Scopus (17) Google Scholar Although the dynamic expansion mechanism allows transient enlargement of the ECDS, in severely calcified and stenotic iliofemoral arteries, the eSheath may not be able to expand adequately during the THV ECDS advancement to allow a smooth passage. Excessive push force may be necessary to engage the dynamic expansion mechanism to advance the THV but may risk damaging the THV as shown during our initial case. Worse yet, the THV may get stuck, and major vascular complication may occur. As demonstrated in our case series, predilation to expand the eSheath is safe with no downside but can ensure smooth passage of the THV. We chose an 8-mm balloon for the 23-mm and 26-mm S3U THV and 9 ​mm for the 26-mm S3 THV, equivalent to their crimped diameter. In fact, Edwards Lifesciences is currently developing an improved version of its eSheath to allow predilation of the sheath with larger dilators, to make advancing the THV through the sheath easier (personal communication). To the best of our knowledge, this was the first described report of the balloon angioplasty technique to facilitate TF-TAVR with the balloon-expandable THV in severely calcified iliofemoral vasculature. Dr. Khera is a physician proctor and consultant for Medtronic. He is a consultant for Abbott and Boston Scientific and Terumo. Dr. Sharma receives honoraria for the Speaker’s Bureau from Abbott Vascular, Boston Scientific, and Cardiovascular Systems Inc. Dr. Tang is a physician proctor for Medtronic, a consultant for Medtronic, Abbott Structural Heart, and Neochord, and a physician advisory board member for Abbott and JenaValve. The remaining authors have nothing relevant to disclose. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.