Funnel-Shaped Expansion of Balloon-Expandable Transcatheter Aortic Valve Caused by Separated Tip of Expandable Sheath

Abstract

An 86-year-old woman with a history of hypertension, atrial fibrillation, and lacunar cerebral infarction underwent transcatheter aortic valve implantation for symptomatic severe aortic stenosis using a 23-mm SAPIEN 3 Ultra RESILIA valve (Edwards Lifesciences). As the prosthetic valve traversed a 14-F Edwards eSheath+, it sheared off the distal tip of the sheath, which became affixed to the valve. The adherent tip remained attached throughout balloon expansion and deployment, thereby impeding full expansion and producing an atypical funnel-shaped configuration. With continued balloon inflation and sustained pressure, complete expansion was achieved, and the prosthetic valve was deployed without incident.

Take-Home Message

If the SAPIEN 3 Ultra RESILIA traverses the eSheath+ into the aorta with marked resistance, promptly confirm that the sheath's distal tip component has not remained affixed to the distal end of the prosthesis.

Graphical Abstract

Case Summary

An 86-year-old woman with hypertension, atrial fibrillation, and prior lacunar cerebral infarction presented to her primary care physician with exertional dyspnea. She was diagnosed with heart failure and referred to our institution for further evaluation and management. Transthoracic echocardiography demonstrated that aortic valve area was 0.89 cm², peak velocity was 3.8 m/s, and mean aortic gradient was 40.5 mm Hg, confirming severe aortic stenosis. With symptomatic severe aortic stenosis, we elected to proceed with transcatheter aortic valve implantation. Because preprocedural cardiac computed tomography showed an annulus area of 358.9 mm², a 23-mm SAPIEN 3 Ultra RESILIA valve (Edwards Lifesciences) was selected. Although protruding calcification was observed in the abdominal aorta, bilateral iliofemoral arteries had sufficient diameters without tortuosity; therefore, a transfemoral approach was selected (Figure 1A). A 14-F Edwards eSheath+ introducer was advanced via the right femoral artery to the abdominal aorta without significant resistance. The operator noted a marked increase in resistance at the sheath exit despite the smooth passage of the valve through the expandable portion of the sheath (Figure 1B). Applying stronger forward pressure allowed the valve to successfully advance into the aorta (Figure 1C, Video 1), and subsequently the valve was mounted onto the balloon in normal fashion (Figure 1D, Video 2). Although the valve was positioned at the annulus (Figure 1E), on initiation of expansion, it exhibited an unusual funnel-shaped configuration (Figures 1F and 1G). Ultimately, complete expansion of the bottom of the valve was achieved with continued balloon inflation (Figures 1H and 1I, Video 3). Careful review of the fluoroscopic images revealed that the distal struts of the crimped valve were persistently encircled by the separated tip of the eSheath+, from when the valve passed though the eSheath+. Examination of the retrieved eSheath+ also confirmed the absence of the tip (Figures 1J and 1K). Based on these findings, we concluded that as the prosthetic valve traversed the eSheath+, it sheared off the distal tip of the sheath, which remained affixed to the valve from balloon expansion through deployment and produced the atypical funnel-shaped expansion. After the procedure, there were no embolic events, valve function was good (mean gradient 8.2 mm Hg with trivial paravalvular leakage), and the patient was discharged on day 4. To our knowledge, this report is the first to show a funnel-shaped SAPIEN 3 Ultra RESILIA expansion caused by a separated eSheath+ tip.

Figure 1.

Separated Sheath Tip Causing Funnel-Shaped Expansion of SAPIEN 3 Ultra RESILIA

(A) Anatomical assessment of the bilateral iliofemoral arteries. (B) Marked resistance was noted at the sheath tip. (C) The separated sheath tip was attached to the distal struts of the valve. (D) The separated tip remained stationary during valve-balloon alignment. (E) The separated tip was brought into the left ventricle. (F) Initiation of valve implantation. (G) The valve, whose distal struts were encircled by the separated sheath tip, was expanded in a funnel-shaped configuration. (H) The tip was eventually fractured, resulting in delayed expansion of the distal frame. (I) The tip migrated into the left ventricle and disappeared immediately. (J) No sheath tip was found on the retrieved eSheath+. (K) Comparison between the retrieved eSheath+ (red arrow) and a new one (white arrow).

In this case, we performed transcatheter aortic valve implantation via the transfemoral access because the iliofemoral arteries were straight and large enough for big sheath insertion. However, given that the sheath compression owing to protruding calcification in the abdominal aorta may be a potential cause of the sheath tip fracture, an alternative access via the subclavian or carotid artery would have been helpful to avoid this event.¹

Funding Support and Author Disclosures

Dr Ishizu has been the proctor of intracardiac echocardiography-guided transcatheter aortic valve implantation for Johnson & Johnson. Dr Shirai has been the proctor of transfemoral transcatheter aortic valve implantation for Edwards Lifesciences, Medtronic, and Abbott Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Take-Home Message

• •If the SAPIEN 3 Ultra RESILIA traverses the eSheath+ into the aorta with marked resistance, promptly confirm that the sheath's distal tip component has not remained affixed to the prosthesis's distal end.

Appendix

Video 1

Sudden Valve Jump on eSheath+ Exit

The prosthetic valve forcefully protruded from the sheath.

Video 2

Balloon Alignment of the Prosthetic Valve

Uneventful balloon alignment.

Video 3

Prosthetic Valve Expanded in a Funnel-Shaped Configuration

Unusual funnel-shaped expansion of the valve.