Safety and Feasibility of Transcaval Aortic Valve Replacement with the LOTUS Edge System

ABSTRACT

Background

To establish the safety of transcaval TAVR with the LOTUS Edge system.

Methods

A single center prospective observational study was performed over the course of eight months. Median follow up period was 45 days.

Results

Ten patients underwent transcaval TAVR with the LOTUS Edge system with 100% procedural success. No patients suffered access-related complications or significant bleeding with either the expandable or static sheaths. One patient died due to periprocedural subarachnoid hemorrhage.

Conclusions

Our data suggest transcaval TAVR with the LOTUS Edge delivery system is safe and feasible in patients otherwise unsuitable for transfemoral access.

Abbreviations: TAVR: Transcatheter aortic valve replacement; TTE: Transthoracic echocardiogram; LVEF: Left ventricular ejection fraction; CT: Computed tomography; IVC: Inferior vena cava; VARC-2: Valve Academic Research Consortium-2

KEYWORDS:

• Transcatheter aortic valve replacement
• transcaval
• alternative access
• aortic stenosis
• LOTUS

Disclosure statement

Dr. Lee is a consultant for HeartFlow. Dr. Frisoli is a clinical proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr. Eng is a proctor for Edwards LifeSciences, Boston Scientific and Medtronic. Dr. Wang is a consultant for Edwards LifeSciences, Boston Scientific, Materialise, and HighLife Medical. Dr. O’Neill is a consultant to Abiomed, Medtronic, and Boston Scientific.

Consent

Patient consent for publication of the clinical vignette was obtained by the authors.

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website.

Additional information

Funding

The authors report no funding in support of this paper.