2021 Scientific Sessions

Single Center Experience with the LOTUS Edge Transcatheter Heart Valve

Presenter

Dr. Giorgio A. Medranda, MD, FSCAI, NYU Langone Hospital—Long Island, Glen Cove, NY
Dr. Giorgio A. Medranda, MD, FSCAI1, Cheng Zhang, PhD2, Brian C Case, MD, FSCAI3, Charan Yerasi, M.D.4, Brian Forrestal, MBBS5, Chava Chezar-Azzerad, MD3, Toby Rogers, MD5, Itsik Ben-Dor, MD5, Lowell F. Satler, M.D., FSCAI6 and Ron Waksman, M.D.5, (1)NYU Langone Hospital—Long Island, Glen Cove, NY, (2)MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC, (3)MedStar Washington Hospital Center, Brooklyn, NY, (4)MedStar Washington Hospital Center, Elkridge, MD, (5)MedStar Washington Hospital Center, Washington, DC, (6)MedStar Washington Hospital Center, Bethesda, MD

Keywords: Embolic Protection, Structural Heart Disease (SHD) and TAVI/TAVR/Aortic Valve

Background

The LOTUS Edge transcatheter heart valve (THV) offered a number of attractive features for patients with significant left ventricular outflow tract area (LVOT) calcium but was recently retired because of recurrent issues with its delivery system. Nonetheless, we still believe it is valuable to report the results of our experience with the LOTUS Edge THV across the full spectrum of surgical risk, including some with bicuspid aortic stenosis.

Methods

We report in-hospital outcomes of patients from our institution who underwent transcatheter aortic valve replacement (TAVR) using the LOTUS Edge THV.

Results

Of the 59 patients who underwent TAVR using the LOTUS Edge THV, 18 were high-risk (most of whom had moderate or severe LVOT calcium), 36 were intermediate-risk (one of whom had a bicuspid valve) and 5 were low-risk bicuspid patients enrolled in the LRT trial. Although we saw a high success rate in THV implantation, conduction disturbances were common, with similarly high rates of new permanent pacemaker (PPM) implantation across all risk groups (Table 1). Overall, stroke occurred in 11.9% of patients, and in 3/5 low-risk bicuspid patients, but overall occurring less frequently in patients with cerebral embolic protection using cerebral embolic protection.

Conclusions

Despite representing a niche for the LOTUS Edge, high rates of stroke and the need for PPM should give us pause when considering treatment options for patients with significant LVOT calcium.