Safe and effective treatment of aortic regurgitation in LVAD patients using a dedicated self-expanding TAVI device

Background
Aortic regurgitation (AR) can occur in up to 30% of patients with left ventricular assist device (LVAD) within the first year after implantation and significantly affect their outcome. Due to comorbidities and mortality risks, surgery is often not a suitable treatment option. Transcatheter aortic valve implantation (TAVI) is the standard treatment for Aortic stenosis but faces its difficulties in treatment of AR.

Objectives
This retrospective study intends to describe the clinical outcome of treatment with the Trilogy JenaValve (JV) system in LVAD-patients suffering from AR.

Methods
This multicenter registry study includes 17 LVAD patients from Germany and the USA who were diagnosed with relevant symptomatic AR but considered unsuitable for surgery. As the chosen treatment, transcatheter aortic valve replacement was performed using the Trilogy JenaValve. Patient characteristics, perioperative complications, device success at 30 days, as well as reinterventions and 1 year mortality were analyzed.

Results
The mean age was 65.1 ± 12.4 years, 47.1% (8) were female. 94.1% of patients were in NYHA class III-IV, while the estimated risk of mortality by the European System for Cardiac Operative Risk Evaluation II was 16.4 ± 12.4. The mean time of LVAD support was 4.3 ± 2.6 years. Two patients suffered from a minor vascular complication; one patient had a major vascular complication. Two patients suffered from a transient ischemic attack. There was no conversion to open heart surgery or any case of valve embolization. Only one patient needed a second valve due to paravalvular leckage, and one patient died in the hospital. At 30 days, vital status was known for 100% and device success was 86.7%. No patient needed a valve-related reintervention during follow-up.

Conclusions
The Trilogy TAVI system in LVAD patients with AR offers a safe and effective treatment for patients not suitable for surgery. Our results are comparable to the outcomes of non LVAD patients treated with the JV.