800.05 Effect of J-Valve on Left Ventricular (LV) Ejection Fraction (EF) and LV Geometry: A Multi-Center Compassionate Use Study in Patients With Aortic Regurgitation
Recommended Citation
Bashir H, Garcia S, Palmer C, Schmidt C, Yildiz M, Reardon M, Frisoli TM, Fam N, Chung E, Kereiakes DJ. 800.05 Effect of J-Valve on Left Ventricular (LV) Ejection Fraction (EF) and LV Geometry: A Multi-Center Compassionate Use Study in Patients With Aortic Regurgitation. JACC Cardiovasc Interv 2024; 17(4):S66.
Document Type
Conference Proceeding
Publication Date
2-1-2024
Publication Title
JACC Cardiovasc Interv
Abstract
Introduction: Severe aortic regurgitation (AR) is the indication for 20-30% of surgical aortic valve replacements and is associated with increased morbidity and mortality. No transcatheter device has received U.S. approval for the treatment of AR. J-valve is a short frame, self-expanding TAVR device specifically designed for treatment of severe AR. Methods: From 2019 through 2023 patients with symptomatic severe AR who were not surgical candidates or excluded from the ALIGN-AR trial were treated as part of the compassionate use program at five North American centers (The Christ Hospital, Henry Ford Hospital, Houston Methodist, St. Michael’s Hospital). We report the echocardiographic changes in LVEF and LV geometry of 23 patients treated in the early experience with this novel device. LV geometry was categorized as normal (normal RWT (relative wall thickness), normal LV mass (LVM), CH (increased RWT, increased LVM), EH (normal RWT, increased LVM), or CR (increased RWT, normal LVM). Results: A total of 23 patients (mean age 73.9 ± 16.6 years; 61% male) with symptomatic AR (96% NYHA class III/IV, all with grade 3 or 4 AR) and paired echocardiograms were included. The mean pre-procedural LVEF was 46.3% ± 15.4. Post-procedural AR was none/trivial in all patients, and 22/23 survived to 30 days. Follow-up echocardiograms at 30 days revealed improvement of mean LVEF 47.2 ± 14.1 (p-value 0.24); 1 year echo revealed LVEF 51.9% ± 10.9 (p-value 0.033). LV geometry preprocedural was characterized as 36% CH; 50% EC; and 14% normal. 1 month follow-up, 25% CH; 10% CR; 25% EH; and 40% normal. 1 year follow-up 7% CH; 27% CR; 33% ER; and 33% normal. (Figure 1) Conclusion: Following J-valve placement for symptomatic, severe AR, left ventricular (LV) geometry and ejection fraction often revert toward normal and away from concentric hypertrophy in a large proportion of patients. [Formula presented]
Volume
17
Issue
4
First Page
S66
