One year efficacy and safety outcomes of the dry pericardium aortic valve system: A first in human feasibility study

Published in Congress: EuroPCR 2024

Link: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2312573

Dr. Özkan Karaca

 Introduction:
In transcatheter aortic valve implantation (TAVI), the process of compressing the TAVI device to reduce the profile of the valve and facilitate delivery to the aortic valve through a catheter; it is complicated by requiring specialized tools, specialized skills, more staff, and extra time, increasing the cost and risk of the procedure. There is no fully pre-assembled dry pericardium TAVI aortic valve system on the market yet. The dry pericardium Vienna aortic valve already installed in the delivery system eliminates the need to compress the valve during TAVI procedures. The introduction of these devices can make this procedure much simpler and reduce human errors. More importantly, it is ready for immediate use in hospitals, making it easy to apply in both routine and emergency scenarios.

Objective:
The VIVA study focused on the safety, feasibility, clinical and hemodynamic performance of the Vienna system up to 1-year follow-up.

Methods:
This is the first prospective, nonrandomized, single-arm, single-center, feasibility study in symptomatic patients with severe aortic stenosis. The study consisted of seven visits spread over 1 year. The study evaluated 10 patients with severe symptomatic aortic stenosis who were at moderate or high surgical risk and underwent Vienna aortic valve implantation. Valve Academic Research Consortium 3-defined safety outcomes were evaluated up to 1-year follow-up. The main outcomes included all-cause mortality, neurological events, overt bleeding, cardiac structural complications, valve-related complications, conduction disturbances, myocardial infarction, acute kidney injury, and structural valve disruption. Technical success (at exit from the procedure room), device success (at 30 days), early safety (at 30 days), and clinical efficacy (at 1 year) were also evaluated. Hemodynamic outcomes were evaluated for up to one year.

Results:
The average patient age was 79 ± 5 years and 60% were male. Cover sizes used: 26 mm (10%), 29 mm (30%), 31 mm (60%). Baseline hemodynamic improvements were significant; the mean aortic valve pressure gradient (mmHg) decreased from 48.7 to 8.1, the aortic valve area (cm2) increased from 0.75 to 1.91, and the maximum jet speed through the aortic valve (m/s) was 4. It decreased from .41 to 1.95 (p < 0.0001). Moderate/severe paravalvular leak was not observed and computed tomography (CT) scans revealed no evidence of hypoattenuated leaflet thickening. CT scans performed at 3 months post-TAVI revealed a significant decrease in aortic annulus eccentricity at the valve inlet from 22.3±7.3% to 10.4±6.5% compared to pre-implantation (p=0.04). One life-threatening bleeding event, two cases requiring post-procedure pacemaker implantation, and three ischemic events were recorded in the study; only one of these caused permanent neurological impairment. Importantly, there were no cardiovascular deaths and only one non-device-related non-cardiovascular death was identified and confirmed to be unrelated to the device. Improvements in quality of life and functional status were observed but were not statistically significant.

Conclusions:
This study; the established efficacy and safety indicators of the Vienna aortic valve, coupled with the absence of cardiovascular mortality for up to 1 year, have demonstrated that it can be used safely in patients with symptomatic severe aortic stenosis.

Comment:
The dry pericardium Vienna aortic valve was designed to simplify the procedure and potentially reduce healthcare costs by reducing resource and equipment needs, as well as procedural errors. The 1-year hemodynamic results and endpoints of the study showed that this procedure is safe for use in patients with severe aortic stenosis at moderate to severe surgical risk. These initial findings suggest that the pre-mounted dry pericardial Vienna aortic valve is a viable option for further investigation in ongoing long-term multicenter clinical trials.