There are controversies regarding transcatheter aortic valve implantation (TAVI) in cases of challenging anatomical complexity, such as horizontal aorta (HA). This is primarily because aortic angulation (AA) impacts the procedure differently depending on the valve type used. As previously studied, angulation complicates crossing, implantation, and coaxial positioning with commissural alignment.
In the study presented by Eckel C. et al., the clinical outcomes of self-expanding ACURATE Neo2 valve and balloon-expandable Edwards SAPIEN Ultra valve were compared using propensity score matching. The study retrospectively included consecutive patients treated with transfemoral TAVI from January 2017 to January 2023 using Ultra and Neo2 systems at two high-volume centers in Germany.
AA was measured as the angle between the virtual basal ring of the aortic annulus and the horizontal plane. Horizontal AA was defined as an angle greater than 48°, and severe AA was defined as an angle that exceeded 51.7° (measured by 3Mensio on the coplanar plane).
The primary endpoint (PEP) was in-hospital mortality, need for bailout maneuvers during the procedure, and technical success. Secondary endpoints included 30-day mortality, 30-day stroke, 30-day device success, and procedural complications.
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The final cohort comprised 492 patients (Neo2 n = 246; S3 Ultra n = 246), with an average age of 81.9 years; 43.9% of subjects were women. The Neo2 group had a higher rate of predilation (18.0% vs. 93.9%, p < 0.001) and postdilation (6.5% vs. 33.7%, p < 0.001), with high technical success in both cases (93.1%). When evaluating device success, Ultra valves (80.5% vs. 88.6%, p = 0.018) had a significantly lower performance rate, mainly due to a higher incidence of elevated gradients (≥20 mmHg; 11.9% vs. 1.6%, p < 0.001). Device migration and embolization rates (0.4% vs. 2.0%, p = 0.216), as well as bailout maneuvers (0.8% vs. 0.4%, p = 1.000), were comparable between devices.
There were no statistical differences regarding all-cause mortality (1.3% vs. 2.7%, p = 0.330). However, an analysis of hemodynamic variables related to long-term valve performance showed hemodynamic superiority favoring Neo2, with a lower incidence of patient-prosthesis mismatch (PPM) (12.0% vs. 3.3%, p = 0.001) and lower gradients.
Regarding paravalvular leak (PVL), balloon-expandable valves showed a lower incidence of at least moderate PVL (0.0% vs. 3.3%, p = 0.007).
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When stratifying angulation as mild (20-43°), moderate (43-50.3°), severe (50.4-56.1°), or extreme (56.2-87°), implant depth was shallower in severe and extreme angulations (5.0 mm vs. 5.0 mm vs. 4.0 mm vs. 4.0 mm, p = 0.031), with higher numerical PVL (1.6% vs. 0.7% vs. 3.1% vs. 1.5%, p = 0.070).
Conclusions
Successful valve implantation in horizontal aorta with TAVI was achievable; the rate of technical success was high. In this series, the Neo2 device showed a lower incidence of post-procedural gradients. The Neo2 short stent-frame and stabilizing arches may allow for greater coaxiality and stability, justifying this hemodynamic advantage.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Outcomes of transfemoral TAVR using two new‐generation devices in patients with horizontal aorta.
Reference: Eckel C, Kim WK, Wasif B, Grothusen C, Elsässer A, Dohmen G, Charitos EI, Sossalla S, Möllmann H, Blumenstein J. Outcomes of transfemoral TAVR using two new-generation devices in patients with horizontal aorta. Catheter Cardiovasc Interv. 2024 Jun 11. doi: 10.1002/ccd.31094. Epub ahead of print. PMID: 38860614.
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