Early-generation TAVR valve shows durable results in high-risk patients at 5 years
Click Here to Manage Email Alerts
Key takeaways:
- An intra-annular self-expanding transcatheter heart valve showed durable results at 5 years.
- The data suggest that a newer-generation valve might also achieve favorable clinical and hemodynamic outcomes.
Pooled 5-year data of an intra-annular self-expanding transcatheter heart valve in patients with severe aortic stenosis at high surgical risk showed good indicators of durability, researchers reported.
Rishi Puri, MD, PhD, FRACP, staff cardiologist for coronary and structural interventions and medical director of the IVUS/Angiography Core Laboratory at Cleveland Clinic, presented 5-year pooled results from the PORTICO IDE, PORTICO I and PORTICO CAP trials of the TAVR system (Portico, Abbott) at Cardiovascular Research Technologies. The valve was approved by the FDA in 2021 but has since been replaced by the next-generation Navitor valve (Abbott), which was approved by the FDA in 2023.
For the present analysis, “We were focused on deepening our understanding of how an early-generation, self-expanding, intra-annular, transcatheter aortic valve platform performed from a durability and hemodynamic perspective in the midterm (5-years) and how it stands up to other devices in the space,” Puri told Healio.
The analysis included 1,464 patients with severe symptomatic aortic stenosis at high or extreme surgical risk (mean age, 82 years; 59% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 5.9%).
Puri and colleagues found the rates of clinical outcomes were as follows:
- all-cause mortality: 13.2% at 1 year, 28.8% at 3 years and 47.5% at 5 years;
- CV mortality: 7.3% at 1 year, 15.1% at 3 years and 26.8% at 5 years; and
- stroke: 3.3% at 30 days, 7.1% at 2 years and 12.6% at 5 years.
Mean gradient declined from 49.4 mm Hg at baseline to 6.94 mm Hg at 5 years, whereas effective orifice area increased from 0.73 cm2 at baseline to 1.83 cm2 at 5 years, Puri said during the presentation.
At 5 years, 68.8% of patients had no or trace paravalvular leak, whereas 29.2% had mild paravalvular leak and 2% had moderate paravalvular leak, he said.
Among the 454 patients who had NYHA HF classification data at 5 years, 37.4% were class I, 48% were class II, 13.4% were class III and 1.1% were class IV at 5 years, he said, noting that only 3.5% were class I at baseline.
Severe patient-prosthesis mismatch at 30 days occurred in 5.6% of all patients and in 4.7% of those with small annuli, Puri said, noting that nearly three-quarters of patients in both cohorts had no mismatch or an insignificant one.
At 5 years, no patients had severe hemodynamic structural valve deterioration and 0.62% had moderate hemodynamic structural valve deterioration, whereas 3% had bioprosthetic valve failure, 1.2% had valve-related death and 1.8% had valve reintervention, Puri said, noting that the rates were slightly higher but still very low in those with small annuli compared with those with large annuli.
“These data points, among others, provide reassurance that the design features of the latest generation of Abbott’s Navitor will provide similar, if not superior data in younger, lower-risk individuals,” Puri told Healio. “These data provide reassurance and anticipation on what a transcatheter aortic valve may look like at 10 years — which still is the holy grail of the TAVR field. The really interesting finding is that the hemodynamic data were consistent across all valve sizes. This speaks to Abbott’s leaflet engineering designs and how we are starting to dispel the notion that only supra-annular transcatheter aortic valve designs are capable of achieving optimal hemodynamics.”
Collapse
Puri R, et al. Late-breaking trials | Structural/LAA. Presented at: Cardiovascular Research Technologies; March 9-12, 2024; Washington, D.C.
Click Here to Manage Email Alerts