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TAVI in Patients With High-Risk Symptomatic Native AR
Quick Takes
- TAVI using a dedicated transfemoral system in patients with symptomatic severe aortic regurgitation (AR) at high risk for surgical mortality was associated with a promising safety profile as well as low morbidity and mortality at 1-year follow-up.
- Anatomical challenges of a commercially available transcatheter heart valve may be largely overcome with a dedicated device with design features that enhance positioning and anchoring in patients with native AR.
- Additional studies are indicated to reduce rates of permanent pacemakers and to assess the outcomes and the role of this therapeutic option in a broader population of patients and with longer-term follow-up.
Study Questions:
What are the outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation (AR) using the Trilogy transcatheter heart valve?
Methods:
The investigators conducted the ALIGN-AR trial, a prospective, multicenter, single-arm study. They recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe AR at high risk for mortality and complications after surgical aortic valve replacement (SAVR) at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for noninferiority with a prespecified performance goal of 40.5%. The primary efficacy endpoint was 1-year all-cause mortality compared for noninferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing.
Results:
Between June 8, 2018, and August 29, 2022, the investigators screened 346 patients. They excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic AR deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75.5 years (standard deviation 10.8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) nondisabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97.5% confidence interval, 19.2-34.0]) patients (p for noninferiority < 0.0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7.8% [3.3-12.3]) patients at 1 year (p for noninferiority < 0.0001).
Conclusions:
The authors report that this study shows the safety and effectiveness of treating native AR using a dedicated transcatheter heart valve for patients with symptomatic moderate-to-severe or severe AR who are at high risk with SAVR.
Perspective:
This study reports that TAVI using a dedicated transfemoral system in patients with symptomatic severe AR at high risk for surgical mortality and complications was associated with a high technical success rate and promising safety profile as well as low morbidity and mortality at 1-year follow-up. While TAVI is a well-established treatment option for patients with aortic stenosis, the use of available transcatheter heart valve devices in patients with AR is difficult, related to challenges with valve anchoring in the native aortic annulus and paravalvular regurgitation. This study suggests that these anatomical challenges may be largely overcome with a dedicated device with design features that enhance positioning and anchoring in patients with native AR. Additional studies are indicated to reduce rates of permanent pacemakers and to assess the outcomes and the role of this therapeutic option in a broader population of patients and with longer-term follow-up.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve Insufficiency, Transcatheter Aortic Valve Replacement
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