medwireNews: Using a transcatheter heart valve especially designed for patients with pure aortic regurgitation shows promising clinical outcomes with low complication rates following transfemoral transcatheter aortic valve implantation (TAVI), US researchers report.
Writing in The Lancet, Torsten Vahl (Columbia University Irving Medical Center, New York) and co-authors explain that although transfemoral TAVI is an established treatment for patients with aortic stenosis, commercially available transcatheter heart valve devices are difficult to use in patients with aortic regurgitation. They say this is due to “challenges with valve anchoring in the native aortic annulus and paravalvular regurgitation” as well as “unacceptable rates of embolization.”
However, the current ALIGN-AR study “showed that these anatomical challenges can be largely overcome with a dedicated device with design features that enhance positioning and anchoring in patients with native aortic regurgitation,” they remark.
The prospective trial included 180 patients (mean age 76 years, 53% men) with symptomatic, moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement who were treated with the Trilogy transcatheter heart valve (JenaValve Technology, Irvine, California, USA). The device is purposely designed to address the challenges of TAVI for aortic regurgitation. Most (68%) patients had New York Heart Association (NYHA) functional class III or IV disease and 16% had a pre-existing pacemaker.
Vahl and team report that the procedure was technically successful in 95% of patients, in that the valve was implanted in the appropriate position via transfemoral access without access site intervention, which they say “compares favourably with off-label TAVI for pure aortic regurgitation.”
At day 30, the primary composite safety endpoint of the study had occurred in 26.7% of patients. This consisted of all-cause mortality, any stroke, life-threatening or major bleeding, acute kidney injury stage 2–3 or dialysis (7-day endpoint), major vascular complications, surgery or intervention related to the device (including coronary intervention), new permanent pacemaker implantation, and moderate or severe total aortic regurgitation. The researchers note that the rate of 26.7% achieved noninferiority relative to a prespecified safety performance goal of 40.5%.
Among the individual outcomes, there were four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes within the 180 trial participants, and 36 (24%) of 150 patients without a prior pacemaker received a new pacemaker within 30 days.
Noninferiority was also achieved for the primary efficacy endpoint of 1-year all-cause mortality, which occurred at a rate of 7.8%, and fell within the prespecified performance goal of 25.0%.
In addition, the investigators say they “observed substantial improvements in left-ventricular remodelling and functional status.”
Specifically, paravalvular regurgitation at 1 year was none or trace in 92% of patients, while mean left ventricular mass declined from 323.7 g at baseline to 219.5 g at 1 year, and mean left ventricular end-systolic dimension decreased from 39.6 cm to 34.2 cm during the same period. In addition, NYHA functional class improved by at least one category in 83% of participants, and at 1 year 50% of participants were class I.
Vahl et al conclude: “This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement.”
They add: “The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary.”
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