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Transfemoral TAVR with repositionable valve successful at 30 days
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In patients with severe aortic stenosis, transfemoral transcatheter aortic valve replacement with a repositionable valve appears to yield a high rate of device success, no moderate or severe residual aortic regurgitation, and low 30-day rates of major vascular complications, death and stroke, according to recent findings.
In the prospective study, researchers evaluated 110 patients (mean age, 81 years; 51% women) who underwent TAVR with the 23 mm (n = 20), 25 mm (n = 43) or 27 mm (n = 47) repositionable valve system (Lotus, Boston Scientific). The valve system is not yet approved for use in the United States.
Patients had multiple comorbid conditions, including porcelain aorta, pulmonary disease or decreased left ventricular function. The patients had a mean American Society of Anesthesiologists score for perioperative risk of 3.6. The mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 6.5%, and the risk as predicted by logistic EuroSCORE estimates was 15.5. The mean EuroSCORE II was 7%, with 74.5% patients defined as intermediate risk for surgery.
Procedures were done without general anesthesia using a transfemoral access route. Follow-up was 30 days.
The study’s primary outcome was device success, defined as the absence of procedural death and correct positioning of a single valve into the proper anatomical position and intended performance of the valve. Secondary outcomes were 30-day all-cause mortality, disabling and nondisabling stroke, life-threatening bleeding, major vascular injury and new pacemaker implantation resulting from second-degree or third-degree atrioventricular block.
The researchers found no residual moderate or severe aortic regurgitation in the patient cohort, and a low rate of mild aortic regurgitation (9.1%). No patients experienced valve embolization, required a second valve or required conversion to surgery.
There was no difference in residual aortic mean gradient by echocardiography between groups (overall mean, 12.1 mm Hg).
A high rate of device success was observed (95.5%), and no difference was seen among groups. All of the 4.5% of patients with vascular complications had them because of closure device failure plus a decrease in hemoglobin levels of more than 3 g/dL, according to the researchers.
Slightly elevated mean aortic gradients greater than 20 mm Hg were seen in all patients without device success (22 mm Hg, n = 2; 23 mm Hg, n = 2; 32 mm Hg, n = 1). Among patients with device failure, no difference was seen in oversizing relative to annulus or LV outflow tract, LV ejection fraction, eccentricity index or presence of LV outflow tract classification vs. patients who achieved device success.
A total of 24.1% of patients, not including patients with previously implanted pacemakers, required implantation of a new pacemaker due to a third-degree or type II second-degree atrioventricular block. Depth of implantation did not differ between patients with and without the need for a permanent pacemaker.
The 30-day rate of all-cause mortality was low at 0.9%, as were the rates of disabling (2.7%) and nondisabling stroke (0.9%), with no significant difference between valve sizes.
“Transfemoral aortic valve implantation with the repositionable Lotus valve is associated with a high rate of device success,” the researchers wrote. “With the use of the Lotus valve there is a low risk of moderate or severe residual aortic regurgitation due to the option to reposition and even retrieve the valve. In addition, there was no need for a second valve and no conversion to surgery.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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