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TAVR may benefit patients with bioprosthetic surgical aortic valve failure
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Valve-in-valve transcatheter aortic valve replacement is associated with low mortality and major complication rates and improved outcomes in high-risk patients with degenerated aortic valve bioprostheses, according to registry data from PARTNER 2.
The PARTNER 2 trial included a nested registry of patients with failed bioprosthetic surgical aortic valves who were at high risk for reoperative surgery. After enrollment of 100 patients, additional patients were enrolled in a continued access registry.
A total of 365 patients — 96 in the initial registry and 269 in the continued access registry — underwent valve-in-valve procedures. The mean age of the patients was 79 years, and mean Society of Thoracic Surgeons score was 9.1%.
At 30 days, the all-cause mortality rate was 2.7%, cardiac death rate was 2.5%, stroke rate was 2.7% and disabling stroke rate was 2.2%, the researchers reported. Additionally, at 30 days, 5.9% of patients were rehospitalized, 14.6% experienced major bleeding and 4.1% experienced major vascular complications. Conversion to surgery occurred in 0.6%, coronary occlusion occurred in 0.8% and new pacemakers were inserted in 1.9%.
At 1 year, the rates of all-cause mortality and cardiac mortality were 12.4% and 9%, respectively. The rate of stroke was 4.5%, rehospitalization was 15.9% and pacemaker insertion was 2.6%.
From the initial registry to the continued access registry, mortality decreased at 30 days (8.2% vs. 0.7%; P = .0001) and 1 year (19.8% vs. 9.8%; P = .006).
Echocardiographic follow-up at 1 year showed that mean gradient was 17.6 mm Hg (95% CI, 16.2-19.1), and effective orifice area was 1.16 cm2 (95% CI, 1.11-1.21). Paravalvular regurgitation that was more than mild occurred in 1.9% of patients, the researchers wrote.
Left ventricular ejection fraction increased from 50.6% at baseline to 54.2% at 1 year, whereas mass index decreased from 135.7 g/m2 at baseline to 117.6 g/m2 at 1 year. There were also reductions from baseline to 1 year in mitral (34.9% vs. 12.7%; P for trend < .0001) and tricuspid moderate or severe regurgitation (31.8% vs. 21.2%; P for trend < .0001).
Quality of life also improved, with Kansas City Cardiomyopathy Questionnaire scores increasing from 43 at baseline to 76.2 at 1 year (P < .0001), and mean 6-minute walk test distance increasing from 163.7 m at baseline to 248 m at 1 year (P < .0001).
“The use of [valve-in-valve] TAVR for the treatment of high-risk patients with degenerated aortic bioprostheses is associated with relatively low rates of mortality and major complications, improved hemodynamics and excellent improvement in functional and [quality-of-life] outcomes at 1 year,” the researchers wrote. “Longer follow-up is required to determine the clinical importance of residual stenosis, particularly in smaller surgical valves and the durability of transcatheter valves in this context.”
In an accompanying editorial comment, Blase A. Carabello, MD, from the East Carolina Heart Institute at East Carolina University in Greenville, North Carolina, wrote that the study offers information on how to treat patients with degenerated aortic surgical bioprostheses.
“Webb et al have substantiated the feasibility, effectiveness and safety of [valve-in-valve] TAVR for failed aortic bioprostheses in high-risk patients, most of whom had [aortic stenosis] pathophysiology,” Carabello wrote. “It has to be true that it is the obstruction-caused pressure overload of [aortic stenosis] that is the disease’s major pathological instrument. The data herein provide insight into how much pressure overload reduction is necessary to provide adequate clinical improvement.” – by Melissa Foster
Disclosure: Edwards Lifesciences sponsored the PARTNER 2 trial. Please see the full study for a list of the researchers’ relevant financial disclosures. Carabello reports no relevant financial disclosures.
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