Self-expanding TAVR tied to less structural valve deterioration at 5 years vs. surgery
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Transcatheter aortic valve replacement using a self-expanding bioprosthesis was associated with lower risk for structural valve deterioration vs. surgical valve replacement at 5 years, researchers reported.
Factors associated with lower risk for structural valve deterioration included male sex, higher age and having a history of hypertension, PCI and atrial fibrillation, according to data published in JAMA Cardiology.
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“An increase in valve durability may have an important influence on the need for subsequent reintervention in younger patients during their lifetime. Using death as a competing risk, this pooled analysis showed that structural valve deterioration was lower in randomized controlled trial patients undergoing TAVI than surgery,” Daniel P. O'Hair, MD, chair of cardiovascular surgery at Boulder Community Health in Colorado, and colleagues wrote.
To better understand the 5-year incidence, clinical outcomes and predictors of hemodynamic structural valve deterioration in patients who underwent self-expanding TAVR or surgery, O’Hair and colleagues conducted and analysis of 4,762 participants (mean age, 82 years; 55% men) in the CoreValve US High Risk Pivotal trial, CoreValve Extreme Risk Pivotal trial, CoreValve Continued Access study and the SURTAVI trial.
In the CoreValve US High Risk Pivotal trial, researchers determined that TAVR for high- and extreme-risk patients with symptomatic severe aortic stenosis reduced risk for stroke and improved aortic valve function at 1 year compared with surgical valve replacement. The results were published in Seminars in Thoracic and Cardiovascular Surgery.
The SURTAVI trial evaluated the efficacy and safety of TAVR with a self-expanding valve (CoreValve Evolut R, Medtronic) in patients with severe aortic stenosis at intermediate surgical risk compared with surgical valve replacement for the outcomes of all-cause mortality or disabling stroke at 24 months.
As Healio previously reported, TAVR with a self-expanding valve was noninferior to surgery for intermediate-risk patients.
For the present study, the primary endpoint was the incidence of structural valve deterioration through 5 years, which the researchers defined as an increase in mean gradient of 10 mm Hg or more from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of one grade or more.
Researchers reported that the cumulative incidence of structural valve deterioration while treating death as a competing risk was lower in patients who underwent TAVR compared with those who underwent surgery (HR = 0.46; 95% CI, 0.27-0.78; P = .004), an effect that was most pronounced in patients with annuli of 23 mm diameter or smaller (HR = 0.21; 95% CI, 0.06-0.73; P = .02).
Structural valve deterioration was associated with increased 5-year all-cause mortality (HR = 2.03; 95% CI, 1.46-2.82; P < .001), CV mortality (HR = 1.86; 95% CI, 1.2-2.9; P = .006) and valve disease or worsening HF hospitalizations (HR = 2.17; 95% CI, 1.23-3.84; P = .008), according to the study.
Moreover, higher body surface area was associated with increased risk for structural valve deterioration while male sex, higher age and having a history of hypertension, PCI and AF were associated with lower risk.
“Although long-term 10-year follow-up is ongoing, valve durability using clinically relevant structural valve deterioration criteria should be an important consideration for the selection of the first bioprosthetic valve in lower-risk patients with symptomatic severe aortic stenosis,” the researchers wrote.
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