TAVI Associated with Lower Risk of Structural Valve Deterioration than Surgery

Use of self-expanding transcatheter aortic valve implantation (TAVI) was associated with a lower rate of structural valve deterioration than surgical aortic valve implantation in patients at intermediate or high risk, according to a recent analysis.

Leveraging data from the CoreValve US High Risk Pivotal and SURTAVI clinical trials, results of the pooled post hoc analysis demonstrate use of self-expanding TAVI was associated with a relative reduction in risk of structural valve deterioration compared with surgery, with this reduction in risk most pronounced in those with smaller annuli.

“We found that the cumulative incidence of SVD was significantly lower among randomized patients treated with a self-expanding supra-annular transcatheter valve than surgery,” wrote investigators. “Doppler-derived [structural valve deterioration] was associated with a 2-fold increased risk of late mortality and hospitalizations for valve disease or worsening heart failure.”

As popularity of transcatheter valve implantation and replacement continues to increase, a greater understanding of incidence, outcomes, and predictors of hemodynamic structural valve deterioration in those undergoing TAVI or surgery stands have a major impact on patient care. Investigators sought to examine these trends from large-scale randomized clinical trials using data from the aforementioned CoreValve US High Risk Pivotal and SURTAVI clinical trials, with supplementation by the CoreValve Extreme Risk Pivotal trial and CoreValve Continued Access Study.

From the randomized lineal trials, investigators obtained data related to 2099 individuals. Of these, 1128 received TAVI and 971 received surgery. When pooled with the non-randomized clinical trial populations, the cohort included 4762 patients, with 3791 receiving TAVI. The 4762-patient cohort had a mean age of 82.1 (SD, 7.4) years.

The primary end point of interest for the investigators’ analyses was the incidence of structural valve deterioration through 5 years from the randomized clinical trials. Investigators pointed out factors associated with structural valve deterioration and its association with clinical outcomes were estimated for the pooled randomized clinical trials and the non-randomized clinical trial population. For the purpose of analysis, structural valve deterioration was defined as an increase in mean gradient of 10 mmHg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mmHg or greater or new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more.

Upon analysis, results indicated the cumulative incidence of SVD treating death as a competing risk was more than halved among those with TAVI (2.20%) compared with those who underwent surgery (HR, 0.46 [95% CI, 0.27-0.78]; P=.004). Investigators pointed out their analysis revealed this decrease in risk was most apparent among those with an annulus of 23 mm in diameter or smaller, with structural valve deterioration occurring among 1.32% with TAVI and 5.84% who underwent surgery (HR, 0.21 [95% CI, 0.06-0.73]; P=.02).

Analysis of clinical outcomes indicated structural valve deterioration was associated with increased 5-year all-cause mortality (HR, 2.03 [95% CI, 1.46-2.82]; P <.001), cardiovascular mortality (HR, 1.86 [95% CI, 1.20-2.90]; P=.006), and valve disease or worsening heart failure hospitalizations (HR, 2.17 [95% CI, 1.23-3.84]; P=.008). Analysis of predictors suggested there was a higher risk of developing structural valve deterioration in patients with a higher body surface area (HR, 1.28 [95% CI, 1.05-1.55]) and there was a lower risk of structural valve deterioration in men (HR, 0.62 [95% CI, 0.39-0.99]), older patients (HR, 0.97 [95% CI, 0.95-1.00]), and those with history of hypertension (HR, 0.55 [95% CI, 0.30-0.99]), percutaneous coronary intervention (HR, 0.62 [95% CI, 0.38-1.00]), and atrial fibrillation (HR, 0,57 [95% CI, 0.35-0.91]).

“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],” investigators concluded.

This study, “Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk,” was published in JAMA Cardiology.