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A large-scale analysis of data from a pair of RCTs and a nonrandomized registry provide insight into the risk of valve deterioration seen with TAVR vs SAVR and to what extent this might influence risk of mortality.
Further supporting use of transcatheter aortic valve replacement (TAVR) against surgical aortic valve implantation (SAVR) was presented at the American College of Cardiology’s 71st Annual Scientific Session.
An analysis of data from the CoreValve US High Risk and SURTAVI trials, data from the study suggests the risk of structural valve deterioration (SVD) was lower with TAVR than with SAVR and investigators highlighted the impact of deterioration on prognosis, with results indicating SVD was associated with a nearly 2-fold increase in risk of death or rehospitalization in the first 5 years following either procedure.
“Heart surgeons tend to worry that in younger, lower-risk patients, replacement valves inserted using TAVR may fail more quickly than surgically inserted valves,” said Michael Reardon, MD, professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center, in a statement from the ACC. “The results of this study suggest exactly the opposite—that at five years, the TAVR-inserted valve has less structural deterioration than the surgically inserted one.”
With funding from Medtronic, the current study was designed with the intent of exploring differences in rate of SVD and impact on overall prognosis among patients undergoing TAVR or SAVR. Combining data from the CoreValve US Pivotal and SURTAVI trials, investigators obtained information related to 1128 patients who underwent TAVR and 971 patients who underwent SAVR for inclusion in their analyses. Investigators pointed out SVD was assessed in both of these trials using Doppler echocardiography. Additionally, investigators hoped to assess risk factors for predicting deterioration using these patients and more than 2000 other TAVR patients from a nonrandomized database.
For the purpose of analysis, SVD was defined as an increase in mean gradient of 10 mmHg or more from discharge or 30-day mark to last echo and gradient of 20 mmHg or greater at last echo or new-onset/increase of central aortic regurgitation considered moderate or greater in severity. Assessments of 5-year cumulative risk incidence of SVD were calculated using Fine-Gray regression interval censoring and univariate Cox proportional hazards assessed the association of SVD as a time-dependent covariate with clinical outcomes, including all-cause mortality, cardiovascular mortality, and hospitalization for aortic valve disease or worsening heart failure.
Upon analysis, SVD was identified among 20 TAVR patients and 34 SAVR patients. When assessing rate of SVD, results indicated those in the TAVR cohort had a significantly lower rate of SVD compared to the SAVR cohort (2.3% vs 4.4%; P=.009), with a similar trend found in patients with small (1.39% vs 5.86%; P=.049) and large aortic annular diameters (2.48% vs 3.96%; P=.067).
Further analysis demonstrated SVD was associated with a significant increase in risk for the composite outcome measure (HR, 1.96 [95% CI, 1.38-2.80]; P <.001) as well as reductions in risk for individual components, including all-cause mortality (HR, 1.98 [95% CI, 1.42-2.76]; P <.001), cardiovascular mortality (HR, 1.82 [95% CI, 1.17-2.84]; P=.008), and hospitalization for aortic valve disease or worsening heart failure (HR, 2.11 [95% CI, 1.19-3.74]; P=.01) among the entire study cohort, which included the pooled trial cohort and the nonrandomized registry. Compared to their counterparts without SVD, patients with SVD were younger (79.3±8.7 vs 82.1±7.4), more likely to have undergone prior PCI (22.7% vs 33.5%), and more likely to have a history of atrial fibrillation or atrial flutter (24.7% vs 37.8%).
“As TAVR is being used among a wider patient population, valve durability is becoming more important to clinicians when selecting a treatment option. Patients need a valve that can accommodate their activity levels while remaining hemodynamically stable for years to come,” Reardon added, in a statement from Medtronic. “These outcomes confirm what clinicians have long believed about Evolut and CoreValve and allow for greater confidence in the strength of the platform regardless of patient’s overall surgical risk.”
This study, “5-Year Incidence, Outcomes and Predictors of Structural Valve Deterioration of Transcatheter and Surgical Aortic Bioprostheses: Insights from the CoreValve US Pivotal and SURTAVI Trials,” was presented at ACC.22.