Mortality Signal Emerges 2 Years After Valve-in-Valve TAVR for Failed SAVR

For patients with failed bioprosthetic surgical valves, the choice of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) carried upfront advantages, but was ultimately associated with a higher risk of late mortality compared with redo surgery, a retrospective population-based cohort study showed.

Records from three states showed that the all-cause mortality rate at 5 years was 23.4% among patients who underwent ViV TAVR and 13.3% among those who underwent standard redo surgical aortic valve replacement (SAVR) in a propensity-matched analysis, reported Shinobu Itagaki, MD, MSc, of Mount Sinai Hospital and the Icahn School of Medicine at Mount Sinai in New York City, and colleagues.

The landmark analysis showed death curves separating starting at 2 years, after which ViV TAVR was associated with significantly higher mortality (HR 2.97, 95% CI 1.18-7.47), they noted in JAMA Cardiology.

As for heart failure hospitalizations, ViV TAVR was similarly linked to a higher 5-year cumulative incidence of events (24.1% vs 10.1%), a difference that again became significant after 2 years (HR 3.81, 95% CI 1.57-9.22).

“To what extent the observed differences stem from patient imbalances, bias, or procedural limitations warrants further exploration and in younger patients highlights the critical need for a randomized comparative effectiveness trial of ViV-TAVR vs redo SAVR,” the group wrote.

The study was based on state records spanning 2015 to 2020 from California, New York, and New Jersey. The propensity-matched analysis was based on 375 TAVR-SAVR pairs with comparable baseline characteristics.

Results remained consistent after adjusting for institutional variations in use of either procedure, the authors wrote.

In an editor’s note, Vinay Guduguntla, MD, and Robert Bonow, MD, MS, both of Northwestern University Feinberg School of Medicine in Chicago, noted that this report “adds to a growing body of evidence that ViV-TAVR may be associated with excess long-term morbidity and mortality.”

However, “the difference in outcomes may be due to a variety of factors, such as patient-prosthesis mismatch and valve thrombosis, or simply reflect the selection of a less invasive ViV procedure for older patients with greater comorbid conditions that cannot be accounted for in observational data,” they cautioned.

Itagaki and colleagues surmised that the poor results with TAVR in their study may be related to significant prosthesis-patient mismatch and residual left ventricular outflow obstruction being potentially higher after ViV TAVR versus redo SAVR — which could not be confirmed within the limited scope of the study.

However, ViV TAVR did carry the advantages of fewer periprocedural complications (e.g., major bleeding, new pacemaker implantations) and faster recovery. Periprocedural mortality and stroke rates were comparable between the ViV TAVR and redo SAVR groups.

There were no differences in the 5-year incidence of stroke, reoperation, major bleeding, or infective endocarditis, according to Itagaki’s group.

Additionally, the report confirms the growing adoption of ViV TAVR, which increased from 35.3% of cases in 2015 to 62.5% of cases in 2020.

“Although the most recent international guidelines recommend ViV-TAVR for patients with failed bioprosthesis who are symptomatic or at high or prohibitive surgical risk, the rapid increase in the use of ViV-TAVR … suggests that indication creep to other populations without an adequate evidence base may be occurring,” the authors wrote.

ViV TAVR has become an important topic in the field due to TAVR’s expansion to younger, low-risk patients. For these patients, one valve procedure may not be sufficient to last a lifetime.

“Determining the optimal replacement strategy for failed SAVR is imperative, especially as younger patients face a nearly 80% lifetime risk of reintervention,” Guduguntla and Bonow stressed.

The study included 1,771 patients who underwent either ViV TAVR or redo SAVR for a failed bioprosthetic valve, namely structural valve degeneration or failure as the indication for reintervention. Exclusion criteria included TAVR or redo SAVR within 5 years from initial SAVR, infective endocarditis, and concomitant surgical procedures.

Mean age was 74.4, and 37% were women. A median 11 years had passed from primary SAVR to the study procedure.

Before propensity score matching, the patients who underwent ViV TAVR were about a decade older, had higher frailty scores, and were more likely to have a history of other cardiac surgeries and comorbid conditions.

“There were significant baseline differences between the treatment groups, biases related to referral, selection, and treatment, as well as individual patient preferences, that propensity matching may not adequately address,” Itagaki and colleagues acknowledged.

Moreover, they said their databases lacked important variables such as the size and type of bioprosthetic valves implanted and the relevant echocardiographic or hemodynamic data that would identify prosthesis-patient mismatch.

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