For high-risk patients, valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) for the treatment of failed TAVR with balloon-expandable valves resulted in acceptable outcomes at 5 years according to results from the PARTNER 2 study presented Saturday at the TCT Connect virtual conference.
ViV TAVR is the accepted strategy for the treatment of failed surgical aortic valve replacement (SAVR). Early data on ViV TAVR for the treatment of failed TAVR suggest that it is also safe and effective. Longer-term data on clinical outcomes and valve durability are lacking.
Rebecca Hahn, MD, of New York Presbyterian/Columbia University Medical Center, New York, presented the 5-year outcomes of ViV TAVR from the PARTNER 2 trial at TCT Connect.
This subgroup analysis included 365 patients who underwent ViV TAVR for the treatment of a failed TAVR valve. The investigators examined all-cause mortality, death or stroke, quality of life, functional status, hemodynamic valve deterioration (HVD) and bioprosthetic valve failure (BVF) at 5 years. The investigators used the Valve Academic Research Consortium (VARC)-3 definitions.
Among the 365 patients included in this analysis, the mean age was 78.9±10.2 years with a mean Society of Thoracic Surgeons score of 9.1±4.7. At 5 years, the rate of all-cause mortality was 50.6%, and the stroke rate was 10.5%. This was comparable to intermediate-risk patients undergoing native-valve TAVR (mortality 46.0% and stroke 15.3%).
HVD or BVF occurred in 6.6% of patients at 5 years. SAVR was required in 6.3% of patients (n=16). Hemodynamics at 1 year were maintained at 5-year follow-up (mean gradient 17.8 mmHg at 1 year vs. 16.8 mmHg at 5 years; Doppler velocity index 0.37 vs. 0.37). The rate of moderate or severe paravalvular leak also remained stable from 30 days to 5-year follow-up (2.2% vs. 3.2%). New York Heart Association functional class (NYHA FC) improved in 88.7% of patients at 1 year and 87.7% of patients at 5 years. Kansas City Cardiomyopathy Questionnaire (KCCQ) score also remained stable from 1 year to 5 years (76.7 vs. 74.2).
In patients undergoing ViV TAVR for the treatment of degenerated TAVR, HVD occurred in 5.9% of patients and BVF in 4.7% of patients at 5 years. This translates to 1.2 per 100 patient-years for HVD and 0.88 per 100 patient-years for BVF.
Hahn concluded that ViV TAVR for failed TAVR demonstrated acceptable 5-year outcomes compared to intermediate-risk native-valve TAVR patients, with early functional status and quality-of-life improvements maintained at 5-years.
The PARTNER 2 Trial was funded by Edwards Lifesciences (Irving, California).