Objectives:
Transcatheter aortic valve-in-valve implantation (ViV) is an innovative treatment for failed tissue valves (TV) in patients at high surgical risk. However, direct comparative data with standard repeat surgical aortic valve replacement (RE-SAVR) is scarce. We aimed to compare outcomes after ViV to conventional RE-SAVR in two European centers with established interventional programs.
Methods:
Retrospectively we explored in-hospital databases for patients ≥60 years, treated for degenerated TV. Patients with endocarditis and combined procedures were excluded. Primary endpoints were adjudicated according to VARC-2 criteria.
Results:
Between 2002 and 2015, 130 patients were treated for isolated failure of aortic TV’s (ViV: n=71, RE-SAVR: n=59). In ViV, Edwards Sapien valve (ESV) was most frequently used (n=36) but implanted into larger TV’s (CoreValve TV size: 22.2±1.3mm vs. ESV TV size: 24.1±2.0mm, p<0.01). Both age and logistic EuroSCORE I were higher in ViV compared to RE-SAVR (78.6±7.5 vs. 72.9±6.5 ys, p<0.01; 25.1±18.9 vs. 16.8±9.4%, p<0.01). Thirty-day mortality was not significantly different with 4.2% (3/71) after ViV vs. 5.1% (3/59) post RE-SAVR (p=1.0). Device success was achieved in 54.9% (n=39) in ViV and all RE-SAVR patients (p<0.01). Perioperative stroke was not observed after ViV and in 2 patients after RE-SAVR (3.4%, p=0.2). Intensive-care stay was longer after RE-SAVR (3.4±2.9d vs. 1.9±1.8d, p<0.01). Following ViV, 22.5% (n=16) of patients had mild aortic regurgitation, vs. 11.3% (n=8; p=0.25) after RE-SAVR. Mean transvalvular pressure gradients at discharge were higher post ViV (19.3±7.3 vs.12.2±5.6mmHg, p<0.01). Rate of permanent pacemaker implantation was lower after ViV (9.9% vs. 27.1%, p<0.01). Survival at 90- and 180-days was 93.8% and 91.8% vs. 94.4% and 94.4% after ViV and RE-SAVR respectively (p=0.87).
Conclusion:
Despite a higher risk profile, early mortality was not different between the two treatment arms. Although ViV resulted in elevated postoperative transvalvular pressure gradients and therefore a lower rate of device success, mortality after 180-days was similar to RE-SAVR. At present, both techniques serve as complementary approaches and allow individualized patient care.