Objectives: Recently, rapid deployment valves (RDV) have been introduced to facilitate less invasive treatment of aortic stenosis. However, at present, there is no compelling data available that provide a direct comparison with conventional biological valves (CBVs). The aim of this analysis was to analyze the nationwide German data concerning RDVs for the treatment of patients suffering from aortic valve stenosis and conduct a head-to-head comparison with CBVs.
Methods: A total of 36,639 patients who underwent surgical aortic valve replacement (sAVR) with and without coronary artery bypass surgery (CABG) using CBV or RDV at 78 German centers between 2011 and 2015 were prospectively enrolled into the German Aortic Valve Registry (GARY). Baseline, procedural and acute short-term outcome parameters were analyzed for CBVs and RDVs using 1:1 propensity score matching. Furthermore, three RDVs were compared with each other.
Results: For isolated sAVR 20,937 patients were identified who received a CBV whereas 1,125 patients were treated with an RDV. RDVs were significantly more often implanted through minimally invasive access sites (CBV 22.4 versus RDV 58.3%, p < 0.001). Patients treated with an RDV presented with significantly reduced procedure (160 [135–195] versus 150 [127–179] min, p < 0.001), cardiopulmonary bypass (83 [68–104] versus 70 [56–87] min, p < 0.001) and aortic cross clamp times (60 [48–75] versus 44 [35–57] min, p < 0.001), but showed significantly elevated rates of new pacemaker implantation (3.7 versus 8.8%, p < 0.001) and disabling stroke (0.9 versus 2.2%, p < 0.001) whereas in-hospital mortality was similar (1.7 versus 2.2%, p = 0.22). These findings persisted after 1:1 propensity score matching. Detailed analysis of the three RDVs revealed statistically non-significant different new pacemaker rates and significantly different post-operative transvalvular gradients.
Conclusion: This is the largest all comers data analysis on RDVs showing shorter operating times for RDV implantation. However, the incidence of new onset pacemaker implantation and disabling stroke was higher with RDVs and no beneficial impact on short-term mortality was seen. The three RDVs present with different complications profiles particularly with regard to pacemaker implantation and post-operative transvalvular gradients.
