Early hemodynamics and clinical outcomes of isolated aortic valve replacement with stentless or transcatheter valve in intermediate-risk patients.

OBJECTIVE: Stentless aortic valves have been developed to overcome obstructive limitations associated with stented bioprostheses. The aim of the current multi-institutional study was to compare hemodynamics of transcatheter (TAVR) and the Freedom SOLO Stentless (FS) valve in an intermediate risk population undergoing surgical aortic valve replacement.

METHODS: From 2010 to 2014, 420 consecutive patients underwent isolated surgical aortic valve replacement with FS and 375 patients underwent TAVR. Only patients with intermediate operative risk (Society of Thoracic Surgeons score 4-10) and small aortic annulus (≤23 mm) were included. After a propensity matched analysis 142 patients in each group were selected. Thirty-day postoperative clinical and echocardiographic parameters were evaluated.

RESULTS: Mean prosthesis diameter was 22.2 ± 0.9 mm for FS and 22.4 ± 1.0 mm for TAVR. In-hospital mortality was 2.1% for FS and 6.3% for TAVR (P = .02). Postoperative FS peak gradients were 19.1 ± 9.6 mm Hg (mean 10.8 ± 5.9 mm Hg); TAVR peak gradients were 20.2 ± 9.5 mm Hg (mean 10.7 ± 6.9 mm Hg) P = .57 (P = .88). Postoperative effective orifice area was 1.93 ± 0.52 cm(2) for FS and 1.83 ± 0.3 cm(2) for TAVR (P = .65). There was no prostheses-patient mismatch in either group. Postoperative grade 2-3 paravalvular leak was present in 3.5% for TAVR and 0.7% for FS. Postoperative permanent pacemaker implant rate was 12% for TAVR and only 1 case (0.7%) in the FS group (P < .001).

CONCLUSIONS: In patients with small aortic annulus and intermediate risk, both FS and TAVR demonstrated similar excellent hemodynamic performance. TAVR demonstrated greater mortality and rates of pacemaker insertion. Further studies are warranted to validate TAVR indications in this subset of patients.