Objectives: Transcatheter aortic valve replacement (TAVR) by transapical approach is accepted for severe aortic stenosis in patients with high risk for conventional surgical therapy. Herein is reported the initial clinical results of this technique in a reference center
Methods: We conducted a longitudinal prospective single center study including 54 consecutive patients (mean age 79 ± 7.5 years, 59% male) who underwent, between November 2008 and October 2013, TAVR with Edwards Sapien valves throught transapical approach. The etiology was native aortic stenosis in 83% (mean gradient = 49 ± 18.3 mmHg and area = 0,7 cm2), 11% aortic disease and 3 patients had degenerated biological valvular prostheses, being 65% in class III/IV NYHA. The major comorbidities were coronary heart disease in 56% (status post-coronary surgery 37%), diabetes (37%), peripheral artery disease (31%) and chronic renal failure (24%). The logistic EuroSCORE was 19.8 ± 11.2 and EuroSCORE II 5.5 ± 3.5%, with STS mortality score 5.1 ± 3.7 and 23.7 ± 7.6 STS morbidity.
Results: Analysis following the VARC-2 criteria (Valve Academic Research Consortium), showed 30-day mortality of 5.6%; peri-procedural myocardial infarction 7.4%; disabling cerebral vascular accident 1.9%; severe haemorrhage 14.8%; major vascular complications 5.6%; pacemaker implantation 11%. Unplanned extracorporeal circulation was used in 5 cases and prosthetic dysfunction occurred in 4 patients (shift valve in 2 cases). The median hospital stay was 8.0 days, with re-hospitalization in 12.2% of cases. The composite VARC-2 endpoints were: device success = 90.7%; early safety at 30 days = 75.9% and clinical efficacy after 30 days= 83.7%.
Conclusion: The transapical approach was found as an effective therapy for patients at high risk for conventional surgery.