Author + information
- S1936879815022141-12d246720650ed034e3cd3636e56c3c4Giuseppe Rescigno,
- S1936879815022141-de2921a25425d00c6aa8f577625a368aBenedetto Del Forno,
- S1936879815022141-006fff4179c4d15316eab7ff8c8f1dedGiulia Gironi,
- S1936879815022141-db878d31448dcd6fbb48375d1d10b534Alessandro D'Alfonso,
- S1936879815022141-3d0b3a71d7e10eaeadc756593f47128aMichele Danilo Pierri and
- S1936879815022141-f1a1919ba4a71c5821bb031863f9ad65Mauro Borioni
Transapical transcatheter aortic valve implantation (TA-TAVI) represents a viable treatment in high-risk patients affected by severe aortic valve stenosis with poor vascular accesses. The Symetis Acurate TA is a new device that has shown good results and a relatively friendly implantation technique. The aim of this study was to evaluate the safety of the Symetis Acurate TA implantation during the learning curve and the immediate and follow-up results in a surgical department without previous TAVI experience.
From June 2013 to April 2015, 16 patients (8 females, mean age 80 ± 2.8 years) underwent a Symetis Acurate TA transapical aortic valve implantation. The mean Logistic Euroscore was 21.3 ± 11.2%; 15 patients (93%) were in NYHA functional class III/IV. Seven patients (43.7%) were redo surgeries. All patients were affected by severe multivessel disease preventing a vascular approach. A proctor supervised the first 10 cases.
Valve deployment was successful in all patients. The combined 30-day safety endpoints were evaluated according to VARC-II criteria. The mortality rate was 12.5% (2 patients). One haemorrhagic stroke was recorded (6.25%). No stage-3 acute kidney injury, acute myocardial infarction, access complication, needing for pacemaker implantation or need for repeated procedure were observed. In one case (6.25%) a re-exploration for bleeding was necessary. In two cases (12.5%) a moderate paravalvular leak was shown at hospital discharge. Mean follow-up was 13 months; a patient died for non-valve related causes; all survivors were in NYHA class I/II; one rehospitalization for cardiac cause (acute coronary syndrome for a new coronary artery stenosis that needed PCI) was registered.
Despite no previous experience with other devices and percutaneous approaches, the Symetis Acurate TA™ allowed a safe learning curve and good immediate and follow-up results. Nevertheless, a longer than usual proctoring phase seems mandatory when a surgical group should start a new program.