The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (
NCT01991431).
Background
TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.
Methods
ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.
Results
A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation.
Conclusions
TAo access for TAVR seems to be a safe alternative to the transapical procedure.
