Transaortic Access May Be a Safe Alternative to Transapical Access for TAVR

September 13, 2016—In the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Vinayak Bapat, MD, et al published findings on using transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) in the ROUTE registry (2016;9:1815–1822). 

According to the investigators, ROUTE (Registry of the Utilization of the TAo-TAVR Approach Using the Edwards Sapien Valve) was established to assess the safety and effectiveness of the use of TAo access for TAVR procedures.

The background of the study is that TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is commonly used as the first-line approach, TAo access is an option for patients who are 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 have been published.

As summarized in JACC: Cardiovascular Interventions, ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients who had severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using a Sapien XT or Sapien 3 valve (Edwards Lifesciences). The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in-hospital and 30-day complication rates.

The study included a total of 301 patients with a mean age of 81.7 ± 5.9 years and a Society of Thoracic Surgeons score of 9% ± 7.6%. 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 including myocardial infarction (1%), stroke (1%), 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.

TAo access for TAVR seems to be a safe alternative to the transapical procedure, concluded the investigators in JACC: Cardiovascular Interventions.