Published online ahead of print last month in the Journal of the American College of Cardiology, the study results hold promise for patients with severe aortic stenosis who are not candidates for a transfemoral procedure.
A team of highly skilled interventional cardiologists and cardiothoracic surgeons, including Mauricio G. Cohen, M.D., associate professor of medicine, and Donald B. Williams, M.D., professor of clinical surgery, evaluated 44 patients with severe aortic stenosis who underwent transaortic TAVR at University of Miami Hospital between January 2012 and June 2012. The patients were compared with 76 others who received transapical TAVR, which involves inserting a catheter between the ribs and through the tip of the left ventricle, between May 2009 and June 2012.
In the study, “The Transaortic Approach for Transcatheter Aortic Valve Replacement: Initial Clinical Experience in the United States,” the researchers noted that 28 percent of transapical patients experienced significant blood loss during access site closure, while perioperative blood transfusion in transaortic patients was reduced by 61 percent.
In addition, the median ICU stay for transaortic patients was half that of transapical patients. Transaortic patients also had a shorter overall hospital stay.
“Prolonged recovery time is a significant limitation in transapical TAVR, and this is the first study that shows you can reduce length of hospital stay by using transaortic access, which is even more important in patients with compromised lungs” said Cohen, who is also Director of the Elaine and Sydney Sussman Cardiac Catheterization Laboratory at University of Miami Hospital. “You also have more control in the transaortic approach, because the aorta is much more stable than a beating heart.”
To investigate the learning curve for both procedures, the study authors compared the first 20 cases with subsequent cases in the transaortic and transapical groups. The rate of procedural adverse events did not change between the first 20 and subsequent cases in the transapical group. However, such complications occurred less often after the first 20 cases in the transaortic group, “suggesting a more favorable technical learning curve,” the authors wrote.
“This is a significant finding that was not observed before,” said Williams, the study’s senior author.
Other outcomes, such as technical device success, 30-day mortality, and 30-day Valve Academic Research Consortium safety and efficacy outcomes did not change between the early and later experience in either group.
“TAVR via the transaortic approach, using the commercially available device in the United States, is technically feasible and appears to be associated with favorable outcomes in inoperable patients with severe aortic stenosis who are not candidates for transfemoral access,” the authors concluded. “The transaortic approach expands the current alternative options for TAVR access sites, and development of a dedicated delivery platform is recommended to further improve its efficacy and safety.”
The authors noted that the study, the largest cohort of patients to undergo transaortic TAVR in the United States, was performed without the newer-generation Sapien XT valve and delivery system (Ascendra-2, Edwards), which are commercially available in Europe but not the United States.
Other authors of the study are Joel A. Lardizabal, M.D., former interventional cardiology fellow; cardiology fellows Brian P. O’Neill, M.D., and Harit V. Desai, M.D.; medical residents Conrad J. Macon, M.D., and Alex Rodriguez, M.D.; Claudia A. Martinez, M.D., assistant professor of clinical medicine; Carlos E. Alfonso, M.D., assistant professor of clinical medicine; Martin S. Bilsker, M.D., associate professor of medicine; Roger G. Carrillo, M.D., associate professor of clinical surgery; Alan W. Heldman, M.D., professor of medicine; and William W. O’Neill, M.D., former professor of medicine, who is now Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital.
University of Miami,