New data from the Transcatheter Valve Therapy (TVT) Registry suggest that vascular complications are decreasing with transcatheter aortic valve replacement (TAVR), whereas site-reported stroke rates are remaining stable with the therapy.
The TVT Registry is a joint initiative of the Society of Thoracic Surgeons (STS) and American College of Cardiology, along with multiple stakeholders, designed to capture data on patient characteristics, procedural variables and outcomes with TAVR.
In the present study, researchers aimed to provide an overview of current TAVR practices and trends in the United States, with an emphasis on demographics, in-hospital procedural characteristics and outcomes.
In all, the study included 26 414 TAVR procedures performed at 348 US centers as of December 31, 2014. Researchers compared temporal trends in 2014 with those in 2012 and 2013.
Results comparing the 2 time periods indicated that patients who receive TAVR remain elderly (mean age, 82 years) and have multiple comorbidities, as evidenced by a high mean STS predicted risk of mortality of 8.34% for surgical valve replacement. Patients were also highly symptomatic—with 82.5% having a New York Heart Association functional class score of III or IV—and had poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score, 39.1).
In addition, researchers found changes in procedure performance during the 2 time periods, as there was an increase in use of moderate sedation (5.1% vs 1.6%) and femoral access using percutaneous techniques (66.8% in 2014). Rates of vascular complications were reduced in 2014 (4.2% vs 5.6%), and site-reported stroke rates remained stable at 2.2%.
Long-term surveillance registries that include consecutive patients undergoing TAVR, such as the TVT Registry, can “inform the design of prospective trials to help ensure that innovations in technology and procedural management yield improved clinical outcomes,” the researchers wrote.
In an accompanying editorial, Michael J. Reardon, MD, and Neal S. Kleiman, MD, both of the Houston Methodist DeBakey Heart & Vascular Center, wrote that these data provide insight into how TAVR is evolving.
“Patient characteristics seem to suggest a rightward shift in the selection of patients for TAVR, such that fewer extremely high-risk and more intermediate- to high-risk patients are undergoing the procedure,” they wrote.
The authors added that the TVT Registry played an important role in the acceptance and Centers for Medicare & Medicaid Services approval of direct aortic access for TAVR.
“In Sweden, the TASTE (Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia) investigators demonstrated that simple clinical questions concerning currently available therapy, such as intracoronary thrombectomy during primary percutaneous coronary intervention, can be answered using a randomized trial with data collection performed using an existing registry (SCAAR),” Drs Reardon and Kleiman wrote. “Important questions remain to be resolved, particularly in regard to antithrombotic therapies, in patients who have undergone TAVR. Use of the registry is likely to become a useful mechanism to resolve these questions in a broad national population.”
- Holmes DR, Nishimura RA, Grover FL, et al. Annual outcomes with transcatheter valve therapy from the STS/ACC TVT Registry. J Am Coll Cardiol. 2015; doi:10.1016/j.jacc.2015.10.021.
- Reardon MJ, Kleiman NS. Watching a procedure evolve: Sequential findings from the TVT Registry. J Am Coll Cardiol. 2015; doi: 10.1016/j.jacc.2015.11.008.