Transcatheter aortic valve replacement (TAVR) continues to evolve, and remains “safe and effective,” according to an annual STS/ACC TVT Registry report published Nov. 30 in the Journal of the American College of Cardiology (JACC).

The report provides an overview of current U.S. TAVR practice and trends, and includes the 26,414 TAVR procedures performed from Jan. 1, 2012 through Dec. 31, 2014 at 348 centers enrolled in the STS/ACC TVT Registry. Patients were elderly, with a mean age of 82 years, had multiple comorbidities, were highly symptomatic, were often frail, and had poor self-reported health status.

Comparing temporal trends from 2012-2013 vs. 2014, results show that there was an increased use of moderate sedation and an increase in femoral access using percutaneous techniques. In addition, vascular complication rates decreased from 5.6 percent to 4.2 percent. The authors explain that “mortality, myocardial infarction, kidney injury, and neurological complications are low, and patients appear to be clinically stable despite statistically significant changes.”

“The most important takeaway is the fact that the TAVR procedure continues to change since its initial approval by the U.S. Food and Drug Administration in 2011,” says David R. Holmes Jr., MD, MACC, chair of the STS/ACC TVT Registry Steering Committee. “Patients undergoing TAVR remain primarily elderly and high-risk for surgical replacement, but the predicted risk of mortality has declined over the course of time. This is the result of changes in regulatory instructions for use and approval of alternative access points.”

The authors conclude that the registry “is central to a novel approach for post-market surveillance and is the foundation for continuing efforts to provide timely and actionable learning on the basis of scientific evidence throughout the full product life cycle of new emerging technology.”

In an accompanying editorial, Michael J. Reardon, MD, FACC, and Neal S. Kleiman, MD, FACC, explain that “these observations suggest that patient selection for TAVR in the U.S. has remained reasonable, with excellent efficiency and continued safety.” They add that moving forward, “as TAVR enters the mainstream of clinical practice, the registry must embrace new challenges, but will also be able to provide new opportunities.”

Also commenting on the report, Valentin Fuster, MD, PhD, MACC, editor in chief of JACC, notes, “In addition to presenting a new clinical option for patients with severe aortic stenosis, TAVR represents a breakthrough in clinical care delivery through the partnership of two prominent specialties coming together – surgeons and interventional cardiologists. This is a clear example of how medicine can improve through a team effort.” 

Keywords: Aged, Aortic Valve Stenosis, Comorbidity, Conscious Sedation, Health Status, Myocardial Infarction, Patient Selection, Registries, Surgeons, Transcatheter Aortic Valve Replacement, United States Food and Drug Administration, STS/ACC TVT Registry, National Cardiovascular Data Registries

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