Under Surveillance: Ballooning Numbers, Better Survival, Lower-Risk Patients in Latest TVT Registry Data

Decreases in expected risk of mortality and in actual in-hospital mortality are among the trends being seen among patients who have undergone TAVR in the United States since mandatory data reporting began in 2011.

The predominant theme of the latest annual report from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry is that results overall are better and continuing to improve as a direct result of advances in technology, operator experience, and patient selection as well as decreases in complications, lead author Frederick L. Grover, MD (University of Colorado School of Medicine, Aurora, CO), said in an interview with TCTMD.

Reported online in the Journal of the American College of Cardiology on December 9, 2016, the new data show sharp growth in TAVR procedures, from 4,627 in 2012 to 24,808 in 2015 (P < 0.0001), for a total of 54,782 procedures since the registry began. There has also been an increase in the number of US centers performing TAVR, from 198 when the registry began to 418 as of the end of last year.

“There’s been a gradual reduction in the risk of the patients who are undergoing TAVR as indicated by the STS PROM [score],” Grover added. “So, patients are [at] slightly less risk, but in general the average age is still mid-80s.”

Mortality, Stroke, Regurgitation Decline

The TVT Registry has captured information for all patients who received commercially approved transcatheter valve devices in the United States from 2012 through 2015. Enrollment in the nationally audited registry was mandated as a condition of reimbursement by the Centers for Medicare & Medicaid Services (CMS) following the National Coverage Decision for TAVR. In addition to TAVR, the registry also collects data on transcatheter mitral valve repair and on mitral valve-in-valve and valve-in-ring procedures.

Other TAVR trends and observations in this year’s report include decreases in:

• Predicted risk of 30-day operative mortality
• In-hospital mortality
• Mortality at 30 days
• Mortality at 1 year
• In-hospital stroke
• Stroke at 30 days
• Atrial fibrillation
• Acute kidney injury
• Moderate/severe regurgitation

Pacemaker insertion within 30 days of TAVR, however, increased from 8.8% to 12.0%, a shift the researchers suggest is most likely due to commercial availability of self-expanding TAVR devices. To TCTMD, Grover said this is an active area of research that hopefully will result in declining need for pacemakers going forward.

Trends related to access route also were seen in the registry, with femoral increasing from 75.9% to 86.6% and transapical decreasing from 14.5% to 6.1%. Rates of aortic valve intervention at 30 days stayed the same over time, as did those of 30-day valve-related readmission.

“For the most part, I think we are continuing to see positive things in the area of TAVR,” Grover said. “We don’t know the long-term durability of the valves, . . . but this type of disruptive technology is probably going to change forever how we practice, hopefully in a good way.”

Future Directions

In their report, Grover and colleagues also note that the TVT Registry is expanding in anticipation of capturing the arrival of other valve technologies, including tricuspid valve replacement, and adding metrics to report forthcoming appropriate use criteria for TAVR procedures.

“If FDA can depend on good postmarket surveillance data from users of these devices, [it may] increase the efficiency and the speed with which they can release devices if they appear good,” Grover noted. “[The registry] is an important health policy endeavor, as well as a means of measuring the quality of these devices.”

In an interview with TCTMD, Jack Lewin, MD (Cardiovascular Research Foundation, New York, NY), said the TVT Registry “has given FDA and CMS a lot more comfort and courage to proceed forward with these new catheter procedures.”

Lewin, who was involved in the registry’s creation, added that these sorts of data enable researchers and clinicians to understand more about variations in complications and readmissions nationwide. They also, he said, give cardiovascular teams a “learning platform” through which they can see how they are performing in comparison to others.

“From a device point of view, the annual report is a very powerful tool, because it helps us see which technologies are going to be successful,” Lewin commented. Although there is much more to learn, as TAVR moves toward younger populations “we may see new patterns and best practices emerge that aren’t always supported even with clinical trials,” he predicted. “And that is remarkable.”