Changes in devices, procedures major driver of improvement in TAVR outcomes
BOSTON — Changes in devices and procedural care were the biggest factor in improvements in short-term outcomes for patients undergoing transcatheter aortic valve replacement, researchers reported at TCT 2022.
Changes in patient comorbidities, due to TAVR becoming more widely available to lower-risk patients over time, were a major factor in improvements in long-term mortality after TAVR, but changes in devices and procedural care were also a factor, according to an analysis of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies registry.
“We believe that our findings emphasize the importance of device iterations and non-device procedural factors to short-term mortality and complications of TAVR, and maybe have important implications for future device innovation, particularly as we move to the treatment of other forms of valvular heart disease,” Suzanne V. Arnold, MD, MHA, professor of medicine at the University of Missouri-Kansas City School of Medicine and clinical scholar at Saint Luke’s Mid-America Heart Institute, said at a press conference.
Arnold and colleagues analyzed 161,196 patients included in the TVT registry who underwent TAVR at 596 U.S. hospitals between 2011 and 2018 to determine the contribution of changes in patient risk and procedure improvements to improved TAVR outcomes over time.
The researchers assessed factors from five mediator clusters: demographics, non-CV comorbidities, CV comorbidities, device factors and non-device-related procedural factors.
The outcomes of interest were 30-day and 1-year mortality and a composite of 30-day adverse events including death, stroke, acute kidney injury, bleeding and paravalvular leak.
From 2011 to 2018, 30-day mortality dropped from 6.7% to 2.4%, 1-year mortality dropped from 19.9% to 10.1% and the 30-day composite outcome dropped from 25.3% to 10.5%, with the latter drop mostly driven by death, bleeding and paravalvular leak, Arnold said at the press conference.
Device factors and non-device procedural factors played the biggest role in the improvement in 30-day mortality and the 30-day composite outcome over time, Arnold said, noting that before they were accounted for, the OR for whether 30-day mortality was more or less likely for later procedures was 0.87 and the OR for the composite outcome was 0.84, and after they were accounted for, the OR for 30-day mortality was 1 and the OR for the composite outcome was 0.96, with the remaining 0.04 being explained by the operator learning curve.
In other words, device factors and non-device procedural factors accounted for 70% of the improvement in 30-day mortality and 67% of the improvement in the 30-day composite outcome, Arnold said.
In contrast, she said, device factors and non-device procedural factors accounted for 45% of the improvement in 1-year mortality, about the same as CV and non-CV comorbidities.
“Although U.S. patients have become younger and healthier over time, it appears that the changes in devices and procedural care are primarily driving the reductions in short-term outcomes,” Arnold said at the press conference. “Whereas changes in patient comorbidities are associated with reductions in long-term mortality. The learning curve, or improvements in operator skill, is associated with reductions in complications. There remained a strong association between changes in device and procedural factors and long-term mortality, and this is likely driven by their association with short-term complications, which then have an impact on long-term mortality.”
Perspective
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I was surprised in a way to see that even the long-term data showed a signal for operator experience and device enhancements being a big determinant of longer-term outcomes. I would have thought long-term outcomes would be driven primarily by the patients’ comorbidities. Once you get over the early risk of the procedure, one would think that in those who have survived 30 days with a working prosthetic valve, the long-term outcomes would be related to how sick they are. It was an interesting analysis. Dr. Arnold and her team are quite good at doing the appropriate risk adjustments to get to the important points.
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Arnold SV, et al. Late-Breaking Clinical Science Session in Structural Heart Disease: Session IV, in Collaboration With the Journal of the American College of Cardiology. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).